Time’s up

Previously, in Actelion v. Icos Corporation (as they say in TV shows): Actelion filed a nullity suit against the French part of European patent EP’092 owned by Icos Corporation (belonging to the Eli Lilly group) and relating to a particular formulation of the blockbuster drug tadalafil. Icos disputed Actelion’s standing. Actelion prevailed, except regarding some dependent claims relating to therapeutic uses of the formulation unrelated to Actelion’s business.

Today’s episode is dedicated to the second legal defense brought by Icos, based on the French statute of limitations. Icos argued that Actelion’s action was time-barred – successfully so.

A few years ago, the statute of limitations was never brought up as a legal defense in nullity suits in France. In fact, the Code de la propriété intellectuelle does not contain any specific limitation provision regarding nullity claims – contrary to, e.g., infringement claims.

Everything changed further to the reform of the Code civil enacted in 2008. Amended article 2264 now provides that “personal or real actions are time-barred five years from the day when the owner of a right knew or should have known the facts making the action possible“.

In other terms, the general limitation period in ordinary civil law is five years. Numerous exceptions are provided in specific areas of the law, but as mentioned above, no exception is provided for nullity patent suits. On the other hand, before the 2008 reform, the general limitation period was 30 years. Therefore, whether or not the general limitation period applied to patent nullity claims was irrelevant since it exceeded whatever time was needed by nullity plaintiffs anyway.

But a few years after the reform, litigants started to realize that the new statute of limitations had become a thorny issue in patent invalidity lawsuits. If I recall correctly, I was skeptical the first time I heard about it, because it intuitively seemed wrong that a patent nullity claim could possibly be time-barred. But soon enough, everyone had to acknowledge that the 2008 reform had had unintended but far-reaching consequences in patent law, and that nullity claims could now be time-barred.

As an important side note, this does not mean that defendants in infringement suits are now unable to fend off a claim based on an invalid patent. It is always possible to raise invalidity as a defense (or exception) to an infringement claim. But a revocation counterclaim may be time-barred. In such a case, the invalidity of the patent may be acknowledged by the court without any erga omnes revocation.

As far as direct nullity actions are concerned, they are of course fully impacted, as they may be held entirely inadmissible if time-barred.

Not only is this situation unsatisfactory, but a major problem is then the determination of the starting point of the limitation period. In this respect, court decisions over the past few years have been all over the place.

We do not know for sure whether the Actelion ruling will be held in the future as representative of “established case law” or whether it will be reversed or ignored. But since it is probably the most recent judgment on this sensitive question, I view it as of today as a reasonable reference for predicting future cases.

It is now time to go back to the particulars of the case.

Freakier than the Donnie Darko rabbit: the time-bar moose.

A first argument raised by Actelion was that the abovementioned article 2264 of the Code civil is not applicable to patent nullity claims. This argument failed, in keeping with previous rulings. The court held that the nullity action was a “personal” action under article 2264 and thus subject to the limitation period:

Like a tort action (which it is admittedly not), a [patent nullity action] has a function of cessation of the unlawful, in the competition relationship between the parties (said unlawful being here made up of a legal act the validity conditions of which are not fulfilled), and it is thus appended to a relationship of quasi-tort obligation. In this sole respect it pertains to the category of personal actions. This category is in fact broad as it is the category of ordinary law, whereas real actions are in a determined number. 

The court rejected further arguments that the action serves a general interest and should therefore not be subject to the limitation period:

The fact that nullity, with its erga omnes effect, incidentally serves a general interest does not legally imply that the action should not be subjected to a limitation period. Neither does the fact that it is open to all, as it is not limited to a certain person, contradict its personal character, as the plaintiff must justify its personal standing and only pursues a personal interest with its action. 

Then comes the central issue of the starting point of the limitation period. Many propositions have been made in this respect: publication date of the application, grant of the patent, actual knowledge of the patent, etc.

Here is how this panel of the Paris Tribunal de grande instance saw it:

The starting point of the limitation period must thus be set to the day, which is determined in concreto, when [Actelion] knew or should have known, in view of the progress of their research and of the seriousness of their project […], that the EP’092 patent could possibly thwart said project. Therefore, neither the publication of the grant of the patent (which would in fact require an unrealistic watch for market players and is unrelated to the development of the project conferring standing), nor the knowledge of the grounds of nullity of the title (which may be significantly before the knowledge of the facts and economic considerations giving rise to standing and in practice goes back to the publication of grant) are appropriate starting points. 

In other terms, the court rejected any automatic starting point such as the patent grant, as was argued by the patentee as a first line of defense (or worse, the publication of the application, as was suggested in earlier decisions). This would of course make the determination much easier but would be illogical as you could then be time-barred before even acquiring standing to sue…

Instead, a full appraisal of the facts and circumstances of each case is necessary. In this respect, a strong parallel was made between the appraisal of standing and the starting point of the limitation period.

The way I understand the judgment, the limitation period starts running when the party acquires standing to sue.

This has the advantage of ensuring overall consistency in the assessment of the admissibility of a nullity action.

