More than just diapers

Rulings from the Enlarged Board of Appeal of the EPO are scarce – this is what makes them so eagerly awaited by the patent profession.

2019 may turn out to be an exceptional year in this respect though, with already three official referrals so far and an imminent fourth one which has not yet been officially issued as of today.

But sometimes I wonder whether these rulings are not in fact too scarce. Overall, the case law of the Boards of Appeal is consistent and contradictions between decisions are infrequent. But there is always room for improvement, right?

Case in point: sufficiency of disclosure and the issue of so-called unclear parameters.

If you read sections II.C.4.5 (“Parameters“) and II.C.7.2 (“Article 83 EPC and Clarity of Claims“) of the EPO case law book, and if you are able to summarize the standard to be applied regarding this question, you will deserve some kudos.

The issue is the following. Some claims contain parameter features, such as “Property X is more than threshold Y“. There are cases wherein the application or patent at stake does not explain in a satisfactory manner how to measure property X. As a result, property X may be close to impossible to measure for the skilled person; or the skilled person may be aware of different possible ways to proceed, leading to wholly different results.

There is little doubt that this can give rise to an objection of lack of clarity of the claims (art. 84 EPC). The real head-scratcher is whether it also gives rise to an objection of insufficiency of disclosure (art. 83 EPC), or can give rise to this objection in some special circumstances.

This is of course extremely important because insufficiency of disclosure is a ground for opposition (and nullity, for that matter), whereas lack of clarity is not. In other words, if the answer to the above question is no, then an ill-defined parameter already present in the granted claims cannot be challenged after grant, no matter how serious the problem is.

Let me just state, incidentally, that on a practical standpoint this can be a major concern for third parties, who can be at a complete loss as to whether they infringe or not, and what to do in order not to infringe.

A large number of Board decisions have addressed this question, in various ways. The question has however never been referred to the Enlarged Board of Appeal.

Only the Boards of Appeal or the President of the EPO can refer a question to the Enlarged Board “to ensure uniform application of the law, or if a point of law of fundamental importance arises” (art. 112 EPC). Parties can only request a referral but without any power whatsoever to force a referral.

Can the case law of the Boards on the relationship between art. 83 and art. 84, in particular as far as ill-defined parameters are concerned, be considered as uniform or not?

My personal impression is that there is some degree of divergence, although this is in fact denied in some decisions.

One approach in particular that has been applied is that the impossibility for the skilled person to know whether he/she is working within the scope of the claims (“forbidden area“) is tantamount to an impossibility of carrying out the invention. 

In T 1811/13 (November 8, 2016), Board 3.2.05 noted that this approach originates from decision T 256/87 and “appears to have gone unnoticed until 2003” (reasons 5.1); that it was adopted by four decisions issued by Board 3.2.06 between 2004 and 2007, including in particular T 464/05; and that on the other hand many other decisions have rejected this approach since 2003, because “the definition of the scope of a claim was related to Article 84 EPC rather than Article 83 EPC“.

Board 3.2.05 concluded (reasons 5.1) that:

It may, therefore, be said that today there is agreement or at least a clearly predominant opinion among the boards that the definition of the “forbidden area” of a claim should not be considered as a matter related to Article 83 EPC. The present board shares this opinion.

Decision T 647/15, issued by the same Board 3.2.05 almost contemporaneously (September 8, 2016), states pretty much the same.

So far so good. Except that Board 3.2.06 in fact stands by its earlier case law.

This was notably illustrated in T 1188/15 of November 24, 2016.

In T 626/14 of  May 24, 2018, Board 3.2.06 explicitly disagreed with the comments made by Board 3.2.05 in T 1811/13 and T 647/15 regarding the earlier 3.2.06 case law, embodied by T 464/05. Said the Board (reasons 1.4.1):

