David Wigley, Ph.D.

David Wigley, Ph.D.

Sutherland Asbill & Brennan LLP

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Patent Infringement Safe Harbor and Importation Redefined: Ruling Incentivizes Generic Pharmaceutical Offshore Product Testing

A recent ruling by the U.S. Court of Appeals for the Federal Circuit has provided an apparent loophole for manufacturers to avoid infringement liability for conducting patented manufacturing quality control steps offshore. On...more

11/13/2015 - Hatch-Waxman Patent Infringement Pharmaceutical Industry Quality Control Plan Supply Chain Teva Pharmaceuticals

De Novo Review of Claim Construction No Longer the De Facto Standard

On January 20, the U.S. Supreme Court, in Teva Pharmaceuticals USA, Inc. v. Sandoz, rejected the de novo review standard applied by the U.S. Court of Appeals for the Federal Circuit when reviewing all claim construction...more

1/22/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Intellectual Property Litigation Patent Litigation Patents Pharmaceutical Industry Prescription Drugs SCOTUS Standard of Review Teva Pharmaceuticals Teva v Sandoz

Legal Alert: Monsanto Ruling Protects Innovators of Self-Replicating Biotechnology

On May 13, 2013, a unanimous U.S. Supreme Court held in Monsan to v. Bowman that the doctrine of patent exhaustion does not permit a farmer to reproduce patented seeds for planting and harvesting without the patent holder's...more

5/15/2013 - Biotechnology Bowman v Monsanto Genetically Engineered Seed Infringement Monsanto Patent Exhaustion Patents SCOTUS Seeds

Do Patents Control Self-Replicating Technologies? Supreme Court Hears Argument that Sale of Patented Seed Exhausts Future Patent

Patent infringement arises when one “makes, uses, offers to sell, or sells” a patented invention without authority from the patent holder. However, once the first authorized sale of the patented product has occurred, the...more

5/8/2013 - Bowman v Monsanto Genetically Engineered Seed Infringement Monsanto Patent Exhaustion Patents SCOTUS Seeds

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