Bill James, a partner in Goodwin's IP Litigation Group, has 21 years of experience in patent litigation related to pharmaceutical and biotechnology products. He has significant experience with Hatch-Waxman litigations, representing both plaintiffs and defendants, including first-to-file cases and multi-defendant ANDA drug challenges, and has participated in several appeals before the U.S. Court of Appeals for the Federal Circuit.

Dr. James also advises pharmaceutical and biotechnology companies on freedom-to-operate, due diligence, licensing and prosecution issues, and has experience coordinating worldwide patent litigation strategies and providing strategic counseling on biosimilar products.

Experience

Erfahrung

工作经历

Dr. James’s recent work includes representing:

  • Fresenius Kabi in Hatch-Waxman litigation brought by Shire Pharmaceuticals in the District of Delaware, related to the drug icatibant (Firazyr®), which is indicated for the treatment of hereditary angioedema (HAE).
  • Aegerion Pharmaceuticals and the University of Pennsylvania, as lead counsel in successfully defeating IPRs brought by the Coalition for Affordable Drugs challenging Aegerion patents covering the use of its lipid-lowering Juxtapid® (lomitapide) product.
  • Actavis/Teva in Hatch-Waxman litigation brought by Tris Pharma in the District of Delaware related to the drug Quillivant® (methylphenidate) in the District of Delaware.
  • Actavis/Teva in Hatch-Waxman litigation brought by Astra—Zeneca in the District of Delaware involving the drug Brilinta® (ticagrelor).
  • Teva Pharmaceuticals and Yeda Research and Development in the trial of consolidated cases in the District of Delaware relating to Teva’s 40mg three times weekly Copaxone product.
  • Teva Pharmaceuticals and Yeda Research and Development in consolidated Hatch-Waxman litigations concerning proposed generic equivalents to Teva's blockbuster multiple sclerosis drug Copaxone®. Following trial, the court ruled that Teva and Yeda's nine patents in suit were valid, enforceable and infringed by the proposed generic products of defendants Sandoz/Momenta Pharmaceuticals and Mylan/Natco Pharma. Teva Pharmaceuticals USA v. Mylan Pharmaceuticals and Teva Pharmaceuticals USA v. Sandoz (S.D.N.Y.)
  • West-Ward Pharmaceuticals in Hatch-Waxman litigation brought by Helsinn and Roche in the District of Delaware on patents concerning the drug product Aloxi® (palonosetron HCl).
  • West-Ward Pharmaceuticals in Hatch-Waxman litigation brought by Spectrum Pharmaceuticals in the District of Nevada on patents concerning the drug product Fusilev® (levoleucovorin).
  • West-Ward Pharmaceuticals in Hatch-Waxman litigation brought by Hospira in the District of Delaware related to the drug Precedex® (Dexmedetomidine).
  • Teva Pharmaceuticals at trial in the Southern District of New York in a Hatch-Waxman litigation brought by Gilead Sciences on patents concerning the drug product Emtriva® (emtricitabine).
  • Intervet 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. Intervet v. Merial Limited et al. (D.D.C.)
Professional Activities

Dr. James is a member of the American Bar Association, the New York Intellectual Property Law Association and the American Intellectual Property Law Association.

Professional Experience

Prior to joining Goodwin in 2014, Dr. James was a partner at Kenyon & Kenyon in Washington, D.C., where he served on the firm’s Management Committee.

Recognition

Dr. James was named by IAM Patent 1000 – The World’s Leading Patent Professionals as one of the world’s leading patent litigators, 2016 - 2017.

In The News

In den Nachrichten

在新闻中

Credentials

Anmeldeinformationen

专业资格

Education

J.D., 1996
New York University School of Law
D.V.M., Physiology, 1989
Oklahoma State University

Admissions

Bar

New York
District of Columbia
U.S. Patent and Trademark Office (USPTO)

Courts

U.S. District Court for the Eastern District of New York
U.S. District Court for the Southern District of New York
U.S. Court of Appeals for the Federal Circuit
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