Dance Marches On For Biosimilars In Amgen V. Sandoz

January 17, 2017

By: N. Scott Pierce

Law360

Law360

By Scott Pierce, Hamilton Brook Smith Reynolds


Law360, New York (published January 13, 2017) -- Two sections of the Biologics Price Competition and Innovation Act of 2009 are the subject of writs of certiorari that have just been granted by the U.S. Supreme Court to the parties in Amgen Inc. v. Sandoz Inc. Ultimately at stake is billions of dollars in annual revenue generated in the burgeoning biologics industry. At issue is congressional intent settling patent disputes prior to expiry of a 12-year exclusivity period granted to the first licensee approved for commercialization of a biological product by the U.S. Food and Drug Administration.Scott Pierce

Section (k) of the BPCIA (42 U.S.C. §262(k)) enables approval of products that are “biosimilar” to a “biological product.” Section (l), also known as the “patent dance,” prescribes a procedure for exchange of information, including patents and potentially confidential information. Both sections are intended to expedite identification and resolution of any possible patent disputes after filing of an abbreviated biologics license application ("subsection (k) application”). “Biological products” are distinct from drugs regulated under the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”) in that biological products generally are derived from nature. “Biosimilarity” under the BPCIA is based on lack of “clinically meaningful differences” from a previously approved “reference product.”

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January 17, 2017

By: N. Scott Pierce

Law360

Law360

By Scott Pierce, Hamilton Brook Smith Reynolds


Law360, New York (published January 13, 2017) -- Two sections of the Biologics Price Competition and Innovation Act of 2009 are the subject of writs of certiorari that have just been granted by the U.S. Supreme Court to the parties in Amgen Inc. v. Sandoz Inc. Ultimately at stake is billions of dollars in annual revenue generated in the burgeoning biologics industry. At issue is congressional intent settling patent disputes prior to expiry of a 12-year exclusivity period granted to the first licensee approved for commercialization of a biological product by the U.S. Food and Drug Administration.Scott Pierce

Section (k) of the BPCIA (42 U.S.C. §262(k)) enables approval of products that are “biosimilar” to a “biological product.” Section (l), also known as the “patent dance,” prescribes a procedure for exchange of information, including patents and potentially confidential information. Both sections are intended to expedite identification and resolution of any possible patent disputes after filing of an abbreviated biologics license application ("subsection (k) application”). “Biological products” are distinct from drugs regulated under the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”) in that biological products generally are derived from nature. “Biosimilarity” under the BPCIA is based on lack of “clinically meaningful differences” from a previously approved “reference product.”

View a PDF of the Full Article

 

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