[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 05:12:16 PDT 2018


URL for the blog is here. https://www.keionline.org/27205

On Wed, Mar 14, 2018 at 8:09 AM, James Love <james.love at keionline.org>
wrote:

> 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
> grant.
>
> The letter concludes with these comments on the proposed remedy for
> non-disclosure.
>
> -------------
>
> 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]
>
> HHS-Azar-KEI-Patent-7964580-SOF-14March2018
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670 <(202)%20332-2670>, US Mobile: +1.202.361.3040
> <(202)%20361-3040>, Geneva Mobile: +41.76.413.6584
> <+41%2076%20413%2065%2084>, twitter.com/jamie_love
>



-- 
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


More information about the Ip-health mailing list