Seeing the patent half empty

As an introduction, I am pleased to pass on the announcement of the upcoming patent seminar of the Institut de Boufflers, which will take place next week – online as you may guess.

The program is here, it looks great as usual, and I personally will be honored to participate in a panel discussion on the second day of the seminar (Nov. 25), dedicated to the evolution of European patent law. See you there.

Moving on to today’s case law report, I rarely miss an opportunity to comment on a decision touching upon a serious point of insufficiency of disclosure.

As a matter of fact, this ground of nullity is so seldom successful that it suddenly becomes quite interesting when it is – especially in the non-medical arts.

Directbuy is a French company specialized in electronic cigarettes and related liquids and accessories. It is located in Heillecourt, Lorraine, 5527 inhabitants (says Wikipedia). It filed a French patent application in April 2015, which was granted on November 3, 2017 under number FR 3034627. The patent relates to a device for assembling an e-cigarette and filling it with liquid.

In January 2018, Directbuy initiated infringement proceedings based on this patent against LCCF Distribution, another company located in Saint Martial d’Albarède, population of 467, (yes, that would be more than 10 times fewer than Heillecourt) in Dordogne. What would I do without Wikipedia indeed.

LCCF Distribution filed a nullity counterclaim, raising several grounds of nullity.

Had they prevailed on their first ground of nullity, the decision of the Paris Tribunal judiciaire would have been even more remarkable – but they did not.

This first ground of nullity was indeed that the patent did not relate to an invention.

Here is claim 1 of the patent:

A device for assembling and filling a vial with liquid for an electronic cigarette comprising at least one means for filling said liquid to which means are connected for supplying this liquid, characterized in that said means for filling are connected to means for supplying at least two liquids of different compositions through selection means to select, under the impulse of appropriate control means, the distribution of a liquid or a mixture of liquid in varying proportions.

Liquid selecting means – so pre-Covid…

LCCF’s argument was that the claim merely recites results to be achieved and that the structural and functional means allowing to obtain these results were not disclosed. In other terms, only a technical problem was claimed.

As you can see, this argument already had a flavor of insufficiency of disclosure. It was squarely rejected by the court as follows:

It is recalled that, in order to determine whether a patent application relates to an invention falling within the scope of patents, it is necessary to examine the nature of the problem that the patent application proposes to solve and the solution it intends to provide therein. Patentability can relate only to solutions having a technical character, while an immediate technical result in the industrial field is necessary, even though this result is weak and of weak interest.

The patent in dispute, highlighting the shortcomings linked to the traditional method of making manual mixtures of liquid, sometimes dangerous for the user and with imprecise nicotine concentrations, intends to solve these difficulties by implementing a device for assembling and filling a liquid vial by methods providing for mechanical filling by means of supplying at least two different liquids through selection tools.

The patent, which does not simply describe results, therefore proposes a technical solution to solve a technical problem.

However, turning to the second ground of nullity, insufficiency, the court noted that the description of the patent was excessively empty:

The description is particularly limited as to the described device. It merely reproduces the wording of claim 1 of the patent to explain the only including figure which is extremely schematic.

No details are given on the nature of the filling means and the liquid supply means. The means of selection invoked are not described. No explanation is given on the means of calculating the nicotine concentration of the liquid mixture which are only mentioned.

The description does not include any embodiment of the invention which may clarify the claims. 

Consequently, the patent is not sufficiently described for a person skilled in the art to be able to implement the invention (with the sole assistance of the description and the drawing).

Therefore, the patent was revoked in its entirety, without examining the other grounds of nullity of lack of novelty and lack of inventive step.

I have had a look at the patent at stake, and it is true that the description is rather succinct. The description is only two and half pages long, of which one page is dedicated to the prior art. In the rest of the description, the various “means” recited in claim 1 and its two dependent claims are mentioned, but without much in terms of additional explanations.

In other words, the court’s analysis of the patent appears to be correct. What they did not address, though, is common general knowledge. Could it somehow make up for the shortcomings of the description?

