Novartis Pharmaceuticals Corporation et al v. Roxane Laboratories, Inc., 1-13-cv-01973 (DED August 25, 2016, Order) (Sleet, USDJ)
Tuesday, August 30, 2016
Antipsychotic Drug Patent Not Invalid Under 35 U.S.C. § 101
Following a bench trial, the court found that plaintiffs' antipsychotic drug patent was not invalid for unpatentable subject matter because the claims contained an inventive concept. "The patent-at-issue in this case addresses natural relationships to which the claims add conducting CYP2D6 genotyping tests to determine the appropriate dose of iloperidone to reduce QTc-related risks. . . . The court finds it persuasive that the dosage step in the [patent] does not apply to all patients, but only a specific patient population based upon their genetic composition. The dosage step requires applying genetic tests in a highly specified way. Moreover, the process of using this genetic test to inform the dosage adjustment recited in the claims was not routine or conventional and amounted to more than a mere instruction to apply a natural relationship. This combination of elements is sufficient to ensure that the claims amount to significantly more than just a natural law."