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In recent years the Federal Circuit, in reviewing both litigation and prosecution decisions, has revived the doctrine of written description under 35 U.S.C. § 112. The court has applied the doctrine to biotechnology patents—specifically those claiming genuses of antibodies, DNA sequences or other biologic molecules (i.e., molecules made by processes occurring in living cells). These claims are frequently the target of written description attacks by both the U.S. Patent and Trademark Office and by private litigants. In this article, we review several recent Federal Circuit decisions on the written description requirement and some ways that biotech IP stakeholders can draft patents that stand up better to the new § 112 law.

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Christopher Loh has extensive experience counseling clients and litigating matters involving biotechnology and life sciences, including in the areas of antibody biosimilars, targeted cancer therapies, diabetes treatments and siRNA technologies. Christopher has a B.S. in Molecular Biochemistry and Biophysics and in Economics from Yale University.


    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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