Event Session
Obviousness and Life Sciences: Trends & Strategies for Success**
October 30, 2024 @ 9:30 AM EST
9:30 AM ET
October 30, 2024
Obviousness and Life Sciences: Trends & Strategies for Success**
One of the more recent developments with respect to obviousness is the recent and increasing use of clinical trial evidence tied together with argument that it would have been reasonable to expect success. This puts the brands in a very difficult position because the inventor’s own work that is necessary in order to generate the invention is being used against the patent applicant to argue and attempt to prove obviousness. Of course, if you apply before having that information you could have a 112 description sufficiency problem, but brand owners are increasingly contemplating filing before having the data provided by clinical trials. Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. and Salix Pharmaceuticals, LTD. v. Norwich Pharmaceuticals, Inc.
Another interesting issue relates to the Federal Circuit’s recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (April 2024), where the court questioned the availability of secondary considerations, specifically directing the district court to address whether secondary considerations are appropriate to demonstrate non-obviousness where the patent owner had other patents in the field that would block others from even attempting to work in the same space.
This panel will discuss obviousness generally, and specifically the interplay between 35 USC 103 and 35 USC 112, use of clinical trials as the foundation for an obviousness rejection, and the use of secondary considerations to prove, or disprove, obviousness.
Materials
CAFC Panel Splits on Reasonable Expectation of Success Analysis
SCOTUS Scraps Vanda’s Bid for Guidance on Obviousness Standard
Survey
https://www.surveymonkey.com/r/Obviousness-and-Life-Sciences
One of the more recent developments with respect to obviousness is the recent and increasing use of clinical trial evidence tied together with argument that it would have been reasonable to expect success. This puts the brands in a very difficult position because the inventor’s own work that is necessary in order to generate the invention is being used against…
Session Speakers
Sponsors
