Hardcore litigation

A few years back, it was a common thought that standard-essential patents (SEPs) are the jewel in the crown of a telecom IP portfolio. SEPs are patents that are mandatory to work for the implementation of an industry standard, such as for instance the GSM (2G), UMTS (3G) or LTE (4G) standards in the telecom industry. Because it is not possible to make and market devices which do not implement the relevant standards, SEPs may seem like the perfect tool for putting pressure on potential licensees because any non-infringement defense is supposed to be made more difficult.

But nowadays, SEPs probably look much less powerful than they used to.

First of all, patent owners have to abide by the rules of standards-setting organizations, which require them to offer licenses on FRAND (Fair, Reasonable And Non Discriminatory) terms. Defendants have questioned whether it is allowable at all to enforce FRAND-encumbered IP rights against third parties, especially when it comes to the mother of all remedies, namely injunctive relief. This FRAND defense has given rise to complex legal discussions (revolving in particular around the issue of what is a willing or unwilling licensee) which have culminated in the CJEU.

But more fundamentally, the overall outcome of the many smartphone patent wars which have been waged in the past few years, both based on SEPs and on non-SEPs, is far from being positive for patent owners – despite a few resounding wins. Therefore, it seems that SEPs did not deliver on their promise of being easier to win on by practically excluding any non-infringement challenge.

Although SEP litigation has been much more abundant in Germany and the U.S. than in France, one case decided on last year confirms this global trend in a spectacular fashion.

Core Wireless Licensing is a monetizing entity holding a portfolio of more than 2,000 patents acquired from prolific patent applicant Nokia. The majority of these patents were declared as essential for the 2G, 3G and/or 4G standards at the ETSI (European Telecomunications Standards Institute). Core negotiated a license on this portfolio with the Korean giant LG Electronics between 2012 and 2014, without success.

In 2014, Core started legal action in France against LG. Core did not request an injunction but requested that the court should award damages for the past as well as force LG into a license and set the level of royalties for the future.

It is not possible in practice to ask a court to look at an entire portfolio of hundreds or thousands of patents. On the other hand, Core did need a finding of infringement in order to get the court to issue the requested order.

Thus, Core selected a group of five SEPs from the portfolio and claimed that these five patents were infringed by LG.

Why five patents and not just one? Well, the rationale may have been that every single patent is at a risk of being found invalid, or not infringed. But the more patents you pile up, the more unlikely it becomes, on a purely statistical standpoint, that they will all be found invalid or not infringed. The defendant needs to fend off all patents in order to win, while the plaintiff only needs one to get through. So, was this indeed a rock-solid strategy?

The answer is no.

The Tribunal de Grande Instance (TGI), defying the odds, held that there was no evidence of infringement of any of the five SEPs, and rejected all of Core’s requests.

I know that it is always much easier to explain why a strategy failed after the facts, but in my view there are two main circumstances which may account for this prima facie surprising outcome.

Contrary to what you could think, telecom litigation is not always kawaii.
Contrary to what you could think, telecom litigation is not always kawaii.

The first circumstance is that Core requested accelerated proceedings. Note that these were proceedings on the merits, and not proceedings for obtaining a provisional order. But the claimant did request and obtain an extremely tight schedule based on the alleged urgency of the case. Practically speaking, the judge immediately set a date for the trial at the onset of the action: the complaint was served on LG on September 30, 2014, and the pleadings hearing took place on January 16, 2015, the latest written submissions of the parties having been filed respectively four days and one day before that date…

This is as much of a rocket docket as you can possibly think of.

The second circumstance is that the case was extremely complex. Both on a legal standpoint, with five patents at stake and thus five separate validity and infringement discussions, plus a FRAND defense, plus an exhaustion defense based on alleged pass-through rights from the electronic chip manufacturer Qualcomm; and on a technical standpoint, because the five patents were rather abstract and difficult to grasp for a non-specialist.

We can easily imagine that the French judges, with no technical education and no technical assistance whatsoever, confronted with probably hundreds of pages of written submissions to digest containing highly sophisticated developments on signal processing, having heard oral explanations for a couple of hours at best, and having dozens of other cases on their desks to review in the same period of time, were faced with an insurmountable task.

This is reflected in the decision itself. If we take the first patent in the list, one issue with respect to infringement related to two steps in a process which appeared to be in a different order in the patent claims and in the technical specification for the UMTS standard which was relied upon by the plaintiff as evidence of infringement. The court held:

However, as rightly put by the defendants, contending that the operations of data propagation and power modification can be performed in any order in the 3GPP TS 25.213 V.11.4.0 specification is a statement that is not confirmed or justified by any evidence. 

More generally, any claimant has the burden of proving its case. It is indisputable that Core have limited themselves, in order to show that the 786 patent is essential, to filing an analysis drafted by an expert that they have hired and selected, without proceeding in a meticulous, precise and understandable way with demonstrating that the reduction in power described by the patent is necessarily reproduced by all cell phones implementing the 3GPP TS 25.213 V.11.4.0 and 3GPP TS 25.302 V10.0.0 specifications. It should be added that infringement by equivalence requires another demonstration, namely that other means can be used to implement the same patentable result, which is not present either.   

