COMMISSIONER LEHMAN:  Okay, thank you.  Next, I
       would like to ask Donald Barrack to come forward, please.
 
       MR. BARRACK:  Mr. Secretary and other
       distinguished members of the panel, my name is Donald
       Barrack, and I am pleased to present these views on behalf
       of Bristol-Myers Squibb Company.  A health-care and consumer
       products company, employing approximately 20,000 people in
       the United States.
 
       The headquarters of Bristol-Myers Squibb is
       located at 345 Park Avenue in Manhattan, New York City. 
       Bristol-Myers Squibb Company is a research-based company, as
       evidenced by the more than $1 billion it spends each year on
       research and development.
 
       These hearings have been called to receive
       comments on issues arising from the Uruguay Round Agreements
       Act.  The questions presented in the PTO's notice addressed
       the interrelationships between the Uruguay Round Agreements
       Act and the 1984 Hatch-Waxman amendments to the Food, Drug
       and Cosmetic Act and to the Patent Code.
 
       In exploring these interrelationships, it must be
       appreciated that the Uruguay Round Agreements Act explicitly
       accords precedence to existing Federal legislation unless it
       is specifically provided otherwise.
 
       The principal focus of my comments today will be
       the effect of the Uruguay Round Agreements Act on the Food
       and Drug Administration approval process for abbreviated new
       drug applications.
 
       My premise is a simple one.  The Uruguay Round
       Agreements Act replaces 35 U.S.C. 154 with a new section
       154.  No other statutory provisions related to the ANDA
       approval process were amended in a manner that impacted that
       process.
 
       The Hatch-Waxman amendments to the Food, Drug and
       Cosmetic Act made it possible for ANDA applicants to gain
       regulatory approval for their products based largely on the
       safety and efficacy data generated by pioneer NDA filers.
 
       At the same time, the FDA was required, for the
       first time, to acknowledge the existence of patents.  If an
       ANDA applicant seeks approval to market a product while
       relevant patents are enforced, it must notify the patentee
       and recognize the possibility of an infringement suit.
 
       The ANDA approval process described in the
       Hatch-Waxman amendments is certainly not, by any stretch of
       the imagination, a windfall for pharmaceutical patentees. 
       Rather, it is a recognition by Congress that it took
       valuable rights from NDA holders and from patentees,
       pharmaceutical patentees, when it allowed ANDA applicants to
       piggyback the NDA filing, and at the same time, reverse the
       Federal Circuit's 1984 Roche v. Bolar decision.
 
       As we know, that decision was reversed with
       Section 271(e)(1), which permits ANDA applicants to file and
       pursue their applications for regulatory approval while the
       relevant patents remain in force.
 
       The language of the Uruguay Round Agreements Act,
       the Food, Drug and Cosmetic Act, the Patent Code, and the
       October 1994 FDA rules implementing the Hatch-Waxman
       amendments leaves no room for doubt that ANDA applicants
       must submit patent certifications or recertifications with
       respect to timely filed patent information including revised
       patent expiration dates.
 
       An example of updated patent information used in
       the preamble to the FDA's October 1994 rules is a patent
       expiration date that has been extended under 35 U.S.C. 156. 
       The analogy to the redefined expiration dates of the Uruguay
       Round Agreements Act, Section 154(c) of the Patent Code,
       could not be clearer.
 
       Bristol-Myers Squibb, of course, recognizes that
       new Section 154(c) contains a provision limiting remedies. 
       In some circumstances, the remedies of 35 U.S.C. 283, 284,
       and 285 will not be available to a patentee who has
       benefitted from the redefinition of patent term.
 
       The statutory language is specific to these
       sections of the Patent Code.  Nothing in the language limits
       a patentee's remedies and rights under Section 271(e) and
       under the Food, Drug and Cosmetic Act.
 
       As noted previously, this is entirely reasonable,
       in view of the benefits derived by ANDA applicants from the
       1984 Hatch-Waxman amendments.
 
       It cannot reasonably be argued that Congress
       overlooked the ANDA approval process when it enacted the
       limitation of remedy section of the Uruguay Round Agreements
       Act, Section 154(c).  To the contrary, Section 271(e) was
       examined, it seemed, by the conforming amendments and its
       fundamental provisions remain unchanged.
 