Yet, T1811/13 and T647/15 themselves concentrate only on an individual aspect in e.g. T464/05, namely ‘the area covered by the claim’ without addressing the actual findings in that decision regarding the issue of Article 83 EPC. In fact, T464/05 draws a distinction between the two objections under Articles 83 and 84 EPC respectively and explains the significance thereof. For example, T464/05 considers in Reasons 3.3.2 not the boundaries of the claimed subject-matter which was the subject of T1811/13 and T647/15, but the lack of indications in the patent concerning the measurement of a particular parameter. This is stated in T464/05 as resulting in ‘an undue burden for the skilled person trying to reproduce the invention’. Likewise, in Reasons 3.2, the crucial issue in respect of sufficiency of disclosure concerns the issue of whether a skilled person ‘is capable of reliably measuring (the) parameter’. Thus, T1811/13 and T647/15 do not cause the present Board to see anything which would undermine the reasoning in T464/05 concerning Article 83 EPC. In the sense that a parameter to be measured was at issue in T464/05 with regard to Article 83 EPC, the Board in the present case is faced with the same issue, i.e. the undue burden created by the lack of any information allowing the skilled person to reliably measure the defined thickness. This, as explained supra, results in the skilled person being unable to know whether he has arrived at the invention or not, such that the invention is not sufficiently clearly and completely disclosed.  

In summary, Board 3.2.06 in T 626/14 maintains its position, and insists that if the skilled person is unable to know whether he or she has arrived at the invention, due to a lack of information in the patent, this amounts to an insufficiency of disclosure.

How did the other Board 3.2.05 react? In case T 250/15 (July 20, 2018), one of the opponents requested that the Enlarged Board of Appeal be consulted regarding the question of sufficiency of disclosure in the case of an ill-defined parameter. The Board found the requirements of sufficiency of disclosure to be met in the case at hand, and rejected the request for a referral.

In particular, the Board had this to say regarding the latest comments by Board 3.2.06 (reasons 2.6, translated from French):

The present Board notes that decision T 626/14, just like case T 464/05, concerns a particular constellation in a certain technical field. The present case is however different in that the parameter of the number-average molecular weight Mn relates to a clearly defined property which is inherent to the material. Besides, it has not been challenged that the skilled person has a limited number of appropriate and generally known measurement methods. Therefore, T 626/14 cannot put into question the conclusions expressed above regarding the sufficiency of disclosure of the invention, and the request for a referral to the Enlarged Board of Appeal which was orally presented by respondent I must be rejected. 

In a nutshell, for Board 3.2.05, the facts of the case are different from those of T 626/14, and the parameter at stake here does not raise any difficulty for the skilled person.

Again, so far so good. But the comment on “a particular constellation in a certain technical field“, on the other hand, is puzzling.

The technical field of T 464/05 and T 626/14 is that of sanitary articles, such as diapers and the like.

What could be so special about this technical field? In T 464/05 the contested parameter was a “weighted average mass vapor transmission rate (MVTR)” and in T 626/14 it was simply a thickness which is nevertheless difficult to measure as it relates to a fibrous layer, so that a certain pressure needs to be applied in order to make the measurement.

Admittedly, these two parameters were very specific ones, but there is no doubt that other problematic examples can be found in many other technical fields. There is nothing unique about the diaper constellation.

Fish density on an absorbent article: an ill-defined parameter?

A divergence of approach between some Boards, each one consistently applying its own case law, is not unheard of.

For example, novelty of dosage regimen claims led to disagreements between Boards 3.3.02 and 3.3.04, before the Enlarged Board issued its decision G 2/08.

Is it fair to say that there is such a similar divergence nowadays between Board 3.2.06 and (at least) Board 3.2.05?

If so, would a referral to the Enlarged Board of appeal (in a case fit for this purpose of course) not be a much better solution than putting any divergence under the rug?

The legal standard to be applied to a patent should not depend on its IPC classification and the business distribution scheme of the Boards.

As a disclaimer, what is discussed above is not the full picture of ill-defined parameters. Yet further legal standards have been suggested and debated.

For example, in T 1845/14 of November 8, 2018, Board 3.3.03 analyzed another line of case law, embodied by T 593/09, T 608/07, T 815/07 and T 172/99, according to which “the criterion applied for assessing sufficiency of disclosure was whether the unclear parameter of the claim was so ill-defined that the skilled person would not have been able, on the basis of the disclosure as a whole and using their common general knowledge, to identify (without undue burden) the technical measures (e.g. selection of suitable compounds) necessary to solve the problem underlying the patent at issue“.

After a very thorough analysis, Board 3.3.03 came to the conclusion that this “is not a suitable criterion for assessing sufficiency of disclosure when the problem or an effect derivable from it are not explicitly or implicitly part of the definition of the claimed subject-matter” (reasons 9.8).

