Will case law crystallize?

Today, it is back again to one of the topics regularly addressed on this blog, namely the statute of limitations for patent nullity actions in France (but not only!).

Matthieu Dhenne was kind enough to send me a brand new decision from the Paris Tribunal de grande instance (TGI) which, once more, sheds new light on this thorny issue.

The patent at stake is the French part of EP 1455756, to Merck Sharp & Dohme Corp. (MSD). The patent was granted on July 9, 2008. It was opposed by two generic drug manufacturers. At first instance, the patent was maintained in amended form, according to a decision dated December 3, 2010. The opponents appealed, and their appeals were dismissed by the Board of appeal in a decision dated July 17, 2014. The publication of the amended patent took place on September 23, 2015.

Soon thereafter, on December 2, 2015, Ethypharm filed a nullity action with the Paris TGI, requesting that the French part of the patent should be revoked.

Quite predictably, MSD argued that the nullity action was time-barred.

If one directly applied the recent case law of the Paris Cour d’appel (discussed here), this should be a winning argument. Indeed, the Cour d’appel has proposed that the five year-limitation period be computed from the date of grant of the patent. With this in mind, in this case, the limitation period would have ended on July 9, 2013.

But you and I know that things are not that straightforward, as the Paris TGI does not follow the case law of the upper court, and generally favors an in concreto determination of the starting point for the limitation period (see a recent example here).

Yet, in today’s ruling you will not find any protracted discussion of an in concreto starting point. Instead, the issue is disposed of in just one paragraph:

[…] 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. 

I must say I have mixed feelings about this.

My initial reaction was, oh no, you must be kidding me, there is now yet another way of determining the starting point for the limitation period? This is not legal uncertainty anymore, this is legal chaos.

A few seconds later, I thought, well yes, it does make sense after all, you can’t possibly be expected to shoot at a moving target. When a patent is modified during opposition proceedings, any appeal filed at the EPO has a suspensive effect, and thus it is only once the appeal proceedings are terminated that the content of the patent is final.

A party must act within five years from the date at which they knew or should have known that the patent at stake is a possible impediment for their current or future business activities, or else be time-barred (this is more or less what I understand to be the TGI’s usual position). And how can a party know this before the patent is even its final form?

However, this ruling raises more questions than it provides answers.

What if an opposition is rejected by the opposition division and the patent thus maintained as granted instead of as amended? Should the reasoning be the same? What if an opposition is filed by a straw man (which is allowable at the EPO) and there is thus an unverifiable suspicion that the nullity claimant itself may be the true opponent, in an attempt to artificially extend the limitation period by several years?

In his message to me, Matthieu Dhenne also noted that the court’s reasoning could be applicable to other situations: limitation proceedings, but also a prior nullity suit brought forward by a third party. Taking this one step further, he observed that a patent right can in fact be modified at any time and is therefore theoretically never “stabilized” until it expires (sometimes, it can even be retroactively “stabilized” only after its expiry). He thus suggested that the full consequence of the court’s reasoning should be that the limitation period can only start running at the expiry of the patent, so that the well-identified drawbacks of this limitation period should in practice never occur.

Matthieu added that there would thus be a complete parallelism between the limitation period for infringement actions and nullity actions. Accordingly, invalid patents would not be able to unduly hinder free competition.

Definitely an interesting suggestion, but is it really what the TGI had in mind? I am quite sure we can expect more surprises in future decisions.

Apart from this, the decision is worth the read beyond the admissibility part.

First, it turns out that the nullity claim was held ill-founded on the merits and thus dismissed. As the patent in suit is a pharma patent, this is already quite remarkable. A majority of pharma patents which are litigated in this country are revoked one way or another.

Second, the decision tackles the very interesting issue of plausibility.

There has been a significant trend in France for patents to be revoked when they are held to be of a speculative nature. See for instance previous posts here, here and there.

In the present case, Ethypharm argued that the patent was of the speculative kind, which resulted in insufficiency of disclosure and lack of inventive step.

Now may be a good time to have a look at claim 1:

A nanoparticulate composition comprising the compound 2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-(4-fluoro)phenyl-4-(3-(5-oxo-1H,4H-1,2,4-triazolo)methylmorpholine, or a pharmaceutically acceptable salt thereof, the compound having adsorbed on the surface thereof at least one surface stabilizer in an amount sufficient to maintain an effective average particle size of less than about 1000 nm; where “effective average particle size of less than about 1000 nm” means that at least 95% of the particles, by weight, have a particle size of less than about 1000 nm.

