IP Issues Associated With Drug Development
- Sterne, Kessler, Goldstein & Fox
Biotechnology companies and universities discover a large percentage of innovative drugs approved by the U.S. Food and Drug Administration each year. These companies, however, are sometimes unprepared for the intellectual property considerations that arise as a promising drug (either their own or one licensed from a university) progresses through clinical trials.
Numerous issues emerge that go far beyond procuring patent protection for the product and the company's platform technology. They include seeking patent protection for downstream discoveries, the renewed importance of process patents, data exclusivity, inventorship disputes, and clearance of third party patents covering commercial manufacturing methods and patient administration protocols.
Key IP issues can arise during each phase of drug development. They include challenges during target identification, drug discovery, lead candidate selection, production scale-up, product lifecycle management, brand management and commercial launch.