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Subject Matter Jurisdiction › Patent Dance

Jones Day

Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

Jones Day on

In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of...more

Fish & Richardson

Dismissal Demonstrates Need for Clarity on BPCIA Disclosure Steps

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On March 1, Judge Sleet of the District of Delaware granted Amgen’s Motion to Dismiss for lack of subject matter jurisdiction Genentech’s Complaint for Declaratory Judgment. The Complaint sought a declaration that Amgen...more

Foley & Lardner LLP

Will The Avastin Biosimilar Patent Dance Go On?

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Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

Womble Bond Dickinson

Courts Answer Key Questions Over the Reach of the BPCIA

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Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

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