Generic’s High Court Win Opens New Battleground with Pharmas

Heather Mewes, partner in the Litigation Group with Fenwick & West, was recently quoted in the Law360 article, "Generic’s High Court Win Opens New Battleground with Pharmas."

The Supreme Court recently ruled that Caraco Pharmaceutical Laboratories could challenge Novo Nordisk's use code for a patent covering a diabetes drug as overbroad. As pharmaceutical companies frequently rely on method-of-use patents once the patent protections for the underlying compounds themselves expire, this ruling could cause a potential rise in litigation between brand-name drug makers and generics.

In this case, the method-of-use patent happened to line up closely with only one of the three approved uses for the diabetes drug, but the facts may not always be so clear in other cases, according to Fenwick & West LLP partner Heather Mewes.

"There's a lot of other patents where the scope of the patents doesn't match so closely with the various methods of use," Mewes said. "Sometimes patents are not that neat ... and you could certainly see some real factual battles happening in these counterclaim battles over whether the use codes are accurate."

In the wake of this decision, the safest approach for patent holders would be to write a use code that directly tracks the patent claims; however, the high stakes involved with brand name drugs will likely lead manufacturers to continue to push boundaries.

"I frankly think there's so much money in these successful drugs that anything they can do will be done," Mewes said. "Even days matter in terms of the recovery for some of the brand-name drugs and what happens to those profits when a generic comes on the market."

Even when generic companies get their drugs approved only with limited labels, they can often still profit off the full-range of FDA-approved uses for the drug, Mewes said.

"Lest we feel too badly for generics on this, the thing to remember is even though drugs may be marketed for a particular use ... that doesn't mean these drugs will never be prescribed for a patented use," Mewes said.