The court’s findings on the other four patents were similar: each time, the court stated that the defendants’ non-infringement defense had not been clearly proven wrong by the claimant.

The bottom line is that demonstrating that an SEP is infringed is not a piece of cake – since a declaration at the relevant standards-setting organization that the patent is or may be essential cannot be taken for granted, as the organization does not check whether this is indeed the case. So, any declaration of essentiality notwithstanding, the burden of proof remains on the patent proprietor to demonstrate infringement, and the TGI’s decision reminds us that it is a heavy one.

Indeed, the wording and technical explanations used in a patent are usually very different from the wording and technical explanations used in a standard specification. Again, unless you are a specialist in signal processing, it can prove difficult to get your bearings.

So, is there any solution at all for telecom patent owners – except waiting for the advent of the UPC, which will likely have more resources and be better equipped for handling complex litigation of this kind, notably owing to the presence of technical judges?

Well, there may be one. Article L. 615-20 of the Code de la propriété intellectuelle provides that the court may

either ex officio or upon request of a party, appoint any consultant for following the proceedings from the case management, and be present at the hearing. The consultant can be authorized to ask questions to their parties or their representatives. 

Judges without any technical background can thus get assistance from a technically skilled consultant in order to make a better-informed decision on a case.

This option has seldom been used by courts and litigants. Does it add a layer of procedural complexity to a case? Yes. Is the outcome of the case highly dependent on the consultant’s skills, not only on the technical standpoint, but also in terms of understanding the patent law issues which are really at stake for the court? Certainly. So, isn’t this a solution which is far from ideal? I would agree, but it could also be the only acceptable one in this particular context.

To finish on the Core case, the court rejected all claims and counterclaims. The invalidity counterclaims were not examined as they were submitted in an auxiliary manner. The court also held that there was no need for setting a FRAND royalty rate in the absence of demonstration of the essential character of the patents; and that there was no need to force Core to file the Nokia / Qualcomm license agreement, again in view of the essentiality finding. Furthermore, the court rejected LG’s counterclaim for damages based on Core’s alleged bad faith in the negotiations, as well as LG’s counterclaims for abuse of dominant position and for abuse of procedure.

The court’s position on the negotiations between the parties is actually noteworthy:

[…] the negotiations between the parties lasted for more than two years, which tends to show that neither of them behaved with enough bad faith to prompt the other one to stop this phase. 

Besides, the parties blame each other so that the court, which does not know everything about these negotiations, is not in a position to state that bad faith is more on one side than the other. 

Again, the message is clear: each party should prove its case, and allegations will not suffice.


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 2ème section, April 17, 2015, Core Wireless Licensing Sàrl v. LG Electronics France & LG Electronics Inc., RG No. 14/14124.

Sufficiently suitable

My good friend Lionel Vial’s brand new website is up and running! And in order to celebrate, Lionel kindly sent me another contribution on the appraisal of sufficiency of disclosure of functional claims. He writes:

In our previous post regarding the sufficiency of disclosure requirement applied to therapeutic purpose-limited product claims when there is a doubt that the therapeutic effect is attained, Renaud wondered if the bar had been raised.

Well, the decision discussed today might be just another hint that there is indeed a trend towards a wider application of the requirement of achievement of the claimed technical effect by the Boards of appeal of the EPO in regard of sufficiency of disclosure.

Decision T 528/11 was rendered on November 19, 2015 on an appeal formed by the opponent (appellant) against the decision of the opposition division to uphold European patent No. EP 1427808.

Claim 1 of the main request filed during the appeal proceedings read:

An isolated bacterial strain of the genus Lactobacillus characterized by that it is selected from the group consisting of the strain of Lactobacillus casei subsp rhamnosus, LN 113, deposited under number LMG P-20562, and the strain of Lactobacillus fermentum, LN 99, deposited under number LMG P-20561, and having the ability to colonise and become established in a human vagina, displaying a disturbed vaginal flora of microorganisms, upon vaginal administration, even during menstrual discharge, wherein said bacterial strain or strains is/are considered established if the bacterial strain or strains is/are still present in the vagina after at least two menstrual cycles from the time of administration, said strains were deposited at Belgian Coordinated Collections of Microorganisms on 14 June 2001 (emphasis added).

Among other arguments, the appellant submitted that although the deposit of strains LN 99 and LN 113 ensured their availability, this did not guarantee that they fulfilled the functional feature required by claim 1 (underlined above). None of the examples of the patent showed that the deposited strains indeed had this feature, which was necessary in order to meet the requirements of Article 83 EPC. The in vivo assay, required to reliably determine whether the strains had the alleged feature, was not described in the prior art. Post-published document D13 could not be used to prove sufficiency of disclosure. The functional feature that strains LN 99 and LN 113 were required to exhibit was not reproducible. Thus, according to decision G 1/03 (OJ EPO 2004, page 413), there was a lack of sufficiency of disclosure (see point XI of the Summary of Facts and Submissions).

