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Sanofi-Aventis U.S. LLC had reason to assert a patent on two insulin drugs against a potential competing product, a Massachusetts federal court said in dismissing a lawsuit claiming the drugmaker monopolized the market.
Lantus is a diabetes treatment sold in vials or an injector pen. The plaintiffs contended that Sanofi’s legal patent monopoly on the drug ended in February 2015. They said Sanofi illegally extended its monopoly by listing six other patents in the “Orange Book” of FDA-approved drugs and suing Eli Lilly & Co. even though those patents that didn’t really apply to the product.
Magistrate Judge Judith G. Dein held Jan. 10 that purchasers of Lantus and Lantus SoloSTAR have no monopolization case against Sanofi. The plaintiffs failed to allege that Sanofi was unreasonable in listing patents in the Orange Book for Lantus or that it engaged in sham litigation with rival drugmaker Eli Lilly to keep its product out of the market, she said.
Two different plaintiffs asserted claims, which could have resulted in treble damages, that Sanofi made an illegal $11.7 billion in monopoly profits as a result of its scheme. The court’s decision derails the lawsuit. The plaintiffs, filing on behalf of a nationwide class of purchasers, can refile their complaint in hopes of overcoming the failures that Dein identified.
The complaint said Sanofi gave Eli Lilly a license to make its competing products in a patent settlement, and Eli Lilly agreed not to market a generic competitor to Lantus before Dec. 15, 2016. That was almost two years after the primary patent on Lantus expired but well within the term of Sanofi’s other related patents.
Dein said the plaintiffs failed to allege that Sanofi’s conduct was unreasonable with regard to at least one of the patents it used against Eli Lilly’s proposed generic version. The FDA guidance on listing products like Sanofi’s injector pen for Lantus is ambiguous. Given that lack of clarity on whether it was required to list its injector pen patents in the Orange Book, Sanofi was not unreasonable in doing so as a matter of law, Dein said.
The plaintiffs’ claim that litigation against Eli Lilly was a “sham” also failed because they didn’t allege enough facts to show that Sanofi’s patent suit was objectively baseless. If one patent was reasonably listed and asserted, then the remaining patents Sanofi advanced couldn’t have caused problematic delays in marketing the generic, Dein said.
The case is In re Lantus Direct Purchaser Antitrust Litig. , D. Mass., CIVIL ACTION NO. 16-12652-JGD, 1/10/18 .
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