MYLAN PHARMACEUTICALS INC. v. MERCK SHARP & DOHME CORP
- Sep 29 2022 |
- Category: CAFC Updates
Merck owns U.S. Patent 7,326,708, which describes sitagliptin dihydrogenphosphate, a dipeptidyl peptidase-IV (“DP-IV”) inhibitor, which can be used for treating non-insulin-dependent (i.e., Type 2) diabetes. Mylan petitioned for inter partes review (“IPR”) of the ’708 patent, arguing that certain claims were anticipated by a Merck-owned International Patent publication by Edmondson. The Board held that Mylan failed to show that the claims of the ’708 patent were anticipated or would have been obvious over the cited prior art at the time the alleged invention was made. Mylan appeals, raising three challenges. First, Mylan contends that the Board erred in determining that a 1:1 stoichiometry of sitagliptin DHP was not anticipated, either expressly or inherently, by Edmondson. However, the CAFC finds that the Board’s finding that Edmondson does not expressly disclose a 1:1 sitagliptin DHP salt, (which finding was grounded in the testimony from Mylan’s own expert that nothing in Edmondson directs a skilled artisan to sitagliptin from among the 33 listed DP-IV inhibitors), was supported by substantial evidence. With respect to inherently disclosing a 1:1 sitagliptin DHP salt, while the CAFC does not provide a specific number defining a “limited class,” they hold that the Board did not err in finding that a class of 957 predicted salts that may result from the 33 disclosed compounds and eight preferred acids, some of which may not even form under experimental conditions, is insufficient to meet the “at once envisage” standard set forth in In re Petering, 301 F.2d 676, 681 (C.C.P.A. 1962). Second, Mylan contends that the Board erred in determining that the ’708 patent antedates Edmondson. Here the CAFC finds that because Merck reduced to practice the subject matter of the claims before Edmondson published, Edmondson would merely be a 35 U.S.C. § 102(e) reference, and because it is undisputed that the invention claimed in the ’708 patent and the subject matter of Edmondson were commonly owned by Merck at the time of the invention, the exception in § 103(c)(1) applies and that the Board’s antedation determination was supported by substantial evidence. Third, Mylan contends that the Board erred in determining that it failed to prove that claims 3 and 4 of the ’708 patent would have been obvious over Edmondson combined with two other references. The Board found that there was no motivation to combine and that there was no reasonable expectation of success in combining the references, and the CAFC finds that the Board’s decision was supported by substantial evidence. In addition, the CAFC finds that the Board did not err in its evaluation of purported objective indicia of nonobviousness. Accordingly, the CAFC affirms.