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. 

The trend extends

Usual readers of this blog will certainly get the impression that the author sometimes repeats himself. And they will be right.

On a number of occasions, I expressed the view that French courts have gotten very strict on added matter (i.e. extension of subject-matter beyond the content of the application as filed) over the past few years. I mean “strict” as in “EPO strict“. And this trend seems to be further confirmed based on two recent decisions by the Paris Cour d’appel.

First of all, in a previous post, I reported on a first instance judgment in Jean Chéreau v. Frappa, in which two European patents were revoked for added matter. One patent fell because of a number of intermediate generalizations. The other one fell because the term “roughly longitudinally movable” was replaced by “longitudinally movable” – which was interpreted as having a fundamentally different technical meaning.

The patent proprietor appealed, but to no avail, as the initial judgment was confirmed on appeal, in a ruling dated February 28, 2017.

Second of all, another patent was revoked by the Paris Cour d’appel on the same ground of nullity on January 24, 2017.

Extension patents are OK but patent extensions are not.

Here are the basic facts of the case. Mr. Damour owns a French patent No. FR 2943699 filed on March 31, 2009, directed to a fire resistant sandwiched panel for doors. An exclusive license was granted to the Compagnie de Fabrication Industrielle de Menuiserie (COFIM).

On July 31, 2012, Mr. Damour and COFIM sued a French woodworking company called Breheret for infringement of the patent. However, in a judgment dated December 4, 2014, the Paris Tribunal de grande instance revoked all claims asserted against the defendant, for lack of inventive step.

The plaintiffs appealed and filed a request for limitation of the patent in parallel, which was granted by the INPI (French patent and trademark office) on July 22, 2015.

The Cour d’appel reviewed the limited claims, and came to the conclusion that they were invalid, but this time due to extension of subject-matter.

Here is a working translation of claim 1, with revision marks relative to claim 1 as granted:

A fire-resistant sandwich panel, [in particular] for the production of doors integrated into fire-block units or facades of fire-resistant technical ducts or for the production of fire hatch covers, said panel consisting of at least one core (1) having a density greater than 400 kg/m3, sandwiched between two wood fiber-based facings (2) having a thickness comprised between 1.5 and 50 mmboth facings being assembled to said core (1) by means of a binder preferably by gluing, characterized in combination

– in that the core (1) extends up to the edge of the panel so that there is no need for the use of bands, and a reliable stability of the fixation means is obtained, 

– in that the core (1) consists of a fiber reinforced silicate material having a density greater than 700 kg/m3,

– and in that said core has a thickness comprised between 6 and 30 mm. 

Ironically, among these various changes, the court focused on the recitation that the core extends up to the edge of the panel and concluded that this represented… an extension of subject-matter.

Here is the relevant part of the ruling:

According to lines 20-24 on page 5 of the patent application as filed, which disclose an example of panel of the invention: “the mechanical features of the core 1 and the facings 2 make it possible to avoid the provision of bands. The core 1, which is made of a hard material, provides strength up to the periphery of the panel, which is sufficient to obtain a good hardness of the edges and a reliable stability of the fixation means (such as hinges, espagnoles, brackets or the like)”. These lines, the drafting of which is ambiguous, must be read in the light of the description of the invention presented from line 14 on page 2 to line 5 on page 3, from which it can be derived that it is the use of the core, the material of which is chosen for its high fire resistance, sandwiched between two wood fiber facings, and not the fact that it extends to the edge taken as such, which makes it possible, on the one hand to obtain a hard edge which is not friable over time, and on the other hand to provide the panel with mechanical resistance qualities which are sufficient to afford a good stability of the fixation elements. 

Claim 1 as limited thus adds a technical effect which extends the scope of the patent in that it indicates that it is the fact that the core extends to the edge which affords a better fixation of the ironwork. 

On page 4, lines 7-9 of the application as filed, it is specified that “the drawing shows that the core 1 extends up to the edge 3, therefore illustrating that the use of bands is unnecessary”. This relates to figure 1 showing an embodiment of the invention, and only makes a connection with the fact that the core extends to the edge and that bands are unnecessary. 

It results from the above that claim 1 as limited must be revoked as extending beyond the content of the patent application as filed.  

To put it otherwise, when looking closely at the application, it seems that the patent proprietor mixed language from two passages of the application. In the first passage it is mentioned that the core extends up to the edge and that the use of bands is unnecessary. In the second passage, it is mentioned that the mechanical features of the core and facings make it possible to avoid the use of bands; and that the core, made of a hard material, provides strength to the periphery and thus a reliable stability of the fixation means.

