MR. ENGLEBERG:  My name is Alfred Engleberg, and I
       am an attorney in private practice in Greenwich,
       I would like to address what I believe are four
       key issues that arise out of the URAA, in relationship to
       the 1984 Waxman-Hatch legislation.  That are, in order, the
       status of patent term extensions granted prior to June 8,
       1995; the status of pending ANDAs, which are pending before
       June 8, 1985; what happens to ANDAs which are filed after
       June 8, 1995; and lastly, the status of the Orange Book.
       First, with respect to patent term extensions,
       which apparently have been at the back of everybody else's
       agenda, and so I moved them up on mine so that we can talk
       about them.
       There is no question whatsoever that all of the
       patent term extensions granted by the Patent Office up to
       now have been based on the 17-year patent term and based on
       specific limitations that were calculated based on an
       expiration date after 17 years.
       I note specifically that the Patent Office, in its
       current procedure, issues something called the Notice of
       Final Determination and a Certificate of Extension, in
       connection with each application.  If you look at those, you
       will find that in each case, consideration is given to
       Section 156(c)(3) of the extension provisions which is the
       so-called 14-year cap, and the number of days which is
       listed in the Certificate reflects the cap.
       The important point with respect to that is, that
       you cannot after June 8th simply take a Certificate of
       Extension or the days in the Certificate of Extension and
       tack it onto a 20-year term.  
       It does not work.  It would be improper.  It would
       come up with the wrong answer in every many situations.
       That leads to the question, what is the status of
       these prior extended patents?  Are they entitled to any
       I think the answer is that when Section 156 was
       amended in the URAA, no amendment was made to change the
       limitation that says that a patent can only be extended
       once.  Nor was any amendment made with respect to the
       question of whether or not an application could be filed
       after 60 days from the time of an NDA approval.
       So what we have is a situation where those
       amendments which were required for retroactivity were simply
       not made.  Now, let me state clearly, because I think it is
       the fact, that no one who has gotten a patent term extension
       up to June 8, 1995, is going to be deprived of anything. 
       They got exactly what they were entitled to under
       Waxman-Hatch and they are going to get exactly what they are
       entitled to under the URAA.
       Their patents are going to last for at least 20
       years, or 17 years, whichever is longer, and they may indeed
       last longer than that if the extension lasts longer than
       But if you go back and recalculate and reissue
       Certificate of Extensions, which is what you would have to
       do, you will be violating the statute.  You will be issuing
       a second extension.  You will be accepting an application
       after the 60 days from the approval and you will be
       upsetting the entire scheme that was created.
       After June 8, 1995, which is often the case when
       new legislation comes along, people's rights will be
       different and it will be determined at the time the
       application is made.  But I think you are powerless to do
       anything, based on the statute.
       Turning now to pending ANDAs --
       COMMISSIONER LEHMAN:  Would you expect that there
       would be litigation?  I mean, I assume they could always be
       litigated.  You say we are powerless, I mean --
       MR. ENGLEBERG:  I think as long as there is a
       dissatisfied party and enough money at stake, there will be
       litigation on every issue we are discussing here today.
       The question is, what should the regulators do in
       the first instance, giving maximum respect to the language
       and intent of the two statutes involved?   And I think that
       is all we are discussing.
       I believe the question can arise when someone
       tries to lift a date in the Orange Book in some way that the
       FDA disagrees with.  It could arise if the Patent Office
       ends up certifying the dates, there.  There are any number
       of ways it can arise.  But it will arise, we can be sure of
       Now, let me just say, we disagree entirely with
       those who have said that we need a legislative fix, here. 
       No two statutes ever exquisitely blend together.
       But if you look at the purpose and you look at the
       language and you look at what is actually demanded by
       statute and what has been done by regulation and what can be
       fixed by regulation, you can come to some very logical
       As to the pending ANDAs, we can all agree that
       every pending ANDA, that is, every ANDA filed before June
       8th, had a correct certification.  It was correctly
       certified under a paragraph 3 certification that a patent
       would expire as of a certain date.
       There is absolutely nothing in the Waxman-Hatch
       legislation, the statute as passed, that requires an
       amendment to a certification.  The rules with regard to an
       amendment are just that.  They are rules and regulations
       enacted by the FDA, based on their interpretation of what
       would be consistent and proper in carrying out the conceived
       purposes of Waxman-Hatch.
       They now have to look to see if the URAA requires
       them to make an amendment to their regulations in that area
       in order to make these two statutes consistent.
       We get, then, to the question of what date is this
       pending ANDA entitled to and what date is it entitled to as
       an effective date for a market date?
       The answer, I believe, which is somewhat different
       than what you have today, is that the provisions of Section
       532 URAA, which grandfather in the parties who made acts or
       substantial investment is, in fact, a self-executing statute
       with respect to pending ANDAs.  That there is no discretion. 
       That they are entitled to that statutory license, as a
       matter of law.
       Let me tell you why.  The Section 154(c)(2) and
       (3) of URAA really only has two requirements.  It says that
       if you were engaged in acts or you made a substantial
       investment prior to June 8th, which became infringing by
       virtue of the law coming into effect on June 8th, you get
       the relief.
       Let's look at an ANDA.  An ANDA was filed.  It was
       based on certain acts.  Let's forget about investment.  It
       was based on certain acts by the applicant, conducted before
       June 8, 19885.  Those acts were not infringing by virtue of
       271(e)(1).  They were exempted under the so-called Roche v.
       Bolar exemption.
       Why?  Because the applicants sought approval as of
       the expiration date of the patent.
       On June 8th, those acts will become infringing. 
       Why?  Because the certification in the ANDA says, "I want
       approval as of the date I previously certified."  That date
       is no longer the expiration date of the patent and Roche v.
