Adding pepper to a tomato and broccoli salad

At this time, all readers are probably already aware of the issuance of opinion G 3/19 of the Enlarged Board of Appeal on May 14, 2020.

I know, twelve days is a long time in the internet era.

But trust me, Lionel Vial’s below report on this topic is worth reading.  Lionel loves making predictions, and his forecast on plants and animals obtained by essentially biological processes is that this hot topic is not about to cool down and that we are in for ongoing legal controversy – and possibly one or more future referrals.  

Is the illustrated cactus a plant obtained by an essentially biological process?

Here is Lionel’s report.

As this blog has consistently strained to keep pace with the seemingly never ending developments regarding the patentability of plant and animals obtained by essentially biological processes, as reported here, here and here, we felt compelled to comment on opinion G 3/19 of the Enlarged Board of Appeal (EBA) of the EPO, which was rendered on May 14, 2020.

To make a long story short, G 3/19 (Pepper) follows from a referral pursuant to Article 112(1)(b) EPC of the President of the EPO, itself following from decision T 1063/18 of Board of Appeal 3.3.04 of December 5, 2018, which decided that in accordance with Article 164(2) EPC, the interpretation of Article 53(b) EPC by the EBA in decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II) prevailed over Rule 28(2) EPC.

In other words the Board of Appeal decided plants and animals obtained by essentially biological processes were not to be considered exceptions to patentability pursuant to Article 53(b) EPC in spite of Rule 28(2) EPC, which was introduced by a Decision of the Administrative Council of June 29, 2017 and entered into force on July 1, 2017. Rule 28(2) EPC provides that under Article 53(b) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.

There are two parts in opinion G 3/19, a part which relates to institutional provisions and a part which relates to substantive provisions.

Turning first to the substantive part of the opinion, which directly impacts daily practice at the EPO, the EBA, adopting a “dynamic interpretation” of Article 53(b) EPC for the circumstance, has abandoned the interpretation of Article 53(b) EPC given in decision G 2/12 and G 2/13, in the light of Rule 28(2) EPC.

As a consequence, this new understanding of Article 53(b) EPC has a negative effect on the allowability of product claims or product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.

It is to be noted that the EBA goes beyond the wording of Rule 28(2) EPC and also excludes plant material exclusively obtained by means of an essentially biological process. This may call for future clarification (see below).

Besides, in order to ensure legal certainty and to protect the legitimate interests of patent proprietors and applicants, the Enlarged Board ruled that the new interpretation of Article 53(b) EPC given in G 3/19 has no retroactive effect on European patents containing such claims which were granted before July 1, 2017, when Rule 28(2) EPC entered into force, or on pending European patent applications seeking protection for such claims which were filed or have a priority date before that date.

This contradicts the Decision of the Administrative Council which provided in its Article 3 that Rule 28(2) EPC applied to European patent applications filed on or after July 1, 2017, as well as to European patent applications and European patents pending at that time.

At this stage of the post, we should self-congratulate for having foreseen in our previous post on the subject of July 3, 2017 that the consequence of the Decision of the Administrative Council would be that plants and animals exclusively obtained by means of an essentially biological process are exceptions to patentability, but that the new Rule 28(2) EPC could not apply to patents and applications filed before July 1, 2017. However, to be frank, at that time we had not anticipated that a Board of Appeal would refuse to apply Rule 28(2) EPC pursuant to Article 164(2) EPC because it was in contradiction with the interpretation of Article 53(b) given by the EBA.

This brings us to the institutional part of the opinion of the EBA.

The EBA does not consider that there would be a general prohibition on adopting secondary legislation [by the Administrative Council] which concerns the interpretation of a provision of primary legislation given by itself (see point XXV.3.1).

Besides, the EBA considers that the exception to patentability brought by Rule 28(2) EPC is not incompatible with the wording of Article 53(b), which does not rule out this broader construction of the term “essentially biological processes for the production of plants or animals” and that Rule 28(2) EPC could be considered to reflect the Contracting States’ intention to give a special meaning to that term (see point XXVI.6).

