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; APPROVAL BY FOOD AND DRUG AD-
MINISTRATION OF RELATED APPLICATIONS. 
(a) COMPULSORY LICENSING.— 
(1) IN
GENERAL.—Chapter 14 of title 35, 
United States Code, is amended by adding at the 
end the following: 
‘‘§ 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.’’. 
(2) CONFORMING AMENDMENT.—The table of 
sections for chapter 14 of title 35, United States 
Code, is amended by adding at the end the following 
new item: 
‘‘158. Compulsory licensing.’’. 
(b) RELATED
APPLICATIONS
UNDER
FEDERAL 
FOOD, DRUG, AND COSMETIC ACT.—If a person author-
ized to manufacture a drug under section 158 of title 35,