Cutting the limitation period

The statute of limitations for nullity suits is probably one of the worst aspects of French patent law.

But as a blogger, I have to confess that I am grateful for it. If it weren’t for this odd aspect of our statute, the supply of notable French judgments to comment on would be much sparser. Sometimes it is even all there is to talk about. Like in this recent decision E. Leclerc v. Bilz Werkzeugfabrik, where it is in fact the sole topic addressed by the court.

In this case, two German companies, which I will call Innovat and Bilz (but which in truth have much longer names) filed a European patent application in 2000, on a device for clamping tools. The patent was granted in January 2003. It was opposed, and the opposition was rejected by the EPO in February 2007.

In June 2017, the French company E. Leclerc initiated nullity proceedings in connection with this patent. In case French readers are wondering, this company is said to be specialized in making, purchasing and selling cutting tools: it thus appears that it has nothing to do with the famous eponymous supermarkets.

Cutting-edge cutting tools.

The patent proprietors raised a limitation defense, and this objection was addressed in a preliminary judgment after a first hearing.

E. Leclerc’s first line of argumentation against this defense was that the statute of limitations does not apply to patent nullity claims.

A long shot for sure, as many other litigants have made such contentions before, to no avail. But, interestingly, E. Leclerc came up with a number of reasons in support for this position, some of which I have not come across before.

For instance, the nullity plaintiff contended that applying a limitation period to a nullity action would run contrary to Regulation (EU) No. 316/2014 relating to technology transfer agreements.

This regulation defines a limited exemption for technology transfer agreements from the general prohibition of anti-competitive practice under article 101 of the Treaty on the Functioning of the European Union. Article 5 of the regulation specifies that the exemption does however not apply to “any direct or indirect obligation on a party not to challenge the validity of intellectual property rights which the other party holds in the Union, without prejudice to the possibility, in the case of an exclusive licence, of providing for termination of the technology transfer agreement in the event that the licensee challenges the validity of any of the licensed technology rights“.

Quite creative, but beside the point for the court, which noted that the regulation only applies to agreements in which a licensor allows a licensee to exploit a technology, which is not the case here.

E. Leclerc also relied on the UPC agreement, which, they said, excludes any statute of limitations for patent nullity actions. The argument was easily dismissed by the court since, as we all know, the agreement is not yet in force.

They also relied on the executive order of May 9, 2018 (presented here) which is bound to eliminate the limitation period for patent nullity suits. But unfortunately, this order is not currently in force either. It is scheduled to enter into force together with the UPC agreement, precisely.

E. Leclerc also stated that, since the claims of a patent are never stabilized as they can always be limited, the limitation period never starts running.

This notion of “stabilization” of the claims derives from a couple of judgments in which it was held that, when the claims are modified in opposition or limitation proceedings, this postpones the start of the limitation period, because the claims are not stabilized before the date of modification. See previous discussions here and there.

Some have thus taken this logic as far as suggesting that claims are in fact never stabilized because there is always the possibility that the patentee may amend them any time by way of limitation proceedings. Ergo, the limitation period may well exist but it can never start running, problem solved.

The court did not buy this theory:

Finally, even if the claims of a patent may change, this mere likelihood cannot prevent the implementation of a rule of limitations.  

At the end of the day, the court thus once again confirmed that the statute of limitations does apply to nullity actions.

Caramba, encore raté” as Hergé famously wrote in his classic Tintin comic books.

Then the next step, as always, is to determine the starting point for the limitation period. Here, the Paris Tribunal de grande instance (TGI) once again stuck to its in concreto appraisal – although appeal judges seem to be on a different page, as already discussed several times on this blog.

In particular, the court noted that the grant of a patent cannot trigger the time bar. Otherwise, an undue monitoring of published patents would be required from all stakeholders.

Interestingly, the court also added that the rejection of the opposition against the patent by the EPO in February 2007 could not be taken as a starting point either, for the same reason“. In one of the other cases already recalled above, it was decided that the starting point was the decision of a Board of appeal to maintain the patent in amended form, in opposition proceedings. So, as most of us suspected, this earlier decision cannot be extrapolated to some sort of automatic rule.

For the court, the fact that E. Leclerc already marketed many types of spindles in 2010, or that they filed a patent application in 2011 for a cutter for composite materials, was not taken into account by the court either, as “it does not imply that they were aware at that time of all patents granted to competitors concerning devices for clamping and releasing tools“.