This drug composition is useful in the treatment of nausea and vomiting, especially those induced by a chemotherapeutic treatment. The short name of the active compound is aprepitant. According to the patent, the technical problem at stake was to improve the bioavailability of aprepitant. This is stated in the patent but no experimental test results are present, which led Ethypharm to consider that there was no evidence in the patent that the technical problem was properly solved.

Ethypharm also tried to use some of MSD’s posterior testing against them, by claiming that they proved that there were features missing in the patent which were essential for successfully implementing the invention.

The court was not convinced that there were indeed such essential features missing. The court also noted that there was a reference in the patent in suit to a prior U.S. patent disclosing the so-called “Nanocrystal” method, for making nanoparticles with a surface modifier adsorbed thereon, having an average size of less than 400 nm. This Nanocrystal patent also taught that such nanoparticles improve the bioavailability of poorly water-soluble actives.

Thus, said the court, the improvement in bioavailability provided by the nanoparticle form of aprepitant was plausible.

In such a case, the court continued, evidence which is external to the patent can indeed be taken into consideration for demonstrating that the technical problem is solved. The court then reviewed a number of articles and reports and was satisfied that the technical effect of improving bioavailability was well achieved.

In summary, this is an important decision for the fine-tuning of the appraisal of a speculative patent-type objection.

To me, the take-away message is that a reference in a patent to a prior art document disclosing a technical effect provides some plausibility that the technical effect is indeed achieved.

From drug crystals to crystal balls: could they possibly help us decipher future case law?

The patent survived other attacks of insufficiency of disclosure, extension of subject-matter and lack of inventive step. Quite remarkably, the main claim was in particular found to be non-obvious over the “Nanocrystal ” European patent of the same family as the U.S. patent mentioned above, which was used for supporting the plausibility of the technical effect.

The court held that:

[The “Nanocrystal” prior art] does not disclose chemical structures or features of drugs intended to be used by this process. It only mentions that it can be implemented with a large variety of medicinal substances, the substance having to be poorly soluble, that is less than 10 mg/mL, so that the skilled person does not know which actives […] can be tested with a reasonable expectation of success. He was all the less incited to do so that in December 2001, i.e. almost ten years after the priority date of [the Nanocrystal patent], the nanonization process, which has a number of constraints (in particular the heat released during milling may change the structure of the active substance and reduction to a very small size may create a problem of chemical and physical stability), was used on only four active substances (danazol, steroid A, compound WIN 63,394 and naproxene) with a verified effect on bioavailability […]. 

I have the uneasy feeling that there may be a contradiction here between the sufficiency and inventive step prongs of the court’s reasoning.

If the teaching of the Nanocrystal patent cannot be applied in an obvious manner to aprepitant, and if there are many technical uncertainties, why is it then not necessary for the MSD patent to contain evidence in the form of experimental tests showing that the process can in fact be effectively applied to this particular drug?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, January 26, 2018, Ethypharm SAS v. Merck Sharp & Dohme Corp., RG No. 16/01225.

A light ruling

The case discussed today is not a light case of patent infringement. Nor is it a case of light patent infringement. It is rather a case of patent infringement regarding light technology, namely LED-based lamps emitting light in multiple colors.

The litigation at stake pits Philips Light North America Corporation against France-based Commerce Spectacle Industrie (CSI).

This is a multifaceted dispute, but the prong of the litigation of interest to us today is Philips’ infringement claim against CSI based on the French part of European patent No. EP 1016062, and CSI’s counterclaim for revocation.

As a one sentence summary, the Paris Tribunal de grande instance (TGI) held that the patent was valid but that infringement was not sufficiently proven.

For once, let’s start with the infringement part of the decision.

Claim 1 of the patent as maintained in amended form in opposition proceedings at the EPO reads as follows:

An illumination apparatus comprising:
– a plurality of light emitters of at least two different colours adapted to be coupled to a power circuit including a power source and a common potential reference;
– driver means for driving the plurality of light emitters, the driver means comprising at least two switches connected to the plurality of light emitters and said power circuit and corresponding to respective current paths of the at least two different colour light emitters;
– a controller for periodically and independently opening and closing the at least two switches, the controller having an alterable address assigned to itself such as to identify and respond to a respective portion of an input data stream assigned thereto, which data stream portion is assigned to that controller;
– each light emitter being an LED; and
– said controller being arranged to generate a plurality of PWM signals, the PWM signals having uniform frequency, each signal corresponding to a respective colour of the plurality of LEDs of different colours, each said PWM signal causing a respective one of the at least two switches to be opened and closed at the uniform frequency according to respective independent duty cycles, and wherein said data stream portion comprises data for determining the respective duty cycles of the at least two different colour LEDs.

