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 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.

Smells like revocation

Believe it or not, it is somewhat difficult for this blogger to know what his readers are most interested in. Do they yearn for complex legal discussions? Are they rather keen on getting their hands dirty with an insight into actual patents and prior art documents?

The good thing is that today’s post will contain a little bit of both – hoping that the answer to my question is not “none of the above“.

Reckitt-Benckiser owns European patent No. EP 1891197 which is entitled “Process for manufacturing improved dispensing devices“. This patent owner is no small fish, but rather a giant in the hygiene industry. Think of the brands Air Wick, Calgon, Clearasil, Cillit Bang, Durex. But today, Harpic is the type of products we are talking about.

In June 2013, two companies of the Bolton group, namely the Italian Bolton Manitoba and the French Bolton Solitaire, filed a nullity suit against the French part of the European patent.

On March 13, 2015, the Paris Tribunal de grande instance (TGI) dismissed the nullity claim. Bolton appealed, and the Paris Cour d’appel issued its judgment a couple of weeks ago.

The first interesting aspect in the appeal judgment is… the application of the statute of limitations to the nullity claim.

One would think that we have heard enough about this topic on this blog lately, and one would be wrong.

As is usual now in a patent nullity lawsuit, the admissibility of the request for revocation was challenged by the patent proprietor. The proprietor deemed that the limitation period for the nullity claim started running from the publication date of the application.

In the present case, the application had been published before the amended statute of limitations entered into force on June 19, 2008 (as discussed here, this amended statute brought the default limitation period from 30 years down to 5 years, which initially created the legal mess that we are now in). Therefore, the patentee said, the starting point was postponed to June 19, 2008, when the amended statute entered into force; and the limitation period expired on June 19, 2013, i.e. five days before the nullity complaint was served.

On the other hand, the nullity plaintiff argued that the five-year limitation period only started from the publication of the grant of the patent, namely August 27, 2008, so that the nullity action was timely filed and admissible.

The court ruled that

[…] the limitation period can only start running from the date on which the person against whom [the patent] is asserted can validly act; pursuant to article 64 EPC, a European patent confers rights as from the publication of the mention of grant, so that a nullity action against a European patent application does not exist. The limitation period for the action can thus only start running, in the present case, from the publication of the patent grant at the earliest

There is a lot to digest in this single sentence:

  • It is a good thing that the publication of the application was not upheld as a valid starting point – this is the last thing we need right now.
  • The choice of the patent grant as the starting point is consistent with the recent ruling by the same panel of the Cour d’appel in Halgand v. RP Nicoll, discussed here.
  • The court did not perform an in concreto assessment, which currently continues to be applied by the judges in the TGI (see the discussion here).
  • However, the wording used by the court, i.e. can thus only start running in the present case, from the publication of the patent grant at the earliest“, does not fully contradict the in concreto approach. Here, the nullity plaintiff seems to have taken the position that the starting point did not need to be accurately determined, as it could anyway not be before the publication of the patent grant, which thus ensured the admissibility of the action in any case. And the appeal judges fully followed this approach.

Therefore, all in all, this new ruling does not change much relative to the previous situation. Or, as they say in every good mystery novel, the plot thickens.

Having found the nullity action admissible, the court turned to the merits of the case, and more particularly to the contention that claim 1 of the patent did not involve an inventive step.

This is the second interesting aspect in the judgment, since the Cour d’appel reversed the decision under appeal in this respect, and declared claim 1 invalid although it had survived the first instance proceedings.

The patent in suit is directed to a manufacturing process for a sanitizing toilet block. Claim 1 reads as follows:

A process for the manufacture of a lavatory dispensing device useful for the delivery of at least one treatment composition, preferably a cleaning composition and/or a sanitizing composition to a sanitary appliance, preferably a toilet bowl which method comprises the steps of: 

– providing a composition to an extruder,
– forming an extrudate from said composition;
– inserting part of a hanger into said extrudate;
– compressing the extrudate to encase or enrobe said part of a hanger thereby forming said lavatory dispensing device.

The next generation sanitary appliance for your toilets.

I understand that the relevant prior art was the following:

  • Some prior art references taught the manufacturing of toilet blocks by placing a hanger in a composition comprising paradichlorobenzene, and compressing the composition onto the lower end of the hanger. These blocks are “cageless”, that is they are provided on their own and not in a plastic cage.
  • Other prior art references disclosed the manufacturing of toilet blocks by an extrusion process, and their inclusion into cages.

