COMMISSIONER LEHMAN:  If not, the next witness, I
       believe, is Gerald J. Mossinghoff, former Commissioner of
       Patents and Trademarks.  
 
       Welcome, Mr. Mossinghoff.
 
       MR. MOSSINGHOFF:  Thank you, Mr. Secretary.  
 
       I represent the Pharmaceutical Research and
       Manufacturers of America, PRMA, as we call it.  We are at
       15th and L, in downtown Washington.  I am very pleased to
       participate in this very important hearing.
 
       In my prepared statement, which I think you have
       and I hope can be made a part of the record, in the first
       six pages, I discuss generally how the law should operate.
 
       I would say, if I understand the previous
       testimony given, I tend to agree with it.  I think to carry
       out the desires of the first three spokesmen would require a
       change in the law, require a legislative change.  We thought
       the focus here was principally on what the law is and how it
       can be implemented.  We think it gives very little room for
       policy or discretion.  It really is a self-executing law
       that did extent the term of patents.
 
       So with that as background, let me go to the
       questions you specifically asked.  Question No. 1, should
       the FDA revise the patent term expiration dates currently
       listed in the Orange Book for those patent entitled to a
       longer term?
 
       Our answer is that they must do that.  There is no
       discretion.  And indeed, I think the authority of the
       Secretary to grant a NDA approval is limited by the fact
       that if it contains an error, significant error of material
       fact, that that is one of the reasons why the Secretary
       lacks the power, Secretary of HHS lacks the power.
 
       Second answer, should the PTO at the request of an
       NDA or ANDA holder, certify or verify the expiration dates? 
       The 1984 Hatch-Waxman amendments and the FDA implementing
       regulations specify that the new drug application or
       application holders submit patent information to FDA.  There
       is no legal requirement for the Patent and Trademark Office
       for certification or verification.
 
       On the other hand, in the case of disputes about
       the proper revised patent expiration date -- and it could
       get complicated, I believe, in some cases -- a verification
       procedure, we think, by the Patent and Trademark Office
       would be very helpful and we would even be willing to pay a
       reasonable fee to have that done, if the Office were willing
       to do that.
 
       Third, should NDA and ANDA holders be required
       holders be required to submit to FDA revised patent
       expiration dates for those patents currently listed.  By law
       and regulation, NDA holders must be given an opportunity to
       submit to FDA revised patent expiration dates for patents
       currently listed in the Orange Book.  While Section 314.53
       does not specify a time period for submission of changes,
       the submission in our view would clearly be considered if it
       were made any time prior to 30 days after the June 8 cutoff
       date.
 
       Four, if the revised patent term dates are
       published in the Orange Book and the Green Book, and if PTO
       does not certify or verify, what if any submission should
       FDA require to verify the dates?
 
       FDA should continue to accept patent information,
       in our view, directly from the NDA applicants and applicants
       holders, in accordance with the 1984 law, the Agency's 1994
       regulations, and its procedures in place prior to that.
 
       The criminal sanctions in Federal law for
       intentionally filing false information, obviously, would
       cover this situation. 
 
       In addition, there is a Patent Information Dispute
       Resolution Procedure outlined in FDA regulations which we
       think could come into play in this case.
 
       Five, if the revised patent term expiration dates
       are published, this question addresses what information
       related to substantial investment be required by FDA?  
 
       We believe that the decision on whether there has
       been substantial investment and a decision on whether or not
       we are in this delta period, is obviously one for the
       Federal courts to make and not for FDA to make and not for
       the Patent and Trademark Office to make.
 
       The last two questions, should the Patent Office
       take any action with respect to existing patent term
       extensions under Section 156?
 
       There, we say the patent has received a new
       expiration date as a result of enactment of the Uruguay
       Round Amendments.  The number of days of the patent term
       previously granted under the Hatch-Waxman amendments, by
       law, must be added to the new expiration date.
 
       Finally, what approach should the Patent Office
       take with respect to calculation of new patent term
       extensions under 156?
 
       There, the longer of the 17- or 20-year patent
       term, under the URAA, must be used in determining patent
       term extensions under Section 156.  We believe that,
       although there are arguments that can be made to the
       contrary, we believe that the courts will ultimately hold
       that the 14-year overall limitation on extensions will
       continue to apply.
 
       Mr. Commissioner, that completes the summary of my
       statement.
 
       COMMISSIONER LEHMAN:  Thank you very much.  I
       assume you wouldn't oppose legislation changing that 14-year
       limitation?
 
       MR. MOSSINGHOFF:  That 14-year limitation is an
       important block, I think, and we think that --
 
       COMMISSIONER LEHMAN:  It is not an extension to a
       longer period of time.
 
       MR. MOSSINGHOFF:  As I say, it is not consistent
       with extensions done internally.  I think we could make a
       good policy case for legislation which would do that, but it
       again would require a change in the law.
 
       We think, under existing law -- and again, I think
       an argument can be made to the contrary -- but we think,
       ultimately, the courts will hold that the 14-year current
       law limitation would override these others.
 
       COMMISSIONER LEHMAN:  We have heard a lot of
       discussion here in the last two days that -- in fact, we
       have heard it even raised to the level of a constitutional
       principle -- that all patent applicants should be entitled,
       basically, to at least a 17-year term.  That is, at least,
       an equal term.
 
       In fact, the Patent Office is really committed to
       doing that.  Moving to a 20-year term from filing doesn't in
       any way suggest that people should get less than 17 years of
       effective patent protection because, certainly, we ought to
       be able to process those patents within three years.
 
       MR. MOSSINGHOFF:  Absolutely.
 
       COMMISSIONER LEHMAN:  But you are the one
       industry, it seems to me, where the critics have a point to
       make and it is not a result of the Uruguay Round
       implementing legislation.  You have been laboring under this
       for a long time, because as a practical matter, you don't
       have oftentimes 17 years of patent protection.
 
       Now, the Hatch-Waxman legislation attempts to
       address that, in part, but clearly it doesn't make you
       completely whole with regard to these, if your measurement
       of success is that you absolutely, totally, are guaranteed
       17 years of protection.
 
       So I am just suggesting if we want to respond to
       these people who, I think, have made some fairly persuasive
       arguments that we should get full 17 years of protection,
       perhaps we ought to revisit Hatch-Waxman.
 
       MR. MOSSINGHOFF:  We would welcome that.  At the
       time, it was an arbitrary limitation of what all other
       patent holders get, all other inventors get, and we would
       certainly welcome the idea of making the case to your
       administration and to the Congress that perhaps it is time
       to remove that arbitrary limitation in America's most
       successful high technology industry.
 
       COMMISSIONER LEHMAN:  Thank you very much.  Are
       there any other questions?
 
       [No response.]