Where is the finish line?

Did you think you would never hear again of the thrilling subject of the French statute of limitations, and of its very controversial application to patent nullity suits? Well, think again.

In a previous post on the loi PACTE, I mentioned that the new provision putting an end to the time bar on patent nullity suits would immediately enter into force but that it remained to be seen how this would be interpreted in practice.

And so it is that, after spending lots of ink and pixels on how the statute of limitations applies to patent nullity actions, we may now have to devote more ink and pixels to a discussion on how exactly the statute will no longer apply.

Without further ado, as they say, I will now leave the floor to Matthieu Dhenne who will provide his insight on this matter.

I would like to come back to an issue close to my heart, as readers of this blog already know: the limitation period of actions for the annulment of industrial property titles.

I will not recall here the entire debate, already mentioned many times on this blog. The issue can be summarized by recalling that French judges applied a 5-year limitation period of the French Civil Code to these actions and that a debate has arisen about this case law, in particular because of the disastrous solutions to which it led.

The legislator has since intervened to combat this case law by declaring that these actions shall not be time-barred.

But a new debate is starting to emerge. Indeed, French Act No. 2019-486 of May 22, 2019, on the growth and transformation of companies – known as the “PACTE Act” – specifies that actions for the annulment of industrial property titles are not subject to any limitation period, while providing that that this applies to the “titles in force on the day of its publication“.

How should we interpret this provision?

The statute of limitations – the finish line.

Let us immediately rule out the interpretation according to which the parliament, by aiming at the titles in force on the day of the publication of the act, has excluded, on the contrary, the titles that were not (yet) in force on this date. This interpretation is disqualified, because it makes no sense. Indeed, we cannot consider that a transitional provision may have another object than transitional law, which deals with the application of an Act to past facts (i.e. facts that happened prior to its entry into force).

Only one question seems interesting with regard to the transitional provision discussed here: could it induce a retroactive effect by applying to titles in force on the day of the publication of the act, even though this day is after the limitation period has expired?

For instance, could a Court of Appeal apply the new Act to a case in which the limitation period applied at first instance? We should recall that the prevailing principle in French Law is that of the non-retroactivity of new laws, which is deduced from Article 2 of the French Civil Code; and that its counterpart is the immediate effect of new laws. Article 2222 of the same Code specifies that the limitation period, once expired, cannot be called into question.

The legislator may, however, provide, by way of exception, for the retroactivity of a law, if this is clearly and sufficiently stated. In this case, Article 124 of the PACTE Act does not specifically state that it is “retroactive”, but this is not required by Article 2 of the Civil Code or by the interpretation of the French Supreme Court (Cour de Cassation). Moreover, the specific mention that the law is “retroactive” would, as such, be of little use because it would be too vague.

Except if one considered that a specific reference to retroactivity is indeed mandatory – which the Cour de Cassation has never held – there is no evidence to suggest that the transitional provision in question is not clear or sufficient. We are therefore in a situation where it will be up to the judges to interpret the provision as closely as possible to the spirit of the text.

It must be kept in mind that the legislator intended to put an end to a jurisprudence that was belied by its text. It was therefore appropriate to refrain from restricting its application either to ongoing trials or to proceedings for annulment introduced after its entry into force or to actions for annulment based on titles issued after its entry into force. On the contrary, the text had to be worded in such a way that it could apply to all titles in force, which included all the aforementioned cases, but also titles previously issued and which had not given rise to legal proceedings on the date of the publication of the law.

Thus, the wording “titles in force on the day of its publication” seems to cover all pending and future actions and seems therefore retroactive.

I will have the opportunity to come back in more detail to this subject next week on @DeBoufflers Blog and then in the journal Propriété Industrielle (December issue); the latter will include a detailed response to an article supporting the opposite thesis, which was published in the same journal this summer.

Thank you Matthieu.

Transitional provisions are often tricky and can give rise to divided case law.

We have been there before, when the number of courts having jurisdiction in patent matters was reduced from 10 to 7 and then down to 1. And so, I would not be surprised if we got surprised again.

The art of the seal

The new set of rules recently adopted in France on the protection of trade secrets can potentially affect many aspects of IP litigation, including in particular the handling of evidence that may contain confidential information.

New judgments are therefore bound to come under scrutiny in order to determine whether there is a change in practice or not: in particular is there any heightened effort by the courts to preserve the parties’ confidential information? In Conversant v. LG, it seemed that maybe there was.

