Momenta, Sandoz Get $120 Million Lovenox Settlement Approved

Momenta Pharmaceuticals Inc. and Novartis AG unit Sandoz Inc. got final approval from a Tennessee federal judge for a $120 million settlement of claims that they tricked regulators into incorporating a patent on their blood thinner Lovenox into a drug testing standard.

Judge Waverly D. Crenshaw Jr. gave his blessing May 29 to the agreement, which will hand $40 million to the attorneys representing the class action plaintiffs, after giving it a preliminary nod in January. The deal calls for contributions of $85 million from Sandoz and $35 million from Momenta.

It resolves an antitrust lawsuit accusing the two drugmakers of concealing their pending Lovenox patent application while lobbying the U.S. Pharmacopeial Convention in favor of a testing protocol that would require generic makers to infringe the patent, which was later approved.

The patent covered a method for testing the quality of Lovenox’s active ingredient, used to treat and prevent clots and heart attacks.

The companies must have known what they were doing, because they had just convinced the USPC to condition the testing protocol on the withdrawal of another patent application by nonparty Sanofi-Aventis SA, the original maker of Lovenox, the suit claimed.

The scheme allegedly worked, with the agency approving a protocol that forced generic Lovenox makers to infringe the patent by performing mandated quality tests.

The drugmakers subsequently used the patent to block a generic Lovenox product made by Amphastar Pharmaceuticals Inc. But the U.S. Court of Appeals for the Federal Circuit reversed, allowing Amphastar to start selling it.

Momenta and Sandoz settled Amphastar’s antitrust counterclaims for $60 million about a year ago.

Meanwhile, a group of hospitals, insurers, pension funds, and uninsured consumers filed their antitrust lawsuit against Momenta and Sandoz in the U.S. District Court for the Middle District of Tennessee.

Crenshaw rejected their Sherman Act allegations in 2018 but let their state law antitrust claims move forward. He certified the case as a class action in September.

Lieff Cabraser Heimann & Bernstein LLP was lead counsel for the class. Momenta was represented by Axinn, Veltrop & Harkrider LLP. Sandoz was represented by Alston & Bird LLP.

The case is Hosp. Auth. of Nashville & Davidson Cty. v. Momenta Pharms., M.D. Tenn., No. 15-cv-1100, 5/29/20.