Remember when the PTAB denied institution of two IPR petitions filed by Kyle Bass’s Coalition for Affordable Drugs V LLC’s (CFAD) against Acorda Therapeutics, Inc. (Acorda)? Well, if at first you don’t succeed, try citing different prior art!
In the two previous Acorda proceedings (IPR2015-00720 and IPR2015-00817), the PTAB rejected CFAD’s argument that posters displayed at a scientific conference qualified as prior art. During prosecution, Acorda disclosed the posters in an Information Disclosure Statements (IDS). But, in denying those petitions, the PTAB stated that the IDS submission did not constitute an admission that the posters qualified as prior art, and that CFAD presented insufficient evidence as to how long the posters were displayed at the conference.
Less than two weeks after the PTAB denied institution of those IPR petitions, CFAD filed two new petitions¹ against the same patents and that relied on different prior art references. On March 11, 2016, the PTAB – indeed the same panel that denied institution previously – granted the new petitions.
These institution decisions are interesting for at least two reasons. First, the primary prior art reference relied upon by CFAD is an Acorda prospectus SEC filing document (S-1) that describes, among other information, Acorda’s therapeutic focus area and lead candidate clinical development status, including information related to dosing regimens and patient results. According to Acorda, the S-1 is not statutory prior art because CFAD did not demonstrate that the S-1 was publicly accessible and because the document does not teach or suggest the dosing regimen recited in the challenged claims. While noting that Acorda will have an opportunity during the trial phase to submit declaratory evidence from a person knowledgeable about the publication of the S-1 and the information it contains concerning the dosing regimens, the PTAB concluded that CFAD sufficiently established that the S-1 was publicly available, that a person of ordinary skill in the art would have been aware of Acorda’s involvement in the particular field and, thus, would have monitored and sought information about studies involving Acorda’s lead drug candidate.
These institution decisions are also interesting because the PTAB routinely denies follow-on petitions attacking the same patent. In particular, the PTAB has denied many petitions that use a past institution decision denying IPR as a roadmap to cure defects, especially in instances where there is a reasonable inference that prior art references newly presented in a second petition were known to the petitioner when it filed its first petition. [See generally, Unilever v. The Procter & Gamble Co., Case IPR2014-00628]. Here, there is no discussion and, therefore, no explanation, by either party or by the PTAB, as to why the S-1 could not have been presented and relied upon for an unpatentability ground in the earlier petitions. The missing discussion is particularly noticeable because CFAD comprises investment entities that likely monitor SEC filings and, thus, likely were aware of the S-1.
Having failed to secure an IPR institution decision once by relying on posters at a scientific conference as the primary prior art references, the CFAD has succeeded in a follow-on petition that relies on completely different prior art… the institution decisions suggest that petitioners can sometimes have multiple bites of the apple after all.
Having failed to secure an IPR institution decision once by relying on posters at a scientific conference as the primary prior art references, CFAD succeeded in a follow-on petition that relies on completely different prior art. It remains to be seen whether Acorda can knock-out the newly cited prior art during the proceedings. Regardless, the institution decisions suggest that petitioners can sometimes have multiple bites of the apple after all.