1.This Act may be cited as the
Elimination of Neglected Diseases Act
of 2006
.
2.Patent extension
and restoration
(a)Chapter 14 of title 35, United States Code, is amended by
inserting after section 156 the following:
156a.Extension and
restoration of patent terms relating to neglected and tropical
diseases
(a)In
this section, the term—
(1)AIDS
means the acquired immune deficiency syndrome;
(2)AIDS
drug means a drug indicated for treating HIV;
(3)eligible
patent means a patent that—
(A)claims—
(i)an approved new
molecular entity standard review drug;
(ii)an active
ingredient of such new molecular entity standard review drug;
(iii)a process of
making or using the new molecular entity standard review drug; or
(iv)a process of
making an active ingredient of such new molecular entity standard review drug;
and
(B)is owned by or
licensed to a person that has filed and received approval of an application
described in section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)(1)), for a tropical disease product;
(4)HIV
means the human immunodeficiency virus, the pathogen that causes AIDS;
(5)neglected
or tropical disease means—
(A)HIV, malaria,
tuberculosis, and related diseases; or
(B)any other
infectious disease that disproportionately affects poor and marginalized
populations, including those diseases targeted by the Special Programme for
Research and Training in Tropical Diseases cosponsored by the United Nations
Development Program, UNICEF, the World Bank, and the World Health
Organization;
(6)new
molecular entity standard review drug—
(A)means a drug
that—
(i)has never been
marketed in the United States;
(ii)appears to have
therapeutic qualities superior to the therapeutic qualities of another drug
that is marketed in the United States; and
(iii)is designated
by the Secretary of Health and Human Services under section 524 of the Federal
Food, Drug, and Cosmetic Act as having a new molecular entity chemical type
classification and standard review drug treatment potential classification,
other than drugs developed to treat serious or life-threatening diseases;
and
(B)shall not include
a subpart E drug or an AIDS drug;
(7)regulatory
review period means the period described under section
506(g)(1)(B);
(8)subpart E
drug means a drug developed or evaluated under special procedures for
drugs to treat life-threatening or severely debilitating illnesses under
subpart E of part 312 of title 21 of the Code of Federal Regulations;
and
(9)tropical
disease product means a product that—
(A)is approved for
use in the treatment of a neglected or tropical disease;
(B)is a new drug,
antibiotic drug, biological product, device, diagnostic, or other tool for
treatment, as those terms are used in the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) and the Public Health Service Act (42 U.S.C. 201 et
seq.); and
(C)is certified by
the Secretary of Health and Human Services under section 524 of the Federal
Food, Drug, and Cosmetic Act .
(b)The term of an eligible patent shall be extended by a
period not to exceed 2 years and not less than 6 months in duration if—
(1)an application in
conformance with the requirements of subsection (d) is submitted to the
Director by either the owner of record of the patent or its agent on the later
of—
(A)on or before the
date specified under subsection (d)(3); or
(B)within 45 days
after the date of issuance of the patent;
(2)the term of the
eligible patent that is the basis of the application has not expired prior to
the date that the application is submitted under subsection (d);
(3)the regulatory
review period for the tropical disease product has not been relied upon to
support an application to extend the term of another patent under this section
or under any other provision of law; and
(4)the Food and Drug
Administration has certified the eligibility of that tropical disease product
for patent extension.
(c)The term of a patent for a tropical disease product
shall be restored by a period equal to the number of days in the regulatory
review period, if, with respect to the patent that is the basis for
application—
(1)the owner of
record of the patent or its agent submits an application to the Director on the
later of—
(A)on or before the
date specified under subsection (d)(3); or
(B)on or before 45
days after the date of issuance of the patent;
(2)the patent has
not been previously restored or extended under this section;
(3)the term of the
patent has not expired prior to the date that the owner of the record of the
patent or its agent submits an application to the Director;
(4)the regulatory
review period for the product has not been relied upon to support an
application to extend the term of another patent under any section of this
title; and
(5)the Food and Drug
Administration has certified the eligibility of that tropical disease product
for patent restoration.
