A remedy worse than the disease?

Before leaving the floor to Lionel Vial for the second part of his thorough report on the recent Merck v. Actavis appeal decision (the first part is here), I would like to follow up on the issue of patent eligibility of dosage regimen inventions in France.

Indeed, such inventions were again deemed to be excluded from patentability in at least two relatively recent first instance decisions, namely:

The Akzo decision was issued before the Merck v. Actavis appeal ruling went out but this is not the case for the Mylan decision.

In this second decision, the written proceedings were formally closed on February 10, 2015 and the hearing took place on March 9, 2015. This is later than the January 30, 2015 Merck v. Actavis appeal ruling, but not much later. It is possible that neither the parties nor the first instance judges were aware of the outcome of the Merck v. Actavis appeal in due time, which could be the reason why the position taken by the first instance court is not in line with that of the appeal judges.

The other posible explanation is that the Tribunal de grande instance de Paris might not be in a mood for applying Merck v. Actavis. Such an attitude would not be unheard of – it even has a name in the French legal system, “resistance” of the lower courts.

We will thus have to wait for further cases to know for sure.

Now, back to Lionel, on a different aspect of Merck v. Actavis.

We have seen in our previous post that the Cour d’appel de Paris, in its decision of January 30, 2015 (Merck Sharp & Dohme v. Actavis Group & Alfred E. Tiefenbacher) affirmed that posology features were admissible in further medical use claims.

Still, in view of the lack of novelty finding of the Court regarding claims 1 to 3 of European patent No. EP 0724444 (the ‘444 patent) filed on October 11, 1994 in the name of Merck & Co, the decision as a whole does not make it much easier for patentees to defend such claims in France.

As a reminder, claim 1 of the ‘444 patent read:

The use of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one [i.e. finasteride] for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

The Court based its decision regarding novelty on two documents.

The first document was European patent No. EP 0285382 (the ‘382 patent) filed on March 30, 1988 in the name of Merck & Co. Inc. According to the Court, the ‘382 patent discloses the use of finasteride for treating androgenic alopecia, as well as, in the case of benign prostatic hypertrophia, oral administration of finasteride and the administration of a dose of finasteride from 5 to 2000, preferably from 5 to 200 mg and in particular of 5, 10, 25 50, 100, 150, 250 and 500 mg. However, the ‘382 patent does not specify the dose claimed in the ‘444 patent.

The second document, the so-called “document S”, is an article by Elizabeth Stoner (one of the inventors of the ‘444 patent): The clinical development of a 5 alpha-reductase inhibitor, finasteride (1990), J. Steroid Biochem. Mol. Biol. 37:375-8. According to the Court this article discloses the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia, wherein the dose of the active principle finasteride may vary from 0.04 to 1 mg. It is important to note that the Court did not mention that alopecia treatment by finasteride at this dosage was disclosed in this document. A close reading of the article indeed confirms that it is not the case.

In view of these documents the Court considered that:

With this document S, all the teachings of the Merck patent [i.e. the ‘444 patent] are already disclosed while this patent does not additionally comprise a specific, different technical teaching, from that of the EP 0285382 prior art, so that claim 1 of the EP 0724444 patent is deprived of novelty.

Claim 2: The use as claimed in claim 1 wherein the dosage is 1.0 mg.

This claim thus also lacks novelty, since the S document discloses this dosage in combination with claim 1 which is devoid of any novel technical effect.

Claim 3. The use as claimed in claim 1 or 2 wherein the treatment is of male pattern baldness.

The document EP 0285382 also relates to male pattern baldness and destroys the novelty of this claim combined with the two other revoked claims.

There are worse things than androgenic alopecia, such as having your hair cut by this machine
There are worse things than androgenic alopecia, such as having your hair cut by this machine

What can we make of all this?

First, we believe that each of the two documents leads to an independent lack of novelty finding regarding claim 1 by the Court.

Thus, when considering document S, the Court apparently construed the term “useful for” of claim 1 as simply meaning “suitable for” (in the sense of the Guidelines for Examination in the EPO, section F-IV, 4.13). Accordingly, the simple fact that document S discloses a medicament which could be used in the treatment of alopecia with the dosage specified in claim 1 is considered novelty destroying by the Court, even if this potential use is not mentioned in the document.

In doing so, the Court did not apply decisions G 1/83, G 5/83 and G 6/83 of the Enlarged Board of Appeal (EBA) of the EPO which allowed Swiss-type claims (e.g. the use of compound X for the manufacture of a medicament for the treatment of disease Y) in the EPO’s practice. As a reminder, according to these decisions, it is justifiable to derive the novelty of the preparation of the medicament from a new therapeutic use of said medicament.