If the Board did not share the same appreciation of the facts and arrived at the conclusion that the claimed invention was sufficiently disclosed (see points 10-14 of the Reasons), it nevertheless followed the appellant’s view as to the application of the requirement of sufficiency of disclosure to the feature at stake:

According to decision G 1/03 (supra), “(i)f an effect is expressed in a claim [and is not achieved by the claimed subject-matter; added by the board], there is lack of sufficient disclosure. Otherwise, i.e. if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step” (cf. G 1/03, supra, point 2.5.2 of the Reasons).

In line therewith, the claimed strains LN 99 and LN 113 must have the functional feature cited in claim 1. Otherwise, there is lack of sufficient disclosure (point 9 of the Reasons).

This famous obiter dictum of the Enlarged Board of Appeal is an enlightening reminder of the principles underlying the interplay between insufficiency of disclosure (as in decision T 609/02) and lack of inventive step (as in decision T 939/92) when there is a doubt that an effect is achieved.

Attaining the technical effect - always vital!
Attaining the technical effect – always vital!

However, in our opinion the present decision marks an evolution in the application of this sufficiency of disclosure principle to product claims.

Indeed, following decision T 609/02, this principle was mainly applied to a particular subset of product claims, the therapeutic purpose-limited product claims (“Product X for use in the treatment of Y”), i.e. so-called medical use claims, which are in fact hybrid between product and use claims. For these claims, attaining the claimed therapeutic effect is a functional technical feature of the claim.

In the present case, what the board refers to as a functional feature (underlined above) is generally considered to merely define a suitable use of the claimed bacterial strain, as can be construed from the tell-tale expression “having the ability to”. In fact, it is clear, e.g. from the Guidelines for Examination in the EPO (F-IV, 4.13) that such features are usually not considered as true functional features like those of medical use claims:

Similarly, a claim to a substance or composition for a particular use should be construed as meaning a substance or composition which is in fact suitable for the stated use; a known product which prima facie is the same as the substance or composition defined in the claim, but which is in a form which would render it unsuitable for the stated use, would not deprive the claim of novelty. However, if the known product is in a form in which it is in fact suitable for the stated use, though it has never been described for that use, it would deprive the claim of novelty. An exception to this general principle of interpretation is where the claim is to a known substance or composition for use in a surgical, therapeutic or diagnostic method (see G‑II, 4.2).

In contrast to an apparatus or product claim, in case of a method claim commencing with such words as: “Method for remelting galvanic layers” the part “for remelting …” should not be understood as meaning that the process is merely suitable for remelting galvanic layers, but rather as a functional feature concerning the remelting of galvanic layers and, hence, defining one of the method steps of the claimed method (see T 848/93).

Accordingly, the Board’s finding extends the scope of application of this sufficiency of disclosure requirement for product claims outside the field of medical use claims to which it was confined. Should this decision be followed, the requirement of achievement of the recited technical effect could thus expand to just about any technical field provided the product claim considered recites that a feature is suitable for attaining an effect.

Given the feeble gain in terms of patentability offered by “suitable for” features, in contrast to non-functional features, their usefulness could in the future very well be outweighed by the risk they impart to the claims containing them. Accordingly, drafters should be cautious when incorporating them in a claim. As for opponents, well, it is a promising new field to explore.

Lionel, I do hope you are right. It would probably be a good idea for the EPO to look more closely at the sufficiency of disclosure of functionally-drafted claims – in all fields of technology.

I personally tend to think that “suitable for“-type functional features can be powerful weapons in the hands of patent owners. In practice, it can be quite difficult for an opponent to demonstrate with absolute certainty that a prior art product is “suitable for” a certain purpose not explicitly stated in the prior art disclosure. The patent proprietor simply needs to cast enough doubts on the nature of the prior art product (based on the necessary incompleteness of the disclosure), which is easier than having to positively demonstrate something. And once novelty is acknowledged, inventive step generally follows since the problem-and-solution approach requires some explicit motivation in the prior art, which will often be missing assuming that the claimed purpose is not explicitly recited.

As all Spider-Man fans know very well,

With great power comes great responsibility.

Therefore, it is certainly appropriate for the Boards of Appeal to very carefully check whether there is sufficient information in the patent (and not merely in post-published evidence) for carrying out the claimed functional feature – or any unclaimed technical effect relied upon for arguing inventive step, for that matter. Otherwise, it is simply too easy for deep-pocketed firms to preempt future technological developments by skillfully drafting and then prematurely filing many patent applications directed to potential future inventions that have not yet been actually carried out. I have come across a significant number of such “paper” patents in the past few years, and they may be a symptom that it is indeed time to raise the bar for real.


CASE REFERENCE: Board of Appeal 3.3.08, T 528/11SCA Hygiene Products AB v. Ellen Aktienbolag, November 19, 2015.

Getting a handle on limitation

Last week’s post was about a famous chemical case which found its way up to the Cour de cassation twice, due to a tricky limitation issue combined with a tricky SPC issue.

Today, I would like to reassure readers versed in the mechanical arts. Yes, they too are entitled to get some fun with fancy limitation questions.

