Novo’s Prandin patent submission may be challenged

Novo Nordisk A/S (OMX: NOVO B) said after market close on Tuesday that the US Supreme Court reversed a Court of Appeals ruling from 2010 on generic drug maker Caraco Pharmaceutical’s right to challenge Novo’s patent submissions for type 2 Diabetes drug Prandin (repaglinide). The Appeals Court ruling had earlier reversed a District Court for Caraco’s and a separate appeal at The Court of Appeals is pending.

Novo has a method-of-use patents for the compound in combination treatment with generic antidiabetic drug metformin still valid for several years while the patent for repaglinide expired in 2009 . The drug is approved for three different uses and Caraco wants to manufacture it for the other two unpatented uses, something that the US Congress has recently made possible.

The issue has to do with earlier finding that pharmaceutical companies may sometimes submit incorrect patent information to the FDA. The Supreme Court ruled that generic drug makers can challenge how branded drug patents are described. This will have wider implications on how pharma will have to word their NDA filings; with more clarity and less wide ambiquity.

Novo Nordisk maintains that its patent filing is correct. US Sales of Prandin and repaglinide/metformin tablet marketed as PrandiMet were approximately 1 billion DKK (~ 176 million USD) in 2011. Novo Nordisk's share closed at all time high levels of 854 DKK for the day.