Atlanta, Ga. – Parker Poe Adams & Bernstein LLP is pleased to announce that its Life Sciences Industry Team secured a favorable decision for Mylan before the U.S. Court of Appeals for the Federal Circuit. The ruling sets a new precedent on an important issue for pharmaceutical companies relying on prior disclosures of related compounds to challenge patents.
Bausch Health (formerly Valeant Pharmaceuticals) had sued Mylan for patent infringement related to Mylan’s generic version of Relistor®, a drug used to treat adults with opioid-induced constipation and chronic non-cancer pain or advanced illness. Mylan countered that the patent covering the drug was invalid because, among other things, the claimed duration of drug stability at the subject pH range would have been obvious over the prior disclosures of overlapping pH ranges for structurally similar compounds. The U.S. District Court for the District of New Jersey granted summary judgment against Mylan, ruling that to prove the patent claim was obvious, Mylan needed to show that the pH ranges in the prior disclosures were for the same compound.
Mylan appealed the lower court’s ruling, and in a case of first impression, a three-judge panel of the Federal Circuit sided with Mylan, agreeing that prior disclosures of structurally and functionally similar compounds could render the claimed stability and pH range invalid. Reviewing its prior precedence, the Federal Circuit held that “[w]hen compounds share significant structural and functional similarity, those compounds are likely to share other properties, including optimal formulation for long-term stability.” Writing that “Because these … molecules bear significant structural and functionality similarity, and because the prior art of record teaches pH ranges that overlap with the [claimed] pH range … , Mylan has at least raised a prima facie case of obviousness sufficient to survive summary judgment,” the Federal Circuit reversed the lower court and remanded the case for a further examination of the facts. The full Federal Circuit also recently denied Bausch’s request for reconsideration and an en banc rehearing at the appellate level.
The team at Parker Poe that argued the case was led by Robert Florence and included Karen Carroll, Micheal Binns, and Crystal Regan.
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