The case at hand relates to French patent No. FR 2843372 (FR’372), which is concerned with a sales display pack for door or window handles. The patent proprietor Société de Fonderie du Centre (SOFOC) has apparently had a complicated relationship with DIY store chain Bricorama over the past twenty years. A recent episode of their hectic partnership is an infringement lawsuit brought by SOFOC against Bricorama based on FR’372.

Interestingly, the legal action was started only one month after a limitation of the patent was granted by the INPI (French patent office).

Bricorama counterclaimed for invalidity – why would they not – and my focus will be on their argument that some of the patent claims were invalid due to extension of the scope of protection after grant, further to the alleged “limitation” of the patent. Speaking EPO language, this would be an “Art.123(3) objection“.

The patent as granted comprised a main claim and seven dependent claims. Claim 1 read as follows:

Sales display pack for door or window handles comprising a finger-plate and a lever-handle, characterized in that it is composed firstly of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of the said handle(s) to be presented on said cardboard fitting into cut-outs formed in said cardboard, the said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the handle(s) to the said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handle(s).

After the limitation, claim 1 was worded as follows (the highlighted expressions corresponding to added features):

Sales display pack for door or window handles comprising a finger-plate and a lever-handle, characterized in that it is composed firstly of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of two handles to be presented on said cardboard fitting into cut-outs formed in said cardboard, so that the finger-plates rest against the presentation flap, said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the two handles to the said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handles.

It was not challenged that amended claim 1 was more restricted than claim 1 as granted.

The issue was that, together with the amendment of claim 1, the patent proprietor had also filed five brand new claims 9 to 13 which, they said, were merely dependent claims.

New claim 9 was worded as follows (the highlighted portions being in my view the most important ones):

A set of two door or window handles attached to a sales display pack, each handle comprising a finger-plate and a lever-handle, characterized in that the sales display pack is composed of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of the two handles fitting into cut-outs formed in said cardboard, the finger-plates resting against the presentation flap, said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the two handles to said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handles, the sales display pack being according to one of claims 1 to 8.

The following new claims 10 to 13 were also directed to a set of handles attached to a sales display pack, making reference to claim 9. For the defendant, claim 9 was an independent claim, and not a mere dependent claim as advocated by the plaintiff. They also argued that claims 9 to 13 extended the scope of protection of the patent and were thus invalid.

Fancy handles are best displayed in their natural environment.
Fancy handles are best displayed in their natural environment.

The Tribunal de grande instance (TGI) ruled in the defendant’s favor:

It is true that claim 9 repeats the wording of claim 1 regarding the definition of the sales display pack, but it is directed to “a set of two door or window handles characterized in that the handles are attached to a sales display pack”. Now, claim 1 only relates to the sales display pack which supports the handles, and not to the set composed of these distinct elements. The scope of protection under Article L. 612-6 of the Code de la propriété intellectuelle, restricted to the sales display pack in claim 1, is extended in claim 9 to a different product made of the combination of the handles and previously characterized sales display pack. Claim 9 adds relative to the features of claim 1 and concerns a distinct subject-matter, whereas claims 10 to 13, which are mere embodiments of claim 9, depend on it. 

With this assessment of the nature of claim 9, it comes as no surprise that the TGI found that there had been an extension of the scope of protection:

[…] Article L. 613-24 of the Code de la propriété intellectuelle mentions limitation only as far as claims are modified. Per se, the addition of 5 dependent claims cannot be analyzed as a modification of preexisting claims. In fact, [SOFOC] does not contend that going from 8 to 13 claims would be the result of a mere redrafting of the initial claims 1 to 8, which remain unchanged – with the exception of the definition of the number of handles supported by the sales display pack. 

Moreover, it is now acknowledged that claim 9 does not simply repeat the features of claims 1 to 8 but includes a set made of the sales display pack and two handles in the scope of protection conferred by the patent. Even if it is clear that the description relates to a sales display pack intended for supporting door or window handles, it does absolutely not institute the combination of the two elements of the invention, and by the way the sole drawing of the patent does not show the handles. The latter are only mentioned in the description in order to understand the purpose of the sales display pack, which is the sole subject-matter of the invention. Also, the modification of claim 1 was sufficient to limit the protection to a sales display pack intended for supporting two door or window handles, without any need for the addition of 5 new claims. Thus, independent claim 9 and dependent claims 10 to 13 involve a broadening of the scope of protection conferred by the patent, which in fact would have had a significant impact on a possible damages computation, to a new object not comprised in the description and in the features of initial claims 1 to 8. They are therefore invalid.

In summary, the amendment was objectionable on two grounds.

First, limitation proceedings are not meant to add claims, but rather to modify and more precisely restrict existing claims. This seems to be in keeping with the Guidelines for examination in the EPO (section D-X, 4.3):

Likewise, adding dependent claims in limitation is not permissible if not directly caused by the limitation introduced in the claims.

In the present case, the addition of the supplemental claims seems to have been uncorrelated to the modification of claim 1 and thus unjustified.

