News & Analysis as of

Subject Matter Jurisdiction Biosimilars

Goodwin

Litigation Update: AbbVie v. Alvotech hf (Adalimumab)

Goodwin on

We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more

Kramer Levin Naftalis & Frankel LLP

Northern District of Illinois Holds That a Biosimilar Applicant Is Not a Necessary Party to a BPCIA Lawsuit

On Aug. 23, 2021, the U.S. District Court for the Northern District of Illinois denied Alvotech hf.’s motion to dismiss AbbVie’s biosimilar lawsuit involving its blockbuster arthritis drug, Humira. AbbVie Inc. et al. v....more

Goodwin

Genentech Seeks to Dismiss and Strike Amgen’s Counterclaims and Certain Defenses in Bevacizumab Biosimilar Litigation

Goodwin on

As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative...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...

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

McDonnell Boehnen Hulbert & Berghoff LLP

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...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

Wilson Sonsini Goodrich & Rosati

Sandoz v. Amgen: Interpretation of the Biosimilar Act Results in Dismissal for Lack of Subject Matter Jurisdiction for Declaratory...

On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more

11 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide