Novartis Sues to Block Generic Sales of Top Drug Gilenya for MS

(Bloomberg) -- Novartis AG has launched legal attacks on about two dozen generic-drug makers in a move to protect U.S. sales of its best-selling branded drug.

The lawsuits, filed in federal court in Wilmington, Delaware, come just days after Novartis won a patent case last week that had challenged the originality of a patent on Novartis’s Gilenya drug, used for treating multiple sclerosis.

Novartis is seeking court orders blocking any potential generic versions of Gilenya until the patent has expired, in December 2027, and to collect damages if copies are made before then. Gilenya’s main patent expires in August 2019. Defendants include Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals Industries Ltd. and Mylan NV.

Gilenya, whose active ingredient is fingolimod, had U.S. sales of $1.7 billion in 2017, accounting for 3.5 percent of company revenue, according to data compiled by Bloomberg.

The lawsuits, which allege infringement, weren’t unexpected after the U.S. Patent and Trademark Office’s review board rejected claims by four generic companies related to the patent on the dosing of the drug, according to Michael Yee of Jefferies & Co. Novartis could lean on that victory to try to block generic competition, he said before the lawsuits were filed. It remains unclear if the generic companies will still launch rivals to Gilenya and risk costly damages.

“Since any potential generic product may infringe the dosage regimen patent which was upheld as valid by the US PTO, Novartis is asserting this patent,” said Eric Althoff, a spokesman for Novartis, based in Basel, Switzerland.

President Donald Trump praised Novartis on Thursday morning for holding off on price increases, a week after he attacked the company over its reported plans for a series of hikes.

“Thank you to Novartis for not increasing your prices on prescription drugs,” Trump wrote on Twitter. “Likewise to Pfizer.”

The cases are Novartis Pharmaceuticals Corporation v. Apotex Inc., 18-cv-1038; Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA Inc., 18-cv-1039; Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries Ltd., 18-cv-1040; and Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc., 18-cv-1043; U.S. District Court, Delaware (Wilmington).

--With assistance from Susan Decker and James Paton.

To contact the reporter on this story: Christopher Yasiejko in Wilmington, Delaware, at cyasiejko1@bloomberg.net

To contact the editors responsible for this story: David Glovin at dglovin@bloomberg.net, Larry Reibstein, Heather Smith

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