The Federal Circuit affirmed infringement of a process patent covering genetically engineered bacteria for producing the amino acid threonine, holding that importing bacteria manufactured abroad using the patented method constitutes infringement under 35 U.S.C. § 271(g) even when the manufacturing was performed under a foreign license that did not extend to the United States.

Priceline.com’s patent on the ‘name-your-own-price’ reverse auction method for travel services was one of the defining e-commerce patents of the late 1990s — illustrating the type of business method patent that became common after State Street Bank and creating competitive tensions that anticipated the post-Alice invalidity wave that would eventually threaten such patents.

The Federal Circuit affirmed non-infringement, holding that Amgen’s synthetic consensus interferon-alpha (INFERGEN) did not infringe Schering’s recombinant DNA patents because it duplicated no natural interferon subtype and therefore did not use the patented recombinant DNA methods to produce a natural subtype.

The Federal Circuit reversed a finding of priority in favor of Genentech, holding that reduction to practice of a recombinant protein invention requires the inventors themselves — not a third party — to recognize the utility of what they have made.

The Federal Circuit held that the common-law experimental use exception to patent infringement is narrow and does not protect activities performed with a commercial purpose, even if the infringer never ultimately sold the infringing product.

The Federal Circuit held that the “offer to sell” prong of patent infringement under § 271(a) requires the offer to be made within the United States, and does not extend to offers made abroad for products to be assembled and used abroad.

The Federal Circuit affirmed summary judgment of non-infringement in an ANDA patent case, holding that Bayer’s repeated prosecution statements characterizing its claimed nifedipine crystal surface area range as ‘special’ and producing ‘superior’ performance created a clear and unmistakable surrender of broader ranges, precluding any claim of infringement under the doctrine of equivalents.

The Federal Circuit affirmed invalidity of a lacrosse stick patent under the on-sale bar of § 102(b), holding that subjective uncertainty about whether a commercially sold product possessed claimed performance characteristics cannot serve as an escape from the bar — if the product was ready for patenting and was commercially offered for sale more than one year before filing, the bar applies even if the seller did not know whether the product met the patent’s performance criteria.

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 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 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 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.