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Dear Mr

Dear Mr. Clarke

Thank you for taking the time to speak with me regarding the proposed changes to implement patent term adjustment. During our discussion, I raised a number of points that I would like to submit as written comments. First, I am concerned that there does not appear to be any mechanism for a third party to challenge the computation of a term adjustment. If the term granted is too long, you can imagine that a potential licensee would be interested in seeing the term corrected. Similarly, if a pharmaceutical patent containing an overly generous term is listed in the FDA Orange Book,, a potential ANDA applicant may not have any way to challenge the date and, upon filling a Para. III certification, may be forced to stay off of the market unnecessarily long, thereby depriving the public of lower cost drugs. Second I would like to request that both the initial and final determinations of patent term adjustment be accompanied by a work sheet showing all of the relevant dates and how the answer was derived. This work sheet will help everyone. It will help the applicant confirm that the determination is correct and that could reduce the burden placed upon the PTO of dealing with petitions for patent term adjustment under Rule 1.705 from applicants who do not understand how the figures were derived. Preventing needless petitions which could just slow the reconsideration process is in everyone's interest. Providing a work sheet would also make any request for reconsideration more focused and would ease the PTO's review process. An applicant could point to a specific entry on the work sheet that is allegedly in error and suggest to the PTO what the correct data, and the resulting adjustment, should be. The PTO could then review the work sheet and the alleged error and more quickly determine if the applicant is correct. This would place far less burden on the PTO. This process would also be greatly assisted by allowing practitioners to purchase the PTO's software, or by providing an interactive tool on the PTO's web site which would allow practitioners to double check the computations. This would allow a practitioner to double check their own analysis without creating additional errors which would only further complicate the review process. A practitioner might be correct that the PTO goofed on a computation of term adjustment. But in proposing a correction, he or she might also make a mistake and that might just make things more complicated and time consuming. The program or web site tool could reduce such compounding of errors. In addition, a practitioner may learn that despite the PTO's error, the end result in terms of the overall adjustment,is in fact the same. Thus, even if the PTO were wrong in how it got to that number, there would be no reason to request correction (no harm - no foul) and a needless petition could be avoided. 
Thank you again. If you have any questions, please do not hesitate to contact me. 
Very truly yours, 
Michael H. Teschner of Lerner, David, Littenberg, Krumholz & Mentlik - Phone 908-654-5000, Fax 908-654-7866 

Dear. Mr. Clark

It was a pleasure speaking with you again yesterday. I would like to use this opportunity to memorialize some of the comments I made during that conversation. Specifically, I noted my concern with regard to the proposed rules codified in 37 C.F.R. § 1.704(5) and (9). Subsection (5) will penalize the applicant for filing an application with an unexecuted declaration, something which is very common in today's practice. Of course, this practice does not, in any way, slow down the Patent Office's ability to prosecute an application and therefore, suggesting that filing an application with an unexecuted declaration is a source of "applicant's delay" is contrary to fact. More importantly, I believe that this provision is actually going to cause the Patent Office a considerable amount of administrative headache and may possibly cause the very thing which the Patent Office is seeking to avoid, namely granting patent term adjustments. We have been encouraged by the Patent Office in the past to hold off on filing executed declarations until we receive a Notice of Missing Parts because of the difficulty the Patent Office has in matching up papers submitted shortly after an application is filed. Now, waiting for the convenience of the Patent Office will cause prejudice to the applicant. Accordingly, it is now in my interest to send the executed declaration into the Patent Office immediately upon receipt. This will minimize "applicant's delay." However, the Patent Office is likely to have difficulty in matching up the declaration with the file and will likely needlessly send a Notice of Missing Parts. We will respond that in fact we did supply the proper documentation and will provide a postcard stamped from the Patent Office regarding same. The Patent Office will then have to go back to its records, creating a significant administrative burden and, potentially, interfering with the prosecution process. Not only will this cause an administrative drain on the Patent Office, it may in fact cause that which the Patent Office seeks to avoid, namely delay attributable to the Patent Office. I also believe that Subsection (9) can be a great source of inequity. For example, if a patent application is filed without an abstract, it will be considered applicant's delay until an abstract is provided. That may not be discovered for months later until the Examiner takes up the case. If that isn't bad enough, the rules as currently written suggest that an abstract which is submitted but which does not comply with all of the requirements for an abstract would constitute "applicant's delay." The rules for an abstract currently set forth a certain number of words. Should that number be exceeded by one word, technically speaking, the abstract would not be in compliance and an Examiner could object on that basis. It is possible, the way the rules are currently written, that that small oversight could be considered "applicant's delay" and accordingly, the entire period from filing until responding to the Official Action could count against the applicant. This is harsh to say the least. At very least, I believe that it would be appropriate to expand the missing parts practice to include examination of the application to ensure that it is in condition for publication. If there is going to be an objection to the abstract, or if an abstract is missing, then that should be identified early allowing applicants to fix it without dramatic effects on patent term adjustment. This would also serve the Patent Office's goal of ensuring that the application is in condition for publications at a relatively early date. In addition, everyone's goals could be better met by not holding against the applicants the submission of an incomplete application until after a Notice of Missing Parts is issued. That Notice should identify anything that is missing or not sufficiently in compliance with the rules to allow for publication. You could start counting the "applicant's delay" from the mailing date of the Notice of Missing Parts. This would effectively use the patent term adjustment provisions as the encouragement to respond quickly. Please call if you have any questions.  

Michael H. Teschner of Lerner, David, Littenberg, Krumholz & Mentlik - Phone 908-654-5000, Fax 908-654-7866 

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Last Modified: 9/16/2009 12:14:58 PM