In the first instance judgment, claim 1 was found to be inventive. The TGI commented on the teaching of the prior art as follows:

– the process of fixing a hanger to a cageless device only concerns compositions containing paradichlorobenzene, known for its low solubility, which has now been prohibited since it is considered as a dangerous material; 

– the insertion of the hanger occurs when the block is molded; 

– none of the […] patents suggests a compression after an extrusion, to attach the hanger; 

– compositions containing at least one surfactant (which leads to the block breaking off) are in the prior art always placed in a support. 

Therefore, the skilled person was not naturally prompted by this prior art to contemplate a toilet block containing surfactants, to be used without a cage, by inserting a hanger into a block obtained by extrusion, and then compressing the extrudate to encase the hanger. 

The existing prejudice that cages were required to support and contain sanitary treatment blocks was overcome, since it is now possible to make cageless devices which comprise a suspending hanger and a composition as a compressed full block tied to the suspending hanger, said solid block compositions comprising one or more chemical compounds, preferably at least one surfactant composition. 

It is remarkable that the first instance court did not apply the problem and solution approach. Though this reasoning “made in EPO” is more and more often relied upon by litigants and judges in France, it is by no means mandatory.

It is also noteworthy that the TGI, when discussing why the skilled person would not have achieved the invention in an obvious manner, made reference to a number of features which are actually not present in claim 1.

For example, the court seemed to consider that the composition of the block comprises surfactants and does not comprise paradichlorobenzene. According to the court, this is very important, as only paradichlorobenzene-based blocks were disclosed as being compressively tied to a hanger – in view of the particularly low solubility of this chemical. But claim 1 does not explicitly exclude the presence of paradichlorobenzene, and does not specifically call for the presence of surfactants (which are recited in dependent claim 10). Claim 1 merely mentions a “treatment composition, preferably a cleaning and/or a sanitizing composition“.

Furthermore, the court considered that there was a prejudice against cageless devices comprising a sanitary composition (as opposed to a merely deodorizing, paradichlorobenzene-based composition). But claim 1 does not explicitly exclude the presence of a cage in addition to the hanger. This is in fact the subject-matter of dependent claim 8.

As for the appeal judges, they did not follow the problem and solution approach either. But they did reach a different conclusion: 

In the end, at the priority date of European patent No. 1891197, in view of the teaching of the above documents, the skilled person […] knew processes for making blocks for toilet bowls suspended by hangers; desirous of making a cageless suspended lavatory block, not based on molded paradichlorobenzene (deemed toxic) but on treatment compositions comprising surfactants, obtained by extrusion, he could use the same process starting from an extruded composition as taught in [a couple of patents]; he also knew from the teaching of [another patent] that it was possible to compress an extrudated block to give it a shape or to close the opening resulting from the insertion of the hanger.   

It is striking that the Cour d’appel shared the TGI’s appraisal of the crux of the invention, namely providing a cageless device for a block comprising surfactants.

The TGI was thus not blamed for its extremely extensive interpretation of claim 1 in view of the description of the patent. 

As far as I can tell, the different conclusion was in fact reached due to a new prior art citation, namely a reference disclosing the compression “of an extrudated block to give it a shape or to close the opening resulting from the insertion of the hanger” – whereas the first instance judges had noted that “none of the […] patents suggests a compression after an extrusion, to attach the hanger”. 

First instance judgments are very often confirmed on appeal in France. One exception to this general trend is when new facts arise, such as a new prior art document like in the present case.

CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 2, October 20, 2017, Bolton Manitoba & SASU Bolton Solitaire v. Reckitt Benckiser LLC, RG No. 15/09777.

Beware, drafters!

This may well be the fourth post almost in a row on a pharma case. Although pharma patent litigation is typically not hyperactive in France, each single case usually generates many interesting questions.

Today is no exception, not only from the litigation perspective but also from the viewpoint of a patent drafter. There are in fact at least two aspects in the decision of the Paris Tribunal de grande instance (TGI) which can be taken as significant warnings for patent attorneys.

The patent in suit is EP 0984957, owned by Swedish company AstraZeneca AB, and it looks quite simple and straightforward.

Claim 1 of the patent simply reads: “the magnesium salt of S-omeprazole trihydrate“.

S-omeprazole, also known as esomeprazole, is a blockbuster drug used in the treatment of gastric ailments. The patent is directed to a specific form of the drug.

