Smart invalidation

Today’s post will be relatively short, I think, as it will merely confirm a trend already noted in earlier posts for instance here, here and there.

The trend is that, yes, it is incredibly difficult to win a patent nullity case based on public prior use.

On April 4, 2011, Grenoble-based company Smart & Green (formerly IPW Europe) filed a nullity suit against Mr. Christophe Frilley, owner of French patent No FR 2944858. It took 6 years for the Paris Tribunal de grande instance (TGI) to issue a decision. But before a rumble of discontent starts spreading in the readership, I should add that the TGI judges cannot be blamed for this long period of time, based on what I could gather from the public inspection of the patent file.

In fact, at the time the nullity suit was filed, the patent had not been granted yet. The judgment does not specify whether a formal stay was pronounced, but at any rate the case could certainly not progress until the grant of the patent.

In addition, the plaintiff apparently also filed a claim for ownership of the patent application. This led the French patent office to stay the grant proceedings, from May 2011 to September 2014, at which point the ownership claim was withdrawn, which led the French patent office to resume the grant proceedings.

The patent finally issued in August 2015. A few days later, the patent proprietor filed a request for limitation of the patent, which was granted a few months afterwards. 

Foreign readers may wonder why the applicant did not simply amend the claims before issuance of the patent, as opposed to afterwards. The explanation is simple: there are only limited time frames within which an applicant can amend claims, in French grant proceedings. In this case, the relevant time frame had closed after the applicant responded to the preliminary search report back in 2010. Therefore, the applicant was unable to react to the plaintiff’s nullity arguments by way of a claim amendment in the grant proceedings. He had to take advantage of limitation proceedings after grant.

Let’s now move on to the nullity arguments presented by Smart & Green.

Looking for something smart and green? How about this 1895 “mechanical flower for advertising purposes“?

The patent at stake relates to a lighting assembly. Smart & Green argued that the claimed invention had been disclosed in its so-called Rock lamp (for swimming pools) which was allegedly put on the market in 2008. 

The court was convinced that the Rock lamp was indeed made available to the public before the filing date of the patent, since at least samples of the lamp were sent to third parties for future marketing.

However, there was not enough evidence that these lamp samples were according to the claims of the patent. In particular, claim 1 of the patent as limited mentions a plurality of diffusers which can interchangeably accommodate a lighting module, in a waterproof manner.

But the documentation from 2008-2009 provided by the claimant did not clearly show whether this feature was present. 

By way of example, one email mentioned that any diffuser could be adapted on the lamp, but the court noted that it was unclear whether this meant that the Rock lamp was modular, as required by claim 1; or whether it simply meant that manufacturing could be adapted to include any diffuser.

Smart & Green had also filed two Soleau envelopes in 2008 on a so-called Little Rock lamp (for a presentation of what is a Soleau envelope, see this previous post). But again, the product described in these documents did not clearly comprise interchangeable diffusers.

The court was apparently more convinced that the feature at stake was indeed shown in internal development documents dating back to the summer of 2008. But these documents were not public and related to a so-called “IPW Lamp Project“. It seems that there was no evidence that the IPW Lamp Project was implemented in the Rock lamp which was made available to the public – or that it was publicly disclosed in any other way.

This led the court to reject the public prior use challenge.

Fortunately for the plaintiff, they also had good old traditional prior art in store as well, in the form of a Japanese patent application and a European patent application. 

The court held that each of these documents disclosed most of the features of claim 1, except the two which were added in the limitation proceedings, per which the diffuser can interchangeably be fixed to the lighting module owing to clicking or screwing, and a sealing ring is provided between the lighting module and the diffuser.

But these features were found to be obvious for the skilled person, even without referring to any specific secondary reference: the clicking or screwing fixation would be achieved simply based on common general knowledge, whereas the sealing ring was obvious to provide in view of the objective of supplying a waterproof lighting assembly.

Claim 1 was thus canceled for lack of inventive step. The dependent claims were quickly reviewed one by one, and as we like to say in French, the baby was thrown out with the bathwater.

I promised a short post, so now seems like a good time to stop.

