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On May 1, 2017, a Federal Circuit panel in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2016-1284, 2016-1787, held four pharmaceutical patents invalid under the on-sale bar of 35 U.S.C. § 102(b). Three patents were governed by the version of 102(b) that existed prior to the passage of the 2011 America Invents Act (“AIA”). A fourth was governed by the post-AIA version of 102(b). With the Helsinn decision, the Federal Circuit clarified that, under the post-AIA version of 102(b), public disclosure of the existence of the sale of a patented item may suffice to invalidate patent under the on-sale bar, even if “the details of the invention” are not “publicly disclosed in the terms of sale.”

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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.

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Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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