But as far as today’s ruling is concerned, I am not so sure the recent law had any impact on the judge’s assessment of seized evidence.

Here is the context.

Bayer Intellectual Property GmbH owns European patent No. EP 2164496, on a formulation for treating coccidiose and iron deficiency in farm animals, such as piglets.

In November 2017, the French company Ceva Santé Animale let Bayer know that they intended to launch a veterinary product in several European countries, and Bayer replied that the product would infringe their patent. Ceva nevertheless continued to prepare for the launch of the product.

The dispute suddenly crystallized a few months ago. First, Ceva obtained a marketing authorization for their product, Forceris, in April 2019. Then, on May 16, oral proceedings took place in connection with Ceva’s opposition against EP’496 at the EPO, and the opposition division rejected the opposition. On the same day, Bayer sent a cease-and-desist letter to Ceva. Ceva postponed the launch in the Netherlands and agreed to give Bayer a 2-month advance notice prior to such launch. But no similar undertaking was made with respect to France.

Still on May 16 (definitely a busy day for Bayer’s legal team), an ex parte order for infringement seizure was issued. The seizure was carried out 4 days later at Ceva’s headquarters.

Ceva immediately filed a motion in court to request the placement of the seized documents and information under seal.

In fact, the bailiff who performed the seizure had spontaneously placed some of the seized evidence under seal and had redacted some of the seized information – but Ceva deemed that this was not enough.

The interim order further to Ceva’s motion was issued on June 7.

With piglets, there is always money at stake.

In summary, Ceva argued that Bayer did not need the seizure, as they already had information on the composition of the Forceris product; and that the seized information was highly confidential and could unfairly distort competition if revealed to Bayer.

Unsurprisingly, Bayer disagreed and requested on the contrary that the evidence placed under seal by the bailiff should be released to them.

In her order, the judge first noted that Bayer’s knowledge of technical information on the allegedly infringing product (due to prior exchanges between the parties) was irrelevant.

Indeed, the infringement seizure procedure aims at collecting evidence relating not only to the existence of an infringement, but also to the extent of the infringement.

Second, she noted that the provisions on the protection of trade secrets not only apply to seized exhibits, but also to mentions contained in the bailiff’s report:

[…] The abovementioned provision (article R. 615-2 par. 5) only cites “seized exhibits” but  it must also apply to mentions in the infringement seizure report which derive from these exhibits. Otherwise, as stated by Ceva, the protection of trade secrets would be circumvented simply by mentioning the contents of the seized documents in the report. 

Pragmatic and fair.

Then, the judge deemed that a redaction of the bailiff’s report was not required in this case; nor was the placement under seal of most of the seized exhibits.

Here is the standard to be applied, as reminded in the order:

The judge of the infringement seizure should only order justified and proportionate measures, taking into account the opposite interests and rights at stake: on the one hand, [the interests and rights] of the seized party to enjoy the protection of its trade secrets and confidential information, if it can prove this qualification; and on the other hand, [the interests and rights] of the proprietor to gain access to any relevant documents which may enable to characterize the infringement, even before any finding by the court as to the existence of the infringement, including confidential information, provided that it appears to be necessary for demonstrating infringement, in order not to deprive the infringement seizure of any efficacy. 

I don’t think this standard is substantially different from the one that was traditionally applied before the 2018 trade secret law.

In this case, the judge refused to seal information appearing on one page of the bailiff’s report and in two seized exhibits, relating to commercial plans regarding Forceris.

Ceva stated that Bayer could use the information to adjust the launch of its own competing product, Boycox Iron. But the judge noted that “the countries [where Forceris is to be marketed] are more or less those countries where pigs are raised“. In other terms, the information was obvious and not protected.

I am not sure this reasoning is completely convincing, especially in view of the “more or less” language (“peu ou prou” in the original version).

The judge further noted that the business plan had already been disclosed in the Dutch proceedings, so that the information was not confidential. This, to me, is a much stronger point.

One of the exhibits contained the price of the Forceris product. But the judge also refused to seal it.

The first reason was that Bayer needed the information for the assessment of damages. The second reason was that Ceva has disclosed its recommended price in Italy, so that the judge could not see why the information would be confidential in France (even if the French price was different from the Italian price).

Again, I tend to find this latter reason not fully satisfactory. The fact that a company has decided not to keep some information confidential does not mean that they have given up on confidentiality of all information.