On the other hand, on a practical standpoint, I think this approach makes it extremely difficult for a party to determine whether they are time-barred from starting a contemplated nullity suit. Indeed, as explained in the previous post, the appraisal of standing is complex and seems to rely on converging lines of evidence depending on the plaintiff’s research and commercial projects. It is already hard to guess in advance whether the court will be satisfied that the projects are sufficiently precise and advanced for standing to be acknowledged. But determining when exactly the party’s projects became sufficiently precise and advanced looks like a game of roulette to me.

Another drawback of the court’s approach in Actelion is that the knowledge of the grounds of nullity was explicitly not taken into account. But in order to decide whether to claim the revocation of a patent, you not only must have an interest in putting this claim forward, but you also need to find actual reasons why the patent should be revoked. Most of the time, a careful review of the patent and a full prior art search should make it possible for a diligent party to determine such reasons. But there are certainly more complex situations, where the existence of a ground of nullity may be incidentally revealed, e.g. by way of a testimony, experimental tests or the like, at a certain time which may be too late for launching a nullity suit.

Let’s now examine how the court applied the general principles set forth above to the present case.

Icos relied on four facts which they claimed demonstrated that the action was time-barred (bearing in mind that the complaint was filed in June 2015):

  • an article submitted by Actelion’s researchers in 2005 to a scientific journal on the combination of the drugs bosentan and sildenafil (a drug having the same function as tadalafil, the one claimed in the patent at stake) for the treatment of pulmonary hypertension (PHTN);
  • an annual report dated 2010 mentioning a phase IV clinical trial on the above drug combination for the treatment of PHTN;
  • a patent application filed in 2007 by Actelion on drug combinations for the treatment of PHTN, which in particular mentioned tadalafil in claim 3;
  • a marketing authorization (MA) for Adcirca granted to the Eli Lilly group on October 1, 2008 (Adcirca apparently corresponding to the formulation of tadalafil protected in EP’092, for the treatment of PHTN).

The court considered the 2005 article as “too early to characterize a real business interest of the plaintiffs“, but on the other hand as indicative of a “real scientific interest for this type of combination therapy“. The court further noted that the 2010 annual report confirmed that there was continuing research in this field.

The patent application of 2007 was seen as evidence that tadalafil had been identified as an interesting compound for combination PHTN therapy and had been the subject-matter of serious research.

But the fact held to be the most determining one was the marketing of Adcirca by the Eli Lilly group. Said the court:

[…] Actelion, as a leader in the treatment of PHTN, and using tadalafil in the combination therapy which had been under development for more than 3 years, could not possibly ignore the marketing of a directly competing drug, and see in it, and therefore in the patent that the drug implemented, a serious threat for its economic activity. 

In their submissions, Actelion argued that the limitation period could not start running until their development projects became sufficiently specific in order for the EP’092 to be identified as an obstacle. But the court rejected this argument, noting that this requirement was not taken into account for the appraisal of standing and thus could not be taken into account either for the appraisal of the limitation period. The limitation period could thus start running even before potential R&D on the formulation claimed in EP’092 – and in addition there was no evidence that such specific R&D was indeed conducted at a later stage, according to the court.

Again, consistency between the two admissibility requirements was given a paramount importance in the court’s reasoning. In particular, the court found that there was a contradiction in the claimants’ position since, on the one hand, they presented their combination therapy trials as relevant to characterize their standing, and on the other hand they deemed that their 2007 patent application claiming tadalafil in a combination therapy was not representative of a serious business interest.

Consequently, the court held that on October 1, 2008 at the latest (i.e. on the day Eli Lilly was granted the Adcirca MA):

the plaintiffs knew or should have known that the EP’092 patent could represent an impediment to their business and could be asserted against them by the patentee. 

The action was thus deemed inadmissible.

Again, on a practical standpoint, this outcome is very unfortunate, as nullity actions are a useful tool of economic regulation, skimming legally unfounded monopolies. And on a theoretical standpoint, several points in the judgment are surely open to criticism.

But the worst part of it all is probably the legal uncertainty entailed by such a complex and fuzzy appraisal of both standing and the starting point of the limitation period. This is not good news for decision makers.

So, we will have to watch out for further decisions on this topic. An amendment of the statute opening the door more broadly again to nullity claims might in fact be the best way forward, but I do not think that this is in store.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, March 16, 2017, Actelion Pharmaceuticals Ltd. & Actelion Pharmaceuticals France v. Icos Corporation, RG No. 15/07920. 

Where we stand

When it comes to nullity actions in France, there are two topics which have been ultra hot for a few years, and which I think have not yet been addressed on this blog. Maybe precisely because they were too burning hot.

The first topic is standing, and the second one is the statute of limitations. Both are major stumbling blocks on a third party’s way to a preemptive strike.

A recent judgment by the Paris Tribunal de grande instance (TGI) in a pharma case addresses both topics, head-on. Therefore, now seems to be a good time to finally venture into these hazardous waters.

In the case at hand, Actelion Pharmaceuticals filed a nullity suit against the French part of European patent No. EP 1200092 (EP’092) to Icos Corporation (a company of the Eli Lilly group) in June 2015. The patent proprietor challenged the admissibility of the action because they said (1) the claimant did not have standing and (2) the action was time-barred.

So, where do we stand on standing?

