Teva infringed UCB patent, rules Fed Circuit
The US Court of Appeals for the Federal Circuit yesterday, June 24, upheld a lower court’s finding that UCB’s patent is infringed by a planned generic version of Neupro (rotigotine), a patch to treat Parkinson’s disease.
In its decision, the Federal Circuit found that District Judge Leonard Stark of the US District Court for the District of Delaware had concluded correctly on both the infringement of US patent number 6,884,434, and the invalidity of a second patent owned by UCB, US patent number 8,232,414.
The infringed patent (‘434) claims a transdermal therapeutic system comprising rotigotine, a drug used for the treatment of Parkinson’s disease.
Following a bench trial in 2017, Stark concluded that generic products created by Watson Laboratories and Actavis Laboratories (now Teva subsidiaries) infringed the ‘434 patent under the doctrine of equivalents.
“Actavis’s products use a polyisobutylene adhesive, rather than the claimed acrylate-based or silicone-based polymer adhesives, but the district court found the adhesives in this context to be substantially similar and that nothing in this case barred application of the doctrine of equivalents,” said Circuit Judge Raymond Chen, on behalf of the court.
Yesterday, Chen concluded that there was no good basis in the prosecution history to bar the application of the doctrine of equivalents.
At district court level, Stark also rejected Actavis’s arguments of anticipation and obviousness in relation to the ‘434 patent. Again, the Federal Circuit affirmed this finding.
On cross-appeal, UCB asked the court to reverse the district court’s invalidation of the ‘414 patent claims due to prior public use.
In August 2007, UCB halted manufacturer of Neupro patches when an unknown solid precipitated during the dissolution step.
Over the next few months, UCB investigated and discovered that the solid was a polymorph of rotigotine. Polymorphs are different 3D, solid-state, crystalline structures of the same chemical compound.
UCB filed a patent application to cover the newly discovered Form II polymorph of rotigotine, resulting in the ‘414 patent, called “Polymorphic form of rotigotine and process for production”.
Stark found the ‘414 patent was invalid, because the Form II invention was in actual use before the correct invention date.
The Federal Circuit dismissed UCB’s appeal, after deciding that the district court had reasonably found that a patient had used Neupro patches that contained Form II rotigotine before November 28, 2007 (the ‘414 patent’s filing date).
“We do not find clear error in the district court’s finding that Actavis presented clear and convincing evidence of public use before the date of invention under section 102(a). Accordingly, we affirm the district court’s invalidation of the asserted ‘414 patent claims,” concluded Chen.
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