Copyright 1999 Federal News Service, Inc.
Federal News Service
JULY 1, 1999, THURSDAY
SECTION: IN THE NEWS
LENGTH:
1000 words
HEADLINE: PREPARED STATEMENT OF
REPRESENTATIVE ED BRYANT
BEFORE THE HOUSE JUDICIARY
COMMITTEE
SUBCOMMITTEE ON COURTS AND INTELLECTUAL PROPERTY
SUBJECT -
HEARING ON H.R. 1598
THE FAIRNESS IN DRUG PATENTING ACT
BODY:
Thank you Mr. Chairman for holding this
important hearing, which marks the continuation of a serious, bipartisan effort
to enact a process that protects patent integrity.
Mr. Chairman, I first
would like to offer some background leading up to the introduction of H.R. 1598,
the Patent Fairness Act of 1999. My own interest in this important issue goes
back to hearings held just over a year ago by the Judiciary Committee. At that
time, we had recently completed work on H.R. 400, which encompassed a series of
reforms that were designed to bring patent laws up to date. One section of H.R.
400 addressed delays at the U.S. Patent and Trademark Office and how. time could
be restored to those who hold patents.
That legislation, in turn, prompted
me to examine other instances in which federal regulatory delays had diminished
the useful life of an invention. I soon learned that one of those areas involves
so-called "pipeline" drugs that were affected by the Drug Price Competition and
Patent Term Restoration Act of 1984, commonly known as the Hatch-
Waxman Act.
Hatch-Waxman, as you know, included a
two-year limitation for patent term restoration for pipeline drugs. The
limitation reflected an expected Food and Drug Administration average approval
time of 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 special legislation to deal with
individual cases of inequities discovered in the implementation of HatchWaxman.
In each case, Congress concluded that the general rules adopted in 1984 were
insufficient when applied to a particular situation. Certainly, inequities
existed. One drug, Daypro, which helps people who suffer from arthritis, spent
just over 21 years in regulatory review. Remarkably, that was more years than
its total patent life. In 1996, Congress passed an appropriations measure that
extended the effective patent life of Daypro by roughly five years.In examining
the details of Daypro, it became clear that the inequities extended beyond this
one drug. I reached a simple conclusion: Congress needs a better way of
addressing inequitable - or potentially inequitable situations in which
regulatory delay has diminished the useful life of a patent. Congress, in short,
needs to enact a process to handle these issues rather than tackling each
situation on an ad hoc, case-by-case basis.
As you remember, Mr. Chairman, a
committee hearing last year examined how to deal with these issues in the
future.
From all this, Rep. McDermott and I arrived at the process outlined
in H.R. 1598. This bill clearly is in the public good because it is based on two
worthwhile principles: 1) Patents are an important incentive for research and
inventions, and; 2) that Congress should not make patent extension decisions on
a case-by-case basis. Let me discuss each principle in detail.
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; it is
a relationship 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 drug. At the same
time, we also know that R&D can be expensive. This is particularly true when
it comes to pharmaceutical innovations. Without strong and fair patent
protection, research-based pharmaceutical companies would not have the incentive
or the wherewithal for the research that leads 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 H.R. 1598 would not do. It does not automatically
extend a patent. H.R. 1598 instead establishes a fair and open process that is
conducted in a public forum. This would be an independent, non-political review.
H.R. 1598 would institute this administrative procedure for seven pipeline drugs
that had an unusually long NDA review of more than five years. All affected
parties would be able to make their case, to have their day in court, so to
speak. And they 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 H.R. 1598 fulfills 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 I(.R. 1598 has about 50 co-sponsors, including
members from both sides of the aisle in this committee and the House as a whole.
I also am gratified that Senator Torficelli has introduced legislation in the
Senate that also envisions an independent review process. I believe this support
demonstrates clearly that there is widespread and growing support for a fair,
independent process that protects patent integrity.
In sum, Mr. Chairman,
H.R. 1598 is the fight solution. The Patent Fairness Act of 1999 offers 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.
And I thank the Chair.
END
LOAD-DATE: July 2, 1999