An enlightening invention.

Philips’ case primarily relied on experimental tests conducted on the allegedly infringing lamps by an expert appointed by them.

CSI criticized the report drafted by the expert. One major criticism was that Philips’ expert had used an oscilloscope for the experimental tests, without following the procedure set out in the instruction manual for this apparatus. In particular, the expert’s report did not show that the oscilloscope had been preheated for 30 minutes as recommended in the manual, and that a proper calibration had been performed.

CSI added that there were a number of loopholes in Philips’ demonstration, namely that “the expert report does not mention a periodic opening and closing of the switches, that [Philips] does not show how the current paths are and does not establish the presence of respective current paths […], that they never show how a switch would be connected to the diodes“.

Did the court see the light, readers are probably wondering?

Of course the answer depends whose side you are on, but the court did find that CSI’s criticisms had merit:

For each product, [Philips] relies on measures made with an oscilloscope, the conditions of use of which are not specified in the expert report […], although it is true that the instruction manual [….] notably requires a preheating of at least 30 minutes and a calibration before each use so as to allow optimal measurements […]. These basic precautions were not taken, so that the measurements obtained are necessarily suspect. It cannot be understood how the absence of a calibration could have no impact on the shape or (supposedly uniform) frequency of the signals, nor how the absence of preheating would not affect the measurements. The [alleged] continuous use [of the oscilloscope] for all measurements after the first one, which cannot be determined in the absence of any timing information in the report, and which cannot be derived from the order of the annexes which does not necessarily reflect the order of the operations, is not proven and may not compensate for a possible original malfunction.

Frankly, I am not sure what to make of all this.

On the one hand, we all remember from our science classes that calibration is not just for window-dressing. Did the expert proceed according to accepted practice or not? If the report is silent on this, the defendant and the judges cannot know for sure.

But on the other hand, any experimental report can always, always, be criticized for some choices that were made in the setup, or some omissions in the report itself.

Therefore, wouldn’t it be reasonable to consider that, if one party has taken the trouble of conducting experimental trials to prove its case, and if the other party wants to challenge the results of the trials, this other party should also make the effort of conducting counter trials – instead of simply pointing to potential loopholes?

Well, at any rate it does not look like this is the approach followed in France. The infringement plaintiff has the burden of fully proving the existence of the infringement, and the burden does not shift to the defendant by providing evidence which is anything short of bullet-proof.

That said, it seems that in the present case the demonstration of infringement was incomplete anyway, irrespective of the credibility of the expert’s report. And this would have been by itself sufficient to throw out the infringement claim – although the judgment does not contain many details:

Assuming that these measurements were sufficient, they would demonstrate an independent command of colors, but not the existence of “respective current paths” […], i.e. paths related to each light source, since independence does not per se imply an exclusive assignment. And the diagrams supplied for each product only show one light source, which prohibits any appraisal of the “respective” character of the current paths. 

Philips’ solace was that the patent was found to be valid. CSI had only raised lack of inventive step as a ground of nullity.

As a confirmation of a now well-established trend, the court followed the problem and solution approach for assessing inventive step – primarily because the parties themselves used this reasoning.

Here is the court’s summary of the appraisal to be conducted:

Since the parties, at least primarily, apply the non-mandatory “problem/solution” approach, it will be adopted […] by the court. It requires, in order to allow an objective examination of the inventive step without hindsight: 

– objectively identifying the closest prior art, i.e. a prior art reference which discloses subject-matter developed for the same purpose or having the same goal as the claimed invention and essentially having similar technical features requiring few structural modifications, 

– assessing the technical results achieved by the claimed invention relative to this prior art, 

– defining the technical problem which the invention purports to solve by obtaining these technical results, 

– examining whether, in view of the closest prior art, the skilled in the art would or would not [have been] suggested with the claimed technical features to achieve the results obtained by the claimed invention. 

In brief, this quite closely matches the EPO’s beloved reasoning.

In the present case, the parties seemed to agree that there were two partial problems at stake. Here, again, the court relied on the EPO practice, even making reference to the Guidelines for examination:

As set out in section G-VII, 7 of the Guidelines for examination at the EPO, if the claimed invention is in principle considered as a whole, which excludes that the inventive step of a combination of features be appraised for each feature taken in isolation, such a separate appraisal is necessary if the claim is made of a juxtaposition of features, and not of their combination which implies that the functional interaction between them produces its own technical effect exceeding the sum of the technical effects that they individually produce, namely a synergy effect. 