As for the usefulness of the price for the computation of damages, this is of course a central point. In some cases, courts have decided that there should be a ruling on infringement first, before the patentee can access any price-related information. But in other cases, such as this one, they have decided otherwise. This is a delicate case-by-case balance, which, again, has apparently not really been altered by the new trade secrets provisions.

Other exhibits were OKed by the judge as well, as they related to invoices, orders and the like and were therefore relevant for the patentee as they contained information on the distribution network.

Only one exhibit was withheld by the judge, namely some commercial documentation which “it does not appear justified and proportionate to disclose to Bayer in view of the information already collected“.

On the other hand, the judge granted Bayer’s counterclaim for disclosure of the evidence spontaneously placed under seal by the bailiff during the seizure.

The last nail in the coffin was the following sentence:

There is no legitimate reason to prohibit Bayer from using the elements [thus] lawfully obtained in other proceedings in France or abroad. 

This is an important reminder of how useful the French infringement seizure can be in a situation of global litigation.

All in all, the judge’s ruling seems to favor efficiency of the proceedings: lengthy expertise proceedings on the exhibits are avoided, and the patentee has now all the necessary information to sue other parties if needed, and file submissions on all aspects of the case including damages. But whether the defendant’s trade secrets were sufficiently preserved in the process may be open for discussion – with the caveat that, as is often the case, the order is relatively brief and does not make it possible to fully appraise the entire context.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, June 7, 2019, Ceva Santé Animale SA v. Bayer Intellectual Property GmbH, RG No. 19/54542.

Dolce vita for Amgevita®

Judgments on preliminary injunctions are uncommon, and thus particularly interesting.

So are judgments on prior user rights. Thus, when a case combines both aspects, things get truly exciting.

Fresenius Kabi Deutschland acquired the biosimilars activity of Merck KgaA in April 2017. European patent application No. EP 3145487, filed in May 2015, was part of the deal. The patent was later granted, on August 22, 2018.

The patent relates to a pharmaceutical composition which is a biosimilar of the drug Humira®, based on the antibody adalimumab as an active ingredient.

Humira® is what people call a blockbuster drug. It has a number of therapeutic indications, including rheumatoid arthritis, psoriasis, Crohn’s disease and other inflammatory conditions.

Humira® was developed by Abbott and, according to the court, the SPC which protected the originator’s product expired in France on October 16, 2018.

Several biosimilar drugs were developed and obtained a marketing authorization (MA) from the European Medicines Agency (EMA), including the Californian group Amgen. See here for a news report on the Humira® biosimilar landscape. Amgen’s drug is called Amgevita®. It was the first biosimilar approved by the EMA in March 2017. Its price was set in France the day after the expiry of the Humira® SPC, and my understanding is that Amgevita® was then immediately placed on the market.

Meanwhile, as mentioned above, the EP’487 patent was granted to Fresenius on August 22, 2018. Fresenius was really on the starting blocks with this patent: looking at the EPO file wrapper, the communication under R. 71(3) EPC on the intent to grant was dated July 6, 2018, and the applicant replied by paying the prescribed fee and filing the claim translations… on July 6! This is as responsive as you can be.

But Fresenius’ impatience was quite understandable, in view of the imminent expiry of the Humira® monopoly; and because they were of the opinion that Amgevita® infringed EP’487.

A number of exchanges between Fresenius and Amgen took place in October-November 2018. And since Amgen would not bend, Fresenius initiated infringement proceedings in front of the Juge des référés, i.e. the judge in charge of urgency proceedings in the Paris Tribunal de grande instance, on November 14, 2018. Fresenius notably requested a preliminary injunction (PI) against Amgen.

In parallel, Amgen filed an opposition against the patent at the EPO in December 2018.

The French hearing took place on January 14, 2019, and the judge issued her decision one month later – ruling in Amgen’s favor.

Tutto bene per Amgen.

Amgen challenged Fresenius’ request for PI by stating that such a measure would be unwarranted given that Fresenius itself does not have a product on the market; and by arguing that the patent is invalid and that there is no infringement.

In the decision, the judge first summarized the standard to be applied as follows:

[The judge] must rule on the challenges raised by the defendant, including regarding the validity of the patent itself. She must appraise the seriousness of the challenges, and at any rate should assess the proportion between the requested measures and the infringement alleged by the claimant and take the decision to ban the marketing of the infringing product or not, in view of the risks taken on one side and the other. 