       Bolar no longer protects them.
       But, 532 of URAA does, and says, "You are entitled
       to go on the market."  That is the statutory scheme.
       What does the FDA do about it?
       The FDA requirements, as they now stand say that a
       party has to amend a certification if he believes or if his
       original certification becomes incorrect, or if he believes
       it is incorrect.
       Well, it is not incorrect.  It correctly certifies
       that that party wants to go on the market as of the original
       expiration date because that is precisely what the URAA says
       he is entitled to.
       So, I would submit to you that, in fact, the 
       FDA does not even have to amend its regulations.  It can
       interpret the existing regulations to say that no mistake
       had been made and no correction is required.
       I would suggest, however, and we think it makes a
       little more sense, to put it in writing, and for purposes of
       clarity, to say that those who had pending ANDAs are
       entitled to the relief of URAA and, therefore, need not
       Now, what does this do to the patent owners?  Is
       this unfair?  
       No, it is not unfair because there is nothing in
       Waxman-Hatch that takes a single Title 35 remedy away from
       patent owners.  If the FDA says that a pending ANDA can go
       on the market, as of the original patent approval date, the
       patent owner can sue for patent infringement.
       He can get a preliminary injunction.  He can test
       the water on whether or not these acts or investments
       qualify for the statutory relief under URAA, and in fact,
       this is the only we are going to get this issue to court in
       a timely fashion.
       What Pharma and Bristol and others are trying to
       accomplish here is to create an administrative maze, throw
       up their hands, say "we got a technical problem; you need a
       legislative fix," but what they are really trying to do is
       to moot out the issue by time and to prevent the Geneva
       generics of the world, who have an approval in-hand today,
       to go on the market on August 8th.  To block that approval,
       to tie it up in an administrative boggle, so that they get
       an extra six months, even though the URAA says you are not
       entitled to that six months.
       You can't let that happen, if you follow the
       mandate of the Administrative Procedure Act, and enact
       regulations that are consistent and harmonize these two
       What about ANDAs after June 8th?  From June 8th
       on, every patent has a new expiration date.  It is
       undeniable.  That is what the URAA does.  It creates a new
       patent expiration date.
       And for an ANDA filed after June 8th, it is
       unclear whether that applicant will be entitled to the
       benefit of URAA 532, the statutory license, or not.  Once
       before, the FDA was faced with a situation of how to
       interpret a paragraph 4 certifications and concluded in the
       instance of inequitable conduct that the statutory scheme of
       Waxman-Hatch didn't make any sense unless you permitted
       paragraph 4 certifications for inequitable conduct.
       I would suggest to you that it wouldn't make any
       sense in this instance other than to make it a paragraph 4
       certification for those who think they made a substantial
       investment or engaged in acts before June 8th, and it would
       work very well.
       Very simply, people would file an application,
       just as they would certify non-infringement or
       unenforceability.  They could certify non-enforceability by
       virtue of statutory license.  They would put the patent
       owner on notice at the beginning of the ANDA process, and
       you would let the courts litigate the issue of substantial
       investment while the ANDA is pending.
       It is fair to the patent owners.  It is fair to
       the ANDA holder.  It is fair to the public.  It resolves the
       issue at the earliest possible moment.
       I see my time is up.  I have not had time to
       address the Orange Book issue.  I will be happy to answer
       any questions.
       COMMISSIONER LEHMAN:  You can certainly supply any
       further information in writing.
       I would like to ask you a question.  That is, Mr.
       Barrack indicated that, in his view, because Congress chose
       to attack this problem by restricting the remedies available
       to the patent holder and leaving them only with certain
       remedies, mainly the right to equitable remuneration, that
       therefore clearly every other right that attaches to the
       extended patent would apply.
       How do you respond to that?  I mean, that would
       indicate that if you have a 20-year term, you have a 20-year
       MR. ENGLEBERG:  What Congress did was say:  You
       have a 20-year term, but you also have a compulsory license
       for those people who acted in reliance on current law.  That
       is what the statute says.
       For the interim period, we are going to grant the
       compulsory license to those people caught in the middle.  We
       are going to grandfather them, and those people are only
       going to pay equitable remuneration.
       So the scheme set up by Congress to protect
       against the retroactive damage that the change in patent law
       could cause to occur contemplates that there will be
       competition, contemplates that there will be no exclusivity. 
       And what Mr. Barrack is proposing is that the generic never
       get up to bat on that issue because the ANDA process and the
       FDA will bar the door.
       COMMISSIONER LEHMAN:  Yes, that is precisely the
       point, though.  That since they took a very selective --
       they used a very surgical drafting technique, I think his
       point is -- and they did not modify the FDA's powers in this
       MR. ENGLEBERG:  The answer is, they didn't have to
       modify the FDA's powers as to pending ANDAs because pending
       ANDA's, as I just said in my remarks, already had correct
       certifications in them.  There is no statutory requirement
       for amendment.  It is a matter of regulation.
       COMMISSIONER LEHMAN:  I understand what your point
       MR. ENGLEBERG:  If you want to carry out -- let me
       just say one thing.
       There is no statutory history, as we all well
       know.  There was no discussion of drugs.  There was no
       discussion of a carve-out or giving the drug companies back
       anything that they may or may have lost in 1984.
       This poor, plain, and simple was a statute enacted
       due to the requirements of the TRIPS text and the GATT
       treaty, and to argue that anyone intended any kind of
       particular benefit for the drug companies, or for anyone
       else for that matter, is just not the case.
       I mean, this can and should be harmonized, and it
       should not be used to create an administrative net for
       people to hide behind so that these issues cannot be
       litigated in a prompt fashion and in the public interest.