[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4131 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4131

   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.


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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:
``Sec. 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.
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