The decisive fact in the case was rather a cease and desist letter sent by Innovat and Bilz’s attorney to E. Leclerc in May 2014. E. Leclerc was also targeted by an infringement suit in the Landgericht of Mannheim, but based on a different, national German patent, which led to a judgment in March 2016.

The judges thus held that the starting point for the 5-year limitation period was this cease and desist letter of May 2014. E. Leclerc’s action was thus not time-barred. As a result, the lawsuit will now proceed on the merits.

I have mixed feelings about this ruling.

On the one hand, the outcome makes a lot of sense to me. If we have to live with this statute of limitations for patent nullity suits – which we do – then some formal correspondence between the parties regarding possible infringement of the patent at stake seems to be a very reasonable place to start from in order to apply the rule.

On the other hand, I wonder how this ruling can be reconciled with other similar recent judgments.

Take MEP v. Raccords & Plastiques Nicoll for instance, where the Cour d’appel reached the exact opposite conclusion, by taking the grant of the patent and not a cease and desist letter as the starting point. Is there a blatant contradiction here? Or was MEP v. Raccords & Plastiques Nicoll special because in this case the nullity plaintiff worked in a highly specialized area and had business relationships with the other party?

Then take LuK v. Valeo Embrayages, a judgment by the same section of the Paris TGI as today’s decision. In this case, like in others, the court performed a thorough analysis of the business projets of the nullity plaintiff and determined when so-called “points of contact” between their technology and the patent at stake occurred. There is no such detailed analysis in today’s decision.

As always, I don’t think we should read too much into a seemingly different approach from one judgment to the next. The way the parties do or do not argue in their submissions is certainly a major factor in the court’s reasoning.

Now, my two cents, for what it is worth – and it is quite a subjective one.

I have the impression that the courts (at least the first instance courts, from which we have a larger sample of judgments to digest) make a moderate and measured application of the statute of limitations; and that a relatively heavy burden is placed on the nullity defendant to convincingly show that, for some specific reasons, the plaintiff was or should have been aware of the patent more than 5 years before the complaint was filed.

In other terms, it could be worse!


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, SA E. Leclerc v. Bilz Werkzeugfabrik GmbH & Co. KG & Innovat Gesellschaft für Sondermaschinenbau, Mess-und Steuerungstechnik mbHRG No. 17/09311.

Suspect suspicions

What are the top three traits of the French system that foreign companies like best? 

Good transportation infrastructure? Maybe. L’art de vivre? Very probably. But first and foremost: the saisie-contrefaçon. OK, there may be some patent attorney bias here.

As readers of this blog are surely aware, the saisie-contrefaçon (infringement seizure) is a special tool in the hands of patent right holders, in the form of an ex parte order for an unannounced inspection at a third party’s premises in order to gather evidence of possible infringement.

Traditionally, the order for seizure has been viewed as straightforward to obtain.

Basically, you show up in front of a judge; you show your patent, the status of the renewal fees, an excerpt from the patent register; then you explain what kind of evidence you want to get and where. And you’re pretty much good to go.

But from time to time, a court decision takes a different approach and makes this traditional view entirely derail.

Such is the judgment recently issued by the Paris Cour d’appel in Arconic v. Constellium Issoire.

Arconic owns European patent No. EP 1392878 on a process to produce sheets of aluminum.

It may be useful to copy here claim 1 of the patent, as a reference:

A process for producing a sheet or plate product comprising:
(a) providing an aluminium alloy consisting of 0.5 to 1.8% Si, 0.5 to 1.5% Mg, up to 1.2% Cu; up to 1% Mn, up to 1% Zn, up to 0.4% Cr, up to 0.5% Ag, up to 0.3% Sc, up to 0.2% V, up to 0.2% Hf, up to 0.2% Zr, the balance being aluminium and incidental impurities;
(b) heating the alloy;
(c) hot rolling the alloy to reduce its thickness by at least 30%;
(d) thermally treating the alloy hot rolled in (c) at 543°C (1010°F) or more;
(e) further hot rolling the alloy to further reduce its thickness;
(f) solution heat treating the alloy at 543°C (1010°F) or higher;
(g) quenching the alloy.

On October 4, 2017, Arconic requested and obtained an order for performing a seizure in the premises of Constellium Issoire, which belongs to the Constellium group. Arconic and Constellium are direct competitors as they both manufacture aluminum plate products, notably for Airbus’ A380 aircraft.

The seizure took place on October 10, 2017. On October 26, Constellium filed a motion to obtain the cancellation of the order for seizure. The judge in charge of urgency proceedings granted Constellium’s motion and issued an order on December 22, 2017 canceling the order for seizure.

