In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with the support of the Laura and John Arnold foundation, has petitioned the PTAB seeking Inter Partes Review of Gilead’s U.S. Patent Nos. 7,429,572 & 7,964,580, which purport to encompass sofosbuvir, one of the active components of anti-Hepatitis C drugs Sovaldi®, Harvoni®, and Epclusa®. I-MAK v. Gilead, IPR2018-00103, IPR2018-00119 & IPR2018-00120. The challenged patents are said to cover methods and compositions for treating Hepatitis C using nucleoside analogs, including sofosbuvir. In an accompanying press release, I-MAK suggested that they may file additional IPRs against additional patents that allegedly cover prodrug forms and crystal forms of sofosbuvir as well. I-MAK also simultaneously released a whitepaper detailing their economic analysis of several additional drugs (including lenalidomide (Revlimid®) and imatinib (Gleevec®)), suggesting that they may have additional targets in mind.

Reciting the worldwide Hepatitis C infection rate and medication costs for current Hepatitis C medications that can exceed $100,000 for a full course of treatment, I-MAK argues that “unmerited” patents are a leading cause of drug unaffordability, and advocates challenges to the validity of drug patents as a means of inviting generics producers to enter the market. According to their press release, I-MAK has been challenging patents in various countries since 2006, though this IPR petition filed against Gilead appears to be the first time they have challenged a patent through the IPR process. While there had been previous attempts by non-competitors to invalidate drug patents in the PTAB (for example, in IPRs filed by Kyle Bass’ hedge-fund affiliated Coalition for Affordable Drugs), this appears to mark the first time one or more nonprofit entities has filed an IPR petition for the express purpose of reducing drug costs.

While the Patent Act clearly gives non-competitors the right to file a petition for an IPR proceeding, I-MAK may encounter limitations if it is unsuccessful. This is because the Federal Circuit has held that an entity that has not suffered an injury-in-fact related to the failure to invalidate a patent lacks standing to appeal a PTAB loss. [1] On the other hand, the Federal Circuit has also held that the patent owner does have standing to appeal an adverse decision by the PTAB. [2]

Whatever the final disposition of the present petition, it appears that the use of IPRs by non-competitors to attack drug exclusivities has gained new life, particularly in view of I-MAK’s white paper addressing additional drugs. It will be informative to monitor over the next few months the number of IPR petitions filed by I-MAK and the number of drug products challenged.

Update, 10/27/2017: On October 26, 2017, two additional petitions were filed, I-MAK v. Gilead, IPR2018-00121 and IPR2018-00122, both challenging U.S. Patent No. 8,334,270, which is also purported to cover aspects of sofosbuvir.

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[1] See Phigenix, Inc. v. Immunogen, Inc. 845 f . 3d 1168, 1173–76 (Fed. Cir. 2017); Consumer Watchdog v. Wisconsin Alumni Research Foundation, 753 f . 3d 1258 (Fed. Cir. 2014).

[2] See Personal Audio, LLC v. Electronic Frontier Foundation, 867 f . 3d 1246 (Fed. Cir. 2017).

Written by: Daniel K. Yarbrough, Ph.D. and Kerry S. Taylor, Ph.D.