U.S. Biosimilars - Red Flags for Patent Attorneys

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On March 14, 2013, Knobbe Martens Partner Carol Pitzel Cruz presented at the 24th C5 Forum on Biotech Patenting 2013. This conference allows attendees to benchmark against the best practice strategies employed by the market leaders. Speakers provide up-to-the-minute clarity on the latest regulatory developments, case law, challenges and opportunities in biotech patenting. The seminar was titled "The Red Flags Every Patent Attorney Needs to Know to Successfully Navigate the Regulatory Landscape for Biosimilars”.

Pitzel Cruz’s presentation analyzed the key features of the new Food and Drug Administration guidelines for American biosimilar approval under the Biologics Price Competition and Innovation Act.

Please see the full presentation below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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