1 00:00:04,040 --> 00:00:04,766 Good morning everyone. 2 00:00:04,766 --> 00:00:06,460 My name is Elaine Woo and I'm 3 00:00:06,507 --> 00:00:08,043 one of the principal councils or 4 00:00:08,043 --> 00:00:09,711 directors of the China team of IP 5 00:00:09,711 --> 00:00:11,232 experts here at the USPTO's Office 6 00:00:11,232 --> 00:00:12,676 of Policy International Affairs. 7 00:00:12,680 --> 00:00:14,912 I would like to welcome everyone to this 8 00:00:14,912 --> 00:00:17,153 webinar on biopharma patents in China 9 00:00:17,153 --> 00:00:19,188 litigation licensing and patent linkage. 10 00:00:19,190 --> 00:00:20,438 According to industry sources, 11 00:00:20,438 --> 00:00:22,310 China is the world's second largest 12 00:00:22,358 --> 00:00:23,237 biopharmaceutical market and 13 00:00:23,237 --> 00:00:25,288 continues to grow at a fast pace, 14 00:00:25,290 --> 00:00:27,240 particularly as the country's growing 15 00:00:27,240 --> 00:00:29,190 wealth and rapidly aging population 16 00:00:29,248 --> 00:00:30,933 creates strong demand for health 17 00:00:30,933 --> 00:00:32,618 care products in an increasing 18 00:00:32,671 --> 00:00:34,646 number of diseases including cancers, 19 00:00:34,650 --> 00:00:36,186 cardiovascular diseases and diabetes. 20 00:00:36,186 --> 00:00:38,490 The increase of China's by Chinese 21 00:00:38,543 --> 00:00:40,433 biopharma companies of reflects the 22 00:00:40,433 --> 00:00:41,945 industry's growth and potential 23 00:00:41,945 --> 00:00:43,795 and why company formation decline 24 00:00:43,795 --> 00:00:45,207 in other major markets. 25 00:00:45,210 --> 00:00:47,412 More than 140 new biotech companies 26 00:00:47,412 --> 00:00:49,270 emerged in China from 2010. 27 00:00:49,270 --> 00:00:52,390 To 2020, in recognizing this potential, 28 00:00:52,390 --> 00:00:54,074 China's policymakers have embarked 29 00:00:54,074 --> 00:00:57,162 on a mission to advance the industry 30 00:00:57,162 --> 00:00:59,122 by enacting policies explicitly 31 00:00:59,122 --> 00:01:01,082 to improve the industry. 32 00:01:01,090 --> 00:01:01,614 This morning, 33 00:01:01,614 --> 00:01:03,448 we'll be talking about the new IP 34 00:01:03,448 --> 00:01:04,928 laws and regulations that China 35 00:01:04,928 --> 00:01:06,680 has recently enacted as part of 36 00:01:06,732 --> 00:01:07,740 this overall effort, 37 00:01:07,740 --> 00:01:09,686 and also as part of its obligations 38 00:01:09,686 --> 00:01:11,593 to implement the US China Economic 39 00:01:11,593 --> 00:01:12,610 and Trade Agreement, 40 00:01:12,610 --> 00:01:15,298 or the Phase one agreement that both 41 00:01:15,298 --> 00:01:17,430 countries entered into two years ago. 42 00:01:17,430 --> 00:01:18,912 Let me go ahead and introduce 43 00:01:18,912 --> 00:01:20,360 the speakers to the program. 44 00:01:20,360 --> 00:01:22,028 Our first speaker today is Larry 45 00:01:22,028 --> 00:01:23,914 Lee and Pat Attorney with many 46 00:01:23,914 --> 00:01:25,350 years experience and expertise, 47 00:01:25,350 --> 00:01:26,505 the biopharma industry. 48 00:01:26,505 --> 00:01:29,176 He is part of the USPTO's China 49 00:01:29,176 --> 00:01:30,668 team of IP experts. 50 00:01:30,670 --> 00:01:32,326 The Chinese team of China team 51 00:01:32,326 --> 00:01:33,430 of IP experts here. 52 00:01:33,430 --> 00:01:35,854 The PTO consists of a dedicated group of 53 00:01:35,854 --> 00:01:38,522 China IP experts with 11 US based lawyers, 54 00:01:38,522 --> 00:01:40,087 three IP attached shades that 55 00:01:40,087 --> 00:01:41,570 are offices in Beijing, 56 00:01:41,570 --> 00:01:43,600 Guangzhou and Shanghai and five 57 00:01:43,600 --> 00:01:46,057 China base US Lloyd Excuse ME 58 00:01:46,057 --> 00:01:47,457 5 China based lawyers. 59 00:01:47,460 --> 00:01:50,028 All of our lawyers have a very good deal of 60 00:01:50,028 --> 00:01:52,454 expertise in China IP law as well as U.S. 61 00:01:52,460 --> 00:01:52,743 law. 62 00:01:52,743 --> 00:01:54,441 One of our important missions is 63 00:01:54,441 --> 00:01:56,087 to help improve the IP environment 64 00:01:56,087 --> 00:01:58,158 in China and also in the US for 65 00:01:58,158 --> 00:01:59,628 the benefit of our companies, 66 00:01:59,630 --> 00:02:01,310 whether they are looking to export 67 00:02:01,310 --> 00:02:03,747 to China or to partner in some way 68 00:02:03,747 --> 00:02:05,317 with Chinese firms are dealing 69 00:02:05,317 --> 00:02:06,819 with Chinese made counterfeits 70 00:02:06,819 --> 00:02:09,069 entering the US or other markets. 71 00:02:09,070 --> 00:02:10,948 Our next speaker is Jonathan Miao. 72 00:02:10,950 --> 00:02:13,743 He is with NTD IP attorneys and 73 00:02:13,743 --> 00:02:16,330 partners in in Beijing office. 74 00:02:16,330 --> 00:02:19,172 Jonathan joined NTD in 2003 and has 75 00:02:19,172 --> 00:02:21,582 extensive expertise and experience in 76 00:02:21,582 --> 00:02:23,830 patent related contentious matters. 77 00:02:23,830 --> 00:02:26,166 He is now leading a team of specialized 78 00:02:26,166 --> 00:02:28,160 in providing legal services in the 79 00:02:28,160 --> 00:02:29,845 fields of chemistry and biotech. 80 00:02:29,850 --> 00:02:32,370 Jill Ge is with the Shanghai office at 81 00:02:32,370 --> 00:02:35,156 Allen and Overy in his her next speaker. 82 00:02:35,160 --> 00:02:37,694 She is this is a UK based 83 00:02:37,694 --> 00:02:38,780 multinational law firm. 84 00:02:38,780 --> 00:02:40,925 She has extensive experience in 85 00:02:40,925 --> 00:02:43,070 patents and trade secret matters 86 00:02:43,147 --> 00:02:44,731 and routinely advises clients 87 00:02:44,731 --> 00:02:47,107 in the area of life sciences. 88 00:02:47,110 --> 00:02:49,798 Lin Sun-Hoffman is a founding partner 89 00:02:49,798 --> 00:02:52,689 in Leo Jung Chen and Hoffman. 90 00:02:52,690 --> 00:02:54,736 Doctor Lynn Hoffman is a PAT 91 00:02:54,736 --> 00:02:56,690 attorney with 20 years experience 92 00:02:56,690 --> 00:02:59,305 focused on innovative life sciences. 93 00:02:59,310 --> 00:03:01,278 She has deep knowledge of all 94 00:03:01,278 --> 00:03:02,590 aspects of patent practice, 95 00:03:02,590 --> 00:03:04,552 ranging from policy, 96 00:03:04,552 --> 00:03:06,650 patent prosecution, due diligence, 97 00:03:06,650 --> 00:03:09,328 opinion work and of course, licensing 98 00:03:09,328 --> 00:03:12,120 and technology transfer negotiations. 99 00:03:12,120 --> 00:03:14,108 Each speaker will speak about 10 minutes, 100 00:03:14,110 --> 00:03:15,875 after which we will have 101 00:03:15,875 --> 00:03:16,934 moderated panel discussion. 102 00:03:16,940 --> 00:03:19,999 We will have Q&A period after discussion. 103 00:03:20,000 --> 00:03:22,898 Please ask questions using the email box. 104 00:03:22,900 --> 00:03:27,100 Ask China IP at USPTO Gov again, 105 00:03:27,100 --> 00:03:30,336 ask China IP at uspto.gov. 106 00:03:30,336 --> 00:03:31,224 Before we start, 107 00:03:31,224 --> 00:03:34,316 I also wanted to give you an idea of the 108 00:03:34,316 --> 00:03:36,194 audience that registered for the program. 109 00:03:36,200 --> 00:03:38,048 We asked on a volunteer basis for 110 00:03:38,048 --> 00:03:40,257 you to take a short survey with us. 111 00:03:40,260 --> 00:03:42,084 I want to quickly go through some of 112 00:03:42,084 --> 00:03:44,017 the results of the survey to give you a 113 00:03:44,017 --> 00:03:45,819 flavor of those who are attending today. 114 00:03:45,820 --> 00:03:47,656 While a small number of you took the survey, 115 00:03:47,660 --> 00:03:50,756 this does offer a snapshot of the audience. 116 00:03:50,760 --> 00:03:52,880 We first asked the size of the company 117 00:03:52,880 --> 00:03:54,499 with which you are affiliated. 118 00:03:54,500 --> 00:03:57,090 61% responded that the size of the 119 00:03:57,090 --> 00:03:59,008 thousand employees are over 22% of 120 00:03:59,008 --> 00:04:00,442 those who answered said they were 121 00:04:00,442 --> 00:04:01,668 from companies between one and. 122 00:04:01,670 --> 00:04:05,200 50 with the remainder from. 123 00:04:05,200 --> 00:04:06,616 Companies a little larger than that, 124 00:04:06,620 --> 00:04:08,264 but under 1000 employees. 125 00:04:08,264 --> 00:04:10,730 The second question asks what your 126 00:04:10,805 --> 00:04:13,549 primary lines of business in China were. 127 00:04:13,550 --> 00:04:16,082 55% of those respondents said that 128 00:04:16,082 --> 00:04:18,126 they manufactured outside China for 129 00:04:18,126 --> 00:04:20,782 import and sale in China and 33% or 130 00:04:20,782 --> 00:04:23,939 manufacturing in China for sale in China, 131 00:04:23,940 --> 00:04:26,855 16% or manufacturing inside China 132 00:04:26,855 --> 00:04:29,187 for export outside China. 133 00:04:29,190 --> 00:04:31,272 The third question asked with the 134 00:04:31,272 --> 00:04:33,911 primary IP concerns are that your company 135 00:04:33,911 --> 00:04:36,287 faces the biggest challenges faced by 136 00:04:36,287 --> 00:04:38,507 companies or patent related challenges, 137 00:04:38,510 --> 00:04:40,058 followed by concerns 138 00:04:40,058 --> 00:04:41,606 regarding IP enforcement. 139 00:04:41,610 --> 00:04:43,746 Other prevalent problems include 140 00:04:43,746 --> 00:04:46,416 Chinese government pressures to transfer 141 00:04:46,416 --> 00:04:48,290 technology to Chinese entities, 142 00:04:48,290 --> 00:04:49,778 Chinese government interferences 143 00:04:49,778 --> 00:04:51,266 with IP licensing, 144 00:04:51,270 --> 00:04:53,150 and concerns about protecting 145 00:04:53,150 --> 00:04:55,030 and enforcing trade secrets. 146 00:04:55,030 --> 00:04:56,577 We've asked companies to tell us whether, 147 00:04:56,580 --> 00:04:58,064 over the course of last five years, 148 00:04:58,070 --> 00:04:59,630 there was any change. 149 00:04:59,630 --> 00:05:01,580 The IP situation in China. 150 00:05:01,580 --> 00:05:03,602 53% of those respondents said there 151 00:05:03,602 --> 00:05:05,600 was a noticeable improvement in the 152 00:05:05,600 --> 00:05:07,370 enactment of laws that address concerns 153 00:05:07,370 --> 00:05:09,598 of rights holders regarding enforcement, 154 00:05:09,600 --> 00:05:10,980 25% said there was improvement, 155 00:05:10,980 --> 00:05:14,193 but 75 cent percent said there was no change 156 00:05:14,200 --> 00:05:17,119 with regard to obstacles to IP licensing, 157 00:05:17,120 --> 00:05:19,460 12% said there was an improvement, 158 00:05:19,460 --> 00:05:21,812 12% said the situation had gotten 159 00:05:21,812 --> 00:05:24,300 worse and 75% said there was no 160 00:05:24,300 --> 00:05:26,588 change regarding pressures from the 161 00:05:26,588 --> 00:05:28,536 government to transfer technology. 162 00:05:28,540 --> 00:05:30,556 89% said there was no change. 163 00:05:30,560 --> 00:05:31,021 Finally. 164 00:05:31,021 --> 00:05:33,326 With regard to unauthorized disclosure, 165 00:05:33,330 --> 00:05:35,758 infringement stemming from regulatory 166 00:05:35,758 --> 00:05:38,186 or other government processes, 167 00:05:38,190 --> 00:05:40,086 11% said there was an improvement, 168 00:05:40,090 --> 00:05:43,100 but 89% said there was no change. 169 00:05:43,100 --> 00:05:43,594 With that, 170 00:05:43,594 --> 00:05:45,323 let's go ahead and start the program. 171 00:05:45,330 --> 00:05:46,323 One last thing. 172 00:05:46,323 --> 00:05:48,640 There will be a post program survey. 173 00:05:48,640 --> 00:05:49,146 Please click. 174 00:05:49,146 --> 00:05:51,630 Click on to the link to take a survey. 175 00:05:51,630 --> 00:05:53,226 We would very much appreciate if you 176 00:05:53,226 --> 00:05:55,153 do it soon so we can continually 177 00:05:55,153 --> 00:05:56,047 improve our webinars. 178 00:05:56,050 --> 00:05:56,518 With that, 179 00:05:56,518 --> 00:05:58,390 I'm going to turn it over to Larry 180 00:05:58,451 --> 00:06:00,166 who will give a general overview of 181 00:06:00,166 --> 00:06:02,160 some of the changes we have seen 182 00:06:02,160 --> 00:06:03,665 recently in patent related law, 183 00:06:03,670 --> 00:06:05,990 laws and regulations that deal 184 00:06:05,990 --> 00:06:07,886 with biopharma, the biopharma area. 185 00:06:07,886 --> 00:06:09,952 Over to you Larry. Thank you. 186 00:06:09,952 --> 00:06:11,534 Alright. Thank you, Elaine. 187 00:06:11,534 --> 00:06:14,502 So just to give you guys the 188 00:06:14,502 --> 00:06:17,516 sense of the scale in the past, 189 00:06:17,520 --> 00:06:21,258 I believe a year and three months. 190 00:06:21,260 --> 00:06:23,240 There were, I don't remember 191 00:06:23,240 --> 00:06:24,824 the exact number already, 192 00:06:24,830 --> 00:06:27,730 I think 60 or 80. 193 00:06:27,730 --> 00:06:29,730 Amended a loss or regulations 194 00:06:29,730 --> 00:06:31,730 that came out from China, 195 00:06:31,730 --> 00:06:35,510 so at least a lot has been happening on paper 196 00:06:35,510 --> 00:06:38,940 and hopefully today through the speakers Jill 197 00:06:38,940 --> 00:06:41,306 Jonathan Lynn, you can get a sense, 198 00:06:41,310 --> 00:06:44,798 uh, the some of the early facts of 199 00:06:44,798 --> 00:06:47,230 these legislations on the ground. 200 00:06:47,230 --> 00:06:48,270 Of course, 201 00:06:48,270 --> 00:06:52,114 we only have a very limited time today to 202 00:06:52,114 --> 00:06:54,802 cover very cover just selected topics, 203 00:06:54,810 --> 00:06:58,289 but let me try to broaden a bit to 204 00:06:58,289 --> 00:07:01,161 cover a few just a few topics that 205 00:07:01,161 --> 00:07:04,249 we don't have time to go through 206 00:07:04,249 --> 00:07:06,958 in more detail before I do that, 207 00:07:06,958 --> 00:07:09,040 I want to quickly mention something 208 00:07:09,108 --> 00:07:11,268 about patent linkage you may have 209 00:07:11,270 --> 00:07:13,580 heard the pen linkage being referred 210 00:07:13,580 --> 00:07:16,430 to as early dispute resolution system. 211 00:07:16,430 --> 00:07:18,656 I think that's the phrase actually 212 00:07:18,656 --> 00:07:20,510 used in in phase one. 213 00:07:20,510 --> 00:07:22,886 Agreement between the US and China 214 00:07:22,890 --> 00:07:24,878 that may be a more precise name, 215 00:07:24,880 --> 00:07:28,525 even though it's kind of a mouthful to say. 216 00:07:28,530 --> 00:07:31,656 And just see it's more precise 217 00:07:31,656 --> 00:07:34,712 because that's kind of a spelled out 218 00:07:34,712 --> 00:07:37,028 what exactly the patented system is. 219 00:07:37,030 --> 00:07:40,195 It provides a certainty with 220 00:07:40,195 --> 00:07:42,727 the early dispute resolution, 221 00:07:42,730 --> 00:07:45,736 you resolve the dispute before the 222 00:07:45,736 --> 00:07:49,521 generic goes to the market that that early, 223 00:07:49,521 --> 00:07:51,406 that certainty for lack of 224 00:07:51,406 --> 00:07:53,620 a better way to describe it. 225 00:07:53,620 --> 00:07:55,964 I always try to tell people who perhaps 226 00:07:55,964 --> 00:07:58,316 don't know the linkage system very well. 227 00:07:58,320 --> 00:08:01,750 It's a way of avoiding the *****. 228 00:08:01,750 --> 00:08:04,738 And a generic or biosimilar applicant 229 00:08:04,738 --> 00:08:06,730 applicant playing Russian roulette. 230 00:08:06,730 --> 00:08:07,795 In that sense, 231 00:08:07,795 --> 00:08:11,408 it's kind of a win win system is up course. 232 00:08:11,410 --> 00:08:13,558 How exactly we implement 233 00:08:13,558 --> 00:08:15,706 it is still important, 234 00:08:15,710 --> 00:08:19,028 but fundamentally the concept in my 235 00:08:19,028 --> 00:08:23,119 mind is always sort of a win win design. 236 00:08:23,119 --> 00:08:23,986 So with that, 237 00:08:23,986 --> 00:08:27,133 let me let me move on to a few topics 238 00:08:27,133 --> 00:08:29,518 that I think our speakers probably don't 239 00:08:29,518 --> 00:08:31,902 have a whole lot of time to cover. 240 00:08:31,910 --> 00:08:36,380 The first one is pending extension. 241 00:08:36,380 --> 00:08:38,520 Term extension. 242 00:08:38,520 --> 00:08:41,896 You may hear that as sort of pan 243 00:08:41,896 --> 00:08:44,645 term compensation or even sometimes 244 00:08:44,645 --> 00:08:46,550 ten term adjustment. 245 00:08:46,550 --> 00:08:50,285 But in the US law at least ten term 246 00:08:50,285 --> 00:08:53,564 extension refers to the compensation 247 00:08:53,564 --> 00:08:56,960 plan term due to marketing approval delay. 248 00:08:56,960 --> 00:08:57,914 In other words, 249 00:08:57,914 --> 00:09:00,140 you got your pattern but you cannot 250 00:09:00,140 --> 00:09:02,640 commercialize your pen because you 251 00:09:02,640 --> 00:09:05,481 gotta get approval whenever the product. 252 00:09:05,481 --> 00:09:09,317 Is sort of a medicine or even medical 253 00:09:09,317 --> 00:09:12,192 device that involves human health. 254 00:09:12,192 --> 00:09:15,804 I just want to quickly point out, 255 00:09:15,810 --> 00:09:18,064 uh, many of you may be aware, 256 00:09:18,070 --> 00:09:21,535 actually the during the draft law process, 257 00:09:21,540 --> 00:09:23,992 the pen term extension, 258 00:09:23,992 --> 00:09:26,444 which is compensating the. 259 00:09:26,450 --> 00:09:29,375 A regulatory approval delay or 260 00:09:29,375 --> 00:09:32,986 marketing approval delay and also Patent 261 00:09:32,986 --> 00:09:35,956 term adjustment which is compensating 262 00:09:35,956 --> 00:09:39,294 for Patent Office delay in the 263 00:09:39,294 --> 00:09:41,898 draft law process for both the. 264 00:09:41,900 --> 00:09:42,905 patent law amendment. 265 00:09:42,905 --> 00:09:44,580 The draft panel amendment rather, 266 00:09:44,580 --> 00:09:46,492 actually said May compensate, 267 00:09:46,492 --> 00:09:48,882 may compensate for regulatory delay, 268 00:09:48,890 --> 00:09:51,896 may compensate for Patent office delay, 269 00:09:51,900 --> 00:09:54,540 but the final panel law, 270 00:09:54,540 --> 00:09:56,668 which came into effect, 271 00:09:56,668 --> 00:09:58,796 I believe June 1st. 272 00:09:58,800 --> 00:10:01,704 Last year for Patent Term Extension 273 00:10:01,704 --> 00:10:03,616 and the Patent term adjustment, 274 00:10:03,616 --> 00:10:05,896 both have the word shall, 275 00:10:05,900 --> 00:10:08,396 so that's that's a very good 276 00:10:08,396 --> 00:10:10,574 welcome change from the final 277 00:10:10,574 --> 00:10:13,178 law compared with the draft law. 278 00:10:13,180 --> 00:10:15,238 patent term adjustment for of 279 00:10:15,238 --> 00:10:17,321 course plan for plan office delay 280 00:10:17,321 --> 00:10:20,135 that that one is not limited to two 281 00:10:20,135 --> 00:10:22,910 biopharma patterns that's all patterns 282 00:10:22,910 --> 00:10:25,821 and pattern extension is limited 283 00:10:25,821 --> 00:10:28,856 towards those patterns and requires. 