This is not a pipe

A regular patent law blogging activity comes with a number of serious pitfalls. Rambling may be one of them.

I hope readers will amicably warn me if this blog ever gets there – unless this point has already been reached?

A couple of weeks ago, when commenting on the recent pemetrexed decision of the Paris TJ, I lamented that French courts have a tendency to rely on the detailed choice of words in the description of a patent to draw dramatic conclusions concerning its scope of protection – either to restrict it or to broaden it beyond the literal wording of the claims.

I would like to continue this conversation today, but with a different perspective, namely an SPC angle; the case I would like to look at is the latest judgment in the Inegy® litigation (already reported on by others here and there).

Merck Sharp & Dohme Corp. (MSD) owns SPC No. FR05C0040 (FR’040) based on European patent EP 0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin”. The originator’s product has been marketed as Inegy®.

At least four different lawsuits have taken place in France concerning this SPC, some of which have already been mentioned on this blog:

  • One involving Biogaran. MSD’s request for preliminary injunction was rejected in April 2018, and this rejection was confirmed in June 2018 (see this post), the reasons being that the SPC appeared to be invalid.
  • One involving Mylan and one involving Sandoz, in parallel. Here, MSD surprisingly obtained a preliminary injunction in March 2019 (see this post). This was however overturned on appeal in February 2020 (see this post), as the SPC appeared to be invalid.
  • One involving Teva, not yet mentioned on this blog.

Teva launched a generic version of Inegy® in April 2018 and initiated nullity proceedings against EP’599 and the FR’040 SPC. What was still known as the Paris TGI at that time rejected Teva’s nullity claim in October 2018, on the merits this time. By the way, this could be why a preliminary injunction was initially ordered against Mylan and Sandoz in March 2019 although it had been previously denied with respect to Biogaran in April-June 2018 (this piece of the puzzle was missing the last time I wrote on this topic).

Today’s decision is the ruling by the Paris Cour d’appel on Teva’s appeal against the October 2018 judgment. The first instance judgment has now been overturned, and the Cour d’appel has declared the FR’040 SPC invalid – consistently with its previous rulings of June 2018 and February 2020, but this time on the merits.

In the decision, the court rejected Teva’s objections to the validity of the basic EP’599 patent, but entertained Teva’s claim that the SPC itself is invalid under articles 3(a) and 3(c) of the SPC regulation. The reasoning is mostly in line with the February 2020 ruling already discussed here, so I may as well be brief.

EP’599 specifically claims:

  • a very broad family of compounds in claim 1 (in the form of a Markush formula);
  • ezetimibe as a specific compound in dependent claim 8; and
  • a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of the above compounds, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).

As a reminder, the FR’040 SPC is directed to the combination of ezetimibe and simvastatin.

The test of article 3(a) of the SPC regulation is whether the product was protected by the basic patent; and the test of article 3(c) of the SPC regulation is whether the product protected by the basic patent had already been the subject of a certificate.

In this case, MSD had already obtained an earlier SPC (No. FR03C0028) for ezetimibe itself.

The court reviewed the relevant case law of the CJEU, placing special emphasis on Sanofi, also known under the name of the other party, Actavis (C-443/12). In that case, based on a same patent, Sanofi had obtained a first SPC on the drug irbesartan based on a first MA, and then a second SPC on the combination of the drug irbesartan with a diuretic substance, HCTZ, based on a second MA. The CJEU ruled that, in this case, the grant of the first (mono) SPC prevented the grant of the second (combo) SPC.

The court found that the facts of the present case are very close to those of Sanofi – which, I think, is quite convincing.

Merck countered that, in Sanofi, the second compound HCTZ was not explicitly recited, only the therapeutic class (diuretics) was. But the court cited paragraph 30 of Sanofi: “it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent“. The court deemed that this reasoning applies in the present case.