That said, even if sufficiency had been acknowledged (taking into account common general knowledge), there may have been serious issues concerning novelty and inventive step as well – which may be why the court directly went for the jugular.

In fact, looking at the preliminary search report issued by the EPO (on behalf of the INPI), all three claims as filed were deemed to lack novelty over a D1 document and to lack inventive step over a D2 document combined with a D3 document.

In its response to the search report, the applicant did not amend the claims and argued thusly:

The prior art is analyzed as follows: 

Document D1 is an article published online and reviewing the state of the art in the field of electronic cigarettes and machines for filling vials with liquid for these cigarettes.

Document D1 does not disclose all the technical features recited in claim 1 of the invention. 

Document D2 is a patent application publication relating to a method for filling vials for electronic cigarettes and the related device .

Document D2 does not disclose all the technical features recited in claim 1 of the invention. 

Document D3 is a patent application publication describing a device for filling containers in the pharmaceutical field. 

Document D3 does not disclose all the technical features recited in claim 1 of the invention. 

These three documents are therefore not relevant for the appraisal of novelty. 

The applicant’s comments on inventive step were of the same nature. As a next step, the patent was granted.

As I am sure all readers are well aware, the French patent statute has been recently amended by the PACTE law. One major aspect of the reform was to strengthen examination of national patent applications in France. The patent at stake was granted under the former, pre-PACTE provisions, which, obviously, made it possible to obtain a patent without spending much effort on setting out why exactly the invention deserved one.

I have heard, and even expressed myself, concerns that the PACTE reform may hurt local applicants wary of the higher costs typically associated with more serious, EPO-type prosecution.

On the other hand, maybe today’s decision could be viewed as an example of why raising the bar, while not a perfect solution, was in fact necessary.

CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 1ère section, February 6, 2020, Directbuy v. LCCF Distribution, RG No.18/02372.

Insufficiently disclosed or reasoned?

After almost 2 months spent buried at home, is there a more appropriate patent to discuss today than one relating to underground civil engineering equipment?

The patent in suit is FR 2941716, granted on April 22, 2011 to the French company SEMAP, and later limited in front of the INPI in July 2016.

SEMAP has been marketing underground chambers for the connection of e.g. telecom cables since 2013, via its distributor Frans Bonhomme.

The adverse party in the case is the British company Northstone (NI) Ltd., active in the same business, via its distributor PUM Plastique.

Since 2007, Northstone had been supplying the French telecom provider Orange with connection chambers. But in 2014, Orange revised the procurement of these goods and granted the entirety of the market to Frans Bonhomme – SEMAP’s distributor. Northstone learned on this occasion that Orange had concerns about a possible infringement of SEMAP’s FR’716 patent.

This led Northstone to initiate legal proceedings in March 2016, with a claim for nullity of the FR’716 patent, an auxiliary claim for a declaration of non-infringement, and an additional claim for damages due to disparagement.

An underground chamber suitable for the next confinement stage?

The plaintiff raised two grounds for nullity: insufficiency of disclosure and lack of inventive step.

Claim 1 of the patent as limited reads as follows:

Connection chamber device consisting in a rectangular cuboid part buried underground, closed on the upper side by one or more lids, and containing means for connecting wires or cables belonging to a distribution network, characterized in that it is constituted by the superposition, by interlocking means, of at least two elements, each obtained by molding a composite material, and each comprising a peripheral wall comprising two skins delimiting a space, as well as openings for the injection of concrete into said space, in that the upper element has means for adaptation of a frame for receiving one or more lids on its upper side, and in that the lower element comprises a bottom provided with water evacuation means, the bottom of the lower element being fixed thereto by interlocking means, which have the same profile as the interlocking means of the two lower and upper elements. 

The important part here is the presence of the openings for the injection of concrete. The nullity claimant argued that the disclosure of the patent was insufficient with respect to this particular feature.