Arconic appealed, but its appeal has now been dismissed by the Paris Cour d’appel.

So what was the problem with the initial order for seizure, and why did it deserve to be canceled, according to the appeal judges?

The focus of the discussion was Arconic’s statement in its initial request that they had reasons to suspect that Constellium infringed the patent at stake.

Arconic provided evidence for this suspicion, and the court performed a thorough review of said evidence.

The evidence comprised in particular a scientific article from three Constellium employees, a specification from Airbus, a standard and a publication on aluminum alloys, and an excerpt from Constellium’s website.

Based on this evidence, the court concluded that:

  • Arconic’s aluminum alloy is designated as 6013 while Constellium’s is designated as 6156.
  • Both alloys, based on Airbus’ specification, are made by lamination and a so-called T4 thermal treatment.

But the court then stated that this was insufficient to infer that most features of claim 1 of the patent at stake were implemented by Constellium.

In particular, the fact that the 6156 alloy is made by lamination and thermal treatment is perfectly conventional. Claim 1 of EP’878, on the other hand, requires a precise sequence of process steps, including the application of a certain temperature, a defined reduction of thickness of the alloy, etc. Thus, the court said, Arconic in fact did not know which process is used by Constellium.

Admittedly, the composition of the alloy itself, which is also recited in the form of elemental weight ranges in claim 1 of the patent, does cover the 6156 alloy. But the claimed ranges are sufficiently general to also cover further competitors’ products of the same category (the 6061 and 6082 alloys). Besides, it is clear when reading the patent that the invention is about a manufacturing process, not about a new alloy, added the court.

The tin man – which alloy is he made of?

Another reason for Arconic’s infringement suspicion was that, according to them, the mechanical properties of the plates made by Constellium could only be obtained with the patented manufacturing process.

The court accepted that Constellium’s 6156 plates seem to have very similar properties to Arconic’s 6013 plates, since both products are used by Airbus for the A380 aircraft.

But, the court continued, this does not imply that Constellium’s plates are necessarily made with the patented process, since different processes can of course lead to the same product.

As a further remark, the court noted that Constellium itself owns a later patent (EP 1809779) for a process of making 6056 or 6156 aluminum alloy products, and asserts that their industrial process is based on this patent.

As a conclusion, the court held:

Thus, the reasons set out in support of the request [for seizure] turn out to be wrong. More particularly, it cannot be derived therefrom any “suspicion” of infringement, nor “good reasons to assume” that the alloy plates supplied by Constellium would infringe Arconic’s patent. 

The final part of the judgment contains a more legal discussion. Arconic argued that its right to a seizure

only depends on the demonstration that the right at stake exists, without any further requirement of evidence concerning infringement itself.

As I said in the beginning, at the risk of oversimplifying, this is indeed probably the general opinion among the French patent profession.

Arconic in particular pointed to the so-called “enforcement directive” No. 2004/48/EC. Article 7 of the directive begins like this:

Member States shall ensure that, even before the commencement of proceedings on the merits of the case, the competent judicial authorities may, on application by a party who has presented reasonably available evidence to support his claims that his intellectual property right has been infringed or is about to be infringed, order prompt and effective provisional measures to preserve relevant evidence in respect of the alleged infringement, subject to the protection of confidential information.

The directive thus refers to the presentation of “reasonably available evidence” as a prerequisite for obtaining e.g. an order for seizure. But, Arconic remarked, this notion was not transposed in the relevant provision of the Code de la propriété intellectuelle, namely article L. 615-5. Since article 2 of the directive makes it possible for Member States to provide means which are more favorable to right holders, this must be interpreted to the effect that French law does specifically not require “reasonably available evidence” as a precondition for an order for seizure.

The court did not frontally disagree, but replied as follows.

[…] The property right conferred by a patent is neither absolute nor discretionary, and is still subject, in the case of a request for seizure, to the appraisal of its merits by the judge […], notably when, as is the case here, the reasons set forth in its support turn out to be wrong. 

Besides, article 3 of the [enforcement directive] requires that proceedings which are necessary to ensure that IP rights are respected must be fair and proportionate. In the present case, as there is no tangible suspicion of infringement, the court can only remark that the requested seizure measure would, as a main consequence, allow Arconic to know about Constellium’s aluminum alloy product manufacturing process. As these two companies are direct competitors regarding this products in front of companies in the aeronautic business, such as Airbus, Constellium can rightly fear that manufacturing secrets could detrimentally be disclosed, or even that its credibility with common customers could be harmed. Lastly, the court is surprised that it is only on October 4, 2017 that Arconic decided to initiate infringement seizure proceedings, although this direct competition with respect to Airbus dates back to 2004. 

