United States: Evidence Of Priority To Provisional Application And That Prior Art Was Not Work Of Another Defeated Obviousness Challenge In IPR

The Patent Trial and Appeal Board (the "Board") issued a final written decision determining that the Coalition for Affordable Drugs (ADROCA), LLC ("Petitioner") failed to prove unpatentable claims 1-52 of U.S. Patent No. 8,440,703 (the "'703 Patent") owned by Acorda Therapeutics, Inc. ("Acorda"). The '703 Patent covers using a composition with the compound fampridine to treat certain neurological disorders. The Board had instituted inter partes review(IPR) on three obviousness grounds, each including the reference known as "S-1." S 1 is an Acorda Securities and Exchange Commission filing that describes clinical trials testing fampridine's effect on certain neurological disorders. At trial before the Board, Acorda argued that the '703 Patent was entitled to the filing date of its provisional application, eliminating S-1 as 102(b) art, and that S-1 reported the inventors' own work, eliminating S-1 as 102(a) art.

Every claim in the '703 Patent requires treatment with the composition for at least two weeks. The '703 Patent's corresponding provisional application described a treatment regimen with fampridine that included a two-week upward titration to reach a certain dosage followed by 12 weeks of stable treatment at that dosage. Certain of the claims also require an average steady state plasma concentration ("CavSS") of the drug within a certain range. The provisional application reported the CavSS levels for treatment using a 10 mg dosage of the drug.

Petitioner argued that disclosure of a 12-week treatment does not specifically teach treatment for two weeks and that there would always be two different concentrations used during the two-week titration period disclosed in the provisional application. Petitioner also argued that the provisional application failed to teach the entire claimed CavSS range. In response, Acorda's experts explained that there would be no change in dosage during the two-week titration period that corresponded to stable treatment using the lowest dose (10 mg). Moreover, one of skill would consider the standard deviation of reported CavSS values and would understand that the application discloses CavSS values across the entire claimed range. Acorda also introduced declarations from inventors and noninventors indicating that the cited portions of S-1 were the inventors' own work.

The Board credited Acorda's experts' testimony related to the lowest-dose treatment and concluded that the provisional application supported the "two-week limitations" of the '703 Patent claims. The Board also agreed that one of skill would consider the standard deviation and would have understood the provisional application to disclose the claimed CavSS range. Accordingly, the Board concluded that all claims of the '703 Patent were entitled to the priority date of the provisional application and that the S-1 reference was therefore not 102(b) prior art to any claim in the IPR.

The Board next considered whether the S-1 reference was the work of others. The Board concluded that Petitioner met its initial burden by presenting S-1 as prior art that, on its face, lists authors that differ from the inventors. However, Acorda responded with declarations indicating that the inventors were the sole source of the cited portions of S-1, satisfying its burden of production to refute Petitioner's argument. Petitioner's reply did not persuade the Board that S-1 was not solely attributable to the named inventors. Thus, the Board held that S-1 was not "work by others" and could not qualify as prior art under 102(a). S-1 was therefore not prior art to any claim in the IPR. Because all potential obviousness grounds included S-1, the Board held that Petitioner failed to prove the claims of the '703 Patent unpatentable as obvious.

Finally, the Board noted that the patents challenged in three related IPR proceedings (IPR2015-01853, IPR2015-01857 and IPR2015-01858) included similar claims. The Board applied its analysis to the claims in those proceedings and, in each case, determined that Petitioner failed to meet its burden to prove those claims unpatentable. The Board's Final Written Decision therefore resolved those related IPRs.

Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc. IPR2015-01850, IPR2015-01853, IPR2015-01857, IPR2015-01858, Paper No. 72 (PTAB Mar. 9, 2017).

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