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On August 14, 2014, the U.S. Food and Drug Administration (FDA) issued Draft Guidelines on the direct de novo classification process, a means of accelerating the approval of new types of medical devices posing only low to moderate health risks.[1]  The FDA created de novo classification in 1997, but after the process failed to achieve its purpose of expediting approval, the FDA introduced an alternative de novo process called “direct” de novo.

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Posted On Jun - 16 - 2016 Comments Off READ FULL POST

Written Description Problems of the Monoclonal Antibody Patents after Centocor v. Abbott 

Written By: Hyeongsu Park - Edited By: Kendra Albert

The market for therapeutic antibodies is projected to reach hundreds of billion dollars within the next several years. In Centocor v. Abbott, the Court of Appeals for the Federal Circuit (“Federal Circuit”) held that a patentee cannot claim an antibody unless the specification describes it, even if he/she fully characterizes the antigen, and the court vacated a $1.67 billion jury verdict, the largest patent infringement award in U.S. history.

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Posted On Mar - 13 - 2014 Comments Off READ FULL POST
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