[Ip-health] KEI request that HHS take ownership of US Patent 7, 964, 580 on sofosbuvir, now held by Gilead, for non-disclosure of NIH grants

James Love james.love at keionline.org
Wed Mar 14 05:09:46 PDT 2018

In the attached letter dated March 14, 2014 to Secretary of the Department
of Health and Human Services (DHHS) Alex Azar, KEI is asking for an
investigation into a failure to report NIH funding on US patent 7,964,580.
This is the first patent in the FDA Orange Book for all Gilead sofosbuvir
based drugs or combination drugs for HCV.

The letter from KEI focuses on a series of NIH grants from July 2003 to
July 2007, to Pharmasset. The principle investigator for these grants was
Jinfa Du, one of the three inventors listed on the patent, all of whom were
employees of Pharmasset.

Three of the grants, 1R01DK066922-01, 5R01DK066922-02 and 5R01DK066922-03,
had the same title, “2′-AND/OR 4′-C-MODIFIED NUCLEOSIDES AS ANTI-HCV
AGENTS.” The abstract for these grants included this text:

In this grant proposal, we plan to design and synthesize a total of one
hundred and ninety novel 2′-C- and/or 4′-C-modified nucleosides, as well as
3′-deoxynucleosides as potential anti-HCV agents. We will determine the
anti-HCV activity of a series of newly designed compounds in vitro. In
addition, in preparation for in vivo proof of principle studies, adequate
safety and favorable pharmacokinetic (PK) profiles of candidate compounds
will be determined in relevant animal models. Furthermore, potent HCV
polymerase inhibitors will be used to select for drug-resistant viral
mutants, and therefore, selection of HCV replicons with the proper
mutations will be a relevant part of this proposal. [emphasis added]

A review of the patent shows, without difficulty, that the invention is
based upon the work funded by the NIH in these three grants.

KEI asks DHHS to investigate the non-disclosure, and also to undertake
measures to remedy the failures to disclose. Specifically, KEI ask DHHS to
take title to the patent, an action that is possible under the provisions
of the Bayh-Dole Act and the contractual requirements of the Pharmasset

The letter concludes with these comments on the proposed remedy for


The patent in question may be worth billions of dollars. In addition to
whatever liability for royalties Gilead could be responsible for stemming
from its use of a government owned patented invention (if the government
takes possession), there would be opportunities to use the Bayh-Dole
royalty-free right to exercise considerable leverage over the prices of all
SOF-based HCV treatments.

In considering the remedies, KEI notes that there have been several recent
requests to use 28 USC § 1498 to obtain access to affordable generic
versions of SOF-based HCV treatments for veterans, 5 for state-run HCV
programs, 6 and more generally to extend treatment to more persons who are
infected with HCV. 7 In the past, and as you know from your involvement in
the 2001 ciprofloxacin case, 8 government agencies have been reluctant to
use § 1498 for cases involving pharmaceutical drugs, out of concerns over
the compensation required. However, when the government uses its
royalty-free rights in connection with a § 1498 non-voluntary use of a
patented invention, the risks of excessive compensation can be
significantly reduced. Even if a § 1498 remedy is ultimately not used, the
possibility of such an action will be considered more likely if the public
has rights in this patent, and hence, a government agency will have more
leverage to negotiate a better price — one that can expand treatment to all
persons who are infected, as opposed to only those with the most serious
immediate health consequences.

Indeed, taking action to remedy the non-disclosure of the patent creates
all sorts of opportunities to advance the public’s interests. For example,
the federal government could condition Gilead’s right to continue using the
patent upon the provision of at-cost HCV medicines for veterans receiving
care from the Department of Veterans Affairs, and thus remedy medicines for
veterans receiving care from the Department of Veterans Affairs, and thus
remedy the situation where the high cost of sofosbuvir-based treatments has
depleted the Department resources budgeted for health care for veterans.
[Footnotes in the letter omitted]


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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