Catégorie : Patent Law

“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.

The reasons why you should choose France for IP Litigations


The French IP judicial system offers significative advantages that are, most of the time, still not well known around the world. Let’s see very briefly some of these advantages.



The saisie-contrefaçon allows the holder of an intellectual property right, upon receiving the authorization of a judge, to call upon a bailiff (in certain cases, a police commissioner or a judge) to collect evidences of an infringement at the infringer place.

  • ex-parte proceedings;
  • evidences can be used for proceedings abroad;
  • you can execute it as soon as you obtained the authorization;
  • you must file a summons during the month following the saisie.


Preliminary Injunctions

French Courts granted the highest number of PI last year.


  • you just need to bring a “reasonable evidence” of the infringement
  • you can obtain provisional damages (more than 13 million in a pharma case in 2016).
  • Preliminary injunctions could be ordered very fast and ex parte:
  • Protective briefs do not exist under French law. 

See here our detailed article about this topic.


Legal costs

No Court Fees.

The legal costs can be recovered in significant part (we obtained more than €1.000,000 in a pharma case in 2016).

Moreover, in patent litigation, the attorney fees are eligible to the research tax credit (crédit d’impôt recherche).


Specialized Courts

The Paris High Court has an exclusive competence for hearing disputes concerning Patents, Community Designs and Community Trademarks.

This specialization offers better decisions (and especially credible around Europe) and legal certainty about the results you can obtained.

Should we prefer Germany or France for Preliminary Injunctions in IP cases?

In the recent past, preliminary injunctions (“PI”) were almost impossible to obtain before French jurisdictions. But during the last year Paris High Court (i.e. Tribunal de Grande Instance”) granted PI in three patent cases (Minakem v. Melchior and M2I, Novartis v. Teva, Searle v. Sandoz). In Novartis v. Tevathe Court also granted more than 13 million Euros as provisional damages. At the same time, PI are more and more difficult to obtain in Germany. This is all the more interesting when a litigation is cheaper in France than in Germany (no court fees and lawyers’ fees are cheaper). Is it time to change pan-European IP litigation strategies? Perhaps. But let’s compare German and French PI systems: requirements (1), proceedings (2) and results (3).

1°) What are the requirements?

In both countries, the claimant must should demonstrate an infringement or an imminent infringement. However, the requirements seem stricter in Germany (a) than in France (b)

a) Germany

German courts usually require that infringement can be established « without difficulty« or they use similarly restrictive language. For this reason, concerning a patent infringement, it is unlikely that a preliminary injunction will be issued, if infringement can only be established by expert testimony which is usually the case when only equivalent infringement is alleged. As a general rule the infringement has to be obvious from the accused device itself. It is, however, permissible (and in many cases advisable) to provide the court with expert reports in order to illustrate the infringement and the technical background of the invention.

With regard to the urgency, the claimant must show that the matter is so urgent for him that he cannot wait for the outcome of a standard court proceeding. There is no fixed deadline, but a delay of one month for example, starting from the date on which the right holder becomes aware of the infringement, will usually not be considered excessive.

When determining the necessity for a preliminary injunction, German courts will also, among other factors, consider the validity of the title(e.g. the patent). This requirement, while seeming fairly straightforward from a French perspective, constitutes an exception from one of the basic tenets of German patent law: the separation principle. According to this principle, German courts generally have to treat titles as valid, unless they are declared void in a separate proceeding. The courts cannot invalidate a title in preliminary injunction cases, but they can refuse to grant the preliminary injunction based on doubts about the validity of it. Many courts require the plaintiff to merely show that there are no substantial doubts about the validity of the title. But there are also decisions that call for a stricter standard and will only allow preliminary injunctions if the title has survived an opposition or invalidity proceeding.

b) France

Pursuant to the French Law, the claimant must only show« reasonable evidence« that its rights are likely to be infringed or that such infringement is imminent. It is advisable for a claimant to support its application with prima facie evidence of infringement, preferably by way of a court bailiff’s report. The report is drawn by a public officer operating under oath without pre-assessment of the claimant’s rights or the merits of the case.