But the bottom line is that I am still looking forward to reading a successful public prior use argument these days.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, March 24, 2017, Smart & Green v. Christophe Frilley, RG No. 11/06949.

No claim is etched in stone

The appeal ruling reported on today kept people waiting for a very long time, but the wait was worthwhile for case law observers, as it contains a number of interesting aspects.

The patent at stake is EP 0570484. It was filed on February 4, 1992 and claimed a priority back to February 4, 1991. The patent proprietor, Trikon Technologies Inc., had an infringement seizure conducted in September 2006 and then sued Alcatel Vacuum Technology France (AVTF) for infringement of the patent.

In case you are wondering what the usual pun in the title of this post is about, the patent relates to high density plasma machines for depositing or etching a substrate.

Over the course of the litigation, the original companies disappeared, the patent was sold, so, in order not to get lost, I will simply refer to the parties as the plaintiff and defendant, or similar designations.

In the first instance judgment dated March 3, 2009, the patent claims asserted by the proprietor were revoked by the Tribunal de grande instance for lack of novelty.

The plaintiff appealed, and this is when the case got dormant for a very long time. Presumably both sides dragged their feet. Well, when I say the case got dormant, this is not entirely accurate, as a lot actually happened.

First, the proprietor initiated central limitation proceedings at the EPO – and later abandoned it.

Then, a national request for limitation was filed at the French patent office (INPI), and was finally granted in September 2012, after a number of objections by the patent office and the defendant acting as a third party.

In May 2014, the defendant filed a motion for canceling the order for infringement seizure. Never too late! The appeal judgment does not mention what the objection was, but it was certainly a serious one, as the plaintiff gave up and withdrew its seizure exhibits from the record. Finally, the appeal went to trial in December 2016.

As I said, there are several interesting aspects in the ruling, but I will focus on the appraisal of the limited claims by the appeal judges.

First, an unconventional objection was raised by the defendant. According to article 564 of the Code de procédure civile, “new claims” may not be filed on appeal. By “new claims” is meant legal claims, not patent claims of course. The question is which claims filed on appeal are really new and which ones are not so new. In particular, according to article 566:

Parties may also make requests explicit if they were virtually comprised in the claims and defenses submitted to the first judge, and add thereto any claims which are an accessory thereto, a consequence thereof, or a complement thereto.  

In this case, claim 1 of the patent as limited comprised new features which had thus not been debated in first instance. The defendant then argued that the infringement case based on claim 1 as limited was a “new claim” according to article 564 and thus inadmissible. A very interesting argument indeed, but a long shot, as the court noted that the patent proprietor was entitled to limit its claims “at any time“, and that the limitation was retroactive, pursuant to article L. 613-24 of the Code de la propriété intellectuelle.

Therefore, this inadmissibility defense was rejected. It is true that if it had been successful, the benefits of limitation during litigation would have been considerably affected.

The second way the defendant challenged the limitation was by asserting that the subject-matter of the limited claims extended beyond the contents of the application as filed.

Here is claim 1 as limited, wherein the highlighted portion represents the main changes relative to claim 1 in the application as filed:

A system for generating a high density plasma comprising:

a plasma confinement chamber of cylindrical form;

means for injecting a gas to be ionized into the chamber;

means disposed adjacent the chamber for generating a longitudinal magnetic field in the chamber; and

means for generating high frequency energy at a frequency of 13.56 MHz and at power in the range of 100 W to 5 kW, comprising an impedance adaptation circuit;

the system being characterized in that an antenna forming means comprises:

a single loop element encompassing the cylindrical chamber, the loop element being disposed in a plane at an angle of in excess of 45° to the central axis of the chamber, and positioned in an intermediate region along the length of the chamber, said single loop element being coupled to the means for generating high frequency energy. 

State of the art etching… in 1899. For a bit of nostalgia: the patent was granted 4 months after filing.

The court started by restating the standard to be applied, which was accurately imported from the EPO doctrine:

The content of the application as filed must be interpreted as encompassing the description, the claims and drawings, as well as any teaching, even implicit, directly and unambiguously deriving therefrom, as understood by the skilled person.