Matthieu Dhenne, whose firm represented the patent proprietor in this case, wrote to me that there are a number of reasons why he believes the decision was wrongly decided.

First, he says the proportionality principle does not apply to an infringement seizure which remains an exceptional measure and is disproportionate by nature. He states that the travaux préparatoires concerning the transposition of the directive show that the proportionality principle was voluntarily not introduced into our statute. As a result, the court’s line of reasoning compromises legal certainty and jeopardizes the entire balance of the system. He also insists that a seizure is intended for gathering evidence, not appraising infringement. Matthieu adds that the court’s suspicion of the patentee was unwarranted and that it cannot be possibly demanded from the patentee that they should search for patents owned by the defendant. Whether any other, especially later, patent is indeed implemented or not by the defendant is irrelevant to the possible infringement of the main patent at stake, he argues.

I agree that there are a number of statements in the two above paragraphs quoted from the judgment which are controversial.

It is true that a seizure can result in business secrets being disclosed to a competitor. But the usual way to prevent this is for the seized party to request that the seized information and documents be sealed, and that an expert be appointed by the court to sort out the evidence, so that only information directly relevant to the demonstration of infringement be communicated to the right holder.

As for the fear that the defendant’s reputation be harmed, it seems irrelevant here, as the seizure was performed in Constellium’s premises, not at a third party’s.

The fact that Arconic waited a lot before initiating legal proceedings should probably not come into play either. Indeed, a patentee’s right to sue for infringement is never time-barred.

That said, I am not sure I am fully comfortable with the notion that a patentee’s right to a seizure should be automatic.

It does make sense for the court to carefully look at the specifics of each case before deciding whether this right can be exerted in the circumstances at hand or not.

In this particular case, it seems to me that what the court really did not like was that the “suspicions” of infringement mentioned in the original request for seizure, were not actual or legitimate suspicions, based on the evidence offered.

Would the outcome have been favorable if the plaintiff had played it differently, for example by (1) not mentioning suspicions of infringement but explaining that a seizure is the only possible way for them to determine whether there is any infringement; and (2) immediately offering that the seized evidence be sealed by default so as to be later remitted to a court-appointed expert?

I guess we will never know and can only have suspicions in this respect.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, September 11, 2018, Arconic Inc. v. SAS Constellium Issoire, RG 18/01099.

Standard or not standard?

Traditionally, non-practicing entity patent infringement suits have been  relatively few and far between in France.

Without the huge financial stakes of U.S. litigation, and without the lure of German bifurcation, the French legal system has, to some extent, resisted the trend so far. There are a few counter-examples, though.

Like the case discussed today, between famous Intellectual Ventures (IV) and SFR, one of the major French telecommunications companies.

Among the many patents owned by IV is EP 1304002, entitled “Arranging Data Ciphering In a Wireless Telecommuncation System” and originally filed as a PCT application by Nokia Mobile Phones Ltd, in Finland.

As you have probably already guessed, IV initiated legal proceedings in front of the Paris Tribunal de grande instance (TGI), alleging infringement of the EP’002 patent. The alleged infringement mainly relates to the WiFi technology.

You will not know who won at the end of the post, because no one did – the lawsuit is not over yet. In fact, the pleadings hearing is presently scheduled to take place on November 23, 2018. So there is still plenty of time left for you to take your morning off at the new courthouse.

The decision discussed today is only an interim order issued by the judge in charge of case management (JME in the local jargon).

Can you believe there are actually patent applications on methods for identifying patent troll activity? Do some of them get acquired by NPEs, just for the irony of it?

Among the various defenses raised by SFR, there is a rather interesting one, which is that the EP’002 patent is a standard essential patent (SEP).

Two standards were mentioned by SFR: 3GPP TS 33.234 (a 3G standard issued by ETSI – short for European Telecommunications Standards Institute), and 802.11.2012 (a WiFi standard issued by IEEE – short for Institute of Electrical and Electronics Engineers). According to SFR, the EP’002 patent was not declared as essential by its then owner Nokia – a member of both ETSI and IEEE – although it should have been. Due to this omission, they argued, the infringement action should be deemed inadmissible.

Now, apparently SFR did not have all the necessary evidence at hand.