284 00:10:28,860 --> 00:10:30,519 A marketing approval. 285 00:10:30,519 --> 00:10:33,284 In addition to our panel 286 00:10:33,284 --> 00:10:36,059 amendment and various measures, 287 00:10:36,060 --> 00:10:41,084 the there's a I think several SPC Ji 288 00:10:41,084 --> 00:10:44,860 traditional interpretations also came out. 289 00:10:44,860 --> 00:10:46,540 In addition, 290 00:10:46,540 --> 00:10:51,196 Cipla also amended its examination guidelines 291 00:10:51,200 --> 00:10:54,560 in that examination guideline amendment. 292 00:10:54,560 --> 00:10:58,214 I want to highlight a rule that 293 00:10:58,214 --> 00:11:00,531 is particularly critical to 294 00:11:00,531 --> 00:11:02,490 the innovative biopharma. 295 00:11:02,490 --> 00:11:05,619 Companies and that relates to order pants, 296 00:11:05,620 --> 00:11:06,270 panties, 297 00:11:06,270 --> 00:11:08,220 ability to file, 298 00:11:08,220 --> 00:11:09,520 post filing, 299 00:11:09,520 --> 00:11:12,560 supplemental data to prove inventive 300 00:11:12,560 --> 00:11:15,600 step or sufficiency of enablement. 301 00:11:15,600 --> 00:11:18,610 And I believe it's maybe 302 00:11:18,610 --> 00:11:22,600 20 as late as 2013 or so. 303 00:11:22,600 --> 00:11:24,238 China categorically categorically 304 00:11:24,238 --> 00:11:27,514 design reject supplement data if the 305 00:11:27,514 --> 00:11:30,099 data is not in your application. 306 00:11:30,100 --> 00:11:31,339 Sorry auto block. 307 00:11:31,339 --> 00:11:34,230 And that has changed quite a bit, 308 00:11:34,230 --> 00:11:36,156 as seen Jonathan and Elaine will 309 00:11:36,156 --> 00:11:38,451 have time to get into a little 310 00:11:38,451 --> 00:11:40,021 bit more detail with regard 311 00:11:40,021 --> 00:11:42,228 to the supplemental data rule. 312 00:11:42,230 --> 00:11:44,234 I want to also quickly mention 313 00:11:44,234 --> 00:11:46,078 something that is not limited 314 00:11:46,078 --> 00:11:47,826 to the biopharma industry. 315 00:11:47,830 --> 00:11:51,010 That is the so-called abnormal applications 316 00:11:51,010 --> 00:11:54,730 and by CIPa announcement announcement. 317 00:11:54,730 --> 00:11:58,360 I think the total number. 318 00:11:58,360 --> 00:11:59,238 Mentioned. 319 00:11:59,238 --> 00:12:02,750 The number of abnormal 320 00:12:02,750 --> 00:12:05,970 applications is eighty 815,000. 321 00:12:05,970 --> 00:12:09,927 That's quite a bit for year 2021. 322 00:12:09,927 --> 00:12:10,404 Uh, 323 00:12:10,404 --> 00:12:13,266 I think that by my calculation, 324 00:12:13,270 --> 00:12:13,825 uh, 325 00:12:13,825 --> 00:12:14,935 about uh, 326 00:12:14,935 --> 00:12:20,790 that's about 15 to 20% of the total amount of 327 00:12:20,790 --> 00:12:24,086 applications receives and that's quite a bit. 328 00:12:24,090 --> 00:12:25,366 And the word abnormal. 329 00:12:25,366 --> 00:12:27,628 Of course you might ask because it 330 00:12:27,628 --> 00:12:29,350 doesn't exist in the US system. 331 00:12:29,350 --> 00:12:31,150 What do you mean by abnormal? 332 00:12:31,150 --> 00:12:33,482 And there's actually quite 333 00:12:33,482 --> 00:12:34,648 extensive definitions, 334 00:12:34,650 --> 00:12:37,202 but the gist of it is that the 335 00:12:37,202 --> 00:12:39,095 application is not submitted for 336 00:12:39,095 --> 00:12:41,459 the for the purpose of securing. 337 00:12:41,460 --> 00:12:44,136 Protection of invention. 338 00:12:44,136 --> 00:12:47,180 I think you may never see 339 00:12:47,180 --> 00:12:48,440 this in CIP announcement, 340 00:12:48,440 --> 00:12:50,800 but but I think it's fair to say 341 00:12:50,800 --> 00:12:52,359 it's pretty much applications 342 00:12:52,359 --> 00:12:55,053 submitted for the sole purpose of 343 00:12:55,053 --> 00:12:57,488 getting subsidy and in that regard, 344 00:12:57,488 --> 00:12:57,870 the 345 00:13:00,180 --> 00:13:02,600 CIPA actually announced the subsidies. 346 00:13:02,600 --> 00:13:05,438 They will eliminate all subsidies by 347 00:13:05,440 --> 00:13:09,512 2025 and all the provincial and local IP 348 00:13:09,512 --> 00:13:13,279 offices are men are required I believe, 349 00:13:13,280 --> 00:13:16,910 to reduce their subsidy like by 25%. 350 00:13:16,910 --> 00:13:21,410 Every year towards the total elimination 351 00:13:21,410 --> 00:13:26,656 by 2025 and as recent as just last month, 352 00:13:26,660 --> 00:13:29,390 January 27th, I believe Cipa also announced 353 00:13:29,390 --> 00:13:32,090 a measure that included some more details 354 00:13:32,090 --> 00:13:34,865 on how they will punish applicants who 355 00:13:34,865 --> 00:13:37,619 violates the good faith in IP field, 356 00:13:37,620 --> 00:13:40,460 for which abnormal application is a big part. 357 00:13:40,460 --> 00:13:42,445 The bad Faith trademark application 358 00:13:42,445 --> 00:13:45,236 is is another big part of that 359 00:13:45,236 --> 00:13:46,696 violation of good faith. 360 00:13:46,700 --> 00:13:50,330 And I actually see a welcome 361 00:13:50,330 --> 00:13:54,108 welcome step of good step actually. 362 00:13:54,108 --> 00:13:57,330 In that announcement, because the 363 00:13:57,330 --> 00:14:01,200 announcement said uh with regard to. 364 00:14:01,200 --> 00:14:03,092 Either abnormal application or 365 00:14:03,092 --> 00:14:05,930 violation of good facing IP field 366 00:14:05,930 --> 00:14:10,230 which is concealing important facts. 367 00:14:10,230 --> 00:14:12,274 For a long time, 368 00:14:12,274 --> 00:14:14,829 actually the rights holders uh 369 00:14:14,829 --> 00:14:17,699 have been pushing have been. 370 00:14:17,700 --> 00:14:22,163 Telling us that conceding priority is kind of 371 00:14:22,163 --> 00:14:25,590 the ultimate cost of abnormal applications. 372 00:14:25,590 --> 00:14:27,670 Uh, I think concealing 373 00:14:27,670 --> 00:14:30,270 important facts is it's kind. 374 00:14:30,270 --> 00:14:32,190 It's a welcome step forward. 375 00:14:32,190 --> 00:14:33,162 Of course, 376 00:14:33,162 --> 00:14:36,078 it's still not exactly conceding priority. 377 00:14:36,080 --> 00:14:37,628 And with that I think sorry, 378 00:14:37,630 --> 00:14:40,210 I aim to like take 7 or 8 minutes I 379 00:14:40,284 --> 00:14:42,786 think are already overrun my time. 380 00:14:42,790 --> 00:14:45,275 Let me just stop there and welcome 381 00:14:45,275 --> 00:14:47,299 any questions through the email box. 382 00:14:47,300 --> 00:14:51,292 Let me turn the floor to actually 383 00:14:51,292 --> 00:14:54,124 who's going to go after me. 384 00:14:54,130 --> 00:14:55,096 Jonathan, Jonathan. 385 00:14:55,096 --> 00:14:55,579 Alright. 386 00:14:55,579 --> 00:14:56,062 Yeah, 387 00:14:56,062 --> 00:14:57,028 go ahead, 388 00:14:57,030 --> 00:14:57,500 Jonathan. 389 00:15:00,080 --> 00:15:02,530 OK. Thank you, Larry. Yeah. 390 00:15:02,530 --> 00:15:04,498 So this is not my slides. 391 00:15:04,500 --> 00:15:07,108 Uh, since he can you change to my 392 00:15:07,108 --> 00:15:10,053 slides my slides is bio former patent 393 00:15:10,053 --> 00:15:12,608 prosecution litigation not this one. 394 00:15:12,610 --> 00:15:16,970 Thank you. Yeah. Yeah. OK. Thank you. 395 00:15:16,970 --> 00:15:22,310 I mean, it's like sometimes. Point. Uh. 396 00:15:22,310 --> 00:15:26,254 Firstly I want to show you some recent 397 00:15:26,254 --> 00:15:29,408 data about the patent filings in China. 398 00:15:29,410 --> 00:15:30,640 As Larry mentioned, 399 00:15:30,640 --> 00:15:32,676 in recent years, every year, 400 00:15:32,676 --> 00:15:35,497 China has a huge amount of patent 401 00:15:35,497 --> 00:15:37,750 filings in the year of 2020, 402 00:15:37,750 --> 00:15:40,481 China again ranked number one in 403 00:15:40,481 --> 00:15:44,087 the in the major major economies. 404 00:15:44,090 --> 00:15:48,186 And as to the field of bio former, 405 00:15:48,190 --> 00:15:51,473 we can also see that China still 406 00:15:51,473 --> 00:15:54,471 has the largest number of patent 407 00:15:54,471 --> 00:15:57,957 filings and since the year of two. 408 00:15:57,960 --> 00:16:03,308 2013 China is supporting US at accelerated 409 00:16:03,308 --> 00:16:08,658 speed and as of October last year, 410 00:16:08,660 --> 00:16:11,565 China has more than half of the 411 00:16:11,565 --> 00:16:14,670 patterns in the field of bio farmer. 412 00:16:18,910 --> 00:16:21,140 In spite of the increase, 413 00:16:21,140 --> 00:16:24,990 the amount of patent filing every year, 414 00:16:24,990 --> 00:16:29,316 as Larry mentioned that in recent years 415 00:16:29,316 --> 00:16:34,532 seen IPA is taking initiatives to improve 416 00:16:34,532 --> 00:16:38,684 their examination efficiency and also to 417 00:16:38,684 --> 00:16:42,700 improve the quality of China patterns. 418 00:16:42,700 --> 00:16:45,040 Last year, in October last year, 419 00:16:45,040 --> 00:16:47,674 the director of CMLP announced that 420 00:16:47,674 --> 00:16:51,637 they are now able to reduce the every 421 00:16:51,637 --> 00:16:54,287 time needed for invention patent 422 00:16:54,287 --> 00:16:56,477 examination to about 19 months. 423 00:16:56,480 --> 00:16:58,464 Yeah, that's pretty fast. 424 00:16:58,464 --> 00:17:00,100 Uh, and in the meanwhile, 425 00:17:00,100 --> 00:17:02,574 we can see that there is a steady 426 00:17:02,574 --> 00:17:04,656 decrease of the grant rate of 427 00:17:04,656 --> 00:17:05,979 inversion pattern in China, 428 00:17:05,980 --> 00:17:08,735 which I think indicates the 429 00:17:08,735 --> 00:17:11,945 improvement of the patent quality in 430 00:17:11,945 --> 00:17:15,200 China and and and decrease of the so 431 00:17:15,200 --> 00:17:16,936 called garbage patent applications 432 00:17:16,936 --> 00:17:19,539 or abnormal pattern application. 433 00:17:19,540 --> 00:17:22,438 So having said that with the huge 434 00:17:22,438 --> 00:17:25,404 number of patent applications in Bell 435 00:17:25,404 --> 00:17:29,372 former field and with the increase. 436 00:17:29,372 --> 00:17:32,962 Improvement of examination efficiency and 437 00:17:32,962 --> 00:17:36,328 improvement of patent quality in China. 438 00:17:36,330 --> 00:17:39,946 I think China for those who are players 439 00:17:39,946 --> 00:17:42,607 and innovators in bio former field, 440 00:17:42,610 --> 00:17:45,771 China is becoming more and more important 441 00:17:45,771 --> 00:17:49,377 and attractive not only because China 442 00:17:49,377 --> 00:17:53,170 is awarding a so-called aiding society, 443 00:17:53,170 --> 00:17:56,334 but also because China is now becoming 444 00:17:56,334 --> 00:17:59,058 more and more friendly to innovators. 445 00:17:59,060 --> 00:18:00,860 Yeah, especially in the bell, 446 00:18:00,860 --> 00:18:01,730 former field. 447 00:18:04,820 --> 00:18:06,776 Uh, so haven't talked about this? 448 00:18:06,780 --> 00:18:09,200 Uh, this uh this data. 449 00:18:09,200 --> 00:18:12,021 Firstly, I want to keep the audience 450 00:18:12,021 --> 00:18:14,965 a brief introduction to the patent 451 00:18:14,965 --> 00:18:17,173 prosecution and patent litigation 452 00:18:17,173 --> 00:18:18,829 patent infringement litigation 453 00:18:18,905 --> 00:18:21,530 in China with a focus on the 454 00:18:21,530 --> 00:18:24,106 difference between China and the US. 455 00:18:24,106 --> 00:18:26,998 Uh, so as to patent prosecution, 456 00:18:27,000 --> 00:18:30,340 I think there are many. 457 00:18:30,340 --> 00:18:33,310 The difference lies in 3/3 aspects. 458 00:18:33,310 --> 00:18:37,090 The first aspect is in China and the US, 459 00:18:37,090 --> 00:18:39,300 although we both have the 460 00:18:39,300 --> 00:18:40,626 grace period requirements, 461 00:18:40,630 --> 00:18:44,380 but in China we have only six months 462 00:18:44,380 --> 00:18:48,265 grace period and also the grace period 463 00:18:48,265 --> 00:18:51,092 exemptions are strictly limited to 464 00:18:51,092 --> 00:18:54,362 4 scenarios and the first scenario, 465 00:18:54,370 --> 00:18:56,272 the disclosure for the first time 466 00:18:56,272 --> 00:18:58,280 for the purpose of the public. 467 00:18:58,280 --> 00:19:02,708 Interest was introduced with the amendment, 468 00:19:02,710 --> 00:19:06,038 the 4th Amendment to the Chinese patent law. 469 00:19:06,040 --> 00:19:08,659 Uh, and to my knowledge in US you can 470 00:19:08,659 --> 00:19:11,147 have a novelty grace period of up to 471 00:19:11,147 --> 00:19:13,435 one year and almost no restriction 472 00:19:13,435 --> 00:19:15,600 to the manner of disclosure. 473 00:19:15,600 --> 00:19:17,000 So as grace period, 474 00:19:17,000 --> 00:19:20,426 I think in US you have more limited 475 00:19:20,426 --> 00:19:23,230 grace period requirement and secondly. 476 00:19:25,460 --> 00:19:27,878 As to the post filing data 477 00:19:27,880 --> 00:19:30,580 regarding the formality and content 478 00:19:30,580 --> 00:19:33,760 requirements for the post filing data, 479 00:19:33,760 --> 00:19:36,955 I think the US has also a more lenient 480 00:19:36,955 --> 00:19:39,770 and open attitude toward classifying 481 00:19:39,770 --> 00:19:43,322 data compared with practice in China. 482 00:19:43,330 --> 00:19:48,020 After the phase one, China US agreement, 483 00:19:48,020 --> 00:19:51,415 now we have already have some very 484 00:19:51,415 --> 00:19:54,278 extensive isn't and observable improvement 485 00:19:54,278 --> 00:19:59,206 in the attitude toward post filing data. 486 00:19:59,210 --> 00:20:01,050 And the third aspect regarding 487 00:20:01,050 --> 00:20:02,522 the difference between China, 488 00:20:02,530 --> 00:20:07,510 USA is is what can be what can be protected, 489 00:20:07,510 --> 00:20:09,750 what can be claimed regarding 490 00:20:09,750 --> 00:20:11,542 the Biopharm field? 491 00:20:11,550 --> 00:20:15,180 I think we have substances including 492 00:20:15,180 --> 00:20:17,377 antibodies, vaccines and compositions. 493 00:20:17,377 --> 00:20:20,022 All these substances can also 494 00:20:20,022 --> 00:20:22,578 be pattern patented in China. 495 00:20:22,580 --> 00:20:25,700 I think the same in US. 496 00:20:25,700 --> 00:20:28,540 Uh, so in general, uh, 497 00:20:28,540 --> 00:20:32,080 the the method for diagnosis. 498 00:20:32,080 --> 00:20:35,368 Or or master or the treatment of disease 499 00:20:35,368 --> 00:20:39,280 are not patentable in China for human need, 500 00:20:39,280 --> 00:20:41,314 terrorism or considerations. 501 00:20:41,314 --> 00:20:44,026 Uh, for similar reasons. 502 00:20:44,030 --> 00:20:45,956 Drug Administration methods, 503 00:20:45,956 --> 00:20:49,166 including the dosage interval between 504 00:20:49,166 --> 00:20:53,209 dosing and the roads of the administration. 505 00:20:53,210 --> 00:20:56,018 Those are not patentable in China, 506 00:20:56,020 --> 00:20:59,380 but there is something that deserves 507 00:20:59,380 --> 00:21:01,620 a deserves further mention. 508 00:21:01,620 --> 00:21:03,498 That is, for the second use, 509 00:21:03,500 --> 00:21:06,475 the second use of a known drug 510 00:21:06,480 --> 00:21:08,736 for second use of new drug. 511 00:21:08,740 --> 00:21:12,286 If you claim it as a method for four. 512 00:21:12,290 --> 00:21:13,290 Treatment of these years, 513 00:21:13,290 --> 00:21:15,030 of course, that is not possible, 514 00:21:15,030 --> 00:21:17,391 but you can drop it in the 515 00:21:17,391 --> 00:21:19,506 manner of so-called Swiss style. 516 00:21:19,510 --> 00:21:21,868 And with that you can obtain 517 00:21:21,868 --> 00:21:23,980 a patent protection in China. 518 00:21:27,590 --> 00:21:31,146 Before I, uh, we move to the 519 00:21:31,146 --> 00:21:32,670 patent infringement litigation, 520 00:21:32,670 --> 00:21:36,140 I want to talk about the pattern related 521 00:21:36,140 --> 00:21:39,460 cost system in China and in China for 522 00:21:39,543 --> 00:21:41,979 the pattern infringement litigation 523 00:21:41,979 --> 00:21:45,675 and the patent validity litigation we 524 00:21:45,675 --> 00:21:48,900 have the so-called bifurcated systems. 525 00:21:48,900 --> 00:21:50,730 That means the patent infringement 526 00:21:50,730 --> 00:21:52,910 case and the patent validity case. 527 00:21:52,910 --> 00:21:57,290 They go through different court systems. 528 00:21:57,290 --> 00:21:59,322 For patent infringement litigation, 529 00:21:59,322 --> 00:22:03,537 we have the so-called 1 + 4 + N system. 530 00:22:03,540 --> 00:22:05,700 So at the Supreme Court level 531 00:22:05,700 --> 00:22:07,630 or the appellate court level, 532 00:22:07,630 --> 00:22:10,954 we have an IP tribunal inside 533 00:22:10,954 --> 00:22:12,346 the Supreme Court, 534 00:22:12,346 --> 00:22:15,680 which is specialized in hearing IP cases, 535 00:22:15,680 --> 00:22:18,524 especially cases involving technical 536 00:22:18,524 --> 00:22:22,079 issues including the patent disputes. 537 00:22:22,080 --> 00:22:25,592 Then at the trial stage we have we 538 00:22:25,592 --> 00:22:29,616 have 4 specialist IP IP cards which 539 00:22:29,616 --> 00:22:32,320 respectively located in Beijing, 540 00:22:32,320 --> 00:22:32,824 Shanghai, 541 00:22:32,824 --> 00:22:36,352 Guangzhou and Highland and we also have 542 00:22:36,352 --> 00:22:41,282 a 24 IP tribunals in different provinces 543 00:22:41,282 --> 00:22:46,139 and which can which can hear cases 544 00:22:46,140 --> 00:22:48,312 across their traditional jurisdiction. 545 00:22:48,312 --> 00:22:52,249 So with such a such a design 546 00:22:52,249 --> 00:22:54,569 called system for patent. 547 00:22:54,570 --> 00:22:57,394 In the cases we are now having a 548 00:22:57,394 --> 00:22:59,353 kind of concentrated prediction 549 00:22:59,353 --> 00:23:02,845 which can help to uniform the 550 00:23:02,845 --> 00:23:05,425 criteria for for case judgment 551 00:23:05,425 --> 00:23:09,222 and also can to some extent avoid 552 00:23:09,222 --> 00:23:12,300 the so-called local protectionism. 553 00:23:15,280 --> 00:23:18,536 And then as to the patent invalidation cases, 554 00:23:18,540 --> 00:23:23,279 they go through a different a different 555 00:23:23,280 --> 00:23:26,460 approach or different root cause system. 556 00:23:26,460 --> 00:23:28,800 So for patent invalidation cases, 557 00:23:28,800 --> 00:23:31,656 they always start from the scene IPA, 558 00:23:31,660 --> 00:23:35,188 the Chinese Patent Office. 