Opinion ID: 213278
Heading Depth: 3
Heading Rank: 1

Heading: Content and Scope of the Prior Art

Text: The district court erred in several of its findings on the disclosure of the Sulak articles and the ’749 patent, which then infected the court’s summary judgment decision. Regarding Sulak, the court rejected all consideration of the articles’ teaching of the use of unopposed estrogen because that use was mentioned only as a “theoretical,” rather than a tested, solution to estrogenwithdrawal headaches. Duramed, 701 F. Supp. 2d at 1169. A reference, however, is prior art for all that it discloses, and there is no requirement that a teaching in the prior art be scientifically tested, see PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1363-64 (Fed. Cir. 2007), or even guarantee success, see Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1295 (Fed. Cir. 2006), before providing a reason to combine. Rather, it is sufficient that one of ordinary skill in the art would perceive from the prior art a reasonable likelihood of success. Id. DURAMED PHARMA v. WATSON LABS 10 Regarding the ’749 patent, the district court first found that the patent “provides no reference or basis to a practitioner on the effects of adding unopposed estrogen to the end of an extended regimen in regards to hormone withdrawal headaches.” Duramed, 701 F. Supp. 2d at 1170. The ’749 patent, however, expressly teaches the administration of 7 days of 10 μg ethinyl estradiol during the traditional hormone-free period following a variety of extended-cycle COC regimens. ’749 patent col.9 ll.48-52. Moreover, it teaches that the administration of unopposed estrogen is to reduce the “incidence of side effects, such as headaches within the framework of premenstrual syndrome.” Id. The district court also found that the ’749 patent discloses a variety of COC regimens and thus concluded that the patent “does not teach any one specific combination that would establish consistent knowledge in the community.” Duramed, 701 F. Supp. 2d at 1170. However, the question is not whether there existed a consistent COC regimen in the art, but rather whether one of ordinary skill in the art would have been motivated to combine the Kovacs regimen with 7 days of low-dose, unopposed estrogen with the reasonable expectation that the addition of low-dose estrogen would successfully reduce the incidence of estrogen-withdrawal headaches during the hormone-free period. Based on its errors in assessing the content of these prior art references, the district court improperly analyzed and rejected the teaching of each in isolation, concluding that each alone failed to establish by clear and convincing evidence a motivation to combine. Specifically, while recognizing that the Sulak articles identify headaches as a symptom of hormone withdrawal, the court ignored the articles’ suggestion of unopposed estrogen as a possible solution, concluding instead that, because it remained an untested solution, “the Sulak article does not 11 DURAMED PHARMA v. WATSON LABS show by clear and convincing evidence that a person of ordinary skill would have added unopposed estrogen to the traditional hormone-free interval to alleviate the hormone withdrawal symptoms that arise during that period.” Id. at 1169-70. The district court next, as described above, rejected the disclosure of the ’749 patent in its entirety, and thus failed to address its teaching of the use of unopposed estrogen to treat headaches following various extended-cycle COC regimens in light of the teaching of a specific extended-cycle COC regimen in Kovacs. Id. at 1170. Finally, the district court analyzed the Kovacs article without reference to the ’749 patent or the Sulak articles, concluding that because the article taught that women on the regimen reported headaches “scattered throughout the [menstrual] cycle,” and itself did not mention the use of unopposed estrogen, “the [Kovacs] article does not provide clear and convincing support” that a practitioner would treat headaches associated with the regimen by adding unopposed estrogen. Id. at 1169. Accordingly, the district court failed to properly consider the collective teaching of the prior art in light of the common sense and creativity of the person of ordinary skill in the art. See KSR, 550 U.S. at 419-21. The district court also appears to have applied an incorrect evidentiary standard on summary judgment, incorrectly placing the burden of proof on the nonmoving party, Watson, to show clear and convincing evidence of invalidity as a matter of law. In this case, Duramed moved for summary judgment of nonobviousness, and thus the burden rested with Duramed to show that Watson had failed to come forth with clear and convincing evidence of an essential element of its prima facie case of obviousness. See Eli Lilly, 251 F.3d at 962. Although the ultimate evidentiary burden of showing clear and convincing evidence does not change on summary judgment, DURAMED PHARMA v. WATSON LABS 12 Watson could defeat summary judgment by showing a genuine issue of material fact, which, if believed by the finder of fact, could provide clear and convincing evidence of a motivation to combine the prior art references. See Freedman Seating, 420 F.3d at 1364; see also Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed. Cir. 1998) (“If facts remain in dispute, this court weighs the materiality of the dispute, i.e., whether resolution of the dispute one way or the other makes a difference to the final determination of obviousness.”). That is the standard the district court should have made clear it was applying on summary judgment.