Fungicides Ltd.

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

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

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

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

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

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

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

The court stated as follows:

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

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

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

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

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

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

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

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

[…]

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

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

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

On March 17, 2015, this petition was dismissed.

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

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

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

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

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

so that

the claimed combination was disclosed by the initial description. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

Nice models required

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

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

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

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

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

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

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

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

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

Formula

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

also considered that:

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

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

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

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

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

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

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


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

You only die twice

Some readers may have a sense of déjà vu when reading today’s post, as I am going to talk once again about the finasteride saga.

In Lionel Vial’s first post and second post on the topic, it was explained how the Cour d’appel de Paris confirmed the revocation of the French part of Merck’s patent No. EP 0724444 (EP’444) for lack of novelty. The case was remarkable in that the court endorsed the principles set out by the Enlarged Board of Appeal in G 2/08: they held that second medical use claims containing a dosage regimen feature are not excluded from patentability and that novelty can be conferred by the dosage regimen feature. Yet, the court also held that, in this case, the claimed invention was in fact not novel over the prior art. This ruling was the result of a revocation claim brought by Actavis.

But there was another case in parallel to this one, with a revocation claim brought by Teva. This led to another ruling on the same date, where the same panel of the Cour d’appel confirmed again that the French part of EP’444 was invalid – but on a different ground, namely insufficiency of disclosure. So, I should probably say a word on this one as well, not only because Teva was represented by my former colleagues of August & Debouzy, but also because the court’s reasoning is in my view as interesting as in the Actavis case.

Readers may remember that the main claim of EP’444 was the following:

The use of 17β-(N-tert-butylcarbamoyl)-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.

Here are now Merck’s explanations regarding the nature of their invention, in the court’s own words:

They state that the technical problem to be solved was to identify a compound the mode of administration of which would offer the best guarantee in terms of safety (low dosage) and efficiency, so as to provide an improved treatment of androgenic alopecia. They explain that they have very surprisingly discovered that the oral administration of low daily doses of the finasteride compound, from 0.05 mg to 1.0 mg, was particularly effective for treating this condition.

The court examined whether the description of the patent was sufficiently clear and complete to enable the skilled person to carry out this invention. In this respect, they relied on the following standard:

Regarding an invention relating to a further treatment, even if, as rightly put by the appellant, it is not necessary to demonstrate clinically the therapeutic effect, nevertheless the pharmaceutical effect demonstrated in the application must directly and unambiguously reflect the claimed therapeutic applications, so that the skilled person understands based on commonly accepted models that the results reflect these therapeutic applications.

[…]

The inventor must indicate that the result was investigated and exists, by any experimental or non-experimental information, which establishes and makes explicit the claimed pharmaceutical effect, as from the filing date. 

In other terms, second medical use inventions are subjected to a somewhat stricter sufficiency test that other inventions. The basic test for most inventions is whether it is possible to make the claimed product or implement the claimed use without undue burden. The stricter test applied here demands in addition that evidence of the pharmaceutical effect be present in the application itself. Data form clinical tests is not required, as those are usually conducted quite late in the drug development process. But some kind of research must at least have been conducted and some results obtained, that the skilled person can interpret as reflecting the claimed therapeutic use.

This seems like a sound approach in order to curb speculative patents, or “paper” patents, which could be used as an evergreening weapon, so as to preempt mere ideas or working hypotheses and block all future R&D efforts.

To some extent, I think the Boards of appeal of the EPO have adopted a similar principle, notably in T 609/02. An entire section of the patent attorney bible Case Law of the Boards of Appeal of the European Patent Office, 7th edition, September 2013 (II.C.6.2) is precisely dedicated to the particular “level of disclosure” which is required for medical use claims.

This is not to say that the principle is applied with the same strictness in Munich as in Paris. Practically speaking, the heightened sufficiency test mainly seems to be used by the Boards to strike out claims seeking to cover excessively large classes of compounds for certain uses, notably classes of compounds defined according to their purported function or use (also known as reach-through claims), as well as medical use claims wherein there is no demonstration of a direct link between the claimed compound(s) and the medical treatment at stake; but patents such as the present one, directed to a new dosage in an already known medical use of a given compound, are probably much more immune to an insufficiency challenge at the EPO.

Anyway, the Cour d’appel was clearly dissatisfied with the contents of the EP’444 patent:

[…] The description does not indicate what is the advantage or the technical effect resulting from this type of oral adminsitration. It does not contain any element showing the potential efficacy of the lower finasteride dosage, so that this mode of administration has no relevance for the skilled person.