559 00:23:35,190 --> 00:23:37,782 Starting from the CNIPE 560 00:23:37,782 --> 00:23:39,078 validation proceeding, 561 00:23:39,080 --> 00:23:41,244 which is administrative proceeding, 562 00:23:41,244 --> 00:23:45,129 so if one party is not satisfied 563 00:23:45,129 --> 00:23:48,270 with the decision made by CNIPA 564 00:23:48,270 --> 00:23:50,790 regarding the validity of the pattern, 565 00:23:50,790 --> 00:23:54,493 that party can come bring a judicial 566 00:23:54,493 --> 00:23:57,818 review case before Beijing IP cards. 567 00:23:57,820 --> 00:23:59,248 So for this kind of case, 568 00:23:59,250 --> 00:24:01,679 after Beijing EBT card is a is 569 00:24:01,679 --> 00:24:04,150 a trial state is a trial stage. 570 00:24:04,150 --> 00:24:06,598 Although it is the second stage. 571 00:24:06,600 --> 00:24:09,295 And then after the Beijing IP court, 572 00:24:09,300 --> 00:24:11,148 we still have, uh, 573 00:24:11,148 --> 00:24:13,458 the the party still have 574 00:24:13,458 --> 00:24:15,438 opportunity for for a pallet, 575 00:24:15,440 --> 00:24:17,942 for apparent stage which is at 576 00:24:17,942 --> 00:24:21,188 this as the IP tribunal of the 577 00:24:21,188 --> 00:24:24,140 Supreme Court where the party can 578 00:24:24,140 --> 00:24:27,417 get the final the final judgment, 579 00:24:27,420 --> 00:24:29,814 the final judgment and now you can 580 00:24:29,814 --> 00:24:32,339 see for both the patent invalidation 581 00:24:32,339 --> 00:24:34,704 case and the pattern infringement 582 00:24:34,704 --> 00:24:37,190 case at the appellate stage. 583 00:24:37,190 --> 00:24:39,345 They converge to the same 584 00:24:39,345 --> 00:24:41,069 IP tribunal that is, 585 00:24:41,070 --> 00:24:43,737 the IP tribunal in the Supreme Court. 586 00:24:48,220 --> 00:24:50,884 Uh, so this on this slide I showed 587 00:24:50,884 --> 00:24:53,860 some of the major difference between 588 00:24:53,860 --> 00:24:55,652 AS2 patent infringement litigation 589 00:24:55,652 --> 00:24:58,710 between China and the US in USA, 590 00:24:58,710 --> 00:25:01,146 you have the very powerful and 591 00:25:01,146 --> 00:25:02,770 efficient discovery process for 592 00:25:02,839 --> 00:25:04,739 evidence collection in China. 593 00:25:04,740 --> 00:25:06,588 We don't have that in less 594 00:25:06,588 --> 00:25:08,520 you have the jury in China. 595 00:25:08,520 --> 00:25:12,978 We have something that maybe maybe 596 00:25:12,980 --> 00:25:15,010 maybe similar but quite different 597 00:25:15,010 --> 00:25:17,040 which is the peoples juror. 598 00:25:17,040 --> 00:25:19,175 But the people draw these 599 00:25:19,175 --> 00:25:21,310 sit together with the judge. 600 00:25:21,310 --> 00:25:23,977 They form a form of a panel 601 00:25:23,977 --> 00:25:26,484 together with the judge to hear 602 00:25:26,484 --> 00:25:29,028 the case and make the decision. 603 00:25:29,030 --> 00:25:29,876 And also US, 604 00:25:29,876 --> 00:25:31,850 you have the magma hearing in China. 605 00:25:31,850 --> 00:25:33,278 We don't have that. 606 00:25:33,278 --> 00:25:36,630 And also for the for the process in 607 00:25:36,630 --> 00:25:39,030 China generally for infernal dedication 608 00:25:39,030 --> 00:25:41,960 it takes relatively shorter time. 609 00:25:41,960 --> 00:25:46,620 You can get a judgement relatively quicker. 610 00:25:46,620 --> 00:25:49,840 Uh, and also as to the possibility 611 00:25:49,840 --> 00:25:52,471 of getting injunction in China almost 612 00:25:52,471 --> 00:25:54,973 in each and every infant case, 613 00:25:54,980 --> 00:25:57,854 so long as the pattern infringement 614 00:25:57,854 --> 00:25:59,770 is established and approved, 615 00:25:59,770 --> 00:26:02,655 you can almost always get 616 00:26:02,655 --> 00:26:04,386 an injunction order. 617 00:26:04,390 --> 00:26:07,169 Uh, but as to the damage compensation, 618 00:26:07,170 --> 00:26:10,334 as you may have seen from previous 619 00:26:10,334 --> 00:26:12,947 reports that the partner monetary 620 00:26:12,947 --> 00:26:15,095 compensation awarded in China 621 00:26:15,095 --> 00:26:17,780 is relatively low compared that 622 00:26:17,865 --> 00:26:19,935 the penalty get in the USA. 623 00:26:19,940 --> 00:26:22,130 But in recent years we have 624 00:26:22,130 --> 00:26:24,589 seen a steady increase of the 625 00:26:24,589 --> 00:26:26,437 monetary compensation in China. 626 00:26:26,440 --> 00:26:26,722 Uh, 627 00:26:26,722 --> 00:26:28,132 another thing is about the 628 00:26:28,132 --> 00:26:29,760 evidence used in the pattern. 629 00:26:29,760 --> 00:26:32,855 Infant litigation in USI think 630 00:26:32,855 --> 00:26:35,950 the affidavits and depositions are 631 00:26:36,050 --> 00:26:38,906 widely used and witness or also 632 00:26:38,906 --> 00:26:42,530 widely used in the court proceeding. 633 00:26:42,530 --> 00:26:43,342 But internal, 634 00:26:43,342 --> 00:26:46,184 although we also have this kind of 635 00:26:46,184 --> 00:26:49,240 evidence also acceptable in court proceeding, 636 00:26:49,240 --> 00:26:52,082 but generally we tend to think that 637 00:26:52,082 --> 00:26:55,002 this kind of evidence has relatively 638 00:26:55,002 --> 00:26:57,798 lower probative value compared with the. 639 00:26:57,800 --> 00:26:58,840 Documentary evidence. 640 00:26:58,840 --> 00:27:00,920 Or in other words, 641 00:27:00,920 --> 00:27:02,680 in a legal proceeding, 642 00:27:02,680 --> 00:27:04,440 internal documentary evidence always 643 00:27:04,440 --> 00:27:06,989 appears a higher probability value. 644 00:27:11,010 --> 00:27:13,475 So having briefly talked about 645 00:27:13,475 --> 00:27:15,940 the Chinese practice in patent 646 00:27:16,024 --> 00:27:18,448 prosecution patent litigation, 647 00:27:18,450 --> 00:27:22,170 I want to introduce a recent case that 648 00:27:22,170 --> 00:27:25,698 handled by myself and with this case we 649 00:27:25,698 --> 00:27:29,117 can see how how they proceeding works 650 00:27:29,117 --> 00:27:32,455 and how we can share some detailed 651 00:27:32,455 --> 00:27:35,560 take away points with our audience. 652 00:27:35,560 --> 00:27:37,460 In this case, our client, 653 00:27:37,460 --> 00:27:39,060 the right holder, uh. 654 00:27:39,060 --> 00:27:41,460 the IT is not a penalty. 655 00:27:41,460 --> 00:27:44,346 It is a licensee of Chinese 656 00:27:44,346 --> 00:27:47,486 patent which protect a novel, 657 00:27:47,486 --> 00:27:51,224 Cellulitis which is as M4 658 00:27:51,224 --> 00:27:53,840 for Cellulitis treatment. 659 00:27:53,840 --> 00:27:56,768 It can help it can be used for 660 00:27:56,770 --> 00:28:00,178 washing use or for fabric processing. 661 00:28:00,180 --> 00:28:04,632 It can reduce the force on our 662 00:28:04,632 --> 00:28:06,540 clothes especially sweaters. 663 00:28:06,540 --> 00:28:10,159 Uh, so there is one event infringer 664 00:28:10,160 --> 00:28:12,785 who's producing the same product 665 00:28:12,785 --> 00:28:16,300 with exactly the same file sequence, 666 00:28:16,300 --> 00:28:17,992 and the infringer, 667 00:28:17,992 --> 00:28:21,376 or was actively selling the product, 668 00:28:21,380 --> 00:28:22,996 but at a much, 669 00:28:22,996 --> 00:28:26,026 much lower price and the with with 670 00:28:26,026 --> 00:28:28,596 that the infant grabbed almost 671 00:28:28,596 --> 00:28:32,153 all the market share of our our 672 00:28:32,153 --> 00:28:34,967 client read holder or the licensee. 673 00:28:34,970 --> 00:28:37,090 So other other picture, 674 00:28:37,090 --> 00:28:40,698 these are the product we we see 675 00:28:40,698 --> 00:28:44,051 that we we we purchased from this 676 00:28:44,051 --> 00:28:46,642 infringer and you can see the 677 00:28:46,642 --> 00:28:49,743 label on the other bot on the 678 00:28:49,743 --> 00:28:52,208 barrels and these labels are. 679 00:28:52,210 --> 00:28:56,044 All covered up by by notary public in China. 680 00:28:56,050 --> 00:28:56,968 So in China, 681 00:28:56,968 --> 00:28:57,886 as I mentioned, 682 00:28:57,890 --> 00:29:00,615 we have a relatively stricter 683 00:29:00,615 --> 00:29:03,340 requirement on formality of evidence. 684 00:29:03,340 --> 00:29:07,029 So so to purchase the products and 685 00:29:07,029 --> 00:29:09,886 get the purchased product notarized 686 00:29:09,886 --> 00:29:13,408 is always the most important step 687 00:29:13,408 --> 00:29:17,353 in the evidence fixation over 688 00:29:17,353 --> 00:29:19,380 invalidation litigation case. 689 00:29:23,350 --> 00:29:26,190 So uh, always before so 690 00:29:26,190 --> 00:29:28,462 before initiating the lawsuit, 691 00:29:28,470 --> 00:29:30,270 there is a long way. 692 00:29:30,270 --> 00:29:33,358 We spent a long time to prepare the 693 00:29:33,358 --> 00:29:35,935 case from identifying the infringement 694 00:29:35,935 --> 00:29:39,367 and align with the client team. 695 00:29:39,370 --> 00:29:41,656 About the goals of the enforcement 696 00:29:41,656 --> 00:29:44,889 actions and to assess the possibility of 697 00:29:44,889 --> 00:29:47,069 infringement related with passionate, 698 00:29:47,070 --> 00:29:48,948 but the patterns and more importantly, 699 00:29:48,950 --> 00:29:52,910 we spend a long time to collect evidence 700 00:29:52,910 --> 00:29:56,838 to conduct the purchase and to collect 701 00:29:56,838 --> 00:30:00,023 evidence about the production scale, 702 00:30:00,030 --> 00:30:02,522 collect their environment impact 703 00:30:02,522 --> 00:30:06,260 assessment and a lot of evidence. 704 00:30:06,260 --> 00:30:09,676 So once we have all the evidence ready. 705 00:30:09,680 --> 00:30:12,704 We we started talking about the the 706 00:30:12,704 --> 00:30:15,854 infringer to see whether there is a 707 00:30:15,854 --> 00:30:18,500 possibility to settle this case so 708 00:30:18,584 --> 00:30:21,578 that both parties can resolve these. 709 00:30:21,580 --> 00:30:24,184 This dispute in a more efficient way. 710 00:30:24,190 --> 00:30:26,524 So in this case the infringer 711 00:30:26,524 --> 00:30:28,080 they are quite disturbing. 712 00:30:28,080 --> 00:30:30,840 They didn't even acknowledge 713 00:30:30,840 --> 00:30:32,910 their infant activity. 714 00:30:32,910 --> 00:30:35,586 So then we decide to initiate 715 00:30:35,586 --> 00:30:37,809 the lawsuit and so generally 716 00:30:37,809 --> 00:30:40,024 once you initiate the lawsuits. 717 00:30:40,030 --> 00:30:41,686 And the post priorities, 718 00:30:41,686 --> 00:30:44,732 we fail over evidence to show the 719 00:30:44,732 --> 00:30:46,636 infringement and the evidence 720 00:30:46,636 --> 00:30:49,016 to support our damage claim. 721 00:30:49,020 --> 00:30:50,970 The other party will fail Conrad, 722 00:30:50,970 --> 00:30:53,592 and then the court will organize 723 00:30:53,592 --> 00:30:55,612 the evidence exchange and the 724 00:30:55,612 --> 00:30:57,718 Post party will see the evidence 725 00:30:57,718 --> 00:31:00,007 submitted by the early part other 726 00:31:00,007 --> 00:31:02,275 party and to check the authenticity, 727 00:31:02,280 --> 00:31:06,150 credibility and order, order requirements. 728 00:31:06,150 --> 00:31:09,517 Other requirement on the on the evidence. 729 00:31:09,520 --> 00:31:11,956 Another will have the three trail 730 00:31:11,956 --> 00:31:13,580 conference on such conference. 731 00:31:13,580 --> 00:31:17,372 The judge will will review evidence 732 00:31:17,372 --> 00:31:20,840 submitted by both parties and hear 733 00:31:20,840 --> 00:31:23,875 opinions from both parties and 734 00:31:23,875 --> 00:31:28,475 to figure out what is the focus 735 00:31:28,475 --> 00:31:31,355 of dispute between parties. 736 00:31:31,360 --> 00:31:32,881 In our case, 737 00:31:32,881 --> 00:31:35,416 since both parties has sent 738 00:31:35,416 --> 00:31:38,098 efficient apparent dispute on the 739 00:31:38,098 --> 00:31:40,723 infringement assessment and we assert 740 00:31:40,723 --> 00:31:44,007 there is informed the other party, 741 00:31:44,010 --> 00:31:46,308 they said their product is different 742 00:31:46,308 --> 00:31:48,848 from what is claimed in our claims. 743 00:31:48,850 --> 00:31:53,631 So the judge decided to use independent 744 00:31:53,631 --> 00:31:55,680 judicial appraisal institution 745 00:31:55,785 --> 00:31:58,520 and arrange a separate test, 746 00:31:58,520 --> 00:32:01,690 a separate test and the. 747 00:32:01,690 --> 00:32:04,444 The the the the conclusion of 748 00:32:04,444 --> 00:32:07,315 the test showed that their bio 749 00:32:07,315 --> 00:32:10,123 sequence is exactly the same as 750 00:32:10,123 --> 00:32:13,087 clean as claimed in our claim. 751 00:32:13,090 --> 00:32:15,450 Then after that other receiving 752 00:32:15,450 --> 00:32:17,338 the judicial appraisal report 753 00:32:17,340 --> 00:32:20,046 that judged I think 754 00:32:20,046 --> 00:32:21,850 two additional court hearings, 755 00:32:21,850 --> 00:32:24,930 firstly to review the judicial report here, 756 00:32:24,930 --> 00:32:27,840 opinions of both parties on the 757 00:32:27,840 --> 00:32:30,477 judicial report and the informal 758 00:32:30,477 --> 00:32:32,877 assessment and also here. 759 00:32:32,880 --> 00:32:35,720 Review the evidence about 760 00:32:35,720 --> 00:32:37,140 monetary compensation. 761 00:32:37,140 --> 00:32:40,339 Then last year we received the judgment. 762 00:32:40,340 --> 00:32:42,630 Yeah. 763 00:32:42,630 --> 00:32:44,334 So in this judgment, 764 00:32:44,334 --> 00:32:44,760 uh, 765 00:32:44,760 --> 00:32:47,610 they we we received the injunction 766 00:32:47,610 --> 00:32:50,748 order and the judge issued an 767 00:32:50,748 --> 00:32:53,608 injunction against the other products 768 00:32:53,608 --> 00:32:57,132 or the infringing products and also 769 00:32:57,132 --> 00:33:00,564 we our client was awarded monetary 770 00:33:00,564 --> 00:33:03,160 compensation of 10 million RMB. 771 00:33:03,160 --> 00:33:06,190 That was the highest record in 772 00:33:06,302 --> 00:33:09,620 the field of at least the end 773 00:33:09,620 --> 00:33:12,598 them or anything and then yeah. 774 00:33:12,600 --> 00:33:16,225 Uh, uh, and also in this case, uh, 775 00:33:16,225 --> 00:33:19,855 in this amount of monetary compensation, 776 00:33:19,860 --> 00:33:23,940 part of the awarded for as a punitive 777 00:33:23,940 --> 00:33:26,684 compensation file photo punitive 778 00:33:26,684 --> 00:33:29,110 compensation because during the 779 00:33:29,110 --> 00:33:31,110 proceeding of our court hearing, 780 00:33:31,110 --> 00:33:34,960 the 4th amendment of Chinese patent law 781 00:33:34,960 --> 00:33:36,028 came into force. 782 00:33:36,028 --> 00:33:39,580 And so for some part of the compensation 783 00:33:39,580 --> 00:33:42,688 we we we satisfy the conditions. 784 00:33:42,690 --> 00:33:45,538 Full for punitive compensation. 785 00:33:45,538 --> 00:33:48,350 Yeah. And what makes us very happy? 786 00:33:48,350 --> 00:33:50,158 So in this case, 787 00:33:50,158 --> 00:33:53,016 the judge also award award compensation 788 00:33:53,016 --> 00:33:55,990 for attorney fee of 1,000,000 RMB. 789 00:33:55,990 --> 00:33:58,630 That's that's a pretty high amount 790 00:33:58,630 --> 00:34:00,980 compared with the previous cases. 791 00:34:04,090 --> 00:34:06,634 So as a take away points 792 00:34:06,634 --> 00:34:08,910 from from from this case. 793 00:34:08,910 --> 00:34:11,626 So firstly I want to send a 794 00:34:11,626 --> 00:34:14,745 message to our audience now in 795 00:34:14,745 --> 00:34:17,225 China for willful infringement. 796 00:34:17,230 --> 00:34:19,195 We have a punitive compensation 797 00:34:19,195 --> 00:34:21,824 which can be as high as five 798 00:34:21,824 --> 00:34:24,428 times of the damage to the 799 00:34:24,428 --> 00:34:27,428 patentee or to the right holder. 800 00:34:27,430 --> 00:34:29,240 Uh, the second one is, 801 00:34:29,240 --> 00:34:32,159 I think this is something unique in 802 00:34:32,159 --> 00:34:34,468 the patent infringement case in China, 803 00:34:34,470 --> 00:34:36,420 which is a judicial appraisal 804 00:34:36,420 --> 00:34:38,928 when both parties have a dispute 805 00:34:38,928 --> 00:34:40,836 on the infant assessment, 806 00:34:40,840 --> 00:34:44,536 the judge will elect a judicial 807 00:34:44,536 --> 00:34:46,384 independence judicial appraisal 808 00:34:46,384 --> 00:34:49,136 institution to determine to run test, 809 00:34:49,140 --> 00:34:51,068 to determine whether there 810 00:34:51,068 --> 00:34:52,996 is a patent infringement. 811 00:34:53,000 --> 00:34:55,163 The third one is about the shift 812 00:34:55,163 --> 00:34:57,199 of burden of proof in China. 813 00:34:57,200 --> 00:35:01,200 I think we may talk about this later if we 814 00:35:01,303 --> 00:35:05,308 have time in the Q&A session in this case. 815 00:35:05,310 --> 00:35:07,398 Since we have already proved there 816 00:35:07,398 --> 00:35:09,590 is a clear infringement then as 817 00:35:09,590 --> 00:35:11,070 to the monetary compensation, 818 00:35:11,070 --> 00:35:12,520 since we as the parenting, 819 00:35:12,520 --> 00:35:14,886 we don't have evidence to show how 820 00:35:14,886 --> 00:35:17,733 much is the exact profit of the of 821 00:35:17,733 --> 00:35:19,925 the infringer and then we request 822 00:35:19,925 --> 00:35:22,389 for shift part of the burden of 823 00:35:22,389 --> 00:35:24,616 proof to the other party also 824 00:35:24,616 --> 00:35:26,511 them to produce their financial 825 00:35:26,511 --> 00:35:28,617 book and their sales contract, 826 00:35:28,620 --> 00:35:32,476 the judge gives so and and also made 827 00:35:32,476 --> 00:35:35,910 the judgment on monitor compensation. 828 00:35:35,910 --> 00:35:38,470 According to the evidence collected. 829 00:35:38,470 --> 00:35:40,750 The first point is about the 830 00:35:40,750 --> 00:35:43,390 licensees right to sue the infringer. 831 00:35:43,390 --> 00:35:45,066 In this case, however, 832 00:35:45,066 --> 00:35:48,192 our client is a common or normal 833 00:35:48,192 --> 00:35:51,853 ordinary licensee is not a sole licensee. 834 00:35:51,860 --> 00:35:55,370 So for for ordinary licensee, 835 00:35:55,370 --> 00:35:57,876 in order to have the right to 836 00:35:57,876 --> 00:35:58,950 sue the infringer, 837 00:35:58,950 --> 00:36:01,446 I need to firstly have authorization 838 00:36:01,446 --> 00:36:03,890 from the from the patentee. 839 00:36:03,890 --> 00:36:04,836 Besides that, 840 00:36:04,836 --> 00:36:08,147 the licensee also need to have a 841 00:36:08,147 --> 00:36:10,180 declaration from the patentee. 