News & Analysis as of

Disclosure Requirements Amgen

Buckingham, Doolittle & Burroughs, LLC

Amgen is Not the End of Chemical Innovation

Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Files Reply Brief in Amgen v. Sanofi

Amgen recently filed its Reply brief to the Supreme Court in Amgen v. Sanofi.  While a conventional proportion of Amgen's Reply is directed to arguments Respondent Sanofi made in its brief, at trial, and before the Federal...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

Foley & Lardner LLP on

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- En Banc Rehearing Petitions Filed

On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more

Mintz - ML Strategies

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

Mintz - ML Strategies on

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)

In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more

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