A federal appeals court has affirmed a ruling that Apotex’s application for a generic version of the anti-inflammatory eye treatment Acular infringed a patent (US5110493) held by Roche Palo Alto LLC and licensed to Allergan LLC, finding the Canadian drugmaker had failed to prove that the reverse doctrine of equivalents was applicable in the case.
The whole Judgement (2008) can be read here.
Roche’s patent covers drug formulations for treating eye inflammation and covers products sold as ACULAR and ACULAR LS. The two formulations differ in their proportion of various drugs such as an ammonium preservative and a surfactant.
Hoping to sell generic versions, Apotex filed two ANDAs with the FDA – one for each formulation. In response, Roche filed two separate infringement actions against Apotex (the ACULAR and ACULAR LS cases respectively). In 2007 the CAFC put a final nail in the ACULAR case by affirming the district court’s holding that the patent was not invalid and not unenforceable (infringement had already been decided). This appeal involves ACULAR LS.
The whole story about this case in detail can be read here.
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