On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by Samsung Bioepis. Eticovo is a biosimilar to Enbrel® (etanercept), which is marketed by Amgen, Inc. (“Amgen”). Like Enbrel, Eticovo was approved across five eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic
On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging infringement of seventeen patents: U.S. Patent Nos. 6,180,391; 7,083,948; 7,118,884; 7,384,765; 7,427,659; 7,662,930; 7,735,525; 7,781,395; 8,191,566; 8,273,707; 8,940,878; 8,952,138; 9,418,416; 9,632,095; 9,643,997; 9,704,239; and 9,856,287. The case is assigned to Judge Claire C. Cecchi
As we previously reported here, earlier this year the Supreme Court agreed to hear its first case arising under the Biosimilars Price Competition and Innovation Act (“BPCIA”) in the cases of Sandoz v. Amgen and Amgen v. Sandoz. Our earlier post provides the factual background on this case, which involves Sandoz’s application to
Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World Biosimilar Congress in San Diego, California, on Wednesday, May 24, 2017. The 30-minute session covered: (1) the BPCIA’s “patent dance”; (2) what’s at stake in Sandoz v. Amgen, and the potential outcomes and practical implications of the
The Supreme Court heard oral arguments on Wednesday in its first biosimilar case. On a petition filed in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039, and a cross-petition filed in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195, the Court was asked to interpret two provisions of
As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz, Inc. v. Amgen, Inc., et al., Case No. 2015-1039 and on Amgen’s cross-petition in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195. On January 25, 2017, the Supreme
The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”). On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039 and on Amgen’s conditional cross-petition for certiorari