The Federal Circuit reversed a grant of summary judgment, holding that genuine factual disputes existed over whether a trade show brochure triggered the on-sale bar or anticipated the patent, because neither party had presented evidence on how a person of ordinary skill in the art would understand the brochure.
The Supreme Court held that when the Federal Circuit reviews USPTO factual findings, it must apply the Administrative Procedure Act’s ‘substantial evidence’ standard — not the stricter ‘clearly erroneous’ standard applied to district court fact findings — changing the appellate review framework for patent examination decisions.
The Supreme Court unanimously established a two-part test for the on-sale bar to patentability under § 102(b) — holding that an invention is ‘on sale’ before the critical date when it is (1) the subject of a commercial offer for sale and (2) ready for patenting, resolving a circuit split about whether reduction to practice is required.
The Federal Circuit held that UC’s broad patent claims on the insulin cDNA sequence and all vertebrate and mammalian insulin cDNA sequences were invalid for lack of written description — establishing that broad genus claims in biotechnology must be supported by disclosure of a representative number of species sufficient to support the claimed scope.
The Supreme Court unanimously reaffirmed the doctrine of equivalents and held that prosecution history estoppel applies even to unexplained claim amendments — establishing that when a patent claim is narrowed during prosecution without explanation, courts should presume the amendment was made for a patentability reason, creating estoppel that bars the doctrine of equivalents for that limitation.
The Federal Circuit affirmed that Genentech’s patent claims on human growth hormone (hGH) methods were limited by the written description in the specification — holding that claims cannot be broader than what the specification actually describes, even in pioneering biotechnology cases, and establishing important written description doctrine for biotech patent claims.
The Supreme Court unanimously held that the interpretation of patent claims is a question of law for the judge to decide — not a question of fact for the jury — fundamentally establishing that patent claim construction (the Markman hearing) is a judicial function and marking a turning point in how patent trials are structured.
The Federal Circuit reinforced the principles of conception and reduction to practice in patent priority disputes, clarifying that an inventor’s conception must be complete and definite before any reduction to practice can begin — an important decision for inventorship and priority determinations in pharmaceutical and biotech research.