INSIGHTS

Client Alerts & Publications

Commentary Trevor Rubin Commentary Trevor Rubin

Plot Twist: Splicing Together DNA From Two Species Is NOT The Same As Mixing Yogurt Cultures

On February 20, 2026, the U.S. Court of Appeals for the Federal Circuit reversed a Delaware district court’s summary judgment of ineligibility, holding that REGENXBIO's gene therapy patent claims are not directed to a natural phenomenon. In doing so, Judge Stoll—joined by Judges Dyk and Hughes—provided a masterclass in how to properly apply the “markedly different characteristics” test from Diamond v. Chakrabarty to modern biotechnology. And the biopharma world is collectively exhaling.

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Commentary Trevor Rubin Commentary Trevor Rubin

So You Want to Compound a Patented Drug? A Legal Survival Guide for the Brave, the Bold, and the Bewildered

On February 8, 2025, I was watching Super Bowl LIX. On came a commercial by Him & Hers offering to deliver weight loss medications to your door. And they looked a lot like Ozempic® and Wegovy®. Being a pharma patent geek watching with another pharma patent geek, we stopped talking about using MALDI-TOF in infringement analyses and started asking a question that Novo Nordisk single-handedly made vogue last week. Why don’t compounders run afoul of patent law all the time? Or do they?

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