The Board then added (reasons 9.9):

The view expressed above could be perceived as a deviation from the above cited decisions or other decisions of the Boards of Appeal in which a criterion for assessing sufficiency of disclosure was whether the ambiguity of a parametric definition deprived the person skilled in the art of the promise of the invention. However, there is no need to refer a question to the Enlarged Board of Appeal as the diverging views arise from a different approach regarding the meaning of the term “invention” in relation to the issue of sufficiency of disclosure and the approach taken in the present decision is supported by the decisions of the Enlarged Board of Appeal G 2/98 (see above) and G 1/03 (see above).

Interestingly, the Board in this case did find the claimed invention to be insufficiently disclosed despite setting aside a legal standard which would have been more demanding for the patent in suit. Said the Board (reasons 11.3):

The ambiguous definition of a parameter in a claim may result in the scope of the claim to be broader than the patentee might have intended. In such a case the question arises whether the teaching of the patent in suit, which was directed to the claimed subject-matter having regard to a specific meaning of that parameter (which, however, was omitted), would nevertheless have enabled the skilled person to carry out the invention outside of the scope intended by the patentee, using common general knowledge and a reasonable amount of experimentation.

It was decided that the teaching was insufficient in this respect.

Anyway, this was another example of a criterion previously applied in the EPO case law, now said to be erroneous by a Board, on the same topic of unclear parameters.

Time will tell whether T 1845/14 will be followed or not, and whether a unanimous frame of reasoning regarding ill-defined parameters will finally emerge from the case law, with or without the involvement of the Enlarged Board.

In the meantime, we may have to deal with a constellation of approaches.

Araxxe wields the axe

Never put all your eggs in the same basket” is probably a truism in many contexts. Including the one of patent rights.

Case in point: Araxxe, a French company, owns European patent No. EP 2087720. The patent gets opposed, gets killed by the opposition division of the EPO, and does not get resurrected by the Board of appeal. But it turns out that Araxxe had another egg in its basket, namely French national patent No. FR 2908572 – originating from the priority application. And the Paris Tribunal de grande instance (TGI) held that the patent was valid and infringed.

Let’s take a few steps back to look more precisely at what happened.

The French patent FR’572 was granted in March 2009. A couple of months later, Araxxe sent a warning letter to the Belgian company Meucci Solutions. Since the exchanges between the two firms did not lead to a resolution, Araxxe filed a complaint in front of the Paris TGI in December 2009. At that time, the European application claiming priority from FR’572 was still pending at the EPO. This led the TGI to issue a stay of proceedings in May 2011. Such a stay is ordered as of right, since the French part of the European patent substitutes for the French patent when it is definitely granted. By “definitely” is meant that a possible opposition should be taken into account.

In this case, Meucci Solutions (later renamed Sigos), did file an opposition against EP’720 after grant, in 2013. The opposition division revoked the patent, and the Board of appeal confirmed this revocation in November 2016 (case T1645/15).

Araxxe could have withdrawn the French designation of the European application in order to try to avoid such a long stay of proceedings. Indeed, the European application as filed contained the same claims as the French patent as granted. Therefore, it was extremely unlikely that the European patent would end up having a broader scope of protection than the French patent. But they did not do so.

Thus, the case resumed after the termination of the EP proceedings, with no EP-FR substitution having taken place due to the demise of the European patent.

Interestingly, Araxxe asserted only claim 8 of the French patent.

One basket, different eggs.

Here is claim 1:

A method for generating scheduled communication operations over one or more communication networks from an information system and verifying their correct invoicing, comprising:
– allocating resources within said information system for a call campaign over a predetermined period of time,
– managing communication equipment in shared time, 
– executing communication or transaction operations, in response to execution orders received from a call scheduling site, 
– collecting invoicing data produced by the operator, and
– automatic data correlation allowing anomaly identification,
characterized in that the method is simultaneously implemented for a plurality of communication operators, the allocated resources being shared, each communication operator being able to issue communication or transaction operation execution orders.

Here is now claim 8:

Application of the method of any one of claims 1 to 6, for the purpose of detecting traffic bypass operations by third parties, said method implementing a comparison of theoretically expected caller identifiers with identifiers actually recorded by the call receiving robot. 

The defendant not only challenged the validity of claim 8, but also that of claim 1, since claim 8 makes reference to claim 1. But the court refused to consider the attack against claim 1, because claim 8 is independent from claim 1, they said.

Under French practice, invalidity counterclaims are in principle only examined when they relate to the claims alleged to be infringed – regrettably so, I would say. This part of the decision is thus relatively unsurprising. As to whether claim 8 can truly be termed an independent claim, I have some doubts. Any dependent claim could actually be termed independent, in that case. Not that this categorization really matters in the end anyway.

