Methylphenidate – USA

Methylphenidate – USA

On Jul. 07, 2022, Federal Circuit affirmed District Court decision and found patents valid.

 

Background: This is a Hatch-Waxman case which involves QUILLIVANT XR (Methylphenidate) oral ER suspension product.  Tris pharma asserted U.S. Patent Nos. 8,465,765, 8,563,033, and 8,778,390 patents against ANDA filer, Actavis. District court held that all asserted claims would have been obvious under 35 U.S.C. § 103. Tris appealed the district court’s decision. On appeal, Federal Circuit remanded back and 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.” On remand, the district court held that Actavis failed to show that the challenged claims would have been obvious. Actavis appealed. You can read the previous decision summaries “here“, “here” and “here“.

 

FC analysis: On appeal, Actavis argued that the district court erred in finding no motivation to combine with a reasonable expectation of success. Federal Circuit said that the district court’s findings are supported by the record and Actavis has failed to show any clear error by the district court. All of the claims at issue require a liquid MPH formulation with 45-minute onset of action, a 12-hour duration and single mean peak. Court said that skilled artisan would not 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. Actavis’ expert testified that a single peak profile did not necessarily correlate with clinical effects, such as the claimed 12-hour duration or 45-minute onset. Similarly, one of the inventors testified that there was no perceived benefit to having a single peak profile. Moreover, prior art taught away from pursuing a liquid formulation with a single peak, 12-hour duration, and 45-minute onset. Early MPH formulations with single mean peak profiles were considered “‘robust failure[s]’ because of their inability to produce an early onset and extended duration effect.” Use of the single mean peak profile therefore can quickly achieve a 45-minute onset but not a 12[-]hour effect, or can achieve a 12[-]hour effect but not an earlier onset.” To achieve both an early onset and longer duration, a formulator would seek a concentration profile with two separate (bimodal) peaks, not single peak.

 

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