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. 

Free infringement

Infringement proceedings are a thing of many possible metaphors, and one of them may be an assault course. Invalidity defenses, non-infringement arguments, burden of proof issues, procedural traps are some of the hurdles that a plaintiff has to go over along the way.

So, after climbing up so many walls, nets and ropes, it is really too bad when the plaintiff falls into a muddy pit just before the finish line. In the case at hand, the muddy pit was the assessment of damages.

Pick your track to a judicial win.

On March 20, 2014, the Paris Tribunal de grande instance (TGI) held that the two companies Carrera and Texas de France had committed acts of infringement of European patent EP 1067822 directed to a heating element for a heating or cooking apparatus, owned by Muller & Cie.

The court pronounced a permanent injunction against the defendants and ordered that they should provide accounting information regarding the infringing devices in order to make it possible to compute damages.

This judgment was confirmed by the Paris Cour d’appel on September 6, 2016. In the meantime, in view of the accounting information filed by the defendants, the TGI issued a second judgment dated January 14, 2016, in which Carrera and Texas de France were condemned to pay Muller damages of respectively 327,733 euros and 280,130 euros for Muller’s commercial prejudice, plus 100,000 euros for its moral prejudice.

The defendants appealed, which leads us to today’s judgment, issued on December 9, 2016.

In short, the appeal judges set aside the decision of January 14, 2016 and set the total amount of damages to… zero euro. How is this even possible, since acts of infringement were indeed committed?

The answer is that the legal basis for Muller’s computation of damages was held to be incorrect, and no alternative, legally correct computation seems to have been proposed by the plaintiff.

The method for the computation of damages is set in article L. 615-7 Code de la propriété intellectuelle:

In order to set damages, the court separately takes into account:

1° Negative economic consequences of the infringement, including lost profits and losses suffered by the harmed party;

2° Moral prejudice inflicted to said party;

3° And profits made by the infringer, including savings on intellectual, material and promotional investments made owing to the infringement.

However, the court may, alternatively and upon request of the harmed party, grant a lump sum in terms of damages. This lump sum is higher than the amount of royalties or rights which would have been due if the infringer had asked for the authorization to use the right that it infringed. This sum does not exclude the further indemnification of the moral prejudice of the harmed party.  

The current wording of the article derives from the implementation of the enforcement directive 2004/48/EC, with a later modification in 2014. And it is not really crystal clear.

Computation of damages based on the “negative economic consequences” of the infringement is a conventional and well-delineated exercise.

On the other hand, how “profits made by the infringer” are to be “taken into account” by the court is not self-evident. It is also not so clear whether the plaintiff has full discretion to rely on the alternative lump sum calculation, or whether, in some circumstances, it is mandatory to rely on one assessment method or the other.

If we focus first on the issue of how infringer’s profits are to be “taken into account“, one way to interpret this provision would be to consider that the infringer’s profits may be awarded to the claimant as an alternative to loss profits damages. Another way would be to consider that the infringer’s profits are merely a modulating factor in the assessment of loss profits.

In the present case, Muller put forward a radical theory – successfully so in first instance, i.e. that the entire infringer’s profits should be awarded to the patent proprietor. However, this method was fully discarded at the appeal stage.

The Cour d’appel noted that Muller did not personally exploit the patent. The patent was exploited through six licensed subsidiaries, which tried to intervene in the infringement proceedings. However, the respective license agreements were not registered with the French patent register, so that they were not enforceable against third parties. Accordingly, the claims brought by the six licensees were previously held inadmissible in the initial 2014 judgment – and the unregistered licensees did not appeal.

In this particular context, the Cour d’appel deemed that the sole proper methodology for assessing damages was the so-called indemnifying royalty provided in the last paragraph of article L.615-7:

[Muller] does not claim the payment of the indemnifying royalty which was however rightly mentioned by the appellant, but this mode of compensation should be applied in this case. This royalty indeed corresponds to the percentage of the turnover that Muller could have claimed from the two companies sued for infringement, if the authorization to exploit the patent that it owns had been requested, with an additional penalty to take into account the existence of the wrongful acts committed against it. 