In other words, the Court did not consider that the Swiss-type claim 1 of the ‘444 patent could be considered as a further medical use claim. As the Court did not elaborate on its construction of claim 1 in view of document S, it can only be speculated that the Court would have decided differently if the claim had stuck to the phrasing of the Swiss-type claim devised by the EBA, i.e. the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

As then regards the lack of novelty finding based on the ‘382 patent, the decisive point in the ratio decidendi of the Court appears to be the lack of “different technical teaching” associated to the posology feature.

The Court derived this requirement from point 6.3. of the reasons in G 2/08:

Therefore, it is important to stress that, beyond the legal fiction of Article 54(5) EPC, for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regime, the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies.

In particular, the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching.

Furthermore, assuming for the sake of argument that the claimed modalities of the dosage regime would only consist in a mere selection within the teaching of a broader prior disclosure in the state of the art, then novelty could only be acknowledged if the criteria developed in the jurisprudence of the boards of appeal with respect to selection inventions would be fulfilled. One typical issue in such kinds of cases is whether the dosage regime defined in the claim has been shown to provide a particular technical effect as compared with what was known in the state of the art.

In the present case, the Court did not state whether it considered that the subject-matter of claim 1 ought to be treated as a selection invention, but nonetheless applied a high standard regarding this novelty requirement, by equating it with a requirement of a showing of a different technical effect over the prior art, which goes beyond what is usually required for a selection invention, or even for inventive step assessment, before the EPO.

Claim 1 of the Merck patent [i.e. the ‘444 patent] recites a dose from about 0.05 to 1.0 mg and this patent specifies, as mentioned above, that ‘it would be desirable to administer the lowest dosage possible of a pharmaceutical compound to a patient and still maintain therapeutic efficacy’.

However, this patent does not indicate that the retained dosages could yield a different result from that obtained with the different dosages specified by the prior patent. The assays reported in the text of the patent indicate that the dosage of 0.2 and 1 mg/day during 6 weeks is ‘useful for the treatment of alopecia’ but nothing indicates that the technical results are different from those yielded by the prior patent. It is not demonstrated that the claimed dosage has an effect on the efficacy or the outcome of the treatment.

It is neither demonstrated that the dosage claimed in the Merck patent leads to potential side effects different from those yielded by the dosages of the prior art.

In any case, regardless of whether the standard applied by the Court should be one of novelty or inventive step, it is likely that, in the present case, the report, by one of the cited experts, that the side effects of finasteride were similar for a dosage of 5 mg or 1 mg convinced the Court that the claimed invention did not deserve a patent.

Accordingly, while this decision establishes that posology features may well be admissible in further medical use claims in France, patentees should still expect a hard time defending them, especially when the claims are of the Swiss type.

Many thanks Lionel, and happy holidays to all – and this includes pharma innovators and generic drug manufacturers alike!


CASE REFERENCE: Cour d’appel de Paris, pole 5, 2ème chambre, January 30, 2015, Merck Sharp & Dohme Corp. v. Actavis Group EHF et al., RG No. 10/19659.

Getting the dosage right

Today I am very happy that this blog is hosting a guest post from Lionel Vial. I am sure Lionel would agree that he is a little bit of a “drug addict“. Yes, to avoid any misunderstanding, this is short for “pharma patent addict“.

So, here is what Lionel has to say about recent French case law developments regarding the patentability of dosage regimen inventions in our country.

The local position regarding the admissibility of posology features in further medical use claims has been the subject of a long lasting controversy which ended this year.

As our distinguished readers surely remember, on February 19, 2010 the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) decided that where it is already known to use a medicament to treat an illness, Article 54(5) of the European Patent Convention (EPC) does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness, in particular where a dosage regime is the only feature claimed which is not comprised in the state of the art (G 2/08)

A French judge though is not one to be impressed by a 44-page long decision from the EPO, and even the EBA, as is evidenced by the decision of the Paris Tribunal de Grande Instance (TGI) of September 28, 2010 (Actavis Group & Alfred E. Tiefenbacher v. Merck Sharp & Dohme).

This case notably dealt with an invalidity action brought against claims 1, 2 and 3 of European patent No.0724444 (the ‘444 patent) in the name of Merck & Co. filed on October 11, 1994 and granted on August 6, 1997, for an alleged lack of industrial application, lack of novelty and lack of inventive step.

