1.This Act may be cited as
the Public Research in the Public
Interest Act of 2006
.
2.
(a)The
purpose of this Act is to promote global public health and America’s national
security by ensuring that innovations developed at federally-funded
institutions are available in eligible developing countries at the lowest
possible cost.
(b)Congress
finds the following:
(1)It is in the
national interest of the United States that people around the world live
healthier lives, and that they perceive the United States in a more favorable
light.
(2)The United States
Government funds a major portion of all academic research.
(3)Congress funds
universities and Federal research laboratories as institutions dedicated to the
creation and dissemination of knowledge in the public interest.
(4)The Federal
Government’s investment in science and technology fuels a thriving
pharmaceutical industry and rising longevity and quality of life in the United
States. In 2000, a Senate Joint Economic Committee Report found that public
research was instrumental in developing 15 of the 21 drugs considered by
experts to have had the highest therapeutic impact on society.
(5)Millions of
people with HIV/AIDS in developing countries need antiretroviral drugs. More
than 40,000,000 people worldwide have HIV and 95 percent of them live in
developing countries. Malaria, tuberculosis, and other infectious diseases kill
millions of people a year in developing nations.
(6)The World Health
Organization (WHO
) has estimated that 1/3
of the world's population lacks regular access to essential medicines,
including antiretroviral drugs. The WHO reported that just by improving access
to existing medicines roughly 10,000,000 lives could be saved around the world
every year.
(7)To help address
the access to medicines crisis, the World Health Organization’s 2006 Commission
on Intellectual Property Rights, Innovation, and Public Health recommended that
universities adopt licensing practices designed to increase access to medicines
in developing countries.
(8)The Department of
State has reported to Congress under the President’s Emergency Plan for AIDS
Relief that, [I]n every case generics prices present an opportunity for
cost savings; in some cases, the branded price per pack of a drug is up to 11
times the cost of the approved generic version.
.
(9)Since sales of
the patented, brand-name versions of such medicines are minimal or non-existent
in many impoverished regions of the world, allowing generic versions of those
medicines will have minimal impact on the sales of brand-name, patented
versions in such regions, or the licensing revenues of publicly funded research
institutions, while saving an untold number of lives.
3.In this Act:
(1)Associated
medical productThe term associated medical product,
when used in relation to a subject invention, means any medical product of
which the manufacture, use, sale, offering for sale, import, or export relies
upon or is covered by the rights guaranteed by title in that invention.
(2)The term associated rights,
when used in
relation to a subject invention, means—
(A)all patent and
marketing rights, possessed by a current or former holder of title in that
invention, or licensee of rights guaranteed by such title, that are reasonably
necessary to make, use, sell, offer to sell, import, export, or test any
associated medical product ever made, used, sold, offered for sale, imported,
or exported by that party; and
(B)the right to rely
on biological, chemical, biochemical, toxicological, pharmacological,
metabolic, formulation, clinical, analytical, stability, and other information
and data for purposes of regulatory approval of any associated medical
product.
(3)The
term drug has the meaning given such term in section 201 of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).
(4)The term eligible country
means any
country of which the economy is classified by the World Bank as
low-income
, or lower-middle-income
.
(5)The term fair royalty
, when used in
relation to a subject invention, means—
(A)for a country
classified by the World Bank as low-income
at the time of the
sales on which royalties are due, 2 percent of a licensee’s net sales of
associated medical products in such country; and
(B)for a country
classified by the World Bank as lower-middle-income
at the time
of sales on which royalties are due, 5 percent of a licensee’s net sales of
associated medical products in such country.
(6)The
term invention means any invention or discovery which is or may be
patentable or otherwise protectable under title 35, United States Code, or any
novel variety of plant which is or may be protectable under the Plant Variety
Protection Act (7 U.S.C. 2321 et seq.).
(7)The term medical device means a device, as
defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(h)), and includes any device component of any combination product,
as that term is used in section 503(g) of such Act (21 U.S.C. 353(g)).
(8)The term medical product means any drug,
treatment, prophylaxis, vaccine, or medical device.
(9)The term neglected research
means any use
of a subjected invention or the associated rights in an effort to develop
medical products for a rare disease or condition, as defined in section
526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bb(a)(2)).
(10)The term subject institution means any
institution of higher education (as such term is defined in section 101(a) of
the Higher Education Act of 1965 (20 U.S.C. 1001(a)) or research that receives
federal financial assistance, including Federal laboratories as defined in
section 12(d) of the Stevenson-Wydler Technology Innovation Act of 1980 (15
U.S.C. 3710a(d)).
(11)The term subject invention means any
invention—
(A)conceived or
first actually reduced to practice by a subject institution, or its employees
in the course of their employment, on or after the effective date of this Act;
or
(B)in which a
subject institution holds title, provided the invention was first conceived or
reduced to practice on or after the effective date of this Act.
