With support from Bates White, pharmaceutical manufacturer Amgen Inc. recently settled litigation with Teva Pharmaceuticals USA Inc. concerning Teva’s challenge to the validity of Amgen’s patents for Neupogen. The client obtained a favorable outcome through an agreement that prevents Teva from introducing its infringing drug in the United States before November 2013.
Dr. Douglas Bernheim testified on behalf of Amgen in Amgen v. F. Hoffman-La Roche to advise the court considering whether to grant a permanent injunction against Roche’s sales and marketing of a product that infringes Amgen’s patents. The judge issued a court order that agreed with Dr. Bernheim’s conclusions and cited his testimony extensively.
Many healthcare industry participants invest substantial resources in developing innovative products and technologies. We evaluate the role of intellectual property rights in rewarding innovators and spurring innovation. Our professionals have been called upon to evaluate these issues and others in temporary and permanent injunction proceedings as consulting and testifying experts on such economic issues as irreparable harm, adequacy of monetary damages, balance of the burdens, and public interest. We also quantify the impact of alleged infringement in patent, trademark, and copyright cases by evaluating the competitive landscape and calculating but-for damages, price erosion, reasonable royalties, and future damages. In breach-of-contract claims, our clients count on us to exhaustively model but-for market share scenarios and calculate damages.
- In Janssen Products, L.P. v. Lupin Limited, serving as a testifying expert regarding commercial success as a secondary consideration of patent nonobviousness on behalf of plaintiff Janssen alleging patent infringement in connection with certain generic drug manufacturers’ Paragraph IV Abbreviated New Drug Applications (ANDAs) concerning generic versions of Janssen’s PREZISTA® HIV treatment prescription drug. Provided expert report and deposition testimony.
- In Teva v. Amgen, supported Professor Tomas Philipson of The University of Chicago to evaluate economic issues related to the injunction sought by Amgen to prevent Teva from introducing its infringing drug, Neutroval, in the United States. Submitted an expert report that provided economic opinions concerning the application of the four factors identified in the U.S. Supreme Court’s opinion in eBay v. MercExchange. Analysis addressed the economic incentives created by Medicare’s reimbursement policies and the long-run repercussions of Teva’s anticipated infringing sales. A court-approved settlement enjoined Teva from introducing Neutroval into the United States until November 2013—only one month before the patents at issue will expire.
- Provided written report, deposition, and hearing testimony on behalf of Amgen in Amgen v. F. Hoffman-La Roche to advise the court considering whether to grant a permanent injunction against F. Hoffman-La Roche’s sales and marketing of a product that infringes Amgen’s patents. Testimony focused on the implications of recently introduced Medicare reimbursement policies on competitive dynamics among drug manufacturers and the impact of the potential entry of F. Hoffman-La Roche’s product on Amgen, healthcare providers, Medicare, and third-party payors.
- Evaluated the net benefits associated with granting patent term restoration for a brand-name pharmaceutical for which the U.S. Patent and Trademark Office did not grant such extension. Our work resulted in a white paper that updated a previous CBO legislative scoring document. The analysis focused on the likely benefits associated with continued marketing and the resulting expanded use of the brand-name drug in terms of improved clinical outcomes relative to existing therapies.
- Calculating the expected impact of certain life-cycle management strategies on the value and timing of generic competitive entry decisions on behalf of a pharmaceutical manufacturer.
- Computed damages arising from lost sales of a major antiviral pharmaceutical product resulting from an alleged breach of contract (failure to provide adequate marketing and promotional support). Our work involved development of but-for scenarios, modeling of demand for antiviral pharmaceuticals, forecasting lost sales under hypothetical market outcomes, and preparation of an expert report.