I
107TH CONGRESS
1ST SESSION
H. R. 3235
To amend title 35, United States Code, to provide for compulsory licensing
of certain patented inventions relating to health care emergencies.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 6, 2001
Mr. BROWN of Ohio introduced the following bill; which was referred to the
Committee on the Judiciary
A BILL
To amend title 35, United States Code, to provide for com-
pulsory licensing of certain patented inventions relating
to health care emergencies.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Public Health Emer-
gency Medicines Act’’.
SEC. 2. COMPULSORY LICENSING OF PATENTED INVEN-
TIONS.
(a) IN GENERAL.—Chapter 14 of title 35, United
States Code, is amended by adding at the end the fol-
lowing:
‘‘§ 158. Compulsory licensing
‘‘(a) COMPULSORY LICENSING OF PATENTED INVEN-
TIONS IN PUBLIC HEALTH EMERGENCY.—In the case of
any invention relating to health care the Secretary of
Health and Human Services shall have the right to au-
thorize use of the subject matter of the patent without
authorization of the patent holder or any licensees of the
patent holder if the Secretary makes the determination
that the invention is needed to address a public health
emergency.
‘‘(b) COMPENSATION FOR USE OF A PATENT.—In ex-
ercising the right under subsection (a) to authorize other
use of the subject matter of a patent, the right holder shall
be paid reasonable remuneration for the use of the patent.
In determining the reasonableness of remuneration for the
use of a patent, the Secretary of Health and Human Serv-
ices may consider—
‘‘(1) evidence of the risks and costs associated
with the invention claimed in the patent and the
commercial development of products that use the in-
vention;
‘‘(2) evidence of the efficacy and innovative na-
ture and importance to the public health of the in-
vention or products using the invention;
‘‘(3) the degree to which the invention benefited
from publicly funded research;
‘‘(4) the need for adequate incentives for the
creation and commercialization of new inventions;
‘‘(5) the interests of the public as patients and
payers for health care services;
‘‘(6) the public health benefits of expanded ac-
cess to the invention;
‘‘(7) the benefits of making the invention avail-
able to working families and retired persons;
‘‘(8) the need to correct anti-competitive prac-
tices; or
‘‘(9) other public interest considerations.
‘‘(c) EXPORT OF HEALTH CARE PRODUCTS IN PUB-
LIC HEALTH EMERGENCIES.—The Secretary may author-
ize the use of a patent, without authorization of the patent
holder or any licensees of the patent holder, to export
medicines or other health care products that are needed
to address global public health emergencies, when the le-
gitimate rights of the patent holder are protected in the
export market.
‘‘(d) CONSISTENCY WITH TRIPS.—The Secretary of
Health and Human Services may adopt regulations to im-
plement the purposes of this section, consistent with the
Agreement on Trade-Related Aspects of Intellectual Prop-
erty Rights referred to in section 101(d)(15) of the Uru-
guay Round Agreements Act.
‘‘(e) DEFINITION.—In this section, the term ‘health
care product’ means any drug or device (as those terms
are defined in section 201 of the Federal Food, Drug, and
Cosmetic Act), any biological product (as defined in sec-
tion 351 of the Public Health Service Act), or any tech-
nology or process to the extent the technology or process
is applied to health or health care.’’.
(b) CONFORMING AMENDMENT.—The table of sec-
tions for chapter 14 of title 35, United States Code, is
amended by adding at the end the following new item:
‘‘158. Compulsory licensing.’’.
Æ