Tag Archives: biotechnology law

Astrazeneca v Apotex – Patent That Label!

I recently had a chance to re-read AstraZeneca LP v. Apotex, Inc., Appeal No. 2009-1381, 1424 (Fed. Cir. Nov. 1, 2010) and realized that it is a virtual case note on how to extend patent term by “patenting the label.” … Continue reading

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EMA Draft Guidelines For Biosimilar Antibodies Released

From Dr. Stefan Danner On November 18, 2010, the European Medicines Agency (EMA) released draft versions of two guidelines relating to the regulatory approval of monoclonal antibodies: the “Guideline on biological medicinal products containing monoclonal antibodies”1 and the “Guideline on … Continue reading

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Prometheus V. Mayo – Fed. Cir: “We Got It Right The First Time.”

Today, following the vacation and remand of its earlier decision by the Supreme Court post-Bilski, the Federal Circuit again reaffirmed its reversal of the District Court (copy at the end of this post) and held: “The asserted method claims satisfy … Continue reading

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Stayin’ Alive – Patent Office Extends “Provisional Application Period.”

On December 8th, the Patent Office announced plans to implement a “Missing Parts Pilot Program” that would permit applicants at the end of the one-year U.S. provisional application term to defer substantive examination for up to 12 months by filing … Continue reading

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