Since a famous Barilla case a few years ago, courts seem to have gotten tougher on the appraisal of the standing of nullity claimants, and much ink has been spilled on this topic.

In this context, it is interesting to extensively quote the court’s general remarks on the issue in Actelion, as they are rather complete and enlightening:

[…] The standing to file an action for nullity of a French patent or of the French part of a European patent must be appraised under the requirements of ordinary law and therefore must be personal, legitimate, actual and current on the day the complaint is filed. However, posterior evidence can enlighten the court on the situation at this date or even enable a regularization […]. 

This latter point is interesting. It suggests that even in the absence of standing on the day the complaint is filed, the action may still be admissible if standing can later be acknowledged. By way of example, it is conceivable that the patentee’s behavior after the filing of the complaint may legitimize the lawsuit.

The court’s general guidance then goes on as follows:

The existence of the claimants’ standing must be appraised in view of the object and purpose of the action for nullity of the patent […]. The grant of the patent, whether it is a reward for an investment and a creative effort of the inventor, or for the disclosure of an invention, confers an advantageous monopoly to its owner which is legitimate and admissible in a context of free competition and free innovation only to the extent that its validity requirements are met. A nullity suit thus aims, for a competitor, at retroactively clearing the market of an unjustified obstacle and […] benefits to all when it is filed as a main action and is successful. In this context, the nullity standing must be assessed in concreto and in a flexible manner, in view of the general interest which the action serves: it must be acknowledged for any person who, personally, has an economic activity in the field of the invention which is effectively, or potentially but certainly, impeded by the claims the nullity of which is requested.  

In this respect, the nullity plaintiff must establish the existence of an actual and serious project which may be hampered by the patent, but does not have to establish effective marketing acts, let alone the existence of infringement in advance, claim by claim, by disclosing all of its technical advances;  the advantage conferred by the nullity action […], namely the improvement of the legal situation of the plaintiff, lies in the certainty that they will be able, once their project is set, to engage in costly research necessary for the manufacture and marketing of a product which may compete with the invention, without risking being sued by the patent proprietor and without waiting for this to happen. In particular in the pharmaceutical field, standing borders a prevention interest which is objectively substantiated, as there is no justification for punishing a cautious competitor. 

In other terms a balance has to be struck.

Unlike oppositions at the EPO, a nullity action may not be filed by any person. The claimant must have an actual and objective interest in the patented invention which must be clearly demonstrated, and this is to be appraised on a case by case basis. On the other hand, nullity suits are not exclusively reserved to actual infringers. There must be an incentive for competitors willing to clear their way before actually working the claimed invention or even before spending “costly research” to this end.

At this point, it is probably time to have a look at the patent at stake, which relates to the drug tadalafil, the active substance in the famous drug Cialis for the treatment of erectile dysfunction.

Tadalafil is an inhibitor of an enzyme called phosphodiesterase type 5 (PDE-5). It turns out that this active is also useful for the treatment of pulmonary hypertension (PHTN).

Stop killing rhinos! There is no tadalafil in the horn.

The EP’092 patent more specifically claims a particular formulation of the drug tadalafil, in a specific particulate form, as well as a method of manufacture. Claim 12 relates to this drug formulation for use in (any) method of treatment. Claims 13 to 19 are Swiss-type claims directed to the treatment of various sexual dysfunctions.

Actelion is active in the field of the treatment of PHTN, one of the illnesses against which tadalafil is useful – and one which is of course different from sexual dysfunction. The court immediately noted that tadalafil may thus be an interesting molecule for Actelion; and that Actelion and Icos / Eli Lilly are competitors in the treatment of PHTN.

But the court did not limit itself to this basic finding and examined in much more detail the evidence pointing to an actual interest by Actelion in the subject-matter of the patent. 

In this respect, the court found it significant that, in the context of parallel nullity proceedings in the UK, Eli Lilly filed a counterclaim for infringement of the British part of the EP’092 patent. Although this counterclaim does not concern the French territory, the court stated that:

This position implies the existence of a threat which may be carried out in France and above all an objective link between the economic activity of the claimants and the French part of the EP’092 patent.

Then, the court reviewed four different aspects of Actelion’s development activities: 

  • a clinical study conducted in 2012 on the treatment of PHTN by a combination of macitentan with a PDE-5 inhibitor;
  • a clinical study published in 2015, on the treatment of PHTN by a combination of selexipag with a PDE-5 inhibitor;
  • an ongoing multinational clinical trial aiming at comparing a triple combination therapy based on macitentan, tadalafil and selexipag with a double combination therapy based on macitentan and tadalafil, for naive patients recently diagnosed with PHTN; and
  • an ongoing French clinical trial on a double combination therapy based on macitentan and tadalafil, as first-line treatment of PHTN.

The two first studies in the list did not specifically involve tadalafil, but since tadalafil is a particular PDE-5 inhibitor, the court concluded that they were relevant. As for the two last trials in the list, they relied on the use of tadalafil and were therefore directly relevant. Interestingly, these two trials were initiated after the nullity complaint was filed. But the court found that they were nevertheless indicative of R&D work already initiated before that date and could therefore be taken into account for assessing standing.