The court, which we still need to get used to calling the TJ (tribunal judiciaire) instead of the TGI (tribunal de grande instance), made an important initial remark on the burden and standard of proof:

The party raising insufficiency of disclosure has the burden of proof. But the patentee needs to prove common general knowledge relied upon, which includes reference textbooks and general technical literature, but in principle not patent literature nor scientific articles. 

It is noteworthy that what is available as documentary evidence of common general knowledge seems to be the same for French courts as for the EPO.

In this case, the court did find that the disclosure was insufficient. Here is what it had to say on this matter:

The patent does not precisely disclose where and how the openings must be made, in order to pour concrete, nor the quality and consistence of the concrete that should be used. It does not discuss either the compatibility of the presence of “braced elements through the internal walls of the double skins” (p.2 l.5) or the presence of “transverse openings for passing wire or cables” with the injection of this concrete. 

At this stage I have mixed feelings about this assessment.

From an EPO perspective, an insufficiency objection presupposes serious doubts substantiated by verifiable facts. Here, the court only notes that some aspects are not discussed in the patent. But whether this does indeed raise difficulties for the skilled person is hard to determine based on such brief explanations.

It is possible that the claimant’s submissions contained more detailed and more convincing arguments, but if so they unfortunately did not find their way into the judgment.

What I do not have mixed feelings about, and what I actually take issue with, is the next part of the reasoning:

Even if, as suggested by SEMAP, the skilled person could do despite these shortcomings using common general knowledge, it remains that there is a blatant contradiction between claim 1 on the one hand, which in its characterizing portion mentions the existence of openings for pouring concrete, which thus appear to be an essential element of the invention, and the description of the patent on the other hand, which mentions towards the very end the advantageous possibility (and therefore not mandatory for implementing the invention) of injecting this material. In view of this contradiction, which does not make it possible for the skilled person to determine whether the presence of openings is necessarily required, or if it is only optional, the patent is insufficiently disclosed and must thus be revoked. 

This, with all due respect, seems to be over the top.

Of course the presence of the openings is required, since it is explicitly recited in claim 1. The mere fact that the word “advantageously” is used in the description to introduce these openings does not make any difference.

Assuming that there is indeed a contradiction between the claims and the description, it appears to be a merely formal one, not a substantial one leading to actual implementation difficulties.

And it could even be argued that there is no contradiction at all, since “advantageously(“de manière avantageuse“) could plausibly be understood as meaning that this is an advantage of the invention (not an optional feature of the invention).

Truth be told, it is not the first time that a French court has picked up on some unfortunate but truly minor drafting inaccuracy and has blown it out of proportion.

The patent being revoked on the ground of insufficiency, inventive step was not addressed.

As for the disparagement claim, it was rejected. There was evidence that Orange had been warned about a potential infringement of SEMAP’s patent. But, unfortunately for the plaintiff, based on the available paper trail, it was not proven that SEMAP was directly responsible for this patent infringement rumor.

There is thus cause for unhappiness for both parties, and it is hard to tell which one is more disgruntled – especially since the court, in a not-so-common move, did not award any cost order under article 700 CPC against either party.

Tribunal judiciaire de Paris, 3ème chambre 3ème section, January 10, 2020, Northstone (NI) Ltd. v. SEMPA SAS & SEMAP Composite SAS, RG No. 16/04839.

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.


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).


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.

A clear judgment

For better or worse, lack of clarity is not a ground for opposition at the EPO. This is not to say that lack of clarity is not a frequent issue in granted patent claims. But there is not much you can do about it. Unless, that is, the lack of clarity also translates into a different type of defect which happens to be a ground for opposition. Such as insufficiency of disclosure, lack of novelty or extension of subject-matter.

So it is a very common game during opposition proceedings for patentees to claim that objections raised against their patents are disguised clarity attacks. And for opponents to reply that no, they are much more than that.

At which point do unclear things become so unclear that they can actually not be reproduced?

The same game can also be played in front of national courts, as lack of clarity is not a ground of nullity either. 

The game seems to be somewhat less popular there. But today’s judgment issued by the Paris Tribunal de grande instance (TGI) provides an illustration.

