On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”) seeking declaratory judgment of non-infringement and invalidity of Amgen’s U.S. Patent No. 9,643,997 (“the ʼ997 patent”). The ʼ997 patent is directed to methods of purifying a protein expressed in a non-native limited solubility form in a non-mammalian

As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment with rituximab was instituted.  The instituted IPR is IPR2017-01168 regarding U.S. Patent No. 8,821,873 (the “’873 patent”), and the PTAB recently issued its Final Written Decision.

Adhering to its institution decision where it

On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups, unions, and retirees, submitted a letter to U.S. Trade Representative Robert Lighthizer to raise serious concerns that the recently renegotiated version of the North American Free Trade Agreement (NAFTA) – now proposed to be called the U.S.-Mexico-Canada Free

Recently, Pfizer was denied institution of two follow-on inter partes review (IPR) petitions, IPR Nos. 2018-00330 and 2018-00331 (“the 2018 petitions”), filed on December 18, 2017, asserting invalidity of Genentech patents, U.S. 6,339,142 (“the ’142 patent”) and U.S. 9,249,218 (“the ’218 patent”).  The Patent Trial and Appeal Board (“the Board”) denied instituting the IPRs using

Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that Amgen has brought against Apotex under the Biologics Price Competition and Innovation Act (the “BPCIA”), based on Apotex’s abbreviated biologic license applications (“aBLAs”) for biosimilars

In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine of equivalents claim made by Janssen Biotech (“Janssen”) with respect to a Remicide®-related patent would ensnare the prior art.

Janssen makes Remicade®, a biologic drug whose active ingredient is the monoclonal

On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz International GMBH (collectively “Sandoz”) in the district of New Jersey alleging infringement of two patents related to Humira®:  U.S. Patent 9,187,559 (“the ʼ559 patent”) and U.S. Patent No. 9,750,808 (“the ʼ808 patent”).

According to the complaint

The PTAB recently instituted a second IPR of US Patent 9,296,821 (“the ’821 patent”), which covers certain uses of Rituxan® (rituximab), a monoclonal antibody marketed by Genentech and Biogen Pharmaceuticals.  The ‘821 patent claims methods of treating low grade or follicular non-Hodgkin’s lymphoma (NHL) by administering rituximab during a chemotherapeutic regimen of cyclophosphamide, vincristine, and