The purpose of the invention according to the description is to reduce the amount of administered finasteride relative to the acceptable dosage already known from the prior art for an indication already disclosed, but the description does not comprise any information on the novel effect of the claimed posology and the particular properties of this new therapeutic application. […]

Moreover, no relevant and convincing result is provided in order to justify the claimed and yet undescribed pharmaceutical effect. 

The court turned in particular to the example section in the EP’444 patent and held that none of the examples was relevant to the claimed therapeutic use.

I had a look at this example section myself, and it seems that the court made a good point here. Examples 1 and 2 relate to methods for making finasteride. They are thus irrelevant to the claimed therapeutic use. Example 3 discloses protocols for the preparation and dosage of 5α-reductase – but no results.

Example 4 describes a protocol for measuring haircount in subjects. Its conclusion is rather vague, though: “Using the above-described methodology, it can be shown that administration of finasteride, in dosages per day per patient of, for example, 1 mg/day or 0.2 mg/day, are useful in the treatment of androgenic alopecia, and promote hair growth in patients with this condition“. This is still largely unspecific in terms of technical effect(s) achieved and has the air of a prophetic example.

Finally, example 5 is sufficiently short to be reproduced here in its entirety: “In another test, finasteride was orally administered for 6 weeks to men with male pattern baldness at doses of 0.2 mg/day and 1.0 mg/day (and, for comparison, 5.0 mgs/day). The results of this test showed a significant reduction in DHT content in scalp tissue of the test participants“. Again, this is largely unspecific in terms of the improvement in the treatment of patients that can be achieved using to the claimed dosage of 0.05 to 1 mg finasteride.

As a line of defense, Merck provided external evidence such as an expert opinion and results from a study conducted in 1993 – the same year the priority application was filed. The court paid little attention to this external evidence and simply stated that it is of no relevance.

This is of course a crucial point. How much you allow a patent proprietor to rely on post-published evidence of a technical effect can make a world of a difference in terms of validity in the pharma and biotech field.

The court’s final conclusion was worded as follows:

[…] The skilled person is unable to reproduce the invention, since he is kept unaware of any specific technical teaching, and he must therefore perform a research program on his own. 

Another finasteride post means another hair picture - this time Picasso-style.
Another finasteride post means another hair picture – this time Picasso-style.

As to the obvious question, why rely on different invalidation grounds in the two parallel nullity suits for knocking the same patent out, I assume that the answer is that courts in this country are very strictly bound by the submissions of the parties, and the plaintiff’s submissions were probably different in the respective cases.

Anyway this striking example of overkill does tell us something about our judges’ approach to what they may perceive as “weak” patents. Sometimes we get the impression that once a court is convinced that the invention at stake does not bring a contribution to the art which is specific and significant enough – and is therefore unworthy of patent monopoly – the ground on which they decide to invalidate the patent is not that important.

So, in this case, lack of novelty was as good as insufficiency of disclosure, given the absence of a “specific technical teaching” (as stated in the Teva judgment) or of a “different technical teaching” (as stated in the Actavis judgment). I am pretty sure that if there had been yet a third parallel case, the patent could also have been invalidated for lack of inventive step in view of the same findings.

As a last word on this finasteride saga (until a report on a potential cassation appeal?), the court noted in the decision that the EP’444 was found valid in the UK, Germany, Italy and the Netherlands. Oops! So much for pan-European consistency.

On the other hand, based on the slim contents of EP’444, I have sympathy for the position of our local judges. Merck’s invention may have been a real and valuable one – this is very possible. But one cannot really tell so based on the patent itself.


CASE REFERENCE: Cour d’appel de Paris, Pole 5, 2ème chambre, January 30, 2015, Merck Sharp & Dohme Corp. v. Teva Santé et al., RG No. 10/23603.

A makeshift win

I am happy to introduce another contribution by Lionel Vial to this blog, for a new update on the war waged by French courts on second medical use claims. Today, Lionel tells us about one such claim which bravely survived a first instance judgment, only to be later butchered on the appeal battlefield:

It is often tempting to rule out of hand seemingly makeshift arguments but the decision we discuss today is a reminder of why it is always a bad idea to do so. It is also yet another reminder that it is not easy to be Swiss in France nowadays.

The decision in question was rendered by the Cour d’appel de Paris on November 3, 2015 (Ethypharm SA v. Alkermes Pharma Ireland Ltd.). It notably dealt with the appeal of Ethypharm against the decision of the Tribunal de Grande Instance (TGI) de Paris of December 21, 2012 to uphold claim 9 of European patent EP 0644755 (the ‘755 patent), which Ethypharm was found to infringe.