The second ground retained by the judges is that new claim 9 and its dependent claims covered a different object from the one covered in the patent as granted. This is probably a more controversial point. For one thing, the TGI analyzed claim 9 as an independent claim, even though it explicitly refers to claims 1 to 8 and includes all the limitations of these preceding claims. This appraisal may not be fully consistent with the definition of independent and dependent claims provided in section F-IV, 3.4 of the Guidelines for examination in the EPO.

But, more importantly, the combination of a sales display pack and two handles, recited in claim 9, was considered as a different object (an aliud) in comparison with the sales display pack as such recited in claims 1 to 8. This approach is comparable to that adopted by the INPI in the Syngenta case discussed last week: the INPI considered that adding a second active substance to a claim directed to a fungicide composition comprising a first active substance resulted in a shift of the scope of protection towards a different object. As explained in the post, the Cour de cassation finally rejected the objection in Syngenta. But did they fully weigh all relevant factors? One cannot really tell based on the brief and cryptic reasons for the decision.

There are, to my mind, valuable reasons for making a distinction between (A) further restricting some features of a claimed object; and (B) adding a supplemental object in a claim. If case (A) undoubtedly corresponds to a real limitation, case (B) is not so simple, as it may in some instances pave the way for a new contributory infringement complaint, or for an increase in the amount of damages, as rightly noted by the court in the above citation – in addition to also making it theoretically possible to extend the duration of protection in the pharmaceutical or phytosanitary field, by way of an SPC application, as discussed last week.

A somewhat more indirect parallel can also be made with the Nespresso judgment discussed in a previous post. The TGI had objected to the presence of a claim directed to a device for the extraction of a capsule, plus the capsule itself, in combination, while the application as filed focused on the device without presenting the capsule as part of the invention. In this case, the nullity ground was extension of subject-matter beyond the contents of the application as filed, and not extension of the scope of protection after grant. But the underlying idea is similar.

A common feature of NespressoSyngenta and Bricorama is that the patent proprietor tried to change the focus of the invention after the filing date in order to gain a particular legal advantage. In all three cases, the judges thwarted the patentees’ strategy:

  • In Nespresso, the combination claim was introduced at a late stage during examination proceedings (after the issuance of the communication on the intent to grant by the EPO) presumably specifically in order to make it possible to sue capsule manufacturers. The combination claim was viewed by the French judges as improperly adding matter.
  • In Syngenta, a dependent claim was limited after grant in the hope of making it compliant with the Medeva standards, as a basis for a combo SPC application. The Cour de cassation validated the limitation but the SPC application was rejected all the same, and the rejection was confirmed by the Cour d’appel.
  • In Bricorama, new claims were added by way of limitation proceedings a few weeks before launching an infringement action, potentially modifying the quantum of damages. Those claims were revoked.

Could it be that courts are not that keen on too smart patentees?

As a final note, SOFOC did not have such a bad time in court after all. Having revoked claims 9 to 13, the court also revoked claims 1 to 4 (for lack of inventive step) but then held that dependent claims 5 to 8 were valid and infringed. This certainly made the judgment much easier for SOFOC to ahem… handle.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, May 21, 2015, Société de Fonderie du Centre SA v. Bricorama France SAS & Bricorama SA, RG No. 2014/02007.

Fungicides Ltd.

National limitation is a much appreciated tool of patent owner litigants in France. In particular, when they are faced with a serious validity challenge, it is often a good option for them to file a request for limitation at the INPI (French patent office) in order to amend their claims – although there may be more unusual reasons for filing a request for limitation, as we will see below.

Limitation proceedings are cheap and generally straightforward, and to some extent there can be more flexibility in terms of allowable claim amendments than at the European patent office. However, when a limitation starts going south, well it can go way south.

This is precisely what happened in a famous Syngenta case. Syngenta prevailed in the end (at least on the limitation aspect of the case), but not without having to plead its case in front of the Cour de cassation (French judicial supreme court) – twice!

This Syngenta case relates to European patent No. EP 0382375 (EP’375), which is directed to fungicides. Claim 1 of the patent as granted relates to a large class of chemical compounds defined according to a Markush formula. Claim 8 of the patent as granted is worded as follows:

A fungicidal composition comprising a fungicidally effective amount of a compound according to claim 1 and a fungicidally acceptable carrier or diluent therefor.

On September 28, 2009, the patent proprietor filed a request for limitation of the French national part of the patent, at the INPI. They requested that claim 8 be amended so as to recite a composition comprising, in addition to a fungicidally effective amount of a compound according to claim 1 and a fungicidally acceptable carrier or diluent, a second active compound selected from the group consisting of (i) fungicide compounds selected from a first list, (ii), insecticide compounds selected from a second list and (iii) plant growth regulator compounds selected from a third list.

The INPI director refused the request for limitation on May 6, 2010, and Syngenta appealed. Appeals against decisions by the INPI director must be brought in front of the Cour d’appel de Paris. On September 7, 2011, the court sided with the INPI director and dismissed the appeal.