Applying these principles to the EP’062 patent, the court focused on the first partial problem only, and found that some of the claimed features were in fact neither disclosed in the closest prior art, nor in the suggested secondary reference. Therefore, it was simply impossible to arrive at a conclusion of lack of inventive step. Besides, the rationale offered by CSI for combining the documents together did not take into account the technical problem at stake in the patent. And the respective prior art documents contained contradictory teaching.

All in all, there were thus several reasons to find the claim inventive, without even having to look at the second partial problem.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, November 16, 2017, Philips Lighting North America Corporation v. SAS Commerce Spectacle Industrie, RG No. 15/09326.

A patent in the cross hairs

Frankly, I am not so fond of the finasteride litigation, previously discussed here, here and there. But this may simply have something to do with the fact that I am sensitive to the issue of hair loss.

That said, I am grateful to Denis Schertenleib for drawing my attention to the cassation ruling issued a few days ago on this topic.

As a reminder, European patent No. EP 0724444 to Merck Sharp & Dohme Corp. relates to the second medical use of finasteride for the treatment of androgenic alopecia, with a particular dosage regimen.

The French part of EP’744 was declared invalid twice by the Paris Cour d’appel: the first time for lack of novelty (what I would call the Actavis part of the lawsuit), and the second time for insufficiency of disclosure (the Teva part of the lawsuit).

Merck did not bow and tried its luck in front of the Cour de cassation – to no avail.

The cassation ruling (Teva part) is interesting in that it confirms the sufficiency standard to be applied in the field of therapeutic inventions.

Merck argued that the appeal decision (which, again, can be found on this page) was legally incorrect on 9 different grounds – or “branches“, as they are nicely called in the supreme court parlance. As I tend to find cassation decisions unreadable, I will try to reformulate these grounds in my own words.

On a general standpoint:

1. The question that the appeal judges should have addressed is only whether the drug with the right dosage could be manufactured by the skilled person.

2. The appeal judges mixed up sufficiency with novelty and inventive step, as they examined whether there was a “specific technical teaching” in the patent, and wrongly looked for a comparison of the invention with the state of the art in the patent. They should have focused on whether the information in the patent made it plausible that the claimed dosage was therapeutically effective.

Example 4 of EP’444 describes a protocol for measuring haircount in subjects. As I commented in my earlier post, its conclusion is rather vague and unspecific in terms of technical effect achieved, which led it to be disregarded by the Cour d’appel. The following grounds were raised in relation with this example 4:

3. The appeal judges failed to realize that the example 4 shows the technical effect linked to the claimed low dosage of finasteride.

4. The appeal judges said that clinical tests are not required for showing a therapeutic use, but then contradicted themselves when they disregarded the example as not corresponding to an actual clinical test.

5. The appeal judges failed to realize that the example provides a methodology making it possible for the skilled person to verify the claimed therapeutic use.

As for example 5 of the patent, it is supposed to show a reduction in the amount of dihydro testosterone (DHT) in the scalp of patients taking finasteride. But it is also quite imprecise and kind of looks like a paper example (just like example 4). The following grounds were raised in relation with this example 5:

6. The same contradiction already mentioned in item 4. happened again when the appeal judges discussed example 5.

7. The appeal judges failed to realize that example 5 shows that the claimed dosage has an effect on the metabolic mechanism involved in alopecia – so that example 5 indirectly also supports the technical effect linked to the claimed low dosage of finasteride.

8. The appeal judges held that the example was doubtful in view of the leaflet of the Propecia drug, without checking if this leaflet was available to the skilled person at the priority date.

9. The example mentions a reduction in the amount of DHT in the scalp of patients after 6 weeks, which is why the Cour d’appel found it doubtful, as the effect on hair growth is supposed to occur after 12 weeks at least. But the court should have realized that this is normal as hair growth can only occur after the reduction in the amount of DHT.

Is Santa going to mail some interesting decisions to me this Christmas?

As usual, the Cour de cassation did not address in a detailed manner each criticism and basically simply stated that the Cour d’appel was right and that the grounds of cassation are ill-founded.

In particular, there is (alas) no general discussion on the level of plausibility required from a patent, and on the conditions under which post-published evidence may be relied upon.

Items No.8 and 9 in the above list were treated slightly differently, though. Those were found to relate to a redundant ground (“un moyen surabondant“) in the appeal decision, which means that the Cour de cassation refrained from stating whether they are correct or not, as anyway there are enough correct grounds in the appeal decision for it to be confirmed.

