Tyco v. Mutual Pharmaceutical: Obviousness of a Pharmaceutical Formulation

Pharmaceutical formulation patents often make for challenging obviousness determinations, as the difficulty of reducing a new formulation to practice is balanced against the prior art, which typically includes the relevant pharmaceutical compound itself. The formulation in this case, however, raised few such concerns for the Federal Circuit.A pharmaceutical formulation is a particular form, such as a tablet or suspension, into which a chemical compound (often referred to as an Active Pharmaceutical Ingredient, or API) is placed in order to be easily administered to patients. Pharmaceutical formulations may vary in a number of ways, such as in their effect (for example, an extended release formulation may prolong the release period of the API) or their dosage (5, 10, or 15 mg of the API, for example).Patent No. 9,211,954 provides an example of the latter. It claims a formulation of the API temazepam, a drug used for the treatment of insomnia. The patent claims priority to September 1986.The obviousness issue in this case revolved around whether the formulation claimed by the '954 patent, which incorporates a 6-8 mg dosage unit of temazapam, was obvious in light of Tyco's prior 15 and 30 mg formulations of temazepam in light of a 1983 edition of the British National Forumulary reference. Formulations of temazepam have been marketed since the 1970's, including Tyco's own RESTORIL. It was undisputed that the only difference between the earlier formulations of RESTORIL and the claimed formulation was the dosage (Tyco's earlier formulations contained 15 and 30 mg doses). The district court granted summary judgment of obviousness based on Tyco's earlier RESTORIL product, together with the BNF dosing guidelines for temazepam.On appeal, the Federal Circuit affirmed the obviousness ruling. The most interesting aspect of the opinion is the section addressing Tyco's argument that the BNF reference - which recommended a 5-15 mg dosage for elderly patients - did not teach the 6-8 mg range of the '954 patent because it did not include or cite any evidence demonstrating that this range would be effective in the treatment of insomnia. The CAFC rejected this argument:The ’954 claims do not discuss the intended use of the capsules in a particular treatment regimen. The manufacture of a 7.5 mg temazepam capsule with the disclosed claim limitations would infringe both claims of the ’954 patent, irrespective of the efficacy of the product. Dr. Orr’s statements did not contest the fact that the BNF refers to dosages of temazepam between 5 and 15 mg. His statements are directed to the utility of temazepam as a treatment for insomnia.Tyco argues that all the properties of a composition of matter relevant to patentability must be considered in evaluating whether that composition would have been obvious in light of the prior art, and that the unclaimed property of effectiveness in treating insomnia renders the claims at issue nonobvious. That argument is unavailing. “The 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.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (noting that “a new use of a known composition . . . may be patentable as a process”). The recommendation in the BNF of a range of temazepam dosages that include the dosages claimed in the ’954 patent renders obvious the claims to those dosages even in the absence of documentation in the BNF of the effectiveness of such dosages.