Hyman Phelps and McNamara
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Kurt Karst is presenting at the U.S. Biosimilars Conference
April 20-21, 2015

Based on demand, ACI has created a forum for EU attorneys to learn about the salient developments in U.S. law as the first wave of biosimilars become a reality in the U.S. At long last, companies are officially moving forward with the first U.S. biosimilar applications and the USFDA has given its stamp of approval to at least one. Already, multiple lawsuits have been filed as both innovator and biosimilars companies fight to gain position and protect their IP. Hear directly from the best of the US bar about how these developments will affect you.

For six years, since the passage of the historic Biologics Price Competition & Innovation Act (BPCIA) which first set the stage for biosimilars in 2010, the key figures shaping the evolving US biosimilars landscape have convened at our conference to formulate solutions to the challenges facing the industry. We are please to bring this event right to the backyard of the EU companies who will doing business in the US. We are pleased to announce that Julia Pike, Head Global IP Litigation at Sandoz is confirmed to give the Keynote Address at this conference.

Join us for an up-to-the-moment treatise on the significant regulatory and IP developments affecting US biosimilars including:

Insights into USFDA’s current initiatives regarding the first wave of biosimilars applications: status of final guidance and updates on meeting FDA’s standards for biosimilarity and interchangeability

• Update on the controversy surrounding competition, substitution, and naming in the US biosimilars arena
• Navigating the burgeoning US biosimilars market and evaluating the risk and commercial opportunity therein
• Obtaining adequate patent protection in the US in light of major changes to core patentability and incorporating new USPTO inter partes review procedures into patent prosecution and litigation strategies
• A cheat sheet for managing the tricky timing mandated for US biosimilars IP litigation and Reviewing the intellectual property cases filed to date including Sandoz v. Amgen and Celltrion v. Janssen: strategies for declaratory judgment actions, preliminary injunctions, and more
• Preparing and coordinating a global biosimilars strategy: Comparing and contrasting the US and EU biosimilars to date

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