Momenta Pharmaceuticals Inc., which receives royalties from the only approved generic version of the blood thinner Lovenox, filed a patent-infringement suit to block a potential rival drug from Teva Pharmaceutical Industries Ltd.
Momenta and its partner, Novartis AG’s Sandoz, began selling copies of the Sanofi-Aventis SA drug after receiving U.S. Food and Drug Administration approval July 23. In November, Teva, the world’s biggest generic-drug maker, told investors that its proposed generic copy met the FDA’s standard for chemical sameness and it was making progress toward approval.
Prices of generic drugs typically fall as more rivals enter the market and, according to Momenta, an additional generic Lovenox would decrease payments it gets from Sandoz. Momenta and Sandoz are seeking an order that would prevent Teva from being able to sell copies of the medicine in the U.S., said Rick Shea, chief financial officer of Cambridge, Massachusetts-based Momenta.
The lawsuit gives Momenta “a promising opportunity to pro-actively prevent further generic competition,” Duane Nash, an analyst with Wedbush Securities in San Francisco, said in a note to clients. Lovenox generated 3 billion euros ($3.95 billion) in sales last year for Paris-based Sanofi.
Momenta’s two patents relate to ways of manufacturing and analyzing the structure of enoxaparin, the active ingredient in Lovenox. The complaint, filed today in federal court in Boston, also asks that Teva be forced to compensate Momenta and Sandoz for any damages.
Teva Denies Infringement
Teva has “built commercial inventory infringing our patents,” Shea said in an interview. “Teva is free to enter the market if they are not infringing our patents.”
Teva denied infringing the two patents and in a statement said that it “intends to seek reimbursement for all legal fees in fighting these baseless allegations.”
Momenta rose 23 cents to $15.65 at 4 p.m. in Nasdaq Stock Market trading. Teva’s American depositary receipts, each representing one ordinary share, fell 22 cents to $49.77. Novartis ADRs rose 50 cents to $54.61.
Momenta and Sandoz are likely to seek an order to prevent Teva from entering the market even before a trial can be held, and if such a request is granted, it would boost Momenta shares by “removing the current state of fear that the next news could be bad news,” said Nash, who has an “outperform” rating on the stock.
Under the terms of the agreement with Basel, Switzerland-based Novartis, Momenta is paid 45 percent of the profits from the sale of Lovenox copies if it’s the only generic version on the market. If another company begins selling a copycat drug, Sandoz instead will pay Momenta a royalty based on net sales, Momenta said in its Nov. 8 quarterly report.
Momenta earned $44.2 million in the quarter ended Sept. 30 from the sales, or 85 percent of total revenue during the period, according to its earnings report.
Lovenox, an injection that helps prevent blood clots, was Sanofi’s second-biggest selling product last year, after the diabetes-medicine Lantus, accounting for about 10 percent of revenue. Sales of the medicine dropped 26 percent in the third quarter because of generic competition, Sanofi said Oct. 28
The case is Momenta Pharmaceuticals Inc. v. Teva Pharmaceutical Industries Ltd., 10cv12079, U.S. District Court for the District of Massachusetts (Boston).