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Proposed BPCIA Reform Legislation Likely To Have Little Effect Even If Passed

In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20...more

Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab

On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more

GSK Sues Pfizer, Pharmacia & Upjohn & BioNTech for Infringing mRNA Vaccine Patents

​​​​​​​Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc....more

REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition

​​​​​​​As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc.,...more

Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

​​​​​​​Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its...more

Coherus and AbbVie File Dueling Motions for Injunctive Relief Relating to Coherus’s HUMIRA Biosimilar

​​​​​​​Our readers may recall that nine HUMIRA biosimilars have been licensed to launch in July 2023, with Amgen’s AMJEVITA the only one to launch to date....more

Update on Arbutus mRNA Vaccine Patent Litigations

​​​​​​​Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE....more

Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market...more

Year in Review: Top Legal Developments of 2022

As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more

Regeneron Files Antitrust Lawsuit Accusing Amgen of Engaging in a Persistent Exclusionary Campaign to Deny Patients Access to...

Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware.  Regeneron alleges that “Amgen is engaged in a persistent exclusionary...more

No License, No Chips, No Problem: Ninth Circuit Delivers Qualcomm a Win in Antitrust Case Brought by the US Federal Trade...

In a much anticipated opinion, the U.S. Court of Appeals for the Ninth Circuit reversed a California district court decision holding that Qualcomm violated U.S. antitrust laws in its licensing of standard-essential patents in...more

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more

In Limelight, Supreme Court Rejects Inducement Liability Without a Direct Infringer

The U.S. Supreme Court, in Limelight v. Akamai, recently reversed a Federal Circuit decision holding Limelight Networks liable for inducing patent infringement. The Supreme Court ruled that a party cannot be held liable for...more

In Nautilus, Supreme Court Relaxes Standard for Finding Patents Invalid for Indefiniteness

The U.S. Supreme Court, in Nautilus v. Biosig, recently reversed a Federal Circuit ruling that a patent is valid as long as the description of what it claims is not “insolubly ambiguous.” The Supreme Court’s decision, which...more

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