Momenta Pharmaceuticals ($MNTA) really wants the U.S. Supreme Court to weigh its argument against Amphastar's rival version of generic Lovenox. After all, a lower court ushered the Amphastar drug onto the market last year, promising to cut into Momenta's blockbuster-level enoxaparin sales.
But Amphastar is equally eager to keep the Supreme Court out of the case. It's been fighting for its own version of the Sanofi ($SNY) blood thinner for years. And now, both companies have filed warring briefs at the court, aiming to sway the justices' decision when they discuss the petition later this month.
Here's the background: Momenta and its partner, Sandoz, were first to launch a copycat version of Sanofi's blood thinner Lovenox, and the generic quickly grabbed market share from the brand. Momenta's copy was so successful, in fact, that Sanofi dropped its own authorized generic in late 2011. Momenta enjoyed having that market all to itself--and was fighting hard in court to keep it that way.
Meanwhile, Amphastar was pulling out all the stops for its version, to be marketed with Watson Pharmaceuticals (now Actavis). It had been first to file for FDA approval, if second to market, and as such had even more time invested. The stakes were high; Momenta's drug raked in $1.28 billion in sales last year.
At issue in the companies' legal arguments is the "safe harbor" provisions in the Hatch-Waxman Act, which set up the current framework for generic approvals and patent challenges. We'll let the legal experts explain the nitty-gritty, but suffice it to say that Momenta maintains that Amphastar's version isn't covered by the safe harbor provision, while Amphastar claims it is. We'll find out June 20 whether the Supreme Court thinks their debate is worth reviewing. Till then, the two companies can continue to duke it out in the market as well as in court.
- read the FDA Law Blog post
Special Report: Enoxaparin - Top U.S. Generic Blockbusters