COMMISSIONER LEHMAN:  Next, I would like to ask
       Roger Foster to come forward, please.
       MR. FOSTER:  Thank you, Commissioner Lehman.  My
       name is Roger Foster.  I am Corporate Counsel for Mylan
       Laboratories, Morgantown, West Virginia, and the testimony I
       am giving here today is in behalf of Mylan.
       Mylan develops, manufactures, and markets generic
       pharmaceutical products and a number of other pharmaceutical
       products in which we have a proprietary interest.  We employ
       more than 1,200 people in four manufacturing facilities, two
       distribution centers, and numerous offices.
       We sell more than five billion dosage units each
       year and one in every six prescriptions filled in the United
       States annually is filled with a Mylan-manufactured product.
       Commissioner Lehman, much of my testimony, or my
       prepared testimony, has already been given by Bob and Don,
       and I don't want to bore you with a repetition.  I would
       like to say that we support much, if not all, of what has
       been said.
       I would like to amplify one point, and that is, in
       my reading of URAA and, in particular, the Waxman-Hatch
       amendments, it is apparent that the intention here is for
       competitors to have some protected status with respect to
       practicing the patented invention during the term as
       extended by URAA.
       I would point out to you that because of the
       statutes, 355(j)(4)(A), I believe, in the Federal Food, Drug
       and Cosmetic Act, there is only one industry, to my
       knowledge, and one industry alone that is denied that
       protection, and that is the generic drug industry.  And that
       is because the Food and Drug Administration is prohibited
       from approving an ANDA during the term of a patent.
       If an ANDA applicant certifies in the application
       that it will not sell the product prior to the expiration
       date of the patent, which is a paragraph 3 certification,
       FDA will not approve the application until after that date
       has come and gone.  So unless we can get, what I believe to
       be a very technical and narrow legislative remedy, this
       problem is going to persist.
       We think that there is much that the FDA and the
       PTO can do with respect to this issue, but we also believe
       that a legislative remedy is called for.  And we would ask
       that the PTO and the FDA lend their support to such a
       What we believe to be the ultimate remedy would be
       a reconciliation of the language of URAA with that of the
       Federal Food, Drug and Cosmetic Act.
       With respect to your specific questions, your
       first question having to do with revising the patent term
       expiration dates currently listed in the Orange Book and
       Green Book.  We believe that you should continue to list the
       pre-URAA expiration dates, as well as those dates that are
       currently listed in the Orange Book.
       We believe that if you fail to include the
       original expiration date and only use the URAA date, the
       extended URAA date, there may be ANDA applicants out there
       who might not realize that they could benefit from the URAA
       transition language.
       With respect to your second question, we believe
       that the PTO must certify the extended expiration date. 
       URAA makes references to documents which are antecedents to
       the actual patent issuance and the PTO is far better suited
       to make a determination with respect to the extended date,
       due to the frequency and complexity of the prosecution
       histories of many of these patents.
       Your third issue is related in some respects to
       the second one.  With respect to the third issue, we simply
       believe that the revised date should be published upon
       certification by the PTO of the extended patent expiration
       Question four, we believe that the PTO must
       certify as to these extended dates to minimize any disputes
       with respect to the date of expiration.  Should FDA fail to
       require such a certification, it should at a minimum require
       a sworn statement from the applicant stating the extended
       expiration date and describing in detail the analysis
       utilized in documents relied upon to arrive at the date.
       The applicant should also be required to certify
       the FDA that no other relevant documents exist with respect
       to that determination.
       With respect to question five, we believe that
       ANDA applicants who have applications on file as of June 8,
       should not be required to amend the certification set forth
       in the application.  Likewise, no information regarding
       substantial investment should be required.
       FDA should regard the commencement of a biostudy,
       or in the case of those products which don't require a
       biostudy, the pivotal study with respect to those products
       as prima facie evidence of a substantial investment.
       With respect to your sixth question, we don't
       believe that there is any evidence to support any contention
       that Congress intended 35 U.S.C. 156 extensions to be
       treated as anything other than a patent term.  Once
       extended, the term of the patent is just that.  It is the
       The term should be treated the same for any and
       all purposes.  Therefore, no distinction should be given or
       made with respect to a patent term extended under 156, as
       opposed to an original term.
       With regard to your last question, the statute
       with regard to 156 extensions is abundantly clear.  No
       patent term, once extended, can then be extended again. 
       That is under 35 U.S.C. 156(a)(2).  The statute makes no
       distinction as to the source of the first extension. 
       Therefore, one must consider a second extension to be per se
       Thank you very much.
       COMMISSIONER LEHMAN:  Thank you.  Are there any
       [No response.]