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Venable LLP

Spotlight On: Biosimilar Litigations - August 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Goodwin

AbbVie Files Second Suit Against Alvotech For Patent Infringement Under the BPCIA

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On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab)....more

Goodwin

Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio

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On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As...more

Herbert Smith Freehills Kramer

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars

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Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more

Goodwin

New BPCIA Litigation: AbbVie Files Suit on Sandoz’s HUMIRA (adalimumab) biosimilar

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Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Knobbe Martens

Abbvie Inc. v. Medimmune Limited

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Federal Circuit Summaries - Before Prost, Dyk and Chen. Appeal from the United States District Court for the Eastern District of Virginia. Summary: A party may not seek a declaratory judgment to obtain piecemeal...more

Goodwin

BI Files Answer to AbbVie’s Complaint in Adalimumab Litigation

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As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira...more

Goodwin

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

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Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more

Patterson Belknap Webb & Tyler LLP

New Biosimilar Litigation Reflects Benefits of Complying with BPCIA

On August 2, AbbVie sued Boehringer in the District of Delaware, alleging infringement of multiple patents related to AbbVie’s blockbuster biologic Humira (adalimumab). Though AbbVie has “more than 100 issued United States...more

Goodwin

Amgen Seeks Discovery Regarding AbbVie’s Patent Dance with Other Biosimilar Applicants

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In the ongoing litigation between AbbVie and Amgen regarding Amgen’s proposed biosimilar for Humira® (adalimumab), Amgen is seeking discovery from AbbVie regarding its exchanges with other adalimumab biosimilar applicants...more

Foley & Lardner LLP

AbbVie Sues Amgen On 10 Of 100 Humira Patents

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On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - July 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc. 1:16-cv-00540; filed June 29, 2016 in the District Court of...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

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - June 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orexo AB et al. v. Actavis Elizabeth LLC et al. 1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware - ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - May 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Hetero USA, Inc. et al. 3:16-cv-02356; filed April 26, 2016 in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - June 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Idenix Pharmaceuticals LLC et al. v. Gilead Pharmasset LLC 1:15-cv-00416; filed May 21, 2015 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - October 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Laboratories FL Inc. et al. 1:14-cv-01309; filed October 15, 2014 in the District Court of...more

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