COMMISSIONER LEHMAN:  Thank you very much.
 
       Next, I would like to ask Robert Armitage to come
       forward, please.
 
       MR. ARMITAGE:  Good afternoon.  My name is Robert
       Armitage.  I am here on behalf of the American Intellectual
       Property Law Association.  Our address is 2001 Jefferson
       Davis Highway, in Arlington, Virginia.
 
       We are an organization of largely patent lawyers,
       and we are not in the pharmaceutical business in any
       significant way.  Nonetheless, we are here today because we
       believe that there are important issues of patent policy.
 
       I might begin by making a slight digression to
       state that the AIPLA strongly opposes H.R. 359.  We believe
       that pharmaceutical companies and others using the patent
       system should not be given the option of either a 20-year or
       17-year patent term, whichever is longer.
 
       Having said this, we also have come to realize
       that in the making of the Uruguay Round Agreements Act,
       there were certain provisions in Section 156 in the way of
       technical amendments that were not addressed and should have
       been addressed and our Association has now come to the
       conclusion that it is time for the administration to take a
       close look at the structure of Section 156 beyond the fact
       that there are technical deficiencies as a result of the
       Uruguay Round Agreements Act.
 
       It is quite clear to us that with the more
       liberal, in certain respects, extension provisions available
       in Europe and Japan, and the seeming endless series of
       special bills in Congress seeking extensions in individual
       cases that we have in the way of the original 1984
       compromise, it is perhaps not now adequate in light of
       experience in developments over the past decade.
 
       Let me say that we come to this, trying to get our
       compass to point to the north.  Having listened now to seven
       or eight speakers, I find that if you follow all the
       arguments, you can spin round and round and round.  We
       clearly believe in just a few, simple, basic principles. 
       Namely, that drugs under the Uruguay Round Agreements Act,
       more or less, should be treated like any other form of
       patented technology.
 
       In the 1984 Waxman-Hatch Act, we believe there was
       a fairly simple role for the patent information being
       inserted into NDAs.  Namely, under that Act, one was not
       entitled to get on the market until patents had expired. 
       Therefore, in the NDA application itself, the NDA applicant
       was required to list those patents whose expiration date was
       to be relevant.
 
       The other seemingly obvious principle, to us, is
       that the patent certification provisions in the ANDA were
       simply designed to establish whether the ANDA applicant
       would be challenging those patents certified or would be
       content to wait until the patents expired to go on the
       market.
 
       Now, if these are the basic principles that the
       ANDA Act itself was designed to hold up generic competition
       under the ANDA law, until patents had expired, then it seems
       to us that the FDA simply must accept new patent information
       under the Uruguay Round Agreements Act.  
 
       This would be the same if a 156 extension were
       granted.  The FDA would need to accept that information.  It
       would be the same if the patentee were forced to file a
       terminal disclaimer.  Certainly, no one would argue that a
       generic applicant ought to be held up under an outdated
       certification for a patent that had been terminally
       disclaimed.
 
       Next, we believe that it is obvious, therefore,
       that the FDA needs to require in order for the public notice
       provision to be satisfied that there be a prompt submission
       of new patent information under the URAA.  
 
       Also, quite clearly, if there is submission of new
       patent information, it seems to us equally obvious that the
       FDA should provide notice to ANDA applicants of the need to
       provide a recertification based on a new patent information
       in the NDA being referenced.
 
       We then come to the suggestion that has been made
       earlier that there ought to be a double listing of patent
       expiration dates.  We do not believe that this is an ANDA
       issue, at all.  It seems to us that if one wishes to file a
       complete new drug application, one is entitled to get on the
       market at any time during the patent term.  It is a matter
       of patent infringement, not a matter of FDA law.
 
       However, in a situation where someone seeks the
       privilege of marketing under the ANDA, the statutory
       principle again seems to us to be quite clear and that is
       one must wait until the expiration date of the patent and,
       therefore, regardless of the level of investment that has
       been made, substantial or otherwise, it is simply not
       relevant.
 
       Now, one of the main reasons that we decided as a
       group of patent and other intellectual property lawyers, to
       testify today, was to make some comments on what the role of
       the Patent and Trademark Office ought to be in these
       matters.
 
       I can summarize that role in a single word, or
       perhaps two words.  None, or almost none.
 
       Basically, the Patent and Trademark Office does
       not have statutory authority over issued patents.  There are
       certainly special situations, such as interferences and
       reissues and patent extension provisions, but basically the
       role of the PTO in these matters, we believe, is a passive
       rather than an active one.
 
       We do believe that the FDA should have the benefit
       of the expertise of the PTO, if the FDA reaches a point
       where receiving new patent certifications or receiving new
       patent information causes ambiguities or uncertainties in
       terms of how the FDA ought to act, but certainly, in our
       view, the PTO should not involve itself in a proceeding
       involving issued patents in which it has no statutory
       authority.
 
       One final comment, I will make, is in terms of the
       patent expiration date that we believe should be calculated
       based on the Uruguay Round Agreements Act.
 
       Certainly, anyone who has heard the testimony
       heretofore today, will realize that this is a legal issue
       that ultimately will be determined by the courts.  We
       believe, however, that the best posture for this, to be
       determined by the courts, is for the FDA and the Patent
       Office to recognize that certain statutory principles,
       namely the following, are involved.
 
       One is that under Section 156, patent extensions
       have been granted for a period of time certain.  They are
       not extensions granted to a date certain.
 
       Second, under the Uruguay Round Agreements Act,
       patents in force on June 8, 1995, were not extended.  The
       statutory terms for those patents were simply reset under
       the Act.  It was not a matter of granting an already
       extended patent, a second patent extension.
 
       Third, we can see no other logical outcome of
       these two facts, than for the Section 156 extension to apply
       as it always has applied to the original expiration date,
       which now would become the expiration date as reset under
       the URAA.
 
       Notwithstanding the comments of Pharma, we further
       see no basis for the Patent Office, the FDA, or anyone else
       in a regulatory setting, to arbitrarily chop these
       pharmaceutical patent terms to 14 years from the date of the
       regulatory approval.
 
       We come to this conclusion because it is clear to
       us that Congress decided, in its wisdom, that patents across
       the board would be extended for the greater of 17- to
       20-years, affording a number of patentees additional periods
       of protection of, in some cases, one to two years.
 
       And we see nothing in the legislative history and
       nothing in the statute to suggest that pharmaceutical
       patents are somehow different and those one- to two-year
       extensions that applied in the case of other patents, as a
       result of the resetting of patent terms under the GATT,
       would not also apply in the pharmaceutical industry.
 
       We have, on a question-by-question basis, in our
       written comments provided answers and, at this point, I
       would end my oral comments, in the absence of questions.
 
       COMMISSIONER LEHMAN:  Thank you very much.  I
       apologize.  I am trying to consult with Mr. Kirk.
 
       Your comments have been really helpful.  If I have
       been talking to him, it is because your comments are so
       helpful, I am trying to use them to sort through all of
       this.
 
       Are there any other questions?
 
       [No response.]
 
       MR. ARMITAGE:  Thank you.