New Dosage of a Known Pharmaceutical: Obvious?

Addressing the obviousness of a patent claiming a new dosage of an otherwise known pharmaceutical formulation, the U.S. Court of Appeals for the Federal Circuit affirmed a decision on summary judgment finding that the prior art presented an obviousness hurdle that arguments of unexpected results and commercial success could not overcome.   Tyco Healthcare Group LP v. Mutual Pharmaceutical Company, Inc., Case No. 10-1513 (Fed. Cir., June 22, 2011 (Bryson, J.). 

In this Abbreviated New Drug Application (ANDA) litigation, to prevent Mutual from marketing a generic version of Tyco’s 7.5 mg temazepam formulation (RESTORIL) for the treatment of insomnia, Tyco asserted a patent having claims directed to hard gelatin capsules containing 6 mg to 8 mg of temazepam, a benzodiazepine. After the district court denied Tyco’s motion for preliminary injunction on the basis that Mutual’s formulation could not literally infringe Tyco’s patent, Mutual moved for summary judgment on non-infringement and invalidity. The district court granted Mutual’s motion with respect to invalidity, finding that the claims were obvious because 15 mg and 30 mg doses of RESTORIL had been on sale more than a year before the priority date of the Tyco patent, a prior art medical reference taught that physicians use temazepam at a dosage of between 5 mg and 15 mg for the treatment of insomnia in the elderly and in recognition of the knowledge in the art that physicians always seek to prescribe the lowest effective dose of medications, particularly hypnotics such as temazepam.  Tyco appealed

The Federal Circuit affirmed, noting a statement made by Tyco in a Supplemental NDA filed with the FDA that stated that the new dosage differed from previous formulations of RESTORIL only in dose. Thus, the Court concluded that the only difference between the prior art (i.e., previous RESTORIL formulations) and the claimed invention was the dose. Further, because the range of dosages disclosed in the prior art overlapped with the claimed dosage range, the Court found the claims to beprima facia obvious.

Tyco’s argument that the prior art did not teach the effectiveness of the claimed dosage range were unavailing as the Court noted that the claims, which are directed to a known composition, were not tied to efficacy. The court pointed to the old adage (In re Spada) that “[t]he discovery of a new property or use of a previously known composition, even when that property and use are unobvious from the prior art, can not impart patentability to the known composition.”

The Court also made quick work of secondary considerations, noting that Tyco’s claims of unexpected results were unsupported by the specification and its argument of commercial success was not sufficient to overcome the strong prima facie case of obviousness.