A few years ago, there was a controversy regarding the standard to be applied with respect to validity challenges to PIs. Was a “manifest” invalidity the only acceptable defense to a request for PI? Recent case law is much more defendant-friendly (and probably much more reasonable, for that matter), as the above quote shows, in particular with the reference to a control of the proportionality of the requested measures.

The judge then turned to the assessment of Amgen’s non-infringement defense, which, as mentioned in the introduction, was based on a prior user right. Or rather, on a “prior personal possession” of the invention, as it is known under French law.

The judge summarized the conditions to be met for such a defense to be effective:

          • the possession [of the invention must be] before the filing date of the patent or its priority date;
          • the possessed technology [must be] identical with the patented invention; 
          • the possession [must be] on the French territory; 
          • those claiming such possession [must have acted] in good faith.

The judge also clarified that, based on longstanding case law, the possession of the invention does not require a commercial exploitation of the invention. Possession, in this context, rather corresponds to the knowledge of the invention.

Let’s now turn to claim 1 of Fresenius’ patent:

An aqueous pharmaceutical composition comprising:
(a) adalimumab;
(b) an acetate buffering agent (or acetate buffer system);
(c) a sugar stabiliser, wherein the sugar stabiliser is a non-reducing disaccharide selected from the group including trehalose and sucrose; and
(d) polysorbate 80; and
wherein the composition:
• has a pH between 5.0 and 5.5;
• is either free of arginine or comprises arginine in a concentration of at most 0.1 mM;
• is either free of phosphate buffering agents or comprises a phosphate buffer system in a concentration of at most 0.1 mM;
• is either free of amino acids or comprises one or more amino acids in a (collective) concentration of at most 0.1 mM; and
• is either free of surfactants, with the exception of polysorbate 80, or comprises one or more of surfactants excluding polysorbate 80 in a collective concentration of at most 0.001 mM.

The other claims depend on or otherwise indirectly refer to claim 1.

Amgen Inc. had applied for an authorization to run clinical trials on the product designated as ABP 501, in front of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), and the authorization was granted on August 13, 2013. This was before the priority date of EP’487.

The ABP 501 formulation was described in the request for authorization as adalimumab “at 50 mg/ml […] formulated with 10 mM sodium acetate, 9.0% (weight/volume) sucrose, 0.1% (w/v) polysorbate 80, pH 5.2“.

The judge noted that those are the essential features of the claimed invention – which seems to be a reasonable conclusion to draw; and that Amgen’s good faith did not appear to be questionable.

Thus, the only remaining point to be discussed, which in my view was the most tricky one, was whether the possession was “personal” and had taken place on the French territory.

This is potentially a major stumbling block to a prior user right defense in this country, especially in large group of companies. Under French law, a very strict distinction is usually applied between various companies, even if they are affiliated. Therefore, if company A “possessed” the invention, this does not necessarily imply that its affiliate B also “possessed” it. Even more so if A is a foreign company, and B a French one.

In this case, the request for authorization to run clinical trials was filed by the U.S. company Amgen, Inc. But the defendant to the lawsuit was a different company, namely the French subsidiary Amgen SAS.

Here is how Amgen passed the hurdle:

In view of the specific organization of the Amgen group, it is reasonable to consider (especially in urgency proceedings) that Amgen SAS, like the other European subsidiaries of the group, had direct access to the document relating to the clinical trials, and thus to the formulation of the biosimilar product ABP501, owing to the “EPIC” platform of the group, as early as March 2013. In fact, part of the clinical trials were performed in France. It must therefore be held that the possession of the formulation which is identical to the patented one, although originating from the U.S., was realized in France. 

Thus, the judge concluded that the prior user right defense raised by Amgen was a serious challenge to the likelihood of infringement.

By way of overkilling, the judge noted that the lack of novelty argument based on prior art document US 2014/0086930 was also serious.

Consequently, Fresenius’ request for PI was dismissed.

I often conclude my posts by stating how much I look forward to the next developments in the litigation (judgment on the merits, appeal…). But in this particular instance, I don’t think there is anything to look forward to, really.

Indeed, we can see on the online European patent register that Amgen withdrew its opposition a few days ago on May 8, 2019. This certainly means that a settlement has been reached. We thus likely will not hear about this dispute anymore.

By the way, the 9-month opposition time limit has not expired yet – it will on May 22. I’m somewhat curious to know whether others will oppose.

