Obvious To Try And The Prima Facie Obviousness Case

Novo Nordisk A/S v. Caraco Pharmaceutical Labs. Ltd.

In a case that has now been three times to the U.S. Court of Appeals for the Federal Circuit and once to the Supreme Court, the Federal Circuit has affirmed a district court ruling that the patent covering the diabetes drug PRANDIN® is invalid as obvious.  Novo Nordisk A/S v. Caraco Pharmaceutical Labs. Ltd., Case No. 11-1223 (Fed. Cir., June 18, 2013) (Prost, J.) (Newman, J., dissenting).  However, the Federal Circuit reversed the district court finding that the patent in issue was unenforceable as a consequence of inequitable conduct. 

Novo Nordisk, proprietor of the PRANDIN® repaglinide product, listed the subject patent in the Orange Book for that product. (See IP Update, Vol. 15, No. 8.)  The patent claim in issue simply recited treatment of Type II diabetes by administering rapaglinide in combination with another compound, metformin.  Novo Nordisk asserted that the combination therapy achieved superior