Summary of FDA public hearing regarding draft guidances relating to the development of biosimilar products *

USA - May 17 2012
On May 11, 2012, the U.S. Food and Drug Administration (“FDA”) held a public hearing entitled Draft Guidances Related to the Development of Biosimilar Products; Public Hearing; Request for Comments at its White Oak Campus.

Co-authors: Jonathan R. Davies.

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A summary of the Supreme Court’s Prometheus decision *

USA - March 21 2012
On March 20, 2012, the Supreme Court issued its much-anticipated decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., unanimously holding that Prometheus’s claims, directed to methods for optimizing the efficacy of a drug, are directed laws to of nature and, consequently, not patent-eligible under 35 U.S.C. § 101.

Co-authors: Krista E. Bianco, Denise W. DeFranco, Erika Harmon Arner.

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Summary of FDA draft guidance on BPCIA *

USA - March 16 2012
On February 9, 2012, the U.S. Food and Drug Administration (“FDA”) released three draft guidance documents related to implementation of the Biologics Price Control and Innovation Act of 2009 (“BPCIA”).

Co-authors: Jonathan R. Davies.

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Preparing your patent portfolio for follow-on biologics *

USA - March 29 2010
On March 23, 2010, President Obama signed into law health insurance reform legislation, H.R. 3590 , a bill which has generated enormous media coverage and publicity.

Co-authors: Jonathan R. Davies.

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Follow-on biologics: a patent litigation perspective *

USA - August 22 2009
In whatever form biosimilar legislation might take, patent holders will need to review their patent portfolios carefully.

Co-authors: Jonathan R. Davies.

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