As such, the new Rule 28(2) EPC has to be taken into account in the dynamic interpretation of Article 53(b) as seen above.

It follows that the content of Rule 28(2) EPC does not stand in contradiction with the new interpretation of Article 53(b) EPC given by the EBA and that there is no conflict between these provisions. Hence, Article 164(2) EPC is not relevant (see point XXVII of the opinion).

As far as we are concerned, we are not sure if it was ever the initial intent of those who drafted the EPC to have the substantive patent law provisions of the EPC, especially Chapter I Patentability, interpreted by the Implementing Regulation, but let’s not be more Catholic than the pope.

So, is this the end of tomatoes, broccoli or pepper decisions? Let us take another bet here: No, in our opinion, other questions will need to be answered by the Boards of appeal of the EPO and perhaps by the EBA.

Here is a short list, probably not exhaustive, of likely questions:

        • Can parts of plants, such as fruits, be considered to be exclusively obtained by means of an essentially biological process?
        • Are plants or animals which are obtained by means of an essentially biological process but which can also be obtained by a non-essentially biological process exceptions to patentability?
        • Are plants or animals which are obtained by a process comprising an essentially biological process and a further step of a technical nature which does not serve to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants exceptions to patentability?

Eventually, this leads us to our concluding riddle: After tomatoes, broccoli and pepper, what will be the name of the plant attached to the next decision, or opinion, of the EBA?


CASE REFERENCE: Enlarged Board of Appeal of the European Patent Office, G 3/19, May 14, 2020, Pepper (follow-up to “Tomatoes II” and “Broccoli II”).

Insufficiently disclosed or reasoned?

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

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

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

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

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

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

An underground chamber suitable for the next confinement stage?

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

Claim 1 of the patent as limited reads as follows:

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

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

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

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

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

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

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

At this stage I have mixed feelings about this assessment.

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

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

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

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

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

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

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

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

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

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

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

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


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

Court hits the bull’s-eye

The case reported on today is a good opportunity to remind all readers that the new statutory provisions on heightened examination of patent applications in France will kick off on May 22 (with the entry into force of another part of the loi PACTE).

In other words, all national patent applications filed on or after May 22 will be subjected to full examination and may be rejected for basically the same grounds of refusal as at the EPO, including lack of inventive step.

Therefore, if you want your patent application to be prosecuted under the current regime (wherein the grounds for refusal are much more restricted), there is only one month left for you to file.

As a further reminder, if a refusal is issued in examination proceedings, the means for redress is an appeal in front of the Paris Cour d’appel – this will not change after May 22, so a surge in such appeals is to be expected in a few years’ time.

For the time being, appeal rulings further to refusals are rare. We should thus certainly review them to get a sense of what may lie ahead.

A few months ago, I reported on a judgment overturning a refusal of an application by Thales on an aircraft GUI invention. Today, I will address a case involving Bull, another French tech company.

Bull is the applicant of national patent application No. FR 16/00894, published as FR 3052274. Unfortunately the file wrapper on the INPI website appears to be incomplete, but I can gather the following:

  • The application was filed on June 2, 2016.
  • On November 9, 2016, the INPI examiner in charge of the application issued a communication stating that the claimed invention appeared to relate to a method for performing mental acts as such. The applicant replied, but this reply is missing from the online file wrapper.
  • On March 27, 2017, another communication was issued, stating that no meaningful search could be carried out.
  • On August 21, 2018, the INPI issued the decision of refusal (also not accessible on the INPI website!) based on ineligibility.

As a comment regarding these proceedings, we are looking at a French application which does not claim a foreign priority. Therefore, the application was sent to the EPO for the search, so that it is the EPO examiner who concluded that the search was not possible. The documents from the EPO are regrettably not present on the INPI website, but they can be accessed via the EP file wrapper of the corresponding Euro-PCT application (which was deemed to be withdrawn, in case you are wondering).

It turns out that the EPO examiner justified the absence of search by stating that the claimed technical features at stake were notoriously known from the state of the art. In the written opinion, the examiner argued that the claimed invention lacked inventive step.

