COMMISSIONER LEHMAN:  Thank you very much.  If
       anything, we have been hearing that some people don't think
       that the 20 years from filing is enough.
       I am agreeing with your last comment.
       Next, Robert F. Green.
       MR. GREEN:  Mr. Secretary, distinguished panel. 
       My name is Robert F. Green.  I am a partner with the law
       firm of Lodi, Point & Mer [phonetic], Chicago, Illinois.  I
       am here today on behalf of Novopharm Limited, Canada's
       largest generic pharmaceutical manufacturer, as well as its
       U.S. subsidiary, Novopharm, Inc.
       I wish to address really only two points today. 
       ANDAs filed prior to June 8, 1995, and the question of
       tacking of a 156 extension onto a GATT term.  
       To put this into context, I have personally looked
       at the Orange Book, as to all listed patents, and have
       determined that over 200 listed patents fall into the
       category of having an extended term as a result of the GATT
       provisions.  This is obviously a significant concern to the
       generic pharmaceutical industry.
       There has been a lot of talk here as to what law
       has changed and what law has not changed, as a result of
       GATT.  I say that to understand answer to that, we have to
       first understand what the law, in fact, is.
       How does a patent become an obstacle to approval
       of an ANDA?  I think we all know that there is registration
       procedure by which an NDA holder registers with the FDA a
       given patent.  Then, when an ANDA applicant comes along,
       there is a certification requirement under 21 U.S.C.
       355(j)(2)(A)(7), and it says that "that ANDA applicant must
       certify with respect to any patent that is then in
       existence, the date upon which such patent will expire." 
       That is a quote.
       The FDA, then, proceeds to examine the ANDA,
       ultimately determines whether it is approvable or not and
       then must face the question of what is the effective date of
       that approval if there is a patent certification under
       paragraph 3.
       When an ANDA applicant under paragraph 3 makes a
       certification, the FDA is then mandated to make an
       approvable ANDA effective in accordance with the provisions
       of 21 U.S.C. 355(j)(4)(B)(2), which requires that the
       approval be made, "effective on the date certified under
       subclause (3)."
       Thus, for any ANDA filed prior to June 8, 1995,
       containing a paragraph 3 certification of expiry based upon
       that original 17-year patent term, the statute permits the
       FDA to delay approval only until the passage of that expiry
       This must be taken, I think, also in concert with
       the provisions of 35 U.S.C. 271(e)(2), the patent
       infringement provision which states that it is an act of
       infringement to submit an ANDA, "if the purpose of such
       submission is to obtain approval to engage in the commercial
       manufacture, use, or sale of the drug claimed in a patent or
       the use of which is claimed in a patent before the
       expiration of such patent."
       The sole potential act of infringement, then, is
       the submission of the ANDA.  Without a doubt, the submission
       of an ANDA prior to June 8, 1995, seeking approval to market
       upon the expiration of that original 17-year patent term is
       not then an act of infringement.
       We submit that there is no statutory authority by
       which the FDA can seek, request, or demand an amended patent
       certification because the term of a certified patent has
       been changed through the implementation of subsequent
       legislation, including the URAA.  
       Congress was conspicuously quiet on this point
       when it did enact URAA.  Accordingly, it is our position
       that with respect to any ANDA submitted prior to June 8,
       1995, seeking approval to market a product, upon expiration
       of the original 17-year date expiry date of a patent, it is
       only that expiry date that can govern with respect to that
       complete ANDA.
       FDA has no statutory basis upon which to require
       recertification, as suggested by the gentleman from
       Bristol-Myers Squibb.  New expiration dates would be
       modified under URAA.  The FDA is authorized by statute to
       delay the effective date of approval for any such ANDA only
       until the "date certified," by the ANDA applicant, which
       would the original 17-year expiry date.
       To take a position otherwise would be to interpret
       the URAA as requiring a retroactive application which
       specifically was not authorized by Congress.  I would like
       to quote from a 1994 U.S. Supreme Court decision, Landgraf
       v. USI Film Products.  In this decision, the Court was
       addressing whether a statute in part should be applied
       From the Court itself:  "The presumption against
       retroactive legislation is deeply routed in our
       jurisprudence.  It embodies legal doctrine centuries older
       than our Republic.  Elementary considerations of fairness
       dictate that individuals should have an opportunity to know
       what the law is and to conform their conduct accordingly. 
       Subtle expectations," such as that of an ANDA applicant
       filed before June 8, 1995, "should not be lightly disrupted. 
       Retroactive legislation presents problems of unfairness that
       are more serious than those posed by prospective legislation
       because it can deprive citizens of legitimate expectations
       and upset subtle transactions."
       James Madison argued that retroactive legislation
       also offered a special opportunity for the powerful to
       obtain special and improper legislative benefits.  According
       to Madison, bills of attainder, ex post facto laws, and laws
       impairing the obligations of contracts were contrary to the
       first principles of social compact and to every principle of
       sound legislation, in part because such measures invited the
       influential to speculate on public measures to the detriment
       to the more industrious and less informed part of the
       Continuing, the Court said:  "A requirement that
       Congress first make its intention clear help ensure that
       Congress itself has determined that the benefits of
       retroactivity outweigh the potential for disruption or
       unfairness.  Since the early days of this Court, we have
       declined to give retroactive effect to statutes burdening
       private rights unless Congress had made clear its intent. 