As a result, 17 pages of the defendant’s written submissions on invalidity were disregarded. Also, the defendant’s arguments that the patentee had “agreed” that its claims were invalid since they had been modified in front of the EPO, did not fly. The court stated that:

Amending claims during examination or opposition proceedings, in view of remarks made in search reports or observations from the patent offices, is a usual and common practice which cannot be considered as an agreement by the applicant that its right is invalid. 

That is a relief for all patent attorneys I guess.

The remaining validity points to be addressed were inventive step and sufficiency of disclosure.

As an important note, EP’720 was revoked for extension of subject-matter. But the claims of the European patent as granted were different from those of the French patent. Most importantly, the French patent claims were identical to those of the European application as filed. As a result, there was no way the objections entertained by the EPO could apply similarly to the French patent.

Concerning inventive step, the court noted that the claims of the European application were initially held to be obvious during examination. But then the patent was granted, and the opposition division viewed the granted claims as inventive in the preliminary opinion annexed to the summons to oral proceedings. I would say that this is largely irrelevant, again because the European claims as granted were different. Anyhow, the court then looked at the prior art relied upon by the defendant and was not able to find any lack of obviousness.

Concerning sufficiency of disclosure, things unfortunately got somewhat murky in the judgment.

The defendant argued that the European claims had to be restricted to recite a “plurality of robots” – which led to the extension of subject-matter trap; and that this was an essential feature without which the invention could not be implemented. The court replied that claim 8 refers to claim 1, which recites “a plurality of robots“, so that there is no issue. Except that I cannot find this phrase in claim 1. Maybe another claim feature was considered as synonymous or equivalent, but the court did not provide any detailed explanation.

It gets worse at the next sentence, when the court remarked that the European patent was granted anyway. This overlooks the defendant’s whole point, which was that the European claims had to be modified in order to be overcome a serious objection.

And it gets more than worse (I would go as far as saying “worserer”) in the following sentence:

The later revocation of this European patent does not have any impact on the validity of the French patent since said revocation was based on a ground which is specific to the EPC (extension of subject-matter), which has no equivalent in French law. 

Readers will be excused if they have fallen from their seats at this point. Extension of subject-matter, of course, has nothing to do with insufficiency of disclosure, and both are fine grounds of nullity under French law.

I am not saying that the insufficiency attack was very serious, or that the court’s decision to uphold the patent was erroneous – I have no personal opinion at this point. But some parts of the judgment seem to have been drafted too hastily. This is most unfortunate at a time when there is a perception of global increase in the quality of French judgments in patent matters.

In the rest of the decision, Sigos’ challenge against the infringement seizure at a data center owned by a third party failed. As did their challenge against a bailiff report on a website dated December 2009 but filed in court only in November 2017, as a reaction to Sigos’ argumentation.

The court then turned to the analysis of infringement. I will not go into a feature by feature analysis, as the main interesting point in my view was the issue of territoriality. Indeed, Sigos argued that it performed most of its activities abroad.

The court replied:

The infringement seizure report, but also the bailiff internet report and the screenshots prove the use or the offer to use of an allegedly infringing process, by Sigos, in France. Therefore, it cannot be denied that the alleged harm takes place in France. It is irrelevant whether the means to control and handle the supposedly involved robots are in Belgium, where Sigos states its global platform […] and its main assets are located, or whether the correlation operations are performed abroad, since it appears […] that they are active in France with the main French phone companies. 

If my understanding of the above paragraph is correct, the court found it irrelevant that part of the steps of the claimed method may be implemented abroad. In that case, this would be a major departure from the traditional view that the use or purported use of a process has to be implemented in France (period) in order to be infringing.

As a consequence, the TGI issued an injunction against Sigos and awarded damages amounting to 378,000 euros and attorney’s fees amounting to 50,000 euros to Araxxe.

I don’t know if an appeal is pending or not, but some points in the decision would deserve to be further clarified.

At any rate, and going back to my initial comments at the beginning of this post, it is always useful for a right holder to have several different patents or applications in its basket especially for important cases, and this will certainly remain true even if/when the UPC comes into force.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 3ème section, February 1, 2019, Araxxe SAS v. Sigos NV, RG No. 15/15784.

Extension of subject-matter and/or of scope

Every profession has its own telltale expressions.