As a first remark, the EPO examiner’s position is quite different from that of the INPI. Lacking inventive step is not the same as not being an invention. And, most importantly, lack of inventive step is not a ground for refusal in France – until May 22.

As a second remark, I do not quite understand the EPO’s practice of not carrying out a search in the case of allegedly notorious technical features. After all, if an invention relies on notorious features, the search should be very easy to complete. The absence of search on the other hand has serious procedural consequences for the applicant and does not make it possible for them to properly challenge the examiner’s reasoning.

Let’s now turn to claim 1 of the application, which reads as follows:

A terminal for establishing communications, the communications being broadcasts inside a group of users, a user of the terminal belonging to at least one group of users, the communication terminal including means for:

          • associating a list of user identifiers with a group identifier,
          • associating a plurality of properties with a user,
          • associating a property activation value with each property,
          • recording an identifier of a current group,
          • recording a value of a current state,
          • updating the value of the current state as a function of a user input,
          • adapting a display as a function of:
          • the identifier of the current group,
          • the value of the current state.

According to the refusal decision, the subject-matter at stake does not comprise any specific technical feature but merely sets out a method for carrying out mental acts implemented by generic computing means.

No applicant should get bull-ied by the patent office.

In the judgment, the court emphasized that the claims have to be interpreted in the light of the description and drawings.

The court then noted that the mention of a terminal comprising a microprocessor, storage means such a hard drive or a memory card, a communication interface and a screen, implies that the application does not relate to a purely abstract method.

The court then went on to analyze the problem set out in the application, and concluded that it is indeed a technical problem:

It is set out (on pages 1 and 2) that the invention is in the field of communication devices and in particular of the maximization of a ratio of information/surface comprising a plurality of users, more specifically for portable terminals such as those used on battlefields; and it provides a mode of global visualization of an aspect of a situation on a screen, so as to circumvent the problem of the state of the art per which fighters are endowed with information systems making it possible to display each fighter’s identifier, mission and operational capacities, but not giving any vision for a unit comprising several fighters, so that in a situation of combat stress, it is not possible to remember the corresponding information for each fighter. As a result, the technical problem is that of global visualization of a situation for a unit comprising several fighters, and not of memorization in a stressful situation, which is indeed a problem of a cognitive nature but which is not the one that the invention purports to solve. It thus cannot be considered at this stage that the invention does not provide a technical solution to a technical problem.

The INPI further reasoned that the various claimed means were defined in a purely functional manner and were generic, not clear, and merely related to basic and usual computer tools.

The court was not convinced, as these remarks are not relevant to the issue of whether the claimed subject-matter relates to an invention or not:

The use of technical means to implement a method within the framework of mental activities, thus totally or partly excluding human intervention, can confer to said method a technical character and therefore make it possible to consider it as an invention, just as the patentability of a combination of technical and non-technical features is admitted.

[…] The Director of the INPI can refuse a patent application on the ground of a manifest lack of novelty, and argues that the EPO examiner working on the search report stated that the computer technology relied upon is universally known and widespread, so that the notoriety of such prior art cannot be reasonably challenged. [But he] did not base the refusal decision on a manifest lack of novelty but on article L. 612-12, 5° which only excludes patentability when the subject-matter of the patent application can “manifestly not be considered as an invention under article L. 611-10 Code de la propriété intellectuelle”. The requirements of sufficiency of disclosure, novelty and inventive step cannot be taken into account in the application of this provision. 

Based on these findings, the court considers that the subject-matter of claim 1 relating to a terminal for establishing communications comprising various mutually interacting technical means does not concern a method of performing mental acts as such. It is thus not excluded from patentability for this reason.

All in all, applicants and patent attorneys alike will likely rejoice, as the court has drawn a clear and sound distinction between patent eligibility and the other patentability requirements, in keeping with the case law of the Boards of appeal of the EPO. Also, this approach is consistent with the earlier Thales ruling mentioned at the beginning of this post. This means more international uniformity and more legal certainty.