The ‘755 patent was filed on June 1, 1993 and was granted on March 19, 1997, i.e. well before the entry into force of EPC 2000. Accordingly, claim 9 is under the form of a so-called Swiss-type claim (i.e.use of a substance or composition X for the manufacture of a medicament for therapeutic application Y”). It reads as follows:

The use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

It can be seen that the scope of the claim is rather extensive as it basically covers any process of manufacture of a medicament with particles of a drug substance (different from naproxen or indomethacin) having an average size of less than 400 nm, thanks to the use of a surface modifier which adsorbs onto the drug substance, for increasing the speed with which the substance will exert its activity upon administration.

While all the arguments set forth against the validity of the claim had failed in the first instance, in the course of the second instance Ethypharm found a new motive to be opposed to the validity of claim 9, namely that the claim would cover a method of treatment of the human or animal body and that it would be therefore excluded from patentability.

According to Ethypharm, this would be because claim 9 does not relate to a specified substance or composition but relates to all existing active substances without specifying their therapeutic use, since it covers the use of nanoparticles of any medicament for treating any disease, any patient, by any administration route and with any dosage.

The patentee, Alkermes, made the mistake of not offering any counter argumentation.

In this regard the Court first notes, somehow ironically, that Alkermes apparently intended to respond to the argument, in view of the following statement in their written submissions:

To conclude, we will say a word on the argument of “revocation of claim 9 because it relates to a method of treatment” a last resort makeshift which replaced the equally exotic argument of “nullity of the further medical use claim”.

However, nothing of the sort could be found by the Court in the rest of these written submissions.

This proved to be fatal in the present case, because the argument surfed on the French courts’ supercilious approach to claims liable to cover methods of treatment (see our previous posts here and there) and was thus found to be persuasive by the Court:

[…] In application of that text [i.e. EPC 1973] a European patent can be granted for any further medical use of a known substance or composition, provided the claim is drafted under the so-called “Swiss-type” form, of the use of a product for obtaining a medicament used in a novel therapeutic application;

[…] It is thus necessary that a determined specific substance has a new therapeutic use which is distinct from the state of the art, since a simple claim to a method relating to a therapeutic treatment is not patentable;

[…] In the present case claim 9 of the patent at stake relates to any drug substance, with the only exceptions of naproxen and indomethacin, already taught in the state of the art, with the sole aim of hastening the onset of its action upon its administration to a mammal;

[…] When reading the claim, it appears that it relates to no known determined substance or composition with the view of obtaining a medicament for a novel and determined therapeutic use;

[…] Indeed the claimed hastening of the onset of the action of the medicament is only a mode of action of a medicament, which is by the way undefined, and cannot be considered as a therapeutic use of this medicament;

[…] Accordingly claim 9 only teaches a hastened mode of therapeutic treatment applying to any drug substance (naproxen and indomethacin being excluded) for treating any disease and applying to any patient, whatever the mode of administration of the drug and its dosage;

[…] As a consequence the claim will be revoked […].

The Court thus considered that although it was in the form of a Swiss-type claim, the fact that neither (i) the drug substance nor (ii) the therapeutic use were specified meant that claim 9 was to be considered as covering a method of treatment.

However, with this reasoning it appears that the Court merely assimilates Swiss-type claims to further medical use claims according to Article 54(5) EPC 2000, thereby casting aside the literal sense of Swiss-type claims, which is to cover a process for the manufacture of a medicament. As a reminder, in decision G 5/83, the Enlarged Board of Appeal of the EPO ruled that it is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient.

Should Swiss army knives also be considered as excluded from patentability?
Should Swiss army knives also be considered as excluded from patentability?

Accordingly, the sanction for a Swiss-type claim which is found not to benefit from the special approach of novelty defined in decision G 5/83, for instance because the claim does not relate to a specified therapeutic application, should rather be to consider that the intended therapeutic use is not limiting. This approach is notably illustrated by decision T 1758/07 (see paragraph 3.4.3).

Applied to the present case, the finding of the Court according to which the hastening of the onset of the action of the medicament cannot be considered as a therapeutic use could thus have led to reformulating claim 9 as the use of particles consisting essentially of a drug substance having a surface modifier adsorbed on the surface thereon in an amount sufficient to maintain an average particle size of less than 400 nm or a pharmaceutical composition thereof for the preparation of a medicament suitable for hastening the onset of action after administration to a mammal, with the proviso that the drug substance is other than naproxen or indomethacin.