Let’s say you meet someone at an event who tells you that they will have some cheese “and/or” a glass of red wine; I would bet that you are talking to a patent attorney. Well, especially so if the event is hosted by the CNCPI.

But, as fond as we may be of the “and/or” language, in some occasions it can come back to haunt us. Just ask Nice. Not the city, but an Italian company specialized in automatic doors or gates.

Nice owns European patent No. EP 1509823 directed to an electrical system for controlling a gate or door.

In 2010, Nice filed a complaint for infringement of this patent against FAAC France and FAAC Nord in front of the Paris Tribunal de grande instance (TGI). There are three independent claims 1 to 3 in the patent, the others being dependent claims. Nice initially asserted claims 3 to 23. The two other independent claims 1 and 2 were not at stake. The defendants counterclaimed for nullity.

The following year, as the first instance lawsuit was ongoing, a request for central limitation was filed at the EPO. As a result, a limited version of the patent (B3-1) was published in 2012.

Nevertheless, all asserted claims were held invalid by the Paris TGI in its 2014 judgment. Sadly, the decision does not seem to be readily available online, so I am not sure what ground for nullity was entertained by the first instance court.

Nice appealed and filed a second request for central limitation at the EPO in 2015.

As a result, a second limited version of the patent (B3-2) was published in 2016. This leads us to the recent judgment of the Paris Cour d’appel, which confirmed the invalidity of all asserted claims and in particular independent claim 3. The court held that the subject-matter of the claim extended beyond the contents of the application as filed and that the scope of protection had been extended after grant.

Who needs an automatic door control system when you can have a frog do the job.

Here is claim 3 of the patent as initially granted (B1 version of the patent):

Electrical system for controlling at least one gate or door or similar element of the type moved by means of at least one corresponding electric motor, comprising:
a) an electric network consisting of two electric wires adapted to allow distribution of power supply and digital information;
b) a central control unit having two terminals adapted to be connected respectively but indifferently to the two wires of the network in order to transmit direct-current power supply and to transmit and receive digital information;
c) one or more peripheral units, each having two terminals adapted to be connected respectively but indifferently to the two wires of the network in order to receive direct-current power supply and to receive and/or transmit digital information;
wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements;
wherein a peripheral unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements.

The two last paragraphs of the claim are the important ones for the rest of the discussion. Note the four occurrences of “and/or“.

In the first limited version of the patent (B3-1), a number of features were added; and the two relevant paragraphs of claim 3 were modified as follows:

[…] wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and to a device for entering requests of movement of the gate or door or to a safety device for gates or doors;
wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

In the second limited version of the patent (B3-2), yet further features were added; and the two relevant paragraphs of claim 3 were modified as follows

[…] wherein the central unit is adapted to be electrically connected to the electric motor for controlling operation thereof and to a safety device for the gate or door;
wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

Let’s turn to the appraisal of extension of subject-matter of the final version of the patent, namely B3-2.

In original claim 3 in the patent application as filed, the two relevant paragraphs were the same as in the B1 patent, namely:

[…] wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements;
wherein a peripheral unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements.

“And/or” is usually taken to mean either “and”, or an exclusive “or”.  So, at first sight, one could think that claim 3 in B3-2 was obtained by simply deleting some options from original claim 3, without giving rise to any added matter concern. And one would be wrong, at least according to the Cour d’appel.

Indeed, the court did not simply rely on original claim 3 but turned to the description of the application in order to understand what the subject-matter of the invention, or more specifically of the “third embodiment” of the invention (corresponding to claim 3), actually is about.

The court held the following:

The invention relates to the use of an electric network made of only two electric wires for the entire system, which are designed so as to deliver DC current and numerical information, and so as not to impose constraints on the connection between system equipment and the network. 

This electrical system, intended to control at least a gate or door, must be connected to at least three main devices: 

– an electric motor which sets the gate in motion, 

– a device for entering requests of movement of the gate, 

– a safety device (for example based on a photoelectric cell).

According to the court, claim 3 as filed (or as granted) thus required the presence of all three devices – although they could be connected either to the central unit or a peripheral unit. This was not explicitly stated in claim 3, but the court held that this could be inferred from the description.

The court quoted in particular the following sentence, which is just before the presentation of the various embodiments in the application:

Such an electrical control system must be connected to at least three essential devices: an electric motor for moving the gate, a device for entering requests of movement of the gate (for example a key-operated selector, a command keypad, a remote control receiver, etc.), a safety device (for example a photocell system, a sensitive edges system, a mat presence detector, a radar presence detector, etc.).