The next comment by the court probably deserves to be extensively quoted:

Contrary to Actelion’s […] submissions, each of these different elements in isolation is not sufficient to characterize their standing. But their combination demonstrates that the parties are indeed in a situation of competition on the market of the PHTN treatment, and that the latter may rely on the use of tadalafil and pertains to the technical field of the EP’092 patent, which is a second therapeutic use patent not limited to the treatment of sexual dysfunction, and that the combination [of tadalafil] with products which they market is the subject of research authorized in France. To this objective link with the EP’092 patent one must add the actuality and seriousness of the claimants’ plans in France, which do not require a prior commercialization nor a perfect correspondence with the patent’s claims and notably with the specific particle size which is claimed; as well as the threat against them which materialized in the UK.

As a result, Actelion was found to have standing to request the revocation of claims 1 to 12 of the patent. However, regarding claims 13 to 19, the court concluded that there was no standing, as these claims specifically concerned the treatment of sexual dysfunction, and this was not a pathology field covered by Actelion. 

In summary, the court’s position on standing is the following: 

  • standing is appraised in concreto, and a very detailed demonstration by the nullity plaintiff is requested;
  • the plaintiff does not need to demonstrate that they implement or want to implement the various claim features (this is lucky I would say);
  • on the other hand, evidence is required that the plaintiff works in the narrow technical field of the patent at stake;
  • in this respect, one isolated piece of evidence does not seem to be enough, several converging lines of evidence are required.

All in all, the appraisal appears to be extremely strict and it certainly does not encourage preventive nullity suits in any way, although those may be the most rational and effective way to settle a dispute before infringement actually occurs and damages may be incurred.

In a next post, I will try to address the second aspect of the judgment, namely the statute of limitations – the aspect on which Actelion actually lost the case.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, March 16, 2017, Actelion Pharmaceuticals Ltd. & Actelion Pharmaceuticals France v. Icos Corporation, RG No. 15/07920. 

Fight club

The first rule of fight club is you do not talk about fight club. In legalese, I guess you could call that a confidentiality clause. Among other clubs which have been relatively confidential, there is also, well… confidentiality clubs precisely.

A confidentiality club is an agreement between litigants, per which only specified persons (such as specified outside or in-house attorneys) are granted access to some documents. This can be a useful tool for protecting confidential information from being fully released to the other party, while at the same time making sure that the relevant evidence can be debated.

Although I understand that confidentiality clubs are common at least in the UK, the same cannot be said of France.

Courtesy of Denis Monégier du Sorbier, here is an interesting decision issued almost two years ago, which opens the door to such clubs in this country.

In this case, the Dutch company DSM IP Assets BV obtained ex parte orders for carrying out infringement seizures against three defendants (Univar, Novozymes Biologicals France and Novozymes France), in order to demonstrate infringement of one of their European patents. After the seizures were performed, the seized parties filed a motion in court in which they requested that the seized documents should be placed under seal, and that the orders authorizing the infringement seizures be modified.

Such a motion is handled in urgency proceedings by a single judge from the Paris Tribunal de grande instance (TGI), and it results in an order being issued.

It is well established that seized documents which are confidential in particular as they relate to technological or business secrets, and which are not relevant for the demonstration of infringement, should not be transmitted to the claimant. On the other hand, documents which are relevant for the demonstration of infringement are usually to be released to the claimant, even if they relate to technological or business secrets.

After a seizure, it is a common reaction by defendants to request that all documents be placed under seal. It is then usual for an expert to be appointed by the court to sort out the documents and issue an official recommendation as to which ones may be given to the claimant and may thus be part of the ensuing litigation.

This can be a long and cumbersome process, especially if the amount of documents to be handled is large (which can be the case if documents were seized in a digital form); and especially if the parties fight hard on every piece of information in front of the expert, or in front of the case management judge (whenever they claim that there are issues in the way the expertise is handled).

In the DSM v. Univar case, the judge started by rejecting Univar’s and Novozymes’ request to place all seized documents under seal. He noted the following:

[…] As rightly stated by DSM, it is clear that Univar simply made a list of seized documents and stated that they are all confidential, without explaining, document by document, what the nature or the reason of such confidentiality is. 

Besides, it can be seen on the seizure report written in Fontenay Sous Bois that Ms. Theron, CEO, stepped in so as to redact mentions relating to the enzymes on the list of ingredients / food additives, to the amounts on the sales log and the purchases log, to the names of customers and to the turnover on the statement of sales per client, as well as invoices and delivery slips. 

Similarly, it can be seen on the seizure report written in the secondary office in Lieusaint that Mr. Corby, head of the warehouse, stepped in so as to redact […] the names and addresses of recipients on delivery slips, and the products other than Lactozym Pure cited on the reception orders. 

Thus, it should be emphasized that important information such as customers’ names, amounts of sales and products at stake is actually not accessible. If Univar’s representatives relied on confidentiality so as to redact some information, it can be assumed that the information that they allowed to be seized is not of a confidential nature preventing any disclosure. 

Besides, a number of seized documents are public, as either they can be found on the internet, or they are enclosed with the marketed product, and nothing suggests that they may contain any secret information. 

In summary, it is not sufficient for the defendants to simply ask for a blanket seal on everything, without specifying exactly which information is confidential and why – which makes a lot of sense.

