Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….
The U.S. Supreme Court granted certiorari in Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, to review whether the PTAB applies the correct claim construction standard in post-grant proceedings created by the America Invents Act. The PTAB currently construes patent claims under the “broadest reasonable interpretation” standard. On the other…
On December 16, 2015, AbbVie submitted a Citizen Petition (link) (Docket No. FDA-2015-P-4935) to the FDA concerning the requirements for demonstrating interchangeability between a brand-name reference product and its biosimilar counterpart. In its Citizen Petition, AbbVie requested that the FDA take the following actions: FDA should “ensure that applicants seeking…
The PTAB denied institution on two of Amgen’s IPR petitions (IPR2015-01517, IPR2015-01514) against AbbVie’s Humira. The patents, 8,916,157 and 8,916,158, are directed to formulations of Humira, that Amgen argued were obvious because they combined adalimumab, a known antibody, with known excipients for antibody formulations. Based on the PTAB’s claim construction…
On January 8, 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive global collaboration agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications. According to public information about the agreement, while each company will equally share costs and profits with respect to the products,…
Goodwin Procter announced today the release of the 2016 edition of Biosimilars: A Guide to Regulatory and Intellectual Property Issues. The guide provides clarity to the complex, developing regulatory and legal framework around biosimilars, and the 2016 update offers analysis on the first waves of patent litigation related to biosimilars…
Yesterday Mylan, and Hospira and Celltrion (jointly) filed amicus briefs in support of Apotex’s appeal to the Federal Circuit in Amgen v. Apotex. They joined the Biosimilars Council, which filed its amicus brief Wednesday. Further analysis to come.
Goodwin Procter and the Big Molecule Watch team are looking forward to participating in the 34th Annual J.P. Morgan Healthcare Conference, which brings together leaders from across the industry. If you will be in San Francisco for the conference, we hope you will join us next Wednesday, January 13, 2016,…
Today the Biosimilars Council filed an amicus brief in support of Apotex’s Federal Circuit appeal in Amgen v. Apotex. Further analysis to come.
As we have covered here, and here, Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. On December 30, 2015, Apotex filed its opening appellate brief, in which it argues that because the parties completed the patent dance under 42 U.S.C. §…