Fed Circuit rules against Actavis knee pain generic
Actavis Laboratories cannot market a generic version of Horizon Pharma’s knee pain treatment, an appeals court has ruled.
In a judgment yesterday, October 10, the US Court of Appeals for the Federal Circuit held that Actavis’ generic would infringe a patent covering the formulation for Horizon’s Pennsaid 2% (diclofenac), a nonsteroidal anti-inflammatory topical treatment for knee pain caused by osteoarthritis.
The ruling comes after Horizon Pharma filed a complaint against Actavis for patent infringement in 2017 at the US District Court for the District of New Jersey.
According to the complaint, Actavis sought permission to market a generic version of Horizon’s Pennsaid (diclofenac sodium) prior to the expiration of US patent number 9,539,335, which belongs to Horizon.
In its argument, Actavis said the formulation of Pennsaid 2% would be obvious to a person skilled in the art in view of a previous formulation, Pennsaid 1.5%, and prior art.
Horizon, on the other hand, argued that the changes made to Pennsaid 1.5% were not routine and that the results of the various changes could not be predicted by the prior art.
Horizon said “the prior art reflects that the field of topical pharmaceutical formulations is complex and unpredictable”.
On May 12, 2017, the district court found that Actavis had not shown by clear and convincing evidence that claim 12 of the ‘913 patent, which recites the differences between Pennsaid 1.5% and Pennsaid 2%, is invalid for obviousness.
In the latest decision, the Federal Circuit upheld the district court’s finding that the formulation’s variables “interacted with each other in unpredictable ways” such that “the results emanating into Pennsaid 2% were not obvious” to a person skilled in the art.
Additionally, it agreed with the district court that “the combination of adjustments needed to change Pennsaid 1.5% into Pennsaid 2% was not predictable from the prior art”.
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