Novartis Wins U.S. Appeal Affirming Patent on MS Drug

(Bloomberg) -- Novartis AG won a U.S. appeals court ruling that would block HEC Pharm Co.  from selling a generic version of the blockbuster multiple sclerosis drug Gilenya until 2027.

In a 2-1 ruling, the U.S. Court of Appeals for the Federal Circuit on Monday affirmed the validity of a patent on the dosage regimen for the drug. HEC was a holdout among two dozen generic-drug makers Novartis sued in 2018, most of which have reached confidential settlements with the Swiss pharmaceutical giant.

Gilenya generated $2.13 billion in sales in the first nine months of 2021, as Novartis was able to ward off generic competition to a drug that brings in about 5% of its revenue. 

The issue on appeal was whether the patent clearly explained the dosage regimen for fingolimod, the active ingredient in Gilenya, without the need for a higher first dose to get therapeutic levels up quickly.  HEC argued the patent never explained that the so-called “loading dose” wasn't needed, so the patent was unclear.

Circuit Judge Kathleen O'Malley ruled there was “no clear error” in the trial court's finding that the patent adequately described the invention. 

In dissent, Chief Judge Kimberly Moore said the ruling “dramatically expands” the ability of a patent owner to alter what's covered by the initial description of an invention.

“The inventors do not get to claim as their invention something they did not disclose in the patent,” Moore said.

The case is Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., 21-1070, U.S. Court of Appeals for the Federal Circuit (Washington) 

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