842 00:36:10,180 --> 00:36:13,060 Declaring that the pattern KEY abandoned 843 00:36:13,060 --> 00:36:16,579 its own right to sue the infringer. 844 00:36:16,580 --> 00:36:19,235 So that's all I want to share with you. 845 00:36:19,240 --> 00:36:20,074 Thank you everybody. 846 00:36:20,074 --> 00:36:20,630 Thank you. 847 00:36:27,060 --> 00:36:28,635 Thank you. Jonathan will go ahead and 848 00:36:28,635 --> 00:36:30,763 to our next speaker who will be talking 849 00:36:30,763 --> 00:36:32,828 about patent linkage. Jill, thank you. 850 00:36:36,330 --> 00:36:38,582 Thanks for letting us. 851 00:36:38,582 --> 00:36:40,834 Larry alluded to earlier, 852 00:36:40,840 --> 00:36:43,200 one of the most significant 853 00:36:43,200 --> 00:36:45,088 developments in China regarding 854 00:36:45,088 --> 00:36:47,329 patents would be patent linkage. 855 00:36:47,330 --> 00:36:48,926 And before we dive into that, 856 00:36:48,930 --> 00:36:50,478 it may be worthwhile 857 00:36:50,478 --> 00:36:52,026 explaining what is linkage. 858 00:36:52,030 --> 00:36:54,320 Linkage means that the regulatory 859 00:36:54,320 --> 00:36:57,564 approval of a generic drug is linked 860 00:36:57,564 --> 00:37:00,174 to the resolution of patent disputes 861 00:37:00,174 --> 00:37:02,808 between an innovator and generic. 862 00:37:02,810 --> 00:37:04,718 You may have already sought out. 863 00:37:04,720 --> 00:37:06,855 This is very much likely you are 864 00:37:06,855 --> 00:37:08,709 system the Hatch Waxman system. 865 00:37:08,710 --> 00:37:10,978 They are right or China borrowed 866 00:37:10,978 --> 00:37:14,035 that from the US and to make it work 867 00:37:14,035 --> 00:37:16,794 first we need to have the partner 868 00:37:16,794 --> 00:37:19,058 listings submitted by innovators. 869 00:37:19,060 --> 00:37:22,602 There will also need to be generic 870 00:37:22,602 --> 00:37:25,800 certifications filed by generic when they 871 00:37:25,800 --> 00:37:28,490 submitted their gerneric drug applications. 872 00:37:28,490 --> 00:37:29,276 Most importantly, 873 00:37:29,276 --> 00:37:32,027 there needs to be a mechanism for 874 00:37:32,027 --> 00:37:34,497 the parties to resolve disputes. 875 00:37:34,500 --> 00:37:36,960 With the regulatory approval for the 876 00:37:36,960 --> 00:37:39,810 general being stayed for a certain period. 877 00:37:39,810 --> 00:37:42,618 So in principle. 878 00:37:42,620 --> 00:37:46,316 We have this all in place. 879 00:37:46,320 --> 00:37:47,635 But it's not the system 880 00:37:47,635 --> 00:37:49,550 and it is up and running. 881 00:37:49,550 --> 00:37:51,188 But to reach to this point, 882 00:37:51,190 --> 00:37:53,350 it took quite some years and 883 00:37:53,350 --> 00:37:55,618 you may have heard that US made 884 00:37:55,618 --> 00:37:58,306 theirs in the phase one deal and 885 00:37:58,306 --> 00:38:01,211 China committed to establish this 886 00:38:01,211 --> 00:38:04,256 resolution system for patent disputes 887 00:38:04,256 --> 00:38:06,960 between innovators and generics. 888 00:38:06,960 --> 00:38:08,190 But within China, 889 00:38:08,190 --> 00:38:11,060 this took several years in the making 890 00:38:11,136 --> 00:38:14,040 and understanding that will help you 891 00:38:14,040 --> 00:38:16,729 better understand the system in China. 892 00:38:16,730 --> 00:38:20,515 So importantly part linkage system 893 00:38:20,515 --> 00:38:23,543 touches onto policy imperatives, 894 00:38:23,550 --> 00:38:25,454 which underscores the ongoing 895 00:38:25,454 --> 00:38:27,834 health care reform in China. 896 00:38:27,840 --> 00:38:29,034 On one hand, 897 00:38:29,034 --> 00:38:31,024 the government really wanted to 898 00:38:31,024 --> 00:38:33,928 speed up access to innovative drugs. 899 00:38:33,930 --> 00:38:37,122 And at the same time, and even more, 900 00:38:37,122 --> 00:38:40,593 or grant grant drive here will be to 901 00:38:40,593 --> 00:38:44,328 push down the sky high drug prices in China. 902 00:38:44,330 --> 00:38:47,250 And that means the generic entry in China. 903 00:38:47,250 --> 00:38:49,394 So patent linkage system 904 00:38:49,394 --> 00:38:51,538 touches on both prongs. 905 00:38:51,540 --> 00:38:53,976 The 4th amendment of the patent 906 00:38:53,976 --> 00:38:56,644 law brought to life the present 907 00:38:56,644 --> 00:38:58,556 linkage system in China. 908 00:38:58,560 --> 00:39:00,615 A default false management or 909 00:39:00,615 --> 00:39:03,552 patent law was enacted large here. 910 00:39:03,552 --> 00:39:06,720 So Fast forward to today where 911 00:39:06,818 --> 00:39:08,480 things stand now. 912 00:39:08,480 --> 00:39:09,536 First of all, 913 00:39:09,536 --> 00:39:12,000 a new course of action for patent 914 00:39:12,080 --> 00:39:14,330 linkage has been created and 915 00:39:14,330 --> 00:39:17,816 Article 76 or the PRC patent law. 916 00:39:17,820 --> 00:39:20,610 And discipline court in China. 917 00:39:20,610 --> 00:39:23,194 Has issued judicial interpretation 918 00:39:23,194 --> 00:39:27,070 concerning the litigation for patent linkage. 919 00:39:27,070 --> 00:39:29,998 And both the patents and drug 920 00:39:29,998 --> 00:39:32,886 authorities in China Sea and IPA 921 00:39:32,886 --> 00:39:35,394 and AMP have also weighed in, 922 00:39:35,400 --> 00:39:37,312 issuing their implementing rules 923 00:39:37,312 --> 00:39:40,180 regarding the working of the system. 924 00:39:40,180 --> 00:39:42,390 So for example you have. 925 00:39:42,390 --> 00:39:43,656 Paragraphs for certifications 926 00:39:43,656 --> 00:39:46,188 in the US and in China. 927 00:39:46,190 --> 00:39:49,854 We call it type for certification and this 928 00:39:49,854 --> 00:39:54,210 means that a generic states that it's. 929 00:39:54,210 --> 00:39:56,670 Specific specific solutions does not 930 00:39:56,670 --> 00:39:59,940 fall within the scope or patterns. 931 00:39:59,940 --> 00:40:03,545 Or the innovator's patent is 932 00:40:03,545 --> 00:40:04,987 otherwise invalid. 933 00:40:04,990 --> 00:40:07,223 And the system has been up and 934 00:40:07,223 --> 00:40:08,920 running for quite some time. 935 00:40:08,920 --> 00:40:10,600 For more than six months. 936 00:40:10,600 --> 00:40:13,330 And if you go onto NPS website 937 00:40:13,330 --> 00:40:15,198 over 1000 conduct certifications 938 00:40:15,198 --> 00:40:18,248 are being filed and published. 939 00:40:20,650 --> 00:40:22,682 So next, now look, 940 00:40:22,682 --> 00:40:25,137 let's look at Article 76, 941 00:40:25,137 --> 00:40:27,639 because that is the heart and 942 00:40:27,639 --> 00:40:30,938 center of the patent linkage system. 943 00:40:30,940 --> 00:40:34,396 In China, the concept of artificial 944 00:40:34,396 --> 00:40:37,540 infant infringement is not adopted. 945 00:40:37,540 --> 00:40:41,082 Instead, a new course of action has 946 00:40:41,082 --> 00:40:43,964 been created, and that is called 947 00:40:43,964 --> 00:40:45,828 the scope confirmation action. 948 00:40:45,830 --> 00:40:49,136 This is essentially to determine whether 949 00:40:49,136 --> 00:40:52,167 a generic technical solution falls within 950 00:40:52,167 --> 00:40:54,676 the scope of an innovator's patent. 951 00:40:54,676 --> 00:40:57,345 And under the law, interestingly, 952 00:40:57,345 --> 00:41:01,790 both an innovator and generic may request 953 00:41:01,790 --> 00:41:04,054 that their category determination. 954 00:41:04,054 --> 00:41:06,318 And who has tradiction? 955 00:41:06,320 --> 00:41:09,130 This is even making things 956 00:41:09,130 --> 00:41:11,378 more interesting and trickier. 957 00:41:11,380 --> 00:41:14,404 Both the Beijing IP court as the 958 00:41:14,404 --> 00:41:17,808 judiciary and see an IPA as the 959 00:41:17,808 --> 00:41:20,336 administrative agency now are 960 00:41:20,336 --> 00:41:22,610 having concurrent jurisdiction 961 00:41:22,610 --> 00:41:26,070 to hear Article 76 cases. 962 00:41:26,070 --> 00:41:29,269 This really adds to the complications which 963 00:41:29,269 --> 00:41:33,438 I hope our time to explain a bit more here. 964 00:41:33,440 --> 00:41:36,210 And according to Article 76, 965 00:41:36,210 --> 00:41:40,602 the filing of patent linked placed by the 966 00:41:40,602 --> 00:41:44,359 innovator will stay the generic approval. 967 00:41:44,360 --> 00:41:46,946 As that state period has been 968 00:41:46,946 --> 00:41:50,380 stipulated to be a nine month period. 969 00:41:50,380 --> 00:41:50,842 So. 970 00:41:50,842 --> 00:41:53,614 What are the highlights of the 971 00:41:53,614 --> 00:41:55,000 patent linkage system? 972 00:41:55,000 --> 00:41:57,035 As you were imagine there 973 00:41:57,035 --> 00:41:58,256 will be obligations, 974 00:41:58,260 --> 00:41:59,940 affirmative obligations and it 975 00:41:59,940 --> 00:42:02,460 to be undertaken by both the 976 00:42:02,533 --> 00:42:04,325 innovators and generic companies 977 00:42:04,325 --> 00:42:07,678 for them to avail the benefits and 978 00:42:07,678 --> 00:42:10,968 incentives under the new system. 979 00:42:10,970 --> 00:42:13,122 But very importantly, yeah. 980 00:42:13,122 --> 00:42:16,350 Although the state period is short, 981 00:42:16,350 --> 00:42:18,654 that's only a nine month period 982 00:42:18,654 --> 00:42:21,500 compared to the US 30 month period. 983 00:42:21,500 --> 00:42:24,296 And innovator must pull the trigger. 984 00:42:24,300 --> 00:42:24,824 Otherwise, 985 00:42:24,824 --> 00:42:27,968 always the nine month regulatory stay 986 00:42:27,968 --> 00:42:31,638 in order to slow the generic entry. 987 00:42:31,640 --> 00:42:34,298 The most challenging thing I think 988 00:42:34,298 --> 00:42:36,471 innovative companies now face in 989 00:42:36,471 --> 00:42:38,804 China is to determine where with 990 00:42:38,804 --> 00:42:41,816 which forum they wanted to file. 991 00:42:41,820 --> 00:42:44,874 Their case should be filed with 992 00:42:44,874 --> 00:42:46,910 the IPA demonstrated agency, 993 00:42:46,910 --> 00:42:49,280 or with Beijing IP court. 994 00:42:49,280 --> 00:42:53,960 Or is there a solution in terms of 995 00:42:53,960 --> 00:42:57,077 preserving flexibility by filing 2 cases? 996 00:42:57,080 --> 00:42:58,596 And the fundamental issue, 997 00:42:58,596 --> 00:43:00,870 I think also ties to what 998 00:43:00,948 --> 00:43:03,428 Jonathan explained to you earlier, 999 00:43:03,430 --> 00:43:04,915 because in China, 1000 00:43:04,915 --> 00:43:06,895 patent litigation is bifurcate, 1001 00:43:06,900 --> 00:43:10,530 ihd validity is dealt with separately. 1002 00:43:10,530 --> 00:43:13,026 So validity is very important here 1003 00:43:13,026 --> 00:43:16,439 and now a big controversy and ongoing 1004 00:43:16,439 --> 00:43:19,763 debate is whether a decision handed 1005 00:43:19,763 --> 00:43:23,140 down by CN IPA that can still be 1006 00:43:23,140 --> 00:43:26,730 appealed can terminate the regulatory state. 1007 00:43:26,730 --> 00:43:28,182 In other words. 1008 00:43:28,182 --> 00:43:31,086 Where patent validity is not finally 1009 00:43:31,086 --> 00:43:33,328 settled through further appeals 1010 00:43:33,328 --> 00:43:36,113 cannot drag authority and derogatory 1011 00:43:36,113 --> 00:43:39,410 stay and go ahead and approve drug. 1012 00:43:39,410 --> 00:43:42,180 Now an emerging consensus has 1013 00:43:42,180 --> 00:43:45,760 been that the answer will be yes. 1014 00:43:45,760 --> 00:43:47,090 But at the same time, 1015 00:43:47,090 --> 00:43:48,167 for the generics, 1016 00:43:48,167 --> 00:43:50,680 they are being given the first to 1017 00:43:50,755 --> 00:43:53,077 market exclusivity and that has been 1018 00:43:53,077 --> 00:43:55,830 stipulated to be a 12 month period. 1019 00:43:55,830 --> 00:43:58,478 So that's quite significant 1020 00:43:58,478 --> 00:44:01,126 incentives given to generics. 1021 00:44:01,130 --> 00:44:02,910 Before end of a test, 1022 00:44:02,910 --> 00:44:05,508 there is the so-called patent damages 1023 00:44:05,508 --> 00:44:08,044 claim based on bad faith assertion 1024 00:44:08,044 --> 00:44:10,948 and that is a claim that can be 1025 00:44:11,030 --> 00:44:13,350 exploited by a generic company 1026 00:44:13,350 --> 00:44:16,232 and could be potentially used as 1027 00:44:16,232 --> 00:44:18,480 further leverage buy generic. 1028 00:44:18,480 --> 00:44:21,210 So now we can draw the conclusion. 1029 00:44:21,210 --> 00:44:24,030 There are structurally and fundamental 1030 00:44:24,030 --> 00:44:26,850 difference between the US system 1031 00:44:26,938 --> 00:44:28,288 and China system. 1032 00:44:28,290 --> 00:44:30,555 That's certainly true that China 1033 00:44:30,555 --> 00:44:32,820 to some extent has modeled 1034 00:44:32,906 --> 00:44:35,056 off the Hatch Waxman system, 1035 00:44:35,060 --> 00:44:37,993 but there are certain features from the 1036 00:44:37,993 --> 00:44:40,918 Korean at Canadian patent linkage system, 1037 00:44:40,920 --> 00:44:42,776 garbing borrowed and incorporated 1038 00:44:42,776 --> 00:44:45,560 in the system we're having now. 1039 00:44:45,560 --> 00:44:46,708 At the broadest level, 1040 00:44:46,708 --> 00:44:49,370 I would say that in the United States, 1041 00:44:49,370 --> 00:44:53,074 there 30 years of Hutch Waxman litigation and 1042 00:44:53,074 --> 00:44:56,837 they are detailed and very nuanced rules. 1043 00:44:56,840 --> 00:44:59,542 But in China, the rules are intentionally 1044 00:44:59,542 --> 00:45:02,963 to be loved at a very high level and 1045 00:45:02,963 --> 00:45:05,520 there are ambiguities and uncertainties. 1046 00:45:05,520 --> 00:45:07,525 So indeed, the patent linkage 1047 00:45:07,525 --> 00:45:10,220 rules issued by the sea and IPA, 1048 00:45:10,220 --> 00:45:13,272 an MPA have been said to be 1049 00:45:13,272 --> 00:45:16,149 rules for a trial period. 1050 00:45:16,150 --> 00:45:18,538 So the authorities in China are 1051 00:45:18,538 --> 00:45:20,629 taking the approach of crossing 1052 00:45:20,629 --> 00:45:23,155 the river by feeling the stone. 1053 00:45:23,160 --> 00:45:25,180 This maybe and Chinese 1054 00:45:25,180 --> 00:45:27,200 idiom you've heard before. 1055 00:45:27,200 --> 00:45:31,748 So for sure that challenges ahead. 1056 00:45:31,750 --> 00:45:33,694 Trust and foremost. 1057 00:45:33,694 --> 00:45:36,934 Given the uncertainties and ambiguities, 1058 00:45:36,940 --> 00:45:41,308 it's almost very difficult to forecast and 1059 00:45:41,308 --> 00:45:46,356 also to plan for generic entry in China. 1060 00:45:46,360 --> 00:45:48,284 So this is very, 1061 00:45:48,284 --> 00:45:49,727 very little predictability. 1062 00:45:49,730 --> 00:45:51,450 And then I must say, 1063 00:45:51,450 --> 00:45:51,950 period, 1064 00:45:51,950 --> 00:45:55,950 would that be even sufficient for either the 1065 00:45:55,950 --> 00:46:00,270 IP or speeding IP court to issue a decision? 1066 00:46:00,270 --> 00:46:03,300 And how about the interplay between 1067 00:46:03,300 --> 00:46:04,815 patent invalidation proceedings 1068 00:46:04,815 --> 00:46:07,528 and scope confirmation proceeding? 1069 00:46:07,530 --> 00:46:11,338 Which is the big debate I mentioned earlier? 1070 00:46:11,340 --> 00:46:12,888 Notwithstanding the challenges, 1071 00:46:12,888 --> 00:46:15,984 I think will be worthwhile for 1072 00:46:15,984 --> 00:46:17,695 innovative companies from the 1073 00:46:17,695 --> 00:46:20,313 space and other parts world to now 1074 00:46:20,391 --> 00:46:22,791 better understand the generic entry 1075 00:46:22,791 --> 00:46:25,191 patterns we've seen and observed 1076 00:46:25,200 --> 00:46:26,710 on the ground in China, 1077 00:46:26,710 --> 00:46:29,362 because that probably will help you 1078 00:46:29,362 --> 00:46:31,880 better grasp the system in China, 1079 00:46:31,880 --> 00:46:33,910 there are actually two types 1080 00:46:33,910 --> 00:46:35,128 of generic entries. 1081 00:46:35,130 --> 00:46:38,474 Why is a type of conventional entry which 1082 00:46:38,474 --> 00:46:41,368 you're probably very familiar with that is? 1083 00:46:41,370 --> 00:46:45,074 Generic will only speak to enter into the 1084 00:46:45,074 --> 00:46:48,616 market around the time of patent expiration, 1085 00:46:48,620 --> 00:46:50,285 less the most cost effective 1086 00:46:50,285 --> 00:46:51,284 strategy for them, 1087 00:46:51,290 --> 00:46:51,686 right? 1088 00:46:51,686 --> 00:46:53,270 But now in China, 1089 00:46:53,270 --> 00:46:55,594 because of the cost of a party 1090 00:46:55,594 --> 00:46:57,508 in validation is not as high. 1091 00:46:57,510 --> 00:47:00,271 In recent years we've seen early 1092 00:47:00,271 --> 00:47:02,926 and aggressive entry by generics. 1093 00:47:02,930 --> 00:47:06,444 This means that a generic company may 1094 00:47:06,444 --> 00:47:09,421 seek to invalidate and innovators 1095 00:47:09,421 --> 00:47:12,876 patent including their compound patent. 1096 00:47:12,880 --> 00:47:16,780 Two off the years after innovators 1097 00:47:16,780 --> 00:47:18,730 received marketing authorization. 1098 00:47:18,730 --> 00:47:21,858 Any extreme case we had here in point 1099 00:47:21,858 --> 00:47:25,136 is for Novartis and trust or drug. 1100 00:47:25,140 --> 00:47:27,924 You probably wouldn't believe yet the 1101 00:47:27,924 --> 00:47:30,457 patent was subject to invalidation 1102 00:47:30,457 --> 00:47:33,997 challenge even before the grant or 1103 00:47:33,997 --> 00:47:36,720 the marketing authorization by the MPA. 1104 00:47:36,720 --> 00:47:37,612 Salt 2. 1105 00:47:37,612 --> 00:47:39,842 Better prepare for patent linkage 1106 00:47:39,842 --> 00:47:42,617 litigation in China will be critically 1107 00:47:42,617 --> 00:47:45,335 important for you to gorge the 1108 00:47:45,335 --> 00:47:47,536 intelligence from the Chinese market 1109 00:47:47,536 --> 00:47:50,561 and also to assess the likelihood of 1110 00:47:50,561 --> 00:47:53,166 early and aggressive generic entry. 1111 00:47:53,170 --> 00:47:56,082 For that you of course we need to 1112 00:47:56,082 --> 00:47:58,154 closely monitor generic filings 1113 00:47:58,154 --> 00:48:00,578 and certifications and you will 1114 00:48:00,578 --> 00:48:02,894 also need to prepare actions early, 1115 00:48:02,900 --> 00:48:05,852 get your PLA and notarized and 1116 00:48:05,852 --> 00:48:07,328 legalized documents ready. 1117 00:48:07,330 --> 00:48:10,179 Because in China we have very stringent. 1118 00:48:10,180 --> 00:48:13,930 Formality requirements to follow and action. 1119 00:48:13,930 --> 00:48:15,270 But at the same time, 1120 00:48:15,270 --> 00:48:18,198 you will need to fully assess your case. 1121 00:48:18,200 --> 00:48:21,290 Be cognizant of the potential damages, 1122 00:48:21,290 --> 00:48:25,598 claim against innovators by face assertion. 