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15 May 2019Americas

Fed Circuit dismisses West-Ward appeal in Novartis suit

The Federal Circuit has ruled that a Novartis patent is valid despite an error of reasoning from a district court.

In its  judgment, issued on Monday, May 13, the US Court of Appeals for the Federal Circuit ultimately upheld the district court’s ruling in a patent dispute between Novartis and Hikma Pharmaceuticals subsidiary West-Ward Pharmaceuticals.

Novartis sued West-Ward in 2015 claiming infringement of its patent (US number 8,410,131) covering the use of the everolimus compound to treat advanced renal cell carcinoma (RCC), a type of kidney cancer.

In a 2017 judgment, the US District Court for the District of Delaware ruled that West-Ward had failed to prove that the ‘131 patent was invalid as obvious.

West-Ward appealed against the decision to the Federal Circuit, claiming that the district court had erred in finding that a person of ordinary skill in the art would have lacked motivation to pursue everolimus as a potential treatment for RCC after reviewing the prior art.

The Federal Circuit rebuked the Delaware court, noting that it was “improper to require West-Ward to prove that a person of ordinary skill would have selected everolimus over other prior art treatment methods”.

Nonetheless, the appeals court ruled that the error was “harmless as the district court did not clearly err in its finding regarding reasonable expectation of success”.

The Federal Circuit upheld the district court’s finding that a person of ordinary skill in the art would not have had a reasonable expectation of success when applying everolimus as an RCC treatment.

This was due to the lack of data and the poorer understanding of the molecular biology of advanced RCC at the time.

LSIPR has contacted Novartis and West-Ward for comment.

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Americas
10 December 2018   The US Court of Appeals for the Federal Circuit has reversed one decision and affirmed another in two cases involving Novartis, with both judgments delivering victory to the Swiss pharmaceutical company.

More on this story

Americas
10 December 2018   The US Court of Appeals for the Federal Circuit has reversed one decision and affirmed another in two cases involving Novartis, with both judgments delivering victory to the Swiss pharmaceutical company.