There may be another lesson here for seized parties. Sometimes, some sorting out of confidential information and some redacting already takes place during the seizure itself. On the one hand, this may be the best way to prevent really sensitive information from leaking to the plaintiff. But on the other hand, this needs to be carefully done, as it may then be slightly more difficult to prove that non-redacted information should later be redacted as well.

Then comes the second and most interesting part of the decision, dealing with the defendants’ request for a modification of the seizure orders.

Among the various actions and measures authorized by the orders, one paragraph was about setting up a confidentiality club to handle evidence post-seizure. This is the paragraph that Univar et al. wanted to remove from the orders.

 

Two lawyers actuated by the hands of their respective clients

The judge held as follows:

[The defendants] claim that DSM, by inserting this mention “in the middle of the other requests in a unilateral and totally incongruous manner”, attempted to order a club which has no legal existence and no legal basis, and to which they firmly object. 

They add that the notion of confidentiality club is unknown in our procedure, wherein an expert is appointed to select which documents should remain secret, that the practical terms of how it operates are inconsistent, and that such a club was recently refused in another similar case. 

However, they underestimate the judge’s vigilance by thinking that an entire paragraph could elude his wisdom […]. Actually, if setting up such a club is indeed not provided in the statute, on the other hand it does not contravene the basic principles of our law, since it makes it possible for both parties, in an adversarial manner, to agree on the evidence which can be used in the litigation. 

Moreover, it is of course not mandatory. It is clear that if the parties […] do not agree on setting up such a club, to which no attorney at law or patent attorney could possibly be forced, one of them can file a motion in front of the case management judge to request that an expert be appointed to sort out the exhibits and select those which should remain secret, and this is a solution which would then put the parties back on the usual track. 

So, confidentiality clubs are possible in French patent litigation – although mention is made of another decision in which this option may have been rejected.

This is good news as it is an opportunity for parties to cooperate to a limited extent in order to streamline the proceedings and eliminate the additional cost and pains of formal discussions in front of an expert.

On the other hand, according to the order it is always possible for an uncooperative party to balk at joining the club and to have its case heard in front of an expert and/or of the judge at every step of the way.

Case management may be one of the weak points of patent litigation in France. It works well when the parties do cooperate. But it can be relatively easy for a party wanting to delay the lawsuit (often the defendant, but sometimes also the plaintiff) to disrupt the schedule by filing a number of motions, not complying with the deadlines set by the judge, etc. Such a rogue strategy may work to some extent as (i) the right to be heard is regarded by judges as a paramount principle and (ii) the court’s docket is usually more than full anyway, so that there is little incentive for them to force the parties to move on quickly.

Hopefully, confidentiality clubs may contribute to an overall increase in the efficiency of the system, by arousing a form of cooperation on side issues so as to focus on the real disagreement between the parties.

The real question though is whether they will catch on. Eric Halphen, the judge who issued the order in the case at hand, has left the IP chamber of the Paris TGI since then. We are thus looking forward to his colleagues’ position on such clubs for a streamlined fight.


CASE REFERENCE: TGI Paris, 3ème chambre 2ème section, ordonnance de référé, February 13, 2015, Univar et al. v. DSM IP Assets BV, RG No. 15/00822.

Wizard’s chess

Sometimes litigation can get as complex as a game of chess. Each move by one party triggers a responsive move by the other party. France offers a large number of pieces to chess players, with different possible judges and various procedural rules depending on the nature of the claim filed at each move. And since legal actions sometimes seem to get a life of their own independently of the parties who start them, wizard’s chess would in fact be a more accurate depiction: this is the Harry Potter version of the game where animated pieces fight for real on the chessboard.

Today’s decision is but one move in a wizard’s chess game. The ruling itself is relatively short although it tackles a couple of interesting points on the saisie-contrefaçon procedure. However, the overall context is quite complicated and by itself deserves a post to describe it.

In this game, the white team is SPX Flow Technology SAS (SPX) and the black one is Pierre Fabre Dermo Cosmétique (Pierre Fabre) – that’s because the whites are those which move first.

In 2009, Pierre Fabre hired SPX for developing a sterilization process for cosmetic products. This led to the sale of two sterilization installations by SPX to Pierre Fabre in 2011. The same year, Pierre Fabre filed a French patent application related to this sterilization technology. The patent was granted in 2013.

SPX was not too happy-happy about the patent and therefore filed a declaratory action for non-infringement on October 27, 2014 in front of the Paris Tribunal de grande instance (TGI), in order to be able to continue exploiting the sterilization technology and to sell sterilization equipment to other clients. Two months later, on December 23, 2014, they celebrated Christmas by filing an additional claim against Pierre Fabre for ownership of the patent.

The case management judge decided that the ownership claim should be decided on first, since depending on the outcome it might be useless to look at the non-infringement claim. After an oral hearing which took place on September 22, 2015, a first judgment was handed down on November 5, 2015, in which SPX’ claim for ownership was rejected. An appeal is apparently pending.

Meanwhile, on July 17, 2015, Pierre Fabre sent a cease and desist letter to Cosmetolab, one of SPX’s clients, which had bought a sterilization installation from them. It seems that Pierre Fabre had learned about SPX’ dealings with Cosmetolab in the course of the TGI lawsuit.