The key part of the ruling is translated in its entirety below (I have taken the liberty of dividing up the never-ending single sentence of the ruling into hopefully more intelligible bits):

[…] Firstly, 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 decision mentions first that, regarding claim 1 […], the description does not indicate what the technical advantage or effect resulting from this type of oral administration is. It does not contain any element showing the potential efficacy of any finasteride dosage, and does not comprise any information on the new effect of the claimed dosage and the particular properties of this new therapeutic application. The dosage between 0.05 and 1.0 mg is unrelated to the administration rate and patient body weight. Then, according to the decision, the description of the patent only mentions the “surprising and unexpected” discovery of this new therapeutic application, without describing its particular pharmacological properties relative to the state of the art, which only derive from an arbitrary selection. In view of these findings, the Cour d’appel was in a position to deduce that the patent application did not directly and unambiguously reflect the claimed therapeutic applications; and that the skilled person unaware of any specific technical teaching was not able to reproduce the invention and had to implement a research program him/herself; so that [claims 1 to 3 were] insufficiently disclosed.  

Secondly, regarding the the examples cited in the description of the patent, the appeal decision […] disregarded examples 1 and 2, which relate to the preparation of finasteride, the manufacturing process of which was known for years; and example 3, which does not relate to androgenic alopecia.

[The decision] notes on the one hand that example 4 discloses a photographic protocol for detecting hair growth by counting on a period of twelve months and holds that, since [the example] does not give any information on the conditions of a potential test and does neither describe the experiments nor the technical effect resulting from the lowering of the claimed dosage relative to prior art dosages, this example appears to be a measurement method and cannot be considered as a report on a trial. 

[The decision] notes on the other hand that example 5 does not provide any detail on the experimentation or protocol applied when finasteride is administered for six weeks. The results have shown a significant reduction in the amount of DHT but have not established hair growth or the stop of hair loss. [The decision] holds that, in the absence of any comparison criterion, whereas the reduction in DHT levels in scalp due to the administration of finasteride was already known, this example does not make it possible to compare the effects of the claimed dosage relative to a higher dosage, of the order of 5 mg, disclosed in the state of the art. 

Based on these findings, the Cour d’appel did not misrepresent the patent and did not require a clinical demonstration of the therapeutic effect of the new dosage. [Thus, the Cour d’appel rightly] considered that these examples did not directly and unambiguously reflect the claimed therapeutic application and could not remedy its insufficiency of disclosure as already noted above.

This approval of the approach taken by the appeal judges is of course important for all practitioners in the pharma field.

The trend is now once and for all confirmed, per which patents considered as “paper patentsi.e. seen as overly speculative at the date of filing, will not fare well in France.

Before concluding this post and wishing all readers happy holidays, a final word on two procedural aspects.

First, Merck also criticized the appeal decision for holding Teva’s nullity claim admissible, although, when the first instance judgment was issued in the Teva part of the lawsuit, the patent had already been revoked by the Tribunal de grande instance in the Actavis part of the lawsuit.

The Cour de cassation held that:

[…] The Cour d’appel rightly stated that the decision revoking a patent has an absolute effect [with respect to third parties] only once it is res judicata, that the [Actavis first instance] judgment was under appeal, and deduced that the Teva companies were admissible in seeking the revocation of the same patent. 

This is a welcome clarification.

The last point is that Merck of course also filed a cassation appeal against the other appeal decision in which the same patent was revoked for lack of novelty, as requested by Actavis. Here, the Cour de cassation trod the easiest path and simply dismissed the cassation appeal in a distinct ruling by noting that the patent claims have now been definitely held invalid in view of the Teva ruling.

Too bad for us commentators, as the Actavis part of the lawsuit also involved some interesting legal points.

With that, as promised, I wish all readers happy holidays.


CASE REFERENCE: Cour de cassation, chambre commerciale, December 6, 2017, Merck Sharp & Dohme Corp. v. Teva Pharmaceutical Industries Ltd. & Teva santé, pourvoi No. 15-19726. 

A skinned patent

Prevailing as a patentee in France when your patent belongs to the chemical or pharmaceutical field is extremely difficult. I will in fact provide some figures on this matter soon.

More often than not, patents are skinned alive by the court – and, bad pun intended, even dermatology is not spared, as the present case shows.

Dermaconcept JMC is a French company active in the pharma / cosmetology business. It owns a French patent No. FR 2823671 as well as a European patent No. EP 1404327 claiming the priority of the French patent. Noreva-Led is their exclusive licensee, which markets the brand of products Actipur, for the treatment of acne skin and atopic dermatitis.

Together, they initiated legal proceedings against Laboratoire Bioderma in December 2014. Laboratoire Bioderma, later merged into Naos, was accused of infringing the above patents through their product Atoderm Intensive.