Claim 1 of the ‘444 patent read:

The use of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

All specialists will have noted that being granted before the entry into force of Article 54(5) EPC 2000, the claim is under the so-called Swiss format. Besides, it recites a posology (i.e. dosage regime) feature, namely that the dosage amount is about 0.05 to 1.0 mg (underlined above).

At the priority date of the ‘444 patent, finasteride, the short name of 17β (N-tert-butylcarbamoy-l)-4-aza-5-alpha-androst-1-ene-3-one, was known to be an inhibitor of 5-alpha-reductase, the enzyme catalyzing the transformation of testosterone into the more potent androgen dihydrotestosterone (DHT). DHT is involved in several androgen-related disorders, such as mild-to-moderate benign prostatic hyperplasia and androgenic alopecia, i.e. baldness.

Finasteride was for instance known to be useful for treating alopecia through the reduction of DHT levels, as shown by European patent No.0285382 (the ‘382 patent) filed on March 30, 1988 in the name of Merck & Co. Inc.

The invention forming the subject-matter of the ‘444 patent was thus said to arise from the surprising and unexpected discovery that a low daily dosage of finasteride is particularly useful in the treatment of androgenic alopecia.

Forget about finasteride: proper hair styling is the real cure as instructed in the sequence of Fig.1-6
Forget about finasteride: proper hair styling is the real cure as instructed in the sequence of Fig.1-6

However, the TGI considered that a claim including such a posology feature in fact covered a method for treatment by therapy:

[As a consequence,] it is possible to patent a medicament with the view of treating a first disease and then a second but it is not possible to patent a posology adapted for treating these diseases as it would be an attempt at patenting a method of treatment by therapy, which is not allowed, as such a method is reserved to the field of care and depends from the sole liberty, and associated responsibility, of each physician.

Claim 1 of patent EP 0724444, of which the only novel feature over the prior art is the specified posology is thus excluded from patentability and must therefore be revoked in view of article 53c EPC 2000.

As for decision G 2/08, the TGI issued a concise appreciation thereof:

[Furthermore] Article 54(4) EPC which allows patenting a same medicament for a further therapeutic effect is completely silent on the allowability of patenting a particular posology. Accordingly, the answer of the Enlarged Board according to which “such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art” does not arise from the Convention but from an interpretation of what is a posology, i.e. a further medical use, which it is obviously not.

Apart from the slight errors in applying EPC 2000 rather than EPC 1973 and referring to Article 54(4) instead of 54(5) EPC, it can be retained that the first instance court essentially considered that establishing a posology is part of the exclusive practice of physicians and that it can therefore not be patented.

This decision was immediately applied by the French patent office (INPI), which included in its Guidelines for Examination a provision according to which a claim relating to a posology should be rejected.

An appeal was lodged against the decision of the TGI which led to a decision of the Cour d’appel de Paris of January 30, 2015.

Without addressing the merits of the arguments set forth by the Tribunal, the Court essentially followed the conclusion of decision G 2/08. This is what the Court of Appeal had to say:

It follows from the foregoing that if the patentability of a further medical use claim relying only on a posology feature may be allowed even for a patent depending from the EPC 1973 construed under the light of the later amendment of the convention and of the resulting case law, [the claim] must comply with the requirement of the existence of a different technical teaching, and for this reason it is necessary, as is stated by Merck, to also take into account the features relating to the dosage. [emphasis added]

The situation has thus been clarified in France regarding the admissibility of posology features in further medical use claims: such features are allowed – at least for European patents, that is. Indeed, the situation remains unclear regarding French patents, as the decision only addresses the EPC and because, to date, the INPI has not changed its Guidelines for Examination.

Still, the Court confirmed the first instance judgement by revoking claims 1 to 3. This time the revocation was pronounced on the ground of lack of novelty. The Court considered that the ‘444 patent did not comprise a different technical teaching from that of the ‘382 patent, even though the latter does not disclose the dosage amount claimed by the ‘444 patent. This is what we will look at in a next post.

Many thanks Lionel for this report, and looking forward to the second part of the story – especially because baldness is a serious thing indeed, not to be joked about as I very well know!


CASE REFERENCE: Cour d’appel de Paris, pole 5, 2ème chambre, January 30, 2015, Merck Sharp & Dohme Corp. v. Actavis Group EHF et al., RG No. 10/19659.

Longitudinal vs. roughly longitudinal: same difference?