But again, Muller did specifically not claim an indemnifying royalty. Muller argued that the words “upon request of the harmed party” in article L. 615-7 meant that this mode of calculation was not mandatory. The court concurred and stated that it “could not validly impose such a mode of compensation of its economical prejudice” on Muller. But this turned out to be a self-inflicted wound, as the sole mode of compensation put forward by Muller was not acceptable according to the court, for the two following reasons:

  • first, Muller did not personally suffer any lost profits;
  • second, the infringer’s profits may not be claimed by the plaintiff in the absence of lost profits.

As to the first reason, Muller argued that, although it had not directly suffered lost profits, there were lost profits for the overall Muller group. The court replied that Muller could not possibly claim lost profits suffered by other companies, namely the six licensees, which are distinct legal entities (in fact, it seems that it was not even properly demonstrated that they were part of the same group as Muller). The licensees’ claims were held inadmissible by the TGI, and they did not appeal. Thus, only Muller’s personal lost profits could possibly be compensated.

Yet, no lost royalties were claimed by Muller. On the one hand, the six licenses were apparently royalty-less, so that Muller did not personally lose money due to the licensees’ possible lost sales. On the other hand, Muller could have relied on a depreciation of the invention’s value due to the infringement, but did not do so. Here, the court cruelly noted: “again, it is not the court’s task to compensate an item of prejudice in the absence of a claim from the owner of the right in this respect“.

Then comes the second point on the infringer’s profits. Says the court:

In addition, it is true that the law of October 29, 2007, transposing the 2004/48 directive, provides that the judge should take into account the “profits made by the infringer”. But it did not introduce a possibility to confiscate them into the statute. Said taking into account is limited to the part which may remain, once the losses related to the exploitation have been assessed, in order to achieve a full compensation of the prejudice. 

In other words, according to this court, the infringer’s profits can only be taken into account in the context of the assessment of a commercial prejudice. The confiscation of the infringer’s profits is not an alternative option which would be available to the plaintiff instead of claiming the compensation of a commercial prejudice.

Consequently, Muller’s claim for damages was simply rejected. The court noted in passing that the permanent injunction, which remains in place, is a proper sanction in this case anyway.

The last nail in the coffin was the rejection of Muller’s claim based on the moral prejudice which was said to be insufficiently substantiated.

All in all, this is a tough decision for the patentee, although we can have a feeling that the court was irritated by its behavior. For instance, there is a remark that the patentee obtained evidence of the infringement as soon as July 2009 owing to a bailiff’s report but waited until May 2011 to file its complaint.

It remains to be seen whether the Cour de cassation will have to rule on the Cour d’appel’s interpretation of the legal provision on the apportionment of the infringer’s profits.

In the meantime, one take-away message can be that the best practice for a patent proprietor is certainly to claim an indemnifying royalty, if only as an auxiliary request. Indeed, this should always be a possible option. Better safe than sorry.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, December 9, 2016, SARL Carrera & SAS Texas de France v. SA Muller et Cie, RG No. 16/02891.

Sunset for Cynrise

Easter always brings back chocolaty memories. The question as a child growing up in the Northeastern part of France on Easter morning was whether eggs had been brought by the Easter bunny. And the question as a child also growing up in the Southeastern part of France was whether eggs had been brought by the Easter bells.

It has been a while since the Easter bunny and the Easter bells stopped feeding me with chocolate. But this year there was an even better surprise on Sunday morning, in the form of an SPC-related guest post by Lionel Vial. And as all readers will probably acknowledge, SPCs are a delicacy of their own.

Rush of nostalgia: Easter eggs are no longer what they used to be.

Here is to Lionel.

The case discussed on this Easter day relates to a ruling of the Paris Cour d’appel dated January 20, 2017 which upheld a decision of the French patent and trademark office (INPI) to reject an application for a supplementary protection certificate (SPC) for a biological medicinal product.

French SPC application No. 11C0054 was filed on December 14, 2011 by Laboratoire Français du Fractionnement et des Biotechnologies (hereafter LFB), a French company specializing in medicinal products purified from human blood. The SPC application was based on French patent No. 2722992 filed on July 28, 1994, which claimed a method for the manufacture of a C1-esterase inhibitor concentrate (claim 1), as well as the concentrate obtained by the method (claim 11).