The issue remains that the main claim does have a broad and somewhat vague flavor to it (which is what the EPO examiner had to say in the first place). If the examination proceedings continue, will the INPI try to refuse the application a second time, this time for a manifest lack of novelty? Or will they conclude that, for a pre-PACTE application, they simply do not have the right legal tools to challenge such a claim?

At any rate, the fate of the first computer-implemented invention applications filed as from May 22 will have to be closely monitored, to see which way the new winds will be blowing.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, November 22, 2019, SAS Bull v. Directeur Général de l’INPI, RG No. 18/21161.

Best FRAND forever

One common trait of all standard essential patent (SEP) disputes is their procedural complexity. A lawyer’s dream come true.

A few weeks ago, I reported on the IPCom v. Lenovo litigation. The apparent conclusion was that, in the context of a multidimensional and multinational lawsuit, French courts were not ready to forgo their say. This seems to be confirmed in another high profile case, brought to my attention by Denis Schertenleib.

The case pitches the Dutch giant Philips against Hong Kong-based TCL.

Philips owns a portfolio of patents declared as essential for the 3G and 4G standards with the standard-setting organization ETSI (European Telecommunications Standards Institute). According to a classical plot, Philips and TCL negotiated a patent license for this portfolio and the negotiations failed. It seems that one of the bones of contention was the scope of the license, both in terms of patents and countries.

Philips sued TCL in the UK for infringement of two patents, in October 2018.

TCL started a legal backfire by suing Philips in front of the Paris Tribunal de grande instance (TGI). By the way, have I already mentioned on this blog that the TGI has been renamed TJ (tribunal judiciaire) since January 1, 2020?

What is much less conventional in this plot is that TCL sued not only Philips, but also the ETSI itself.

As a main request TCL asked the court:

  • to declare that Philips’ essentiality declaration to the ETSI amounts to a promise to grant a FRAND license to TCL on all patents declared as essential for the 3G and 4G standards;
  • to determine FRAND conditions for the license and to enjoin Philips to grant it;
  • to enjoin the ETSI to participate in the license granting process;
  • to declare that the conditions offered by Philips are not FRAND-compliant.

At the risk of disappointing readers, we do not have the court’s ruling yet. What we do have is an interim order by the judge in charge of case management dealing with a number of preliminary objections raised by Philips.

A blogger working on his next SEP post during the lockdown.

First, Philips argued that the Paris court lacked jurisdiction.

The discussion here revolves around article 8.1 of Regulation (EU) No. 1215/2012 (known as the Brussels I bis regulation) per which “a person domiciled in a Member State may also be sued where he is one of a number of defendants, in the courts for the place where any one of them is domiciled, provided the claims are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings“.

Again, Philips is a Dutch company. The ETSI, on the other hand, is located in Sophia Antipolis, on the French riviera. Philips argued that the claim against the ETSI was artificial so that the institute was not a “real defendant“. Philips further challenged that the claims against it and against the ETSI were closely related.

The judge in charge of case management disagreed:

It must be noted in this case that the claims against the ETSI on the one hand and Philips on the other hand relate to a same factual situation resulting from the fact that, according to the plaintiffs, Philips does not comply with the IP rules established by the ETSI. 

Although the legal grounds for the requests against the ETSI and Philips are different […], this is not an obstacle to the acknowledgment of an identity of legal situation, […] especially since in this case all requests are expressly subjected to French law, as provided in the rules of procedure established by the ETSI. 

The identity of legal situation supporting these requests is thus characterized. 

It must also be noted that the ETSI is endowed with legal means to ensure that IP obligations are complied with by its members, so that the claims against this institute cannot be held as artificial.

In addition, it must be noted that a decision enjoining the ETSI to participate in the grant of a license if needed by implementing the measures provided in its internal regulations, and one holding that Philips complied with its obligation to offer a license to TCL under FRAND conditions would be incompatible and not only diverging.  

Second, Philips relied on a lis pendens objection (due to the preexisting British lawsuit).

The basis for this objection is article 29 of the Brussels I bis regulation, per which “where proceedings involving the same cause of action and between the same parties are brought in the courts of different Member States, any court other than the court first seised shall of its own motion stay its proceedings until such time as the jurisdiction of the court first seised is established“.

