Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
1011 words
HEADLINE: PREPARED TESTIMONY OF
U.S.
REPRESENTATIVE ED BRYANT
(R-TN)
BEFORE THE SENATE
COMMITTEE ON THE JUDICIARY
BODY:
TESTIMONY
OF REP. EDWARD BRYANT TO U.S. SENATE JUDICIARY COMMITTEE
August 4, 1999
Thank you, Mr. Chairman, for providing me with the opportunity to journey to
the other side of the Capitol in order to present my views on the important
issue before you. It is, indeed, a pleasure to have the opportunity to visit
again with a number of my former colleagues from the House who have exchanged
one view of Washington for another.
I would like to commend one of those
former House members, Senator Torricelli, for his commitment to fair patent
treatment for pharmaceutical products and for his support of a independent
process to review possible inequities in the patent treatment of pipeline drugs.
But before I do so, Mr. Chairman, I also would like to acknowledge your
leadership on this issue over the years. I want to emphasize that, despite my
belief that we need a process to review the patents of some pipeline drugs, I
consider the 1984 Hatch-Waxman Act a monumental achievement. It
has helped spur pharmaceutical research and also enabled consumers to experience
the benefits of this research in a more timely fashion.
We are here to
discuss S. 1172, Senator Torricelli's proposal to establish an independent
process within the Patent and Trademark Office to review the status of seven
pipeline drugs that faced significant delays in the regulatory approval process.
While the bill differs in some respects from the Bryant-McDermott measure, we
are in accord on the core proposal.
This effort is about three principles -
fair play, equity, and removing politics from the patent process. We believe in
fair and equitable treatment of all involved in this issue both in the
regulatory process and in the independent review process that we and Senator
Torricelli propose. Importantly, the review process would be a public process
open to all interested parties and - by taking it out of Congress - we would
provide for a decision on the legal merits.
Hatch-Waxman,
as you know, limited patent restoration for pipeline drugs to two years, which
was intended to deal with a Food and Drug Administration approval time that
averaged slightly more than 2.25 years. But it later turned out that several
drugs were caught in the regulatory approval pipeline much longer.
Since
1984, Congress has occasionally enacted specific legislation to deal with
inequities discovered in the implementation of Hatch-Waxman. In
each case, Congress concluded that the general rules adopted in 1984 were
insufficient when applied to a particular situation. But Representative Jim
McDermott and I, and more than (50) cosponsors from both sides of the aisle,
have concluded that Congress needs a better way of addressing regulatory delays
that have diminished the useful life of a pharmaceutical patent. We believe that
Congress needs to enact a process to handle these issues rather than tackling
each situation on an ad hoc basis.Our approach - and I believe this is true of
Senator Torricelli's proposal as well - is based on two worthwhile principles.
One principle is that patents are an important incentive for research and
inventions. The second principle is that Congress should not make patent
extension decisions on a case-by-case basis.
First, there is no question
that our prosperity in America is built, to a great extent, on research and
development. Patents foster that research. In fact, the relationship of R&D
and patent integrity is one of mutual dependence in which each fosters the other
for the benefit of us all. We know that those who conduct pharmaceutical
research help provide one of the best patient protection policies that we can
buy as Americans. Just ask anyone who has benefited from the healing powers of a
new breakthrough pharmaceutical. At the same time, we also know that R&D can
be expensive. This is particularly the case when it comes to pharmaceutical
innovations. Without strong and fair patent protection, research-based
pharmaceutical companies would not have the incentive or the wherewithal to
continue research that would lead to tomorrow's breakthrough drugs.
The
second principle involves the necessity of establishing a fair, consistent
process to protect the integrity of patents. In this context, it is vitally
important to say what HR. 1598 and S. 1172 would not do. They do not
automatically extend a patent. Rather, they would establish a fair and open
process that is conducted in a public forum. This would be an independent,
non-political review. These bills would apply to seven pipeline drugs than spent
over 60 months in the FDA's New Drug Approval process. All affected parties
would be able to make their case before the appropriate body - the PTO, an
independent agency whose experts deal with the legalities of patent issues day
in and day out.
I believe strongly that these bills fulfill the intent of
Congress. The record since 1984 is clear. When Congress passed
Hatch-Waxman, it believed that there would be relatively quick
FDA approval for drugs that were in the approval "pipeline" at the time. In
fact, that did not occur. Because of lengthy regulatory reviews, many pipeline
drugs received substantially less patent coverage than Congress intended. Often
in Washington we talk of"unintended consequences." Hatch-Waxman
truly involves a case of unintended consequences. But they are consequences
that, nevertheless, should be dealt with.
Mr. Chairman, I am gratified that
H.R. 1598 has attracted so many co- sponsors Democrat and Republican alike. I
also am gratified that Senator Torricelli has introduced parallel legislation. I
think this support demonstrates that there is widespread and growing support to
enact a fair, independent process that protects patent integrity.
In sum,
Mr. Chairman, I believe these bills have identified the right solution. It is a
solution that provides patent integrity and, in so doing, ensures the
continuation of research that leads to breakthrough drugs and other innovations
that truly help people live longer and better lives. Thank you.
END
LOAD-DATE: August 5, 1999
