Over the summer, Goodwin and Bristows sat down with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why it has been so different in those two markets, and what the future holds. In the first…
On September 20, 2019, the District Court for the District of Delaware endorsed a joint stipulation of the parties to dismiss all claims and counterclaims in the Genentech v. Pfizer BPCIA litigation concerning Pfizer’s ZIRABEV (bevacizumab-bvzr), a biosimilar of AVASTIN. According to the stipulation, the parties entered into a settlement…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…
Below are some highlights of recent biosimilar development news from this week: On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. Mochida…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997 in favor of Mylan, thereby resolving all pending disputes between the parties in Amgen v. Mylan, Civil Action No. 17-cv-1235, the BPCIA…
Below are some recent highlights of biosimilar news: On August 20th, two companies announced that they had launched competing biosimilars of Eli Lilly’s FORSTEO (teriparatide) in Europe. First, Gedeon Richter announced that it launched TERROSA in Europe after it received approval from the European Commission. According to the announcement, the…
We have been covering Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of REMICADE (infliximab), as well as a related antitrust litigation filed by retailers Walgreen and Kroger Co. and direct and indirect purchasers of Remicade. The cases generally allege that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive bundling and rebate penalties…
Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos….
On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab). After a jury found that two of the five asserted…
In February of this year, Amgen filed three petitions for inter partes review (IPR) of Alexion Pharmaceuticals’ U.S. Patent Nos. 9,725,504 (IPR2019-00739), 9,718,880 (IPR2019-00740), and 9,732,149 (IPR2019-00741). The claims of the challenged patents are directed to the monoclonal antibody eculizumab, which is the active ingredient in Alexion’s SOLIRIS, or methods…