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Amgen v. Sandoz: Riddles, Mysteries, and Enigmas

By: Sandra King  |   August 5, 2015

On July 21, 2015, the Court of Appeals for the Federal Circuit provided its interpretation of two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), more specifically, the information-disclosure and notice-of-commercial-marketing provisions codified as 42 U.S.C. § 262(l)(2)(A) and (l)(8)(A), respectively. The Court held that the information-disclosure provision, i.e., the “patent dance,” was not mandatory and that the 180-day notice-of-commercial-marketing period was not effective until the biosimilar product was licensed by the FDA.

Ariosa Diagnostics, Inc. v. Sequenom, Inc.: The End of Genetic Diagnostic Method Patents?

By: Andreas Baltatzis and Sandra King  |   July 16, 2015

Last month, in Ariosa Diagnostics, Inc. v. Sequenom, the Court of Appeals for the Federal Circuit found U.S. Patent No. 6,258,540 (“the ’540 patent”) invalid as not being directed to patent eligible subject matter under 35 U.S.C. § 101. --- F/3d ---, 2015 WL 3634649, at *1 (C.A.Fed. (Cal.) 2015).

Post-Approval Clinical Data and the §271(e)(1) Safe Harbor Provision

By: Sandra King  |   June 5, 2015

Last month, the Court of Appeals for the Federal Circuit held in Classen Immunotherapies Inc. v. Elan Pharmaceuticals, Inc.

 

 

Commil USA v. Cisco Systems

By: Andreas Baltatzis  |   June 2, 2015

Commil USA, LLC v. Cisco Systems, Inc. 575 U.S., at ___ , No. 13-896 (2015).

In an entirely unsurprising decision, the Supreme Court once again overruled the Court of Appeals for the Federal Circuit (CAFC).

 

The Patent Application Alert Service

By: Sandra King  |   April 30, 2015

On April 23, 2015, the USPTO announced the release of the Patent Application Alert Service (PAAS). The system is a free service that provides customizable email alerts when patent applications containing specified keywords are published. The alerts allow for interested parties to directly access the published applications that meet their search criteria.

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