In May 2016, both patents were limited at the INPI (Institut National de la Propriété Industrielle) after record-breaking 8-day long proceedings. It is reasonable to assume that this limitation came as a reaction to Naos’ initial invalidity arguments.

The limitation was however apparently not good enough for the Paris Tribunal de grande instance (TGI), as the asserted claims were found invalid in spite.

The court started by throwing out claim 9 of the French patent.

In principle, when there are both a French patent and a European patent claiming the priority of the French patent, the effects of the former cease at the end of the opposition period (assuming that no opposition is filed against the European patent, as was the case here). See article L. 614-13 Code de la propriété intellectuelle (CPI). But this is traditionally believed to be true only insofar as both patents cover the same invention.

Here, claim 9 of the French patent is directed to

A method of cosmetic treatment characterized in that it consists in applying a composition based on nicotinic acid or nicotinic acid amide, and a sphingoid base according to any one of claims 2 to 7 on exposed areas, the composition being of the emulsion type.

As this claim is not present in the European patent, it survives in the French patent. Or rather, survived – until it got revoked by the court, that is.

Article L. 611-16 CPI is worded in a manner very similar to article 53(c) EPC, and it inter alia prohibits patents on methods of therapeutic treatment.

Referring to the description of the patent, the court noted that the composition at stake is meant to treat acne and atopic dermatitis, which are diseases of the skin.

Therefore, the method is not merely cosmetic but also therapeutic, since it does entail a therapeutic effect:

In this respect, the mere mention that the field of the claim is intended to cover only the cosmetic effect is not sufficient to shield this claim from the prohibition of article L.611-16 CPI, since the therapeutic effect is in fact inseparable, and actually is expressly presented as one of the advantages of the invention in the patent description. Therefore, the fact that this method produces an aesthetic effect on the skin, namely a fairer and smoother skin, is not sufficient to shield it from the prohibition of abovementioned article L.611-16 since this effect is only the consequence of the therapeutic treatment of the composition which reduces the presence of blackheads on the skin. 

The court also noted that a very similar claim was deleted from the European application before grant, as the European examiner had raised the same objection. I emphasize this, as it is not everyday that a French court feels bolstered by the opinion of an EPO examiner.

A butterfly batch – the ideal treatment for skin disorders.

Next up were claims 1 and 10 of the French part of the European patent – as limited in front of the INPI – which are respectively a product claim and a Swiss-type claim.

Claim 1 reads as follows:

A dermatological composition useful for the treatment of atopic dermatitis, characterized in that it comprises, in combination, nicotinamide (vitamin PP), and at least one sphingoid base selected from phytosphingosine, tetraacetylphytosphingosine, N-acetylphytosphingosine, and phytosphingosine hydrochloride. 

Claim 10 is directed to:

The use of nicotinamide (vitamin PP), and of a sphingoid base according to claim 1, for preparing a medicinal product for the treatment of atopic dermatitis.

Both claims fell for lack of inventive step.

The closest prior art was found to be a Procter and Gamble (“P&G“) PCT application No. WO 99/47114. Claim 1 of the P&G reference discloses a skin moisturizing composition comprising a vitamin B3 compound and a ceramide pathway intermediate or precursor thereof. Other passages of the document disclose that the vitamin B3 compound can be selected from a list comprising nicotinamide, and that the ceramide intermediate or precursor can be selected from a list comprising some sphingoid bases, including e.g. sphingosine.

Interestingly, the P&G reference does not explicitly mention phytosphingosine or its derivatives, recited in claim 1 of the European patent. As far as I understand, phytosphingosine is a compound which is different from sphingosine.

But the P&G reference contains the following statement:

Ceramide pathway intermediates or precursors are discussed in detail in U. S. Patent 5,578,641 to Simon et al. and U. S. Patent 5,610,040 to Smeets et al., both of which are herein incorporated by reference. 

And it turns out that phytosphingosine is recited as a preferred ceramide pathway intermediate in US 5,578,641.

The court considered that the teaching of this U.S. patent completes the explicit teaching of the P&G reference, so that:

The [P&G reference], the purpose of which is to provide a composition activating and increasing the rate of ceramide synthesis and to provide improved methods of skin moisturizing […] already discloses the composition mentioned in claim 1 of the EP’327 patent, with the additional remark that […] the synergistic effect of the combination was already known. 

In other words, the court relied on the incorporation by reference of US 5,578,641 in the P&G reference in order to determine its overall teaching.

As a next step, the court stated:

It remains to be determined if it was obvious for the skilled person to use this combination to solve the problem at stake, i.e. treat atopic dermatitis.

