Biosimilars: Economic Issues for IP Litigation
In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time. This approval has...
CRA has assisted clients in intellectual property (IP) matters concerning products and services in the life sciences sector, including Hatch-Waxman and BPCIA matters. We have also addressed patent, trademark, and copyright infringement, trade secret misappropriation, and IP licensing. Our experts have quantified damages based on lost profit and reasonable royalty methods and provided opinions on irreparable harm. In addition, we have experience addressing other forms of relief, such as rescission and disgorgement.
Our understanding of the unique dynamics of different therapeutic areas informs assessments of commercial success as a secondary indicator of non-obviousness and the claimed nexus between patented technologies and product success.
Engagements
- 01Breach of contract damages analysis and testimonyCRA was retained by a leading national research university in a breach of contract dispute with a licensee of certain university patent rights related to a...View engagement
- 02CRA assess commercial success for rare disease drugCRA addressed issues relating to commercial success in patent litigation on behalf of an innovator company commercializing a drug for a rare disease. CRA...View engagement
- 03CRA assesses damages for theft of trade secretsCRA provided expert reports and trial testimony in trade secret litigation concerning an early-stage oncology product candidate. Plaintiff claimed that the...View engagement