SPX immediately reacted to this letter by filing a disparagement claim in front of the Tribunal de commerce in Evreux (hometown to both SPX and Cosmetolab) on August 6, 2015, in urgency proceedings. Readers may want to refer to an earlier post in which I have presented some of the specifics of the French Tribunal de commerce and of its urgency proceedings – as opposed to the TGI to which we are more accustomed in patent matters. The judge in charge of urgency proceedings rejected SPX’ complaint. No appeal was filed.

The cease and desist letter was obviously only an initial skirmish in the next battle, since Pierre Fabre then filed a petition for three seizure (saisie-contrefaçon) orders on September 1, 2015. This is an ex parte motion filed in front of one of the judges on duty in the Paris TGI. The orders were granted – as is normally the case, and Pierre Fabre accordingly proceeded with seizures on September 9 and 10, 2015, not only at SPX’ but also at Cosmetolab’s as well as Agro Hall’s, the research center hosting Cosmetolab on a campus in Evreux.

In French patent law, a saisie-contrefaçon is a very usual mise en bouche – an appetizer before the meal consisting of the infringement lawsuit. In this case, since a declaratory action was already pending before the Paris TGI, the meal took the form of a counterclaim for infringement on October 7, 2015.

In the meantime, further urgency proceedings were started by SPX against Pierre Fabre so as to protect some confidential documents seized at Agro Hall’s. However, the parties found a procedural agreement to move this part of the dispute to the main non-infringement case.

Finally (for now!), SPX filed a motion for cancellation of the three seizure orders on October 22, 2015. Cosmetolab and Agro Hall intervened. And this gave rise to the decision that I wanted to talk about today – which obviously plays a relatively minor part in the overall game: namely the order by a (single) judge from the Paris TGI ruling on the motion for cancellation.

Don't be mistaken, wizard's chess is in fact no child's play.
Don’t be mistaken, wizard’s chess is in fact no child’s play.

The argumentation by SPX et al. for canceling the orders was twofold: Pierre Fabre was not entitled to file a petition for these orders, and they had acted in bad faith.

The judge nicely summarized the legal criteria to be applied:

The purpose of the motion for cancellation is to reintroduce the adversarial principle into ex parte proceedings […]; if the petition [for seizure] was granted, those concerned may refer to the judge who issued the order. 

On this occasion, the judge who authorized the seizure hears observations from the seized party or other concerned third party if the seizure did not take place in the premises of the alleged infringers, and he/she examines whether, on the day the seizure was authorized and in view of the explanations and evidence provided by those who request the cancellation, he/she would have issued the same decision, would have limited it or would not have issued it at all. 

The first argument in support of the cancellation claim is probably the most interesting one. Any patent proprietor is entitled to file a petition for a seizure based on its patent. But in this case, a claim for ownership of the patent was pending on the day the petition for seizure was filed. Did this make Pierre Fabre’s petition illegal, as there was a doubt or at least a challenge as to whether Pierre Fabre was the rightful patent proprietor? No said the judge, because Pierre Fabre was the actual owner of the IP at the time the petition was filed, and this is all that matters:

They who petition for a saisie-contrefaçon, in order to demonstrate that their petition is admissible, must file: 

– a copy of the patent at stake,

– a copy of the status of the renewal fees, 

– an extract from the national patent register showing that the petitioner is the patent proprietor as registered. 

In the present case, it is not challenged that [Pierre Fabre] filed such evidence with the judge who authorized the three seizures. 

Although the ownership of the rights was challenged in front of the court in the context of the ownership claim filed by [SPX], on the day the petition was filed [Pierre Fabre] was the owner of the [patent] and was entitled to file such a petition. 

The above quote confirms that it is pretty easy indeed to get a saisie-contrefaçon in France -this is clearly one of the strongest advantages of local practice for patentees.

The second point in SPX and its partners’ argumentation focused on Pierre Fabre’s alleged bad faith. The point was developed in two parts: Pierre Fabre was disloyal because they hid information from the judge in charge of granting the seizure orders; and they distorted the seizure procedure as they were actually looking for other evidence than that needed to prove their infringement case.

There has been a trend in recent case law to cancel orders for seizures when judges felt they had been fooled by bad faith litigants. SPX et al. attempted to follow the trend – but this time to no avail.

The timing of the petition filed by Pierre Fabre was admittedly rather remarkable: the eve of the pleadings of the ownership part of the case. SPX said the petition did not mention that this oral hearing was about to take place. The judge replied that this was not an issue, as the various pending legal proceedings were mentioned in the petition, and practically speaking the judge who issued the orders for seizure was also the chair of the court dealing with the ownership and infringement case, so that she was well aware of the timing.

Regarding the alleged distortion of the seizure procedure, SPX et al. argued that Pierre Fabre’s true agenda was not to find evidence of patent infringement but rather to intimidate Agro Hall so as to stop the business deal with SPX, and also to interfere with the then pending disparagement lawsuit in Evreux.