Proceedings no longer have to be instituted within a short time after the day on which the owner of the IPRs obtained knowledge of the facts on which they are based, so that urgency is not a requirement as a matter of principle. But it is still required in the following cases:

  • when the interim injunction is required ex parte,
  • when the claimant requested the authorization to summons d’heure à heure. These are expedited inter partes interim proceedings served on a very short notice to the defendant.

2°) How to proceed?

a) Germany

As a matter of principle, the competent courtis the court of the defendant’s place of residence. However, in the case of intellectual property right infringements, the claimant can also call the Court in which district the infringement occurred.

German courts are not obligated to hear the defendant before they issue a preliminary injunction. This could be ex parte. Businesses that fear becoming the subject of a preliminary injunction are not defenseless, however.

Companies can preemptively file aprotective brief(“Schutzschrift”) with the court(s) where they suspect the motion to be filed to argue their side of the dispute before a decision is cast.

If a preliminary injunction was granted in an ex parte proceeding the defendant has the possibility to file an appealagainst the Court’s decision. Such an opposition leads to an oral hearing where the validity of the injunction is reviewed by the Court taking into account the defendant’s arguments.

b) France

Competence rules are the same than in Germany. But despite these general rules, the Paris Court of First Instance is the competent Courtto hear (i) patent, (ii) European Union Trade Marks and (iii) Community designs cases. That rule guarantees more legal certainty.

Preliminary injunctions could be ordered very fast and ex parte:

  • d’heure à heure: the claimant must first apply before the motions judge, on an ex parte basis, to be granted the authorization to summon the defendant on an expedite basis. As already mentioned, in his application, the claimant will have to demonstrate the urgency. Once this authorization is granted, the complaint is served to the defendant and the preliminary injunction proceedings take place as described above. The decision can be issued within a few days or weeks.
  • ex parte: the claimant applies before the motions judge, without the defendant being aware and having the right to answer, to be granted a preliminary injunction. The decision is rendered right away. These ex parteinjunctions are very rarely granted.
  • while the substantive proceedings on the merits is already pending: the preliminary injunction is applied before the judge in charge of the proceedings of the case on the merits.

Protective briefs do not exist under French law. The only similar mechanism is the declaration of non-infringement and it only exists in patent cases. The point of bringing this action against the patent owner is to remove any doubt over the infringing or non-infringing nature of the acts taken by the claimant.

Preliminary injunction decisions issued by French Courts can be appealedeither by the claimant or the defendant within 15 days as from the day of the service of the order. The injunction remains enforceable during the appeal proceedings. Specific rulesapply when the preliminary injunction order has been requested ex parte:

  • if the injunction is denied, an appeal may be lodged the time-limit for appeal is fifteen days as from the day the order was issued. The appeal will be lodged, managed and determined as in non-contentious matters.
  • if the injunction is granted, any interested party may refer back to the judge who has given the order to have said order be « withdrawn ». There is no time-limit to do so.

3°) For what?

a) Germany

Claims for cease and desist, information, and confiscation. Claims for destruction, damages and information are excluded from preliminary injunction decisions as the outcome could be irreversible. Preliminary injunctions in patent cases are normally only granted in clear cut cases where the patent is « sufficiently valid », i.e. reasonably likely to be found to be valid and infringed.The claimant may be required to post a bond.

b) France

Claims for cease and desist, information, confiscation. Provisional damages can also be awarded, depending on the circumstances of the case and the seriousness of the infringement. The claimant may be required to post a bond as well.

c) Are “PI” enforceable in other member States?

Preliminary injunctions may also be enforced in other Member States of the EU. The claimant needs to file a request for enforcement with the court in the Member States in which the injunction shall be enforced according to Article 38 (1) Regulation on Jurisdiction and Recognition and Enforcement of Judgements.