They thus wrote both to ETSI and IEEE and requested the “travaux préparatoires” (one of the most well-known French expressions among lawyers, ranking third after “bonjour” and “merci”) for the relevant standards, as well as relevant correspondence between Nokia and both organizations.

France-based ETSI replied that they would provide the requested documentation, but IEEE turned down SFR’s request.

Thus, SFR filed a motion with the JME, requesting a stay and further requesting that IEEE be ordered to hand down the relevant documents. 

IV fought this motion.

First, IV claimed that SFR’s motion was inadmissible.

Indeed, IEEE is based in the U.S., and the French judge has no jurisdiction to directly order a third party to the litigation to hand down evidence, they argued. The only possible procedure would be the letter rogatory, i.e. the French judge should ask U.S. authorities to issue the order.

The judge closely looked at the written response made by IEEE further to SFR’s request. The first part of this response was the following:

Please be advised that it is IEEE’s policy not to provide information that may be used in litigation without a subpoena. This is to protect IEEE’s neutrality in any dispute. If that is necessary, please feel free to let me know and we can arrange the details of service. 

The JME deduced from this response that IEEE was willing to hand down the evidence at stake, and that they just required a formal judicial order for doing so. The judge was happy to oblige, and the formal and cumbersome process of the letter rogatory could thus be avoided.

I note that IEEE’s response does not specify whether the requested subpoena should be specifically issued by a U.S. court, or whether any subpoena would do. It was probably the judge’s understanding that, in the absence of any specific mention, they were open to any form of subpoenaing.

As a second defense against the motion, IV argued that SFR’s request was useless and unjustified.

SFR raised the SEP argument late in the case management procedure, IV said, and only they should have the burden of providing their own evidence. Besides, the second part of IEEE’s written response to SFR reads as follows:

However, a subpoena may not be necessary in this instance as IEEE 802.11 does host a public website that contains a wide variety of working group materials. The IEEE 802.11 website is located http://www.ieee802.org/11/.

But the judge held that SFR was free to raise a new defense at any point within the case schedule (which, in case you are wondering, is nothing like the extremely tight schedule envisioned for the future UPC). Besides, SFR stated that they could not find the relevant documents on the IEEE website, and that in particular the correspondence with Nokia is not supposed to be available on this site. Finally, the supply of evidence by the standard organizations should not take long.

As a result, the judge granted SFR’s request and issued an order for IEEE to send SFR all documents and reports of the working group relating to the relevant part of IEEE 802.11, as well as the relevant correspondence with Nokia, within one month.

On the other hand, the request for stay of proceedings was dismissed – probably because this timeline is supposed to be still compatible with the planned date for the main hearing.

Access to evidence can be challenging in this country especially in the absence of discovery / disclosure. French judges are often reluctant to order a taking of evidence, such as the provision of documents. But in a case such as this one, it does seem rather fair that a defendant should be allowed to explore a particular line of defense by requesting third party-held documents.

We will thus stay tuned, and I am sure the decision on the merits will be most interesting to read – if the lawsuit goes all the way of course.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 7, 2018, Intellectual Ventures LLC v. Société française du radiotéléphone, RG No. 16/16346.

It-which-must-not-be-named

Some pharma cases are somewhat delicate to discuss in a blog post.

Case in point, if I provide the commercial name of the drug at stake in today’s litigation, I am afraid that this post may be classified as a spam and may thus never reach my email subscribers.

You see, it is the sort of drug which is prescribed for the treatment of erectile dysfunction, and which keeps coming up in these pestering unsolicited email messages that you may receive on a daily basis.

Just to be clear, today’s drug-which-must-not-be-named is not the famous one that starts with a V (containing sildenafil as an active compound), but the other famous one that starts with a C (containing tadalafil as an active compound).

He-who-must-not-be-named.

Icos Corporation (of the Eli Lilly group) is the owner of a number of European patents in connection with the C. drug.

First, there is EP 0740668, which was the basic patent for a French Supplementary Protection Certificate (SPC No. FR 03C0017), which expired in November 2017. Second, there are EP 1173181 and EP 1200092, designated as “secondary patents” by the Paris Tribunal de grande instance (TGI).

In November 2014, generic drug company Mylan obtained a marketing authorization (MA) related to the C. drug. In January 2016, Mylan initiated nullity proceedings with respect to the EP’181 and EP’092 patents in front of the Paris TGI. The parties later reached a settlement agreement with respect to EP’092, so that only the fate of EP’181 remained to be decided upon. Icos Corporation and the French distributor Lilly France counterclaimed for infringement of EP’181. The first instance judgment was issued in May 2018.