One take-away message from this ruling is that the sharing of information between the various companies of the Amgen group via a dedicated platform was crucial in securing the French affiliate’s right to use the invention despite the patent. This may be a point to keep in mind for other multinational companies.

Although on the other hand it may also be difficult to put into place as a general rule, in view of the necessity to actively protect trade secrets.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, February 14, 2019, Fresenius Kabi Deutschland GmbH v. Amgen SAS, RG No. 19/50489.

A ruling not so Great for Manitou

In a rather exceptional move, two patent attorneys professional organizations took sides in a lawsuit between two private companies.

In fact, the CNCPI (Compagnie nationale des conseils en propriété industrielle) and the ACPI (Association des conseils en propriété industrielle) filed an intervention in an appeal on points of law in front of the Cour de cassation.

I know this may sound like a nerdy and rather unamusing April Fools’ day prank, but it is not. I have temporarily given up on those since reality has started catching up with the imagination of jesters on a daily basis (anyone up to a Brexit joke these days?).

So, yes there was indeed such an intervention, in the litigation pitching British company JC Bamford Excavators Ltd. (JCB) against Manitou BF.

How did we get there and how did this all end?

JCB specializes in the production of manufacturing equipment e.g. for construction and agriculture. Manitou is a French manufacturer of fork lifts and other heavy equipment.

JCB owns in particular two European patents (EP 1532065 and EP 2263965) that it believes have been infringed by Manitou on the French territory.

On April 26-27, 2017, JCB rented a telehandler called Manitou MT 1840 and had tests performed on this device by two JCB employees, in the presence of two French patent attorneys. These tests were aimed at demonstrating infringement of the patents at stake. The two patent attorneys involved in this testing issued a report for JCB.

On May 5, 2017, JCB filed a complaint for patent infringement against Manitou.

A few weeks later, on June 1, 2017, JCB filed a request for an ex parte order to be authorized to carry out an infringement seizure in Manitou’s premises. It is somewhat unusual for an infringement seizure to be requested after the infringement proceedings have already been initiated, but it is certainly possible to proceed in such a “reverse” order. The ex parte order was granted the next day.

On June 16, 2017, the infringement seizure was carried out by a bailiff in Manitou’s premises. It must have been a rather exhausting one for all those concerned, as it lasted until 2:15 am the next day…

The bailiff was assisted during the seizure by two patent attorneys – as is almost always the case. But the important point here is that the two patent attorneys at stake were those who had assisted JCB with the April testing.

One week later, Manitou filed a motion for canceling the infringement seizure order. The judge rejected the motion in another order dated October 5, 2017. Manitou appealed.

On March 27, 2018, the Paris Cour d’appel set aside the October 2017 order, and canceled the infringement seizure order of June 2017 – thus also canceling at the same time the bailiff’s infringement seizure report.

The court expressed the following principle:

[…] The right to a fair trial set out in article 6 of the European Convention on Human Rights [ECHR] requires that the expert assisting the bailiff should be independent from the parties […]. 

The court then reasoned as follows:

Mr. […] and Mr. […] were designated twice in the same infringement lawsuit between [JCB] and Manitou; a first time on April 26, 2017, upon [JCB]’s request, to perform tests on a Manitou MT 1840 vehicle, and to hand out on May 4, 2017 a private expert report describing the features of the material which was examined; and then by way of an order dated June 2, 2017, in which they were designated as judicial experts to assist the bailiff during the infringement seizure relating again to the MT 1840 model, already examined during the private expertise, as well as to further Manitou models. Obviously, and regardless of their status which requires compliance with rules of ethics, patent attorneys cannot be designated as experts by a judicial authority while they have previously been involved as experts on behalf of one of the parties in the same case […], without violating the impartiality principle required by article 6 [ECHR]. Their designation was illegal, so that the June 2, 2017 order shall be canceled, and the October 5, 2017 order shall be set aside.

JCB filed an appeal on points of law in front of the Cour de cassation.

The Cour de cassation: the Great Manitou of French litigation.

The March 2018 ruling sent some shock waves through the French patent profession as it seemed to establish new requirements for patent attorneys to be able to assist a bailiff during an infringement seizure.

Hit by these shock waves, the two abovementioned patent attorney professional organizations stepped in, in support of JCB’s case.

Hot from the dematerialized press, here is now the judgment issued by the cassation judges a few days ago, which the Cour de cassation set aside the March 2018 ruling of the Paris Cour d’appel.

