Catégorie : SPC

“Ezetimibe case” in France: PIs and almost 4,5 million provisional damages (Paris High Court, MSD vs. Mylan, March 7, 2019)

Mylan commercialized a generic form of ezetimibe/simvastatin and introduced a revocation action against SPC n° FR05C0040. SPC n° FR05C0040 covers the combination Ezetimibe/Simvastatin, which is used for the treatment of dyslipidemia.

MSD raised a “procedural issue” (i.e. “incident de procédure”) in order to ask for PIs and provisional damages immediately (i.e. before the end of the case on the merit).

The Paris High Court issued its decision on March 7, 2019 (here).

As such, a product which is a combination of active ingredients pursuant to the first article of regulation (EC) No. 469/2009, necessarily relates to the invention covered by the patent if each of these ingredients is specifically identifiable according to the claims of the patent, without it being necessary that the second active ingredient of the combination be a new compound taught by the patent and protectable on that basis.

In this regard, in view of the GILEAD decision, the Court of Justice of the European Union does not require that the active ingredients, the combination of which is intended, should be an invention of the basic patent, provided [these ingredients] are identifiable. [The Court] only holds that the combination must necessarily relate to the invention covered by that patent.

This thus applies to a novel composition relating at least to an active ingredient taught by the patent.

[…]

Claim 17 of the patent relates to a pharmaceutical composition of claim 16 (which relates to the pharmaceutical composition according to any one of claims 9, 12 or 15 wherein the cholesterol biosynthesis inhibitor is selected from a group consisting of CoA reductase from HMG), wherein the cholesterol biosynthesis inhibitor is selected from the group to which simvastatin belongs.

The ezetimibe/simvastatin combination, which is thus taught, is therefore necessarily part of the invention resulting from the basic patent, the simvastatin being specifically identified by the patent.

The product marketed under the trademark INEGY, which is a combination of the active ingredients of ezetimibe and simvastatin, therefore appears « protected by a basic patent in force », within the meaning of Article 3(a) of the Regulation (EC) No 469/2009.

It is reminded that under Article 3 (c) of this Regulation, the SPC may only be issued if the product has not already been the subject of a certificate.

However, at the time that ezetimibe alone was marketed under the trademark EZETROL under SPC No. 3C0028, the combination ezetimibe/simvastatin was not subject to a SPC.

Also, at the time the application was made, the product resulting from this combination had not been the subject of a previous SPC.

The condition laid down in Article 3(c) of Regulation (EC) No 469/2009 therefore also appears to be fulfilled.

Thus, two months after the Darunavir case, the Paris High Court granted (once again) PIs based on a SPC. Once again, the Court held a comprehensive interpretation of the CJUE on SPCs. Last but not least: almost 4,5 million provisional damages are granted (after more than 13 million in Novartis vs. Teva last year).

The case seems worse here than in the other cases, because we cannot lodged an appeal against a decision ruling a procedural issue. Mylan will have to wait till the end of the case on the merit in order to be able to challenge this decision.

This recent case law is clearly more favorable than before to rights holders (especially for Pharma-patents and SPCs) and generics manufacturers should rethink their commercialization/revocation strategies in France.

Is it possible to attack a SPC though an administrative procedure in France?

 

Third Parties Observations (TPOs) during SPC examination?

French Law does not provide for TPOs during the SPC examination procedure. As such, the French IP Office (i.e. INPI) rejects TPOs.

Still, it is common practice to file such a TPO because:
– we assume that it could unofficially influence the examiner;
– it is costless (approx. 1 k).

We do not have a definite knowledge of the impact of TPOs during the SPC examination procedure. Only assumptions can be made.

No special formal requirements have to be respected as TPOs are not provided by Law.

 

Appeals against a granted SPC?

Appeals against decisions issued by INPI are generally supposed to be lodged with the Paris Court of Appeal.

In a related domain, a number of third parties have thus tried to challenge decisions of limitation of patents in front of the Court of Appeal, by directly appealing these decisions. But they lost and their appeal being deemed inadmissible. The Paris Court of Appeal has always held that challenges against the limited claims must be brought in the context of a nullity lawsuit. This means that the Paris High Court (i.e. Tribunal de grande instance de Paris) has an exclusive competence for challenges on nullity grounds and that it is therefore impossible to do so before the Court of Appeal (see e.g. Free and Avery Dennisson cases). A contrario, according to this caselaw, an appeal against a decision issued by INPI, which is not founded on nullity grounds, could be admissible (in patent cases and a fortiori in SPC cases).

Therefore, it would be possible to attack a granted SPC on administrative grounds, since the plaintiff does not invoke nullity grounds.

There is no reason to consider that such an administrative proceedings would not succeed provided that:
– the appeal is not founded on a nullity ground;
– the plaintiff has standing, i.e. he can prove his interest to taking legal action (e.g. with an application for a marketing authorization).

This brief paper results from a joint thinking with my friend Lionel Vial.

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