The court also quoted the following characterization of the third embodiment:

In other words, according to this third embodiment, two of the essential devices are connected electrically directly to the central unit, while the third essential device is connected electrically to a peripheral unit.

In contrast, according to claim 3 of the B3-2 patent, the second device was mentioned only in connection with the peripheral unit, and not in connection with the central unit, and the mention in question was the following:

[…] wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

Therefore, according to the amended claim, the device for entering requests of movement can be omitted altogether. This, the court said, is not supported by the application as filed.

Nice argued that, if the claimed peripheral unit is connected to a safety device, then the device for entering requests will be connected to yet another peripheral unit so that the system can work. But the court discarded the argument and said it was an inventive step-type of argument.

Thus, the court declared that the subject-matter of claim 3 extended beyond the content of the application as filed.

Furthermore, since the granted patent was similar to the application as filed and was thus interpreted by the court as not covering the option wherein the device for entering requests is absent from the system, the B3-2 limited patent was also found to suffer from extension of the scope of protection, since this limited patent no longer required the presence of the device for entering requests.

Once again, we are reminded that French courts have a tendency to extensively interpret claims (not just granted claims, but also original claims) in the light of the description.

How would the extension attack have flown with an opposition division at the EPO? I am quite sure that they would have focused more on the exact language used in original claim 3. That said, they could theoretically have reached the same conclusion as the French judges, for instance by noting that going from original claim 3 to amended claim 3 required multiple selections in the “and/or” options, and that there was no pointer to such a multiple selection (or combination of features).

In summary, “and/or” is nice and broad, but beware of what the teaching of the invention actually is.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, November 9, 2018, Nice v. FAAC France, RG No. 16/11888.

The “pays” of the PIs?

A hardly understandable question, I know.

“Pays” is the French word for “country”. As for PIs, this term refers of course to preliminary injunctions. A PI is the most dreaded weapon of right holders.

But this legendary prize is also famous for being extremely hard to seize, notably in France. Although… could the trend have recently changed?

One ruling in particular which was issued last June in a prominent pharma case gave rise to a lot of comments. But another ruling issued just one month later also followed a somewhat similar path.

French chemical company Minakem sued two companies of the M2i group, namely Melchior Material and Life Sciences France (MMLS) and M2i Salin (M2i). MMLS owns a patent family on a method for making bromo methyl cyclopropane and bromo methyl cyclobutane. Minakem claimed ownership of this patent family and also complained that MMLS and M2i infringed its own patent No. FR 3010997, filed a few months before the priority date of the MMLS patent family. The two actions were joined as a consolidated case.

The ruling reported today does not contain much information on the context of Minakem’s ownership claim. It is an order issued by the judge in charge of case management, who was presented with a motion for PI by the plaintiff. MMLS and M2i raised invalidity and non-infringement as means of defense – but both grounds of defense were rejected.

Let’s start with validity first. The defendants argued that claim 1 of the Minakem patent lacks inventive step over a so-called Bayer document.

Now seems like a good time to have a look at the claim, which is quite straightforward:

A method of preparing bromo methyl cyclopropane comprising a step a) of reacting cyclopropylcarbinol with a complex of triphenylphosphite and bromine. 

Making reference to the problem and solution approach for the inventive step reasoning, the judge first noted that all parties agreed that the Bayer document was the closest prior art. According to this document, bromo methyl cyclopropane is prepared by reacting triphenylphosphine with cyclopropylcarbinol, and, after cooling, adding bromine.

The judge then held that there are two differences between the claimed invention and the teaching of the Bayer document, namely:

  • The use of triphenylphosphite instead of triphenylphosphine as a reactant: this is a one-letter difference in the name, and more importantly, three additional oxygen atoms in the molecule.
  • The use of a complex of triphenylphosphite and bromine, instead of adding bromine in a subsequent step.

Two documents were offered as secondary references, designated as D.G. Coe and Eli Lilly.

D.G. Coe teaches that triphenylphosphite can be used as a reactant to make alkyl halides (a class which encompasses the bromo methyl cyclopropane at stake here). But the judge noted that, according to the document, the reaction does not work similarly with all alcohols, and in particular that it provides very unsatisfactory results with cyclohexanol. Since cyclohexanol is a cyclic compound, just like cyclopropylcarbinol, the judge was convinced that the skilled person would have been dissuaded by D.G. Coe from reacting a triphenylphosphite complex with cyclopropylcarbinol, as claimed.

