[Ip-health] March-in rights

Jamie Love james.love at keionline.org
Mon Jul 13 07:05:56 PDT 2015

Government subsidies for R&D do not necessarily lead to NIH march-in
rights, unless the "'subject invention'  . . .  [was] conceived or first
actually reduced to practice in the performance of work under a funding

None of the patents for sofosbuvir declare federal march-in rights.  So,
one would have to first establish that the march-in rights exist, and then
ask that they be exercised.

The US government provides billions of dollars in subsidies for R&D that do
 no qualify for march-in rights, under current federal law.


35 U.S. Code § 201 - Definitions
Current through Pub. L. 114-19. (See Public Laws for the current Congress.)

As used in this chapter—
(a) The term “Federal agency” means any executive agency as defined in
section 105 of title 5, and the military departments as defined by section
102 of title 5.
(b) The term “funding agreement” means any contract, grant, or cooperative
agreement entered into between any Federal agency, other than the Tennessee
Valley Authority, and any contractor for the performance of experimental,
developmental, or research work funded in whole or in part by the Federal
Government. Such term includes any assignment, substitution of parties, or
subcontract of any type entered into for the performance of experimental,
developmental, or research work under a funding agreement as herein defined.
(c) The term “contractor” means any person, small business firm, or
nonprofit organization that is a party to a funding agreement.
(d) The term “invention” means any invention or discovery which is or may
be patentable or otherwise protectable under this title 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.).
The term “subject invention” means any invention of the contractor
conceived or first actually reduced to practice in the performance of work
under a funding agreement: Provided, That in the case of a variety of
plant, the date of determination (as defined in section 41(d)  [1] of the
Plant Variety Protection Act (7 U.S.C.2401 (d))) must also occur during the
period of contract performance.
(f) The term “practical application” means to manufacture in the case of a
composition or product, to practice in the case of a process or method, or
to operate in the case of a machine or system; and, in each case, under
such conditions as to establish that the invention is being utilized and
that its benefits are to the extent permitted by law or Government
regulations available to the public on reasonable terms.
(g) The term “made” when used in relation to any invention means the
conception or first actual reduction to practice of such invention.
(h) The term “small business firm” means a small business concern as
defined at section 2 ofPublic Law 85–536 (15 U.S.C. 632) and implementing
regulations of the Administrator of the Small Business Administration.
(i) The term “nonprofit organization” means universities and other
institutions of higher education or an organization of the type described
in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501
(c)) and exempt from taxation under section 501(a) of the Internal Revenue
Code (26 U.S.C. 501 (a)) or any nonprofit scientific or educational
organization qualified under a State nonprofit organization statute.

On Sun, Jul 12, 2015 at 9:51 AM, George Carter <gmcfiar at gmail.com> wrote:

> Should we petition the government, venal as it is, to exercise march-in
> against Gilead?
> Not sure there is a case, if Pharmasset is a small business as the
> originator, tho NIH clearly helped. But as in the case of ritonavir, NIH is
> so corrupt and blind they said no. However, sofosbuvir is a different
> matter.
> These urls are of some interest:
> http://patent.laws.com/patent-protection/march-in-rights
> https://www.law.cornell.edu/uscode/text/35/203
> and from Wiki
> https://en.wikipedia.org/wiki/Bayh%E2%80%93Dole_Act#Petitions_for_march-in_rights
> Petitions for march-in rights
> The government's march-in right is one of the most contentious provisions
> in Bayh-Dole. It allows the funding agency, on its own initiative or at the
> request of a third party, to effectively ignore the exclusivity of a patent
> awarded under the act and grant additional licenses to other "reasonable
> applicants." This right is strictly limited and can only be exercised if
> the agency determines, following an investigation, that one of four
> criteria is met.[24] The most important of these is a failure by the
> contractor to take "effective steps to achieve practical application of the
> subject invention" or a failure to satisfy "health and safety needs" of
> consumers.
> Though this right is, in theory, quite powerful, it has not proven so in
> terms of its practical application —as of January, 2015, no federal agency
> has exercised its march-in rights. Five march-in petitions have been made
> to the National Institutes of Health.
> In In Re Petition of CellPro, Inc.,[25] CellPro petitioned the NIH in
> March 1997 after five years of patent litigation with The Johns Hopkins
> University and Baxter Healthcare. CellPro had a patented, FDA-approved
> device for purifying stem cells for use in hematopoietic stem cell
> transplantation procedures; Johns Hopkins had patents on a different method
> to purify stem cells and had licensed them to Becton Dickinson, which had
> sublicensed them to Baxter, which was developing products but had none on
> the market. CellPro argued that the march-in provisions were created for
> this situation, especially because (in its view) availability of essential
> medical technology was at stake. The NIH denied this claim[26] citing:
> Johns Hopkins's licensing of the subject invention
> Baxter's use, manufacturing, and practice of the subject invention
> Baxter's application to the Food and Drug Administration (FDA) to market
> the invention
> The actual clinical benefit of purifying stem cells for use in
> hematopoietic stem cell transplantation was unknown
> Government intervention into markets has adverse effects and there is
> insufficient cause to do so in this case.
> In In the Case of NORVIR, the NIH received requests[27] from Essential
> Inventions in January 2004, and other members of the public and members of
> the United States Congress,[28] to exercise march-in rights for patents
> owned by Abbott Labs covering the drug ritonavir, sold under the trade name
> Norvir, a prescription drug used in the treatment of AIDS. In 2003 Abbott
> raised the price of Norvir 400% for U.S. customers (but not for consumers
> in any other country), and had refused to license ritonavir to another
> company for purposes for providing protease inhibitors coformulated with
> ritonavir.[29] The NIH denied the petition finding no grounds to exercise
> its march-in rights.[28] The NIH cited:
> The availability of Norvir to patients with AIDS
> That there was no evidence that health and safety needs were not
> adequately met by Abbott, and
> That the NIH should not address the issue of drug pricing, only Congress.
> In In the Case of Xalatan the NIH received a request[30] from Essential
> Inventions in January 2004 to adopt a policy of granting march-in licenses
> to patents when the patent owner charged significantly higher prices in the
> United States than they did in other high income countries, on the basis of
> Pfizer's glaucoma drug being sold in the United States at two to five times
> the prices in other high income countries. The NIH held that “the
> extraordinary remedy of march-in was not an appropriate means for
> controlling prices.”[31]
> In In the Case of Fabrazyme[32] patients with Fabry disease petitioned on
> August 2, 2010, for march-in rights in response to Genzyme's inability to
> manufacture enough Fabrazyme to treat all Fabry patients. In 2009, Genzyme
> rationed the drug to less than a third of the recommended dose as a result
> of manufacturing problems and FDA sanctions, but did not anticipate being
> able to meet the market needs until late 2011. The patients had a return of
> their symptoms and were put at greater risk of morbidity and mortality at
> the reduced dosage. The petitioners contended that where a licensee of a
> public invention has created a drug shortage, the public health
> requirements of the Bayh–Dole Act are not met and other manufacturers
> should be allowed to enter the market.
> On November 3, 2010, the NIH denied the petition for march-in, stating
> that under the then-current FDA drug approval process, it would take years
> of clinical testing to bring a biosimilar of Fabrazyme to market and
> therefore march-in would not address the problem.[33] The NIH also stated
> that it would continue to monitor the situation and if Genzyme could not
> meet its production deadlines, or if a third party licensee requested a
> license, the march-in request would be revisited. The NIH additionally
> required regular updates from Mount Sinai School of Medicine, the patent
> holder, which agreed to not seek injunctions for potentially infringing
> products being sold during the shortage. On February 13, 2013, NIH's Office
> of Technology Transfer issued a "close out" letter stating that: "The
> December 2012 report from Genzyme stated that: (1) U.S. Fabry patients
> remain on full dose regimens, (2) Genzyme continues to accommodate new
> patients with full dosing and without placing them on a waiting list; and
> (3) Genzyme is able to provide full doses of Fabrazyme® to patients
> transitioning to Fabrazyme.® [34]
> On October 25, 2012 the NIH received a petition on behalf of a coalition
> of public interest groups to exercise its march-in rights against AbbVie
> over its antiretroviral drug ritonavir (sold under the name Norvir®). On
> October 25, 2013 NIH denied the petition[35] stating that, as in 2004 when
> similar pricing and availability issues regarding the same drug were raised
> and discussed at public hearings, the NIH'S role in the case was limited to
> compliance with the Bayh-Dole Act and that "...the extraordinary remedy of
> march-in is not an approropriate means of controlling prices of drugs
> broadly available...".
> ***
> Thoughts from the lawyers in the group?
> George M. Carter
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James Love.  Knowledge Ecology International
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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