Again, the judge disagreed:

[…] The claim in front of the High court of justice of England and Wales is based on infringement of the British part of European patents No. […]. It only concerns Philips and TCL. 

The present lawsuit concerns Philips, TCL, and also the ETSI. It consists in determining whether Philips […] offered a worldwide license on a [patent portfolio] under fair, reasonable and non-discriminatory conditions. 

As a result, the condition of triple identity of cause of action, subject-matter and parties is not met, and there is no reason to decline jurisdiction in favor of the English court.

Third, Philips relied on a related actions objection (still due to the preexisting British lawsuit).

This time, it is article 30 of the Brussels I bis regulation that comes into play:

1. Where related actions are pending in the courts of different Member States, any court other than the court first seised may stay its proceedings.

2. Where the action in the court first seised is pending at first instance, any other court may also, on the application of one of the parties, decline jurisdiction if the court first seised has jurisdiction over the actions in question and its law permits the consolidation thereof.

3. For the purposes of this Article, actions are deemed to be related where they are so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings.

This objection was no more successful than the previous ones:

As mentioned by TCL, the trial on the FRAND license issue will only proceed in the UK if TCL does not renounce requesting such a license […]. No risk of irreconcilable judgments under article 30 of the Regulation is established, so that the objection based on related actions cannot be sustained and the present court does not have to decline jurisdiction. 

I must say that this part of the judgment is somewhat less clear to me than the rest. I assume that what the judge meant is that the objection is premature as there is no indication at this time that the same question will be asked to the British court and the French court.

As a result, the judge rejected all objections raised by Philips, so that the litigation can proceed further.

The ETSI also requested that the claims against it should be declared inadmissible. However, this other objection needs to be examined by the full court, so that the judge in charge of case management has not ruled on it.

This interim judgment is of particular interest because the jurisdiction of the Paris TJ was acknowledged with respect to TCL’s FRAND determination requests, independently of any infringement, non-infringement or validity claims regarding any French patent or French part of a European patent.

Suing France-based ETSI as a co-defendant was what made it possible to achieve this outcome.

If this strategy continues to prove successful (which remains to see), it will mean that it can be replicated in any other 3G or 4G standard-related dispute, in other words that any IP right owner can be sued in France with respect to FRAND determination claim. So this is kind of a big deal.

On the other hand, I have read comments on this judgment according to which the decision was the first one to qualify the promise by a patent owner to grant a FRAND license under the ETSI IPR Policy as a “stipulation pour autrui”, namely a third-party beneficiary clause that creates a direct contractual relationship between the ETSI member (patent owner) and a third party (would-be licensee).

It has indeed long been proposed that an essentiality declaration with the ETSI amounted to this contractual mechanism of “stipulation pour autrui“. But I personally fail to find in the judgment any clear confirmation that the judge agreed with this qualification.

What I do find in the judgment is a mention that the ETSI agrees with this qualification; and a discussion on the legal grounds of the claims against Philips and the ETSI, the latter one being the “stipulation pour autrui“. But I do not understand this discussion as an acknowledgment that the proposed legal qualification is correct. However, it is likely that future judgments in this litigation will provide more clarity.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 1ère section, ordonnance du juge de la mise en état, February 6, 2020, SAS TCT Mobile Europe et al. v. Koninklijke Philips NV et al., RG No. 19/02085.

Back to the old normal?

Let me first start by wishing that all readers are safe and well, in these exceptional and difficult times.

As so many of us have to remain home all day in the foreseeable future, with the dreadful pandemic newsfeed as a main distraction, I said to myself, what better way to take my mind off it than to write about… a pharma case?

And so, here is an update on the Inegy® patent dispute (judgment kindly provided by Denis Schertenleib).

Difficult to think about anything else these days.

One year ago, Lionel Vial and I reported on a preliminary injunction ordered against Mylan due to the likely infringement of SPC FR05C0040 owned by Merck Sharp & Dohme Corp. (MSD).

