I am happy to introduce another contribution by Lionel Vial to this blog, for a new update on the war waged by French courts on second medical use claims. Today, Lionel tells us about one such claim which bravely survived a first instance judgment, only to be later butchered on the appeal battlefield:
It is often tempting to rule out of hand seemingly makeshift arguments but the decision we discuss today is a reminder of why it is always a bad idea to do so. It is also yet another reminder that it is not easy to be Swiss in France nowadays.
The decision in question was rendered by the Cour d’appel de Paris on November 3, 2015 (Ethypharm SA v. Alkermes Pharma Ireland Ltd.). It notably dealt with the appeal of Ethypharm against the decision of the Tribunal de Grande Instance (TGI) de Paris of December 21, 2012 to uphold claim 9 of European patent EP 0644755 (the ‘755 patent), which Ethypharm was found to infringe.
The ‘755 patent was filed on June 1, 1993 and was granted on March 19, 1997, i.e. well before the entry into force of EPC 2000. Accordingly, claim 9 is under the form of a so-called Swiss-type claim (i.e. “use of a substance or composition X for the manufacture of a medicament for therapeutic application Y”). It reads as follows:
The use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.
It can be seen that the scope of the claim is rather extensive as it basically covers any process of manufacture of a medicament with particles of a drug substance (different from naproxen or indomethacin) having an average size of less than 400 nm, thanks to the use of a surface modifier which adsorbs onto the drug substance, for increasing the speed with which the substance will exert its activity upon administration.
While all the arguments set forth against the validity of the claim had failed in the first instance, in the course of the second instance Ethypharm found a new motive to be opposed to the validity of claim 9, namely that the claim would cover a method of treatment of the human or animal body and that it would be therefore excluded from patentability.
According to Ethypharm, this would be because claim 9 does not relate to a specified substance or composition but relates to all existing active substances without specifying their therapeutic use, since it covers the use of nanoparticles of any medicament for treating any disease, any patient, by any administration route and with any dosage.
The patentee, Alkermes, made the mistake of not offering any counter argumentation.
In this regard the Court first notes, somehow ironically, that Alkermes apparently intended to respond to the argument, in view of the following statement in their written submissions:
To conclude, we will say a word on the argument of “revocation of claim 9 because it relates to a method of treatment” a last resort makeshift which replaced the equally exotic argument of “nullity of the further medical use claim”.
However, nothing of the sort could be found by the Court in the rest of these written submissions.
This proved to be fatal in the present case, because the argument surfed on the French courts’ supercilious approach to claims liable to cover methods of treatment (see our previous posts here and there) and was thus found to be persuasive by the Court:
[…] In application of that text [i.e. EPC 1973] a European patent can be granted for any further medical use of a known substance or composition, provided the claim is drafted under the so-called “Swiss-type” form, of the use of a product for obtaining a medicament used in a novel therapeutic application;
[…] It is thus necessary that a determined specific substance has a new therapeutic use which is distinct from the state of the art, since a simple claim to a method relating to a therapeutic treatment is not patentable;
[…] In the present case claim 9 of the patent at stake relates to any drug substance, with the only exceptions of naproxen and indomethacin, already taught in the state of the art, with the sole aim of hastening the onset of its action upon its administration to a mammal;
[…] When reading the claim, it appears that it relates to no known determined substance or composition with the view of obtaining a medicament for a novel and determined therapeutic use;
[…] Indeed the claimed hastening of the onset of the action of the medicament is only a mode of action of a medicament, which is by the way undefined, and cannot be considered as a therapeutic use of this medicament;
[…] Accordingly claim 9 only teaches a hastened mode of therapeutic treatment applying to any drug substance (naproxen and indomethacin being excluded) for treating any disease and applying to any patient, whatever the mode of administration of the drug and its dosage;
[…] As a consequence the claim will be revoked […].
The Court thus considered that although it was in the form of a Swiss-type claim, the fact that neither (i) the drug substance nor (ii) the therapeutic use were specified meant that claim 9 was to be considered as covering a method of treatment.
However, with this reasoning it appears that the Court merely assimilates Swiss-type claims to further medical use claims according to Article 54(5) EPC 2000, thereby casting aside the literal sense of Swiss-type claims, which is to cover a process for the manufacture of a medicament. As a reminder, in decision G 5/83, the Enlarged Board of Appeal of the EPO ruled that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.
Accordingly, the sanction for a Swiss-type claim which is found not to benefit from the special approach of novelty defined in decision G 5/83, for instance because the claim does not relate to a specified therapeutic application, should rather be to consider that the intended therapeutic use is not limiting. This approach is notably illustrated by decision T 1758/07 (see paragraph 3.4.3).
Applied to the present case, the finding of the Court according to which the hastening of the onset of the action of the medicament cannot be considered as a therapeutic use could thus have led to reformulating claim 9 as the use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament suitable for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.
Incidentally, this would also have had the valuable advantage of doing without the rather confusing notion that a claim found not to relate to a therapeutic use could be considered at the same time to cover a method of treatment.
Thank you Lionel for this report. As already mentioned in last week’s post, the TGI and the Cour d’appel are quite strictly bound by the (written) submissions of the parties. So, not every surprising ruling can be blamed on the courts themselves.
As a postscript I would also like to bring the first instance decision to readers’ attention.
One issue that was discussed in this decision was the admissibility of the disclaimer “with the proviso that the drug substance is other than naproxen or indomethacin” in claim 9. This “undisclosed disclaimer” was introduced to distinguish the claimed invention from a prior art under Art.54(3) EPC. The TGI applied the test set out in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal (without quoting those) and held that the disclaimer passed the test and was allowable. This issue is not addressed again in the appeal ruling since the claim was found invalid on another ground.
I thought that some readers irritated by the marked deviation of French case law from EPO case law on the topic of patent eligibility might find solace in this remarkable illustration of consistency.
CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, November 3, 2015, Ethypharm SA v. Alkermes Pharma Ireland Ltd., RG No. 2012/23743.