The SPC application was further based on marketing authorization (MA) No. EU/1/11/688/001 for Cinryze® comprising “C1 inhibitor, human (INN)” as active ingredient.

For those whose curiosity goes beyond patent law, C1 is one of the proteins forming the complement system, which itself is part of the innate (i.e. non-adaptive) immune system. The C1 inhibitor is a natural protein, found in blood, the role of which is to regulate the activation of the complement system. The C1 inhibitor is especially useful for individuals suffering from a rare autosomal dominant disease, caused by a deficiency of functional endogenous C1 inhibitor, which manifests itself in the form of angioedema attacks.

The SPC application was rejected on December 22, 2014 by the INPI for not complying with Article 3(d) of Regulation (EC) No. 469/2009 (hereafter the SPC regulation), i.e. the MA for Cinrize® was considered not to be the first authorization to place the product on the market as a medicinal product.

This was because a prior MA had been issued on June 28, 1999 for Esterasine comprising “human C1 esterase inhibitor” as active ingredient.

LFB lodged an appeal against the decision of the INPI before the Paris Cour d’appel and essentially argued that the human C1 inhibitors of Cinrize® and Esterasine were in fact two different products.

The precise arguments used by LFB are not very clearly summarized in the decision.

But it appears that LFB stressed that the way biological medicinal products, such as Cinrize®, are manufactured has an impact on their molecular structure, which, in the present case, was evidenced by a half-life of 56 hours for Cinrize® vs. 30 hours for Esterasine.

This did not convince the Cour d’appel which considered that:

The regulation relating to SPCs does not provide for exceptions to the definitions of a “product” and a first MA for biological medicinal products or blood products which would allow defining them as a function of their methods of manufacture or under their commercial names; it is therefore irrelevant that the SPC application is based on an MA for the “Cinryze” drug since the product protected by the basic patent is “the C1 inhibitor, human”; [besides] if LFB, after having initially claimed the latter, has amended the application by claiming “the C1 esterase inhibitor of the Cinryze drug”, this limitation made after the objections of the INPI cannot be effective since either the patent or the MA only relate to the “C1 inhibitor” as active ingredient of the Cinryze drug. 

To put it more clearly, the Cour d’appel took a very formal approach of Article 3(d) of the SPC regulation and simply considered that, if the names of the active ingredients mentioned in two different MAs are the same, then both MAs in fact relate to the same product, without further consideration as to the true physicochemical identity between the two products, as in the case of biological medicinal products obtained by different methods of manufacture.

LFB also argued that, in the assessment report of the European Medicines Agency (EMA) which led to the MA, the purified and concentrated C1 INH (i.e. C1 inhibitor) after pasteurization and nanofiltration is considered as the active substance.

The Cour d’appel responded that

the subject matter of this report was a marketing authorization application for Cinryse, so that, if [the report] specifies what its active ingredient is, it does not conclude that it would be a new product, the novelty of the medicinal product being different from that of its active ingredient; accordingly this does not contradict the decision of the INPI.

Moreover, the Cour d’appel noted that this latter argument was not submitted to the INPI which, therefore, could not do otherwise than decide that the MA for the drug Cinryze was not the first one for the active ingredient which is the “C1 inhibitor, human”.

It is to be noted that the latter argument was however decisive in overcoming the objection of the Dutch patent office based on Article 3(d) of the SPC regulation for the corresponding SPC application in that country (NL SPC application No. 300510), thereby securing the grant of an SPC.

It is therefore tempting to imagine that the fate of the French SPC application could have been changed for the best had the attention of the INPI examiner been drawn to the definition of the active substance in the assessment report of the EMA.

As a final note, this case reminds us of the ruling of the Paris Cour d’appel of April 12, 2016 which upheld the decision of the INPI to reject SPC application No. 08C0003 covering Cervarix®(GlaxoSmithKline Biologicals) which was discussed here.

In that case also the Cour d’appel refused to take into account the impact of the manufacturing process of biological products (production in yeast cells vs. insect cells) on their structure, sticking to the definition of the product given in the MA.

One can wonder if this literal approach, which has the advantage of simplifying examination of SPC applications, is in keeping with the fundamental objective of the SPC regulation which is to make up for the insufficiency of the period of effective protection of a medicinal product under a patent to cover the investment put into pharmaceutical research as recalled by the CJEU in C‑130/11 (Neurim).

