IgorGolovniov /
30 August 2019GenericsRory O'Neill

Federal Circuit blocks Sandoz generic

The US Court of Appeals for the Federal Circuit has ruled that claims in an Allergan patent detailing the results of a glaucoma treatment are material to its patentability, after an unsuccessful invalidation appeal brought by Sandoz.

The ruling affirms a previous decision of the US District Court for the District of Delaware blocking a generic version of Allergan’s Combigan glaucoma drug.

The case turned on whether certain claims in the patent, outlining the results of administering the drug, had an impact on its patentability.

These clauses, known as 'wherein clauses', detail the benefits to efficiency and patient safety of administering the drug according to the claimed method.

According to Sandoz’s argument, these clauses merely detailed the “intended results” of administering the formulation. If the district court had judged the ‘wherein’ clauses to be non-limiting, then the patents would be invalid as the remaining claims were obvious, Sandoz claimed.

The Federal Circuit, however, sided with Allergan in affirming the district court’s decision.

“The specification of the patents-in-suit demonstrates that the claimed invention is ultimately a formulation … that allows for increased efficacy and safety, i.e., a decreased risk of adverse events,” the ruling said.

The court also cited litigation in which Allergan asserted the patents, and in which the ‘wherein’ clauses were relied upon in a demonstration of the drug’s patentability.

In a concurring opinion, chief judge Sharon Prost said that Sandoz’ appeal “falters from the start”.

“Sandoz attempts to label over half the claim language in claim one as a mere ‘intended result’,” Prost wrote.

“We should not begin with the presumption that text in the body of the claim may be meaningless and can only be saved by clear statements in the specification or prosecution history,” she added.

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