[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 09:45:12 PDT 2016


This second bill was more related to the Anthax attacks on the US following
911.   The first Brown bill, introduced in May, before 911, was the more
general CL, and the more important bill.

The actual negotiations over a CL for Anthrax were first done in the
context of 28 USC 1498,  (some context here:
http://www.cptech.org/ip/health/cl/cipro/), a law that is useful, but not
really designed for this purpose.

Both Brown's 2001 bills (HR 1708 and HR 3235) would have created better
legislative frameworks than 1498, when it comes to compensation to the
patent holder, because they provide the appropriate policy for setting
royalties.  The narrower emergency bill would not do much for high prices
in general, which is why HR 1708 (107th Congress) is the one to look at
today, in my opinion.

On Fri, Apr 29, 2016 at 12:13 PM, Damiano de Felice <ddefelice at atmindex.org>
wrote:

> This is the other bill
>
> https://www.congress.gov/bill/107th-congress/house-bill/3235/text
>
> [Congressional Bills 107th Congress]
> [From the U.S. Government Printing Office]
> [H.R. 3235 Introduced in House (IH)]
>
>
>
>
>
>
>
> 107th CONGRESS
>   1st Session
>                                 H. R. 3235
>
>    To amend title 35, United States Code, to provide for compulsory
>    licensing of certain patented inventions relating to health care
>                               emergencies.
>
>
> _______________________________________________________________________
>
>
>                     IN THE HOUSE OF REPRESENTATIVES
>
>                             November 6, 2001
>
> Mr. Brown of Ohio introduced the following bill; which was referred to
>                      the Committee on the Judiciary
>
> _______________________________________________________________________
>
>                                  A BILL
>
>
>
>    To amend title 35, United States Code, to provide for compulsory
>    licensing of certain patented inventions relating to health care
>                               emergencies.
>
>     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.
>
>     (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 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.''.
>     (b) 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.''.
>                                  <all>
>
>
>
>
> --
> *Damiano de Felice, PhD*
> Deputy Director for Strategy, Access to Medicine Foundation
> Co-Founder and Co-Director, Measuring Business & Human Rights
> Member, World Economic Forum Global Agenda Council on Human Rights
> Tel: +31 646372432 | Skype: dami.defelice | Twitter: @damidefelice
>
> On 29 April 2016 at 18:01, Kirsten Myhr <myhr at online.no> wrote:
>
> > It was a bill on ciprofloxacin (Ciprobay)I think. Introduced beacuse the
> US
> > wanted to build a stock for treating any Anthrax outbreak and found
> Bayer's
> > price too high. I have used that example many times when teaching.
> >
> > Kirsten Myhr
> >
> > -----Opprinnelig melding-----
> > Fra: Ip-health [mailto:ip-health-bounces at lists.keionline.org] På vegne
> av
> > Srividhya Ragavan
> > Sendt: fredag 29. april 2016 17.52
> > Til: Jamie Love <james.love at keionline.org>; Ip-health
> > <ip-health at lists.keionline.org>
> > Emne: Re: [Ip-health] In 2001, 20 members of the House of Representatives
> > introduced a bill on compulsory licensing
> >
> > I remember this one - I think this is the anthrax bill. There was another
> > one too around the same time. This is a good one to show how America
> reacts
> > when it affects their own.
> >
> >
> > Srividhya  Ragavan
> > Professor of Law
> > Texas A&M School of Law
> > Fort Worth, TX - 76102
> >
> >
> > -----Original Message-----
> > From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf
> > Of
> > Jamie Love
> > Sent: Friday, April 29, 2016 10:47 AM
> > To: Ip-health
> > Subject: [Ip-health] In 2001, 20 members of the House of Representatives
> > introduced a bill on compulsory licensing
> >
> > 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
> > _______________________________________________
> > Ip-health mailing list
> > Ip-health at lists.keionline.org
> >
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> >
> > _______________________________________________
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> >
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> >
> >
> >
> > ---
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> >
> >
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> >
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-- 
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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