Indeed, in the present case, it appears from the assessment report of the EMA that new clinical data was produced for the C1 inhibitor of Cynrize® in support of the MA application. This is probably because the C1 inhibitor of Cynrize® is a biological product the structure of which depends on the manufacturing process, thereby making it impossible to rely on clinical data obtained with previous C1 inhibitors.

It is generally considered that clinical trials amount for the larger part of investment in drug development. It could therefore be considered that the active ingredient of Cynrize® is a new product the development of which necessitated investment entitling it to SPC protection.

As such, when assessing conformity with Article 3(d) of the SPC regulation, perhaps the necessity to generate specific clinical data in order to obtain an MA for a biological product should be the primary criterion for determining if an MA is the first one to place the biological product on the market, rather than simply determining if the name of the active ingredient is the same one as that of a prior MA.

Thank you Lionel. Easter being about resurrection even more than about chocolate eggs, it remains to be seen whether this SPC application may come back to life on cassation appeal.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, January 20, 2017, SA Laboratoire Français du Fractionnement et des Biotechnologies v. Directeur général de l’INPI, RG No. 16/08814.

Copy and paste

What is new in today’s post? Well, strictly nothing. Nope, nothing new under the sun. 

In fact, the recent ruling by the Cour d’appel de Paris in Avery Dennison RIS France & Avery Dennison Sytèmes d’étiquetage France v. Directeur général de l’INPI is pretty much a copy and paste of Free & Freebox v. Directeur général de l’INPI issued a few months ago and already reported on here.

So is there really a need to discuss it? After all, case law is more interesting when it tackles new issues or when it features a change in practice.

But the point is, sometimes even established case law can be somewhat questionable from a practitioner’s perspective. And in this case, I must say I struggle with fully understanding the court’s reiterated rationale.

Copying an IP judgment – a paradox?

The issue at stake is the limitation of a patent in front of the INPI (which is the French patent and trademark office), and which options are available to third parties to challenge this limitation. Appeals against decisions issued by the INPI are generally supposed to be lodged with the Paris Cour d’appel. Accordingly, a number of third parties have tried to challenge decisions of limitation of patents in front of the Cour d’appel, by directly appealing these decisions – oftentimes parallel to ongoing litigation. And they have lost, their appeals being deemed inadmissible. The present case is no exception.

In particular, the Paris Cour d’appel (with the support of the Cour de cassation in Teisseire v. Directeur général de l’INPI) has consistently held that challenges against the limited claims must be brought in the context of a nullity lawsuit. This means that such challenges have to be brought in front of the Paris Tribunal de grande instance (TGI), not the Cour d’appel.

But here is the thing. Grounds for nullity are supposed to be listed in a limitative manner in the law, be it in article L. 613-25 Code de la propriété intellectuelle (CPI) for French patents, or in article L. 614-12 CPI together with article 138 of the European patent convention (EPC) as far as French parts of European patents are concerned. These grounds of nullity notably comprise lack of novelty, lack of inventive step, insufficiency of disclosure, extension of subject-matter beyond the contents of the application as filed and extension of the scope of protection after grant.

What the statutory grounds for nullity do not comprise is lack of compliance with article 84 EPC (or its equivalent in the CPI), per which the claims “shall be clear and concise and be supported by the description” is not a ground for nullity. Just like a lack of clarity is not a ground for opposition at the EPO either.

Nevertheless, when the INPI examines a request for limitation, they are supposed to check whether the claims as limited are clear and concise and supported by the description. See article L. 613-45 CPI together with article L. 612-6 CPI.

The question is whether and how third parties may challenge the result of this part of the examination conducted by the INPI.

If we turn to the parallel situation of limitation proceedings at the EPO, the answer is clear. Only parties to the proceedings can file an appeal against a decision issued by the EPO. A third party, as its name indicates, is not a party to the limitation proceedings and thus cannot appeal the decision of limitation, even if they deem that the limited claims are e.g. unclear.

In France, third party appeals are not ruled out as a matter of principle. By way of example, it is relatively common for a third party to challenge a decision of restoration of a patent by the INPI. See an example here.