This was followed by a long and complex discussion of the teaching of the application, which I will not attempt to fully reproduce here.

In a nutshell, the value of a frequency of 13.56 MHz was mentioned in claim 4 of the application, but (1) this value was not disclosed in association with a power range of 100 W to 5 kW, and (2) claim 4 depended on claims 2 and 3 which recited further features not included in claim 1 as limited.

So one issue was whether the value of 13.56 MHz was generally applicable to the power range of 100 W to 5 kW. And another issue was whether this value could be isolated from the other features disclosed in original claims 2 and 3.

Regarding the first issue, the court considered that the application generally taught a power range of 100 W to 5 kW and a frequency range of 2 to 50 MHz. One sentence in the description read: “to effect wave coupling and establish a high plasma current density, measured in mA/cm2, the antenna loop 12 is driven at 13.56 MHz and with RF energy of the order of 2.0 kW (in the range of 100 W to 5 KW) by the RF energy source 19“. This was interpreted as meaning that the whole power range could be achieved with the preferred frequency of 13.56 MHz, and that the value of 2.0 kW was only an example. The interpretation was confirmed by looking at the examples and figures.

The defendant argued that generating helicon waves required matching a certain frequency with a certain power, but the court did not agree that the invention was only about generating such helicon waves.

Regarding the second issue, original claim 2 mentioned a magnetic field of les than 1000 gauss, a plasma density of more than 1013/cm3 and a loop element at an angle of about 90° relative to the magnetic field; and original claim 3 mentioned a first plasma current and density peak in the grange of about 50 gauss and a second plasma and density peak in the range of about 400 gauss.

The court analyzed the application in detail again and came to the conclusion that these various features were not mandatory or essential, and not inextricably linked with the frequency value of 13.56 MHz.

Thus, there was no extension of subject-matter beyond the content of the application as filed. 

Why on earth original claim 4 was then exclusively dependent on claim 3, which itself depended on claim 2, and why this claim did not directly depend on the broadest claim 1, is unclear to me. Generally, this is a hint that the various technical features at stake are probably interconnected. Not in this case, apparently – but as I said, the technical discussion was quite complex.

Anyway, the patent as limited survived the added matter challenge. It also successfully passed novelty and inventive step challenges.

On the other hand, the court found that there was no evidence of infringement, and this is another interesting aspect of this case. As explained above, the evidence seized in 2006 was no longer part of the record, further to the late challenge brought by the defendant against the seizure order.

The plaintiff relied on technical manuals and technical specifications of the defendant’s various machines. The court did not even examine whether the technical information contained in these documents reproduced the subject-matter of the patent claims.

In fact, it was sufficient for the court to note that there was no clear evidence of any potentially infringing act (such as manufacturing, marketing or the like). The new assignee of the patent filed an affidavit by its vice president and CFO, but this affidavit did not convince the court:

The affidavit […] contains tables originating from Alcatel’s documentation and states that “Alcatel made and sold 129 litigious machines during the litigious time period”. This does not make it possible to identify the machines at stake. And, due to the quality of its author, it cannot represent objective evidence of the manufacturing or marketing of machines reproducing the features of the EP’484 patent. The court notes that, in view of the documents relied on by SPTS as to the number of machines allegedly manufactured and marketed, they did not undertake any effort making it possible to physically identify any one of the allegedly infringing machines. 

Technical documents do not demonstrate the actual manufacturing of the machines that they describe. And even if they were indeed manufactured, it is no possible to determine the date of manufacturing nor the manufacturer. 

Remarkably, the court also rejected a request for the appointment of an expert to assess the extent of infringement and the corresponding damages. 

The take-away message here is that infringement seizures are a powerful tool for IP right holders in this country. But if for some reason the infringement seizure falls apart, it becomes much more difficult for them to prove their case, and courts are generally unwilling to help them complete it.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 – chambre 2, March 10, 2017, TTI Liquidating Inc. et al. v. Pfeiffer Vacuum et al., RG No. 15/01226.

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.