EP’181 or equivalents thereof were or are also litigated in other countries. According to the summary provided by the court, the patents were revoked in Germany, the United Kingdom, Canada and Japan. It may thus come as little surprising that the same outcome was achieved in this country. On the other hand, the ground for nullity that the TGI took into consideration is relatively unexpected, as will be apparent below.

But before getting there, let’s first look at the statute of limitations defense raised by Icos.

Mylan argued that the statute of limitations is not applicable to patent nullity suits. This argument was rejected by the court, in keeping with earlier decisions.

Turning to the determination of the starting point for the limitation period, the court recalled its now established principle of an in concreto determination.

The court thus explained that the grant of the EP’181 patent was not the starting point for the limitation period. The general principle is the following:

The starting point for the limitation period must thus be set at the date, determined in concreto, at which Mylan was or should have been aware of EP’181, due to its intent to market a generic of the drug [C.], which led to the MA obtained on November 21, 2014, since this patent is an impediment to its exploitation.  

In this case, a determining factor to be taken into account was the date at which Icos obtained its own MA:

In this case, the first MA for [C.] was granted in November 2002. By way of application of article R. 5121-28 of the Code de la santé publique, the generic company can only apply for an MA as from the eighth year after the grant of the originator’s MA, and cannot be granted one before the tenth year. Therefore, Mylan could not file an MA application before November 2010.

This reasoning is fully consistent with that applied in another recent case which already involved Mylan.

However, this is not the end of the story here. The court further held:

In this case, an additional fact should be taken into account in the in concreto analysis of standing and the starting point for the limitation period. […] [Namely, Icos corporation] filed a request for limitation of the EP’181 patent on February 14, 2014 with the European patent office, and the limitation of the patent was published on March 25, 2015. 

Thus the patent enforceable against Mylan could only be known on this date, so that the starting point for the limitation period is March 25, 2015. 

In another recent case, the starting point of the limitation period was postponed by a court to the date of the decision of the Board of appeal of the EPO in the opposition appeal regarding the patent at stake. The relevant paragraph of this decision may be worth quoting again here:

[…] It is only on [July, 7, 2014, i.e. the date of the Board of appeal’s decision] that the drafting of the patent which is sought to be revoked was stabilized and that Ethypharm was able to precisely know the content of the claims of said patent as well as all the facts making it possible for them to act, so that the action is not time-barred and is admissible. 

We now have a confirmation that limitation proceedings, just like opposition proceedings, may result in a postponement of the limitation period for nullity actions.

It remains to be seen how general this principle is and in particular whether it extends e.g. to the impact of other lawsuits involving third parties.

Turning now to the merits of the case, claim 1 of EP’181 as limited reads as follows:

A pharmaceutical unit dosage composition comprising 1 to 5 mg of [tadalafil], said unit dosage form suitable for oral administration up to a maximum total dose of 5 mg per day.

Independent claim 10 is a Swiss-type claim containing similar features.

Mylan raised all classical grounds for nullity, but the court focused on insufficiency of disclosure.

After reviewing the description of the patent, the court noted the following facts:

  • There are several molecules belonging to the class of type 5 phosphodiesterase (PDE5) inhibitors.
  • Among them, particular reference may be made to sildenafil, the active compound of V., marketed at the priority date of the patent in doses of 25, 50 and 100 mg.
  • However, sildenafil generates a number of side effects, such as facial red patches, or a lowering of blood pressure.
  • The invention thus relates to a low dosage of the known alternative drug tadalafil, in order to provide an effective treatment of erectile dysfunction without the side effects associated with sildenafil.
  • The patent also contains a number of examples showing the efficacy and the absence of side effects of low dosage forms of tadalafil.

The court was apparently quite puzzled by the patent as a whole:

The problem expressed in the description of the patent is to provide a principle which avoids the issues of red patches and side effects of sildenafil by a particular dosage of tadalafil. 

Indeed, and as rightly noted by Mylan, no side effect associated with tadalafil is mentioned in the patent, so that the dosage suggested for tadalafil curiously addresses a problem associated with another active compound. 

The court then referred to a standard mentioned in the so-called “finasteride” judgment of December 6, 2017 by the Cour de cassation, commented on this blog:

[…] When a claim relates to a [second] therapeutic application of a substance or composition, obtaining this therapeutic effect is a functional technical feature of the claim. Therefore, in order to meet the requirement of sufficiency of disclosure, it is not necessary to clinically demonstrate this technical effect; but the patent application must directly and unambiguously reflect the claimed therapeutic application, so that the skilled person can understand, based on commonly accepted models, that the results reflect this therapeutic application.

