Prevailing as a patentee in France when your patent belongs to the chemical or pharmaceutical field is extremely difficult. I will in fact provide some figures on this matter soon.
More often than not, patents are skinned alive by the court – and, bad pun intended, even dermatology is not spared, as the present case shows.
Dermaconcept JMC is a French company active in the pharma / cosmetology business. It owns a French patent No. FR 2823671 as well as a European patent No. EP 1404327 claiming the priority of the French patent. Noreva-Led is their exclusive licensee, which markets the brand of products Actipur, for the treatment of acne skin and atopic dermatitis.
Together, they initiated legal proceedings against Laboratoire Bioderma in December 2014. Laboratoire Bioderma, later merged into Naos, was accused of infringing the above patents through their product Atoderm Intensive.
In May 2016, both patents were limited at the INPI (Institut National de la Propriété Industrielle) after record-breaking 8-day long proceedings. It is reasonable to assume that this limitation came as a reaction to Naos’ initial invalidity arguments.
The limitation was however apparently not good enough for the Paris Tribunal de grande instance (TGI), as the asserted claims were found invalid in spite.
The court started by throwing out claim 9 of the French patent.
In principle, when there are both a French patent and a European patent claiming the priority of the French patent, the effects of the former cease at the end of the opposition period (assuming that no opposition is filed against the European patent, as was the case here). See article L. 614-13 Code de la propriété intellectuelle (CPI). But this is traditionally believed to be true only insofar as both patents cover the same invention.
Here, claim 9 of the French patent is directed to
A method of cosmetic treatment characterized in that it consists in applying a composition based on nicotinic acid or nicotinic acid amide, and a sphingoid base according to any one of claims 2 to 7 on exposed areas, the composition being of the emulsion type.
As this claim is not present in the European patent, it survives in the French patent. Or rather, survived – until it got revoked by the court, that is.
Article L. 611-16 CPI is worded in a manner very similar to article 53(c) EPC, and it inter alia prohibits patents on methods of therapeutic treatment.
Referring to the description of the patent, the court noted that the composition at stake is meant to treat acne and atopic dermatitis, which are diseases of the skin.
Therefore, the method is not merely cosmetic but also therapeutic, since it does entail a therapeutic effect:
In this respect, the mere mention that the field of the claim is intended to cover only the cosmetic effect is not sufficient to shield this claim from the prohibition of article L.611-16 CPI, since the therapeutic effect is in fact inseparable, and actually is expressly presented as one of the advantages of the invention in the patent description. Therefore, the fact that this method produces an aesthetic effect on the skin, namely a fairer and smoother skin, is not sufficient to shield it from the prohibition of abovementioned article L.611-16 since this effect is only the consequence of the therapeutic treatment of the composition which reduces the presence of blackheads on the skin.
The court also noted that a very similar claim was deleted from the European application before grant, as the European examiner had raised the same objection. I emphasize this, as it is not everyday that a French court feels bolstered by the opinion of an EPO examiner.
Next up were claims 1 and 10 of the French part of the European patent – as limited in front of the INPI – which are respectively a product claim and a Swiss-type claim.
Claim 1 reads as follows:
A dermatological composition useful for the treatment of atopic dermatitis, characterized in that it comprises, in combination, nicotinamide (vitamin PP), and at least one sphingoid base selected from phytosphingosine, tetraacetylphytosphingosine, N-acetylphytosphingosine, and phytosphingosine hydrochloride.
Claim 10 is directed to:
The use of nicotinamide (vitamin PP), and of a sphingoid base according to claim 1, for preparing a medicinal product for the treatment of atopic dermatitis.
Both claims fell for lack of inventive step.
The closest prior art was found to be a Procter and Gamble (“P&G“) PCT application No. WO 99/47114. Claim 1 of the P&G reference discloses a skin moisturizing composition comprising a vitamin B3 compound and a ceramide pathway intermediate or precursor thereof. Other passages of the document disclose that the vitamin B3 compound can be selected from a list comprising nicotinamide, and that the ceramide intermediate or precursor can be selected from a list comprising some sphingoid bases, including e.g. sphingosine.
Interestingly, the P&G reference does not explicitly mention phytosphingosine or its derivatives, recited in claim 1 of the European patent. As far as I understand, phytosphingosine is a compound which is different from sphingosine.
But the P&G reference contains the following statement:
Ceramide pathway intermediates or precursors are discussed in detail in U. S. Patent 5,578,641 to Simon et al. and U. S. Patent 5,610,040 to Smeets et al., both of which are herein incorporated by reference.
And it turns out that phytosphingosine is recited as a preferred ceramide pathway intermediate in US 5,578,641.
The court considered that the teaching of this U.S. patent completes the explicit teaching of the P&G reference, so that:
The [P&G reference], the purpose of which is to provide a composition activating and increasing the rate of ceramide synthesis and to provide improved methods of skin moisturizing […] already discloses the composition mentioned in claim 1 of the EP’327 patent, with the additional remark that […] the synergistic effect of the combination was already known.
In other words, the court relied on the incorporation by reference of US 5,578,641 in the P&G reference in order to determine its overall teaching.
As a next step, the court stated:
It remains to be determined if it was obvious for the skilled person to use this combination to solve the problem at stake, i.e. treat atopic dermatitis.
Thus, the only difference between the claims at stake and the teaching of P&G was the fact that the composition is used for treating atopic dermatitis.
This means that the court fully took into account the therapeutic purpose recited in product claim 1 (“a dermatological composition useful for the treatment of atopic dermatitis“) as well as in Swiss-type claim 10 (“for preparing a medicinal product for the treatment of atopic dermatitis“).
This finding is rather logical but not so straightforward given the (past?) tendency of French courts to come up with unconventional claim constructions especially when therapeutic inventions are at stake.
Going back to the final step of the inventive step reasoning, the court noted that atopic dermatitis, as set forth in the patent in suit, is known as being related to an alteration of the barrier function of the skin.
The P&G reference itself mentions that the composition improves said barrier function.
The court then turned to a secondary reference, Korean patent application No. KR 2000-0024485, specifically concerned with the treatment of atopic dermatitis. It is explained in the document that atopic dermatitis is related to skin dryness, wherein skin moisturizing is significantly reduced, which impairs the barrier function. The Korean document adds that nicotinamide increases lipid synthesis in the skin, therefore supporting the barrier function of the skin and curbing atopic dermatitis.
The court thus concluded:
It can be derived from this that the skilled person, knowing the effects of the combination comprising a vitamin B3 compound and a ceramide precursor on skin moisturizing, looking for a way to alleviate the effects of atopic dermatitis, and knowing that the latter is characterized by skin dryness and impairs the barrier function thereof, but also that nicotinamide strengthens this barrier function and that its combination with an intermediate or precursor of ceramide synthesis produces an amplified effect on the ceramide synthesis properties of vitamin B3 compounds, would use this same combination for the treatment of atopic dermatitis without exercising any inventive step.
Claims 1 and 10 were thus declared invalid, and the infringement claims were not examined.
Whether the judges got it right or not, at least the decision looks well reasoned and in line with European case law.
One reservation, though, is that there is no discussion in the judgment as to whether P&G was a proper starting point for the inventive step reasoning at all, despite the fact that the claimed therapeutic purpose was not mentioned in the document.
This point may not have been raised by the nullity defendants. And it may not be a big deal anyhow. It can be surmised that a similar reasoning of lack of inventive step could have been made starting from the Korean application (which is concerned with atopic dermatitis) and combining it with P&G.
CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, July 7, 2017, Dermaconcept JMC & Laboratoires Nora-Led v. Naos, RG No. 15/00069.