CIS/Index
Copyright © 1999, Congressional Information
Service, Inc.
00 CIS H 52188
TITLE: Patent
Fairness Act of 1999
CIS-NO: 2000-H521-88
SOURCE: Committee
on the Judiciary. House
DOC-TYPE: Hearing Retrieve
the full text of testimony
DATE: July 1, 1999
LENGTH:
iv+121 p.
CONG-SESS: 106-1
ITEM-NO: 1020-A; 1020-B
SUDOC: Y4.J89/1:106/61
CIS DOCUMENT ON DEMAND: 1-800-227-2477
(Full Text Reproductions)
GPO-STOCK-NO: 552-070-25663-6.
SUMMARY:
Committee Serial No. 61. Hearing before
the Subcom on Courts and Intellectual Property to review patent issues, focusing
on proposals to revise the patent process for drugs.
Considers
the following bills:
H.R. 1598 (text, p. 2-5), the Patent
Fairness Act of 1999, to establish an administrative process for Patent and
Trademark Office review of drug company requests to extend patents for certain
drugs for which an investigational new drug (IND) application had been submitted
to FDA prior to enactment of the Drug Price Competition and Patent Term
Restoration Act of 1984, also known as the Hatch-Waxman Act.
Purpose of bill is to provide certain drug companies with an opportunity to
receive a patent term extension to compensate for FDA delays in completion of
the drug approval process.
Draft bill, the Fairness in
Pharmaceutical Testing Act of 1999, to limit to generic drugs application of the
so-called Bolar exemption to the Hatch-Waxman Act, which allows
third parties access to testing data owned by pharmaceutical patent holders in
cases where the sole purpose of the data use is for FDA approval of a drug.
Purpose of bill is to prevent application of the Bolar exemption to new drugs
and biologics.
Supplementary material (p. 115-121) includes
submitted statements and correspondence.
CONTENT-NOTATION: Drug patent process revision
BILLS: 106
H.R. 1598
DESCRIPTORS:
SUBCOM ON COURTS AND INTELLECTUAL PROPERTY. HOUSE;
FOOD AND DRUG ADMINISTRATION; MEDICAL REGULATION; PHARMACEUTICAL INDUSTRY;
GOVERNMENT AND BUSINESS; BIOLOGIC DRUG PRODUCTS; PATENT FAIRNESS ACT; PATENT AND
TRADEMARK OFFICE; PATENTS; DRUGS; DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT; FAIRNESS IN PHARMACEUTICAL TESTING ACT
00-H521-88
TESTIMONY NO: 1 July 1, 1999 p. 10-26
WITNESSES (and witness notations):
TORRICELLI, ROBERT
G. (Sen, D-NJ)
BRYANT, ED (Rep, R-Tenn)
MCDERMOTT, JIM (Rep, D-Wash)
WAXMAN, HENRY A. (Rep, D-Calif)
BERRY, MARION (Rep, D-Ark)
STATEMENTS:
Differing views on H.R. 1598 and related issues.
CONTENT NOTATION:
Drug patent process
revision
00-H521-88 TESTIMONY NO: 2
July 1, 1999 p. 29-84
WITNESSES (and witness notations):
HUTT, PETER B. (attorney)
DOWNEY,
BRUCE L. (Chairman, CEO, and President, Barr Laboratories)
BERDON, ANDREW M. (Vice President and General Counsel,
Purepac Pharmaceutical Co.; both representing Coalition for Affordable
Pharmaceuticals)
SPICEHANDLER, JONATHAN R. (Dr.)
(President, Schering-Plough Research Institute; representing Schering-Plough
Corp)
LEHMAN, BRUCE (President and CEO, International
Intellectual Property Institute)
KEALEY, MAURA (Deputy
Director, Public Citizen Congress Watch)
MEYER, GERALD F.
(Senior Consultant, AAC Consulting Group)
ORR, WILLIAM
(Chairman, National Alternative Fuels Association)
STATEMENTS AND
DISCUSSION:
Opposing views on H.R. 1598; unfairness of
Hatch-Waxman Act provisions establishing different patent terms
on the basis of whether or not an IND application had been submitted prior to
Act enactment; review of generic pharmaceutical companies objections to efforts
of brand-name companies to obtain patent term extensions.
Differing opinions on Schering-Plough efforts to extend
patent term for loratadine, an antihistamine marketed as Claritin; review of
drug affordability issues related to patent term extensions proposed by H.R.
1598; perspectives on patent issues.
CONTENT NOTATION:
Drug patent process revision
TESTIMONY
DESCRIPTORS:
ORR, WILLIAM; ANTIHISTAMINES; MEDICAL
ECONOMICS; LORATADINE
00-H521-88 TESTIMONY NO: 3
July 1, 1999 p. 85-113
WITNESSES (and witness
notations):
BINDER, GORDON (Chairman and CEO, Amgen)
SELDEN, RICHARD F. (Dr.) (CEO, Transkaryotic Therapies,
Inc)
BURGOON, RICHARD P., JR. (Vice President, Arena
Pharmaceuticals, Inc)
STATEMENTS AND DISCUSSION:
Differing views on proposal to limit application of the
Bolar exemption to generic drugs; feared adverse impact of the proposal on
biotechnology and pharmaceutical research and competition.
CONTENT NOTATION:
Drug patent process revision
TESTIMONY DESCRIPTORS:
AMGEN; MEDICAL
RESEARCH; COMPETITION
LOAD-DATE: October 30, 2000
