Halobetasol & Tazarotene – USA

Halobetasol & Tazarotene – USA

On Dec, 01, 2022, New Jersey court found halobetasol patents valid in a Hatch-Waxman suit.

 

This case concerns patents related to the pharmaceutical products Duobrii® (halobetasol propionate & tazarotene) and Bryhali® (halobetasol propionate (HP)). Padagis filed ANDAs to produce generic versions of these pharmaceutical products. Plaintiff Bausch Health sued Pedagis for infringement of US 10,251,895; US 10,426,787 (“Combination Patents”), and US 8,809,307; US 10,478,502 (“HP Patents”). The parties have stipulated to infringement of the claims at issue. However, Padagis contends that the asserted patent claims are invalid, pursuant to 35 U.S.C. § 103 and the definiteness requirement of 35 U.S.C. § 112.

 

As of the Priority Date for the HP Patents, HP was known in the art as a topical treatment for psoriasis and was commercially available as branded product Ultravate at a concentration of .05%. This superpotent corticosteroid medication was known to have the potential to cause serious systemic side effects, including HPA axis suppression, if too much steroid penetrated a patient’s skin and entered the bloodstream. As of 1995, the FDA-approved label for Ultravate warned that it should not be used for more than two weeks. As of the Priority Date for the HP Patents, an important problem to the POSA was that many psoriasis patients need topical treatment for longer than two weeks, but, because of the systemic side effect of HPA axis suppression, Ultravate could not be used for longer than two weeks (superpotent corticosteroid duration (SCD) problem).

 

Court said that POSA attempting to solve the SCD problem would not have been motivated to reduce the risk of systemic side effects with topical corticosteroids by lowering the concentration of the steroid in the formulation,
since the POSA would have expected that such a change would reduce efficacy. Moreover, the Blum reference teaches that a .02% HP formulation is less effective for the treatment of psoriasis than a .05% HP formulation. Blum reference thus taught away from using .02% HP for the treatment of psoriasis and would have motivated a POSA to use a .05% HP formulation for maximum efficacy. The next problem in Defendants’ case for the obviousness of the HP Patents concerns the selection of diethyl sebacate as a solvent. Other references teach the use of solvents to enhance skin penetration of topical corticosteroids and thus it would increase the concentration in the blood. Therefore, there was no expectation of success in lowering the concentration of halobetasol. The safety and efficacy of Bryhali® was an unexpected result and it solved long-felt but unmet need of SCD problem. Padagis has failed to prove, by clear and convincing evidence, that the claims of the HP Patents at issue are invalid as obvious. With respect to combination patents, court said that the evidence presented does not demonstrate that, a POSA would have reasonably expected the claimed combination to manifest the properties of synergistic efficacy and synergistic reduction of at least an adverse event, within the meaning of “synergistic” used in the Combination Patents. Padagis has not demonstrated that the claimed synergy limitations are properties of the composition or treatment method that would have been reasonably expected by a POSA as of the Priority Date. The significance of this determination is that Padagis has failed to demonstrate that the synergy limitations of the combination patent claims at issue are inherent and obvious.

 

Also, Padagis did not prove, by clear and convincing evidence, that any claims in the HP Patents containing the term, “liquid oil component,” are invalid for indefiniteness. Nor did Padagis prove, by clear and convincing evidence, that the “claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform with reasonable certainty, those skilled in the art about the scope of the invention.”

 

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