On December 6, 2016, the Supreme Court heard oral argument on the interpretation and application of 35 U.S.C. § 271(f)(1) in Life Technologies Corp., et al. v. Promega Corp. At issue is whether the export from the United States of a single component of a patented multi-component invention, that is later assembled outside the United States, qualifies as an infringing act under 35 U.S.C. § 271(f)(1). The parties’ dispute focuses on the interpretation of the statutory language “substantial portion of the components of a patented invention,” and specifically, whether determining if a given component constitutes a “substantial portion” requires a quantitative assessment of the number of components, an evaluation of the component’s subjective importance, or both.

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    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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