Opinion ID: 4502549
Heading Depth: 3
Heading Rank: 1

Heading: Reliance on Multiple References

Text: A patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claimed invention, either expressly or inherently. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). An anticipatory prior art reference must also “enable one with ordinary skill in the art to practice the invention.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1342 (Fed. Cir. 2005) (internal quotations and citations omitted). “As long as the reference discloses all of the claim limitations and enables the ‘subject matter that falls within the scope of the claims at issue,’ the reference anticipates.” In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009) (emphasis added) (quoting Schering Corp., 339 F.3d at 1380–81). Galderma argues that the district court erred by finding the asserted claims anticipated based on disclosures found in two references, in contravention of settled law that anticipation must be based on disclosure in a single reference. According to Galderma, although the district court was permitted to look to other references to interpret the allegedly anticipatory reference, it was strictly prohibited from using additional references “for a very specific teaching.” Galderma’s Br. 22 (citing Studiengesellschaft Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed. Cir. 1984)). Galderma argues that the district court erred by relying on Manetta for its teaching of the Soolantra formulation. Id. at 23. In Galderma’s view, based on the parties’ stipulation that McDaniel’s formulation was enabled Case: 19-2396 Document: 58 Page: 9 Filed: 01/29/2020 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. 9 by Manetta, the district court incorporated one of the Manetta formulations into McDaniel, erroneously finding the asserted claims anticipated. Galderma further contends that the district court confused enablement with anticipatory disclosure. Id. at 23– 26. Galderma argues that we have looked to additional references “solely to show enablement of an anticipatory reference,” not, as here, for “whether an enabled reference discloses all claim limitations.” Id. at 25 (citing Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1372 (Fed. Cir. 2001)). According to Galderma, Manetta’s enablement of McDaniel’s formulation only means that a person of ordinary skill in the art (“POSA”) could practice the general formulations disclosed in McDaniel. It cannot mean that McDaniel discloses the specific formulation disclosed in Manetta. Teva, on the other hand, sees no error in the district court’s finding of anticipation. It argues that anticipation is evaluated from the perspective of a POSA and the knowledge of a POSA can be shown with extrinsic evidence, “without running afoul of the single-reference rule for anticipation.” Teva’s Br. 33. According to Teva, Galderma’s stipulation that “‘Manetta enables McDaniel in 2012 as to the formulation,’” is “directly relevant evidence” of the perspective of a POSA. Id. at 34. Teva argues that there is no error because “[i]t follows [from the parties’ stipulation] that a skilled artisan with McDaniel in hand would envisage” the specific formulation disclosed in Manetta. Id. at 35. Teva further argues that the district court’s findings are consistent with our precedent. It argues that disclosure of a genus (here, McDaniel’s disclosure of a 1–5% ivermectin formulation) can anticipate a claimed species if a POSA would discern or possess the species (here, the Soolantra formulation) upon reading the disclosure. Id. (citing Bristol-Myers, 246 F.3d at 1380). According to Teva, Case: 19-2396 Document: 58 Page: 10 Filed: 01/29/2020 10 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. Manetta’s Soolantra is “undoubtedly a species within the scope of McDaniel’s disclosure,” and, given that this formulation necessarily achieves the claimed results, a POSA’s possession of the formulation before the critical date anticipates. Id. (citing Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005)). Teva’s arguments ignore the axiom that a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention. Turning to another reference “for a very specific teaching” runs afoul of these settled principles. See, e.g., Dart Indus., 726 F.2d at 727 (rejecting an anticipation challenge where the challenger relied on two additional articles “for a very specific teaching, not for any light they shed on what [the anticipatory reference] would have meant to those skilled in the art”). Here, the district court erred by finding the asserted claims anticipated by the disclosures of McDaniel and Manetta, in contravention of settled law. We reject Teva’s arguments