Copyright 1999 Federal News Service, Inc.
Federal News Service
AUGUST 4, 1999, WEDNESDAY
SECTION: IN THE NEWS
LENGTH:
991 words
HEADLINE: PREPARED STATEMENT BY
U.S. REP.
JIM MCDERMOTT
(D-WA)
BEFORE THE SENATE JUDICIARY
COMMITTEE
SUBJECT - S. 1172, THE DRUG PATENT TERM RESTORATION REVIEW
PROCEDURE
ACT
BODY:
I am pleased the
Senate Judiciary Committee is reviewing the facts behind the Drug Patent Term
Restoration Review Procedure Act of 1999. I have sponsored similar legislation
in the U.S. House of Representatives, H.R. 1598 -- the Patent Fairness Act - and
I appreciate the opportunity to share with you the reasoning behind the
proposal.
The Patent Fairness Act encompasses three principles: fair play,
equity and taking politics out of the process.
Maintaining the integrity of
our system of patents is central to whether or not our sociey. continues to
receive the desired public benefits from pharmaceutical research -- or any other
type of cost- intensive research for that matter.
Creating a fair and
impartial process, where an independent body can determine whether or not to
restore lost patent life, is a matter of fairness. Not only is the right thing
to do, it ,also is a matter of ensuring adequate incentives for research and
development in the future.
This bill takes the first step in attempting to
find a long-term solution to the patent-integrity issue that has affected
several drugs. These drugs were inadvertantly caught in a review process that
took significantly longer than Congress anticipated.
As a result of this
lengthy delay, the patent life of these "pipeline" drugs - drugs that were at
FDA for more than 60 months -- was reduced by an unintended consequence that had
nothing to do with their medical safety. I believe that the developers of these
pharmaceuticals deserve to have their grievances evaluated in a fair and
impartial manner.
There are two important questions: What type of process
can we put in place to guarantee fair and reasonable evaluation of the issues?
And, what types of assurances should be embedded in this process to make sure it
is equitable and removed from politics?
H.R. 1598 answers these questions.
Our bill establishes a process that is fair, equitable, independent, separated
from politics, fully open to the public, and subject to judicial review. Let me
expand on these features.
The bill establishes an independent and public
review process within the U.S. Patent and Trademark Office. This would be a new
administrative procedure --one that is fair and impartial.
The Patent and
Trademark Office is the right place to hold a heating about these issues,
because these issues involve questions not of medical research, but of the
definition of patent life.
Within the office, a procedure would be
established to review claims for patent term restoration to compensate for
unanticipated lengthy regulatory review of five years or more in the FDA's New
Drug Approval proceeding.The process established by this legislation would be
akin to a court hearing.
Any company that believed its product was
unintentionally deprived of patent protection would have the opportunity to
present its case. Any other interested party would also be free to argue its
side of the case. Both sides would be treated equally.
Everything would
occur in the open. The review board would be bound by objective criteria. And,
after an opinion had been rendered, each side would be allowed an additional
opportunity, for judicial review.
Contrast the process H.R. 1598 would
establish to the way things usually work around here. Patent
extensions - regardless of their merits - can be slipped into a bill in
the middle of the night, by some Congressman or Senator, regardless of the
consequences. I disagree with that tactic and I think it's a lousy way to
legislate.
By turning over the issues of patent integrity to an independent
panel of experts, as H.R. 1598 would do, the process would be driven by public
policy objectives-not politics.
And finally, our legislation would require
the Commissioner of Patents and Trademarks to evaluate the review procedure
established by the bill and report to Congress.
Another way to describe the
legislation is to outline what it does not involve.
There is no preferential
treatment for any affected pipeline drug. There are no arbitrary decisions.
There are no guarantees. Our bill is about process, not about a predetermined
outcome.
There is one more point that I would like to make that strikes at
the heart of the argument being made by the generic drug industry against the
Patent Fairness Act. They argue against a fair and open process to resolve
patent disputes because they feel that if a party wins its case before the PTO
and then its case survives judicial review, the American consumer will then be
harmed. Well, I hope that you keep an open mind about this claim. The idea that
generic drug makers - copiers of prescription drugs developed by pharmaceutical
companies - offer lower prices to consumers should NOT be assumed as fact.
For example, last December the Federal Trade Commission filed an
unprecedented $120 million suit against Mylan laboratories for its conspiracy to
horde pharmaceutical ingredients. The hoarding, according to the FTC, led to
more than a 3,000 percent increase in the cost of a hypertension generic drug
and more than a 2,000 percent increase in the cost of an anxiety drug.
Due
to Mylan's actions, the cost of a bottle of pills rose from $11 to $377 a
bottle, for a drug which the company did not spend one research dime to develop
but copied from one of its competitors. So to say that the generic industry is
somehow a victim of any attempt to look at the fairness of our current patent
system in protecting the rights of companies that spend billions of dollars to
develop life saving drugs is clearly a stretch of the truth.
I am convinced
that the Patent Fairness Act - or similar legislation that also initiates an
equitable process to resolve patent disputes -- is the right solution. As a
medical doctor and psychiatrist, I have seen the benefits of breakthrough drugs
and innovations. They truly can make people's lives better, and there is more to
do.
Thank you.
END
LOAD-DATE:
August 5, 1999 
