In Tris Pharma Inc. v. Actavis Laboratories FL, Inc., No. 21-1495 (Fed. Cir. July 7, 2022) (non-precedential), the Court of Appeals for the Federal Circuit (“Federal Circuit”) affirmed the district court’s holding that Actavis failed to show that the challenged claims would have been obvious.
Tris Pharma, Inc. (“Tris”) owns U.S. Patent Nos. 8,465,765 (“the ‘765 patent”), 8,563,033 (“the ‘033 patent”), and 8,778,390 (“the ‘390 patent”), which have claims related to a liquid methylphenidate (“MPH”) oral suspension with certain pharmacodynamic and pharmacokinetic properties. MPH is used to treat attention deficit hyperactivity disorder.
Tris asserted claims of all three patents against Actavis Laboratories FL, Inc. (“Actavis”) in the U.S. District Court for the District of Delaware. The district court judge held that all asserted claims would have been obvious under 35 U.S.C. § 103. Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 276 F. Supp. 3d 226, 249 (D. Del. 2017). Tris then appealed that decision to the Federal Circuit, which held that the district court “failed to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review” and subsequently vacated and remanded for further fact-finding. Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 755 F. App’x 983, 989 (Fed. Cir. 2018) (Tris I).
On remand, as in the original district court proceeding, Actavis relied on five commercially available MPH formulations, a U.S Patent Application Publication (Scicinski), and several scientific articles as prior art. Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 503 F. Supp. 3d 183, 191 (D. Del. 2020) (Remand Decision). The district court, Judge Connolly presiding, concluded that each aspect of the asserted claims was disclosed by a piece of prior art, but no single reference disclosed all the claim limitations. Id. at 195. Further, Actavis failed to prove by clear and convincing evidence that a person of ordinary skill in the art would have been motivated to combine the prior art references with a reasonable expectation of success, thus the asserted claims would not have been obvious. Id. at 202-03 (D. Del. 2020). Actavis appealed this decision.
On appeal, the Federal Circuit reviews a district court’s legal conclusions regarding obviousness de novo and any factual findings for clear error. Tris Pharma Inc. v. Actavis Laboratories FL, Inc., No. 21-1495, at *7 (Fed. Cir. July 7, 2022) (citing Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724, 728 (Fed. Cir. 2017)). Whether there is a motivation to combine with a reasonable expectation of success and whether objective indicia support a finding of nonobviousness are both factual issues, and such a finding of fact is clearly erroneous only if “despite some supporting evidence, we are left with the definite and firm conviction that a mistake has been made.” Id. at *7-8.
All of the claims at issue require a liquid MPH formulation with a 12-hour duration and single mean peak. Additionally, one claim requires a “therapeutically effective amount of methylphenidate within 45 minutes” (45-minute onset), other claims require a “Tmax of about 4 to about 5.25 hours” (early Tmax range), and only one claim encompasses all of these limitations.
For the 45-minute onset claim, Actavis argued, without supporting evidence, that a skilled artisan would have been generally motivated to use a single mean peak concentration profile. The district court found this was insufficient to show that a skilled artisan would have been motivated to combine a single mean peak profile with “a liquid formulation with a 12-hour duration and 45-minute onset” to achieve the claimed invention. The district court further explained that the evidence was inconsistent with the prior art, which taught away from pursuing a liquid formulation with a single peak, 12-hour duration, and 45-minute onset. Additionally, there was a long-felt unmet need for a liquid formulation. The Federal Circuit found that these fact-findings were not clearly erroneous.
Actavis also asserted that the district court failed to fully consider the disclosures in Scicinski, but the district court found that this art failed to teach a liquid formulation or a 45-minute onset meaning it would need to be combined or modified to reach the claimed properties. Further, experts described Scicinski as “aspirational” and “hypothetical” and noted that the reference “would be dismissed” by a skilled artisan. The Federal Circuit found no error in the district court’s finding.
For the early Tmax range claims, Actavis relied on Scicinski, but the district court again explained that Scicinski (1) did not disclose a liquid formulation for which there was a long-felt unmet need and (2) presented only a hypothetical formulation without any data or explanation for why or how a formulation with the claimed limitations could be accomplished. The Federal Circuit concluded that the district court did not clearly err in finding that Actavis failed to show a motivation to combine with a reasonable expectation of success.
When relying upon multiple references to attempt to show obviousness, the challenger must explain why one of ordinary skill in the art would be motivated to combine or modify the references and what would have provided the basis of a reasonable expectation of success. As the Supreme Court noted in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), there must be “a reason” for a skilled artisan “to combine the elements in the way the claimed new invention does”). The USPTO should be held to the same standard.
Expert testimony, such as provided by the patent owner in this case, may help support attacking the challenger’s position or even show a teaching away. In this case, expert testimony showed that a skilled artisan “would have been indifferent” to and therefore not motivated to use a single peak profile. Tris, at *9. Moreover, there was expert testimony that a single peak profile did not necessarily correlate with clinical effects, such as the claimed 12-hour duration or 45-minute onset. Id.
As noted above, in a prosecution context, an examiner must provide the reasoning in support of an obviousness rejection. In In re Lee, 277 F.3d 1338 (Fed. Cir. 2002), the Federal Circuit vacated the Board’s obviousness rejection based only on “common sense” rather than scientific analysis. The Board did not explain the “common knowledge and common sense” on which it relied. The Federal Circuit cited extensive authority that reliance on “common sense” is insufficient. Instead, “the agency tribunal must present a full and reasoned explanation of its decision. The agency tribunal must set forth its findings and the grounds thereof, as supported by the agency record, and explain its application of the law to the found facts.” Id. at 1342. Conclusory statements do not fulfill the agency's obligation. Id. at 1344-1345. Attacking the prima facie case may help to avoid amending claims and the resulting possibility of prosecution history estoppel.
If the challenger or the USPTO does not establish a prima facie case of obviousness, there is no need to submit rebuttal evidence. However, it still may be helpful. In this case, the Federal Circuit noted the evidence of long-felt unmet need as “confirming” the district court’s conclusion of nonobviousness. Tris, at *11-12.
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