GlaxoSmithKline v. Teva: Federal circuit broadens induced infringement to preclude marketing generics for off-patent indications

Author(s):  
Paul A Braier
Keyword(s):  
2017 ◽  
Author(s):  
Tejas N. Narechania

Patent policy is typically thought to be the product of the Patent and Trademark Office, the Court of Appeals for the Federal Circuit, and, in some instances, the Supreme Court. This simple topography, however, understates the extent to which outsiders can shape the patent regime. Indeed, a variety of administrative actors influence patent policy through the exercise of their regulatory authority and administrative power. This Article offers a novel description of the ways in which nonpatent agencies intervene into patent policy. In particular, it examines agency responses to conflicts between patent and other regulatory aims, uncovering a relative preference for complacency (“inaction”) and resort to outside help (“indirect action”) over regulation (“direct action”). This dynamic has the striking effect of shifting authority from nonpatent agencies to patent policymakers, thereby supplanting some regulatory designs with the patent regime’s more general incentives. This Article thus offers agencies new options for facing patent conflict, including an oft-overlooked theory of regulatory authority for patent-related regulation. Such intervention and regulation by nonpatent agencies can give rise to a more efficient and context-sensitive regime that is better aligned with other regulatory goals.


Author(s):  
Keith A Zullow ◽  
Cindy Chang ◽  
Sean Anderson

In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.


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