The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Biosimilars: The Action Finally Starts" on January 8, 2015 beginning at 2:00 pm (ET). Kevin Nelson of Duane Morris LLP, Brian Slater of Fitzpatrick, Cella, Harper & Scinto, and Elizabeth Weiswasser of Weil, Gotshal & Manges, LLP will discuss the impact of recent cases and other Biologics Price Competition and Innovation Act (BPCIA) developments, including:
• The Federal Circuit opinion, Sandoz v. Amgen, which involves the blockbuster drug Enbrel and addressed whether a biosimilar developer can seek an early adjudication of questions of validity and infringement of patents before it files a biosimilar application;
• Efforts by Celltrion and Hospira to get declaratory judgment on the invalidity of other biological drug patents; and
• Amgen's complaint, filed in October in the Northern District of California, alleging that Sandoz unlawfully refused to follow BPCIA patent resolution procedures (colloquially known as the "patent dance") regarding its application to the Food and Drug Administration for approval of a biosimilar to Neupogen. Amgen's complaint asserts unfair competition under California law, conversion, and patent infringement.
The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
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