Generic maker hits back at Novartis stay bid

HEC claims the delay would buy Novartis months of “unjustified monopoly profits” | Response says the Swiss big pharma company makes $3.8m a day from multiple sclerosis drug at issue.

Generic maker HEC Pharm has told the US Supreme Court that Novartis’ attempt to stay a mandate while appealing should be denied as, if granted, it would “plausibly buy Novartis six-plus months of unjustified monopoly profits”.

HEC’s response to Novartis’ bid was filed yesterday, 5 October, in the patent dispute between the pair.

Two years prior, Novartis accused generic makers, including China’s HEC Pharm, of patent infringement. The dispute with HEC continued, while the other cases were stayed or settled.

While a Delaware court issued a permanent injunction was granted against HEC until the expiration of the '405 patent in December 2027, the US Court of Appeals for the Federal Circuit later concluded that US patent number 9,187,405—which covers a dosing regimen for 0.5mg Gilenya—was invalid.

In September, the Federal Circuit denied Novartis’ petition to rehear a dispute involving a dosing regiment patent for its multiple sclerosis drug Gilenya (fingolimod).

Novartis’ bid to stay the Federal Circuit’s mandate while it appealed to the Supreme Court was denied by the Federal Circuit in late September. Novartis then submitted an emergency motion to the Supreme Court.

Now, in response to the motion, HEC has claimed: “If Novartis does not prevail in this Court, it will improperly extract $3.8 million from payors and patients every day its requested stay remains in effect.

“And not one penny of those improper monopoly revenues will be recoverable from Novartis by anyone. That, respondents submit, must be dispositive in any balancing of the equities. Novartis’s application for a stay should be denied.”

HEC claimed that it was “little wonder that Novartis seeks to stay the Federal Circuit’s mandate”, with the drug maker allegedly making $3.8 million per day on Gilenya in the US alone, “charging at least 10 to 20 times what its generic competitors would”.

“If Novartis can continue to restrain generic competition even for the months it will take until its petition is denied, it will have squeezed virtually every last dollar from its monopoly pricing of Gilenya,” said HEC.

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