A recent study revealed that biotechnology companies or universities discovered 42 percent of all innovative drugs approved by the US Food and Drug Administration (FDA) between 1998 and 2007.
Biotechnology 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. Eric Steffe explains.
As companies that have at least one approved product know, numerous issues emerge that go far beyond procuring patent protection for the product and the company’s platform technology. These issues 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.
Downstream discoveries and corporate publication policies
Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email James Lynn on firstname.lastname@example.org.
biopharma, FDA, USPTO, patent protection, biosimilars