KV Rebuffed in Ritalin Suit

KV Pharmaceuticals remains in litigation after a district court judge denied its motion to dismiss a patent suit brought against it by Celgene and Novartis over a generic version of long-acting (LA) Ritalin.

KV wanted the suit dismissed on the basis that Celgene and Novartis had failed to make a reasonable inquiry about its infringement claims, as required by law, before they filed suit to protect the drug’s patents.

KV notified Celgene last year that it had filed an ANDA with Paragraph IV certifications on two patents for Ritalin LA (methylphenidate HCl), a treatment for attention deficit hyperactivity disorder, in 10-, 20-, 30- and 40-mg strengths. Both the 1998 ’284 patent and a 2003 ’284 patent, which Celgene licensed to Novartis for certain fields of use, expire in December 2015.

Celgene and Novartis responded last October by filing suit in the U.S. District Court for the District of New Jersey.

In a July 17 order, District Court Judge Susan Wigenton denied a motion by KV for sanctions with prejudice, finding that KV’s motion “is premised on an erroneous application of Federal Circuit law,” according to court documents.

KV had alleged that the plaintiffs’ attorneys had not conducted a reasonable and competent prefiling inquiry as required under Federal Circuit law. But Wigenton disagreed, stating that the 45-day period in which the Hatch-Waxman Act requires patent owners to bring suit is too short for Celgene and Novartis to have conducted the analysis KV requested in its motion to dismiss.