Well, let’s face it, although the official purpose of a saisie-contrefaçon is to find and preserve evidence of infringement of an IP right, intimidation is often part of the reasons why a saisie is performed. But this is also true of legal actions in general. In this case, the judge was not convinced that intimidation or interference with other legal proceedings were Pierre Fabre’s actual motives:

[…] [Pierre Fabre] filed […] an infringement counterclaim within the statutory time limit against [SPX], Cosmetolab and Agro Hall, which shows that their intention was really to sue the plaintiffs of the declaratory action. 

No disloyalty has been demonstrated, for the letter of July 17, 2015 is mentioned in the petition as a cease and desist letter to Cosmetolab, and a seizure was subsequently requested against this company. 

Finally and above all, the president of the Evreux Tribunal de Commerce has [already] issued the judgment against which no appeal was filed, so that the evidence collected during the seizures was not used in those proceedings. 

The orders for seizures were therefore not cancelled, and we can thus wait for the next move from one side or the other.

My guess is that the rest of the case will drag on for a very long time. The situation is quite interesting because:

  • On the one hand, the French patent has an equivalent pending at the EPO (with two divisional applications already filed). Now, in such a case, the court must stay the infringement proceedings (article L. 614-15 Code de la propriété intellectuelle) until the European patent is granted and substitutes for the French patent, or until the European application is refused, withdrawn or deemed withdrawn, or until the European patent is revoked. So this can take forever (especially if the divisional applications also need to be taken into account, which is an interesting legal question).
  • But on the other hand, examination proceedings at the EPO were suspended as from January 29, 2015 due to the pending ownership lawsuit.

At the present time, and pending resumption of the examination proceedings at the EPO, this looks like stalemate!


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé-rétractation, 3ème chambre 1ère section, February 11, 2016, SPX Flow Technology et al. v. Pierre Fabre Dermo Cosmétique, RG No. 15/15073.

Lyon’s share

It has been almost seven years now since patent litigation in France has been fully centralized in Paris. Patent cases used to be heard in various Tribunaux de Grande Instance (TGIs) in the entire country. The number of TGIs having jurisdiction for patent matters was progressively reduced and finally all cases were consolidated in Paris.

Similarly, at the appeal level, the Cour d’appel de Paris has now exclusive jurisdiction in all patent cases. We can still see from time to time decisions issued by other Cours d’appel in relation with legal actions started a number of years ago before the centralization was completed.

But new cases do not normally end up in a court outside of Paris, save if the plaintiff makes the unfortunate mistake of filing its writ of summons with the wrong court.

The present case is an exception, but certainly not one due to an ill-informed litigant. On the contrary, this was certainly the result of a sophisticated (although, in the end, unsuccessful) strategy by Swedish pharmaceutical company AstraZeneca AB.

AstraZeneca owns European patent No. EP 0907364 covering the active substance quietapine for treating schizophrenia, and markets a corresponding pharmaceutical product called Xeroquel.

Generic company Mylan filed a nullity action in connection with the French part of the patent on April 28, 2015, in front of the Paris TGI – which, as recalled below, has exclusive jurisdiction for patent matters, including nullity actions of course. Apparently, another nullity action had already been started earlier in 2014 by Accord, and Mylan filed an intervention so as to be part of that nullity action. How Mylan can be part of two different actions having the same purpose is an interesting question which is however not addressed in the decision that I am reporting on today.

Mylan launched its generic version of Xeroquel at risk, without waiting for the outcome of the nullity action. Accordingly, AstraZeneca filed a counterclaim for infringement of the French part of the European patent on June 9, 2015, still in front of the Paris TGI.

Now comes the interesting part.

AstraZeneca attempted to obtain interim relief against Mylan. The usual way to do this, if an infringement claim is already pending in front of the Paris court, is to file a motion with the judge in charge of case management, who then decides on the motion pending the full trial on the merits. But AstraZeneca did not take the usual path.

Instead, AstraZeneca filed a motion for interim relief in front of the “juge des référés“, i.e. the judge in charge of urgency proceedings, at… the Tribunal de commerce (sometimes nicknamed T. com.) in Lyon. In this motion, AstraZeneca did not submit a patent infringement claim, but rather a claim for unfair competition.

Why apply to the juge des référés of the T. com.? Because, AstraZeneca stated, this is the judge having general jurisdiction for granting interim relief in situations of unfair competition. But why a judge in Lyon? Because, the defendant having its seat close to this city, this is the judge who had territorial jurisdiction – still in keeping with general, non-patent rules of judicial organization.

The Lyon judge accepted to hear the case and issued an order prohibiting Mylan from marketing the quietapine generic drug until the expiry of the French part of the European patent, i.e. May 27, 2017, or until a final decision of revocation is issued; a recall of the products was also ordered, as well as a publication of the decision.

In summary, AstraZeneca obtained the most positive result that they could ever have hoped for.

The order was issued on November 12, 2015. Mylan reacted by immediately filing an appeal and by requesting accelerated appeal proceedings. The entire process was, I must say, particularly fast and efficient, since the decision of the Cour d’appel de Lyon on this matter is dated December 17, 2015 – so the complete appeal process took only one month. The Cour d’appel set aside the first instance order and declared that the motion filed in front of the juge des référés in Lyon was in fact inadmissible because the judge had no jurisdiction.

