Novartis secures injunction barring generic MS drugs
A US court has issued an injunction barring the manufacture of generic versions of Swiss pharmaceutical company Novartis’ multiple sclerosis (MS) drug Gileyna (fingolimod).
In the order, issued Monday, June 24, the US District Court for the District of Delaware said that the defendants, including Mylan, Dr. Reddy’s, and Teva, had failed to establish that Novartis’s patent covering the drug was invalid.
Gileyna, which treats remitting-relapse multiple sclerosis (RRMS), is Novartis’ biggest selling drug worldwide.
Novartis sued the defendants in July 2018 over their efforts to bring a generic version of Gileyna to market, and sought an injunction barring such products until the patent dispute was resolved.
The court found that Novartis had proven that the balance of interests favoured its request for an injunction.
“Defendants stand to lose the opportunity to earn on the order of $50 million collectively by not being able to compete over approximately the next year whereas Novartis will irreparably lose a market in which they sell approximately $1.8 billion of drugs,” the court said.
According to the ruling, the defendants had fallen short in proving that the patent should be invalidated and had failed to provide evidence from an appropriate person of ordinary skill in the art.
“The patent contains parts that would be best understood by a pharmacologist even though the claims are principally directed to treatment and therefore to a clinician,” the order said.
The defendants’ failure to submit evidence containing the opinion of a pharmacologist was “likely a sufficient basis to find that defendants are not likely to prevail on their invalidity challenges at trial,” the court found.
The court also ruled that the prior art cited by the defendants did not anticipate the ‘405 patent. The generic manufacturers had argued that a 2006 paper on the use of fingolimod for RRMS treatment by academic Ludwig Kappos invalidated the patent.
According to the court, however, the 2006 paper amounted to a “test” and a “hypothesis” rather than a successfully proven treatment method.
“At its publication date, the .5 milligram dose of fingolimod had never been used on a human MS patient...nobody knew it would be an effective treatment, and no clinician would have prescribed it for an RRMS patient,” the opinion read.
The court also accepted Novartis’ argument that allowing generic versions of the drug to go to market would cause the Swiss company irreparable harm.
“After what might be as long as a year of generic competition by the time we get to trial and I get a post-trial opinion done, Novartis will not be able to raise the price back to where it is now,” the judge said.
Having to raise prices would also do irreparable harm to Novartis’ goodwill, the judge concluded.
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