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”).

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.

A technical silver lining

They say that every cloud has a silver lining.

Thinking about a recent Philips case in which not one, not two, but three patents were revoked by the Paris Tribunal de grande instance (TGI), this saying seems quite fitting.

From the perspective of IP right holders, the dark cloud is of course that we have just been presented with yet another confirmation that patent validity is severely appraised in France. But the silver lining is that, although software patents were at stake, the court did not strike them down for just being that, but on the contrary fully acknowledged the technical nature of the inventions.

The case at hand was certainly a big one for Philips.

Not only were three patents involved, but there were also parallel proceedings against several unrelated defendants.

So much so that there were in fact four judgments issued on the same day: one pitching Philips against HTC, another against Asus, another against Archos and the last one against Wiko.

Philips reproached all defendants for not joining their “Touch enabled device” license program, and retaliated by filing an infringement action based on European patents No. EP 1384134, EP 0888687 and EP 1571988.

The four judgments look substantially identical, so it should be sufficient to look at only one of them.

Claim 1 of EP’134 reads as follows:

A data processing apparatus having a user interface assisting in searching for information from an ordered list a data array, the apparatus comprising:
an array scroller responsive to user actuation; and
a helper character-generator, actuated by continued user actuation of the array, the helper character generator being operative to display a helper character representative of a portion in the list being scrolled.

In brief, this is a user interface invention. The context is that of a long list of elements. In order to facilitate the retrieval of one element in the list by the user, a so-called “helper character” appears. This helper character may represent e.g. a first letter of a name or a first digit of a telephone number. It is thus representative of a cluster of entries in the list. By scrolling from helper character to helper character, the user may select a desired cluster, and then browse within this cluster instead of browsing through the entire list.

Choosing the right song in a menu, a critical decision to make.

The defendants argued that this was a mere presentation of information, and thus not an invention under art. 52 EPC.

Here is the court’s position on this objection:

Displaying the helper character involves continuous actuation by the user in a scrolling array. 

The patent thus relies on the user taking an active part, via an improved interface interacting with him, thus creating a particular technical effect due to the actuation by the user, allowing a faster choice in an array of elements. 

By combining several modes of scrolling down a list of elements, the patent teaches an adaptive user interface for searching and displaying, and thus does not just present information “as such”. It should also be emphasized that the purpose of the invention is to facilitate the selection of an element in a large set of data, on small size devices, taking into account their specific ergonomic design. 

Therefore, the EP’134 patent undeniably implements technical means to obtain a technical solution to a technical problem. Its subject-matter is thus patentable. 

I asked my partner Aujain Eghbali, who is an ace at computer-implemented inventions, what we can make of this.

His main comment was that this is the same type of reasoning that the EPO could have made. He added that the court’s reasoning is in fact quite patent-friendly even by EPO standards.

In particular, the court relied on the ergonomic character of the human/machine interface when assessing the technical nature of the invention. The Boards of appeal of the EPO have sometimes adopted a similar approach (see T 1779/14) but the Guidelines for examination do not take any clear position on the technical nature of such innovations. Section G-II, 3.7.1 suggests that a “physical ergonomic advantage” could be considered as a technical contribution, but specifically in relation with user input.

The court also took note of a statement in the description of the patent, per which human-machine interaction is particularly challenging when the device is small, due to the physiology of the user. Although effects relying on human physiology are acknowledged in the EPO Guidelines (section G-II, 3.7), they are not commonly accepted by examiners as having a technical character, Aujain said.

Going back to the judgment, the EP’134 patent was thus found to meet the requirements of article 52 EPC.

Further objections of insufficiency of disclosure and lack of novelty were also rejected. But the patent finally died of lack of inventive step.

However, it is important to note that all features of claim 1 were fully taken into account in the inventive step reasoning, in keeping with the court’s finding that the claim related to a technical solution to a technical problem.

The court’s negative opinion on the patent was thus fully based on relevant disclosures identified in the prior art. So, this is your good old, traditional, prior art-based lack of inventive step, if you will; not a this-is-not-technical-enough lack of inventive step.

In more detail:

The EP’036 document teaches that, upon continuous actuation of the scrolling key, the first names are sequentially displayed, in the alphabetic order, for each letter, thus providing a search tool. 

