William G. James

William G. James, D.V.M.

Bill James is a patent litigator in Kenyon’s Washington, DC Office. Dr. James has litigated patent cases in the pharmaceutical, biotechnology, medical and mechanical fields. His experience includes every facet of the patent litigation process from trials, Markman proceedings, arguments before the Court of Appeals for the Federal Circuit, to fact and expert discovery, including coordination and management of large multi-party patent litigations. Dr. James has expertise in cases brought under the Hatch-Waxman act and in biotechnology matters. His experience and background uniquely situate him to counsel clients and offer strategic advice on biosimilar issues. He also counsels clients in the pre-litigation context, including freedom-to-operate, validity and infringement analyses. In addition, he represents clients in due diligence investigations, technology transfer and other licensing matters.

Representative matters include:

Teva v. Sandoz; Teva v. Mylan (Copaxone®) – Trial counsel for plaintiffs Teva Pharmaceuticals and Yeda Research and Development in consolidated Hatch-Waxman litigations pending in the Southern District of New York concerning proposed generic equivalents to Teva's blockbuster multiple sclerosis drug Copaxone®. Bench trials were held in July and September 2011 and a decision is pending.

Intervet, v. Merial (Circumvent® - Porcine Circovirus Vaccine) – Represented Intervet in DC District Court and before the Federal Circuit in biotechnology patent litigation brought against Intervet's Circumvent® porcine circovirus vaccine. Dr. James represented Intervet at Markman hearing. Intervet obtained a favorable Markman ruling leading to summary judgment of non-infringement and favorable settlement.

Wyeth v. Intervet (Circumvent® - Porcine Circovirus Vaccine) – Litigation counsel for Intervet in patent infringement litigation brought by Wyeth against Intervet’s Circumvent® porcine cirovirus vaccine. Dr. James represented Intervet at Markman hearing. Intervet obtained a favorable claim construction decision. The case is pending.

Aventis and AMR v. Teva; Aventis and AMR v. Impax (Allegra® - fexofenadine) – Represented Teva Pharmaceuticals in patent litigations brought by Aventis relating its Allegra® and Allegra-D 12 Hour® fexofenadine-containing products. Dr. James represented Teva and Impax in a Markman hearing addressing formulation patents. Clients obtained favorable Markman ruling and summary judgment of non-infringement and invalidity. The cases settled.

Thermo Finnigan v. Applera (DNA analyzer) – Represented defendant Applera (now Life Technologies Corp.) in a patent infringement suit brought by Thermo Finnigan against Applera’s Prism® DNA analyzers. Dr. James represented Applera at the Markman hearing. The case settled after Applera received favorable determinations in a reexamination proceeding brought by Applera.

Merck & Co. v. Teva Pharmaceuticals USA (Fosamax® - alendronate) – Represented defendant Teva Pharmaceuticals in Hatch-Waxman litigation relating to the once-weekly formulation of Merck’s Fosamax osteoporosis drug. Patent claims were determined to be invalid for obviousness by the Federal Circuit.

Purdue Pharma v. Faulding (Kadian® - extended release morphine) – Represented defendant Faulding in a patent infringement action brought by Purdue against Faulding’s Kadian® morphine product. The patent claims were invalidated for lack of adequate written description.

Novo Nordisk v. Biotechnology General and Teva (Human Growth Hormone (hGH)) – Represented defendants Teva and BTG in a patent infringement case brought by Novo Nordisk to stop the sale of hGH by Teva and BTG. The Federal Circuit ultimately affirmed the finding that Novo Nordisk’s patent was invalid and unenforceable.

Biotechnology General v. Genentech (Human Growth Hormone (hGH)) – Represented Biotechnology General in a biotechnology patent infringement suit brought by Genentech against BTG’s human growth hormone product. The patent in suit was found invalid by the district court.