Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
945 words
HEADLINE: PREPARED STATEMENT OF
SENATOR
ORRIN HATCH
BEFORE THE SENATE JUDICIARY COMMITTEE
SUBJEJCT - HEARING ON PIPELINE DRUGS:
PROPOSED REMEDIES FOR RELIEF IN S.
1172
BODY:
Today, the Judiciary Committee
will examine remedies proposed in S. 1172, the Drug Patent Term Restoration
Review Procedure Act of 1999, sponsored by Senators Torricelli and Sessions.
This hearing will help us gauge what legislative action is warranted.
Article 1, Section 8, Clause 8 of the U.S. Constitution reads: "The Congress
shall have the power .... to promote the progress of science and useful arts, by
securing for limited times to authors and inventors the exclusive right to their
respective writings and discoveries."Congress' exercise of a constitutionally
based patent power has important consequences for society and has led to
occasional controversies between various business, consumer, and inventor
interests.
Yet, few would argue with the basic premise that people will be
encouraged to produce inventions if there is some reward as an incentive. The
fundamental question S. 1172 asks of this Committee is: Are there instances
where, through regulatory delay or inefficiencies, Congress' constitutional
responsibility to "promote the progress of science" is undermined to a level
which warrants remedial action and, if so, should an objective mechanism be
established for the consideration of such claims? Assuming the answer to these
questions is yes, the sponsors of S. 1172 have proposed a mechanism for pipeline
drugs.S. 1172 would establish a review process within the Patent and Trademark
Office to assess the treatment of certain pipeline drugs that lost patent
protection due to exceedingly lengthy, regulatory reviews at FDA. Similar
bipartisan legislation, introduced by Congressmen Ed Bryant and Jim McDermott,
has also been introduced in the House of Representatives. The House bill was the
subject of a heating in the House Judiciary Committee on July 1, 1999.
Proponents of S. 1172 believe that proper patent protection for
pharmaceutical products is crucial for the discovery of new, potentially
lifesaving drugs. I agree with this premise, and S. 1172 establishes a mechanism
to determine if such protection has been provided for individual drugs or
whether the dictates of federal drug law and regulations undeservedly eat into
this protection.The review process established in S. 1172 is one which
supporters believe is fair and impartial because an independent body will employ
specified, objective standards to determine whether or not to restore lost
patent life.
It is argued that a processed-based solution is preferable to
Congress acting on an ad hoc case by case basis. Under the bill, only pipeline
drugs that were involved in an FDA review process that took more than 60 months
would be eligible for review. There is no doubt that the protections afforded a
patent holder were significantly reduced and this delay may have been due to
circumstances that were beyond the control of the applicant.On the other hand,
critics of S. 1172 will argue that this legislation is unwarranted because the
resulting additional period of exclusivity will result in additional costs to
consumers. Opponents have suggested that inequities of the past should be given
little consideration and that, as a matter of public policy, Congress'
constitutional responsibility to "promote the progress of science" should be
prospective in approach. Our focus, they argue, should be given exclusively to
advancing policies which rely on innovation to replace products whose patents
have expired.
Finally, critics argue that S. 1172 creates a procedure for
granting partial patent restoration through an entity, the Patent and Trademark
Office, that may inherently favor a patent holder. There is some question about
whether the PTO is the appropriate forum to make decisions relating to the
details of an agency review.As we examine this important issue, I hope we can
examine some of the following questions. Is legislation of this sort in the
interest of American public? Many believe that it is and they may be right. Was
the type of delay suffered by these drug manufacturers one that warrants
legislative action and will such action benefit others? What impact will S. 1172
have on the generic drug industry? Should the Committee only be reviewing
administrative delays affecting pipeline drugs? Or, is it a much broader problem
which warrants a broader, more comprehensive solution?
I look forward to
exploring these, and other questions with our panel of distinguished
witnesses.In the end, we must be mindful of the fact that Congress at one point
in its recent history passed productspecific private relief bills which granted
those products patent term extensions. In fact, Congress has enacted product
specific patent extensions for pipeline drugs. At the time,
critics then argued that such product-specific legislation did not benefit the
public or the institution. Instead, it was suggested that an objective process
be put in place -- a process that subjected the claims for equitable relief to a
set of objective criteria and public scrutiny. S. 1172 appears to be an effort
to rise to this challenge.
Therefore, it is appropriate that this Committee
closely examine the merits of this legislation, with an eye on Congress'
constitutional obligation to promote the progress of science, and balance them
with what is in the best interest of the American public.I believe that a fair
and equitable solution is possible. And I look forward to hearing the
recommendations of our witnesses on what they believe is the appropriate
solution to this crucial issue.
In closing, I want to thank our witnesses
for taking the time to join us today and look forward to hearing their views on
these critical questions.
END
LOAD-DATE: August
5, 1999 
