Copyright 1999 Federal News Service, Inc.
Federal News Service
JULY 1, 1999, THURSDAY
SECTION: IN THE NEWS
LENGTH:
794 words
HEADLINE: PREPARED TESTIMONY OF
SENATOR
ROBERT G. TORICELLI
BEFORE THE HOUSE JUDICIARY COMMITTEE
SUBCOMMITTEE ON COURTS AND INTELLECTUAL PROPERTY
BODY:
I would first like to express my
appreciation to Chairman Coble and Ranking member Berman for holding this
hearing today. My home state of New Jersey is fortunate to be the horne of the
brand name and generic pharmaceutical industry. Together they employ over 60,000
workers and pay $200 million in state and local taxes.
Adequate patent
protection is the basis of the pharmaceutical industry. It provides the
incentive for the Research and Development that is responsible for wonderous new
drugs like those that are lowering and changing the face of health care. But
patent law also provides the framework necessary for the development of market
competition and cost reduction for consumers. Effective patent law must strike a
balance between rewarding R&D and promoting competition.
That is why
today's hearing is so important. Traditionally, patent extensions have appeared
in the dead of night, in end of the year, must-pass legislation with little or
no oversight or debate. With the effort of this committee, Congress is rejecting
that approach. We are saying that while there are differences of opinion on
patent extension, it is an issue that should be decided in the open and with
input from all concerned parties.
The Hatch-Waxman Act of
1984 was a compromise which granted drugs that entered the regulatory review
"pipeline" after its enactment a maximum patent extension of five years. For the
123 drugs already, in the review "pipeline" at the time of enactment, the Act
granted two years of patent protection. While the average review time for these
123 drugs was slightly over two years, 17 drugs had review times twice as long.
Seven of those patents are still in effect today.
Today's hearing on HR
1598, authored by Reps. Ed Bryant & Jim McDermott, and S 1172 which
introduced, addresses the future patent life of those 7 drugs. Each bill
establishes a non-political process by which interested parties can present
their case to the Commissioner of the Patent & Trademark Office. The
Commissioner, if he or she believes the evidence warrants. can grant a patent
extension for up to three additional years. This decision is reviewable to the
Circuit Court by either party.
However, there are significant differences
within the process of each bill that I would like to outline to the Committee.
First, under S 1172, the party seeking the extension bears the burden of proving
they showed due diligence during the regulatory review process. In contrast, HR
1598 has a rebuttable presumption that the extension should be granted. The
party opposing the extension must prove it is undeserved.Second, under S 1172,
the PTO Commissioner must consider public interest factors and, prior to
granting an extension, decide whether an extension would be detrimental to the
public interest or interests of fairness. HR 1598 contains no similar public
interest requirements.
Third, S 1172 provides a mandatory consultation role
for the FDA. Possible delay by the FDA is at the heart of the issue and it is
appropriate that they be consulted prior to a decision. HR 1598 makes FDA
records available but has no consultation role.
Finally, S 1172 recognizes
the significance of generic drugs and contains provisions to encourage market
competition within the drug industry. The first provision is a limited revision
of the "Orange Book Certification". S 1172 would allow generic companies to
certify only to the active ingredient of the patent product. This would simplify
the current requirement of certifying to patents for specific formulations or
for methods of use, as well as to active ingredients. Because this is a new
idea, it applies only to the 7 pipeline drugs in the bill.
The second
provision addresses the recent Circuit Court decision in Mova Pharm. Corp. v.
Shalala regarding when Generic Drug exclusivity is established. S 1172 would
restore the original Congressional intent by providing that generic drug
exclusivity is established upon the filing of a generic drug application and
subsequent suit for infringement. The Court decision, by allowing exclusivity to
be established solely by filing an application, will result in a reward without
the benefit of testing the patent in court.
Mr. Chairman, the issue of
patent extensions in Congress has been controversial. But for my state, and both
sides in this debate call New Jersey home, it is extremely important. The bill I
have introduced represents compromises developed over two years of discussions
with the leading companies in my State. This issue is difficult and contentious
and I appreciate your efforts to it forward. The road to passage is difficult
but is worth pursuing. I look forward to working with you and the Committee in
support of this effort.
END
LOAD-DATE: July 2,
1999 