The court stated as follows:

[…] The INPI director exactly analyzed the scope of the requested modification and rightly noted that it did not result in specifying the composition of the product mentioned in the initial version of claim 8 by restricting it to a list of possible combinations, but on the contrary had the effect of adding to this product a new active selected from a large list, actually offering an immense scope of new possible combinations. 

[…] He rightly noted that the proposed modification adds to the compound with the carrier or diluent according to claim 1 recited in the initial text another compound although neither the claim sought to be modified nor any other claim mentions a compound comprising a second active compound.

I think it is fair to summarize this view as meaning that the modified version of claim 8 was directed to a different product (an aliud), namely a combination of two active compounds whereas the invention claimed in the original patent was just one active compound with some appropriate inactive additives.

Syngenta did not retreat and filed a petition with the Cour de cassation (such petitions being restricted to points of law). This paid off, as the supreme court set aside the ruling from the Cour d’appel on March 19, 2013, holding in extremely concise if not cryptic terms – as always – that the appeal judges had erred by

not investigating whether the subject-matter in the modified claim was not directly and unambiguously disclosed in the description of the patent as granted.

By this, I assume it was meant that the Cour d’appel should not have focused on the claims as granted only, but should have looked for a possible support for the modified version of claim 8 in the description.

So, the case was remitted back to the Cour d’appel for further consideration. This led to a second ruling by the court on October 25, 2013, in which, this time, the limitation got the green light:

This limitation is thus directly and unambiguously supported by the […] initial description, literally copied, and it was thus disclosed.

[…]

This limitation therefore does not entail any broadening of infringement acts nor impinges on the protection of third parties. 

To translate this into EPO jargon, the subject-matter of the modified claim was found not to extend beyond the content of the application as filed (compliance with Art.123(2) EPC), and the modification was also found not to result in any extension of the scope of protection (compliance with Art.123(3) EPC).

Alas! It was the turn of the INPI director to be dissatisfied with the appeal judges, and to thus file another petition with the Cour de cassation. The INPI director (or rather the legal department of the INPI doing the work) may have decided that further judicial clarification was required before adapting the INPI practice for future cases.

On March 17, 2015, this petition was dismissed.

How did all these mushrooms grow from this bag? This mess would never have happened with the proper fungicide combination.
How on earth did all these mushrooms grow from this bag? This mess would never have happened with the proper fungicide combination.

Two points had been raised in the INPI director’s petition:

  • The proposed amendment of claim 8 resulted in a modification of the subject-matter of the patent, and a shift of protection.
  • It cannot be considered that there is direct and unambiguous disclosure in the description for the proposed new claim since there is not enough information for the skilled person to actually implement the claimed subject-matter. No combination of compounds was actually tested and the lists of second active substances in the description were merely of a speculative nature.

As to the latter point, the cassation judges simply noted that

the skilled person, who is a technician skilled in preparing fungicide compositions, does not need to carry out a research work as far as usual dosages for use are concerned

so that

the claimed combination was disclosed by the initial description. 

The theory put forward by the petitioner was that there can be no proper disclosure if the skilled person is not presented with sufficient information to carry out the invention. Readers familiar with EPO practice will immediately see that this theory, on the face of it, mixes up extension of subject-matter with insufficiency of disclosure, which are two distinct requirements under the EPC. Although this approach was certainly unorthodox, it may not have been flat-out absurd. After all, whether any new matter was added relative to the contents of the application as filed has to be appraised by the skilled person. Thus, it is at least arguable that a formal mention of a certain feature in a text could be disregarded by the skilled person as an actual disclosure, in case it does not represent a true technical teaching but rather a mere speculative statement.

The unorthodox theory was not endorsed by the Cour de cassation, but maybe because in this case there was no real insufficiency issue anyway. The way I understand the court’s position, finding out an appropriate dosage for the claimed composition was relatively straightforward and did not require any research program. Thus, the argument could be tried again in another case where there would be greater difficulties for the skilled person presented with a modified claim.

As to the first point in the INPI director’s petition, this was the objection which had prevailed in the first 2011 judgment before being overturned in 2013. The supreme court rejected it by noting that the judgment under appeal had simply applied the supreme court instructions provided in the first cassation judgment.

So, no real surprise there, but frankly I am not sure the Cour de cassation really addressed the central issue of whether the modification in claim 8 shifted the scope of protection towards an aliud or not.

The initial reaction of any practitioner is probably that, since claim 8 as granted had an open language (i.e. a composition “comprising” certain compounds), this claim covered all possible combinations including the compounds recited in the claim. Therefore, adding specific lists of partners into claim 8 necessarily restricts the claim and cannot broaden it.

But things might actually not be that simple. Schematically, claim 8 as granted protected a composition comprising an active A. By seeking to amend this claim to cover a composition comprising an active A in combination with an active B, the patent proprietor may have opened the door for a potential claim of contributory infringement against someone supplying active B to another person making the combination A + B.

