As we reported here, on June 9, 2017, Mylan filed two IPR petitions challenging Sanofi-Aventis’s U.S. Patent No. 7,476,652 (IPR2017-01528) and U.S. Patent No. 7,713,930 (IPR2017-01526), related to Sanofi’s Lantus® (insulin glargine injection). Both petitions were instituted on December 13, 2017, as reported here. On September 10, 2018, Mylan filed ten additional…
As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product. Momenta has not yet filed an aBLA for its abatacept biosimilar candidate, M834, so one of the key issues on appeal is whether Momenta has Article III standing…
As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using adalimumab. Last month, the Federal Circuit ordered Sandoz to show cause why the appeals should not be dismissed for lack…
As we previously reported, a panel of the Federal Circuit in St. Regis Mohawk Tribe v. Mylan held that “tribal immunity cannot be asserted in IPRs.” The Federal Circuit’s decision, if upheld, means that Allergan’s sale and license-back of patents covering its branded product Restasis to the Tribe was ineffective in shielding the…
This morning, the Federal Circuit issued its much anticipated decision in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals. A panel of the court, consisting of Judges Dyk, Moore, and Reyna, held that “tribal sovereign immunity cannot be asserted in IPRs.” Relying on the Supreme Court’s decisions in Oil States and SAS Institute,…
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in favor of the biosimilar applicants. The other five appeals are from final written decisions of the…
Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab. In its decision, the Board explained that it was exercising its discretion to deny the petition in…
Yesterday, Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229, IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline process patents – US Patent Nos. 8,753,645 and 9,265,839. The ‘645 and ‘839 Patents are directed towards a process of conjugating bacterial saccharides to protein carriers in order to improve the immunogenicity of…
On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31, 2018, the PTAB denied institution of this IPR. Separately, on June 4, 2018, Pfizer filed…
Today, the PTO announced proposed rulemaking to change the claim construction standard applied by the PTAB in IPR, PGR, and CBM proceedings. In particular, the PTO proposes replacing the broadest reasonable interpretation standard for construing unexpired patent claims with the standard applied in federal district courts and ITC proceedings as…