Copyright 1999 Federal News Service, Inc.
Federal News Service
JULY 1, 1999, THURSDAY
SECTION: IN THE NEWS
LENGTH:
248 words
HEADLINE: PREPARED STATEMENT OF
THE
HONORABLE HOWARD COBLE
BEFORE THE HOUSE JUDICIARY COMMITTEE
COURTS AND INTELLECTUAL PROPERTY SUBCOMMITTEE
SUBJECT - H.R. 1598, THE
"PATENT FAIRNESS ACT OF 1999,"
THE BOLAR EXEMPTION TO THE
HATCH-WAXMAN ACT,
& TERM ISSUES AFFECTING THE
ALTERNATIVE FUELS INDUSTRY
BODY:
Good afternoon. The Subcommittee will come to order.
Today we will
discuss three patent issues. The first is H.R. 1598, the "Patent Fairness Act of
1999," introduced by our colleague Ed Bryant of Tennessee. Representative
Bryant's bill would allow the Patent and Trademark Office to extend term for
patents of so-called "pipeline" drugs which were subject to lengthy FDA review.
Second, we will examine the so-called Bolar exemption to the HatchWaxman
Act. This provision allows third parties access to testing data owned by
pharmaceutical patent holders, but only for the purpose of using the data for
FDA approval of a drug. Current litigation on this point has compelled us to
reexamine the scope of the exemption. Specifically, did Congress intend the
exemption to apply only to generic drugs, or to new drugs and biologics as well?
Finally, we will hear testimony about specific patent reexamination issues and
regulatory delay affecting the alternative fuels industry.
I will conclude
by noting that we all want a sound health care system that provides access for
our citizens to state-of-the-art pharmaceutical products. That said, I hope we
all can remember to remain civil, and to acknowledge that the focus of the
hearing is on subject matter which is a part of our Subcommittee jurisdiction;
that is, patent law and the criteria by which term is properly restored.
I
now turn to the Ranking Member from California, Mr. Berman, for his opening
statement.
END
LOAD-DATE: July 2, 1999