But when it comes to decisions of limitation, third party appeals are usually stroke out in view of the arguments raised by the appellant.

In the present case, the French part of a European patent was limited by Gemalto, parallel to ongoing patent infringement proceedings against two companies of the Avery Dennison group. Avery Dennison appealed the decision of limitation and argued (among others) that the claims as limited are unclear.

The Cour d’appel rejected the appeal as inadmissible and held in particular that: 

[…] The arguments by Avery Dennison supporting their request for cancellation of the decision of the general director of the INPI, per which the claims as limited are not clear and not supported by the description, are analyzed as arguments of invalidity of the patent enforced against them in the framework of the infringement suit. These arguments, which put into question the limitation itself, i.e. whether the modified claims comply with the law, pertain to the jurisdiction of the judge in charge of assessing the validity of the patent. In this case, there is a counterclaim for nullity of the claims of the […] patent pending in front of this judge. His jurisdiction extends to all patent validity challenges, be it arguments of extension of an absence of limitation or arguments of a lack of clarity of the claims or a lack of support in the description, which are indeed exceptions which can lead to the nullity of a patent

Just to be very clear on this: I perfectly understand that it may make a lot of sense for the same court (the TGI) to be in charge of assessing all challenges against the patent claims.

What I do not understand is the last sentence in the above quote. In other terms, why does the Cour d’appel deem that a lack of clarity of the claims or a lack of support in the description, can lead to the nullity of the patent? 

I can come up with three possible explanations. 

Option 1: the court simply did not (does not) understand that not all conditions to be examined before granting limited claims can be challenged after the limitation, based on the listed grounds of nullity. I think this is unlikely, because the point has certainly been explained to the court time and time again in this case and previous similar ones.

Admittedly, it is probably easy to confuse a lack of support in the description (not a ground for nullity) with insufficiency of disclosure (ground for nullity). Both concepts are quite close, as explained in section F-IV, 6.4 of the EPO guidelines for examination. Actually, lack of support can also be easily confused with extension of subject-matter.

But lack of clarity on the other hand is quite clearly different from insufficiency of disclosure, or any other ground for nullity for that matter.

Option 2: the court deems that judges have such a large discretion in examining the actual grounds for nullity, such as insufficiency of disclosure or even lack of novelty, that they can very well revoke a patent under one of these statutory grounds if there is a lack of clarity in the claims.

This would be a pragmatic approach but not a satisfactory one on the legal standpoint. The legislator purposefully set out a number of distinct requirements to be handled differently. So why should judges be allowed to blur the lines between them?

Option 3: the court believes that all statutory conditions may be examined in the context of a nullity claim or counterclaim, including clarity and conciseness mentioned in article 84 EPC or article L. 612-6 CPI.

This would be a very bold position, since, at least as far as European patents are concerned, article 138 EPC provides that “a European patent may be revoked with effect for a Contracting State only on the grounds that“, and then comes a list of grounds which does not contain lack of clarity and conciseness.

But let’s explore option 3 a little bit more.

If this is indeed what the court has in mind, is this situation specific to limited patents? Does it also extend to patents modified in opposition at the EPO? Or has lack of clarity now also become a ground for nullity for all patents, even those which were not modified after grant?

Dear readers, please feel free to provide more information or to speculate as to yet further possibilities not contemplated here…

One other argument which – as far as I understand – was raised in the appeal, was that the modified claims were not a limitation. Here, the court’s position seems to be that modified claims necessarily lead to a limitation of the scope (and thus are allowable) or to an extension of the scope (and thus can be revoked in a nullity challenge).

But aren’t there yet other situations in which the modified claims could result neither in a limited scope nor in an extended scope? What about for example claims which are modified only to provide some clarification? In such a scenario, shouldn’t a third party be allowed to challenge the decision of limitation per se? After all, the INPI is supposed to only grant actual limitations, not clarifications. And if no extension of scope results from the modification, it should not be possible to challenge it in a nullity suit, oder?

I must admit that this latter question is trickier. But at least the main point raised above really needs to be clarified once and for all.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 10, 2017, Avery Dennison RIS France & Avery Dennison Systèmes d’Etiquetage France v. Directeur général de l’INPI, RG No.15/25007.