[Ip-health] In 2001, 20 members of the House of Representatives introduced a bill on compulsory licensing

Jamie Love james.love at keionline.org
Fri Apr 29 08:46:49 PDT 2016


This would be a  good bill today.  Jamie


Introduced May 3, 2001.

[Congressional Bills 107th Congress]
[From the U.S. Government Printing Office]
[H.R. 1708 Introduced in House (IH)]


107th CONGRESS
  1st Session
                                H. R. 1708

   To amend title 35, United States Code, to provide for compulsory
      licensing of certain patented inventions relating to health.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 3, 2001

Mr. Brown of Ohio (for himself, Mr. Berry, Mr. Stark, Mr. Allen, Mr.
Sanders, Mr. Bonior, Ms. Lee, Mr. LaTourette, Mr. Wynn, Mr. Langevin, Mr.
Davis of Illinois, Mr. Barrett, Mr. Baldacci, Ms. Schakowsky, Mr. Green of
Texas, Mrs. Jones of Ohio, Mr. Nadler, Mr. Lewis of Georgia, Mr. George
Miller of California, and Mr. DeFazio) 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.

    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 ``Affordable Prescription Drugs and
Medical Inventions Act''.

SEC. 2. COMPULSORY LICENSING OF PATENTED INVENTIONS.

    (a) 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 the case of any
invention relating to health care, in which a patent holder, contractor,
exclusive licensee, or assignee has acquired title under this title, the
Secretary of Health and Human Services and the Federal Trade Commission
shall each have the right to establish other use of the subject matter of
the patent without authorization of the right holder if the Secretary or
the Commission (as the case may be) makes the determination described in
subsection (b).
    ``(b) Determination.--The determination referred to in subsection (a)
with respect to an invention claimed in a patent is a determination that
one or more of the following applies:
            ``(1) The patent holder, contractor, licensee, or assignee
referred to in subsection (a) has not taken, or is not expected to take
within a reasonable time, effective steps to achieve practical application
of the subject invention in a field of use.
            ``(2) Establishing other use of the subject matter of the
patent is necessary to alleviate health or safety needs which are not
adequately satisfied by the patent holder, contractor, licensee, or
assignee.
            ``(3) The patent holder has engaged in anti-competitive
behavior. Such determination may include, but is not limited to, a
determination that--
                    ``(A) the patented invention is priced excessively
relative to the median price for developed countries or
                by other reasonable standards, and that such pricing
contravenes the public interest; or
                    ``(B) the patented invention is an essential component
of a health care product that involves patents, and the licensing terms for
the patent on the invention are not reasonable and deter innovation or
product development, contrary to the public interest.
            ``(4) An invention covered by a patent (the `second patent')
cannot be exploited without infringing upon the patent described in
subsection (a) (the `first patent'), insofar as the invention claimed in
the second patent involves an important technical advance.
            ``(5) The invention claimed in the patent is needed for
research purposes that would benefit the public health, and is not licensed
on reasonable terms and conditions.
    ``(c) Factors in Authorizing Other Use.--In exercising the right under
subsection (a) to authorize other use of the subject matter of a patent,
the following shall apply:
            ``(1) In cases involving commercial use, such use may be
permitted only if, prior to such use, the proposed user has made efforts to
obtain authorization from the right holder on reasonable commercial terms
and conditions and such efforts have not been successful within a
reasonable period of time.
            ``(2) The right holder shall be paid adequate remuneration for
the use of the patent.
            ``(3) Where such use is authorized under subsection (b)(4), the
owner of the first patent shall be entitled to a license on reasonable
terms to use the invention claimed in the second patent.
    ``(d) Considerations for Determining Remuneration for Use of a
Patent.--In determining the reasonableness of licensing terms and the
remuneration for the use of a patent under subsection (c), the Secretary of
Health and Human Services or the Federal Trade Commission (as the case may
be) shall consider--
            ``(1) the risks and costs associated with the invention claimed
in the patent and the commercial development of products that use the
invention;
            ``(2) 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; and
            ``(6) the public health benefits of expanded access to the
invention.
    ``(e) Consistency With TRIPS.--The Secretary of Health and Human
Services and the Federal Trade Commission may adopt regulations jointly 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.
    ``(f) 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.''.

    (b) Conforming Amendment.--The table of contents for chapter 14 of
title 35, United States Code, is amended by adding at the end the following
new item:

``158. Compulsory licensing.''.

SEC. 3. REPORT ON PHARMACEUTICAL COSTS AND SALES.

    (a) Report Requirement.--Any person engaged in the manufacture and sale
of any drug approved under section 505 or 512 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355, 360b) for which a patent is still in
effect shall report to the Secretary of Health and Human Services annually
an audit of all financial information relevant to the pricing of that drug
nationally and internationally, including, in formats specified by the
Secretary, an accounting of the costs allocated to research and development
of that drug, as well as costs allocated to other research and development
activities. The Secretary shall transmit the reports filed under this
subsection to the Congress.

    (b) Civil Penalty.--
            (1) Penalty.--Any person who fails to submit a report under
subsection (a) by the date specified pursuant to subsection (c) shall be
liable to the United States for a civil penalty in an amount not to exceed
$25,000 for each such violation. Each day such a violation continues shall,
for purposes of this subsection, constitute a separate violation of
subsection (a). (2) Procedures.--A civil penalty for a violation of
subsection (a) shall be assessed by order of the Secretary of Health and
Human Services after opportunity (provided in accordance with this
paragraph) for a hearing in accordance with section 554 of title 5, United
States Code. Before issuing such an order, the Secretary shall give written
notice to the person to be assessed a civil penalty under such order of the
Secretary's proposal to issue such order and provide such person an
opportunity to request, within 15 days of the date the notice is received
by such person, such a hearing on the order.

            (3) Judicial review.--Any person who requested a hearing in
accordance with paragraph (2) a hearing and who is aggrieved by an order
assessing a civil penalty pursuant to the hearing may seek judicial review
of the order by filing a petition for judicial review in the appropriate
United States district court not later than 30 days after the date on which
the order was issued.

            (4) Failure to pay penalty.--If any person fails to pay an
        assessment of a civil penalty--
                    (A) after the order making the assessment has become a
final order and if such person does not file a petition for judicial review
of the order, or
                    (B) after a court in an action for judicial review of
the order has entered a final judgment in favor of the Secretary of Health
and Human Services, the Attorney General shall recover the amount assessed
(plus interest at currently prevailing rates from the date of the
expiration of the 30-day period referred to in paragraph (3) or the date of
such final judgment, as the case may be) in an action brought in any
appropriate district court of the United States. In such an action, the
validity, amount, and appropriateness of such penalty shall not be subject
to review.

    (c) Regulations.--The Secretary of Health and Human Services shall
issue such regulations as are necessary to carry out this section,
including specifying the dates by which the reports under subsection (a)
must be submitted.



-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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