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A federal jury handed Amphastar Pharmaceuticals Inc a big win on Friday after it was accused of infringing on a patent held by Momenta Pharmaceuticals Inc through its production of a generic version of the blood-thinner Lovenox.
According to court records, the jury ruled on Friday that while AMPH infringed MNTA patent for testing the quality of batches of the drug, the patent was invalid. The lawsuit was filed by Cambridge, Massachusetts-based biotechnology company Momenta and its partner, Novartis AG’s Sandoz unit, that sought $938 million in damages, which began July 11.
“We are very pleased with the jury’s verdict and especially pleased that Amphastar is now out from under this baseless lawsuit,” Michael Sommer, an attorney for Amphastar, said in a statement. He added that a victory for Momenta could threaten to bankrupt Amphastar, cost 1,300 jobs in the U.S., and hurt “all the people who rely on its life- saving medications.”
Momenta Chief Executive Craig Wheeler in a statement said the company was disappointed and was considering its options, including a potential appeal. “We continue to believe in the importance of investing in innovative techniques for bringing products to market and protecting those innovations from unauthorized use,” he said.
During the trial, Momenta’s lawyers defended the validity of the patent for the testing, and argued Amphastar must pay for using the technology without permission. “They used the invention in violation of Momenta’s right on purpose and with knowledge.”
Following the verdict, Shares of Momenta were down around 3 percent, while shares of Amphastar were up about 3 percent.
The case stemmed from Momenta’s partnership with Sandoz to develop and commercialize a generic version of enoxaparin, which is sold by Sanofi Aventis under the brand name Lovenox. Under that agreement, Momenta served as Sandoz’s contract laboratory.
Momenta, whose generic version Lovenox was the first to receive FDA approval in 2010, claimed Amphastar’s infringement and subsequent sales of its own generic caused it to suffer a significant loss of profits.
Momenta also has a generic version of multiple sclerosis drug Copaxone on the market, called Glatopa. It is developing biosimilars to Orencia, Bristol-Myers Squibb’s drug for rheumatoid arthritis, and to Humira, the arthritis blockbuster made by AbbVie.
The Humira copycat is slated for a commercial launch as early as 2020 after generating positive late-stage trial data in November, while the Orencia biosimilar is in a Phase 1 study.
The case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 11cv11681, U.S. District Court for the District of Massachusetts (Boston).