Intellectual Property Disputes
Disputes over intellectual property rights in the health care sector are commonplace, ranging from patent, copyright, or trademark infringement to misappropriation of trade secrets and unfair competition. We have extensive experience in analyzing both
liability and damages issues in such cases, including, for example, the determination of whether the alleged unlawful activity might result in irreparable harm; the evaluation of the commercial success of drugs and medical devices; and the calculation of lost profits and reasonable royalty damages involving
these products. When appropriate, we have used biostatistics to determine the legitimacy of intellectual property claims, based on the relative efficacy, effectiveness, and side effects associated with various drugs and medical devices.
- Medical devices: Industry consolidation and the emergence of valuable new technologies are spurring litigation. We have, for example, undertaken cases in which we have assessed the competitive relationships between products in the context of infringement claims.
- Biotechnology: Advances made years ago have become the subject of current litigation, as patents once thought to have had little value generate successful new products. And the financial promise of tools such as screening and testing devices has prompted licensing and “reach-through” royalty
disputes. In evaluating anticompetitive claims in matters involving generic entry, we have often found it necessary to consider intellectual property issues as well – and the introduction of biosimilars is likely to make this already complicated turf even more challenging to navigate.
- Brand v. generic drugs: Impending patent expiration can often involve Hatch-Waxman disputes over generic entry and patent-validity issues. We have extensive experience both in testifying and supporting expert witnesses in examining such issues as commercial success, damages
related to the direct and indirect purchase of the drug at issue, the validity of statistical analyses of clinical trial data underlying patent claims, and class certification.