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Subject Matter Jurisdiction › BPCIA

Mintz - Intellectual Property Viewpoints

N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA

Mintz - Intellectual Property Viewpoints on

In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss...more

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

Fish & Richardson on

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?

Foley & Lardner LLP on

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

Womble Bond Dickinson on

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

Sheppard Mullin Richter & Hampton LLP

Update: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange...

Sheppard Mullin Richter & Hampton LLP on

In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating...more

K&L Gates LLP

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

K&L Gates LLP on

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of...more

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