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.

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?

The Federal Circuit’s recent decisions have shifted the standards for induced infringement, now considering not just a generic drug's label, but also its marketing practices. This has led to a Supreme Court inquiry on whether a fully carved-out generic label can still encourage infringement.

Section 112 has decisively replaced obviousness-type double patenting (OTDP) as the primary litigation and PTAB vulnerability for ambitious biotech claims, with courts now demanding concrete possession and true enablement of claimed inventions rather than broad, suggestive genus disclosures. Claiming strategy in biotech must focus on disclosure-first breadth, ensuring that specifications clearly exemplify subgenera and teach across the scope of claims to meet strict enablement and written description requirements.​

We’ve been talking about In re Entresto and MSN Pharmaceuticals’ petition for certiorari. The crux of the case remains the same: if you wonder whether a patent can be undone by technology that didn’t exist when it was filed, MSN’s reply brief—and its spirited ode to Edison’s bamboo filament lightbulb—just made your day.

Recently, we posted about MSN Pharmaceuticals Inc.’s petition for certiorari and the several amicus briefs in support of that petition. On November 7, Novartis Pharmaceuticals Corp. filed its brief in opposition. The case squarely presents the long-simmering doctrinal tension over how patent law treats “after-developed” or “after‑arising” technology—innovations not known at a patent’s filing but later alleged to fall within a claim’s scope.

A closely watched petition for certiorari asks the Supreme Court to resolve a fundamental question in patent law: may courts consider after-developed technology when assessing validity under Section 112’s written description and enablement requirements? The petition arises from the Federal Circuit’s decision in In re Entresto, which sustained validity while accepting a broad infringement construction that captured a later-invented chemical “complex.” The outcome could reshape patent drafting, litigation strategy, and freedom-to-operate assessments across life sciences, high tech, and beyond.