The court then came back to the technical problem presented in the patent:

Icos Corporation and Eli Lilly do not dispute that no prior art document describes any side effect related to the use of tadalafil.
And they cannot validly argue that the absence of documentation in this respect does not amount to the absence of a problem, because the onus is on them to show that there was a problem to be solved and that it is solved by the teaching of the patent.
It thus appears that the problem described in the patent relates to sildenafil and not tadalafil, and it cannot be extrapolated that both active compounds have the same side effects, unless one were to admit the resolution of artificial or speculative problems.
In fact, the examples cited in the patent demonstrate that the dosage mentioned in the patent does not address the listed “problems”. 

In summary, the problem to be solved cannot be considered as the reduction in the side effects of tadalafil, because such side effects were not known in the prior art – only side effects of sildenafil were known.

Most of the examples of the patent also do not demonstrate the existence of side effects of tadalafil associated with higher dosages, so that these were held not to “reflect” the alleged therapeutic application (using the wording of the Cour de cassation).

The conclusion reached by the three-judge panel will not doubt cause a stir, as the invention recited in claim 1 was found not to be sufficiently disclosed in the patent.

The finasteride case related to a second therapeutic application invention, for a known molecule. It is well accepted both at the EPO and in French national courts that the new therapeutic application has to be demonstrated in a plausible manner in the patent, otherwise the patent is insufficient.

Yet, in the present case, claim 1 is a classical product claim, with no functional feature. According to EPO case law, there should be no problem of insufficiency of disclosure, because the skilled person is able to manufacture the composition containing the active substance at stake in the claimed dosage range. The question of whether said claimed dosage range provides any technical benefit or not only pertains to the appraisal of inventive step.

Now, as regular readers of this blog are well aware, the French approach to validity is much more fluid than the EPO’s.

If a court is convinced that an invention does not properly solve the alleged technical problem, or that the technical problem is artificial, this can give rise to a number of invalidity objections, including insufficiency of disclosure. My understanding is that the technical problem tends to be viewed by French courts as an integral part of the claimed invention itself.

But there is yet another cause for controversy in the judgment.

I mentioned above that most of the examples of the patent do not demonstrate the existence of side effects of tadalafil associated with higher dosages. That said, there is one example, namely example 7, which does analyze in detail the occurrence of various side effects depending on the dosage of tadalafil. The table of results is in fact even reproduced in the judgment. The court first remarked that some side effects are not present at all at any dosage. So far so good. But, regarding those side effects which are indeed shown to be less frequent in the claimed dosage range than at a higher dosage, the court noted:

Regarding headache, back pain and myalgia […], the reasoning is the same because these effects were never previously observed.

This part of the judgment seems to imply that, at least in the context of drug dosage patents, the existence of the technical problem to be solved must be acknowledged in the prior art, and cannot be demonstrated for the first time in the patent itself.

The invention can thus not be a so-called “problem invention“.

Things should be put into perspective, though, and the present case may not necessarily be generalized. Maybe the court did not believe that example 7 was convincing at all. At the very least, the fact that the dosage originally claimed in the patent, namely from 1 to 20 mg, had to be later restricted to 1 to 5 mg, due to some relevant prior art, certainly contributed to the court’s perception of the patent being invalid.

In fact, the court reviewed all the following claims and concluded that they suffered from the same deficiencies as claim 1, mentioning a lack of inventive step in passing for some of them. Fluidity of the grounds for nullity indeed.

As a final note, this is probably one of the last judgments penned by Ms. Courboulay, who, given her seniority and her involvement in many conferences and events, was often considered as the leading judge in the 3rd (IP) chamber of the Paris TGI.

Ms. Courboulay has now officially retired; but given the large number of important rulings which she authored, there is little doubt that her influence will continue to be felt in the coming years.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, April 5, 2018, Mylan v. Lilly France & Icos Corporation, RG No.16/05073.

Judgment in the box

The burden of proof. A concept with a well-deserved name.

It can indeed be a real burden for a patent proprietor to find clear and convincing evidence that a patent is infringed; or for a defendant to find clear and convincing evidence that the invention was disclosed by the proprietor before the filing date.

The case discussed today illustrates both situations.

In this case, all litigants are from the Toulouse area. Construction Machines Automatiques Spéciales (CMAS) owns French patent No. FR 2755655, filed in 1996, which expired during litigation. The patent relates to a carton making machine.

