Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. recently scored a victory in their ongoing dispute over a patent that Immunex Corporation claims covers Dupixent®, Sanofi and Regeneron’s anti-IL-4 antibody marketed for treatment of moderate-to-severe eczema. In February, the Patent Trial and Appeal Board (“the Board”) instituted two petitions for inter partes
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are typically derived from living cells and used in the treatment, diagnosis, or prevention of disease. Most biologics are produced by genetically engineering living cells to express the therapeutic proteins rather than through traditional chemical synthesis. As proteins
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to Carter. The ’213 patent, “Method for making humanized antibodies,” which Genentech has stated in SEC filings covers technology used in developing the breast cancer drug Herceptin® (trastuzumab), has since been asserted or is otherwise
Sandoz’s request for inter partes review (“IPR”) of U.S. Patent Numbers 9,512,216 (“the ’216 patent”) and 8,802,100 (“the ’100 patent”) was denied by the Patent Trial and Appeal Board (“the Board”) on the grounds that Sandoz did not show that the patents were likely unpatentable. The decisions not to institute an IPR of either patent
We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, or unenforceable. That same day, Celltrion and Teva also filed a suit seeking declaratory
On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit against Genentech, Inc., Hoffmann-La Roche Inc., and City of Hope seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, and/or unforceable. According to Celltrion and Teva, a
On December 5, 2017, the Federal Circuit held oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. The case comes on appeal from an IPR decision where the Board declined to find U.S. Patent No. 8,476,239 (“the ʼ239 patent”) unpatentable as obvious. The ʼ239 patent covers Bristol-Myers Squibb’s (“BMS”) Orencia® product, a
As we previously reported, Pfizer filed three IPR petitions against Biogen-owned patents claiming methods of treatment with rituximab in April 2017. The three proceedings are: IPR2017-01166, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-01167, regarding U.S. Patent No. 8,557,244 (“the ’244 patent”); and IPR2017-01168, regarding U.S. Patent No. 8,821,873 (“the ’873 patent”). Institution
On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”), challenging yet another patent from the Humira® patent portfolio. Humira®, used for the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, continues to be the number one selling drug in the world.[i] With
As previously reported, earlier this year Celltrion, Inc. (“Celltrion”) filed petitions seeking inter partes review (“IPR”) of certain Genentech patents covering Herceptin® (trastuzumab). In particular, Celltrion challenged the patentability of certain claims of U.S. Patent Nos. 7,846,441 (“the ʼ441 patent”); 7,892,549 (“the ʼ549 patent”); 6,626,196 (“the ʼ196 patent”); 7,371,379 (“the ʼ379 patent”). Earlier this month,