Guerbet is a French company specialized in medical imaging products. It owns a French patent No. FR 2927539 on a composition of contrast agent. Bayer Pharma (which I probably do not need to introduce) filed a nullity suit against this patent in July 2015. In May 2016, Guerbet’s patent was limited at the INPI.

Interestingly, this French patent is part of a much broader family including several European applications or patents, two of which were opposed by several competitors. But the litigation was restricted to this French priority patent.

The court nicely summarized the invention in the judgment. The patent at stake relates to an MRI (Magnetic Resonance Imaging) contrast agent formulation.

The formulation is based on a metal of the lanthanide series, such as gadolinium, which is complexed by a macrocyclic chelate, known as DOTA. Free lanthanide is toxic, therefore it needs to be bonded in the complex. In fact, a slight excess of chelate is desirable in order to prevent any risk of undesirable release of free metal within the patient’s body.

But the excess of chelate needs to remain small because the chelate itself is also toxic – although, I assume, less so than gadolinium. An amount of excess free chelate of 0.002 to 0.4% has been found to be optimal. One difficulty is how to accurately achieve this precise dosage on the industrial scale, and in a stable manner. The invention consists in a preparation process in which a certain concentration of free chelate or free lanthanide is achieved in an intermediate formulation, and then an adjustment is carried out in order to reach the proper concentration specifications.

There are two independent process claims 1 and 2 in the patent as limited at the INPI.

For once, let’s start with looking at claim 2:

A process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4% […], the macrocyclic chelate being DOTA and the lanthanide being gadolinium, said process comprising the following successive steps:
a) determination of a theoretical target concentration in free macrocyclic chelate Ctcl in the final liquid pharmaceutical formulation;
b) preparation of a liquid pharmaceutical composition containing the complex of macrocyclic chelate with a lanthanide, and free macrocyclic chelate and/or free lanthanide, by mixing free macrocyclic chelate and free lanthanide in a solution, so as to obtain complexation of the lanthanide by the macrocyclic chelate, the amounts of free macrocyclic chelate and of free lanthanide added being such that there is a deviation between the amounts of added free macrocyclic chelate and free lanthanide and stoichiometric proportions, and such that all the lanthanide is complexed and Ccl > Ctcl, […];
c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate Ccl, the concentration of free lanthanide Cll being equal to 0;
d) adjustment of Ccl so as to obtain Ccl=Ctcl and Cll being equal to 0, by suppressing free macrocyclic chelate and/or by adding free lanthanide and/or by modifying the pH. 

Claim 1 is very similar except that at step b) all the lanthanide is not complexed. The amount of free lanthanide is measured at step c) and more free marocyclic chelate is added at step d) to achieve the target concentrations.

This now leads us to the objection of extension of subject-matter raised by Bayer Pharma.

Bayer Pharma noted that there is a contradiction in step b) of claim 2, which refers to the preparation of a composition which may contain free lanthanide, although it is specified at the end of the step that all the lanthanide is complexed. Such a combination of features was not disclosed in the original application as filed, they said. They also added that the claim was the result of an intermediate generalization, since the feature that all the lanthanide is complexed at step b) was originally disclosed only in connection with a particular embodiment, called case B (involving in particular the use of an excess of macrocyclic chelate at step b)).

But the court was not convinced that this feature could not be generalized to other embodiments, and considered that the contradiction mentioned by Bayer Pharma was a mere lack of clarity, not an issue of extension of subject-matter:

Although this functional feature is made explicit for one of the three variants of the manufacturing process (case “B”), without being contemplated for cases A and C, it remains that it is indeed contemplated as an option disclosed in the initial application. Its title, related to a process for manufacturing a formulation, can lead the skilled person, who is a chemist used to combining different formulas, not to consider that this feature is excluded of all the other embodiments. The fact that this requirement […] can be in contradiction with another feature of this claim (namely the presence of free lanthanide) may potentially be a matter of lack of clarity but not of undue extension of the subject-matter of the patent. 

