Tris Pharma Inc. v. Actavis Labs. Fl, Inc.

Case Name: Tris Pharma Inc. v. Actavis Labs. Fl, Inc., Fed. Cir. Nos. 2017-2557, -2559, -2560, 2018 U.S. App. LEXIS 32774 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, O’Malley, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Sleet, J.) 

Drug Product and Patent(s)-in-Suit: Quillivant® XR (methylphenidate); U.S. Patents Nos. 8,465,756 (“the ’756 patent”), 8,563,033 (“the ’033” patent”), 8,778,390 (“the ’390 patent”), 8,956,649 (“the ’649 patent”), and 9,040,083 (“the ’083 patent”)

Nature of Case and Issue(s) Presented: Plaintiff Tris held the approved NDA for Quillivant XR. Defendant Actavis submitted an ANDA to the FDA seeking approval to market a generic version of that drug. Tris sued Actavis alleging infringement of the patents-in-suit. After a five-day bench trial, the district court found all asserted claims invalid as obvious under 35 U.S.C. § 103. Tris appealed. On appeal, the Federal Circuit found that the district court’s conclusions of law were based on inadequate fact-findings, and therefore vacated and remanded.

Why Plaintiff Prevailed: The Federal Circuit determined that the district court failed to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review. Thus, the Federal Circuit stated that it could not reach the merits of the appeal – whether the Quillivant XR formulation would have been obvious over the prior art.

First, the Federal Circuit discussed the district court’s analysis relating to claims requiring: (i) a single-mean-peak PK profile; (ii) a 45-minute onset of action; and (iii) a 12-hour duration of effect. The court explained that, in holding that one would have expected from the prior art that a single-mean-peak PK profile could provide for rapid onset of action and extended duration of effect, the district court never explained which prior-art references did so and how. The Federal Circuit also faulted the district court for reciting Actavis’s expert’s testimony without being clear if it were making factual findings or merely recounting Actavis’s arguments.

The Federal Circuit further explained that even if it were to interpret the district court’s statements as factual findings, there were still holes in its analysis. For example, the district court never made explicit findings that the references cited taught a 45-minute onset of action or a 12-hour duration of effect. In addition, the Federal Circuit explained that the district court failed to address why a skilled artisan would have been motivated to use a single-peak PK profile to achieve a formulation with a 45-minute onset of action and/or a 12-hour duration of effect with a reasonable likelihood of success. The Federal Circuit therefore concluded that without the requisite factual findings, it could not affirm the district court’s finding of obviousness.

Next the Federal Circuit discussed the district court’s analysis relating to claims requiring a single T_max of about 4 to 5.25 hours and a 12-hour duration of effect. The court agreed with Tris’s argument on appeal that the district court never provided an assessment of the obviousness of a methylphenidate formulation with both an early T_max and 12-hour duration of effect. The court explained that the district court’s analysis with respect to T_max was “cursory” and essentially amounted to a recitation of Actavis’s expert’s testimony. Moreover the district court failed to articulate whether it credited the testimony or explain why or how the testimony supported its conclusion. Further, the district court failed to explain why a skilled artisan would have reasonably expected to achieve a formulation with 12-hour duration and early T_max.

Finally, the court discussed objective indicia of non-obviousness. Tris argued that the district court improperly rejected Tris’s experts’ testimony on unexpected results because it failed to compare the Quillivant XR formulation with the closest prior art. The court agreed with Tris, noting that Tris’s experts compared Quillivant XR to all prior-art products the PK and PD values of which were cited by Actavis. The court explained that while Kao Corp. v. Unilever U.S. Inc., 441 F.3d 963, 970 (Fed. Cir. 2006) stands for the proposition that “when unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art,” there is no rigid requirement that Tris identify and focus on just one piece of prior art. The Federal Circuit held that the district court should have considered Tris’s evidence that its formulation had unexpected properties compared to the known extended-release formulations.

Moreover, the Federal Circuit found the district court’s analysis with respect to the merits of Tris’s unexpected-results argument to be deficient because it addressed only the single-mean-peak PK limitation. The Federal Circuit also found that the district court improperly rejected Tris’s long-felt-need argument because it never identified a product that addressed all three properties (i.e., liquid methylphenidate with a 45-minute onset and 12-hour duration). Thus, the court remanded the issues of unexpected results and long-felt need for further consideration.