1123 00:48:25,600 --> 00:48:29,065 Once you are facing a patent challenge 1124 00:48:29,065 --> 00:48:32,278 by a generic company were all you 1125 00:48:32,278 --> 00:48:34,988 need to do is to fight ruthlessly to 1126 00:48:34,988 --> 00:48:37,108 different validity of your patent. 1127 00:48:37,110 --> 00:48:40,310 But I think at board level we need to be 1128 00:48:40,390 --> 00:48:42,818 done, I think for the broader pattern, 1129 00:48:42,820 --> 00:48:46,036 community is to lobby for clarity, 1130 00:48:46,040 --> 00:48:48,540 consistency and predictability of 1131 00:48:48,540 --> 00:48:51,665 this new patent linkage system 1132 00:48:51,670 --> 00:48:54,470 because CNIP officials have also 1133 00:48:54,470 --> 00:48:56,710 recognized in informal meeting, 1134 00:48:56,710 --> 00:48:58,558 this has been perceived 1135 00:48:58,558 --> 00:49:00,406 as a working progress. 1136 00:49:00,410 --> 00:49:02,900 So we'll be continuing to monitor 1137 00:49:02,900 --> 00:49:05,950 developments in China and things will be 1138 00:49:05,950 --> 00:49:08,578 getting passed more and more interesting. 1139 00:49:08,580 --> 00:49:11,452 I'm conscious of the time so our just 1140 00:49:11,452 --> 00:49:14,642 stop here and to discuss a few further 1141 00:49:14,642 --> 00:49:17,229 slides hopefully in our Q&A session. 1142 00:49:17,230 --> 00:49:18,000 Thanks, Elaine. 1143 00:49:21,640 --> 00:49:22,870 Thank you very much, Jill. 1144 00:49:22,870 --> 00:49:24,376 And we will have our last 1145 00:49:24,376 --> 00:49:25,770 speaker last but not least, 1146 00:49:25,770 --> 00:49:27,118 linson often. Thank you. 1147 00:49:32,020 --> 00:49:33,800 Oh, hi. Thank you, Elaine, 1148 00:49:33,800 --> 00:49:36,170 for the invitation to talk and 1149 00:49:36,170 --> 00:49:38,440 different from previous two speakers, 1150 00:49:38,440 --> 00:49:42,024 Joe and Jonathan, I'm a US patent lawyer, 1151 00:49:42,030 --> 00:49:43,182 licensed patent lawyer. 1152 00:49:43,182 --> 00:49:46,840 So I'm going to talk more on the US 1153 00:49:46,840 --> 00:49:49,530 perspectives on the licensing side, so. 1154 00:49:52,080 --> 00:49:53,348 As as everyone though, 1155 00:49:53,348 --> 00:49:55,250 you have all these pattern right, 1156 00:49:55,250 --> 00:49:57,176 what's the path forward and path 1157 00:49:57,176 --> 00:49:58,912 and you need to commercialize 1158 00:49:58,912 --> 00:50:01,186 or to make the monitor eyes 1159 00:50:01,186 --> 00:50:03,141 with this whatever you invent. 1160 00:50:03,141 --> 00:50:05,920 So when I was practicing for many 1161 00:50:05,997 --> 00:50:08,314 years as a patent lawyer and later 1162 00:50:08,314 --> 00:50:11,320 on my team and us we our firm we 1163 00:50:11,320 --> 00:50:13,895 started getting into a lot of license 1164 00:50:13,895 --> 00:50:16,020 agreement review and drafting we 1165 00:50:16,020 --> 00:50:18,882 found out it's actually these two 1166 00:50:18,882 --> 00:50:21,302 are very important linked linked 1167 00:50:21,302 --> 00:50:23,509 together when you do a pattern. 1168 00:50:23,510 --> 00:50:25,344 You know you need to know what's 1169 00:50:25,344 --> 00:50:27,459 the value there and and through the 1170 00:50:27,459 --> 00:50:29,044 licensing we understand you know 1171 00:50:29,044 --> 00:50:30,922 where different pattern has different 1172 00:50:30,922 --> 00:50:32,802 value and it's very important. 1173 00:50:32,810 --> 00:50:35,314 So as we we know you get exclusive 1174 00:50:35,314 --> 00:50:38,113 rights in in the in the license what 1175 00:50:38,113 --> 00:50:40,781 does license mean here we we we can 1176 00:50:40,781 --> 00:50:42,996 say you know you you licensed you 1177 00:50:42,996 --> 00:50:45,908 give other people the right to use 1178 00:50:45,910 --> 00:50:48,718 your patent exclusive rights or not 1179 00:50:48,718 --> 00:50:51,450 exclusive rights so this is just a. 1180 00:50:51,450 --> 00:50:54,696 brief introduction of whether a license. 1181 00:50:54,700 --> 00:50:55,738 Is just a contract. 1182 00:50:57,990 --> 00:50:59,652 And usually in the license agreement 1183 00:50:59,652 --> 00:51:01,789 in the IP license agreement you have, 1184 00:51:01,790 --> 00:51:03,282 you know the clause, 1185 00:51:03,282 --> 00:51:05,995 where would you grant you grant exclusive 1186 00:51:05,995 --> 00:51:08,816 now exclusive where you use in the. 1187 00:51:08,820 --> 00:51:12,742 So when I doing that when I when we work 1188 00:51:12,742 --> 00:51:15,730 on the cross borders with China and the US, 1189 00:51:15,730 --> 00:51:19,426 we realize I mean the comparison is. 1190 00:51:19,430 --> 00:51:22,070 A lot of Chinese companies doing 1191 00:51:22,070 --> 00:51:24,130 the exclusive license from US, 1192 00:51:24,130 --> 00:51:27,786 they want the drug compound type of license, 1193 00:51:27,790 --> 00:51:29,402 then the fuel restrictions. 1194 00:51:29,402 --> 00:51:32,594 So we we've seen all different kind of 1195 00:51:32,594 --> 00:51:36,308 field people try to get some all fields 1196 00:51:36,308 --> 00:51:39,390 or majority also gather cancer related 1197 00:51:39,390 --> 00:51:43,960 field in from China to from US to China. 1198 00:51:43,960 --> 00:51:46,016 The ratio of the grant of courses you 1199 00:51:46,016 --> 00:51:48,169 patent term is very important in this one, 1200 00:51:48,170 --> 00:51:51,098 so previous speaker also has at a different 1201 00:51:51,098 --> 00:51:53,427 degree talk about the patent terms. 1202 00:51:53,430 --> 00:51:55,056 When you have the duration of 1203 00:51:55,056 --> 00:51:56,670 the grant of your license. 1204 00:51:56,670 --> 00:51:59,650 And another thing is geographic 1205 00:51:59,650 --> 00:52:03,174 restriction was a territory you have 1206 00:52:03,174 --> 00:52:06,317 and of course many of my clients. 1207 00:52:06,320 --> 00:52:08,702 To try to license from US, 1208 00:52:08,702 --> 00:52:10,466 they want the China or Greater China, 1209 00:52:10,470 --> 00:52:12,126 right versus US, 1210 00:52:12,126 --> 00:52:15,990 our US client who licensed from China, 1211 00:52:15,990 --> 00:52:18,055 they would get mostly right 1212 00:52:18,055 --> 00:52:19,707 except for Greater China. 1213 00:52:19,710 --> 00:52:20,614 So it's, 1214 00:52:20,614 --> 00:52:22,874 I've seen this kind of 1215 00:52:22,874 --> 00:52:25,370 trend these days these days. 1216 00:52:25,370 --> 00:52:28,304 And the again the the other one is a 1217 00:52:28,304 --> 00:52:30,661 financial really important you know 1218 00:52:30,661 --> 00:52:33,106 these the financial terms usually 1219 00:52:33,106 --> 00:52:35,730 discussed very early in the term sheet. 1220 00:52:35,730 --> 00:52:37,795 You know you talk about how much 1221 00:52:37,795 --> 00:52:39,849 money 'cause they try to save time 1222 00:52:39,849 --> 00:52:41,511 if you couldn't agree with the 1223 00:52:41,575 --> 00:52:43,627 financial terms then you know it's 1224 00:52:43,627 --> 00:52:45,960 not worthwhile to spend a lot of 1225 00:52:45,960 --> 00:52:47,880 money to do the agreement 'cause. 1226 00:52:47,880 --> 00:52:49,464 It's a long agreement, 1227 00:52:49,464 --> 00:52:53,250 it takes a lot of time and we've seen. 1228 00:52:53,250 --> 00:52:55,194 The trend on the on the fee is 1229 00:52:55,194 --> 00:52:56,840 like if you go to the UN, 1230 00:52:56,840 --> 00:52:58,796 a lot of Chinese clients are 1231 00:52:58,796 --> 00:53:00,819 these days trying to license their 1232 00:53:00,819 --> 00:53:03,101 trying to get a license from the 1233 00:53:03,101 --> 00:53:05,062 US universities and those upfront 1234 00:53:05,062 --> 00:53:07,414 fee as kind of relative low. 1235 00:53:07,420 --> 00:53:09,808 So they go, 1236 00:53:09,808 --> 00:53:12,196 they take this. 1237 00:53:12,200 --> 00:53:14,872 Asset and they want to use apply for 1238 00:53:14,872 --> 00:53:18,136 grant or apply for funds from the investor. 1239 00:53:18,140 --> 00:53:23,604 So that's a trend we've seen quite often. 1240 00:53:23,610 --> 00:53:26,868 When they try to license in the US company, 1241 00:53:26,870 --> 00:53:29,406 they rather to pay and try to find 1242 00:53:29,406 --> 00:53:31,814 the asset more like in the later 1243 00:53:31,814 --> 00:53:33,935 stage and then this case they 1244 00:53:33,935 --> 00:53:36,035 pay a lot higher upfront fee. 1245 00:53:38,080 --> 00:53:40,426 And we did during the negotiation, 1246 00:53:40,430 --> 00:53:43,146 a lot of time that people talk 1247 00:53:43,146 --> 00:53:44,926 about sublicensing in China. 1248 00:53:44,926 --> 00:53:48,910 You in US when you license you say, 1249 00:53:48,910 --> 00:53:49,820 hey, sublicense, 1250 00:53:49,820 --> 00:53:52,550 that's pretty easy to disclose to 1251 00:53:52,550 --> 00:53:55,888 control the sub licensees in China sub 1252 00:53:55,888 --> 00:53:58,238 licensees are very difficult control. 1253 00:53:58,240 --> 00:54:01,003 So in the negotiation they will talk a lot, 1254 00:54:01,010 --> 00:54:03,714 they will negotiate with you how less how 1255 00:54:03,714 --> 00:54:06,389 much they can control the sub licensee. 1256 00:54:06,390 --> 00:54:10,518 So we've seen this. 1257 00:54:10,520 --> 00:54:14,700 During the negotiation that the. 1258 00:54:14,700 --> 00:54:16,996 The licensee, they say we cannot give 1259 00:54:16,996 --> 00:54:18,823 you sub licensees information because 1260 00:54:18,823 --> 00:54:21,560 in China they those last sub licensees, 1261 00:54:21,560 --> 00:54:23,492 they wouldn't give us information and 1262 00:54:23,492 --> 00:54:26,218 also we can have less control over them. 1263 00:54:26,220 --> 00:54:29,136 So these kind of terms for the US side, 1264 00:54:29,140 --> 00:54:31,510 we have to understand that to 1265 00:54:31,510 --> 00:54:33,630 to be aware of that. 1266 00:54:33,630 --> 00:54:34,260 Uhm. 1267 00:54:36,430 --> 00:54:38,960 And the other important thing 1268 00:54:38,960 --> 00:54:42,403 you know in the license is a 1269 00:54:42,403 --> 00:54:44,839 due diligence I found out in. 1270 00:54:44,840 --> 00:54:46,360 In the Chinese company, 1271 00:54:46,360 --> 00:54:50,430 when they come to US to license a technology, 1272 00:54:50,430 --> 00:54:51,876 they look at the people they 1273 00:54:51,876 --> 00:54:53,336 look at the company's name, 1274 00:54:53,336 --> 00:54:55,912 they tend do less about due diligence 1275 00:54:55,912 --> 00:54:58,551 of the IP and then later on when 1276 00:54:58,551 --> 00:55:00,030 there's a problem, there's oh, 1277 00:55:00,030 --> 00:55:01,620 there's all the problem in there. 1278 00:55:01,620 --> 00:55:03,408 So for AUS entity, 1279 00:55:03,408 --> 00:55:06,582 it's better to talk to earlier to 1280 00:55:06,582 --> 00:55:09,742 them say here is our IP and disclose 1281 00:55:09,750 --> 00:55:12,249 more instead of later on when the 1282 00:55:12,249 --> 00:55:14,438 other party comes to you say hey, 1283 00:55:14,440 --> 00:55:16,308 I didn't see this. 1284 00:55:16,308 --> 00:55:18,643 That happens quite quite often, 1285 00:55:18,650 --> 00:55:20,780 so that's that's company had to 1286 00:55:20,780 --> 00:55:23,116 be aware and for the universities 1287 00:55:23,116 --> 00:55:25,642 it's pretty easy for a Chinese 1288 00:55:25,642 --> 00:55:28,484 entity to look at it because it's 1289 00:55:28,484 --> 00:55:30,404 it's most in the publication 1290 00:55:30,410 --> 00:55:32,377 and it's pretty open in and you 1291 00:55:32,377 --> 00:55:34,250 know if it's in the pattern. 1292 00:55:34,250 --> 00:55:36,889 But the company Wise there's a lot 1293 00:55:36,889 --> 00:55:39,772 of know how stuff need to you guys 1294 00:55:39,772 --> 00:55:41,879 to have to talk about huge sites. 1295 00:55:44,210 --> 00:55:47,276 So what we need to be aware 1296 00:55:47,276 --> 00:55:49,180 when your license your. 1297 00:55:49,180 --> 00:55:52,120 Stuff out to a Chinese entity. 1298 00:55:52,120 --> 00:55:54,260 You really have to consider 1299 00:55:54,260 --> 00:55:55,972 the export control issue, 1300 00:55:55,980 --> 00:56:01,516 although it's you know since the CFIUS that. 1301 00:56:01,520 --> 00:56:03,728 That there's a big drop of 1302 00:56:03,728 --> 00:56:05,200 Chinese investor in U.S. 1303 00:56:05,200 --> 00:56:06,396 companies. However, 1304 00:56:06,396 --> 00:56:09,984 there's increased a lot increase of 1305 00:56:09,984 --> 00:56:13,346 license from US to China because the 1306 00:56:13,346 --> 00:56:15,426 Chinese company Chinese investor will 1307 00:56:15,426 --> 00:56:18,139 invest more in the technology in, 1308 00:56:18,140 --> 00:56:21,396 in the location in China the so they 1309 00:56:21,396 --> 00:56:24,466 they they there's no serious review for 1310 00:56:24,466 --> 00:56:28,320 the per say for the license issue yet. 1311 00:56:28,320 --> 00:56:30,774 But you have to consider export 1312 00:56:30,774 --> 00:56:33,050 control especially for the genetic. 1313 00:56:33,050 --> 00:56:35,690 Information. Same issue for China too. 1314 00:56:35,690 --> 00:56:37,490 If you want to license 1315 00:56:37,490 --> 00:56:38,930 Chinese technology to US, 1316 00:56:38,930 --> 00:56:41,877 you have to really watch about this 1317 00:56:41,877 --> 00:56:43,916 genetic information because China has 1318 00:56:43,916 --> 00:56:46,912 very strict it's even the criminal 1319 00:56:46,912 --> 00:56:49,204 punishment if they improperly 1320 00:56:49,204 --> 00:56:52,650 transferred the genetic information into 1321 00:56:52,650 --> 00:56:56,071 foreign countries and also again very 1322 00:56:56,071 --> 00:56:58,297 common in the agreement you review, 1323 00:56:58,300 --> 00:57:00,460 what's the. 1324 00:57:00,460 --> 00:57:03,538 Our governing know the Chinese contract. 1325 00:57:03,540 --> 00:57:06,221 If you work with China to Chinese 1326 00:57:06,221 --> 00:57:08,234 contract is very simple yugiri 1327 00:57:08,234 --> 00:57:10,971 versus US contract is a very long 1328 00:57:10,971 --> 00:57:14,066 and what law to use and so many 1329 00:57:14,066 --> 00:57:16,048 times the compromises are used. 1330 00:57:16,048 --> 00:57:18,696 Hong Kong law or used Singapore 1331 00:57:18,696 --> 00:57:22,378 law that's that's kind of like a 1332 00:57:22,378 --> 00:57:25,013 mutually agreed but you have to 1333 00:57:25,013 --> 00:57:27,790 be aware of the change in here. 1334 00:57:27,790 --> 00:57:31,750 And one really important part in the license, 1335 00:57:31,750 --> 00:57:34,990 in my experience is that definitions, 1336 00:57:34,990 --> 00:57:36,350 you have to make earlier, 1337 00:57:36,350 --> 00:57:38,526 although you say that in the term sheet, 1338 00:57:38,530 --> 00:57:41,060 people more focused on the, 1339 00:57:41,060 --> 00:57:43,685 they're more focusing on the financial term. 1340 00:57:43,690 --> 00:57:46,378 It's the early you define those 1341 00:57:46,378 --> 00:57:49,043 those licensed product IP where you 1342 00:57:49,043 --> 00:57:51,794 know how the better for you 'cause. 1343 00:57:51,800 --> 00:57:53,350 In addition to a patent, 1344 00:57:53,350 --> 00:57:57,370 no heart comprised a lot of the IP in there. 1345 00:57:57,370 --> 00:58:00,835 Many times we found out that the 1346 00:58:00,840 --> 00:58:03,050 US company wants more information. 1347 00:58:03,050 --> 00:58:05,276 The Chinese company so only give you 1348 00:58:05,276 --> 00:58:07,190 this this little they didn't talk 1349 00:58:07,190 --> 00:58:09,290 about in the term sheet time they 1350 00:58:09,350 --> 00:58:11,534 they found out in the licensing I 1351 00:58:11,534 --> 00:58:14,294 mean the agreement time then it's 1352 00:58:14,294 --> 00:58:16,118 more extensive negotiations. 1353 00:58:16,120 --> 00:58:18,976 And the other thing on the 1354 00:58:18,976 --> 00:58:20,404 IP improvement part. 1355 00:58:20,410 --> 00:58:22,948 Many times people license their technology, 1356 00:58:22,950 --> 00:58:24,965 they improve and they they 1357 00:58:24,965 --> 00:58:26,980 try to ditch your name. 1358 00:58:26,980 --> 00:58:29,492 Just put their own IP and they use 1359 00:58:29,492 --> 00:58:31,987 this as their own patent filing. 1360 00:58:31,990 --> 00:58:33,845 So that part you have to understand, 1361 00:58:33,850 --> 00:58:36,954 you have to be aware and some university 1362 00:58:36,954 --> 00:58:40,144 they have like a reach out clause saying 1363 00:58:40,144 --> 00:58:43,038 we want anything in but enabled by 1364 00:58:43,038 --> 00:58:45,971 what pattern it's all also our pattern. 1365 00:58:45,980 --> 00:58:48,206 So this way you kind of control 1366 00:58:48,206 --> 00:58:50,798 how far you can get to your plan. 1367 00:58:50,800 --> 00:58:55,666 It's another negotiation process and the. 1368 00:58:55,670 --> 00:58:57,581 That the term has a lot of 1369 00:58:57,581 --> 00:58:59,629 like how much data you can use, 1370 00:58:59,630 --> 00:59:01,405 how much technology transfer you 1371 00:59:01,405 --> 00:59:03,990 can get and the more you detail, 1372 00:59:03,990 --> 00:59:06,034 the more detailed the better it is. 1373 00:59:06,040 --> 00:59:08,175 But I've seen the discrepancy 1374 00:59:08,175 --> 00:59:09,456 between two sides, 1375 00:59:09,460 --> 00:59:12,330 and especially the Chinese sides. 1376 00:59:12,330 --> 00:59:13,738 Usually they expect more, 1377 00:59:13,738 --> 00:59:15,146 but they didn't understand 1378 00:59:15,146 --> 00:59:16,989 in the early negotiation, 1379 00:59:16,990 --> 00:59:20,147 didn't put more in agreement later on, 1380 00:59:20,150 --> 00:59:21,650 did require require more. 1381 00:59:21,650 --> 00:59:24,560 So that's something you have to be aware. 1382 00:59:27,120 --> 00:59:29,280 And again in the license agreement, 1383 00:59:29,280 --> 00:59:31,205 as you know the due diligence part, 1384 00:59:31,210 --> 00:59:33,170 you have to look at the ownership or 1385 00:59:33,170 --> 00:59:35,155 you also have to discuss about not 1386 00:59:35,155 --> 00:59:36,929 joint ownership and for the joint 1387 00:59:36,929 --> 00:59:38,833 invention when you need to be aware 1388 00:59:38,833 --> 00:59:41,830 what you need to get the license 1389 00:59:41,830 --> 00:59:45,729 and who pays for the patent cost. 1390 00:59:45,730 --> 00:59:47,872 The last slides it's very simple 1391 00:59:47,872 --> 00:59:50,550 is what you need to as a license. 