What neither passage explicitly mentions is that the extension of the core up to the edge results in a reliable stability of the fixation means. This technical effect seems to be rather related to the nature of the core material.

The gold standard applied at the EPO for appraising the allowability of an amendment is whether the amendment can be directly and unambiguously derived from the application as filed as a whole. Here, the court noted that the drafting was “ambiguous“. Therefore, the outcome seems to be in keeping with the doctrine of the Boards of appeal.

It should also come as a warning for patent proprietors who limit their claims in an attempt to overcome first instance revocation grounds. This is a very common strategy, but also one which may sometimes lead them somewhere between Scylla and Charybdis.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, January 24, 2017, COFIM & Vincent Damour v. Breheret, RG No. 15/03652.

The salt of the judgment

When you are in private practice, you sometimes get to work with clients who come up with very creative legal arguments. Or you get to work with clients whose competitors are unfortunately very creative. Rating the chances of success of such creative arguments can be difficult, especially when there is not yet any case law to refer to.

Let us take one example. A patent protects a molecule M1. A competitor markets a drug containing a molecule M2. When this drug is taken up in the body of the patient, molecule M2 is converted to M1. Is this a situation of contributory infringement?

It is not so common for thought-provoking ideas such as this one to be actually tested in court. I was thus quite happy to hear about Shionigi & AstraZeneca v. Biogaran, thanks to Lionel Vial (the decision does not appear on the INPI database). So, if you would like to know the answer to the above question, you may directly go to the end of this post to find out about the guidance offered by the presiding judge of the Paris Tribunal de grande de instance, Marie-Christine Courboulay.

But not so fast, as other aspects of the case are very worth being reviewed.

The patent at stake is EP 0521471 owned by the Japanese pharmaceutical company Shionigi, and licensed to the Swedish group AstraZeneca. The patent covers a drug for the treatment of hypercholesterolemia, called rosuvastatin.

The patent is already relatively old, as it was filed in 1992 and claims a priority of 1991. It went unopposed and expired in 2012. But a Supplementary Protection Certificate (SPC) was granted in 2005 by the French Institut national de la propriété industrielle (INPI), extending the duration of protection until June 29, 2017. And then on top of that, a pediatric extension was granted in 2015, further extending the duration of protection till December 29, 2017.

The SPC was granted for the product simply identified as “rosuvastatin”, based on a Dutch Marketing Authorization (MA) for the drug Crestor, which contains a calcium salt of rosuvastatin.

Biogaran developed a generic version of rosuvastatin. In 2014, Biogaran warned AstraZeneca and Shionigi that they had applied for an MA for the zinc salt of rosuvastatin, and stated that this product did not infringe the SPC. AstraZeneca and Shionigi did not agree with the latter statement.

Two years later, Biogaran obtained its MA and announced that it intended to launch the generic drug in July 2016 – i.e. before the term of the extended SPC.

As a result, AstraZeneca and Shionigi filed a motion for preliminary injunction (PI) in front of the judge in charge of urgency proceedings (juge des référés) on April 26, 2016. The judge issued her order on July 4, 2016.

The criteria assessed by the juge des référés for deciding on the PI are whether infringement is likely, and whether there is any serious validity challenge.

In the present case, Ms. Courboulay deemed that there is no serious validity challenge; but that, on the other hand, infringement is not likely.

As a preliminary step in the reasoning, the claims of the patent were interpreted in view of the description. It is certainly a very good thing when a patent is construed as a first step, and thus in a consistent way for both validity and infringement.

In the present case, this preliminary interpretation step led to a result which may come as a shock to a number of foreign patent attorneys but which seems to be in keeping with the tradition of French patent law.

Claim 1 of the EP’471 patent reads as follows:

The compound (+)-7-[ 4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl-N-methylsulfonylamino)pyrimidin-5-yl)-(3R,5S)dihydroxy-(E)-6-heptenoic acid or a non-toxic pharmaceutically acceptable salt thereof.

This is the full name of rosuvastatin, either in the form of an acid or of a salt – any possible salt, it would seem.

Dependent claims 2, 3 and 4 respectively and specifically relate to the acid form, to the calcium salt and to the sodium salt of rosuvastatin.

