Joined Parties to an Inter-Partes Review Have Right to Appeal
Research Corporation Technologies, Inc. (“RCT”) owns U.S. patent Re 38,551 (“the ’551 patent”) that has 13 claims drawn to certain enantiomeric compounds and pharmaceutical compositions useful for treatment of epilepsy. Argentum Pharmaceuticals LLC (“Argentum”) petitioned for inter partes review of the ’551 patent on 8 grounds. The Board instituted review on two grounds: obviousness of claims 1-9 over Kohn 1991[2] and Silverman[3], and obviousness of claims 10-13 over Kohn 1991, Silverman, and U.S. Patent No. 5,378,729 (“the ’729 patent”). Three days after the institution, three other companies (Mylan Pharmaceuticals Inc. (“Mylan”), Breckenridge Pharmaceutical, Inc. (“Breckenridge”), and Alembic Pharmaceuticals Ltd. (“Alembic”) (collectively “the joining parties”) filed petitions for review with motions for joinder. Each of the joining parties had been sued for infringement of the ’551 patent more than a year earlier and thus would normally be time-barred from filing a petition for inter partes review. However, the Board permitted the joinder pursuant that the joining parties “agree[d] to be limited to an ‘understudy’ role, and limited to evidence and arguments presented in the Argentum Petition in relation to [the instituted grounds].”
The Board’s final written decision found that none of the challenged claims had been shown to be unpatentable. The joining parties appealed the decision; the original petitioner, Argentum, did not.
On appeal, RCT argues that the joining parties lack standing to appeal because they had been sued for infringement more than a year before their own IPR petitions were filed. The Federal Circuit disagreed. 35 U.S.C. §315(c) gives the Board discretion, after institution of an IPR, to “join as a party to that inter partes review any person who properly files a petition…” (emphasis added). The Board’s decision to join the joining parties “as parties” was not challenged by RCT, despite the agreement that their participation be limited to an “understudy role.” 35 U.S.C. 319 provides, “[a] party dissatisfied with the final written decision of the Patent Trial and Appeal Board … may appeal the decision…. Any party to the inter partes review shall have the right to be a party to the appeal.” The Federal Circuit noted that RCT’s argument would require interpreting “party” differently in §315 than in §319, something it declined to do. Accordingly, the Court found the joining parties had standing to appeal, despite their “limited” participation in the IPR.
Continuing to the merits, the Federal Circuit affirmed the Board’s finding that the claims on appeal (claims 8-13; claims 1-7 had been canceled post-appeal in a separate ex parte reexamination) had not been shown to be obvious.
Finally, the Court of Appeals considered the joining parties’ request for remand in light of SAS[4] (failure of the Board to institute on all grounds). The SAS decision had issued after briefing in this appeal was complete. However, as it has repeatedly stated in other cases, the Court instructed that requests for SAS-based relief must be prompt. Here, 6 months had passed from the time of the SAS decision until the time of oral argument. The joining parties did not avail themselves of the opportunity to submit a citation of supplemental authority during that period, and in fact made the request only during their rebuttal argument when RCT had no opportunity to respond. Accordingly, the Court found the request for SAS-based remand had been waived.
[1] Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc., Appeal Nos. 2017-2088, 2017-2089, 2017-2091 (Fed. Cir. February 1, 2019), viewable at http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2088.Opinion.2-1-2019.pdf.
[2] Harold Kohn et al., Preparation and Anticonvulsant Activity of a Series of Functionalized a-Heteroatom-Substituted Amino Acids, 34 J. Medicinal Chemistry 2444 (1991).
[3] Richard B. Silverman, The Organic Chemistry of Drug Design and Drug Action (1st ed. 1992).
[4] SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018). For a complete discussion of the Supreme Court’s SAS decision, see our earlier article here: READ MORE