1392 00:59:50,550 --> 00:59:52,630 Or are you Jerry from the US side, 1393 00:59:52,630 --> 00:59:55,702 you make sure your your license is not 1394 00:59:55,702 --> 00:59:58,814 going to compete with you and and also 1395 00:59:58,814 --> 01:00:02,324 you have to make sure what you reserve 1396 01:00:02,324 --> 01:00:04,904 your rights and sometimes people don't. 1397 01:00:04,904 --> 01:00:07,193 It's it's a lot of vague thing 1398 01:00:07,193 --> 01:00:09,267 in the in the early stages. 1399 01:00:09,270 --> 01:00:11,405 So the more you talk about in 1400 01:00:11,405 --> 01:00:13,666 the term sheet the better it is 1401 01:00:13,666 --> 01:00:15,580 what you want to reserve and. 1402 01:00:15,580 --> 01:00:17,720 Make sure there's no challenge 1403 01:00:17,720 --> 01:00:19,820 to the pattern so this other, 1404 01:00:19,820 --> 01:00:22,370 just like a general review of 1405 01:00:22,370 --> 01:00:24,819 the license issue for your IP. 1406 01:00:24,820 --> 01:00:28,015 So we can I I'll talk more during the 1407 01:00:28,015 --> 01:00:30,738 discussion in terms of concerns over time. 1408 01:00:30,740 --> 01:00:32,600 Thank you here. 1409 01:00:32,600 --> 01:00:34,670 It's mine. 1410 01:00:34,670 --> 01:00:35,706 Thank you very much. 1411 01:00:35,706 --> 01:00:38,339 I want to thank all our excellent speakers 1412 01:00:38,339 --> 01:00:40,869 for the very comprehensive presentations. 1413 01:00:40,870 --> 01:00:43,285 They were excellent and I want to 1414 01:00:43,285 --> 01:00:45,355 remind everybody again that if you 1415 01:00:45,355 --> 01:00:47,287 do have questions for the speakers, 1416 01:00:47,290 --> 01:00:50,110 please email them to ask China 1417 01:00:50,110 --> 01:00:52,710 IP at USPTO dot giovi. 1418 01:00:52,710 --> 01:00:56,230 Again, ask China IP at USPTO dot giovi. 1419 01:00:56,230 --> 01:00:59,078 We'll have a Q&A period after our discussion. 1420 01:00:59,080 --> 01:01:02,293 So I wanted to go ahead and have a 1421 01:01:02,293 --> 01:01:05,267 discussion to kind of pull out some of the. 1422 01:01:05,270 --> 01:01:07,986 The things that each of the speakers 1423 01:01:07,986 --> 01:01:10,381 talked about and and perhaps 1424 01:01:10,381 --> 01:01:13,066 generate kind of discussion maybe 1425 01:01:13,066 --> 01:01:15,080 have maybe that will also generate 1426 01:01:15,080 --> 01:01:16,550 some questions from the audience. 1427 01:01:16,550 --> 01:01:19,478 So I want to go ahead and start 1428 01:01:19,478 --> 01:01:22,078 with Jill who gave an excellent 1429 01:01:22,078 --> 01:01:23,946 presentation on patent linkage. 1430 01:01:23,950 --> 01:01:25,696 Jill, you know, 1431 01:01:25,696 --> 01:01:29,188 you do have in your presentation. 1432 01:01:29,190 --> 01:01:31,404 A slider on the main differences 1433 01:01:31,404 --> 01:01:32,880 between the two panelists, 1434 01:01:32,880 --> 01:01:35,645 liquor systems in China and the US, 1435 01:01:35,650 --> 01:01:37,325 and you mentioned some of 1436 01:01:37,325 --> 01:01:38,330 the various aspects. 1437 01:01:38,330 --> 01:01:40,402 I wanted to ask you about the 1438 01:01:40,402 --> 01:01:42,268 administrative and judicial routes of the 1439 01:01:42,268 --> 01:01:44,104 patent linkage linkage system in China. 1440 01:01:44,110 --> 01:01:45,850 Understand that the patentee 1441 01:01:45,850 --> 01:01:47,590 must pick one route. 1442 01:01:47,590 --> 01:01:50,098 I hope my understanding is correct. 1443 01:01:50,100 --> 01:01:52,836 What are the advantages and disadvantages 1444 01:01:52,836 --> 01:01:55,480 of the administrative and the judicial 1445 01:01:55,480 --> 01:01:57,724 routes and how would you advise 1446 01:01:57,724 --> 01:02:00,247 clients as to which route to choose? 1447 01:02:02,840 --> 01:02:03,636 Thanks, yelling, 1448 01:02:03,636 --> 01:02:06,422 I think this is an excellent question. 1449 01:02:06,430 --> 01:02:08,830 First of all, there are pros and cons. 1450 01:02:08,830 --> 01:02:11,482 I need to be weighed in each 1451 01:02:11,482 --> 01:02:14,312 specific case to optimize your 1452 01:02:14,312 --> 01:02:16,010 position litigation position. 1453 01:02:16,010 --> 01:02:18,230 Visa V the other side, 1454 01:02:18,230 --> 01:02:20,966 so past we can take a look at 1455 01:02:20,966 --> 01:02:22,230 the administrative action. 1456 01:02:22,230 --> 01:02:24,490 Apparently that the single biggest 1457 01:02:24,490 --> 01:02:27,501 advantage I would think is that a 1458 01:02:27,501 --> 01:02:30,173 favorable ruling from the CN IPA as to 1459 01:02:30,248 --> 01:02:33,440 scope confirmation we talked about earlier. 1460 01:02:33,440 --> 01:02:36,811 Well, I thought the regulatory approval and. 1461 01:02:36,811 --> 01:02:40,419 The average time for CN IPA to adjudicate 1462 01:02:40,419 --> 01:02:44,397 and dispose the case is around six months, 1463 01:02:44,400 --> 01:02:46,980 so this means that within the 1464 01:02:46,980 --> 01:02:49,140 9-9 months or regulatory state, 1465 01:02:49,140 --> 01:02:50,586 it is doable. 1466 01:02:50,586 --> 01:02:53,960 If you can achieve a favorable result. 1467 01:02:53,960 --> 01:02:55,560 As to the second option, 1468 01:02:55,560 --> 01:02:57,620 which is the traditional action, 1469 01:02:57,620 --> 01:03:00,994 the Beijing IP quality is very established 1470 01:03:00,994 --> 01:03:03,873 and probably the most experienced IP 1471 01:03:03,873 --> 01:03:07,016 court in China with vast and wealth 1472 01:03:07,105 --> 01:03:09,751 of experience with and with experts 1473 01:03:09,751 --> 01:03:13,732 in every aspect of IP and patent law. 1474 01:03:13,732 --> 01:03:16,497 Are the Supreme Court perfectly 1475 01:03:16,497 --> 01:03:18,504 included provision and? 1476 01:03:18,504 --> 01:03:21,588 On polymer injunction, which is not 1477 01:03:21,588 --> 01:03:24,129 available before they see an IPA, 1478 01:03:24,130 --> 01:03:28,120 if one only uses the administrative route. 1479 01:03:28,120 --> 01:03:30,292 And the current preliminary 1480 01:03:30,292 --> 01:03:31,378 injunction practice. 1481 01:03:31,380 --> 01:03:33,884 As Jonathan mentioned earlier 1482 01:03:33,884 --> 01:03:36,388 is that when Validities? 1483 01:03:36,390 --> 01:03:39,218 In doubt, it will be impossible to 1484 01:03:39,218 --> 01:03:41,320 obtain a preliminary injunction, 1485 01:03:41,320 --> 01:03:42,972 but theoretically, 1486 01:03:42,972 --> 01:03:45,450 procedural flexibility before 1487 01:03:45,450 --> 01:03:47,928 Beijing IP Court, 1488 01:03:47,930 --> 01:03:50,384 I think is a potential consideration 1489 01:03:50,384 --> 01:03:53,769 that will need to be taken into account. 1490 01:03:53,770 --> 01:03:54,688 And naturally, 1491 01:03:54,688 --> 01:03:57,442 the question is from an optionality 1492 01:03:57,442 --> 01:03:58,830 point of view. 1493 01:03:58,830 --> 01:04:01,918 What will be worthwhile? 1494 01:04:01,920 --> 01:04:03,368 Initiating action. 1495 01:04:03,368 --> 01:04:07,712 At both forum to preserve flex 1496 01:04:07,712 --> 01:04:10,498 procedural flexibility and this is 1497 01:04:10,498 --> 01:04:13,934 possible if you go to the EPA 1st 1498 01:04:13,934 --> 01:04:17,510 and then go to the Beijing IP Court, 1499 01:04:17,510 --> 01:04:20,358 it is not under rule possible to do 1500 01:04:20,358 --> 01:04:23,749 that but other way round is not possible. 1501 01:04:23,750 --> 01:04:26,150 You cannot go to Beijing article 1502 01:04:26,150 --> 01:04:29,250 1st and then trying to do the 1503 01:04:29,250 --> 01:04:32,180 case again before they see an IPA. 1504 01:04:32,180 --> 01:04:33,998 So that's where things stand now. 1505 01:04:34,000 --> 01:04:36,610 And according to the statistics. 1506 01:04:36,610 --> 01:04:39,595 Currently the majority users or 1507 01:04:39,595 --> 01:04:42,803 the patented system have opted for 1508 01:04:42,803 --> 01:04:45,902 the Ministry of Roads to see an 1509 01:04:45,902 --> 01:04:48,326 IP have reported that they have 1510 01:04:48,326 --> 01:04:50,708 taken on more than 20 cases. 1511 01:04:50,710 --> 01:04:54,189 And there's only one reported case that 1512 01:04:54,189 --> 01:04:57,798 has been filed with Beijing IP court. 1513 01:04:57,800 --> 01:04:59,277 So you know it's a long answer 1514 01:04:59,277 --> 01:05:00,640 to respond to your question. 1515 01:05:02,890 --> 01:05:04,134 Great. Thank you, Jill. 1516 01:05:04,134 --> 01:05:05,067 That's very interesting. 1517 01:05:05,070 --> 01:05:06,780 Only one case file with 1518 01:05:06,780 --> 01:05:08,490 the the Beijing IP court. 1519 01:05:08,490 --> 01:05:11,220 I'm kind of curious if this is 1520 01:05:11,220 --> 01:05:13,760 a foreign or domestic case. 1521 01:05:13,760 --> 01:05:15,184 But anyway, thank you. 1522 01:05:15,184 --> 01:05:17,556 Yes, the following case is a foreign case. 1523 01:05:17,560 --> 01:05:18,830 OK, interesting. 1524 01:05:18,830 --> 01:05:22,005 Alright, thanks for that Jill. 1525 01:05:22,010 --> 01:05:26,514 I want to turn over to Jonathan next. 1526 01:05:26,520 --> 01:05:28,780 Jonathan, many foreign companies are 1527 01:05:28,780 --> 01:05:31,956 now aware that the judicial process in 1528 01:05:31,956 --> 01:05:34,494 China has limited means of discovery, 1529 01:05:34,500 --> 01:05:35,850 and you mentioned that as well. 1530 01:05:35,850 --> 01:05:37,212 That's one of the big differences 1531 01:05:37,212 --> 01:05:38,829 between the US and Chinese system. 1532 01:05:38,830 --> 01:05:40,936 What are some strategies you suggest 1533 01:05:40,936 --> 01:05:43,228 to foreign companies to help overcome 1534 01:05:43,228 --> 01:05:45,114 this obstacle, particularly U.S. 1535 01:05:45,114 --> 01:05:47,514 companies that are, you know, 1536 01:05:47,514 --> 01:05:49,926 very accustomed to much more discovery 1537 01:05:49,926 --> 01:05:53,109 than is available in the Chinese system? 1538 01:05:53,110 --> 01:05:53,550 Yeah. 1539 01:05:53,550 --> 01:05:56,184 So as I mentioned, in China, 1540 01:05:56,184 --> 01:05:58,806 we don't have the discovery process, 1541 01:05:58,810 --> 01:06:00,331 the basic principle, 1542 01:06:00,331 --> 01:06:03,373 the basic rule of evidence is 1543 01:06:03,373 --> 01:06:06,226 the one who assert here the 1544 01:06:06,226 --> 01:06:09,004 burden of proof to show evidence. 1545 01:06:09,010 --> 01:06:11,130 So that's the basic principle. 1546 01:06:11,130 --> 01:06:13,860 So since there is such a difference 1547 01:06:13,860 --> 01:06:17,297 between the US practice and China practice. 1548 01:06:17,300 --> 01:06:19,060 So for US clients, 1549 01:06:19,060 --> 01:06:21,580 my suggestion is firstly you need to 1550 01:06:21,580 --> 01:06:23,880 fix your evidence in a timely manner. 1551 01:06:23,880 --> 01:06:24,852 For example, 1552 01:06:24,852 --> 01:06:27,768 if you see the infringers offering 1553 01:06:27,768 --> 01:06:30,039 your product on our website, 1554 01:06:30,040 --> 01:06:32,370 then usually instruct your lawyer 1555 01:06:32,370 --> 01:06:35,707 to fix that evidence by inviting a 1556 01:06:35,707 --> 01:06:38,467 notary public to fix that evidence 1557 01:06:38,470 --> 01:06:41,410 and use notarization or like 1558 01:06:41,410 --> 01:06:45,530 time step to fix your evidence. 1559 01:06:45,530 --> 01:06:48,220 And that's the first suggestion. 1560 01:06:48,220 --> 01:06:50,914 The second one is to proactively 1561 01:06:50,914 --> 01:06:53,340 use the mirrors they assisting 1562 01:06:53,340 --> 01:06:56,604 measures provided by by the courts. 1563 01:06:56,610 --> 01:06:58,719 Like evidence, investigation, 1564 01:06:58,719 --> 01:06:59,422 order, 1565 01:06:59,422 --> 01:07:02,937 or evidence production order as 1566 01:07:02,937 --> 01:07:05,557 solution in my example cases. 1567 01:07:05,560 --> 01:07:08,632 In that case we we request the judge 1568 01:07:08,632 --> 01:07:11,709 to issue evidence production order. 1569 01:07:11,710 --> 01:07:15,805 So if the infant refuse to produce 1570 01:07:15,805 --> 01:07:18,270 the evidence production order, 1571 01:07:18,270 --> 01:07:21,582 the judge may rely on or evidence to 1572 01:07:21,582 --> 01:07:24,620 give a much higher compensation award. 1573 01:07:24,620 --> 01:07:26,720 So in that case. 1574 01:07:26,720 --> 01:07:29,226 The the the the infringer will be 1575 01:07:29,226 --> 01:07:31,280 forced to produce their financial 1576 01:07:31,280 --> 01:07:33,848 books and the sales contract. Yeah. 1577 01:07:33,848 --> 01:07:36,004 So that's my answer is thank you. 1578 01:07:38,070 --> 01:07:41,833 Right, OK. Uhm. That. 1579 01:07:41,833 --> 01:07:42,832 That's that's useful. 1580 01:07:42,832 --> 01:07:47,420 Thank you. Lynn, over to you. 1581 01:07:47,420 --> 01:07:49,723 I know that you had mentioned that 1582 01:07:49,723 --> 01:07:52,040 you have handled number biopharma 1583 01:07:52,040 --> 01:07:53,802 licensing transactions including 1584 01:07:53,802 --> 01:07:55,308 Chinese companies licensing 1585 01:07:55,308 --> 01:07:57,380 technologies from US from U.S. 1586 01:07:57,380 --> 01:07:59,060 companies and the other way around. 1587 01:07:59,060 --> 01:08:01,452 I wanted to know from you what are 1588 01:08:01,452 --> 01:08:04,302 some of the more unique aspects of 1589 01:08:04,302 --> 01:08:06,477 such licensing agreements that you 1590 01:08:06,548 --> 01:08:08,512 think are particularly important 1591 01:08:08,512 --> 01:08:11,366 for foreign companies to know and 1592 01:08:11,366 --> 01:08:13,346 addition to that particular would 1593 01:08:13,346 --> 01:08:16,060 be interesting to know some of the 1594 01:08:16,060 --> 01:08:17,950 more common pitfalls from AUS? 1595 01:08:17,950 --> 01:08:20,855 Country perspective and how to you know, 1596 01:08:20,860 --> 01:08:23,180 how would you suggest avoiding 1597 01:08:23,180 --> 01:08:24,706 those pitfalls? OK. 1598 01:08:24,706 --> 01:08:27,090 Thank you for me, 1599 01:08:27,090 --> 01:08:28,980 I think from the audience excitement, 1600 01:08:28,980 --> 01:08:32,208 IP due diligence is very important. 1601 01:08:32,210 --> 01:08:36,128 When they I found out that 1602 01:08:36,128 --> 01:08:38,740 in during the transactions. 1603 01:08:38,740 --> 01:08:40,105 The Chinese company, 1604 01:08:40,105 --> 01:08:42,380 they usually just say OK, 1605 01:08:42,380 --> 01:08:43,940 because Harvard's famous I'm just going 1606 01:08:43,940 --> 01:08:45,789 to go through this famous professor, 1607 01:08:45,790 --> 01:08:46,304 get it. 1608 01:08:46,304 --> 01:08:48,360 And when they look at the pattern stuff, 1609 01:08:48,360 --> 01:08:50,526 they didn't really look at the 1610 01:08:50,526 --> 01:08:52,540 word claim in campus and not 1611 01:08:52,540 --> 01:08:54,740 carefully reviewing what they need. 1612 01:08:54,740 --> 01:08:56,750 That's a that's a skip. 1613 01:08:56,750 --> 01:08:57,980 I thought I kept telling them, 1614 01:08:57,980 --> 01:08:59,388 don't skip this step. 1615 01:08:59,388 --> 01:09:01,840 It's important to know what you get. 1616 01:09:01,840 --> 01:09:03,410 And for the US company, 1617 01:09:03,410 --> 01:09:05,818 I also notice that when they license, 1618 01:09:05,820 --> 01:09:08,928 they thought their license something more. 1619 01:09:08,930 --> 01:09:10,202 But in Chinese side, 1620 01:09:10,202 --> 01:09:12,110 the only CEO only give them 1621 01:09:12,182 --> 01:09:13,510 a piece of sequence. 1622 01:09:13,510 --> 01:09:15,484 We don't give them all the data, 1623 01:09:15,490 --> 01:09:18,164 but death has to be really negotiated, 1624 01:09:18,170 --> 01:09:19,010 talked earlier. 1625 01:09:19,010 --> 01:09:21,110 See know how it's important? 1626 01:09:21,110 --> 01:09:23,158 I want more know how than I need 1627 01:09:23,158 --> 01:09:25,176 and the communication I see there 1628 01:09:25,176 --> 01:09:27,697 was lacking that in their past but 1629 01:09:27,697 --> 01:09:29,804 it's it's like a growing thing and 1630 01:09:29,804 --> 01:09:32,440 what you get when you're not getting 1631 01:09:32,440 --> 01:09:34,470 it even though there's agreement 1632 01:09:34,545 --> 01:09:36,929 sometime the mind is not neat so it's 1633 01:09:36,929 --> 01:09:39,630 a it's a contract issue they need to. 1634 01:09:39,630 --> 01:09:40,200 Talk more. 1635 01:09:42,640 --> 01:09:44,586 Do you like my eyes jumping their 1636 01:09:44,586 --> 01:09:46,848 best from a dispute point of view? 1637 01:09:46,850 --> 01:09:50,108 And I think for this type of licensing deals, 1638 01:09:50,110 --> 01:09:52,022 we've seen foreign companies 1639 01:09:52,022 --> 01:09:54,890 typically wanting to use a Delaware 1640 01:09:54,964 --> 01:09:57,129 court or court in California, 1641 01:09:57,130 --> 01:09:58,930 but you know for this type 1642 01:09:58,930 --> 01:10:00,130 of cross border transactions, 1643 01:10:00,130 --> 01:10:02,475 enforcing a foreign judgment from 1644 01:10:02,475 --> 01:10:05,870 US now still be near impossible. 1645 01:10:05,870 --> 01:10:07,430 There are presidents, presidents, 1646 01:10:07,430 --> 01:10:09,380 but there's no president in 1647 01:10:09,380 --> 01:10:11,457 the context of licensing deals. 1648 01:10:11,460 --> 01:10:12,892 So opting for arbitration. 1649 01:10:12,892 --> 01:10:15,499 And given that China is a member 1650 01:10:15,499 --> 01:10:17,449 of the New York Convention, 1651 01:10:17,450 --> 01:10:19,788 I think will be much desired option 1652 01:10:19,788 --> 01:10:22,719 in terms of dispute resolution 'cause. 1653 01:10:22,720 --> 01:10:24,827 We think that a lot so quickly 1654 01:10:24,827 --> 01:10:26,150 to jumping on that. 1655 01:10:26,150 --> 01:10:28,150 Yeah, thank you for that. 1656 01:10:28,150 --> 01:10:30,418 That is something that I think we we need 1657 01:10:30,418 --> 01:10:32,740 to remind ourselves about arbitration, 1658 01:10:32,740 --> 01:10:33,946 not something that we discussed so 1659 01:10:33,946 --> 01:10:35,618 much here in the US but I think 1660 01:10:35,618 --> 01:10:36,648 that's a really important point. 1661 01:10:36,650 --> 01:10:38,000 Thank you for bringing that up. 1662 01:10:38,000 --> 01:10:38,586 Jill 'cause, 1663 01:10:38,586 --> 01:10:40,344 I know that that's an important 1664 01:10:40,350 --> 01:10:42,950 Ave in China as well. 1665 01:10:42,950 --> 01:10:44,838 Other thing is I I forgot to mention 1666 01:10:44,838 --> 01:10:46,898 is they also need to understand 1667 01:10:46,898 --> 01:10:48,047 the political environment, 1668 01:10:48,050 --> 01:10:51,218 especially the USUS laws, 1669 01:10:51,218 --> 01:10:54,256 the CPS law and and export control. 1670 01:10:54,260 --> 01:10:55,830 They keep adding different lists. 