Claims 2-4 further specify the form of the drug. Claims 5-8 relate to a process for the preparation of the drug. Claim 9 relates to a pharmaceutical composition comprising the drug of claim 1 and another one. Finally, claim 10 is a Swiss-type claim mentioning the treatment of a gastric acid-related condition.

In July 2011, AstraZeneca initiated infringement proceedings against Ethypharm based on this patent in view of the exploitation by this French company of generic esomeprazole.

Ethypharm of course filed a counterclaim for nullity in due time. But things did not go smoothly, and the lawsuit seemed to drag on forever.

First, an expertise was ordered so as to sort out the documents seized during an infringement seizure. Second, the parties discussed and initially agreed to the designation of another expert, as far as I understand in order to weigh on whether there was an infringement or not. Third, this expert was finally not designated, as AstraZeneca admitted that the generic esomeprazole on the market no longer infringed the patent (while maintaining that there had been infringement in the past). Fourth, AstraZeneca was compelled to file the experimental evidence based on which the above admission was made.

In summary, the judge in charge of case management certainly had her work cut out for her. And this leads us to the judgment issued by the TGI on June 23, 2017.

The first aspect of the decision that deserves a discussion is claim interpretation.

The patent proprietor stated that claim 1 covered any magnesium salt of S-omeprazole trihydrate. But, according to the defendant, claim 1 only protects a specific form of magnesium salt of S-omeprazole trihydrate.

The court went for the latter interpretation.

The court referred to article 69 EPC and the protocol on the interpretation, and remarked that “the judge must not make any interpretation if the claim is self-sufficient and should not denature the claim on the pretext of claim interpretation“.

One may wonder if the court did not do just that, i.e. interpret a claim based on the description, although the claim seemed quite self-sufficient.

At least from an EPO perspective, I have little doubt that a claim simply entitled “the magnesium salt of S-omeprazole trihydrate” would be seen as covering any magnesium salt of S-omeprazole trihydrate based on its plain wording.

But this is not the option that the court used. Instead, the court had a close look at the description of the patent and noted inter alia the following:

Since the wording of claim 1 does not comprise any determiner, one should refer to the description and drawings to interpret it, with respect to the skilled person […]. 

It is also specified that omeprazole and its salts as well as the R and S enantiomers of omeprazole and their salts are known from the art […] and that the magnesium salt of the S enantiomer of omeprazole exists in different forms. 

As mentioned in the description, the field of the invention does not relate to a “novel form of S-omeprazole” as suggested by the title of the patent, since this molecule was already identified, but a “novel form  of trihydrate of the magnesium salt of the S-omeprazole” […], which implies that it is a trihydrate form other than known from the art, with specific features such as “substantially pure” […], devoid of magnesium salts of R-omeprazole […] and devoid of other forms of magnesium salts of S-omeprazole (including the dihydrate form used for the preparation of the composition). 

This product is said to be “highly crystalline” […] since it has a larger crystallinity than any other form of magnesium salt of S-omeprazole, including trihydrate forms […]. 

This compound is characterized by an X-ray powder diffractogram [XRD] which shows main peak positions and intensities […], or by spectroscopy […]. 

Crystalline forms at their best

In support of its proposed interpretation, AstraZeneca filed an affidavit by a doctor Byrn, as well as a judgment by the New Jersey district court on a corresponding U.S. patent, per which the magnesium salt of esomeprazole trihydrate was novel at the time the invention was made and the patent was to be interpreted in a broad manner.

By the court was not convinced and noted that

the prior art previously disclosed a non-pure form a magnesium salt of S-omeprazole trihydrate, as can be derived from the laboratory tests performed on molecules recited in previous patents […]. [And] it can be deduced from the aforementioned elements in the description (notably the very title of the patent and the wording of the claims, the use of determiners in the text of the description such as “A” or “This” […] to mention the product […]) that the invention does not relate to any trihydrate of magnesium salt of S-omeprazole as suggested by AstraZeneca, but to a specific trihydrate having defined features (substantially pure, crystalline, with specific peaks) […]. 

The court repeatedly stated in the judgment that some magnesium salts of esomeprazole trihydrate were known from the art. But it does not seem to me to clearly stem from the patent itself. It is possible that the recreation of prior art esomeprazole could show that this particular salt form was already present, but isn’t this rather an issue of novelty of the claim?

Also, it is extremely striking that the court placed so much emphasis on how the description was drafted.

