Here is an update on recent en banc activity at the Federal Circuit in patent cases. Highlights include a new petition presenting a question related to indirect infringement and a response brief addressing obviousness. Here are the details.
- “Does the absence of a specific finding of indirect infringement by a jury render a district court powerless to fashion equitable relief to address an infringer carrying out the infringing conduct through third-parties?”
Teva Pharmaceuticals USA filed its response to Vanda Pharmaceuticals’ petition for rehearing en banc in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. In its petition, Vanda Pharmaceuticals presented the following questions for review:
- “Whether method-of-treatment patents directed to the effect of food on a particular drug are per se obvious because of FDA Guidance acknowledging that food may affect the bioavailability of drugs and should be studied.”
- “Whether the disclosure of the existence of an ongoing clinical trial is evidence of a reasonable expectation of success as to the result of the trial.”
- “Whether a drug-drug interaction patent is obvious when a POSA could not ‘rule out’ the interaction because another compound in the same general category has shown such an interaction.”
Vanda Pharmaceuticals argued the “panel’s decision adopts broad legal pronouncements regarding obviousness that would categorically render entire classes of pharmaceutical subject matter unpatentable.” It also contended, “[u]nder the panel’s reasoning, expensive and time-consuming clinical studies to determine the relationship between drug treatments and food—relationships that often result in meaningful, novel changes to therapeutic courses—are no longer protectable because the Food and Drug Administration (FDA) promulgated a guidance 20 years ago.”
In response, Teva Pharmaceuticals USA now argues “[i]t is hard to imagine a more inappropriate candidate for rehearing en banc” because the “panel in this case issued a non-precedential decision affirming the district court’s application of black-letter obviousness law to case-specific disputed questions of fact.” It also maintained that, “[w]hen not erecting and dismantling straw men, Vanda spends its time making arguments that—while dressed up in legal garb—are in reality thinly veiled disagreements with the factual findings underlying the district court’s obviousness conclusion.”