The case law of the Boards of appeal seems to exclude this type of reasoning, as nicely summarized in section II.E.2.1.1 of the 2013 edition of the case law book:

In G 2/88 (OJ 1990, 93) it was clearly ruled that it is not necessary to consider the national laws of the contracting states in relation to infringement and that this issue is not relevant when deciding upon admissibility of an amendment under Art. 123(3) EPC. With respect to the question of an extension of the scope of protection under Art. 123(3) EPC, it is, rather, appropriate to take into account the fact that the protection conferred by a patent is determined by the terms of the claims, and in particular by the categories of the claims and their technical features, in accordance with Art. 69(1) EPC and its protocol (G 2/88, OJ 1990, 93).

But whether a national court should also exclude any infringement consideration when dealing with the admissibility of a request for limitation is questionable.

Also, the reason why Syngenta desperately wanted to modify claim 8 in the first place was because they had filed a phytosanitary SPC (Supplementary Protection Certificate) application for the commercial fungicide product based on the combination of the active substances azoxystrobin and folpel.

A first SPC had been granted for azoxystrobin itself based on the EP’375 patent. Azoxystrobin was one of the compounds encompassed by the Markush formula in claim 1. Syngenta then wanted to obtain a second SPC for the combination product.

The INPI director refused the second SPC application on September 2, 2009 since the combination product was not “covered” by the patent, since no claim recited a combination of actives. The refusal seems to be in keeping with the later Medeva CJEU ruling per which it is not possible to grant an SPC “relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on“. Syngenta appealed and, a few weeks later, filed the request for limitation of claim 8, in order to introduce the second active compound, folpel, into claim 8, and thus try to circumvent the INPI’s objection.

However, the strategy failed, as the Cour d’appel de Paris confirmed the decision to refuse the second SPC application, on May 30, 2014. Said the court, the INPI director’s decision was correct in view of claim 8 as it stood at the time the decision was made. As a side note, another reason for refusing the SPC application, as of today, would be that it is not permissible to derive a single product SPC and a combination SPC from the same basic patent, as per the Actavis v. Boehringer Ingelheim CJEU ruling – but this is another story.

What I do find remarkable is that, by adding a supplemental active compound in a claim, it becomes theoretically possible to get additional patent protection via an SPC – in keeping with Medeva. Doesn’t this show that alleged limitations should be more scrupulously examined for potential side effects of extension of scope than under the Cour de cassation’s basic approach?


CASE REFERENCE: Cour de cassation, ch. com., March 17, 2015, Directeur Général de l’INPI v. Syngenta Ltd., appeal No. C/2013/28436

Nice models required

The title of this post was not – only – selected in order to artificially boost the stats of this blog, although I guess this could be a possible side effect. No, there is an actual relationship with today’s discussion, which is again the appraisal of sufficiency of disclosure for some pharmaceutical patents.

Very often, these patents are filed too early in a drug development process to comprise any clinical data. At best, they only contain preliminary results from in vitro or animal sudies. Whether this is deemed to be sufficient for the skilled person to implement the claimed invention will depend on the models that are used – that is, the disease models, I am afraid.

I will now leave the floor to Lionel Vial who will explain how this all works.

Renaud’s previous post related to the French way of dealing with the sufficiency of disclosure requirement regarding therapeutic purpose-limited product claims (compound X for use the treatment of Y) when there is a doubt that the therapeutic technical effect has been attained. But how does the EPO deal with it nowadays?

Decision T 2059/13 of December 7, 2015 was rendered on the appeal lodged by patentee Otsuka Pharmaceutical against the decision of the opposition division to revoke European patent No. 1712225.

The patent was revoked under the ground of Article 100(b) EPC (i.e. insufficiency of disclosure) by applying the landmark decision T 609/02 of October 27, 2004, which was discussed in Renaud’s previous post. As a reminder, the catchword of this decision is that

If the description of a patent specification provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, later more detailed evidence cannot be used to remedy the fundamental insufficiency of disclosure of such subject-matter (emphasis added).

Claim 1 of the main request in the appeal proceedings at hand read:

A compound which is a pharmaceutically acceptable acid-addition salt or solvate of a carbostyril compound of the formula (1):

Formula

wherein the dotted line represents a single or a double bond, for use in the treatment of disorders of the central nervous system associated with 5-HT1A receptor subtype, selected from

(i) bipolar I disorder with most recent hypomanic, manic, mixed, depressed or unspecific episode, and

(ii) bipolar II disorder with recurrent major depressive episodes with hypomanic episodes, and cyclothymic disorder.

The other claims also related to the compounds of formula (1) for a further medical use and it was not contested by the parties that in such cases, for the requirement of sufficiency of disclosure to be fulfilled, the suitability of these compounds for the claimed therapeutic application must be disclosed (point 4.1 of the Reasons).

The patentee argued that the facts and circumstances of the present case differed from those underlying T 609/02 in which the chemical structure of the compounds was not identified (point 4.2.2 of the Reasons). Indeed, the above claims are restricted to a group of only two, well identified, compounds.

The Board only partly concurred with the patentee and explained that the usefulness of case law is not confined to similar or identical facts, but lies in the principles or guidance which can be extracted from earlier cases (point 4.2.3 of the Reasons).