The main defendants are: LB Pack, a company created in 2012 a few kilometers away from CMAS; and two ex-employees of CMAS, who also happen to be the founders of LB Pack.

CMAS filed claims of patent infringement and unfair competition against these three defendants. The defendants counterclaimed inter alia for patent nullity.

The first notable question raised in this case is whether the nullity counterclaim was time-barred.

As reported last week, the statute of limitations will no longer be applicable to any patent nullity claim if and when the UPC Agreement enters into force. But in the meantime we have to continue dealing with it and the legal uncertainty that it entails.

Quite surprisingly, the court disposed of this issue in a short paragraph, briefly noting, as if it were self-evident, that the statute of limitations is not applicable to nullity claims when they are raised as counterclaims.

An interesting development indeed, as it was previously held in other cases that nullity counterclaims are to be treated in the same manner as direct nullity claims – with the caveat that, if a defendant is time-barred, nullity can always be raised as a defense (exception) to the effect that the patent should not be enforceable against them, even if the patent is not formally revoked.

Stay tuned to check whether this new approach will hold.

The wonderful things you can make out of cardboard.

The main invalidity argument raised by LB Pack et al. was that CMAS (formerly CMA) had disclosed the invention before filing by showing and selling so-called Minicompact machines.

By way of an interesting strategy, the defendants requested and obtained an ex parte order from a judge allowing them to perform an inspection by a bailiff with a third party, the company Stendhal, that had bought a Minicompact machine in 1995.

The bailiff’s report proved the acquisition of the machine before the filing date of the patent. But the court was not convinced that this machine anticipated the patent claims. The main reason for this was that the machine was subjected to several servicing operations since 1995, including an important compliance operation in 2004, performed by CMAS. In other terms, the court believed that the machine may have been altered, and that the copy inspected by the bailiff during litigation may not be representative of the machine bought in 1995. Thus, the benefit of the doubt was given to the patent proprietor – who was apparently not required to demonstrate that they had indeed modified the machine in a way which would be relevant to the patent in suit.

The patent was thus declared valid.

Turning now to infringement, the shoe was on the the other foot.

An infringement seizure report had been drawn up by a bailiff. This proved that LB Pack had sold one machine to a third party, Sicaf. But the issue was the description of the allegedly infringing machine.

In fact, the bailiff was only able to inspect an unfinished machine, not yet operational, and with some parts not yet assembled. But, said the court, analyzing whether the characterizing portion of the main claim of the patent was implemented by LB Pack could only be done based on a fully assembled machine.

The other documents and evidence found by CMAS did not make it possible to know whether the subject-matter of the patent claims was implemented or not.

As a result, the infringement claim was rejected.

That said, the defendants were not off the hook, as they were found guilty of unfair competition.

It turns out that the bailiff conducting the infringement seizure found evidence that the two ex-employees who founded LB Pack had extensively copied business and technical information belonging to CMAS before leaving. Also, at the time they left the company, they had accessed and taken advantage of one CAD license belonging to CMAS.

The assessment of the court as to the consequences of these illegal actions was then the following:

Even if it is not demonstrated that LB Pack makes and markets machines which infringe CMAS’ patent, it remains that all the saved technical data belonging to CMAS necessarily and unjustifiably made it easier to create new machines which could be very quickly put on the market by LB Pack as from 2013, on the same market, which conferred them an undue competitive advantage.

Finally, it can be derived from the invoices annexed to the infringement seizure report that, owing to the customer and prospect files copied on the laptop of Mr. […], it was easier for LB Pack to solicit customers and thus market its machine more easily notably with Schneider and Durlin which were already customers of CMAS. The misappropriation of customers is thus demonstrated and is an act of unfair competition and free-riding. In view of the invoices from LB Pack seized by the bailiff, the court knows that 3 machines were sold starting from July 2013 for an amount of 235,000 euros, notably to Sicaf, which was a prospect of CMAS, and that maintenance services were also sold to Schneider and Durlin, customers of CMAS. 

Therefore, the acts of unfair competition and free-riding are serious and repeated and the compensation for the harm caused should be set to 80,000 euros. 

One remark here is that an infringement seizure is a procedure specifically intended to gather evidence of patent infringement. However, even in the absence of patent infringement, the evidence found during the seizure can be used against the defendant with respect to other claims, notably in relation with unfair competition.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 4ème section, March 15, 2008, SARL Construction Machines Automatiques Spéciales v. SARL LB Pack et al., RG No. 14/16600.