• Mar 28 2019
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  • Category: CAFC Updates

Alkem and Hikma appeal the judgment of the district court that U.S. Patent No. 7,994,364 relating to the Form A polymorph of tapentadol hydrochloride and a method of treating pain and/or urinary incontinence is not invalid for obviousness or lack of utility. Grünenthal and Assertio cross-appeal the finding that Hikma and Actavis do not infringe U.S. Patent No. 8,536,130 which describes a method of using tapentadol and tapentadol hydrochloride for the treatment of polyneuropathic pain. The case for indirect infringement depended on the proposed label indications.  However, the CAFC agrees that the labels do not implicitly or explicitly encourage or instruct users to take action that would inevitably lead to use of tapentadol hydrochloride for treatment of polyneuropathic pain, so there was no clear error in the district court’s finding of no induced infringement. With respect to contributory infringement, a patent owner must show, inter alia, that there are no substantial non-infringing uses for the accused product. In determining whether the non-infringing uses identified are “substantial,” the district court weighed the testimony of all experts in this case and although there appears to be evidence supporting both positions, the court made credibility determinations that supported the theory of non-infringement and the CAFC saw no reason to disturb those findings. Regarding obviousness, the CAFC finds that the district court did not clearly err in finding that a POSA would not have had a reasonable expectation of successfully producing Form A, as claimed in the ’364 patent, by using the methods outlined in the prior art on the compound disclosed in the ’737 patent (Form B) because, inter alia, there was (1) no known or expected polymorphism of tapentadol; (2) no evidence that the synthesis of Example 25 of the ’737 patent results in any Form A; and (3) no guidance as to what particular solvents, temperatures, agitation rates, etc., were likely to result in Form A.  Accordingly, the CAFC affirms.

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