Thus, the only difference between the claims at stake and the teaching of P&G was the fact that the composition is used for treating atopic dermatitis.

This means that the court fully took into account the therapeutic purpose recited in product claim 1 (“a dermatological composition useful for the treatment of atopic dermatitis“) as well as in Swiss-type claim 10 (“for preparing a medicinal product for the treatment of atopic dermatitis“). 

This finding is rather logical but not so straightforward given the (past?) tendency of French courts to come up with unconventional claim constructions especially when therapeutic inventions are at stake.

Going back to the final step of the inventive step reasoning, the court noted that atopic dermatitis, as set forth in the patent in suit, is known as being related to an alteration of the barrier function of the skin.

The P&G reference itself mentions that the composition improves said barrier function.

The court then turned to a secondary reference, Korean patent application No. KR 2000-0024485, specifically concerned with the treatment of atopic dermatitis. It is explained in the document that atopic dermatitis is related to skin dryness, wherein skin moisturizing is significantly reduced, which impairs the barrier function. The Korean document adds that nicotinamide increases lipid synthesis in the skin, therefore supporting the barrier function of the skin and curbing atopic dermatitis.

The court thus concluded:

It can be derived from this that the skilled person, knowing the effects of the combination comprising a vitamin B3 compound and a ceramide precursor on skin moisturizing, looking for a way to alleviate the effects of atopic dermatitis, and knowing that the latter is characterized by skin dryness and impairs the barrier function thereof, but also that nicotinamide strengthens this barrier function and that its combination with an intermediate or precursor of ceramide synthesis produces an amplified effect on the ceramide synthesis properties of vitamin B3 compounds, would use this same combination for the treatment of atopic dermatitis without exercising any inventive step. 

Claims 1 and 10 were thus declared invalid, and the infringement claims were not examined.

Whether the judges got it right or not, at least the decision looks well reasoned and in line with European case law.  

One reservation, though, is that there is no discussion in the judgment as to whether P&G was a proper starting point for the inventive step reasoning at all, despite the fact that the claimed therapeutic purpose was not mentioned in the document.

This point may not have been raised by the nullity defendants. And it may not be a big deal anyhow. It can be surmised that a similar reasoning of lack of inventive step could have been made starting from the Korean application (which is concerned with atopic dermatitis) and combining it with P&G.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, July 7, 2017, Dermaconcept JMC & Laboratoires Nora-Led v. Naos, RG No. 15/00069.

An electric dispute

When Matthieu Dhenne kindly sent me a copy of the recent judgment Quadlogic Controls Corporation v. SA Enedis, I immediately knew that it would contain a part on the limitation period for nullity claims, as this is one of his favorite topics.

But quite to my delight, when diving into the judgment, I realized that extension of subject-matter is also discussed at length. And it turns out that this is one of my favorite topics.

I will leave it up to readers to decide which favorite topic is more off-putting, his or mine.

Quadlogic is a New-York based company specialized in energy management products. They own European patent No. EP 1260090 to a System and method for on-line monitoring and billing of power consumption.

Enedis, previously known as ERDF, is a subsidiary of EDF, the public company turned private which is still responsible for distributing most of the electricity used in France. Enedis on the other hand is in charge of handling the electricity network.

One huge project that has been keeping Enedis busy for a number of years now is the replacement of traditional electricity meters by smart (and somewhat controversial) meters known as the “Linky” meters. By the end of 2017, 35,000 new Linky meters are supposed to be set up every day.

It is therefore a pretty big deal that Quadlogic stated that the Linky technology infringed the EP’090 patent. In 2015, a number of letters were exchanged between the parties, but no amicable agreement was reached.

Thus, Quadlogic filed an infringement suit in February 2016, after performing an infringement seizure in January. Enedis raised a number of defenses and in particular challenged the validity of the patent and requested its revocation.

At this point, Quadlogic replied that Enedis was time-barred from filing a nullity counterclaim – a classical defense nowadays. However, this time the Paris Tribunal de grande instance (TGI) disposed of the issue relatively quickly.

Although the patent was filed as early as February 2001, it was only granted by the EPO in October 2013.

The court held:

It is established that the nullity of a patent can only be requested as from the date of grant, namely October 9, 2013 so that the nullity requested by Enedis for the first time in its counterclaim of February 21, 2017 is admissible. No limitation period can thus be raised against Enedis. 

As a reminder, there is now a limitation period for nullity claims in this country, according to recent case law, which is 5 years. The starting point of the period is much debated, with diverging views between first instance and appeal judges.