Merck relied on two more recent CJEU rulings, namely Gilead (C-121/17) and Royalty Pharma (C-650/17), but the court found that these concern different situations and are not applicable.

The court then investigated “whether, from the perspective of the skilled person, based on common general knowledge at the filing date of the basic patent, and in the light of the description used to interpret the claims, according to article 69 EPC and its interpretative protocol, the product of the combination of ezetimibe and simvastatin, which is the subject-matter of the second SPC, is a product different from ezetimibe alone, protected by the patent as such“.

The court then turned to the description of the patent. Here is the central part of the reasoning:

The description of the patent, which uses the singular form to designate the invention, and uses the formulation “in yet another aspect” to present the combination of a hydroxy-substituted azetidinone, which is the subject-matter of the invention, with a cholesterol biosynthesis inhibitor, indifferently refers for hydroxy-substituted azetidinones alone and for their combination with a cholesterol biosynthesis inhibitor, to an effect “for the treatment and prevention of atherosclerosis or for the reduction of plasma cholesterol levels” without any indication of the specific therapeutic effect that distinguishes the product composed of ezetimibe alone from that comprising the combination of ezetimibe and a cholesterol biosynthesis inhibitor such as simvastatin. Therefore, the skilled person, who was aware in the prior art of the possibility of combining two anticholesterolemic drugs having different mechanisms of action (paragraph 8 of the patent – an HMG CoA reductase inhibitor and a bile acid sequestrant), and who was familiar with statins, and in particular simvastatin, which have been commonly used since the late 1980s for the treatment of hypercholesterolemia, will not consider that the combination of ezetimibe with simvastatin, or with the 9 other active ingredients also covered by claim 17 (in particular atorvastatin, for which Merck, on the basis of the same reasoning, filed a third SPC on September 12, 2014), constitutes a distinct product protected by the basic patent as such.

The underlying idea is that there is only one invention in the patent, namely ezetimibe itself (or the other compounds of the same class). The combination of ezetimibe with another, well-known, anticholesterolemic drug, is not patentably distinct from that invention, I would say (using U.S. vocabulary).

The court’s conclusion, as far as it is based on a review of the therapeutic effect of the products at stake, and of the actual contribution of the basic patent to the art, seems to make a lot of sense.

There is one portion of the reasoning that I do not feel comfortable with, though, namely the first part of the paragraph, in which the court pays attention to the expressions “the invention” (singular) and “in another aspect” – which, to me, do not really mean anything one way or the other.

Every patent attorney, sometimes every firm, has their own drafting style. This should have no impact on the extent of monopoly granted to a patent proprietor.

Let’s take an example. Imagine that, in the EP’599 patent, the combination of ezetimibe with another anticholesterolemic drug had been presented as being “a second invention“, or “a number of further inventions“. Should this have made a difference? Of course not. Simply naming a product as a distinct invention does not make it so.

“This is not a pipe” – can words change reality?

My fear is that some patent owners may take advantage of the judges’ over-reliance on contingent aspects of the specification to unduly extend the scope of their legal monopoly. Conversely, some may be hurt by innocuous, if unfortunate, syntactic structures.

Going back to the judgment at hand, the court decided that the case was clear and that there wasn’t any need for a reference to the CJEU. The FR’040 SPC was thus formally revoked.

According to reports published on other blogs, this is not the end of the story yet, as a final appeal in front of the Cour de cassation is already pending, at least in connection with the refusal to grant a PI against other generic companies. Presumably, this judgment is also going to be appealed.

As a final note, this seems to be one of these instances of fragmented European landscape. The decision acknowledges that preliminary injunctions have been granted and sometimes confirmed on appeal in Norway, the Czech Republic, Portugal, Belgium and Austria; and have been rejected (with sometimes a confirmation on appeal) in the Netherlands, Germany and Spain.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, September 25, 2020, SAS Teva Santé et al. v. Merck Sharp & Dohme Corp., RG No.18/23642.