In that post, we expressed some surprise at the decision since, back in April 2018, a judge in charge of emergency interim proceedings had refused to issue a preliminary injunction against another generic drug company, Biogaran, based on the same SPC, because the latter was considered likely invalid, which was confirmed on appeal on June 26, 2018 (see this post).

We wondered whether there was thus a new, more patentee-friendly trend in France with respect to preliminary injunctions in general and pharma patent litigation in particular, which is why the March 2019 post was entitled The new normal.

But now, we seem to be back to the old normal, as the Cour d’appel has overturned the preliminary injunction, and effectively re-raised the bar for pharma patent holders. 

As a reminder, Inegy® is a combination of ezetimibe and simvastatin, which is prescribed for reducing cholesterol levels.

Ezetimibe reduces intestinal absorption of cholesterol while simvastatin (belonging to the family of statins) is an HMG-CoA reductase inhibitor which inhibits cholesterol biosynthesis.

MSD’s SPC protecting Inegy® is based on European patent EP0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin”.

EP’599 specifically claims:

  • a very broad family of compounds in claim 1 (in the form of a Markush formula);
  • ezetimibe as a specific compound in dependent claim 8; and
  • a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of the above compounds, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).

On October 17, 2017, Mylan initiated nullity proceedings, to which MSD responded by requesting, on November 30, 2018, that a preliminary injunction to stop selling Mylan’s ezetimibe/simvastatin combination and to pay provisional damages be issued against Mylan.

On March 7, 2019, the judge in charge of case management (JME) granted the preliminary injunction. Mylan appealed, and the JME’s judgment has now been overturned by the Paris Cour d’appel on February 14, 2020.

Like in first instance, Mylan argued that the SPC was invalid because:

  • It was granted for a combination which is not protected as such by the basic patent, in breach of Article 3(a) of the SPC regulation (No. 469/2009), since it does not form the core inventive advance of the patent, which is centered on ezetimibe, in particular in the absence of any research conducted on the ezetimibe/simvastatin combination.
  • The product protected by the basic patent was already the subject of a certificate (i.e. SPC FR03C0028 granted for ezetimibe) in breach of Article 3(c) of the SPC regulation.
  • As is usual in SPC-related cases, the court analyzed the relevant case law from the CJEU. But the court interpreted the Gilead decision (C-121/17, Teva UK Ltd. et al. vs. Gilead Sciences Inc.) differently from the JME at first instance.

According to Gilead:

Article 3(a) of [the SPC regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

The Cour d’appel held that the conditions of Gilead are not automatically met merely because the claims of the patent explicitly mention the active ingredients of the combination product. Something more is required.

The court insisted on the the link between the claimed combination and the technical problem at stake, based in particular on reason 48 of Gilead, which reads: “it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent“.

The court also turned to earlier decisions of the CJEU, namely Sanofi (C-443/12, Actavis Group PTC EHF & Actavis UK Ltd v. Sanofi) and Boehringer (C-577/13, Actavis Group PTC EHF & Actavis UK Ltd v. Boehringer Ingelheim Pharma GmbH & Co. KG) and found that the facts of the present case are similar to those of these earlier decisions.

Here is the court’s summary of Mylan’s key argumentation:

Mylan argues that the basic patent lists a large number of products, namely all known cholesterol-lowering products to be combined with the new active compound ezetimibe, that it does not contain any information on the specific effects of these combinations, and in particular the one associating ezetimibe with simvastatin, and that this combination is therefore not a product distinct from ezetimibe alone, for which the patentee has already obtained an SPC, which would make it possible for them to prohibit the sale of ezetimibe combined with any other product, so that the [SPC] is likely invalid.  

And here is the summary of MSD’s rebuttal:

MSD argues that [the expressly designated] composition of ezetimibe and simvastatin necessarily pertains to the invention for the skilled person, in keeping with Gilead. They add that this combination product is not a mere juxtaposition of two known active substances; it effectively makes it possible to solve the technical problem stated in the patent, namely the development of more effective drugs in the treatment and prevention of atherosclerosis, avoiding side effects, in view of the complementary modes of action of ezetimibe and simvastatin; and that this is a second invention of the EP’599 patent, covered by this patent under article 3(a) of the regulation, so that this case is different from Sanofi and Boehringer. They add that the combination product of ezetimibe and simvastatin has not given rise to an SPC under article 3(c) of the regulation yet, that several products can be protected as such by a basic patent, and that the condition of article 3(c) is also met so that the SPC is valid. 

