Can you protect dosage regimes in France?

The judgment of the Court of Cassation of 6 December 2017, in the case between TEVA and MERCK (patent owner), is the outcome of a long and complex affair concerning the nullity of the French part of the European Patent (EP) n°0724444 describing a dosage regime.

EP 0724444 is a patent for a dosage regime, described in claim 1 as: "The use of 17β-(N-tert-butylcarbamoyl)-4-aza-5-alpha-androst-1-ene-3-one for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg."

Since the decision of the Enlarged Board of Appeal G0002/08 of 19 February 2010, the European Patent Office (EPO) has admitted the patentability of so-called dosage regime claims: “Such patenting is […] not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.”

Two cases in parallel

There is a parallel dispute between ACTAVIS and MERCK (patent owner) over the same patent. In its judgment of 28 September 2010 on ACTAVIS/MERCK, the Tribunal de Grande Instance of Paris diverged from the EPO ruling over patentability of so-called dosage regime claims set out above, on the grounds that: “It is possible to patent a drug to treat a first disease and then a second but not a dosage regime adapted to the treatment of these diseases since in doing so, one tries to patent a therapeutic method that is excluded to belong to the field of care and to depend the only freedom and concomitant responsibility of each doctor".

The Court concluded, therefore, that claim 1, concerning a new dosage in a treatment against alopecia based on finasteride, fall into the exceptions to patentability, ruling: "Claim 1 of patent EP 0724444 whose novelty against prior art lies in the specified dosage is thus excluded from patentability and must therefore be canceled under Article 53c of the CEB 2000 ".

This decision has since been cited in the Guidelines of the French Patent Office, INPI (see page 74). “Dosage regime claim” is one of the examples of a therapeutic method that may be rejected by the Office. To our knowledge, all the decisions by the Tribunal de Grande Instance of Paris on similar cases, have complied with this opinion (see also, for example, TGI PARIS, December 05, 2014, RG 12/1350 or TGI PARIS, 19 juin 2015, RG13/08566).

In parallel to this, in the case TEVA/MERCK, the patent was canceled for lack of description on 9 November 2010.

The two decisions of 28 September 2010 (ACTAVIS/MERCK) and 9 November 2010 (TEVA/MERCK) were both appealed.

On appeal

In January 2015, the Court of Appeal partially reversed the judgment of 28 September 2010 (ACTAVIS/MERCK) and acknowledged that "the patentability of a claim for a second therapeutic indication based solely on a dosage regime characteristic can be accepted" (although, it’s worth noting that the judgement in TGI Paris was confirmed, concerning claim novelty).

In the parallel case, TEVA/MERCK, the Court of Appeal confirmed the judgment of first instance, which cancelled the patent for insufficiency of disclosure.

Two appeals in cassation were then filed by the patentee.

In the context of TEVA/MERCK, the Court of Cassation finally confirmed the nullity of the claims for insufficiency of disclosure in its judgment of 6 December 2017. In fact, the Court found that the description of the patent did not contain an element demonstrating the potential efficacy of the claimed new dosage regime and did not contain any information on the effect and the particular properties of this new therapeutic application that stem only from an arbitrary choice.

Unfortunately, the Court of Cassation did not rule on the exceptions to patentability of the dosage regime claims in the parallel case ACTAVIS/MERCK, the appeal in cassation having been rendered irrelevant by the present decision of 6 December 2017.

The patent is thus definitively annulled on the basis of the insufficiency of the description of claims 1, 2 and 3.

However, there still remains uncertainty as to the exclusion from patentability of dosage regime claims in France, the Court of Cassation having not pronounced on this point. It’s important to note from the ruling, nonetheless, that whatever the claimed invention is, it must be sufficiently disclosed in the sense that it can be carried out by a person skilled in the art.

Novagraaf can assist you in drafting your patent application to ensure this sufficiency of disclosure. Please speak to your patent attorney or contact us below for further information or support.

Adrien Metivet is a Patent Engineer in the Paris offices of Novagraaf