In accordance with these considerations the Board then offered the following statement:

Therefore, for a patent claiming a compound for use in therapy, grounds under Article 100(b) EPC will prejudice the maintenance if the application does not disclose the suitability of the product for the claimed therapeutic application to the skilled person using its common general knowledge. Only once this evidence is available from the patent application, may postpublished evidence be taken into account when assessing sufficiency of disclosure (point 4.2.4 of the Reasons, emphasis added).

Going back to the particulars of the case at hand, the patent in suit properly disclosed and proved that the claimed compounds bind to a receptor called 5-HT1A, or in other terms were 5-HT1A agonists – this was not challenged by the respondents. But the real issue was the link between this biochemical property and the treatment of bipolar disorders.

In this respect, the Board found that the patent as disclosed at its filing date did not render the suitability of either of the compounds of formula (1) for the treatment of any type of bipolar disorder plausible; nor did it provide the information that there is a clear relationship between 5-HT1A receptor agonism and the suitability for the treatment of bipolar disorder (point 4.4.5 of the Reasons).

The Board went on to consider that there was no evidence on file showing that the person skilled in the art was in the possession of common general knowledge at the filing date of the patent in suit (only represented by basic handbooks and textbooks on the subject in question, see points 4.5.1 and 2 of the Reasons) which, together with the disclosure of the application as filed, led to the direct and unambiguous conclusion that 5-HT1A agonists in general, or either of the compounds of formula (1) in particular, were useful in the treatment of any type of bipolar disorder (point 4.5.3 of the Reasons).

Eventually, the Board concluded that the application as filed in combination with common knowledge at the filing date did not disclose the suitability of either of the compounds of formula (1) in the treatment of any type of bipolar disorder. Consequently, the minimum requirements set out in T 609/02 for taking into account post-published evidence were not met (point 4.5.3 of the Reasons).

Modelling of bipolar disorders at a very early stage.
Modelling of bipolar disorders at a very early stage.

The present decision follows the jurisprudence set by T 609/02 (point 9 of the Reasons) and confirmed inter alia by T 433/05 of June 14, 2007 (point 28 of the Reasons), T 801/06 of March 4, 2009 (point 25 of the Reasons), T 1437/07 of October 26, 2009 (point 37 of the Reasons), T 866/08 of September 16, 2010 (point 2 of the Reasons) (kindly brought to our attention by our reader Raoul), T 1685/10 of June 6, 2011 (point 3.1 of the Reasons), and T 801/10 of July 8, 2014 (point 4.1 of the Reasons).

However, it adds a twist to the existing case law by requiring that the skilled person can only rely on common general knowledge, represented by basic handbooks and textbooks, and excluding patent literature and scientific articles, to determine if the experimental data presented in a patent is representative of a metabolic mechanism specifically involved in the disease purported to be treated according to the claimed invention.

This was not expressly mentioned in T 609/02, which although it stated that:

As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application (point 9 of the Reasons for the Decision, emphasis added),

also considered that:

It is required that the patent provides some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art [i.e. not only from the common general knowledge of the skilled person] or demonstrated in the patent per se. Showing a pharmaceutical effect in vitro may be sufficient if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application […] (point 9 of the Reasons for the Decision, emphasis added).

In fact, it is not clear if the skilled person mentioned in T 609/02 should be akin to the one of Article 100(a) EPC, who has access to all the prior art, or to the one of Article 100(b) or of Article 100(c) EPC, who has only access to the contents of the patent and common technical knowledge.

The present decision appears to have decided for the latter solution, while previous decisions did not seem to set restrictions on the type of prior art that should be relied on for assessing the suitability of a product for a claimed therapeutic application (see for example T 433/05, point 29 of the Reasons and T 801/06, point 29 of the Reasons – even though in the latter case the prior art documents used were cited in the opposed patent, but this was not mentioned by the Board).

We cannot foresee if this decision will set a new trend in applying the teachings of T 609/02, but it is surely advisable for applicants to strengthen the description of the in vitro or in vivo disease models relied on in applications containing therapeutic purpose-limited claims, in particular by fully citing the scientific literature on which such models are based.

We would also like to add that even though this decision seems to add a further burden on applicants in regard of the sufficiency of disclosure requirement, it may conversely be a benefit to them when considering the novelty requirement. Indeed, as is clearly expressed in the above-mentioned decision T 1437/07:

A disclosure in a prior art document is novelty-destroying only if the teaching it contains is reproducible. This need for an enabling disclosure is in conformity with the principle expressed in Article 83 EPC. Thus, the requirements of sufficiency of disclosure are identical for a prior art document and a patent (point 25 of the Reasons, emphasis added).

Thanks Lionel! I guess the bottom line is that EPO case law is still in an adjustment phase as to the appropriate sufficiency threshold for second medical use patents. Although this topic is of crucial importance for all practitioners in the pharma industry, I think it is rather unlikely to find its way up to the Enlarged Board of Appeal, which – for better or worse – less often deals with substantive issues of patentability than with procedural questions.


CASE REFERENCE: Board of Appeal 3.3.01, T 2059/13, Otsuka Pharmaceutical Co. Ltd. v. Stada Arzneimittel AG et al., December 7, 2015