However, it is now relatively clear that the starting point cannot be before the grant of the patent. At least the TGI and the Cour d’appel are on the same page on this – see a recent report here.

The court then turned to the merits of the validity challenge and reviewed the amendments made during examination.

1911 – when electricity was still a miracle.

Claim 1 of the patent reads as follows:

A system for monitoring energy usage on a power line comprising:
(a) an electronic microprocessor-controlled digital electricity metering device coupled to a power line and including a non-volatile non-battery-powered memory, wherein said metering device is operable to perform interval metering for each of a plurality of intervals, is operable to store in said memory data acquired by said interval metering for each of said plurality of intervals, in a manner that enables recovery of measurements for individual intervals of said plurality of intervals and is operable to receive a data request and transmit data in response to said request over said power line; and
(b) a data collector coupled to the metering device via said power line, the data collector being operable to receive data from and transmit data to the metering device over the power line; operable to store data received from the metering device over the power line, and operable to receive data from and transmit data to a remotely located computer.

The expression highlighted above was added during examination and was at the center of the court’s attention.

The court noted that the expression could not be found in any of the 63 original claims and thus turned to the description and drawings. Quadlogic apparently relied on a single short passage as a support, which the court thought was a little bit too light:

Quadlogic only quotes the first sentence of paragraph 132 in its submissions, namely: “Interval metering stores independent records of metering data for future recall”. 

And this single sentence in a patent comprising 60 pages of description, supposed to be the crux of the invention, does not mean that individual records of the metering intervals are made. It mentions the possibility of independent records without stating that there is a prior problem that the skilled person had to solve. 

This mention cannot be considered as supporting the added feature, which makes it possible for the invention to exist, since the metering, storing and recovering of metering intervals on energy consumption were known; this feature is the only novel one in view of the known prior art. Since the entire device was known except this feature which is the only one to confer novelty to the invention, in order to avoid extension beyond the content of the application, elements to support the invention itself must be found in the description and drawings. 

What is remarkable in this explanation by the court is that a feature added in order to distinguish the claimed invention from the prior art seems to be subjected to a more thorough and strict evaluation than more innocent features. The EPO on the other hand usually does not make a distinction between novelty-conferring features and non-novelty-conferring features in the added matter analysis.

What is also remarkable is that the court did not simply look at the sentence in isolation, but took into account the general context of the entire patent. In this case, the supporting sentence is only recited in passing, without any statement of a technical problem to be solved. The way I understand it, in order for the invention to be redefined based on a specific feature, this feature must be originally identified as addressing a particular problem.

The court then delved into a more technical investigation.

This sentence “Interval metering stores independent records of metering data for future recall”  means that the recorded interval metering is independent from the values of counting energy consumption.  

The part of the sentence “for future recall” is much too elliptic to be admitted as supporting the recovery of measurements of individual intervals. It only refers to the existence in the system of a function for recovering stored data owing to a transfer to the computer. 

In other words, the sentence relied on by the patentee does not expressly refer to the notion of storing data so as to be able to recover measurements for individual intervals – as claimed. Moreover, the court found that it was not clear that this is what was implicitly meant there. See also the following statement in the judgment:

Indeed, the fact that measurements are stored as “independent records” does not imply that the measurements, wholly or partly related to these records, can be recovered in an individual manner.

In this respect, the EPO’s gold standard of direct and unambiguous derivability seems to be applied by the French judges.

Extensively examining the rest of the description and drawings, the court noted that there was no actual disclosure of technical means to perform the claimed feature:

No means for separately recovering one of the measurements of the non-volatile memory is ever mentioned in the description of the patent. 

[…]

And table 6 […] effectively shows that the measurements of intervals are recorded one after each other, half hour by half hour during a certain time, which is a measurement and storing mode already widely known without adding any means to individualize data. 

The court continued by noting that the recovery of an individual measurement for a certain interval requires for instance predefined addressable memory areas. But no such embodiment was disclosed in EP’090.

In summary, the subject-matter of claim 1 was found to extend beyond the content of the application as filed, the same conclusion applying to all of the following claims, and the patent was declared invalid.

The issue of infringement was accordingly not addressed.

Whether readers agree or disagree with the court’s findings, the good news is that a very thorough assessment of the technical information made available to the skilled person in the application as filed was performed, which looks every bit as good as what we could find in a decision by a Board of appeal of the EPO.

The judgment is also yet another reminder that completely redefining an invention during examination proceedings by digging for some isolated disclosure may be a winning strategy for the grant, but a losing one during opposition or litigation.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, November 2, 2017, Quadlogic Controls Corporation v. SA Enedis, RG No. 16/03165.