The judge referred to article 69 EPC and the interpretative protocol, and made the following comments as to which rosuvastatin salts are protected by the patent:

[The patent] is drafted as disclosing a new pharmaceutical active substance, rosuvastatin, and the pharmaceutically acceptable salts of this substance, and the cited examples are only indicative and do not limit the protection to the only cited examples. However, the description and notably paragraph 007 provides examples of pharmaceutically acceptable non-toxic salts of rosuvastatin and makes reference to two families of metallic ions which were commonly used in the formulation of tablets of statins already known at the priority date, and in particular alcaline metal ions and alcaline earth metal ions. […] Thus, the pharmaceutically acceptable non-toxic salts are in these two families […], as the patent does not give any indication to the skilled person to select a salt in another family. On the contrary, the description focuses on these salts because they were already commonly used for the formulation of statin tablets; it does not provide any other lead, so that the skilled person will select a salt in the families offered by the patent as being the only relevant families for statins. He/she will not try to select salts of other families as the patent does not teach anything in this respect. 

Therefore, only salts belonging to the cited families, namely alcaline metals like sodium or alcaline earth metals like calcium, or those which can be part of the most commonly used cations for the formulation of statin tablets are concerned by the patent. The other salt families are not mentioned and thus excluded from the scope of protection of the patent

In summary, claim 1, taken at face value, covers any pharmaceutically acceptable salts of rosuvastatin. But according to the judge, the actual scope of the patent is narrower, as only two families of salts are covered: alcaline metal salts (such as sodium) and alcaline earth metal salts (such as calcium).

So beware: the interpretation of the claims in view of the description can result not only in a broadening of the scope of protection relative to the literal wording of the claims, but also in a restriction of the scope.

Just to be clear, this finding does not seem to be related to the existence of an SPC. The (re)definition of the scope of the patent was made with respect to the patent, not the SPC. See in particular the following comment in the judgment:

Although the Crestor MA designates the calcium salt of rosuvastatin, the scope of the […] SPC extends to all forms of rosuvastatin as covered by the EP’471 patent.

A judgment to be taken with a grain of salt?

Again, the limitation of the patent devised by the judge may come as a surprise from a European perspective. But I think it is in keeping with traditional French practice. French judges have consistently had a large degree of discretion in defining the scope of protection based on the overall teaching of the patent – or spirit of the invention.

Maybe another way to look at this would be to consider that the invention was sufficiently disclosed in the patent only for the two salt families explicitly mentioned (and exemplified) in the patent, which, as far as I understand, were the two usual salt families for other similar drugs at the priority date. Using other salts would have required further research.

Anyway, the consequence of this interpretation of the claim is that there was no direct infringement of the patent. Indeed, the Biogaran product is a zinc form of rosuvastatin, and zinc does not belong to the alcaline or alcaline earth metal families.

And now comes the last part of the judgment, which deals with an auxiliary argument by the claimants, which was articulated as follows:

Biogaran commits acts of contributory infringement because it provides essential means for implementing the invention [….]. The salt form under which rosuvastatin is administered decomposes as follows, as soon as it reaches the gastro-intestinal system of the patient. The salt is dissolved, which leads to the separation of the cation (for example the calcium or zinc ion) and of the anion (namely rosuvastatin in anionic form). Since the pH of the stomach is low (less than the pKa of the acid group of rosuvastatin), the rosuvastatin anion surrounded by H+ protons attracts them so as to make the free acid form of rosuvastatin. […] Therefore the invention is implemented in vivo, in the patient’s stomach, after the administration of the Biogaran rosuvastatin, which thus infringes the EP’471 patent by contributory infringement. 

An interesting theory, but which did not hold water for the judge:

The act of infringement in suit can only be the supply or marketing of the drug, and not the decomposition of the drug in the patient’s body. […]

Contrary to what is argued by the plaintiffs, contributory infringement does not consist in providing means allowing the decomposition of the rosuvastatin salt in anionic rosuvastatin and salt in the human body. This is a consequence of the ingestion of the drug in the body, and of its mode of action but it is not an essential means of the invention, which only relates to the formulation of the rosuvastatin tablet. […]

[Contributory infringement] cannot be relied upon in the context of an artificial auxiliary argument […] whereas the Biogaran product is a generic of Crestor and thus clearly intended for the same therapeutic indication.

Biogaran does not supply any means but a product equivalent to the one protected by the EP’471 patent and the SPC so that contributory infringement is neither established nor likely.

The reasoning is very clear. Contributory infringement is a notion intended to target suppliers of only part of an invention. It is “artificial” and therefore wrong to try to extend this notion to the situation of a drug which undergoes a chemical transformation into a patented compound only in the patient’s body.

It is remarkable, though, that the judge noted in passing that the Biogaran product is equivalent to the claimed invention. It seems that the plaintiffs did not argue infringement under the doctrine of equivalence. Would the outcome have been different if they had? Maybe we will find out with the case on the merits (assuming it proceeds to trial).


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, July 4, 2016, Shionigi Seiyaku Kabushiki Kaisha & Astrazeneca UK Ltd v. Biogaran, RG No. 16/56067.