The U.S. Supreme Court has the chance to make it easier for generics makers to fight against certain patent protections--or to make sure branded drugmakers have to face certain challenges at all. The justices heard arguments yesterday in a dispute over the rights to a diabetes drug, and the Obama administration is siding with copycat drugmaker Caraco Pharmaceuticals ($CPD) against the Danish pharma Novo Nordisk.
The case involves patent descriptions filed with the FDA--and carve-out indications, which essentially allow copies of a drug to launch for particular uses while one or more indication is covered by a method-of-use patent. In this case, Novo's diabetes drug Prandin has already lost its primary patent protection, but a method patent covers the drug when used in combination with metformin.
Caraco could theoretically win FDA approval for copycat Prandin in the other two agency-approved uses, as Reuters reports. But Novo's description of its method patent submitted to the FDA characterized it more generally--and effectively covered all three approved uses. Caraco challenged that description, but a federal appeals court sided with Novo.
That decision, said the federal government in a brief filed in the case, basically allows branded drugmakers to "preclude generic competition by submitting an overbroad description of its method-of-use patent to FDA." But Novo said its description fulfilled the agency's requirements--and suggested that allowing Caraco to challenge that description wouldn't get generics to market sooner. It would only stall copycat meds in court while companies spent "years and years" fighting over patent issues. The high court is expected to rule by summer.