Starting from this search tool disclosed in EP’036, the skilled person, namely an electrical engineer experienced in designing user interfaces for portable electronic devices, confronted with the problem of selecting an element in a scrolling list on a small size screen, would achieve claim 1 of the EP’134 patent, since the search tool of the EP’036 prior art (underlining the first letter of a name) is only a visual alternative to the generation of a help character, which is anyway taught by the US’949 document. 

The EP’036 document also taught scrolling cluster by cluster, allowing the user, by maintaining the scrolling key pressed, to go from letter to letter in the directory, without having to go through all names starting with the same letter. 

Therefore, the features of claim 1 of the EP’134 patent derive from the state of the art. 

Next up was EP’687, another user-interface patent.

See in particular claim 1:

An electronic device comprising:
– at least one display;
– a controller arranged to cause the display to show a rotating menu comprising a plurality of menu options,
which menu is disposed off centre in the display so that at least one option is rotatable off the display at any one time, whereby an arbitrary number of options may be added to the menu without changing its format.

Again, the court fully acknowledged the technical character of the invention:

[…] The EP’687 patent aims at improving a user interface for a screen. To this end, it allows displaying a menu comprising a plurality of options as well as adding an arbitrary number of options to the menu without changing its format. It thus provides a better identification of options. 

The objective of the EP’687 patent is to facilitate adding more articles to the menu without making the display more complex, as long as at least one option in the menu is out of the screen due to the rotating menu being off-centered. 

Therefore, the patent makes it possible for the user to interact with the device, while adding any number of options to the menu, without modifying the format and while keeping their own character making their identification easier.

Consequently, the EP’687 patent, which ensures a better identification of menu options for the user, by means of a controller which combines a particular option display format and a double function of rotation and addition of options, obviously implements technical means to provide a technical solution to a technical problem. Its subject-matter is thus patentable. 

Like for the previous patent, Philips was also able to fend off insufficiency and lack of novelty challenges, but then stumbled on inventive step, as the prior art was deemed to be very similar to the invention.

The third patent was directed to an activity monitor. Its technical character was not challenged. It was revoked for lack of inventive step all the same.

In summary, the present case seems to confirm a trend recently seen in a Thales decision and on the contrary to drift further away from past case law in which the stance on patent eligibility was considerably stricter.

How apropos then that the INPI (French patent office) has just published an updated version of its examination guidelines containing two new sections C.VII.1.3.1 and C.VII.1.3.2 on computer-implemented inventions.

One section is dedicated to CAD and computer simulations. The other one relates to AI. Both provide additional guidance as to what should be considered technical or non-technical, again quite in line with the EPO approach. Maybe the next revision will contain some additional thoughts on graphical user interfaces?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, July 11, 2019, Koninklijke Philips NV v. SAS HTC France Corporation & HTC Corporation, RG No. 16/02073.

Patentability in small doses

Dosage regimen inventions are one of those subjects wherein French law tends to be unique in the European patent law landscape.

By way of a reminder, patent eligibility of claims directed to dosage regimen inventions was denied in a number of court decisions. In the finasteride litigation, the Paris Cour d’appel finally seemed to align with the principles set out in decision G2/08 of the EPO’s Enlarged Board of Appeal, as it acknowledged that posology features are allowed in further medical use claims. See a summary in a previous post here.

However, first instance judges did not seem willing to follow this case law, as shown by two further decisions from the Paris tribunal de grande instance (TGI) reported on at the beginning of this other post.

In December 2017, the Cour de cassation issued its ruling on the finasteride case. The main topic of the decision however is sufficiency of disclosure, as explained in this post. Some have argued that this decision from the supreme court implicitly “acknowledged the patentability of dosage regime claims“. I tend to disagree, as it seems to me that this was simply not decided upon by the cassation judges.

A few months later, we now have a clear confirmation that the issue of patent eligibility of dosage regimen inventions is absolutely not settled.

The case at hand relates to European patent No. EP 1448207 owned by Hungarian company Richter Gedeon Vegyeszeti Gyar RT (Richter) and licensed to French company Laboratoire HRA Pharma (HRA). In June 2013, the generic drug manufacturer Mylan initiated nullity proceedings in front of the Paris TGI. Mylan launched a generic drug in early 2014. Richter tried to get a preliminary injunction against Mylan, which was denied in June 2014.

The French part of the European patent was voluntarily limited in front of the Institut National de la Propriété Industrielle in October 2014, by turning product claim 1 into an EPC 2000-type therapeutic use claim; and by merging Swiss-type claims 2 and 3 together.

