Momenta Pharmaceuticals Inc. is unlikely to win its patent-infringement case over copies of the blood-thinner Lovenox, so Watson Pharmaceutics Inc. can sell its version until a trial is held, a U.S. appeals court ruled today.
The U.S. Court of Appeals for the Federal Circuit vacated an order that would have prevented Watson partner Amphastar Pharmaceuticals Inc. from selling the copy until an infringement trial can be held. The case was sent back to the lower court for further proceedings.
“Momenta has not established a likelihood of success on its claim on infringement,” the court ruled in a 2-1 decision posted on its website. The panel said the trial judge might want to consider whether to issue a ruling of non-infringement.
The decision limits the right of patent owners to claim infringement of processes that are necessary to maintain regulatory approval of generic medicines by the U.S. Food and Drug Administration. It expands the scope of a federal law that precludes infringement suits for actions taken in order to obtain FDA approval.
“The opinion outlined in the ruling is a setback for Momenta in this particular litigation and has potentially wide ranging implications for all patent holders,” Craig Wheeler, Momenta’s chief executive officer, said in a statement.
Wheeler said the Cambridge, Massachusetts-based company is considering its options. It can seek a review of the decision before all active judges of the Federal Circuit, which specializes in patent law, and appeal to the Supreme Court.
Momenta owns a patent related to enoxaparin, the active ingredient in Lovenox, and gets a share of the profit earned from generic Lovenox sold by partner Novartis AG’s Sandoz unit. Momenta fell 35 cents, or 2.5 percent, to $13.77 at 4:30 p.m. in Nasdaq Stock Market trading.
Charlie Mayr, a spokesman for Parsippany, New Jersey-based Watson, said the company was pleased with the ruling “and we will continue to market the product pending resolution of the pending litigation.”
Sanofi, the Paris-based maker of the branded medicine, reported 2.1 billion euros ($2.6 billion) in Lovenox sales last year, according to data compiled by Bloomberg.
Copying the drug is difficult because it is made by cleaving raw heparin, an anticoagulant, with a type of sugar chain, according to court filings. Momenta’s patent is for a process to ensure the generic version of enoxaparin contains a certain percentage of the sugars, which the FDA listed as a requirement to get approval.
Momenta’s version, the first copy of Lovenox on the market, was getting $260 million a quarter of its version, the Federal Circuit said, relying on court submissions.
“The approval of Amphastar’s version of enoxaparin, and the resultant ruinous competition of another generic version of the drug, threatened this unique market position,” Circuit Judge Kimberly Moore wrote. “Understandably unwilling to give up a billion dollars in yearly revenue, Momenta initiated the present litigation two days after Amphastar received final FDA approval to market its generic enoxaparin.”
Amphastar argued that its use of the patented method was allowable because it was related to submitting information to the FDA to prove its version was an equivalent of Lovenox. The majority of the court agreed, saying the exception isn’t limited to activities that occur before regulatory approval is granted and includes the generation of records Amphastar must keep for possible FDA inspection.
Chief Judge Randall Rader disagreed with the majority, saying that Momenta shouldn’t be deprived of the fruits of its work.
“Momenta made the investment, did the research and engineered the new method,” he wrote. “Amphastar is only able to compete with Momenta by taking its patented invention. Amphastar has not developed its own method, but instead delights in trespassing and refuses to pay a reasonable royalty to make the trespass lawful.”
The appeals court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 12-1062, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 11cv11681, U.S. District Court for the District of Massachusetts (Boston).