The third and last one of the series of posts on how French courts seem to have gotten stricter on extension of subject-matter is dedicated to a dispute between two French truck manufacturers, Chéreau and Frappa. The former sued the latter for infringement of two European patents concerning buffers mounted at the rear end of the vehicle chassis.

Once again, both patents (one of which had gone through and survived opposition proceedings at the EPO) were revoked by the Paris TGI for extension of subject-matter.

Of these two revocations, one was based on a relatively typical reasoning of intermediate generalization: some features were taken from the description and imported into claim 1, and the court decided that it was not allowable to isolate these features from the others with which it was originally disclosed in combination.

The other revocation is more remarkable. The file wrapper of the patent can be found here. Claim 1 as filed related to a vehicle chassis comprising, inter alia, a thrust element. Claim 2 as filed specified that the thrust element was a thrust arm with roughly longitudinal mobility relative to the chassis. In claim 1 as granted, the thrust element was restricted to a thrust arm with longitudinal mobility relative to the chassis. In case you have not noticed, the term “roughly” disappeared in the process, and this turned out to bring about the demise of the patent.

At first sight, the amendment may look like pretty innocuous. In fact, examiners often protest against the presence of vague adverbs such as “roughly”, “approximately” and the like in patent claims, and they regularly request that the applicant should get rid of them before grant. This is hardly ever seen as an issue at all from the added matter standpoint.

So, in the present case, if there was support in the original disclosure for “roughly” longitudinal mobility, why wasn’t there any support for longitudinal mobility as such? In order to understand this, one needs to have a closer look at the application as filed, which contained only one detailed embodiment of the displacement of the thrust arm.

According to this embodiment, the thrust arm rotates around an axis by a few degrees, and this is said to be tantamount to a longitudinal displacement. This comment is quite understandable because, if you zoom in on a portion of a circle, it looks pretty much like a straight line (if my math memories are correct, this is what they call a first order approximation).

In the light of the description, the term “roughly longitudinal” in original claim 2 was therefore interpreted by the court as actually referring to a pivotal movement. By deleting the adverb “roughly”, this was changed to a truly longitudinal movement, but such change was not properly supported by the application as filed.

Quoting from the judgment:

“By omitting the adverb ‘roughly’, Chéreau can argue that claim 1 covers any longitudinal displacement and no longer only a rotation displacement of the thrust arms.

Departing from the roughly longitudinal displacement corresponding to a rotation of a few degrees mentioned in the description, claim 1 covers the longitudinal mobility of the thrust arms by the deletion of the adverb ‘roughly’”.

So, paradoxically, by specifying that the displacement is longitudinal and not just “roughly longitudinal“, the applicant had shifted the scope of protection to claim an aliud. The innocuous-looking amendment was therefore not so innocuous after all.

An example of a pivotal arm having a roughly longitudinal displacement.
An example of a pivotal arm having a roughly longitudinal displacement.

Now, having reporting on this third recent example of added matter ruling, I would certainly be interested in knowing what readers think about this general approach which to me is very reminiscent of EPO practice. Is such harmonization to be welcome? Or are French judges being more Catholic than the pope?


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 4ème section, SAS Jean Chéreau v. SAS Frappa, November 6, 2014, RG No. 12/10879.

Art.123(2) EPC – what else?

As a second installment in the story of how French courts seem to have gotten tougher on extension of subject-matter, I would like to say a few words on our local share of the much commented upon Nespresso IP saga (see e.g. here).

Of the two European patents of the same family that the patentee Nestec and its licensee Nespresso France asserted against several defendants, one (let’s call it the divisional patent) was revoked by a Board of appeal of the EPO, for… well, extension of subject-matter. The other one, namely the parent patent (EP 1646305), went unopposed. But the patent proprietor filed a request for national limitation at the French patent office – in parallel to the ongoing infringement suit. It is therefore the patent as limited in France that was held invalid by the court.

Claims 1 to 9 of the patent as limited are directed to a device for the extraction of a capsule provided with a collar. Claim 10 is directed to the device of claim 6 and a capsule in combination, and it further specifies that the capsule is frustoconical and is asymmetric with respect to the plane of the collar.

The court found that the subject-matter of the EP’305 patent as limited unallowably extends beyond the contents of the application as filed for three different reasons.

How coffee was made before Mr. Clooney
How coffee was made before Mr. Clooney got involved

The first one is the feature of the capsule being provided with a collar. The application as filed does disclose a coffee capsule provided with a collar but, said the court, only specific capsules of this kind, namely those described in a prior art document EP 0512148, as opposed to any capsule with a collar. The capsules disclosed in EP’148 are asymmetric, frustoconical, and the collar is situated on the larger end of the cone.

