Legal Enforcement Cases
ToolGen Files Complaint Against Vertex Concerning Gene Therapy Casgevy®
On November 18, 2025, ToolGen, Inc. (“ToolGen”) filed a complaint (“Complaint”) in the District of Massachusetts alleging infringement ...
USPTO Puts Subject Matter Eligibility Declarations in the Spotlight
On December 4, 2025, U.S. Patent and Trademark Office (USPTO) Director John Squires issued two memoranda addressing subject matter elig...
The Hidden Risks of Information Disclosure: A Costly Lesson from Cornwall
When Royal Cornwall Hospital responded to a routine Freedom of Information request in 2023, they had no idea they were about to expose ...
Keeping the “human” in human resources: Congress may pull the plug on “Robot Bosses”
We’ve all heard the horror stories. A job seeker spends hours tailoring his resume, finally hits “submit,” and within seconds recei...
SEC Advances Capital Formation and Tokenization Initiatives as Congress Passes Venture Capital Bills and Prudential Regulators Address GENIUS Act Implementation and Debanking
The House passed two capital formation bills aimed at easing securities regulations for venture capital funds, and the following day SE...
From “Operation Chokepoint 2.0” to Fair Banking: What the House Report Alleges and How the OCC Responded
On November 25, the House Financial Services Committee majority staff published Operation Chokepoint 2.0: Biden’s Debanking of Digital ...
Sarepta Files Two IPRs Against Genzyme’s Patents Related to Gene Therapy Elevidys®
On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating t...
Ex Parte Reexamination Keeps Looking Like a Better Post-Grant Option for Patent Defendants
The Federal Circuit recently made ex parte reexamination proceedings more attractive for those accused of patent infringement. The Cour...
FDA Approves Lupin’s Pegfilgrastim Biosimilar, ARMLUPEG
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPE...
Sandoz Launches Tyruko® (natalizumab-sztn), First U.S. Biosimilar to Tysabri®
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved bio...