This clarity discussion then continues in the next part of the judgment dedicated to Bayer’s insufficiency objection.

Here is what the court had to say in this context (as usual, I am taking the liberty of slicing our beloved never-ending sentences into shorter phrases):

[…] It can be derived from common general knowledge that it is impossible for both free lanthanide to be present and for the complexation of the lanthanide to be total. Therefore, [the skilled person] will read the patent in a manner which will give it effect. [The patent] recites various steps for making the dissolution process, measuring and adjusting. [The skilled person] will understand that the total complexation of lanthanide can be performed later and that this circumstance does not result in an impossibility to reproduce the [invention], which requires to implement claim 2 as a whole, without focusing on one of its steps only without taking the other ones into account. 

Here, the approach of reading the patent in a constructive manner, with a “mind willing to understand“, as they are wont to say at the EPO, goes as far as making it possible to ignore an apparent contradiction in the wording of a claim.

In other words, the skilled person is presumed to resolve the contradiction by correcting and adding information to the claim.

It is not really surprising that the French court adopted this approach, in view of the longstanding tradition in this country of extensively relying more on the description for interpreting the claimed invention, instead of focusing on the exact wording of the claims.

Apart from this, the rest of the insufficiency discussion is also quite enlightening.

Regarding claim 1 in particular (the variant wherein there is some free lanthanide left at the end of step b)), Guerbet relied on example 2 of the patent.

But Bayer Pharma said that the example was not according to claim 1. Actually, when reproducing this example, a significant amount of free chelate was obtained at the end of step b). This is a problem because, at the following measuring step c), the concentration of free chelate is supposed to be zero, according to claim 1.

The TGI addressed this objection by stating that claim 1 does not require that all the chelate should necessarily be complexed at the end of step b). Otherwise, measuring step c) would actually be useless.

The court added:

Consequently, this step c) comprises a functional feature – achieving a total complexation of DOTA – in order to perform the measurement of free gadolinium which will precisely be made on a sample taken during step c), and which would be useless if the complexation of DOTA were total at the end of step b), as alleged by Bayer Pharma. 

Therefore, even if step c) of claim 1 does not explicitly mention that it requires a modification of the collected sample, this modification implicitly derives from the functional feature that it requires to perform the desired measurement, namely a concentration in free macrocyclic chelate Ccl that has to be equal to zero.

Here again, the court did not restrict the interpretation to what the claim actually recites.

Although the claim is silent as to the collection of a sample and the modification of the sample before performing the measurement, the court considered that these features are implicitly present in the claim in view of the description and in particular example 2.

The court also accepted Guerbet’s explanations that the modification of the sample at step c) could be performed by raising the pH through the addition of meglumine, and that the skilled person could rely on common general knowledge to perform such a modification.

Bayer Pharma further argued that the range of pH making it possible to achieve full complexation was not known. The court again sided with Guerbet on this aspect and accepted that a specialized scientific article and a university textbook discussing chemical equilibriums in general provided the skilled person with the necessary information.

Thus, the process of claim 1 was found to be sufficiently disclosed.

Turning again to claim 2, the patent in suit does not contain any example of implementation. But the court was satisfied that the process of claim 2 was analogous to the process of claim 1, so that it could also be carried out without undue burden.

In keeping with the case law of the Boards of appeal of the EPO, the presence of an example of a chemical invention in the patent is thus not an absolute requirement for sufficiency of disclosure to be acknowledged:

Thus, the skilled person, who may implement claim 1 as indicated above, for the same reasons […], is also able to implement claim 2 notably by relying on common general knowledge, so that the absence of an example to illustrate this claim does not make it insufficiently disclosed. 

The judgment then goes on with addressing an inventive step attack, which was also rejected.

Bayer Pharma’s nullity action thus failed. Who said pharma-oriented patents are always invalidated in this country?

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 23, 2018, Bayer Pharma Aktiengesellschaft v. Guerbet, RG No. 15/12348.