If it is true that the capsules in question are not directly described in this application, it remains that the reference that it contains to the ‘148 patent must be taken into account so as to understand which capsules are meant.

As the defendants rightly point out, this ‘148 patent discloses capsules, made of a soft material, of a frustoconical […] shape, with the collar present on the larger end of the frustum.

Now, the patent as limited does not reproduce these specifications in its claim 1, since it simply describes a capsule with a collar, without mentioning its shape nor the position of this collar.

It is true that, as noted by Nespresso, claim 10 expressly recites that the capsule comprises a collar and an extraction face, and that it is frustoconical. However, this claim does absolutely not mention the position of the collar, and there is no indication that it is located on the larger end of the frustum, whereas it can also be located elsewhere, for instance on the smaller end or also in the middle of the capsule. This omission, which causes the patent as limited to protect a collar which is less specific than the one deriving from the reference made in the patent as filed to the ‘148 patent, is such that it has a scope of protection which is more extended than the initial protection.

This is an extension beyond the application, which as a consequence invalidates claims 1 and 10 of the patent in suit.

Although the expression is not used here, this is a finding of intermediate generalization: during examination proceedings and post-grant limitation, the patentee isolated some features relating to the capsule that is to be used with the device of the invention, without taking the full picture of said capsule. But what is more original here is that the omitted features were not expressly recited in the application as filed. In fact, this is an intermediate generalization relative to the contents of a prior art document cited in the application – in other words a prior art document which the court has considered as being incorporated by reference in the application.

I will skip the second reason for invalidating the patent, which is probably less interesting in the context of this post, and instead I will then turn to the third reason.

As mentioned above, claim 10 relates to a device for the extraction of a capsule plus the capsule itself, in combination. So, this looks like a kit claim. The original set of claims did not contain any such kit claim, but only device claims. The defendants argued that the addition of the kit claim conferred an undue advantage to the patentee and offended legal certainty for third parties, while the patentee’s case was that the application as filed contained a detailed description of how the device interacts with the capsule, so that third parties reading this application should have expected that a kit claim could be later added. Again, the court sided with the defendants:

However, when carefully reading the application as originally filed, it is obvious that this was then only a device patent, describing and protecting “a device for extracting a capsule, as well as the machine comprising this device”, wherein the capsule appeared only in a minimal way, so as to state how it was arranged and how it was extracted, but it was never, as mentioned above, really described for what it was, the only details that were provided being that the capsule was “asymmetric with respect to its collar” and that it could be “of any type”.

[…]

Thus, this is again obviously an extension beyond the application purporting to protect capsules which were not protected before, and the fact that the interaction between the device and the capsules was described did not have the effect at that time to protect these capsules as much as they have been since the grant and even more so since the limitation.

As rightly put by the defendants, this extension cannot be portrayed as insignificant, since it is precisely what makes it possible for the plaintiffs to sue them for infringement today, blaming them for marketing such capsules.

This is an interesting situation because, to some extent, it could be argued that the notion of “combination” between a device and a capsule did not add any new technical information relative to a thorough description of how the device interacts with the capsule. Nevertheless, the court found that the combination claim dramatically altered the subject-matter of the patent, and its potential use against third parties, by making the capsules themselves part of the invention.

In its “limiting feature” decision G1/93, the Enlarged Board of Appeal of the EPO held that:

With regard to Article 123(2) EPC, the underlying idea is clearly that an applicant shall not be allowed to improve his position by adding subject-matter not disclosed in the application as filed, which would give him an unwarranted advantage and could be damaging to the legal security of third parties relying on the content of the original application.

It seems that the TGI took the same view that legal security of third parties is a paramount concern when examining compliance of a patent with Article 123(2) EPC. As bitter as that coffee may be for some, going back to the raison d’être of this rule (which is undoubtedly one of the cornerstones of the European patent system) before applying it to the facts of the case does make a lot of sense.


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 2ème section, Nestec et al. v. Cafés Folliet et al., October 3, 2014, RG No. 10/10179.

Gumming up a patent

Based on a number of judgments issued in France over the last couple of years, it seems that there has been a new trend towards the invalidation of patents due to extension of subject-matter. I have a feeling that, not so long ago, this used to be a ground of revocation that no one really took seriously outside of the EPO. And especially so in France, where there has been a long standing tradition of judges looking more closely at the description of a patent than at its claims, and coming up with their own definition of what the invention really is about, notwithstanding the exact wording used in the claims.