that the doctrine of enablement justified the district court’s reliance on Manetta for a specific teaching. In so arguing, Teva confuses the concepts of anticipation and enablement, just as the district court did. Whether a prior art reference is enabled is a separate question from whether it discloses, expressly or inherently, the claimed limitations at issue. Here, the parties’ stipulation meant only one thing: in 2012, a POSA would have been able to practice the general formulations disclosed in McDaniel, i.e., 1–5% ivermectin, “formulated into a cosmetically-acceptable topical lotion, cream, or gel.” McDaniel at 2:66–3:10. The stipulation cannot mean, as Teva suggests, that McDaniel discloses the specific Soolantra formulation. Our decision in Bristol-Myers is instructive. In BristolMyers, we held that certain method of treatment claims directed to “premedicating” were anticipated by the prior art reference “Kris” suggesting premedicating generally, even Case: 19-2396 Document: 58 Page: 11 Filed: 01/29/2020 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. 11 though Kris did not “actually employ premedication.” 246 F.3d at 1378. We clarified that it was permissible to “look to any references that establish that Kris’s suggestion of [premedicating] would have been enabling to one of skill in the art more than one year prior to [the] earliest filing date of [the patent].” Id. at 1379. At the same time, we found that certain other claims, directed to specific classes of premedicaments (“steroids, antihistimines, H2-receptor antagonists, and combinations thereof”), were not anticipated by Kris, which disclosed “only the use of premedicaments generally.” Id. at 1372, 1380. For this second set of claims, we refused to turn to other prior art references disclosing the use of steroids and H2-histamine antagonists as premedicaments, because Kris did not contain this specific disclosure. Id. at 1380. The difference between our finding of anticipation of the first set of claims in Bristol-Myers and the district court’s finding of anticipation in the present case, is that in Bristol-Myers, the asserted anticipatory reference contained the very disclosure that was found to be enabling based on other references (premedicating generally). By contrast, here, McDaniel does not contain the specific disclosure that is necessary for a finding of anticipation: an ivermectin formulation (such as Soolantra®) that necessarily achieves the claimed efficacy limitations. We refuse to look to Manetta to incorporate a specific disclosure not found in McDaniel, just as we refused in Bristol-Myers to look beyond Kris for a disclosure of the specific premedicaments claimed in the second set of claims at issue in that case. In suggesting that “[i]t follows [from the parties’ stipulation] that a skilled artisan with McDaniel in hand would envisage” the Soolantra® formulation, Teva’s Br. 35, Teva makes the impermissible leap from enablement to disclosure. The parties’ stipulation concerned the enablement of McDaniel. What a POSA “envisages,” on the other hand, is undoubtedly a question of disclosure, not enablement. Case: 19-2396 Document: 58 Page: 12 Filed: 01/29/2020 12 GALDERMA LABS., L.P. v. TEVA PHARM. USA, INC. What a POSA “envisages” from reading a reference is relevant to whether a reference discloses the claim elements “arranged as in the claim.” Net MoneyIn, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Though Manetta enables an embodiment of McDaniel, it does not necessarily follow that a POSA reading McDaniel would at once envisage the undisclosed specific Soolantra® formulation that satisfies the claimed efficacy limitations. In any event, we have previously rejected the proposition that “a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would ‘at once envisage’ the missing limitation.” See Nidec Motor Corp. v. Zhongshan Bd. Queen Motor Co. Ltd., 851 F.3d 1270, 1274– 75 (Fed. Cir. 2017). Here, the district court was not permitted “to fill in missing limitations simply because a skilled artisan would immediately envision them.” Id. We also reject Teva’s arguments that possession of the Soolantra® formulation by a POSA before the critical date anticipates because Soolantra® is “undoubtedly a species within the scope of McDaniel’s disclosure.” Teva’s Br. 35. Teva has not established that McDaniel’s disclosure of 1– 5% topical ivermectin is a small enough genus that the species is anticipated. To the contrary, Teva’s own expert testified that a 1% ivermectin formulation can be achieved in “thousands and thousands of possible” ways. J.A. 6486–87. Accordingly, we conclude that the district court erred in looking outside McDaniel in its anticipation analysis.