Generic Drugmakers Score Big in Rare Federal Circuit Reversal

An unusual Federal Circuit decision has given generic drugmakers a new way to successfully challenge pharmaceutical patents with specific types of claims.

Novartis Pharmaceuticals Corp.‘s patent on the dosage regimen for the blockbuster multiple sclerosis drug Gilenya didn’t have an adequate description, which the Patent Act requires for a patent to be valid, a US Court of Appeals for the Federal Circuit panel ruled June 21 in a new opinion. Inventors must provide a precise definition of what is claimed to show that they possess the invention.

The ruling outlines a new defense generic drug makers accused of infringing ...