In summary of the summaries: for MSD, there are two inventions in the basic patent, namely ezetimibe on its own, and the combination of ezetimibe with other complementary drugs such as simvastatin; for Mylan, the patent is only about ezetimibe itself.

In order to decide between these two propositions, the court looked at the structure of the basic patent, and at the nature of the combined effect of the two active substances.

Concerning the structure of the patent, the court noted that the summary of the invention primarily focuses on the class of compounds to which ezetimibe belongs. And then:

[…] The next paragraphs 15 to 17 which disclose product compositions and notably the association of a hydroxy substituted azetidinone and a cholesterol biosynthesis inhibitor are introduced by the following wording: “in still another aspect, the present invention relates to a pharmaceutical composition” or “the present invention also relates to”, so that the skilled person could consider the combination […] as being another “aspect” of the invention relating to hydroxy substituted azetidinones, and not a distinct invention. 

That sounds like a fair point, but on the other hand, it should scare the hell out of all patent drafters that an apparently innocuous choice of wording can have such dramatic consequences more than 25 years after the patent was drafted.

Concerning the “combined effect” of the active substances (an expression used at paragraph 53 of the reasons of Gilead), the court noted the following:

MSD states in its submissions that the “combined effect” under Gilead of the association of ezetimibe and simvastatin lies in the fact of not having to administer the maximum dose of statin and reducing the risk of side effects. This is not mentioned in the patent, which indifferently mentions that the effect of both hydroxy substituted azetidinones alone and their combination with a cholesterol biosynthesis inhibitor is the “treatment and prevention of atherosclerosis”. Therefore, the skilled person, who knew from the prior art that it was possible to combine two anti-cholesterol substances having different modes of action […] and who knew statins and especially simvastatin, in use since the end of the 80s for the treatment of hypercholesterolemia, would not consider that this combination is a distinct product of the patent (in the absence of any indication at the filing date as to the combined effect of ezetimibe and simvastatin, and the results from later research not having to be taken into account) […].

Consequently, the court seems to consider that, in order for a combo drug to be considered as distinct from a mono drug in a patent, this needs to be stated in the patent itself, and there must be a specific effect for the combination disclosed in the patent.

It remains an open question whether a mere mention of a specific combined effect would suffice or whether the combined effect would have to be plausible at the filing date (by analogy with the requirements of sufficiency of disclosure).

The above will probably be controversial enough, but an additional point made by the court, after concluding that the validity of the SPC was seriously challenged, may be even more controversial. To wit:

At any rate, the proportionality of the measures ordered at first instance is not justified in view of the respective interests relating to originator and generic drugs having obtained marketing authorizations. A financial harm cannot be seen as non-repairable or even poorly repairable, as long as it can later be cured by a damages award, unless under exceptional circumstances which are not justified in the present case, as the SPC at stake expired on April 2, 2019, i.e. less than two months after the preliminary injunction order.   

Just like in the latest post on this blog (in the context of telecom SEP litigation), the proportionality principle has thus been emphasized by the court, which seems to be a tendency on the rise. And just like in this other case, the fact that the expiry date of the IP at stake was nigh was a factor taken into account in the proportionality assessment.

This must be very worrying for originators, as preliminary injunctions have been a powerful deterrent for competitors, and as there are concerns that damages may never completely compensate for the competitive advantage gained by generic drug companies launching before expiry.

The case on the merits is probably going on in parallel, so we will probably get further updates on this case.

As a final note, a very similar decision was issued on the same day, with Sandoz instead of Mylan as the generic defendant.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 14, 2020, SAS Mylan v. Merck Sharp & Dohme Corp. & SAS MSD France, RG No. 19/06114.