       If the statute would operate retroactively, our traditional
       presumption teaches that it does not govern absent clear
       congressional intent favoring such a result."
       Our position on that is, it does not exist in this
       If I could have 30 seconds to address the question
       of the 156 extension?
       Apples and oranges.  I harken back to the days, I
       can still remember, in high school algebra where, to make
       the point that you can't add X and Y, the instructor said,
       "Apples and oranges can't be added together."
       A Section 156 extension is an extension that is
       "specific to an approved product."  The extended term under
       GATT is with respect to all claims of a patent but subject
       to the substantial investment inroad, if you will, that can
       be made by one who has undertaken a substantial investment
       prior to June 8, 1995.
       The rights derived by each are different and can't
       be added together.  I would say, as one point in fact, if
       you look at the Orange Book for the product, Misoprostol,
       this patent contains claims that cover the product per se as
       approved, as well as other claims.  It currently is in
       existence only because of the Section 156 extension.  
       What is the outcome if we add a GATT extension to
       that?  Do the claims in the application that are not
       directed to the approved product then become reincarnated,
       I think this amply indicates that these are apples
       and oranges and cannot be added back to back.  
       I would entertain any questions.
       COMMISSIONER LEHMAN:  Could you tell me a little
       bit about Novopharm?  What is the size of the company?
       MR. GREEN:  It is the largest pharmaceutical
       company, generic pharmaceutical company, in Canada.  I think
       in terms of both dollars, sales, as well as in terms of
       prescriptions filled.  
       It has a substantial presence here in the United
       COMMISSIONER LEHMAN:  What is the annual revenue?
       MR. GREEN:  The President of Novopharm, Inc., is
       actually in the audience.  I would have to defer to him.
       Bob, if you have an answer?
       THE PRESIDENT OF NOVOPHARM:  The annual sales on a
       global basis is in excess of $500 million.
       COMMISSIONER LEHMAN:  Does Novopharm have a
       substantial share of the Canadian market?
       MR. GREEN:  Yes.  It is the largest generic
       pharmaceutical manufacturer.
       COMMISSIONER LEHMAN:  Would you say that more
       generic pharmaceuticals are sold in Canada than in the
       United States?
       MR. GREEN:  At this time, I would say that is
       certainly true because of the compulsory licensing situation
       that was in Canada prior to --
       COMMISSIONER LEHMAN:  I would like to leave you
       with a thought, and that is that at the present time -- we
       are dealing with intellectual property, here.
       MR. GREEN:  Yes.
       COMMISSIONER LEHMAN:  At the present time, the
       Government of Canada is applying exemption to the NAFTA
       Agreement, so-called cultural exemption, to basically
       discriminate against U.S. program suppliers who are trying
       to exercise their intellectual property rights there.
       They have just recently taken the country music
       channel off Canadian cable.  I think they put restrictions
       on CNN.  
       I would have to say that the United States has an
       obligation to protect our intellectual property-based
       industries.  Quite clearly, we have had great difficulty
       with Canada in the past.  You referred to the compulsory
       license that we had.  Fortunately, we have gotten rid of
       that, but obviously there are residual effects.
       The $500 million in sales that Novopharm is
       experiencing in Canada are no doubt a result of their
       ability to seize control through a compulsory license of
       U.S. patents.
       And I would say that, under the NAFTA agreement,
       we are not limited in our ability as we are under GATT, to
       retaliate against Canada for so-called cultural restrictions
       that they place on us.
       So, we will take a very close look at this, but I
       am glad that you have brought to our attention the existence
       of Novopharm.  I have to say that I am completely
       unsympathetic --
       COMMISSIONER LEHMAN:  -- to a Canadian company who
       wants to come to the United States when they are trying, and
       have a history, of trying to keep United States exports out
       of Canada, and then ask for us to give them favorable
       regulatory treatment here.
       I think that, since your CEO is here, he might
       want to make the Canadian parliament and government aware of
       that, because I can assure you the United States is not
       going to look favorably upon Canadian products entering into
       the United States in any area, particularly that involving
       intellectual property, when we are receiving this kind of
       treatment in Canada.  Thank you.
       MR. GREEN:  I appreciate that, Mr. Secretary, and
       simply say that as far as my presentation here is concerned,
       it certainly is not limited to the fact that Novopharm is a
       Canadian company.  I think the concerns expressed here, as
       well as the legal analysis applied to any U.S. generic
       pharmaceutical manufacturer equally.
       COMMISSIONER LEHMAN:  Yes, we might want to take a
       look at the difference between the two companies.  Canada
       has decided to distinguish between its intellectual property
       rights holders and others.  We can do the same.  Okay?
       MR. GREEN:  Again, I would say, don't hold
       Novopharm to the intent of the Canadian government --
       COMMISSIONER LEHMAN:  Well, it is not me who is
       doing it.  I am sorry, it is the Canadian government.
       MR. GREEN:  Yes.  Thank you.