Supreme Court lets patent invalidation stand, generic Cubicin® could be coming

The U.S. Supreme Court will not hear a brand-name antibiotic manufacturer’s appeal of a decision invalidating its patents, meaning that a competitor can proceed with its plans to manufacture a generic version of the drug. A federal district court determined that four patents for the injectable drug Cubicin® were invalid for obviousness. Cubist Pharmaceutical, Inc., later acquired by Merck & Co., Inc., appealed the decision to the Federal Circuit, which sided with the district court in November 2015 (Cubist Pharmaceuticals, Inc. v. Hospira, Inc., Fed. Cir., November 12, 2015). Cubist sought certiorari, arguing that the Federal Circuit’s rules on patents were too restrictive regarding obviousness. Hospira had opposed the petition because it would result in the High court conducting its own factual analysis on the validity of the patent. The High Court’s denial of certiorari means that Hospira, Inc., acquired by Pfizer, Inc. in 2015, may pursue authorization to sell a generic version of the daptomycin product.

Cubicin (daptomycin for injection) is an injectable antibacterial product used to treat complicated skin and structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis. Hospira filed an abbreviated new drug application (ANDA) with the FDA in 2011 to sell a daptomycin product equivalent to Cubicin before the expiration of the Cubist patents. Cubist filed suit pursuant to the Hatch-Waxman Act (P.L. 98-417) alleging that Hospira had infringed on its five patents. Although the court found Hospira infringed on one patent, it determined that the remaining four patents were invalid because they were based, in part, on less frequent administration of a drug, and the benefit of less frequent administration would have been obvious to a person of skill in the art.

The fifth patent expires in June 2016. Upon its expiration, Hospira can move forward with plans to sell a generic daptomycin product.