Locating the key part of a cassation judgment is a rather easy task. Such judgments are so brief that there is hardly any meat at all around the key part. So here it comes (broken down into shorter sentences):

The fact that the patent attorney of the seizing party had, on the initiative of the latter, established a report describing the features of the product at stake, does not prevent a later designation, upon request of the seizing party, as an expert to assist the bailiff in a patent infringement seizure. [Indeed], his mission is not subjected to a duty of impartiality since it is not an expertise under articles 232 and following of the Code de procédure civile. [Therefore], by ruling in this manner, the Cour d’appel breached the above legal provisions [i.e. article 6 ECHR and article L. 615-5 Code de la propriété intellectuelle].  

I bet this ruling will come as a relief for most of the patent profession.

The mistake made by the Cour d’appel seems to have been to consider the patent attorneys assisting the bailiff as court-appointed judicial experts. They are not.

They are supposed to help the bailiff find evidence of infringement, they are not there to provide an impartial recommendation to a judge regarding the outcome of a discussion.

Calling upon patent attorneys to assist the bailiff, as opposed to employees of the infringement plaintiff for instance (which is prohibited), offers a number of guarantees for the seized party, due to the rules of ethics that patent attorneys have to follow. For instance, a patent attorney should not and will not communicate to the plaintiff any confidential information that he/she becomes privy to during the seizure.

But on the other hand there is no requirement for the patent attorney not to have advised the plaintiff in the past – including regarding the case at hand.

By the way, the CNCPI and ACPI’s intervention in the appeal was found admissible.

This may pave the way for similar interventions in the future in case the rights and prerogatives of patent attorneys are at stake in a litigation.


CASE REFERENCE: Cour de cassation, ch. commerciale, March 27, 2019, JC Bamford Excavators Ltd. v. Manitou BF, appeal No. H 18-15.005.

The new normal

What the heck is going on with preliminary injunctions (PIs) in France right now?

Let’s face it, France is not particularly renowned for its patentee-friendliness. But different winds seem to be blowing these days over the Batignolles. Is this mere happenstance? Could it have anything to do with recent judicial appointments? Is there a feeling among our judges that the pendulum should swing back a little bit towards IP right holders? Or has there been a change in the behavior of third parties?

Preliminary injunctions in France: the new normal?

Hard to tell of course, so readers will have to make their own opinion based on a report kindly provided by Lionel Vial on a PI issued just a few days ago. I will now leave him the floor.

There has been a second high-penalty preliminary injunction in a row in the pharma field that we will comment on today after Renaud’s post on darunavir.

The drug at stake is a combination of ezetimibe and simvastatin (Inegy®, MSD France) which is prescribed for reducing cholesterol levels. Ezetimibe reduces intestinal absorption of cholesterol while simvastatin is a HMG-CoA reductase inhibitor (i.e. a statin) which inhibits cholesterol biosynthesis.

The case opposes Mylan, which has been marketing a generic version of the combination since April 18, 2018, and Merck (Merck Sharp & Dohme Corp. & MSD France) before the Paris Tribunal de Grande Instance (TGI).

Merck Sharp & Dohme Corp. holds French Supplementary Protection Certificate (SPC) FR05C0040, of which MSD France is a licensee. The SPC is based on European patent EP0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin” and is set to expire on April 2, 2019.

EP’599 specifically claims ezetimibe in 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 ezetimibe, 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).

On October 17, 2017, Mylan started nullity proceedings against the SPC, to which Merck responded by requesting, on November 30, 2018, that a preliminary injunction to stop selling the ezetimibe/simvastatin combination and to pay provisional damages be issued against Mylan.

Mylan countered that the SPC was invalid because:

    • It was granted for a combination which is not protected as such by the basic patent, in breach of Article 3(a) of the SPC regulation (No. 469/2009), since it would not form the core inventive advance of the patent, which is centered on ezetimibe, in particular in the absence of any research conducted on the ezetimibe/simvastatin combination.
    • The product protected by the basic patent had already been the subject of a certificate (i.e. SPC FR03C0028 granted for ezetimibe) in breach of Article 3(c) of the SPC regulation.

However, principally applying C-121/17 (Teva UK Ltd. et al. vs. Gilead Sciences Inc.), the judge in charge of case management (JME) decided on March 7, 2019 that:

The Court of Justice of the European Union thus considers that a product which is a combination of active ingredients is “protected by a patent in force” where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. The product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent and each active ingredient must be specifically identifiable.