1671 01:10:55,830 --> 01:10:57,927 Now we see farmers on one of the list. 1672 01:10:57,930 --> 01:11:00,234 So all these things they have 1673 01:11:00,234 --> 01:11:02,580 to be aware what's going on. 1674 01:11:02,580 --> 01:11:06,975 Right, exactly. Thank you. Uhm. 1675 01:11:06,975 --> 01:11:10,950 Let's move over to Jonathan. 1676 01:11:10,950 --> 01:11:11,301 Jonathan, 1677 01:11:11,301 --> 01:11:11,652 you, 1678 01:11:11,652 --> 01:11:14,109 you touched this briefly in your presentation 1679 01:11:14,109 --> 01:11:16,169 about the issue of supplemental data. 1680 01:11:16,170 --> 01:11:21,150 Certainly a longstanding issue for US 1681 01:11:21,150 --> 01:11:23,970 and foreign biopharma companies in China. 1682 01:11:23,970 --> 01:11:28,848 Can you explain the issue a little bit more? 1683 01:11:28,850 --> 01:11:30,978 And you had mentioned that it seems 1684 01:11:30,978 --> 01:11:32,936 that the issue perhaps has been 1685 01:11:32,936 --> 01:11:34,904 addressed and wanted to know a 1686 01:11:34,904 --> 01:11:36,907 little bit more about how exactly 1687 01:11:36,907 --> 01:11:39,680 it's been addressed and in your experience. 1688 01:11:39,680 --> 01:11:42,000 Experience of others hasn't 1689 01:11:42,000 --> 01:11:44,870 been addressed in a in a. 1690 01:11:44,870 --> 01:11:46,955 Hopefully satisfactory manner 1691 01:11:46,955 --> 01:11:49,040 for foreign companies. 1692 01:11:49,040 --> 01:11:49,481 Yeah. 1693 01:11:49,481 --> 01:11:50,363 So yes, 1694 01:11:50,363 --> 01:11:53,009 this is indeed a long standing 1695 01:11:53,009 --> 01:11:56,255 issue and also a hot issue for four 1696 01:11:56,255 --> 01:11:58,919 players in the biopharma field. 1697 01:11:58,920 --> 01:12:00,399 Uh and I, 1698 01:12:00,399 --> 01:12:05,240 I would like to say after the first one. 1699 01:12:05,240 --> 01:12:08,957 A treaty between China and the US, 1700 01:12:08,960 --> 01:12:12,626 we have seen a steady improvement 1701 01:12:12,630 --> 01:12:15,165 to warding the the direction 1702 01:12:15,165 --> 01:12:18,700 prescribed in the phase one agreement, 1703 01:12:18,700 --> 01:12:21,436 not only in the substantive examination 1704 01:12:21,436 --> 01:12:24,425 stage but also in the invalidation 1705 01:12:24,425 --> 01:12:27,665 procedure and in the court procedure. 1706 01:12:27,670 --> 01:12:34,002 We all see more lenient attitude toward more 1707 01:12:34,002 --> 01:12:36,834 friendly attitude toward post filing data. 1708 01:12:36,840 --> 01:12:38,193 Indeed, the truth. 1709 01:12:38,193 --> 01:12:41,350 But as to the criteria for the 1710 01:12:41,442 --> 01:12:44,478 acceptance of a post filing data, 1711 01:12:44,480 --> 01:12:48,120 I mean the substantive examination 1712 01:12:48,120 --> 01:12:52,312 I would like to say there is not so, 1713 01:12:52,312 --> 01:12:54,383 so, so huge difference. 1714 01:12:54,383 --> 01:12:58,534 There is still some difference between China, 1715 01:12:58,534 --> 01:12:59,796 US practice. 1716 01:12:59,800 --> 01:13:03,685 So I think the Chinese Examiner they 1717 01:13:03,685 --> 01:13:07,390 still hold that the basis of four. 1718 01:13:07,390 --> 01:13:10,438 For the for the patent system 1719 01:13:10,438 --> 01:13:13,570 is disclosure are for protection 1720 01:13:13,570 --> 01:13:16,251 and based on that they they have 1721 01:13:16,251 --> 01:13:18,339 a still strict requirement that 1722 01:13:18,339 --> 01:13:21,307 the post filing data or the fact 1723 01:13:21,307 --> 01:13:24,413 to be approved by the post filing 1724 01:13:24,413 --> 01:13:26,141 data should be clearly 1725 01:13:26,150 --> 01:13:29,525 and specifically disclosed in the 1726 01:13:29,525 --> 01:13:32,290 written description and based on 1727 01:13:32,290 --> 01:13:35,580 that criteria if the client wants to 1728 01:13:35,677 --> 01:13:39,128 file some post filing data to prove. 1729 01:13:39,130 --> 01:13:42,539 The some technical effect which is not 1730 01:13:42,539 --> 01:13:45,950 actually recorded in the red description 1731 01:13:45,950 --> 01:13:47,994 for for that kind of situation it 1732 01:13:47,994 --> 01:13:50,210 is still not acceptable in China. 1733 01:13:50,210 --> 01:13:53,250 So in short, I mean in general we 1734 01:13:53,250 --> 01:13:55,965 are having more limited and friendly 1735 01:13:55,965 --> 01:13:58,761 at you to post variant data, 1736 01:13:58,770 --> 01:14:02,218 but the the we need to see the 1737 01:14:02,218 --> 01:14:04,460 progress step by step yeah. 1738 01:14:07,470 --> 01:14:11,840 OK, good. Thank you. Uh, let's see. 1739 01:14:11,840 --> 01:14:14,660 Let's let's go back to Jill. 1740 01:14:14,660 --> 01:14:17,644 UM, another question about 1741 01:14:17,644 --> 01:14:20,628 the pan linkage system. 1742 01:14:20,630 --> 01:14:24,370 This is 1 about biologics. 1743 01:14:24,370 --> 01:14:26,337 Are the are the list of what 1744 01:14:26,337 --> 01:14:28,094 pants for biologists only limited 1745 01:14:28,094 --> 01:14:31,140 to sequential structure? So. 1746 01:14:31,140 --> 01:14:33,932 What if I have a patent for say 1747 01:14:33,932 --> 01:14:36,014 cellular extract or something that 1748 01:14:36,014 --> 01:14:38,194 is not a sequential structure? 1749 01:14:38,200 --> 01:14:40,208 Am I out of luck to utilize the 1750 01:14:40,208 --> 01:14:42,420 new patent linkage system? Can you? 1751 01:14:42,420 --> 01:14:44,670 Tell me. Explain that to me. 1752 01:14:44,670 --> 01:14:47,300 Thanks. So thanks for lying. 1753 01:14:47,300 --> 01:14:49,904 So why now the patent linked system 1754 01:14:49,904 --> 01:14:52,762 I mean the patent linkage litigation 1755 01:14:52,762 --> 01:14:56,619 system is only limited to chemicals drugs. 1756 01:14:56,620 --> 01:14:58,676 So biologics are large, 1757 01:14:58,676 --> 01:15:01,760 wouldn't be able to avail of 1758 01:15:01,866 --> 01:15:04,438 the patent linkage system, 1759 01:15:04,440 --> 01:15:07,653 although Article 76 or patent law in 1760 01:15:07,653 --> 01:15:11,507 itself is not limited to chemical drugs. 1761 01:15:11,510 --> 01:15:14,779 And what is happening right now will 1762 01:15:14,779 --> 01:15:17,898 be that about logic companies will 1763 01:15:17,898 --> 01:15:21,138 be able to submit part listings 1764 01:15:21,140 --> 01:15:23,215 and they can list sequential 1765 01:15:23,215 --> 01:15:25,760 structure but can only do that. 1766 01:15:25,760 --> 01:15:28,595 And as I mentioned in my presentation, 1767 01:15:28,600 --> 01:15:31,300 China with right now only inclining 1768 01:15:31,300 --> 01:15:34,610 for this system to be an experiment. 1769 01:15:34,610 --> 01:15:37,506 So in future there will be new rules 1770 01:15:37,506 --> 01:15:39,461 and hopefully biologics will be 1771 01:15:39,461 --> 01:15:42,149 covered and one now be only limited 1772 01:15:42,226 --> 01:15:44,330 to sequential structure only. 1773 01:15:44,330 --> 01:15:47,030 But we will need to. 1774 01:15:47,030 --> 01:15:49,208 Time to see how things unfold. 1775 01:15:51,410 --> 01:15:53,466 OK. Thank you. So let's wait and see. 1776 01:15:53,470 --> 01:16:00,450 OK. Yep. Yep. Alright, uhm. 1777 01:16:00,450 --> 01:16:04,139 Going back to Lynn about licensing trends, 1778 01:16:04,140 --> 01:16:08,028 just just looking into the next few years. 1779 01:16:08,030 --> 01:16:10,244 What licensing trends do you see 1780 01:16:10,244 --> 01:16:12,479 that may be important for a U.S. 1781 01:16:12,480 --> 01:16:13,710 company to know? 1782 01:16:13,710 --> 01:16:14,940 From your experience, 1783 01:16:14,940 --> 01:16:16,770 what you've seen so far? 1784 01:16:16,770 --> 01:16:19,878 Yeah, as I had mentioned earlier that 1785 01:16:19,878 --> 01:16:22,670 the investment trend is dropping their 1786 01:16:22,670 --> 01:16:25,370 licensing trends is increasing from 1787 01:16:25,370 --> 01:16:28,761 China to in license US technology 1788 01:16:28,761 --> 01:16:31,606 to improve their own portfolio. 1789 01:16:31,610 --> 01:16:34,025 And there are like I have many, 1790 01:16:34,030 --> 01:16:36,186 many friends, they move back to China, 1791 01:16:36,190 --> 01:16:37,486 they start a company. 1792 01:16:37,486 --> 01:16:40,185 So I will see more and more in 1793 01:16:40,185 --> 01:16:42,558 license what do we call that from 1794 01:16:42,558 --> 01:16:45,107 from US that especially from early 1795 01:16:45,110 --> 01:16:47,020 early technology for the startup. 1796 01:16:47,020 --> 01:16:48,320 Company like University Technology, 1797 01:16:48,320 --> 01:16:49,945 more and more like that. 1798 01:16:49,950 --> 01:16:52,638 Also from China, there will be more. 1799 01:16:52,640 --> 01:16:55,560 They some company want the late stage asset. 1800 01:16:55,560 --> 01:16:57,280 The company was which had 1801 01:16:57,280 --> 01:16:59,650 equipped with a lot of funding. 1802 01:16:59,650 --> 01:17:02,690 They were in license more late stage 1803 01:17:02,690 --> 01:17:06,155 assets from US for the China rights. 1804 01:17:06,160 --> 01:17:08,428 However because most the company you 1805 01:17:08,428 --> 01:17:11,536 know a lot of IPO company in China 1806 01:17:11,536 --> 01:17:14,330 their their value is cut into half 1807 01:17:14,330 --> 01:17:16,903 those company needs more money and. 1808 01:17:16,903 --> 01:17:17,629 There are. 1809 01:17:17,629 --> 01:17:20,170 There will be some good assets from 1810 01:17:20,245 --> 01:17:22,925 China to our license to the US company 1811 01:17:22,925 --> 01:17:25,766 and they were all licensed more like 1812 01:17:25,766 --> 01:17:28,276 a worldwide acceptor except for X, 1813 01:17:28,276 --> 01:17:29,088 Greater China, 1814 01:17:29,088 --> 01:17:29,494 right. 1815 01:17:29,494 --> 01:17:31,930 So you will get probably more 1816 01:17:32,014 --> 01:17:34,331 good yield for the US company to 1817 01:17:34,331 --> 01:17:36,828 look for in Chinese asset to that. 1818 01:17:36,828 --> 01:17:38,136 So I think that's the trend. 1819 01:17:40,860 --> 01:17:44,804 OK. Interesting. Uhm. OK. 1820 01:17:44,804 --> 01:17:49,950 OK, good. Jill, over to you, 1821 01:17:49,950 --> 01:17:53,550 this is a question about tantrum 1822 01:17:53,550 --> 01:17:55,855 extension and I understand that PAN 1823 01:17:55,855 --> 01:17:57,862 trim extension in the draft LB law 1824 01:17:57,862 --> 01:17:59,527 implementing regulations is only limited. 1825 01:17:59,530 --> 01:18:02,460 Certain classes of improved drugs. 1826 01:18:02,460 --> 01:18:06,625 Uh uhm, it particularly the draft patent 1827 01:18:06,625 --> 01:18:09,349 examination guidelines issued last year. 1828 01:18:09,350 --> 01:18:11,720 Does it mean that improved drugs 1829 01:18:11,720 --> 01:18:13,822 outside those listed are not 1830 01:18:13,822 --> 01:18:15,598 getting hand term extension? 1831 01:18:15,600 --> 01:18:18,510 Is this something you can address? 1832 01:18:18,510 --> 01:18:18,896 Right. 1833 01:18:18,896 --> 01:18:21,598 So we are all still waiting and 1834 01:18:21,598 --> 01:18:24,264 trying to see what will be coming 1835 01:18:24,264 --> 01:18:26,997 out of the final part is amination 1836 01:18:26,997 --> 01:18:29,937 guidelines to be issued by CN IPA. 1837 01:18:29,940 --> 01:18:31,485 Hopefully this will be out 1838 01:18:31,485 --> 01:18:33,030 within the next few months. 1839 01:18:33,030 --> 01:18:35,221 Until that I I don't have a 1840 01:18:35,221 --> 01:18:37,189 clear answer to the question, 1841 01:18:37,190 --> 01:18:39,584 but you are right according to 1842 01:18:39,584 --> 01:18:41,180 the draft examination guidelines, 1843 01:18:41,180 --> 01:18:43,725 only certain improvements will be 1844 01:18:43,725 --> 01:18:46,270 eligible for patent term extension. 1845 01:18:46,270 --> 01:18:48,870 But I think we should take a step back and. 1846 01:18:48,870 --> 01:18:51,355 There are also a few things I 1847 01:18:51,355 --> 01:18:53,420 think company should bear in mind. 1848 01:18:53,420 --> 01:18:57,050 According to the drug examination guidelines, 1849 01:18:57,050 --> 01:19:00,165 only new drug that has not been 1850 01:19:00,165 --> 01:19:02,546 marketed anywhere in the world 1851 01:19:02,546 --> 01:19:05,420 will be eligible for patent term 1852 01:19:05,420 --> 01:19:07,658 extension and that concept new 1853 01:19:07,658 --> 01:19:10,202 drug on actually is not consistent 1854 01:19:10,202 --> 01:19:13,055 with the new drug definition and 1855 01:19:13,055 --> 01:19:15,455 the PRC Drug Administration law. 1856 01:19:15,460 --> 01:19:18,766 So this is also something partitioners 1857 01:19:18,766 --> 01:19:20,419 within apartment community. 1858 01:19:20,420 --> 01:19:22,982 Public debating a lot and trying to 1859 01:19:22,982 --> 01:19:25,162 grapple with the hopefully given 1860 01:19:25,162 --> 01:19:27,677 the perspective from the industry, 1861 01:19:27,680 --> 01:19:30,025 I think not only from foreign companies 1862 01:19:30,025 --> 01:19:32,520 but also from domestic companies are 1863 01:19:32,520 --> 01:19:34,890 China has increasingly become the 1864 01:19:34,890 --> 01:19:37,300 world's innovation hub for life sciences. 1865 01:19:37,300 --> 01:19:40,282 Hopefully there will be better certainty 1866 01:19:40,282 --> 01:19:43,556 and clarity from CN IPA when they 1867 01:19:43,556 --> 01:19:47,910 issue the final examination guidelines. 1868 01:19:47,910 --> 01:19:48,846 OK. Thanks, Joe. 1869 01:19:48,846 --> 01:19:51,030 So this is another wait and see. 1870 01:19:51,030 --> 01:19:53,202 Yeah, yeah. 1871 01:19:53,202 --> 01:19:54,288 OK. 1872 01:19:54,290 --> 01:19:57,450 So I wanted to see if there are 1873 01:19:57,450 --> 01:19:59,910 any questions from the audience. 1874 01:19:59,910 --> 01:20:01,230 We have some more questions 1875 01:20:01,230 --> 01:20:02,550 to ask of the speakers, 1876 01:20:02,550 --> 01:20:04,899 but I wanted to give the opportunity to the 1877 01:20:04,899 --> 01:20:06,827 audience to see if there's any questions. 1878 01:20:06,830 --> 01:20:07,240 Larry, 1879 01:20:07,240 --> 01:20:10,520 I know you've been looking at the questions. 1880 01:20:10,520 --> 01:20:13,348 Are there any things that from the 1881 01:20:13,348 --> 01:20:16,090 audience that we actually have quite a 1882 01:20:16,090 --> 01:20:19,448 few that came in through the ask China IP? 1883 01:20:19,450 --> 01:20:21,106 Uh, email address, let me just. 1884 01:20:21,110 --> 01:20:21,457 Uh. 1885 01:20:21,457 --> 01:20:24,233 I kind of sorted them a little bit. 1886 01:20:24,240 --> 01:20:26,508 The first question I think go 1887 01:20:26,508 --> 01:20:28,770 to probably all three speakers. 1888 01:20:28,770 --> 01:20:30,813 Can you ask the panel the need to have 1889 01:20:30,813 --> 01:20:33,134 a Chinese company as a partner if U.S. 1890 01:20:33,140 --> 01:20:34,812 company plans to commercialize 1891 01:20:34,812 --> 01:20:36,484 a product in China? 1892 01:20:36,490 --> 01:20:37,699 In the past, 1893 01:20:37,699 --> 01:20:40,428 the best practice has also has indicated 1894 01:20:40,428 --> 01:20:42,892 there was a need to have a Chinese 1895 01:20:42,892 --> 01:20:45,236 based company to address local policy, 1896 01:20:45,240 --> 01:20:49,391 local politics and practice also to infer 1897 01:20:49,391 --> 01:20:52,960 ensure fair treatment before the courts. 1898 01:20:52,960 --> 01:20:54,988 And what what is the I 1899 01:20:54,988 --> 01:20:56,990 guess for all three panels, 1900 01:20:56,990 --> 01:20:58,976 what's your take on the question? 1901 01:21:01,700 --> 01:21:04,969 Just from a I can't start from 1902 01:21:04,969 --> 01:21:06,652 licensing part and that's what 1903 01:21:06,652 --> 01:21:08,470 happened to a lot of companies. 1904 01:21:08,470 --> 01:21:10,666 They license their good asset to 1905 01:21:10,670 --> 01:21:14,546 Chinese company like Zylab by Gene. 1906 01:21:14,550 --> 01:21:16,435 They also licensed in license 1907 01:21:16,435 --> 01:21:18,320 that big Chinese farmer actually 1908 01:21:18,385 --> 01:21:20,150 the original life in license. 1909 01:21:20,150 --> 01:21:22,614 A lot of fact and they helped to 1910 01:21:22,614 --> 01:21:24,767 promote their own drugs in in China. 1911 01:21:24,770 --> 01:21:26,802 I think that's uh. 1912 01:21:26,802 --> 01:21:29,342 Good model at this time. 1913 01:21:29,350 --> 01:21:29,880 That's Mike. 1914 01:21:32,130 --> 01:21:34,706 Yeah, I think what we were served on 1915 01:21:34,706 --> 01:21:37,028 equality and that's because of the 1916 01:21:37,028 --> 01:21:39,038 huge patient population in China, 1917 01:21:39,040 --> 01:21:41,888 a lot of multinationals are also trying to 1918 01:21:41,888 --> 01:21:44,418 take advantage of clinical trials in China. 1919 01:21:44,420 --> 01:21:47,030 But as link mentioned in China, 1920 01:21:47,030 --> 01:21:49,487 we have this human genetic data region, 1921 01:21:49,490 --> 01:21:51,656 meaning that if you're trying to 1922 01:21:51,656 --> 01:21:53,770 get clinical data out of China, 1923 01:21:53,770 --> 01:21:55,966 you need to go through certain 1924 01:21:55,966 --> 01:21:57,064 mistreated full process. 1925 01:21:57,070 --> 01:21:59,860 And because of that regime place 1926 01:21:59,860 --> 01:22:02,154 and because of the ongoing. 1927 01:22:02,154 --> 01:22:04,758 Political tensions are would tend to 1928 01:22:04,758 --> 01:22:07,479 believe that it would still be best 1929 01:22:07,479 --> 01:22:10,130 practice to work with a PRC partner, 1930 01:22:10,130 --> 01:22:12,587 but how you can diligence their partner 1931 01:22:12,587 --> 01:22:15,298 and ensure you have safeguards in place 1932 01:22:15,298 --> 01:22:17,680 to ensure a smooth collaboration and 1933 01:22:17,746 --> 01:22:20,138 to get clinical data out of China I 1934 01:22:20,138 --> 01:22:23,665 think will be something that require not 1935 01:22:23,665 --> 01:22:25,774 contractual provisions to protect you, 1936 01:22:25,774 --> 01:22:28,060 but as well as ongoing operational 1937 01:22:28,130 --> 01:22:30,570 vigilance throughout the collaboration. 1938 01:22:34,530 --> 01:22:37,743 Yes. Uh. So from time to time I'm also 1939 01:22:37,743 --> 01:22:40,234 confronted with this kind of question 1940 01:22:40,234 --> 01:22:42,780 from our foreign clients about the 1941 01:22:42,780 --> 01:22:45,450 political impact on the outcome of 1942 01:22:45,450 --> 01:22:48,439 a patent infringement litigation. 1943 01:22:48,440 --> 01:22:50,290 So from my personal experience, 1944 01:22:50,290 --> 01:22:54,982 I think that's not so significant 1945 01:22:54,982 --> 01:22:58,010 because especially in the patent 1946 01:22:58,010 --> 01:23:00,807 infringement litigation. So in our 1947 01:23:00,807 --> 01:23:05,540 case is we are we are asserting over. 1948 01:23:05,540 --> 01:23:08,260 Assertions by using evidence. 