But as a famous singer once said, the times they are a-changin’, which brings us to the invalidation proceedings initiated by Normandy-based company Nexira against the British and Japanese owners of European patent EP 1611159. The patent relates to a modified gum arabic from Acacia senegal (that’s the scientific name of the tree from which the gum is collected). This gum can notably be used as an emulsifier in food products.

The main claim of the patent reads as follows:

A water-soluble modified gum arabic from Acacia senegal, having a weight average molecular weight of not less than 0.9 million Da or an arabinogalactan protein content of not less than 17 weight %, and an RMS-radius of gyration of 42.3 to 138 nm, obtainable by heating unmodified gum arabic at 110°C for not less than 15 hours, wherein the weight average molecular weight, arabinogalactan protein content, and RMS-radius of gyration are obtained by processing the data obtained by subjecting the modified gum arabic to a GPC-MALLS using software ASTRA version 4.5 and wherein said data for the whole peaks in the chromatogram obtained using an RI detector are processed as two peaks, the two peaks being divided into the eluted fraction of high molecular weight components containing the arabinogalactan protein of the gum arabic which eluted first and the eluted fraction of low molecular weight components which eluted at a later time, wherein the arabinogalactan protein content corresponds to the obtained recovery ratio of the peak of the eluted fraction of high molecular weight components which eluted first.

The crux of the discussion was the feature of the radius of gyration. The range of 42.3 to 138 nm was not disclosed per se in the application as filed; but the end values of the range were disclosed in the context of two respective examples.

The judgment does not explicitly refer to the case law of the Boards of appeal of the EPO. But there can be little doubt that the court relied on it, since they called this situation a case of “intermediate generalization”, which is typical EPO parlance. What is more, the standard put forward by the court for determining whether the intermediate generalization is admissible or not closely matches the test routinely applied in Munich. Said the court:

It is possible to generalize a range of values from an example, but such intermediate generalization is only admissible under Art. 123(2) EPC if the skilled person can deduce without any doubt from the application as filed that these features are not closely linked to other features of the embodiment, but that they directly and unambiguously apply to the more general context.

In order for this intermediate generalization to be admissible, it must result from the non-ambiguous information that the skilled person would derive by reading the example and the content of the application as filed.

Taking into account the whole content of the application, determining whether features isolated from the examples are closely tied to other features or not, and using direct and unambiguous derivability as a threshold: all European patent attorneys are familiar with these principles, as they are cornerstones of the assessment of extension of subject-matter by the Boards of appeal.

In the Nexira case, the outcome of the Court’s appraisal was negative:

In the present case, the skilled person could not deduce, without any doubt, when reading the international application, that these features, taken from two embodiment examples based on gum arabic having particular dimensions and composition, are not closely linked to other features of these embodiment examples, and directly and unambiguously apply to the more general context.

As a result, the addition of this range of radius of gyration RMS in claim 1 of the EP’159 patent whereas it was not in claim 1 of the international application, shows an extension of its subject-matter beyond the initial application.

How do you write "gum" in Arabic?
How do you write “gum” in Arabic?

Strictly speaking, it would have been interesting to get more detailed explanations in the decision as to why the radius of gyration in the examples should be viewed as being specific to the samples in question. One can also wonder about the relationship between the range of the radius of gyration and the other parameters recited in the main claim, such as the molecular weight, the protein content and the product-by-process features.

The question of who primarily has the burden of proof in this respect (the plaintiff or the defendant-patent proprietor) is also an interesting one which is not clearly addressed in the judgment –  as there was probably no reason for addressing it.

Anyway, the outcome of the case should not come as a real surprise: it is a risky gamble indeed to take values from an example section of a patent application and insert them into a claim. If the patent at stake had been subjected to opposition proceedings, chances are it would probably have faced a hard Art. 100(c) EPC challenge. The patent proprietors were lucky enough not to be faced with an opposition; but not lucky enough to get their patent tried by a court insensitive to EPO traditional case law.

This situation stands in sharp contrast with other French cases previously discussed here and here, where major deviations from EPO case law were observed, in connection with the issue of patent eligibility.


CASE REFERENCE: Tribunal de Grande Instance de Paris, 3ème chambre, 4ème section, Nexira v. San-Ei Gen FFI Inc. et al., May 28, 2015, RG No. 12/11963.