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US patent board clears path for Mylan to launch version of Sanofi's Lantus

The U.S. Patent and Trademark Appeal Board has ruled in favor of Mylan NV in a patent dispute brought by Sanofi over the vial form of the long-acting insulin Lantus.

Paris-based Sanofi, which sells Lantus in vials and as a disposable injection pen, charged that Mylan was in violation of the patents for the insulin when the Canonsburg, Pa.-based company filed a new drug application for a generic version. Mylan is co-developing the generic with Biocon Ltd.

Lantus controls blood sugar in adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes.

The patent board has now ruled in Mylan's favor, finding that Sanofi's patent claims for the vial form are invalid. The board determined that Sanofi cannot have exclusive rights for the Lantus formulation patents.

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Mylan CEO Heather Bresch said this ruling will improve insulin access to 30 million diabetic Americans and will create competition in the market.

Sanofi spokesman Nicolas Kressman said Sanofi typically does not comment on pending litigation or patent board matters, but the company is protecting its patents and products.

"I want to stress that our scientists' inventions are novel and nonobvious as recognized by the patents we have been awarded by the US Patent and Trademark Office," Kressman said. "By protecting our patented inventions, we are paving the way for the discovery of new medicines to address unmet medical needs."

A complicated road ahead

In a Dec. 13 note, Evercore ISI analyst Umer Raffat said the patent decision presents "one of the most meaningful launch opportunities" for Mylan in the next year or two.

Merck & Co. Inc. was developing a follow-on biologic version of Lantus called Lusduna, even receiving a tentative approval from the U.S. Food and Drug Administration for the product in July 2017. But the company in October decided to abandon development, terminating its agreement on the product with Samsung Bioepis.

With Merck out of the way and the patent board ruling in favor of Mylan, Raffat said the path has been cleared for the generic-drug maker to bring at least one version of a Lantus copycat to market in 2020.

In October 2017, Sanofi also filed litigation against Mylan alleging infringement of 18 patents for Lantus and the pen version, Lantus SoloStar. According to Mylan, the case is pending in the U.S. District Court for the District of New Jersey and no trial date has been set.

Raffat noted that the vial form of the medicine, for which the patent board ruled, makes up a third of the market. The pen form, meanwhile, is the remaining two thirds and remains subject to a patent board complaint from Sanofi and the District Court litigation. A decision on the litigation is expected in September 2019, according to Raffat.

Mylan's partner in the Lantus generic, Biocon, must still secure approval for the generic version from the US FDA as well, according to Raffat.

Kressman said Sanofi believes the patent board's ruling on the vials will have little impact on the timing of the launch for Mylan's generic product, as the court has placed a 30-month hold on the company's plans.

Sales of Lantus for the year ending Oct. 31 were about $2.1 billion and about $4.4 billion for Lantus SoloStar, according to IQVIA.

The U.S. FDA has made a new push for lower-cost versions of insulin medications, issuing new guidance aimed at bringing new biosimilars to market.