BioCentury
ARTICLE | Company News

Novo Nordisk, Sun Pharmaceutical endocrine news

May 9, 2011 7:00 AM UTC

Novo Nordisk disclosed in its 1Q11 earnings that on March 28 the Supreme Court requested the U.S. Solicitor General to provide the view of the U.S. government on Novo's current Use Codes for the use of Prandin repaglinide in combination with metformin to lower blood glucose and a method for improving glycemic control in adults with Type II diabetes. Novo added the later Use Code to protect against Caraco marketing repaglinide as a monotherapy. Caraco claimed that this Use Code is inaccurate and too broad. The Supreme Court will decide by the end of June on whether it will review the Federal Circuit Court of Appeals pending decision on Use Code, which is used to categorize patents based on a drug's therapeutic equivalence to another. In January, Novo appealed a U.S. District Court for the Eastern District of Michigan decision ruling that U.S. Patent No. 6,677,358 covering the combination use of Prandin and metformin for the treatment of Type II diabetes is invalid and unenforceable. Novo initially filed suit in 2005 alleging the ANDA for generic Prandin from Sun's Caraco Pharmaceutical Laboratories Ltd. (NYSE-A:CPD, Detroit, Mich.) subsidiary infringed the '358 patent, which expires in 2018. ...