109 HR 4131 IH: Public Health Emergency Medicines Act U.S. House of Representatives 2005-10-25 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 1st Session H. R. 4131 IN THE HOUSE OF REPRESENTATIVES October 25, 2005 Mr. Brown of Ohio (for himself, Mr. Nadler, Mr. Waxman, Mr. Berry, Mr. Stark, Mr. Allen, and Mr. Kucinich) introduced the following bill; which was referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title 35, United States Code, to provide for compulsory licensing of certain patented inventions relating to health care emergencies, and to provide that applications under section 505 of the Federal Food, Drug, and Cosmetic Act that are submitted pursuant to such licenses may be approved with immediate effective dates.

1.

Short title

This Act may be cited as the Public Health Emergency Medicines Act.

2.

Compulsory licensing of patented inventions; approval by Food and Drug Administration 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 inventions 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 authorize 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 exercising 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 Services 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 invention; (2)evidence of the efficacy and innovative nature and importance to the public health of the invention 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 access to the invention; (7)the benefits of making the invention available to working families and retired persons; (8)the need to correct anti-competitive practices; or (9)other public interest considerations. (c)

Export of health care products in public health emergencies

The Secretary may authorize 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 legitimate 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 implement the purposes of this section, consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay 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 section 351 of the Public Health Service Act), or any technology 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 authorized to manufacture a drug under section 158 of title 35, United States Code, seeks approval of the drug under section 505 of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services may approve the drug with an immediate effective date notwithstanding any limitation on approval pursuant to subsection (c)(3), (j)(4)(D), or (j)(5)(B) of such section.