Copyright 1999 Federal News Service, Inc.
Federal News Service
JULY 1, 1999, THURSDAY
SECTION: IN THE NEWS
LENGTH:
718 words
HEADLINE: PREPARED STATEMENT BY
U.S. REP.
JIM MCDERMOTT
BEFORE THE HOUSE JUDICIARY COMMITTEE
SUBCOMMITTEE ON COURTS AND INTELLECTUAL PROPERTY
SUBJECT - HR. 1598
THE PATENT FAIRNESS ACT
BODY:
Thank you for
allowing me to testify at today's hearing. I am pleased to have the opportunity
to review the facts behind this legislation with you.
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 society 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. And it 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 is impacting several drugs that were 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 appeared to have nothing to do with their medical safety.
There are two important questions: What type of process can we put in place
to guarantee a 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 hearing about these issues,
because these issues involve questions not of medical research, but go to the
core 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 make its
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 has been rendered, each side would be allowed an additional opportunity
for judicial review.
Now contrast the process HR. 1598 would establish with
the way things usually work around here. Patent extensions -
regardless of their merits - are snuck 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.
This is an important point. Our bill is driven by the principle that it is
best to take politics out of the equation, to de-politicize the process, to take
Congress out of the job of deciding individual patent issues.
And finally,
our legislation would require the Commissioner of Patents and Trademarks to
report to Congress an evaluation of the review procedure established by the
bill.
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 answering a predetermined outcome.
We are convinced this
is the right solution. This is the right way to go. 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: July 2, 1999