       In filing ANDAs and seeking tentative ANDA
       approvals before patent expiration date, ANDA applicants are
       availing themselves of the benefits of 35 U.S.C. 271(e).  It
       is unreasonable to argue that ANDA applicants should be
       afforded the benefits of 271(e)(1), while at the same time
       denying pharmaceutical patentees the rights afforded by
       271(e)(4) and by the patent certification provision of the
       Food, Drug and Cosmetic Act.
 
       All of these provisions were enacted as part of
       the 1984 Hatch-Waxman amendments and must be given their
       plain meaning.
 
       The PTO raises the issue of what information
       related to substantial investment should be included in the
       patent certification by an ANDA applicant.  Each ANDA
       applicant will determine for itself the appropriate
       certification to make and the appropriate information to
       include in its notice to the patent and NDA holders.
 
       Sufficient information must be included in the
       notice to allow the patentee to determine whether an
       infringement action is appropriate.  It should be emphasized
       with respect that it is for the courts, not for the FDA, to
       interpret the relevance and meaning of substantial
       investment.
 
       Submissions by ANDA applicants to FDA that do
       address substantial investment are not relevant to any issue
       that the FDA should be considering.
 
       Procedural issues relating to the PTO
       certification or verification of redefined patent expiration
       dates for inclusion in the Orange Book are also raised by
       the PTO notice.  Bristol-Myers Squibb appreciates the
       willing of the PTO to participate in this process and
       suggests that two avenues be available to NDA and patent
       holders for having their redefined expiration dates listed
       in the Orange Book.
 
       Either the NDA holder can bring the information to
       the attention of the FDA in accordance with existing FDA
       rules or the NDA holder can request the Patent Office to
       certify or verify the redefined date to the FDA.
 
       PTO certification or verification should not,
       however, be a prerequisite to inclusion of the patent date
       in the Orange Book.
 
       The two avenues suggested are those currently
       available to NDA and patent holders with respect to 156
       extensions.  Current practice is for the Patent Office to
       copy FDA on notices of grant of Section 156 extensions and
       the FDA revises the Orange Book accordingly.
 
       Procedure here is not believed to be the central
       issue, however.  From the perspective of NDA and patent
       holders, the availability of some procedure that ensures a
       prompt updating of the Orange Book to reflect patent
       expiration dates, redefined by the Uruguay Round Agreements
       Act, is what is needed, followed by implementation of the
       patent certification and recertification requirements of the
       Food, Drug and Cosmetic Act and the FDA rules.
 
       I was pleased to hear the acknowledgement, what I
       consider to be an acknowledgement, by the gentleman from
       Mylan, that the law as it now stands dictates these results. 
       I have no comments on a legislative change, but I
       respectfully suggest that the law as it now stands is as I
       have laid it out.
 
       If I have some time left, I would also like to
       address some brief comments to the relationship of patent
       term extensions under 156 and the redefinition of patent
       terms under new Section 154.
 
       When Congress enacted the Uruguay Round Agreements
       Act, it substituted a new Section 154 for the present
       section of the Patent Code.  Both the newly enacted and old
       sections 154 defined the term of a utility patent.  New
       Section 154, now defines a patent's original expiration
       date.  The language of Section 154(c) is all-inclusive and
       it should not be read as though it excluded one group of
       patents, i.e, patents that have been previously extended
       under Section 156, due to regulatory review.
 
       There is no statutory justification for such an
       exclusionary interpretation and no logically consistent
       position that would support it.
 
       Section 156 of the Patent Code, which was not
       substantively amended by the Uruguay Round Agreements Act
       provides patent term extensions to a small group of patents. 
       Its purpose was to remedy an inequity in useful patent term
       between regulated products and unregulated products.
 
       The Uruguay Round Agreements Act, Section 154(c),
       the new Section 154(c), has an entirely different purpose. 
       The purpose is to provide a minimum -- I emphasize the word,
       minimum -- patent term of 20 years.  There is nothing in the
       Uruguay Round Agreements Act that indicates that the
       Congress intended to recreate a disparity by defining a new
       potentially larger term for patents generally, but excluding
       patents that have been extended under 156.
 
       Thank you very much.