A recent PTAB order found that instituted claims were not unpatentable as anticipated under § 102(b) despite the prior art patent’s disclosure of the administration of the API and a range that subsumed the claimed range of doses. Koios Pharmaceuticals LLC v. Medac Gesellschaft Für Klinische Spezialpräparate mbH et al., IPR2016-01370, Paper 54, (PTAB Feb. 7, 2018). The patent at issue – U.S. Patent No. 8,664,231 – is listed in the Orange Book for Medac Pharma’s Rasuvo® (methotrexate) product.
Petitioner asserted that U.S. Patent No. 6,544,504 (“the ‘504 patent”) disclosed both “subcutaneous administration” and a “concentration of [methotrexate of] more than 30 mg/ml,” as required by the claims. The ‘504 patent teaches that methotrexate “may be administered in a manner as is conventionally practiced,” and specifically identifies parenteral administration of methotrexate. The reference also provided an example involving subcutaneous administration. The ‘504 patent further teaches that the methotrexate is compounded “for convenient and effective administration in effective amounts” in proportions ranging from about 0.1 to about 40 mg/ml in a pharmaceutically acceptable carrier.
Patent Owner argued that the disclosure of “parenteral administration” covers many different modes of administration and that the ‘504 patent provides no information to correlate methotrexate concentrations with any mode of administration. The Patent Owner also argued that the ‘504 patent disclosure is so broad and generic that it provides no information to a person of ordinary skill in the art about how to compound or administrate it.
The Board agreed with the Patent Owner that one of ordinary skill in the art would not have understood the concentration ranges disclosed in the ‘504 patent to be applicable to each mode of methotrexate administration disclosed in that patent. The Board based its decision on the requirement that “a prior art reference . . . not only disclose all elements of the claim within the four corners of the document, but . . . also disclose those elements ‘arranged as in the claim.’” The Board found that the ‘504 patent did not tie subcutaneous administration to a dose of more than 25 mg/week, nor did it disclose the specific concentrations for subcutaneous administration.
Based on this decision, Petitioners challenging claims for method of administration of a drug should be sure to link prior art’s disclosure of a claimed dosage amount to the particular method of administration. Broad statements describing general types of administration modes, coupled with a disclosure of dosage ranges, may not, without more, anticipate the full dosage range obvious for use in each of the described modes of administration.