No Standing for ANDA Partner to Appeal Unfavorable IPR Ruling

The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]

Intention to File an ANDA may be Sufficient to Establish Standing for a PGR Appeal

Around the same time the Federal Circuit decided that a prospective ANDA customer lacked declaratory judgment standing in AIDS Healthcare, reported on here, it held that a prospective ANDA filer has standing to appeal a PTAB decision.  In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., No. 2017-1487 (Fed. Cir. May 2, 2018), a sharply-divided panel found […]

Federal Circuit Holds That a Customer Does Not Have Standing For a Declaratory Judgment

The Federal Circuit recently held that a healthcare provider did not have standing to bring a declaratory judgment action where its only interest was as a purchaser of potential generic versions of the patented drug. AIDS Healthcare Foundation v. Gilead Sciences, Inc., No. 2016-2475 (Fed. Cir. May 11, 2018).  The court held that absent direct […]