16 October 2017Americas

Orexigen defeats Actavis in weight loss pill battle

US pharmaceutical company Orexigen Therapeutics has won a patent infringement case against Actavis Laboratories after suing the company over weight loss pill Contrave (naltrexone HCl/bupropion HCl extended release).

Judge Richard Andrews at the US District Court for the District of Delaware ruled that Actavis infringed claims protecting the drug and had failed to prove invalidity.

The decision, from Friday, October 13, comes more than two years after Orexigen filed the complaint.

Orexigen originally sued Actavis in June 2015, citing infringement of seven patents in Actavis’s filing of an Abbreviated New Drug Application for a generic version of Contrave.

Four patents were later removed from the complaint, leaving three to be litigated, with the trial taking place in June this year. The patents were US numbers 7,462,626; 7,375,111; and 8,916,195.

According to the decision, Contrave is used for “chronic weight management in adults” who are obese or overweight and who have “at least one weight-related comorbidity”, such as type 2 diabetes or hypertension.

Actavis argued that claim 11 of the ‘195 patent is invalid for lack of written description, but Andrews said the company had not proved this by clear and convincing evidence.

The defendant also said that claims 26 and 31 of the ‘626 patent and claim 1 of the ‘111 patent are invalid based on obviousness.

As Andrews noted, Actavis said it would have been obvious to a person of ordinary skill in the art to combine bupropion and naltrexone for treating overweight and obesity because both bupropion and naltrexone were known to cause weight loss.

However, he said: “It seems clear that the weight loss effects of bupropion were known to be relatively modest at best. There is also no dispute that the prior art references reported potential risks associated with bupropion, including the risk of seizure.

“Based on the lack of knowledge of the mechanism of action, combined with the modest effectiveness, I do not think a person of ordinary skill would have found bupropion to be an obvious starting point for further study.”

He went on to reject the obviousness claim, again citing a lack of clear and convincing evidence, before ruling that Actavis had directly infringed claim 1 of the ‘111 patent, while claim 11 of the ‘195 patent and claims 26 and 31 of the ‘626 patent had been infringed indirectly.

In a statement, Michael Narachi, president and CEO of Orexigen, said the court’s positive decision allows the company to continue to fulfil its mission to provide innovative medicine to treat patients who are overweight or struggling with obesity.

He said the three patents in dispute will be valid until 2030.

A spokesperson for Teva, the parent company of Actavis, said the company was disappointed with the result and is considering its options on appeal.

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