French Supreme Court in Finasteride second-medical use litigation acknowledges patentability of dosage regime claims
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| Without the assistance of finasteride, Bob found the Cour de Cassation slightly chilly... |
“The French Supreme Court has put an end to the French Finasteride litigation between MSD and generic manufacturers Teva and Actavis. On appeal, the Paris Court of Appeals had revoked MSD’s second medical use patent including dosage regimen features on grounds of novelty in the dispute against Actavis (though had ruled that such claims are not excluded from patentability in contrast with the first instance ruling), and on sufficiency of disclosure in the dispute against Teva. Sufficiency of disclosure was thus the only legal issue at stake in the case against Teva, while in the case against Actavis, the novelty (and patentability, in cross-appeal) of dosage regime claims was at issue.
On 6 December 2017, the French Supreme Court issued a landmark decision ruling, for the first time, on the requirement for sufficiency of disclosure applicable to second medical use patents. In doing so, it has implicitly confirmed the patentability of dosage regime claims. This decision was a long-awaited. There has not been any decision from the French Supreme Court on the requirement for sufficiency of disclosure applicable to pharmaceutical patents since 1992 and none relating to second medical use claims.
The applicable test for sufficiency of disclosure of second medical use claims is directly derived from the EPO case-law. Indeed, the French Supreme Court used the EPO's very own findings (notably in T-639/95, T-0497/02, T-0609/02, T-0433/05, T-1150/09, T-0338/10, and T-1642/06) to rule that:
The Actavis decision can be found here (in French) and here (in English). The Teva decision can be found here (in French) and here (in English).“Whereas, first, when a claim relates to a further medical use of a substance or a composition, obtaining the therapeutic effect is a functional technical feature of the claim, so that if, to satisfy the requirement of sufficiency, it is not necessary for this therapeutic effect to have been demonstrated clinically, the patent must however, directly and unambiguously reflect the claimed therapeutic application, so that the skilled person understands, on the basis of generally accepted models, that the results reflect this therapeutic application; […] based on these findings, the Court of Appeals was able to deduce that the patent did not directly and unambiguously reflect the claimed therapeutic use and that, in the ignorance of any specific technical teaching, the person skilled in the art was not able to reproduce the invention and was forced to implement a research program, such that claim 1 was insufficiently described, as was claim 2, which is dependent on claim 1 wherein the dosage is 1.0 mg, and claim 3 dependent on claims 1 and 2, in which the treatment is that of pattern baldness”.Although the French Supreme Court declared the Actavis appeal to be moot following the final revocation of the patent in suit after the dismissal of the appeal against Teva, it can be argued that the French Supreme Court has implicitly acknowledged the patentability of dosage regime claims. In the Teva decision, the French Supreme Court repeatedly stressed that the claims in suit concerned a dosage regime. In such a landmark decision on the applicable test for sufficiency of disclosure for second medical use claims (including dosage regime claims), it would have been odd for the French Supreme Court to repeatedly emphasize the nature of dosage regime claims had it actually considered such claims not patentable. This is a great achievement from the French Supreme Court, resolving case-law that had been very unsettled so far on this question."