A word must probably be said here of the differences between a TGI and a T. Com.:

  • TGIs are general courts dealing with civil matters. T. com.s, on the other hand are specialized in handling disputes between commercial companies (or persons).
  • TGIs are exclusively composed of government-appointed judges, while T. com.s are composed of elected judges.
  • Accordingly, TGI judges are professional judges, who are civil servants, while judges in T. com.s are company managers.

I have heard some lawyers familiar with T. com.s say that these courts are somewhat unpredictable and can sometimes render pretty wild decisions. What is almost certain is that the juge des référés was not fully aware of the subtleties of IP law, which is very far from his or her everyday practice.

Judicial organization in France shown on a simplified diagram.
Judicial organization in France shown on a simplified diagram.

So, again, it was a bold and clever move for AstraZeneca to request the preliminary injunction far from the Ile de la Cité in Paris. The judge in charge of case management at the TGI would likely have made a more severe assessment of the patentee’s case – not least because the European patent was already revoked in six other countries, including Germany, the UK and the Netherlands, as we learn in the Cour d’appel decision.

Now, going back to the issue of jurisdiction, article L.615-17 of the Code de la propriété intellectuelle provides that

Civil actions and motions relating to utility patents, including […] when they also concern a connected issue of unfair competition, are exclusively heard by [TGIs] mentioned in a decree […].

The decree in question names the Paris TGI as the one having exclusive jurisdiction for the purposes of article L.615-17.

Therefore the central issue, which was revisited by the Cour d’appel, is to which extent the claim brought by AstraZeneca in Lyon was related to a patent, or a connected issue of unfair competition.

The answer to this question prima facie seems pretty obvious, so how did the patent proprietor defend its position?

Again, they were rather creative, in that they stayed away from the Code de la propriété intellectuelle (which contains the definition of patent infringement), and rather argued that Mylan had committed other torts, and more specifically:

  • violated articles L.4113-6, L.4163-2, L.5122-10 and R.5122-17 of the Code de la santé publique, article 1382 of the Code civil and article 1.2.2.1 of the rules of ethics applicable to pharma labs, by offering free unsollicited samples of generic quietapine to pharmacists;
  • violated articles L.5122-1 and L.5122-2 of the Code de la santé publique, article 1382 of the Code civil as well as the recommendations issued by the ANSM (i.e. the regulatory authority in charge of pharmaceutical products), by inserting the mention “identical to the original drug” on its ads; and
  • violated article 1382 of the Code civil by committing passing off, in view of the aspect of the generic quietapine packaging and tablets.

But such creativity did not pay off in front of the Cour d’appel, which held that:

the facts and evidence submitted to the judge for defining a manifestly illicit breach caused by disloyalty in free competition are necessarily linked to the rights that AstraZeneca derives from their patent, which confers a monopoly to them until its expiry or until its revocation by a court, the effect of which is retroactive, so that the civil action started in front of the juge des référés of the Tribunal de commerce de Lyon is necessarily a connected unfair competition action, so that he does not have jurisdiction due to the subject-matter and the exclusivity of jurisdiction imparted by statute to the Paris TGI. 

Said otherwise, all torts possibly committed by Mylan in this case are closely related to the alleged patent infringement. Patent infringement is a matter for the Paris TGI to rule upon, not for the Lyon T. com., and so are any side claims linked to this patent infringement (such as the passing off claim).

The court also stated that the various violations of the Code de la santé publique alleged by the patentee were not relevant, because this is a law which does not regulate competition between pharma companies:

All the violations of the Code de la santé publique which are alleged do not aim at protecting competition but rather public health, notably by imposing rules of ethics to pharmaceutical labs and by imposing advertising rules protecting drug consumers. 

The alleged violations are not within the ambit of jurisdiction of the juge des référés of the tribunal de commerce, for deciding measures of injunction […] similar to those that the infringement judge could take, because these violations, if they existed, would not constitute a manifestly illicit breach of free competition. 

And thus the logical conclusion was that:

[…] although it is certain that the juge des référés of the tribunal de commerce has in principle jurisdiction with respect to proven unfair competition, when there is a manifestly illicit breach, in order to take preliminary and injunction measures, even if there is a serious defense, because he is the natural judge between two commercial companies, […] the special provisions of the Code de la propriété intellectuelle prevail when, as in the present case, commercial parties are opposed in a lawsuit relating to intellectual property, the judge of which, having jurisdiction for ruling on the validity of the title or on infringement, has been previously applied to, before the urgency unfair competition claim. 

The judge of the Lyon tribunal de commerce has thus in this case no jurisdiction for ruling as he did and committed abuse of power.

Last but not least, the court ordered AstraZeneca to pay 100,000 euros of attorney fees to Mylan, which looks like a fairly high amount in the context of urgency proceedings. Courts have an almost complete discretion in terms of reimbursement of attorney fees, which they decide on as a matter of equity. Usually, when the amount is remarkably high, there is a sense that the court may have wanted to punish the losing party and to send a warning message.


CASE REFERENCE: Cour d’appel de Lyon, 1ère chambre civile, section A, December 17, 2015, Mylan SAS v. AstraZeneca SAS & AstraZeneca AB,
RG No. 2015/08783.