U.S. Patent No. 9,856,287, which is directed to a protein refolding method, is one of the patents-in-suit in the pending Amgen v. Adello (filgrastim) BPCIA litigation and the sole patent-in-suit in the pending Amgen v. Apotex (filgrastim and pegfilgrastim) BPCIA litigation. As we previously reported, in November 2018, Adello and Apotex jointly filed a petition for post-grant review (PGR) of the ’287 patent (PGR2019-00001).
This past Friday, April 19, 2019, the PTAB granted Adello and Amgen’s petition, instituting a PGR of all 30 claims of the ’287 patent on multiple alleged grounds of unpatentability including lack of adequate written description support (claims 1–9 and 16–25), lack of enablement (same), indefiniteness (claims 1–15), anticipation (claims 1–4, 7–19, and 22–30), and obviousness (all claims). The PTAB also issued a scheduling order, calling for oral argument (if requested) on January 29, 2020.
In addition, on April 14, 2019, Fresenius Kabi filed a petition seeking inter partes review (IPR) of claims 1, 4-6, 8-10, 12, 14-16, 19-21, 23-26, 29-30 of the ’287 patent on grounds of anticipation and/or obviousness (PTAB-IPR2019-00971).
Meanwhile, on April 18, 2019, in the Amgen v. Apotex BPCIA litigation, Apotex answered Amgen’s complaint, alleging non-infringement and invalidity defenses and counterclaims, among others. Apotex’s filing follows the district court’s recent denial of Apotex’s motion to dismiss.