On June 9, 2015, the TGI handed down its decision on the merits, revoking the patent. Richter and HRA appealed.

On March 2, 2018, the Cour d’appel confirmed the first instance decision.

The drug at stake in this lawsuit is levonorgestrel, a hormonal substance used as an emergency birth control medicine.

Claim 1 of the patent as limited reads as follows:

Pharmaceutical composition as single application dose, containing 1.5 ± 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice, for use in emergency contraception by administering a single application dose up to 72 hours after the coitus.

Claim 2 of the patent, also modified by way of the national limitation, is the following:

Use of 1.5 ± 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception by administration of a single application dose up to 72 hours after the coitus.

At the priority date of the patent, levonorgestrel was already widely known and used for emergency contraception. It was administered in two doses of 0.75 mg each. The invention thus consisted in replacing these two doses by a single dose of 1.5 mg.

Dosage regimen patents in France are like a game of Hide & Seek.

The court noted the following:

The invention neither modifies the sought contraceptive purpose, nor the used substance (levonorgestrel), nor the total dose of 1.5 mg, nor the administration of the product within 72 hours of non-protected coitus. 

Indeed, it is not challenged that taking two doses of 0.75 mg levonorgestrel is tantamount to one dose of 1.5 mg levonorgestrel, as the additives are not the subject-matter of the invention and anyway are identical for Noverlo 1.5 mg and for Noverlo 0.75 mg.

The court then further held:

Besides, the description of the patent does not contend that the invention makes it possible to obtain better results to avoid pregnancies, or to reduce side effects, but that its purpose is to solve the problem of the difficulty for patients to comply with the taking of the second dose within a period of twelve hours from the first one, while achieving at least the same results without additional side effects. 

Thus, and insofar as the sole contribution of the ‘207 patent consists in taking the product which is identical in its substance, in its total dosage and for the same indication, in one take instead of two without any novel technical contribution or benefit other than the comfort of a single take, the first instance court rightly held that the invention is not patentable under article 53(c) of the European patent convention. 

There you have it, dosage regimen inventions can still be held non-patentable as relating to mere methods of treatment.

This applied similarly to purpose-limited composition claim 1 and to Swiss-type claim 2. This is not surprising as French courts do not typically attach importance to the exact manner in which claims are drafted. They focus on what the invention really is about.

As a further comment, we should never read too much in any given court decision.

In particular, I do not believe the present decision to be a complete reversal relative to MSD v. Actavis. In the present ruling, the court insisted on the fact that there was absolutely no technical contribution, in their opinion: same total dosage, no reduction in side effects, no efficacy improvement. In a different context, with a new dosage providing for instance improved efficacy or fewer side effects, the court might have come to a different conclusion, based on the existence of an actual technical contribution to the art.

As if one deadly wound were not enough, the court inflicted two additional ones to the patent, in a clear effort to make Richter’s way to a cassation appeal as difficult as possible.

The court thus held that the claims of EP’207 lacked novelty over clinical trials on the 1.5 mg dosage which were publicly reported on by the World Health Organization before the priority date.

And the court finally held that the claims lacked inventive step, also in view of the clinical trial reports.

As a final remark, it is somewhat paradoxical that the patent was revoked as relating to a method of treatment, whereas a method of contraception is in principle not considered at least by the EPO as a method of treatment – as pregnancy is not a disease. See example 3 in section G-VI, 7.1.2 of the Guidelines for examination. I do not know whether the argument was raised during litigation or not.

That said, if one adopts this approach, it then means that perhaps the EPO should not have granted claim 2 of the patent at least in this specific form, as the exceptional Swiss-type claim drafting format is not applicable to non-medical uses (so that the claim would or should have been found to lack novelty).


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, March 2, 2018, Richter Gedeon Vegyeszetu Gyar RT & SAS Laboratoire HRA Pharma v. SAS Mylan, RG No. 15/16651.

A skinned patent

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

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

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

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

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

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

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

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

Here, claim 9 of the French patent is directed to

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

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

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

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

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

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

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

A butterfly batch – the ideal treatment for skin disorders.

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

Claim 1 reads as follows:

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

Claim 10 is directed to:

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

Both claims fell for lack of inventive step.

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

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

But the P&G reference contains the following statement:

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

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

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

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

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

As a next step, the court stated:

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

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

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

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

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

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

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

The court thus concluded:

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

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

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

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

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


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