DC finding Actavis did not show Tris’ liquid formulation/blood concentration claims obvious affirmed

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc.

Docket No. 2021-1495 (https://cafc.uscourts.gov/opinions-orders/21-1495.OPINION.7-7-2022_1974736.pdf) (Non-precedential)


July 7, 2022

Brief Summary:   DC decision following remand finding Actavis did not show Tris’ claims obvious affirmed (e.g., “unexpected result”, long-felt unmet need). Summary:  Actavis appealed new DC decision (Remand Decision) following remand from a FC 2018 decision (Tris I) vacating a 2017 DC decision for failing “to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review” and inviting it “to reconsider all the evidence of objective indicia in its overall determination of obviousness” (State Indus., FC 1991).  The patents at issue are US 8,465,765; 8,563,033; and 8,778,390 owned by Tris.  The 2017 DC decision held all the claims to be obvious.  In the Remand Decision, the DC “concluded that 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” to render the challenged claims obvious.  Exemplary claims 1, 9 and 10 of the ‘033 patent claims “[a] methylphenidate aqueous extended release oral suspension” that “provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours [extended release] for methylphenidate” and “an area under the curve (AUC) of about 114 to about 180 ng-hr/mL, Cmax of about 11 to about 17 ng/mL, Tmax of about 4 to about 5.25 hours, and T1/2 of about 5 to about 7 hours following a single oral administration of said suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults” (claim 1), “provides a therapeutically effective amount of methylphenidate within 45 minutes after administering of said suspension and a single average plasma concentration peak” (claim 9), and “has a pH from about 4 to about 4.5” (claim 10) (“these properties describe the change in concentration of MPH in the patient’s bloodstream over time…All of the claims at issue require a liquid MPH formulation with a 12-hour duration and single mean peak.”)  Actavis’ arguments are based on five commercially available MPH formulations, a US patent application, and several scientific articles that the DC found disclosed “various subsets of the claim limitations, but no single reference discloses all of the limitations in any given claim”.  The DC concluded obviousness was not shown because, e.g., that the “evidence indicated that a liquid formulation with the claimed pharmacokinetic and pharmacodynamic properties was ‘an unexpected result,’ particularly in light of evidence that there was a ‘long-felt unmet need’ for such a [liquid] formulation.”  Actavis argued in this appeal that the DC “erred in finding no motivation to combine with a reasonable expectation of success” but the FC panel disagreed (e.g., inconsistent evidence, KSR (“there must be ‘a reason’ for a skilled artisan ‘to combine’”, “one of the inventors testified that there was no perceived benefit to having a single peak profile”, DC “reasonably found that the prior art taught away”; long-felt unmet need for liquid formulation; Immunex, FC 2020; Rembrandt, FC 2017).  The DC decision was therefore affirmed.

This entry was posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Obviousness-Teaching Away. Bookmark the permalink.

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