Federal Circuit Dismisses IPR Appeal For Petitioner’s Lack Of Article III Standing
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  • Federal Circuit Dismisses IPR Appeal For Petitioner’s Lack Of Article III Standing

    On April 23, 2020, the Court of Appeals for the Federal Circuit (CAFC) dismissed an appeal of an inter partes review (IPR) proceeding for lack of Article III standing.  Argentum Pharms. LLC v. Novartis Pharms. Corp., No. 2018-2273, __ F.3d __ (Fed. Cir. Apr. 23, 2020).  The Federal Circuit found that the petitioner failed to prove that it suffered an injury in fact.

    On February 3, 2017, Apotex Inc. and Apotex Corp. filed a petition for IPR of U.S. Patent No. 9,187,405.  The Patent Trial and Appeals Board (PTAB) instituted an IPR on July 18, 2017.  After the institution, six other entities, including Argentum Pharmaceuticals LLC (Argentum), requested joinder under 35 U.S.C. § 315(c), which the PTAB granted.  On July 11, 2018, the PTAB issued a final written decision finding that the petitioners had not demonstrated the unpatentability of the challenged claims.  The petitioners appealed.

    The patent owner filed a motion to dismiss Argentum’s appeal for lack of standing.  Argentum at first relied on the standing of the other six petitioners, but the other petitioners settled during the appeal, making Argentum’s own standing a threshold issue.  The Federal Circuit then ordered the parties to address standing in their respective briefs.  In support of its standing, Argentum argued that it had three concrete injuries in fact.  The Federal Circuit rejected all three and dismissed the appeal without reaching the merits of the PTAB’s decision.

    First, Argentum argued that it faces the real and imminent threat of litigation because it is in the process of filing an Abbreviated New Drug Application (ANDA) for a generic version of the product covered by the ’405 patent with its “manufacturing and marketing partner,” KVK-Tech, Inc. (KVK).  The Federal Circuit found no injury because there was no evidence that Argentum itself would bear the risk of any infringement suit or “anything related to its involvement in the ANDA process beyond generic statements.”  The evidence supported only that KVK will be filing the ANDA and was at risk of being sued for infringement—not Argentum. 

    Second, Argentum argued that it would suffer economic loss, of (1) its investments in KVK’s manufacturing facilities and in the ANDA process, and (2) the profits it would realize once the FDA grants provisional approval of its (not yet filed) ANDA.  The Federal Circuit rejected both types of losses, finding that (1) the evidence regarding its investments was not tied to any products covered by the ’405 patent and (2) the assertion of lost profits was “both conclusory and speculative.”

    Third, Argentum argued that it would suffer injury in that it would be estopped under 35 U.S.C. § 315(e) from raising patentability and validity issues that could have been raised in the IPR in a future litigation.  Citing AVX Corp. v. Presidio Components, Inc., the Federal Circuit reiterated that Section 315(e) is not a sufficient basis for standing “when . . . the appellant is not engaged in any activity that would give rise to a possible infringement suit.”