YEDA RESEARCH AND DEVELOPMENT CO., LTD. V. MYLAN PHARMACEUTICALS INC. & TEVA PHARMACEUTICALS USA, INC. V. SANDOZ INC.
Before Judges Reyna, Bryson, and Stoll. Appeals from the Patent Trial and Appeal Board and the United States District Court for the District of Delaware.
Summary: Non-prior art evidence may be considered when evaluating the knowledge, motivations, and expectations of a POSITA regarding the prior art. In addition, there is no categorical rule in pharmaceutical patent cases precluding obviousness determinations in the absence of a pharmacokinetic and pharmacodynamics profile. Finally, it is not error to apply an “obvious to try” analysis where there are a limited number of permutations of dose and frequency not already disclosed in the prior art.
Yeda Research and Development Co., Ltd. (“Yeda”) is the assignee of three patents claiming a treatment for relapsing-remitting multiple sclerosis (“RRMS”) by injecting 40 mg of glatiramer acetate (GA) three times a week over the course of seven days. Mylan Pharmaceuticals, Inc. (“Mylan”) filed petitions for inter partes review to challenge all claims of the patents. In addition, the patents were the subject of Hatch-Waxman litigation, thus giving rise to the companion case, Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.
Both the Board and the district court found that the prior art disclosed every limitation of the independent claims, other than the dosing regimen of three doses per seven day period. However, both the Board and the district court also found that the missing limitation would have been obvious to a skilled artisan. Accordingly, both the Board and the district court found the claims invalid. Yeda appealed from each.
Appeal from the Board (Yeda v. Mylan)
On appeal, Yeda first argued that the Board erred by relying on a non-prior art reference. The Federal Circuit found that, aside from one instance, which constituted harmless error, the Board relied on the non-prior art reference for purposes of evaluating the knowledge, motivations and expectations of the POSITA in view of the prior art. Such reliance is permissible. Yeda also argued that in light of the Federal Circuit’s decision in Cyclobenzaprine, a reasonable expectation of success is categorically impossible in the absence of a pharmacokinetic and pharmacodynamics (“pk/pd”) profile. The Federal Circuit explained, however, that it “do[es] not read Cyclobenzaprine as establishing a rigid rule categorically precluding obviousness determinations without pk/pd data.” This case is different, the court noted, because the record taught or suggested therapeutically effective formulations and the pk/pd data was largely irrelevant to the invention. Accordingly, the Federal Circuit affirmed the Board’s decision.
Appeal from the District Court (Yeda v. Sandoz)
On appeal, Teva challenged the district court’s obviousness analysis, arguing that the court erred in finding the missing limitation obvious to try. There are two categories of impermissible obvious to try analyses: “when what was “obvious to try” was (a) to vary all parameters or try every available option until one succeeds, where the prior art gave no indication of critical parameters and no direction as to which of many possibilities is likely to be successful; or (b) to explore a new technology or general approach in a seemingly promising field of experimentation, where the prior art gave only general guidance as to the particular form or method of achieving the claimed invention.” Neither category applied in this case because only two dose sizes had been shown to be effective and safe, and the prior art encouraged skilled artisans to pursue less frequent dosing regimens. Further, there were “only a limited number of permutations of dose and frequency to explore that were not already disclosed in the prior art.” Accordingly, the Federal Circuit affirmed the district court’s decision.