EARLY, THOROUGH DEFENSE KEY TO BEATING SALES INJUNCTION

Successfully heading off a preliminary injunction or temporary restraining order halting sales of a generic drug requires quickly convincing the judge why such a move would be harmful to the generic company, according to a legal expert. Issues that can help get a favorable ruling include the impending launch of either an authorized generic or a successor product to the one whose patent is being litigated.

"In our experience, a judge that has more experience with the case is a harder sell for the brand company when it comes in and requests a preliminary injunction or a [temporary restraining order]," attorney Charles Weiss, a partner at law firm Kenyon & Kenyon, told attendees at the Institute for International Research's Generic Drugs Summit Sept. 28. "Patents still have an aura of mystique and infallibility. The branded companies have a high horse they ride on very effectively, and it is desirable to knock them down a little bit," he said.

Demonstrating that the brand firm deliberately delayed requesting the court block sales, even though they knew of the impending launch, is an effective move in getting blocking motions denied, Weiss said. Generic firms can do this by writing letters to the brand firm letting them know when they intend to launch the drug. "You don't want to be the one that delays," Weiss said. The generic firm needs to be in a position where it can tell the judge, "this emergency is of their own making -- don't let them get away with it."

Ideally, judges will be familiarized with the generic firm's defenses and positions before the brand company makes a motion to block generic sales, he said.

A brand drug company might request a preliminary injunction under several circumstances. One is if it does not sue a generic drugmaker for patent infringement within 45 days after the generic firm files to market a version of the brand company's drug, therefore not triggering an automatic 30-month stay on the FDA approving the generic product. The brand firm can also request an injunction when it files a patent infringement suit that does not trigger such a stay. Or, it can ask the court for one just before the 30-month stay ends.