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

The association ezetimibe/simvastatin, which is thus taught, therefore necessarily relates to the invention deriving from the basic patent, simvastatin being specifically identified by the patent.

The product sold under the trademark INEGY®, which is a combination of the active ingredients ezetimibe and simvastatin, therefore appears to be “protected by a basic patent in force”, pursuant to article 3(a) of regulation (EC) No. 469/2009.

It is reminded that pursuant to article 3(c) of this regulation, the SPC can only be granted if the product has not already been the subject of a previous SPC.

The condition provided by article 3(c) of regulation (EC) No. 469/2009 therefore also appears to be fulfilled.

As such, the arguments put forward by MYLAN to demonstrate that there is a doubt as to the validity of SPC No. 05C0040 appear to be lacking seriousness, this SPC obviously fulfilling the requirements of article 3 of regulation (EC) No. 469/2009. It can neither be seriously argued against the sufficiency of disclosure nor against the inventive step, since these conditions are not envisioned by article 3 of the regulation for obtaining a SPC, due note being taken that the disclosure of the ezetimibe/simvastatin combination allows the one skilled in the art to easily reproduce it, while this combination was not known at the filing date of the basic patent.

It follows that by marketing, since April 18, 2018, the generics “EZETIMIBE/SIMVASTATIN MYLAN” comprising a combination of ezetimibe and simvastatin, in violation of SPC No. 05C0040 granting the market exclusivity of this combination to MSD, MYLAN likely infringed.

Too bad for what appears to have been a test by Mylan of the application in France of Justice Arnold’s proposal that, in order to be granted an SPC, a product must infringe the basic patent because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent.

It is also very surprising that there has been a complete change of appreciation of the validity of this SPC, since on April 5, 2018 the judge in charge of urgency proceedings refused to issue a preliminary injunction against Biogaran on the basis of the same SPC because the latter was considered likely invalid, which was confirmed on appeal on June 26, 2018 (see Renaud’s post on the subject here). But then, C-121/17 (July 25, 2018) had not been issued yet and the Cour d’appel mostly relied on C-443/12 (Actavis Group PTC EHF & Actavis UK Ltd v. Sanofi).

However, perhaps the interpretation of the evolving case law of the CJEU by French judges is not the most notable part of this decision.

Indeed, the following substantial damages were awarded:

    • 2,901,779 euros to MSD France
    • 1,460,889 euros to Merck Sharp & Dohme Corp.

As a reminder, in the darunavir case (GD Searle LLC et al. v. SAS Sandoz) the judge in charge of urgency proceedings ordered on January 11, 2019 a preliminary injunction against Sandoz, under a 50,000 euro-penalty per violation of the injunction (Renaud’s post on the subject).

Before that, on June 7, 2018, the judge in charge of case management awarded 5,846,628 euros to Novartis Pharma AG and 7,308,285 euros to Novartis Pharma SAS as provisional damages in the valsartan/amlodipine patent infringement case (see here for a report).

Besides, a preliminary injunction was also recently issued on July 6, 2018 against a potential infringer in a chemistry case, but without provisional damages (see here for a report by Renaud).

Therefore, we may be currently observing a new trend setting in that could make France a very attractive forum for preliminary injunctions, in particular in the pharma field.

An open question is whether this trend could weigh in favor of Paris in relation to the still undecided relocation of the London UPC central division, which is in particular competent for pharmaceuticals.

Out of luck for the time being (the decision on the merits is yet to come) with the ezetimibe/simvastatin combination, maybe Mylan could consider a combination of ezetimibe with atorvastatin, since a recent decision from the Paris Cour d’appel rendered on January 22, 2019 has upheld the decision of the Director of the INPI (French Patent Office) to reject French SPC application No. 14C0068 for “ezetimibe in combination with atorvastatin or pharmaceutically acceptable salts thereof, including the calcium salt of atorvastatin”. But that will be our next post on Patent My French, so stay tuned for more on SPCs!

As always I would like to thank Lionel for this thorough report. The story does indeed need to continue with this appeal ruling of January 22, 2019, which in my view is closely connected to today’s decision – and (spoiler alert) there is a new twist in the saga.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, ordonnance du juge de la mise en état, October 17, 2017, Mylan v. Merck Sharp & Dohme Corp. & MSD France, RG No. 17/14664.