Here is the thing, I think. Paragraph [0009] of the patent for instance starts with: “the magnesium salt of S-omeprazole trihydrate obtained according to the present invention is substantially free from magnesium salts of R-omeprazole“. Then paragraph [0010] starts with: “the compound of the invention is characterized by the positions and intensities of the major peaks […]“.

If my understanding is correct, it could have made a world of a difference if these paragraphs had mentioned that the compound “according to some embodiments” is substantially free from other salts, or that the compound of the invention “may be” characterized by certain positions and intensities of peaks.

Therefore, beware drafters! Even if you get what you consider a broad claim granted, it may be interpreted by a court in a much narrower manner if the description gives the impression that the invention has a number of other essential features.

Surprising? Well, with Munich eyes, certainly. But not really if you are familiar with French case law.

Today’s decision is for instance very reminiscent of the approach recently taken in the rosuvastatin case. Even electronics cases are handled in a similar manner, as illustrated here.

The TGI’s comment on dependent claims 2-4 is enlightening in this respect. Claim 2 mentions that the compound is highly crystalline. Claim 3 mentions that it is stable. Claim 4 mentions that it has a certain XRD pattern. A common way of looking at this would be to state that claim 1 is broader than claims 2-4 and thus is precisely not limited to the specific XRD pattern, or to a highly crystalline form, etc. But the court reached the exact opposite conclusion and noted that

these claims define the specific features of the compound mentioned in claim 1.

Now, one may criticize the court’s rewriting of straightforward claim 1 and the challenge this presents to legal certainty. 

But there may nevertheless be a possible justification for this bold approach.

As the patent only discloses one very specific crystalline form of trihydrate, it could be argued that the protection should be limited to this specific form and should not extend to other forms of trihydrate which were not actually made available to the public by the patent. Maybe this is what the judges had in mind.

After this section on claim interpretation, the judgment contains a section on sufficiency of disclosure and novelty.

Both grounds of nullity were discarded by the court. In fact, the objection of lack of novelty was put forward only in case the patentee’s broad interpretation prevailed – and this was not the case.

And then comes the other important point in the judgment, namely inventive step.

At this point, the patent was revoked, based on a very brief justification.

The court generally made reference to the problem and solution approach. The dihydrate form of the compound was the closest prior art. According to the patent, the new form is more stable and easier to characterize and synthesize.

But the court refused to take this statement of a technical problem into account:

Yet, beside the disclosure of the molecule on a new form (trihydrate) and the presentation of preparation and identification methods of this product, whereas the pharmaceutical industry wants to find further forms of an active, even if the properties to be expected from the new molecular forms are not known, the patent does not define any problem. It just mentions that the product is more stable, easier to synthesize and handle and identify, without however supporting this statement in the patent itself, by studies and researches and results. Thus, the patent does not mention a problem to be solved let alone demonstrate the resolution of this technical problem. 

Moreover, it is acknowledged that in front of the EPO or in litigation the patentee may refer to posterior tests, but these must consolidate results already contained in the patent […]. 

Therefore, claim 1 is invalid for lack of inventive step as it does not solve a technical problem.

To summarize: the patent does mention a technical problem solved by the invention. But in the absence of any experimental evidence in the patent that this problem is indeed solved, the problem is not taken into account. Post-published evidence is considered to the extent that it can merely supplement data already contained in the patent, but not replace it entirely.

So far so good, and the approach taken by the court seems consistent with EPO case law. See in this respect the catchword of oft-quoted T 1329/04:

The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.

However, directly jumping to the conclusion that the claims lack inventive step, as the court did, is something a Board of appeal would probably not do.

Instead, they would likely reformulate the technical problem in a less ambitious manner, e.g. in this case as providing an alternative form of esomeprazole, and would then investigate whether it was obvious for the skilled person to achieve the claimed invention with this unambitious technical problem in mind.

Let’s assume for instance that it was technically difficult to make the trihydrate form. In this case, a Board could arrive at a finding of inventive step. In France, the absence of an ambitious technical problem is in itself indicative of a lack of inventive step.

This confirms that French courts are more severe in the appraisal of inventive step.

At any rate, here comes the second advice for drafters is: beware of the plausibility of the technical effects of the invention!

My understanding is that it is kind of a hot topic at the EPO these days. Well, it is an even more serious matter in this country.

And this does not just apply to “therapeutic” effects.

In this case, the alleged technical effect was not related to the treatment of an illness but rather to physical characteristics of the drug (stability, ease of handling…).

So, we are all doubly warned, I guess.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, June 23, 2017, AstraZeneca AB v. Ethypharm, RG No. 11/11460.