(d)Administrative
provisions
(1)To obtain an extension or restoration of the term of an
eligible patent or patent of a tropical disease product under this section, the
assigner of record and licensee of record of the eligible patent or tropical
disease product or the agent of the assigner of record and licensee shall
submit an application to the Director.
(2)The
application shall contain—
(A)a description of
the approved tropical disease product and the Federal statute under which
regulatory review relating to such product occurred;
(B)the identity
of—
(i)the eligible patent for which an extension
is sought under this section; or
(ii)the patent for a
tropical disease product for which a restoration is sought under this
section;
(C)an undertaking by
the applicant to make publicly available independently audited financial
statements to verify commercialization of the approved tropical disease
product; and
(D)such other
information as the Director may require including additional information to
establish that the eligible patent or tropical disease product meets the
requirements of this section.
(3)Submission of
applicationUpon submission of the application for approval of
the tropical disease product to the Food and Drug Administration, the sponsor
shall give notice of which patent it would extend if the patent becomes
eligible for the extension or restoration upon successfully completing the
research. The Secretary of Health and Human Services shall publish the
notice.
(4)The submission of an application under this section is
an irrevocable election of the application of this section to the eligible
patent or patent for a tropical disease product that is the basis of the
application. An eligible patent or patent for a tropical disease product that
is the basis of an application submitted under this section may not be the
subject of an application made under section 156 or any other provision of
law.
(5)Nothing in this section shall be construed to
prohibit an extension, under an application made under any other section of
this title, of the term of a patent relating to a tropical disease product
that, prior to the effective date of this section, was approved for commercial
marketing for a nontropical disease use.
(e)An
eligible patent may not be extended under this section if—
(1)the tropical
disease product was approved for commercial marketing prior to the date of
enactment of this section; or
(2)the eligible
patent that is the basis of the application under this section expired prior to
the date of enactment of this
section.
.
(b)Designation for
patent extension and restorationChapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 523
the following:
524.Designation
for patent extension and restoration
(a)In
this section:
(1)New molecular
entity standard review drugThe term new molecular entity
standard review drug has the meaning given that term in section 156a of
title 35, United States Code.
(2)The term tropical disease product
has the meaning given that term in section 156a of title 35, United States
Code.
(b)New molecular
entity standard review drugThe Secretary, acting through the
Commissioner of Food and Drugs—
(1)shall designate a
drug as a new molecular entity standard review drug for purposes of section
156a of title 35, United States Code, if that drug—
(A)has a new
molecular entity chemical type classification and standard review drug
treatment potential classification; and
(B)is not a drug
developed to treat serious or life-threatening diseases;
(2)shall apply the
guidance issued in calendar year 2002 on serious or life-threatening diseases
for purposes of paragraph (1)(B);
(3)shall maintain
and annually update a classification list of serious and life-threatening
diseases; and
(4)may remove the
designation of a drug as a new molecular entity standard review drug as
designated under paragraph (1).
(c)Tropical
disease productsThe Secretary shall certify tropical disease
products for purposes of section 156a of title 35, United States
Code.
.
(c)Technical and
conforming amendmentThe table of sections for chapter 14 of
title 35, United States Code, is amended by inserting after the item relating
to section 156 the following:
156a. Extension and restoration
of patent terms relating to neglected and tropical
diseases.
.
(d)
(1)The
Director of the United States Patent and Trademark Office, in conjunction with
the Food and Drug Administration, the Department of Health and Human Services,
and the United States Agency for International Development, shall conduct a
study on the effect of patent extension and restoration on the ability of
pharmaceutical companies to develop and distribute tropical disease products
for poor and marginalized populations.
(2)Not
later than 1 year after the date of the enactment of this Act, the Director of
the United States Patent and Trademark Office shall submit a report on the
results of the study under paragraph (1) to—
(A)the Committee on
Foreign Relations of the Senate and the Committee on Health, Education, Labor,
and Pensions of the Senate; and
(B)the appropriate
committees of the House of Representatives.