As for the second reference, Eli Lilly, it also discloses complexes of the type triphenylphosphite / halogen (e.g. bromine), as well as their potential use for a reaction with aliphatic alcohols, for making alkyl halides. But the document also emphasizes a new use for making vinyl halides by reacting these complexes with enol compounds. The judge concluded that Eli Lilly rather teaches to react the claimed complex with other compounds than aliphatic alcohols such as cyclopropylcarbinol. I am not sure I quite understand why the fact that the document both refers to a traditional use and to a new use of a chemical complex makes the traditional use less obvious than the new use. But on the other hand, it is true that the focus of the document is not on the preparation of alkyl halides.

What I actually found to be perhaps the most instructive in the judge’s reasoning is a mention of two side arguments.

First, the judge noted the following, regarding the sequence of steps in the claimed invention (first, formation of the bromine / triphenylphosphite complex, and then reaction with cyclopropylcarbinol):

This sequence is all the more important as MMLS and M2i precisely insisted on it in order to justify the inventive step of their own patent application filed in the United States, so as to discard the Bayer document which was cited as a prior art, since it disclosed a different order of introduction of reactants. They notably argued that “the particular order of the steps is essential to avoid a side reaction resulting in the opening of the tight ring, thus leading to the formation of a brominated alkene (bromobutene)” and that “this method is advantageous relative to the state of the art”.

This has the flavor of a file wrapper estoppel, and one based on a foreign file wrapper, at that.

But as is usually the case, this only comes as an additional consideration at the end of the reasoning in the ruling.

Second, the judge emphasized that both of the proposed secondary references were fairly old. D.G. Coe was dated 1954, and Eli Lilly was dated 1980.

A strong flavor of secondary indicia of inventive step, if you will.

Some fairly old prior art.

The other defense raised by MMLS and M2i was non-infringement.

The judge in charge of case management thus had to decide whether the existence of infringement was likely or not.

The process implemented by the defendants was known owing to an infringement seizure report.

The main non-infringement argument was that, in the defendants’ process, bromine is used in excess in the reaction with triphenylphosphite (TPP). This leads, they said, to the formation of bromo triphenoxy phosphonium bromide as an intermediate. This is not a TPP / bromine complex as recited in claim 1 of the Minakem patent, they argued, because of the presence of the bromide ion in the intermediate. In contrast, the TPP / bromine complex does not comprise a bromide ion and, according to the description of the patent, it is obtained with an excess of TPP (rather than an excess of bromine). They also insisted that the difference is significant, as their own process leads to a lower proportion of bromo butene by-product than the claimed one.

The judge was not convinced. He noted that the starting materials of the MMLS / Mi2 process are the same as those of the Minakem patent. So is the order of the reaction steps. The judge was not convinced either by the alleged difference in molar proportions of reactants:

[…] The scope of claim 1 of the FR’997 patent is not limited by any proportion, so that it does not necessarily and only cover a process limited to equivalent amounts of bromine and [TPP], and anyway the bromine excess alleged by MMLS and M2i is only low in view of the figures which were communicated. 

It is noteworthy that Minakem filed an affidavit from a chemistry professor that challenged the influence of the relative amount of bromine on the purity of the product.

The judge also noted that the different bromo triphenoxy phosphonium bromide intermediate relied upon by the defendants was not mentioned by the employees who were interrogated during the infringement seizure. And that this intermediate is not mentioned in MMLS’s own patent applications either.

As a conclusion, the infringement of the Minakem patent was found to be likely. The judge thus granted Minakem the PI that they requested, without security in view of Minakem’s financial health. However, the judge rejected Minakem’s request for provisional damages. This is because the evidence for the proposed computation of damages offered by Minakem, based only on an affidavit of their CFO without any external auditing corroboration, was insufficient.

To be continued on the merits! MMLS and M2i have their work cut out for them: it seems like they need to find new arguments if they want to turn the tables and ultimately prevail. I am especially curious to see how the ownership claim in relation to the defendants’ patent family will unfold.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance du juge de la mise en état, 3ème chambre 2ème section, July 6, 2018, Minakem v. Melchior Material and Life Science France & M2I Salin,RG No. 17/15019.

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.