French Supreme Court rules on patentability and validity of dosage regime claims
Sets out the conditions under which a dosage regime may be patented
14 December 2018
On 6 December 2017, the French Supreme Court ("Cour de cassation") put an end to the very long saga involving Merck Sharp & Dohme Corp.'s ("MSD") "Finasteride" molecule used to cure male pattern baldness.
The long awaited judgment of the Cour de cassation, rendered in the MSD v Téva Santé case, is remarkable for two main reasons. First, it admits - though implicitly - the patentability of dosage regime claims. Second, it provides the tools to understand in which circumstances a second therapeutic application based on such new dosage regime can be protected by a patent.
Patentability of dosage regime claims
On the basis of the provisions of Articles 53 c) and 54(4) of the European Patent Convention ("EPC"), pursuant to which a second therapeutic application can be patented if it is new to the state of the art, the European Patent Office ("EPO") had admitted in 2010 the patentability of a second therapeutic application based on a dosage regime change .
However, until now, the position of French judges in this respect remained unclear. The Paris Tribunal de Grande Instance - having exclusive jurisdiction in patent cases as a first instance court - was more than reluctant to follow the patentability trend. Indeed, it considered that a dosage regime did not constitute a first or second therapeutic application but was rather the mere indication of the range in which the substance is efficient to actually cure the disease in respect of the tests described in the patent. In a highly debated judgment dated 28 September 2010 , concerning Finasteride in the MSD v Actavis case, the Tribunal de Grande Instance ruled that "Article 54(4) EPC (…) is completely silent on the allowability of patenting a particular posology. Accordingly, the answer of the Enlarged Board according to which 'such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art' does not arise from the Convention but from an interpretation of what is a posology, i.e. a further medical use, which it is obviously not."
The Paris Court of Appeal made a definitive first step towards the admission of dosage regime patents by ruling in the same MSD v. Actavis case that "the patentability of a further medical use claim relying only on a posology feature may be allowed" . Still, by eventually declaring the patent invalid on the ground of insufficient disclosure in the MSD v. Téva Santé matter – and thus moving the debate from unpatentability to invalidity - the French Supreme Court definitively paved the way towards full recognition of dosage regime claims patentatibility.
Standard for sufficiency of disclosure
Though dosage regime claims appear to no longer be excluded from patentatibility per se, said claims must nevertheless meet the usual validity requirements of novelty, inventive step and sufficiency of disclosure.
In this respect, the second interesting point of the Cour de cassation judgment is that it lays down the principles on the sufficiency standard to be applied to second medical use inventions.
The court ruled that "when a claim relates to a second therapeutic application of a substance, obtaining this therapeutic effect is a functional technical feature of the claim. [Thus], in order to meet the requirement of sufficiency of disclosure, it is not necessary to clinically demonstrate this technical effect [As MSD did], but the patent application must directly and unambiguously reflect the claimed therapeutic application, so that the skilled person can understand, based on commonly accepted models, that the results reflect this therapeutic application". In the case at hand, the Court ruled that, since the patent description mentioned a "surprising and unexpected discovery" - without describing precisely the particular pharmacological action of the regime - the skilled person was not in a position to reproduce the invention without making further research on his own. In other words, for the dosage regime claim to be considered as sufficiently disclosed, it must be described precisely enough to allow the skilled person to manufacture the drug himself with the right dosage to obtain the very same therapeutic effect.
This rather strict standard – which subtly distinguishes "clinical demonstration of technical effect" from "direct and unambiguous reflection of the claimed therapeutic application" and is directly inspired by the case-law of the European Patent Office in this respect , might often lead to invalidity decisions when it comes to dosage regime claims. Only time will tell what awaits.
Key Take-Away Points
- There was some uncertainty in France regarding whether or not a substance or composition known as a "medicament" for treating a certain illness could be patented for use in treating the same disease, where the second or further medical use is based on a novel dosage regime.
- For the first time, the French Supreme Court has admitted, though implicitly, the patentability of dosage regime claims
- Claims should still meet the validity requirements of novelty, inventive step and sufficiency of disclosure.
- The standard for a dosage regime claim to be considered sufficiently disclosed is quite strict. Although it is not necessary to clinically demonstrate the therapeutic effects of the dosage regime, the patent must reflect directly and unambiguously the claimed therapeutic application.