Amphastar Patent Win Boosts Momenta, Sandoz Antitrust Case

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Eleanor Tyler Washington Reporter/Editor Fawn Johnson Washington Editor

By Eleanor Tyler

Amphastar Pharmaceuticals got a boost in its antitrust battle with Momenta Pharmaceuticals Inc. and Sandoz Inc. when it won a related patent infringement lawsuit brought against it by the two companies.

The victory in the infringement case over the method for testing an anticoagulant drug brings Amphastar a step closer to proving that Momenta and Sandoz engaged in anticompetitive conduct. Amphastar CEO Jack Zhang said in a March 20 statement that the company would seek a $100 million bond in the patent case and pursue further damages under a separate antitrust case that was given the green light by the same judge.

Judge Nathaniel Gorton of the U.S. District Court for the District of Massachusetts entered final judgment March 19 against Sandoz and Momenta in the patent infringement case. That allows Amphastar to continue its plans to manufacture a generic version of the anticoagulant drug enoxaparin, which Momenta and Sandoz sell as the brand drug Lovenox.

Momenta and Sandoz sued Amphastar after the Food and Drug Administration required Amphastar to use Momenta’s patented method for testing the drug. But the FDA didn’t know the test was under patent when it issued the testing requirement, and the jury said the patent was invalid because it was too vague. Gorton’s final judgment holds that Momenta is also equitably estopped from enforcing its patent against Amphastar because it lied to get its patented method incorporated in the industry standard.

The patent trial was “extremely helpful for us,” Jason Shandell, president and general counsel of Amphastar, told Bloomberg Law. The two-week trial, involving testimony from “some of the most renowned scientists in the field,” helped “the whole story come out, and the jury really got the gist of it,” he said.

The finding that Momenta lied to the standard setter is an important building block in the antitrust case that Amphastar lodged against Momenta and Sandoz. Amphastar contends that Momenta tricked an important standard-setting organization into adopting its patented method for testing enoxaparin and then sprang a patent enforcement trap on Amphastar when it moved to market a generic version, thus monopolizing the market.

In patent-based monopolization claims, the strength of the patent and an innovator’s right to enforce it counter the weight of claims it misused the privilege. But Momenta and Sandoz will have difficulty raising that argument now that a jury has already found that the patent is invalid and that they can’t legally enforce it.

“At this point, we’re looking forward to proceeding,” Shandell said. The antitrust case is also pending before Gorton.

Amphastar will still need to prove that Momenta’s lies harmed competition and caused Amphastar damages. Gorton held in the antitrust case on March 19 that those claims are sufficient to move on to discovery and further litigation.

Spokespeople for Momenta and Sandoz didn’t respond to a request for comment.

The patent case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc. , D. Mass., No. 11-cv-11681, final judgment 3/19/18 .

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To contact the editor responsible for this story: Fawn Johnson at

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