Tagged as: BPCIA

Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti to host a Biosimilars Market Update Webinar

On November 6th, Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal…

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Comments and Letters to FDA in Response to Biosimilars Action Plan

The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…

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

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 directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808…

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New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed Pegfilgrastim and Filgrastim Biosimilars

Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems.  According to…

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BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

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Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals.  The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…

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Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product.  In particular, Genentech had sought a judgment that Amgen could not market its product…

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