4.Access to
lifesaving medicines developed at government funded institutions
(a)
(1)As a condition of receiving Federal assistance, any
subject institution that conceives, reduced to practice, or holds title in a
subject invention shall be required to grant irrevocable, perpetual,
nonexclusive licenses to the invention and any associated rights the
institution may own or ever acquire, to any party requesting such a license
pursuant to subsection (g).
(2)The licenses described under paragraph (1) shall be for
the sole purpose of—
(A)supplying medical
products in accordance with subsection (e); or
(B)conducting
neglected research anywhere in the world, royalty-free.
(b)The open-licensing requirement created by subsection
(a) and all licenses granted thereunder shall be part of the subject
institution’s title in a subject invention. No transfer or license may be
interpreted in any manner inconsistent with making any grant under subsection
(a) effective, or in any manner that prevents or frees the holder of title in
the invention from granting licenses.
(c)
(1)If a subject institution licenses or grants rights in a
subject invention to any other party, as a condition of such grant the licensee
or grantee, and any future sublicensees or subsequent grantees, ad infinitum,
shall also be required in perpetuity, to grant irrevocable, perpetual,
nonexclusive licenses on any associated rights which the licensee or grantee
may own or later acquire, to any party requesting such a license pursuant to
subsection (g).
(2)The licenses shall be for the sole purposes described in
subsection (a)(2).
(3)Application of
this subsectionThis subsection applies to licenses for a subject
invention acquired under subsection (a).
(d)No
grant or licensee of any subject invention may be interpreted in any manner
that prevents or frees the grantee or licensee from granting licenses for
associated rights under subsection (c).
(e)License for
supply of medical products
(1)A license under subsection (a)(2)(A) shall be a license
for the sole purpose of permitting the making, using, selling, offering to
sell, importing, exporting, and testing of medical products in eligible
countries and the making and exporting of medical products worldwide for the
sole purpose of supplying medical products to eligible countries.
(2)If
the recipient of a license under subsection (a) exercises its right to make and
export a medical product in any country other than an eligible country for the
sole purpose of export to an eligible country, then the licensee shall use
reasonable efforts to visibly distinguish the medical product it manufactures
from any similar medical product sold by others in the country of manufacture,
provided that such reasonable efforts do not require the licensee to expend
significant expense.
(3)
(A)License of
subject inventionA license of a subject invention under
subsection (a)(2)(A) shall be irrevocable and perpetual so long as the licensee
submits to the licensor payment of a fair royalty on sales of any associated
medical product within 90 days of such sales. Failure or refusal of the
licensor to accept the fair royalty shall not terminate or affect in any way
the license.
(B)License of
associated rightsA license of associated rights to a subject
invention under subsection (a)(2)(A) shall be royalty free.
(f)In
accordance with subsections (a) through (d), any license or other transfer of a
subject invention by a subject institution or the licensee or grantee of such
institution for a subject invention, shall be invalid unless—
(1)the license or
grant includes a clause, This grant or license is subject to the
provisions of the Public Research in the Public Interest Act of
2006.
;
(2)the licensor or
grantor complies with the notification requirements of subsection (h);
and
(3)the license or
grant does not include any terms that contradict any requirement of this
Act.
(g)Procedures for
acquisition of licenses
(1)Any party, upon providing to the Food and Drug
Administration—
(A)notification of
its intent to supply medical products or conduct neglected research as provided
in subsection (a);
(B)a specific list
of the rights it wishes to license for those purposes; and
(C)the names of the
party or parties it believes are obligated to grant such licenses under
subsections (a) through (d),
shall
automatically be deemed to receive the license so requested without the need
for any further action on the part of the licensing party if the party or
parties specified in the request do not object and notify the requesting party
of such objection, within 30 days of the publication of such request by the
Administration.(2)
(A)If the party or parties specified under paragraph (1)
object to the grant of a requested license, the requesting party may bring an
action to enforce its right to a license of a subject invention or associated
rights under subsections (a) through (d).
(B)In
any suit under this subsection, the requesting party shall be entitled to
separate, expedited review of the legal issues required to adjudicate whether
it is entitled to the requested license, without prejudice to any other issues
in the lawsuit. If the party objecting to the license is found to have objected
without reasonable cause or without a good faith belief that there was a
justifiable controversy under the facts and the law, the party requesting the
license shall be entitled to attorney’s fees, other reasonably necessary costs
of the lawsuit, and treble damages from the objecting party.
(3)The
Food and Drug Administration shall publish any request made under paragraph (1)
within 15 days of receipt of such request. The Food and Drug Administration
shall also make reasonable efforts to directly notify the parties named in any
such request.
(h)Notification of
transfer or license of subject inventionsThe holder of title or
any license in a subject invention shall notify the Food and Drug
Administration of any grant or license of rights in that invention. The Food
and Drug Administration shall publish all such notifications within 15 days of
receipt.