1949 01:23:08,260 --> 01:23:11,252 So, so long as we have evidence to show 1950 01:23:11,252 --> 01:23:14,126 we have fixed in the infringing products, 1951 01:23:14,130 --> 01:23:16,489 we have our test report and the 1952 01:23:16,489 --> 01:23:18,649 result shows there is infringement. 1953 01:23:18,650 --> 01:23:20,834 At least you can get injunction order 1954 01:23:20,834 --> 01:23:23,299 as to the monetary compensation. 1955 01:23:23,300 --> 01:23:26,132 Uh, at least in my case I didn't 1956 01:23:26,132 --> 01:23:28,659 see such political influence. 1957 01:23:28,660 --> 01:23:28,990 Yeah. 1958 01:23:31,210 --> 01:23:32,594 OK. Thank you everybody. 1959 01:23:32,594 --> 01:23:35,095 Another question is kind of may be 1960 01:23:35,095 --> 01:23:36,895 related with the first question, 1961 01:23:36,900 --> 01:23:38,031 the question asked, 1962 01:23:38,031 --> 01:23:40,670 can you elaborate on the licensee trying 1963 01:23:40,733 --> 01:23:42,869 to improve pattern then ditch the? 1964 01:23:42,870 --> 01:23:44,662 Ditching the pen owner, 1965 01:23:44,662 --> 01:23:46,902 are there any case studies, 1966 01:23:46,910 --> 01:23:48,906 either domestic or foreign, 1967 01:23:48,906 --> 01:23:52,426 and what would you advise the pen 1968 01:23:52,426 --> 01:23:55,485 owner to preempt such an attempt by 1969 01:23:55,485 --> 01:23:58,466 a licensee to ditch the pen owner? 1970 01:23:58,470 --> 01:23:59,643 I've probably can't. 1971 01:23:59,643 --> 01:24:01,610 I can take this question. 1972 01:24:01,610 --> 01:24:03,610 It happens quite a bit. 1973 01:24:03,610 --> 01:24:07,187 A lot happens quite in peoples minds. 1974 01:24:07,190 --> 01:24:07,955 They, you know, 1975 01:24:07,955 --> 01:24:10,089 as a licensee they want take this license 1976 01:24:10,089 --> 01:24:12,098 over then they improve a little bit. 1977 01:24:12,100 --> 01:24:14,424 They ditched license or so they can't, 1978 01:24:14,430 --> 01:24:17,475 they avoid by paying by avoid paying 1979 01:24:17,475 --> 01:24:19,875 maintenance fee and royalty whatever 1980 01:24:19,875 --> 01:24:23,438 downstream and then they become their own. 1981 01:24:23,440 --> 01:24:27,416 IP become their own IP and then. 1982 01:24:27,420 --> 01:24:29,674 As a license or it's really important 1983 01:24:29,674 --> 01:24:31,816 to put some language saying anything 1984 01:24:31,816 --> 01:24:34,860 related and you have to be more space. 1985 01:24:34,860 --> 01:24:36,344 You know just like. 1986 01:24:36,344 --> 01:24:37,086 The university, 1987 01:24:37,090 --> 01:24:38,728 the Big University, 1988 01:24:38,728 --> 01:24:41,458 anything enabled by our technology, 1989 01:24:41,460 --> 01:24:42,903 that's our IP. 1990 01:24:42,903 --> 01:24:47,360 You insist on that and that's very important. 1991 01:24:47,360 --> 01:24:47,683 2. 1992 01:24:47,683 --> 01:24:50,267 Avoid them to get you or and also 1993 01:24:50,267 --> 01:24:53,611 you need to make sure the language if 1994 01:24:53,611 --> 01:24:56,280 they have anything you you need to 1995 01:24:56,280 --> 01:25:00,648 get a free license to for you to use. 1996 01:25:00,650 --> 01:25:01,036 It. 1997 01:25:01,036 --> 01:25:03,738 Yeah, it's being negotiated back and forth. 1998 01:25:03,740 --> 01:25:06,160 I've been representing both sides, 1999 01:25:06,160 --> 01:25:07,090 but the side, 2000 01:25:07,090 --> 01:25:08,950 if you you have upper hand, 2001 01:25:08,950 --> 01:25:11,185 you insist on anything enabled 2002 01:25:11,185 --> 01:25:12,526 by my technology, 2003 01:25:12,530 --> 01:25:15,779 you need to that I need to have a 2004 01:25:15,779 --> 01:25:18,354 share or I need to be the owner. 2005 01:25:18,354 --> 01:25:19,770 Maybe that's too much, 2006 01:25:19,770 --> 01:25:21,912 but you can at least get some 2007 01:25:21,912 --> 01:25:23,340 share out of there. 2008 01:25:23,340 --> 01:25:25,815 I also wanted to add a few points here. 2009 01:25:25,820 --> 01:25:28,404 Fully agree with link as I think I 2010 01:25:28,404 --> 01:25:31,075 had a case where permitted licensee 2011 01:25:31,075 --> 01:25:33,985 using our clients know how and 2012 01:25:34,067 --> 01:25:37,062 filed more than 100 patents in China 2013 01:25:37,062 --> 01:25:39,498 Latin extreme case but it's peaceful. 2014 01:25:39,500 --> 01:25:42,116 The importance of protecting our know 2015 01:25:42,116 --> 01:25:45,689 how and how you can include as much 2016 01:25:45,689 --> 01:25:49,129 as contract protection as you can think of. 2017 01:25:49,130 --> 01:25:51,620 So restrictive covenants in agreement 2018 01:25:51,620 --> 01:25:53,612 will be critically important. 2019 01:25:53,620 --> 01:25:55,846 And I think it's also important 2020 01:25:55,846 --> 01:25:58,592 to have an audit class so that 2021 01:25:58,592 --> 01:26:00,968 you can invoke the rather causes 2022 01:26:00,968 --> 01:26:03,207 some situation is not going right. 2023 01:26:03,210 --> 01:26:05,335 But again there requires certain 2024 01:26:05,335 --> 01:26:07,460 level vigilance oil can properly 2025 01:26:07,527 --> 01:26:09,043 monitor potential filings made 2026 01:26:09,043 --> 01:26:11,855 by a licensee or having any local 2027 01:26:11,855 --> 01:26:14,195 intelligence from employees in China. 2028 01:26:14,200 --> 01:26:17,896 I think this is something a lot 2029 01:26:17,896 --> 01:26:21,232 of companies are facing but but 2030 01:26:21,232 --> 01:26:24,178 contractual protection is the first line. 2031 01:26:24,180 --> 01:26:26,525 Of defense for you have a proper 2032 01:26:26,525 --> 01:26:27,530 contract in place. 2033 01:26:30,440 --> 01:26:31,568 OK. Thank you. 2034 01:26:31,568 --> 01:26:34,200 The next question is with regard to 2035 01:26:34,285 --> 01:26:37,293 Article 14 of the of China's patent law. 2036 01:26:37,300 --> 01:26:40,380 I actually quickly looked at Article 14. 2037 01:26:40,380 --> 01:26:43,670 I think it may the. 2038 01:26:43,670 --> 01:26:46,484 Audience are didn't catch the name here. 2039 01:26:46,490 --> 01:26:48,506 I may have misread Article 14, 2040 01:26:48,510 --> 01:26:50,724 but let me just read your question to you. 2041 01:26:50,730 --> 01:26:53,079 I think there may be 2 sort of two 2042 01:26:53,079 --> 01:26:55,328 aspects that we can separately address. 2043 01:26:55,330 --> 01:26:57,412 So the audience Questions Article 14 2044 01:26:57,412 --> 01:26:59,886 of China's time law allows Chinese 2045 01:26:59,886 --> 01:27:02,875 central government to permit designated 2046 01:27:02,875 --> 01:27:06,150 units to exploit important invention. 2047 01:27:06,150 --> 01:27:07,431 Uh, important invention, 2048 01:27:07,431 --> 01:27:09,566 so long as the exploitation 2049 01:27:09,566 --> 01:27:12,167 fee is paid to the pen holder. 2050 01:27:12,170 --> 01:27:12,673 Essentially, 2051 01:27:12,673 --> 01:27:16,194 Article 14 allows an open licensing system. 2052 01:27:16,200 --> 01:27:21,000 What are possible paths for a pen holder? 2053 01:27:21,000 --> 01:27:23,992 That that a pen holder can take to 2054 01:27:23,992 --> 01:27:25,931 avoid unwanted companies obtaining 2055 01:27:25,931 --> 01:27:29,835 a license to the patentees IP in 2056 01:27:29,835 --> 01:27:32,630 situations such as Article 14, 2057 01:27:32,630 --> 01:27:35,630 and let me explain why. 2058 01:27:35,630 --> 01:27:38,738 I think the Article 14 actually 2059 01:27:38,738 --> 01:27:42,968 maybe may not be about open license. 2060 01:27:42,970 --> 01:27:44,866 I quickly looked at Article 14. 2061 01:27:44,870 --> 01:27:48,220 Actually it's about invention, patent. 2062 01:27:48,220 --> 01:27:51,940 Uh, by a state owned enterprise, 2063 01:27:51,940 --> 01:27:53,940 if that's of great significance, 2064 01:27:53,940 --> 01:27:56,640 the government can. 2065 01:27:56,640 --> 01:27:57,576 It's kind of like the US, 2066 01:27:57,580 --> 01:27:58,476 Martin writes. 2067 01:27:58,476 --> 01:27:58,924 So, 2068 01:27:58,924 --> 01:28:01,612 but I think the audience questions 2069 01:28:01,612 --> 01:28:04,118 still valid sort of two aspects. 2070 01:28:04,120 --> 01:28:07,578 Number one is the state owned enterprise 2071 01:28:07,580 --> 01:28:09,800 produced patterns the government can 2072 01:28:09,800 --> 01:28:13,080 kind of March in if it's important 2073 01:28:13,080 --> 01:28:15,760 and the open licensing system, 2074 01:28:15,760 --> 01:28:18,728 I forgot which article is sort of a 2075 01:28:18,728 --> 01:28:20,829 separate article in the patent law. 2076 01:28:20,830 --> 01:28:22,660 And let me maybe take a 2077 01:28:22,660 --> 01:28:24,630 first stab at the question. 2078 01:28:24,630 --> 01:28:27,318 I think the open licensing system 2079 01:28:27,318 --> 01:28:29,047 is totally voluntary, right? 2080 01:28:29,047 --> 01:28:31,686 So if you don't want your pattern 2081 01:28:31,690 --> 01:28:36,394 to be to be listed as open as listed 2082 01:28:36,394 --> 01:28:39,079 as available to open license. 2083 01:28:39,080 --> 01:28:40,664 You don't have to. 2084 01:28:40,664 --> 01:28:43,040 But once you list your patent 2085 01:28:43,124 --> 01:28:45,599 in that open licensing system. 2086 01:28:45,600 --> 01:28:48,180 And this is a question for all three of you. 2087 01:28:48,180 --> 01:28:50,119 I don't think you can then say, 2088 01:28:50,120 --> 01:28:51,220 oh, I want, I can. 2089 01:28:51,220 --> 01:28:51,589 Uh, 2090 01:28:51,589 --> 01:28:54,172 I don't think you can say two 2091 01:28:54,172 --> 01:28:56,092 potential licensee or I want to 2092 01:28:56,092 --> 01:28:58,323 license to you but not the other 2093 01:28:58,323 --> 01:28:59,981 licensee open licensing system 2094 01:28:59,981 --> 01:29:01,916 mean anybody can license right. 2095 01:29:01,920 --> 01:29:04,098 And you actually list out the 2096 01:29:04,098 --> 01:29:06,080 terms and the fees right. 2097 01:29:06,080 --> 01:29:06,629 Am I right? 2098 01:29:09,410 --> 01:29:11,168 Yes, I think you're right, Larry. 2099 01:29:11,168 --> 01:29:14,952 So the open lessons reading is it's newly 2100 01:29:14,952 --> 01:29:17,724 introduced into the Chinese patent law in 2101 01:29:17,724 --> 01:29:20,561 the 4th Amendment to the Chinese patent 2102 01:29:20,561 --> 01:29:23,240 law and it's voluntary voluntarily. 2103 01:29:23,240 --> 01:29:27,224 It's not something you're forced to to 2104 01:29:27,224 --> 01:29:30,068 allow open lessons of your patterns, 2105 01:29:30,070 --> 01:29:33,730 but you have also once you the cmap, 2106 01:29:33,730 --> 01:29:36,040 even after the scene IPA announced 2107 01:29:36,040 --> 01:29:38,809 that this is an open license pattern, 2108 01:29:38,810 --> 01:29:40,274 you can withdraw. 2109 01:29:40,274 --> 01:29:42,714 You can withdraw your application 2110 01:29:42,714 --> 01:29:45,194 application for for for open lessons 2111 01:29:45,194 --> 01:29:47,789 so so once you announce your pattern 2112 01:29:47,789 --> 01:29:50,442 is open lessons the patterns you you 2113 01:29:50,442 --> 01:29:53,975 need to follow a rule similar to 2114 01:29:53,975 --> 01:29:57,364 the to the friend friend agreement. 2115 01:29:57,364 --> 01:30:01,438 Yeah yeah. That patterns type of rules. 2116 01:30:01,440 --> 01:30:05,290 OK. No discrimination. Yeah. Yeah. 2117 01:30:05,290 --> 01:30:06,557 Oh, OK. Thank you. 2118 01:30:06,557 --> 01:30:09,193 I'm just kind of a what's the best term 2119 01:30:09,193 --> 01:30:11,485 to describe just playing devil's advocate? 2120 01:30:11,490 --> 01:30:13,345 I actually a question just occur to 2121 01:30:13,345 --> 01:30:15,389 me related to the audience question. 2122 01:30:15,390 --> 01:30:17,777 If you really don't want to license 2123 01:30:17,777 --> 01:30:19,560 your patent to a company, 2124 01:30:19,560 --> 01:30:21,800 let's say you put it in the open 2125 01:30:21,800 --> 01:30:22,360 license system, 2126 01:30:22,360 --> 01:30:24,550 then all of a sudden this 2127 01:30:24,550 --> 01:30:25,645 company approached you. 2128 01:30:25,650 --> 01:30:29,178 Can you then say, oh, I want to withdraw? 2129 01:30:29,180 --> 01:30:31,932 Uh, no, at that time, you cannot withdraw. 2130 01:30:31,932 --> 01:30:32,276 Yeah. 2131 01:30:32,276 --> 01:30:32,620 No. 2132 01:30:32,620 --> 01:30:35,135 Yeah, because the other party 2133 01:30:35,135 --> 01:30:37,425 has already approached trust. 2134 01:30:37,425 --> 01:30:39,805 Yeah. Already approached you. 2135 01:30:39,810 --> 01:30:40,337 Yeah. 2136 01:30:40,337 --> 01:30:40,864 Yeah. 2137 01:30:40,864 --> 01:30:44,553 So the actually in the open license 2138 01:30:44,553 --> 01:30:47,364 reading the CMP is the play the 2139 01:30:47,364 --> 01:30:50,069 role of a kind of platform, 2140 01:30:50,070 --> 01:30:51,566 actually see an IPA. 2141 01:30:51,566 --> 01:30:54,365 They have a great concern that they 2142 01:30:54,365 --> 01:30:56,750 may have kind of responsibility 2143 01:30:56,750 --> 01:30:58,658 in publishing and announcing 2144 01:30:58,734 --> 01:31:00,570 the relevant information. 2145 01:31:00,570 --> 01:31:02,718 They don't want to take any 2146 01:31:02,718 --> 01:31:04,150 liability in this region. 2147 01:31:04,150 --> 01:31:06,845 They are only working at a platform 2148 01:31:06,845 --> 01:31:08,430 they providing organizes the 2149 01:31:08,430 --> 01:31:10,245 information for for the users, 2150 01:31:10,250 --> 01:31:11,354 the users, they, 2151 01:31:11,354 --> 01:31:13,562 these they they looking for those 2152 01:31:13,562 --> 01:31:15,299 information on the platform, yeah. 2153 01:31:15,299 --> 01:31:16,346 OK, thank you. 2154 01:31:16,346 --> 01:31:19,459 And going back to the first part of 2155 01:31:19,459 --> 01:31:21,819 the audience question regarding Article 2156 01:31:21,819 --> 01:31:24,989 14 invention made by state owned company. 2157 01:31:24,990 --> 01:31:27,608 The government has a right to license, 2158 01:31:27,610 --> 01:31:29,954 I guess, to forcefully licensed at Penn as 2159 01:31:29,954 --> 01:31:32,480 long as they're reasonable compensation. 2160 01:31:32,480 --> 01:31:34,919 I read it as very similar to the sort 2161 01:31:34,919 --> 01:31:37,779 of March in rights in the United States. 2162 01:31:37,780 --> 01:31:42,425 Do three of you have any experience, 2163 01:31:42,425 --> 01:31:44,550 experience or actually are you 2164 01:31:44,550 --> 01:31:47,256 aware of any marching orders, 2165 01:31:47,256 --> 01:31:50,670 marching rights exercised by the government, 2166 01:31:50,670 --> 01:31:51,544 yet no, 2167 01:31:51,544 --> 01:31:55,040 I don't think there is a precedent case. 2168 01:31:55,040 --> 01:31:55,784 Yeah, OK. 2169 01:31:55,784 --> 01:31:58,016 No, no Case No president case. 2170 01:31:58,020 --> 01:32:01,218 And also this is an article, 2171 01:32:01,220 --> 01:32:04,616 uh specifically for state owned company. 2172 01:32:04,620 --> 01:32:06,852 It has nothing to do with a foreign company. 2173 01:32:06,860 --> 01:32:07,650 Yeah. 2174 01:32:07,650 --> 01:32:08,440 OK. 2175 01:32:10,750 --> 01:32:12,670 I think this is another way to see. 2176 01:32:12,670 --> 01:32:15,722 Well, see Holly roots will be deployed 2177 01:32:15,722 --> 01:32:18,470 at some point. OK. Thank you. 2178 01:32:18,470 --> 01:32:23,948 So we we are actually at a little over time. 2179 01:32:23,950 --> 01:32:25,994 So we this goes to this web 2180 01:32:25,994 --> 01:32:28,260 and R goes to 11:00 o'clock. 2181 01:32:28,260 --> 01:32:29,470 So we are over time. 2182 01:32:29,470 --> 01:32:33,889 So I want to thank again all our speakers 2183 01:32:33,889 --> 01:32:38,666 for excellent presentations for I think 2184 01:32:38,666 --> 01:32:42,412 hopefully a useful Q&A period for everyone. 2185 01:32:42,412 --> 01:32:44,869 I think this is a very interesting. 2186 01:32:44,870 --> 01:32:46,074 I've learned a couple of new things. 2187 01:32:46,080 --> 01:32:48,010 So again appreciate this very 2188 01:32:48,010 --> 01:32:49,940 much and thank you all. 2189 01:32:49,940 --> 01:32:52,406 And a reminder to the audience, 2190 01:32:52,410 --> 01:32:56,064 please go ahead and take the post. 2191 01:32:56,070 --> 01:32:58,910 When our survey so that we can continually 2192 01:32:58,910 --> 01:33:01,566 help to improve these webinars and 2193 01:33:01,566 --> 01:33:03,708 get you the best information we can. 2194 01:33:03,710 --> 01:33:04,920 Thank you again very much. 2195 01:33:04,920 --> 01:33:07,302 Sorry, sorry Lynn actually forgot to 2196 01:33:07,302 --> 01:33:09,322 answer an important question several 2197 01:33:09,322 --> 01:33:11,173 people asked about the slides. 2198 01:33:11,173 --> 01:33:13,088 I want to quickly mention. 2199 01:33:13,090 --> 01:33:15,110 This event is actually recorded 2200 01:33:15,110 --> 01:33:17,957 I think two to three weeks once 2201 01:33:17,957 --> 01:33:19,928 we go through some steps, 2202 01:33:19,928 --> 01:33:23,204 it will be available on PTO website 2203 01:33:23,204 --> 01:33:25,978 and also the slides pending. 2204 01:33:25,980 --> 01:33:28,350 A speaker permission will be all 2205 01:33:28,350 --> 01:33:30,895 posted as well and and we just one 2206 01:33:30,895 --> 01:33:32,873 last thing actually two or three or 2207 01:33:32,873 --> 01:33:34,847 even four questions came in that we 2208 01:33:34,847 --> 01:33:37,199 are not going to have time to address. 2209 01:33:37,200 --> 01:33:40,945 It all relates to the CFIUS and 2210 01:33:40,945 --> 01:33:43,349 the newer version of CFIUS. 2211 01:33:43,350 --> 01:33:45,370 I think it's called Firrma. 2212 01:33:45,370 --> 01:33:45,910 Yeah, 2213 01:33:45,910 --> 01:33:46,450 maybe. 2214 01:33:46,450 --> 01:33:49,690 I'm not sure how much experience 2215 01:33:49,690 --> 01:33:51,942 Lynn has with regard to both, 2216 01:33:51,942 --> 01:33:54,078 but maybe we can address those questions 2217 01:33:54,078 --> 01:33:55,974 through email by Lynn or something 2218 01:33:55,974 --> 01:33:58,478 we kind of run out of time this time. 2219 01:33:58,480 --> 01:33:59,383 Yes, thank you. 2220 01:33:59,383 --> 01:34:00,286 I can't wait. 2221 01:34:00,290 --> 01:34:01,496 We can talk about this later. 2222 01:34:01,500 --> 01:34:01,738 Yeah, 2223 01:34:01,738 --> 01:34:03,166 that's a that's a long story, 2224 01:34:03,170 --> 01:34:03,520 but. 2225 01:34:05,630 --> 01:34:07,088 Yeah. OK. Alright. 2226 01:34:07,088 --> 01:34:09,518 Thank you all very much. 2227 01:34:09,520 --> 01:34:12,248 OK. Thank you, everybody. 2228 01:34:12,250 --> 01:34:14,730