Paul Hastings Scores for Sunovion in Lunesta Patent Fight
In hopes of bringing a generic version of the blockbuster sleep aid Lunesta to market, the generic drug company Dr. Reddy's Laboratories Inc. did something we've never heard of. In an affidavit, the company promised to make its generic version slightly different than the brand-name version sold by Sunovion Pharmaceuticals Inc. According to Reddy's, the minor chemical difference meant it didn't infringe Sunovion's patent on Lunesta, allowing it to sell as much of its generic version as it wanted pending regulatory approval.
Reddy's unusual approach won the blessing of a trial judge earlier this year, but it met its demise at the U.S. Court of Appeals for the Federal Circuit on Thursday.
In a 15-page ruling, a Federal Circuit panel held that Sunovion is entitled to a judgment that Reddy's proposed generic infringes its patents. The decision is a victory for Sunovion and its lawyers at Paul Hastings, led by partner Joseph O'Malley Jr. As a practical matter, it blocks Reddy's from selling generic Lunesta until Sunovion's patent expires.
The active ingredient in Lunesta is a chemical called Eszopiclone, which is the mirror image of another chemical called R-zopiclone. As part of its stated mission of keeping prescription drugs pure and uniform, the U.S. Food and Drug Administration requires that each tablet of Lunesta be almost entirely composed of Eszopiclone and no more than 0.3 percent R-zopiclone. Despite this guidance, in 2008 Reddy's sought FDA approval to market a generic version of Lunesta containing between 0.3 percent and 1 percent R-zopiclone. The FDA rejected the application in 2010, calling the approach "not acceptable."
Undeterred, Reddy's next asked for FDA approval for a generic version of Lunesta containing between zero and 0.6 percent R-zopiclone. Meanwhile, it sought a court ruling that such a generic wouldn't infringe Sunovion's patent. As part of that effort, Reddy's filed a so-called "certification" pledging that regardless of the specification it sent to the FDA, its generic Lunesta would contain at least 0.3 percent R-zopiclone—in other words, it would be ever-so-slightly different than Lunesta. That was good enough for U.S. District Judge Dennis Cavanaugh in Newark, N.J., who granted summary judgment of noninfringement to Reddy's back in January. The ruling left FDA approval as the only remaining obstacle for Reddy's to launch its Lunesta competitor.
The Federal Circuit has now reversed, finding that Reddy's got a bit too creative. "Any so-called 'certification' pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is infringement as a matter of law," the court wrote. Reddy's plan also posed practical difficulties, the court noted, because "it would be practically impossible for Sunovion, the FDA, or any court to monitor Reddy's compliance."
O'Malley declined to comment, as did Stuart Sender of Budd Larner, who represented Reddy's.