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PTAB Upholds Acorda’s Ampyra® Patents, Rejecting Challenges Based on the Inventors’ Own Work

March 15, 2017

By Gerald J. Flattmann, Naveen Modi, Lucas L. Kressel, Michael A. Stramiello, Daniel Zeilberger & Thomas Phalen

On March 9, 2017, the Patent Trial and Appeal Board (“PTAB”) upheld four patents that claim inventions relating to Ampyra®, a novel treatment for multiple sclerosis patients developed by Acorda Therapeutics Inc. (“Acorda”).

The patents were subject to inter partes review (“IPR”) at the request of petitioner Coalition For Affordable Drugs (ADROCA), LLC (“CFAD”), an organization with close ties to hedge-fund manager Kyle Bass.

These proceedings marked CFAD’s second set of challenges to Ampyra. The PTAB denied institution of the first set on August 24, 2015,

after Acorda argued, and the PTAB agreed, that the asserted art was not sufficiently publicly accessible to qualify as a “printed publication” within the meaning of 35 U.S.C. § 102.

In the present follow-on challenges, all instituted grounds alleged obviousness over an S-1 registration statement that Acorda filed with the U.S. Securities and Exchange Commission in September 2003 (“the S-1”).

First, the PTAB determined that the S-1 did not qualify as prior art under 35 U.S.C. § 102(b), citing expert testimony that Acorda’s patents are entitled to the effective filing date of a provisional application filed less than one year after the date on which the S-1 allegedly became available to the public.

Though CFAD’s replies attempted to rebut that evidence, the PTAB was not persuaded, even providing a laundry list of admissions on cross-examination that factored into its decision to “not credit” testimony from one of CFAD’s reply declarants.

Next, the PTAB determined that the S-1 did not qualify as prior art under 35 U.S.C. § 102(a) because it was not work “by others.”

CFAD’s proffered evidence was “simply not enough to carry [its] burden to show that the S-1 is prior art under 35 U.S.C. § 102(a).” Further, the PTAB noted that “even if [Acorda] has the burden to prove that [the] S-1 was the inventors[] own work, it has amply done so.” Acorda presented declarations from both inventors and five other declarants, all reflecting, among other things, that portions of the S-1 relied upon by CFAD were solely the work of the inventors—and not work “by others.” Ultimately, the PTAB found that CFAD’s attempt to “cast[] doubt on the authorship of the relevant portions of [the] S-1 is not sufficient to overcome the ample, unequivocal evidence presented by [Acorda] that supports our finding that the relevant portions of [the] S-1 are the original work of [the inventors] alone.”

These victories add to Paul Hastings's undefeated record in defending bio/pharma patents against challenges before the PTAB.


   IPR2015-01850 (U.S.P. 8,440,703), -01853 (U.S.P. 8,007,826), -01857 (U.S.P. 8,663,685), -01858 (U.S.P. 8,354,437).

   IPR2015-00720 (U.S.P. 8,663,685), -00817 (U.S.P. 8,007,826).

  See Coal. For Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-00720, Paper 15 at 3–6 (P.T.A.B. Aug. 24, 2015).

  See Coal. For Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-01850, Paper 72 at 2–3 (P.T.A.B. Mar. 9, 2017).

   See id. at 24–37.

  See id. at 35–36.

  See id. at 37–43.

Id. at 42–43.

  Id. at 38.

   See id. at 37–41.

  Id. at 42.

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Contributors

Image: Naveen Modi
Naveen Modi
Partner, Litigation Department
Image: Michael A. Stramiello
Michael A. Stramiello
Associate, Litigation Department
Image: Lucas L Kressel
Lucas L Kressel
Associate, Litigation Department
Image: Daniel Zeilberger
Daniel Zeilberger
Associate, Litigation Department
Image: Thomas E Phalen
Thomas E Phalen
Senior Technical Advisor