If the injunction was rendered ex parte, some countries within the EU do not acknowledge the decision and will not serve and enforce it.

Regarding European Union trademarks and community designs, German/French courts may issue injunctions with effect for other Member States or the entire territory of the EU.

First, the claimant must be proprietor of a European Union trade mark or design and there must be an infringement in at least one Member State of the EU.

Second, there are different conditions in which German/French courts have jurisdiction to issue an injunction in such infringement cases:

  1. The defendant is domiciled in Germany/France or, if not, has a subsidiary in Germany/France.
  2. The claimant is domiciled in Germany/France or, if not, has a subsidiary in Germany/France.
  3. The parties agreed on the jurisdiction of France/Germany courts.

If one of the requirements is fulfilled, Germany/France courts have jurisdiction to issue an injunction with effect to every Member State of the EU where an infringement is conducted.


In the past it was not advisable to try to obtain IPR PI before French jurisdictions, because it was almost impossible to obtain.

The recent caselaw calls to think about it differently. With lower requirements (“reasonable evidence”), flexible proceeding (multiple ex parte options) and better results (provisional damages and lower costs), PI before French jurisdictions could now be seriously reconsidered.

Limitation period in patent nullity suits: is this the end?

The Paris High Court and the Paris Court of Appeals state that the limitation period under ordinary law (i.e. 5 years) applies to an action for patent revocation.

It is an error of law. Two brief explanations hereafter (and maybe a way out).

First, it does not comply with article 2224 of the Code civil. Article 2224 provides a limitation period for both actions in personam and actions in rem. Yet the action for patent revocation is neither one nor the other. It is not based on a debt obligation (action in personam), nor on a thing (action in rem). It is based on the defense of free competition. In this regard, we should remind that a patent right, as an exclusivity to operate an invention during a certain period of time, constitutes an exception to free competition. Therefore, as an exception, this right is only justified for patentable inventions. Rather, it is not justified for non-patentable inventions. In other words: the purpose of an action for revocation is mainly to avoid unjustified patents that will negatively affect competition.

Then, the purpose of a limitation period does not apply to it. Such a deadline aims at strengthening legal certainty. Thus, a right holder must act within a strict deadline when his right is infringed. Similarly, a right may be created over time, when a defect originally affecting it disappears. For instance, a trademark can acquire distinctiveness through use. However, on the contrary, in patent law, time may only be harmful. An invention which is not novel or inventive at the date of filing will not become novel or inventive afterwards. Rather, one could discover prior art that was not discussed during the examination phase. Eventually, a limitation period in patent nullity suits will only introduce uncertainty. On the one hand, there are still doubts concerning the starting point of the deadline. According to the case law: date of filing, date of grant or date of formal notice. There is no strict trend concerning this question. Besides, in any event, the plaintiff must prove he was unaware of the existence of the patent: the burden of proof is upon the plaintiff. On the other hand, the defect that originally affects the patent right will not disappear over time. To the contrary, one could discover after grant that a patent is void due to prior art which was not discussed during the examination phase. Therefore, legal protection is not needed and thus not justified because it strengthens situations of facts that will never comply with the legal system. Worse: potentially, a patentee will still be able to use a patent against someone else even after it is found to be invalid.

A change in the law could be the solution. The French legislator has already specified that there is no limitation period in patent nullity suits, but he did it in a text that depends on the ratification of UPC (Ordonnance n° 2018-341)… Thus, the Paris High Court reminded us recently that the limitation period is still applicable till the ratification of UPC (Paris High Court, September 6, 2018). However, perhaps the French legislator will put an end to this catastrophic case law very soon with a specific provision in the « PACTE » Law (Law for SMEs) that will be discussed in the Senate from the end of January (see our post « Loi PACTE : quid de la prescription des actions en nullité des titres de propriété industrielle ? »).

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