Incidentally, this would also have had the valuable advantage of doing without the rather confusing notion that a claim found not to relate to a therapeutic use could be considered at the same time to cover a method of treatment.

Thank you Lionel for this report. As already mentioned in last week’s post, the TGI and the Cour d’appel are quite strictly bound by the (written) submissions of the parties. So, not every surprising ruling can be blamed on the courts themselves.

As a postscript I would also like to bring the first instance decision to readers’ attention.

One issue that was discussed in this decision was the admissibility of the disclaimerwith the proviso that the drug substance is other than naproxen or indomethacin” in claim 9. This “undisclosed disclaimer” was introduced to distinguish the claimed invention from a prior art under Art.54(3) EPC. The TGI applied the test set out in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal (without quoting those) and held that the disclaimer passed the test and was allowable. This issue is not addressed again in the appeal ruling since the claim was found invalid on another ground.

I thought that some readers irritated by the marked deviation of French case law from EPO case law on the topic of patent eligibility might find solace in this remarkable illustration of consistency.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, November 3, 2015, Ethypharm SA v. Alkermes Pharma Ireland Ltd., RG No. 2012/23743.

The undetected fall

Today’s patent is directed to a method for detecting a person’s fall. Such a method has utility in for instance taking care of elderly people. However, in this case, I am afraid that at least one fall went undetected, namely the court’s own fall into the trap of so-called “patent substitution”.

Taking one step back, the case was brought by a certain Laurent M. against his employer Telecom Design. As a side note, it is the INPI’s (French patent office’s) practice to redact people’s names in the court rulings that they publish. Although the need to protect privacy is understandable, this sometimes makes decisions more difficult to read. Besides, oftentimes, these people’s names are available on the public record anyway. For instance, Laurent M. is a designated inventor in a patent identified in the decision, and it is somewhat difficult to miss his full name on the patent’s front page.

Anyway, Laurent M. was hired in February 2008 by Telecom Design. Info Network Systems (INS), Telecom Design’s mother company, filed a French patent application directed to a method for detecting a person’s fall on January 12, 2009. One year later, the same company filed a European patent application claiming the priority of the French patent application. Laurent M. was designated as an inventor on both applications, together with two managers of the company.

Laurent M filed suit against Telecom Design and INS in front of the Paris Tribunal de grande instance (TGI), claiming that he was the sole inventor of this invention, and that he had made the invention before joining Telecom Design. Thus, he claimed, the French IP belonged to him.

Laurent M. won in first instance, since the court acknowledged that he was the sole inventor, and ordered the transfer of the French IP to him. Telecom Design and INS appealed. During the appeal proceedings, Laurent M. requested that the European patent (which had been granted in the meantime) should also be transferred to him.

It is in order to address this additional request by the plaintiff that the Cour d’appel had to deal with the notion of “patent substitution”, which is a principle laid down in Article L. 614-13 of the Code de la propriété intellectuelle:

Insofar as a French patent covers an invention for which a European patent was granted to a same inventor or his successor in title with the same filing date or priority date, the French patent ceases to be in force either at the date at which the time limit for filing an opposition to the European patent expires without any opposition being filed, or at the date at which the opposition proceedings are closed, the European patent being maintained.

However, if the French patent is granted at a later date than either one or the other mentioned in the previous paragraph, as the case may be, this patent does not come into force. [….]

In other terms, in order to avoid a form of double protection on the French territory, a European patent is said to substitute for a French patent, when both patents have three elements in common:

  • Same inventor(s).
  • Same filing or priority date.
  • Same invention.

The court applied this test to the Telecom Design invention and concluded that the European patent had substituted for the French patent, so that the French patent had ceased to be in force on July 19, 2012 (i.e. at the end of the EPO opposition period).

However, this finding is problematic for at least two reasons.

The first reason is that, believe it or not, there was no French patent at all. Looking at the INPI file wrapper, the application never proceeded to grant. The application was declared lapsed on September 30, 2013 for failure to pay the fifth renewal fee. It seems that a request for restoration of rights was submitted and rejected by the INPI – but it is not possible to get more detailed information online.

Article L. 614-13 is quite clear in that substitution can only apply to a granted national patent and not to a national patent application. This makes sense since the claims are not necessarily in a final form until the patent is effectively granted (although in France the opportunities for an applicant to amend claims are more restricted than at the EPO).

I am not sure that the court is to blame for what seems like a serious mistake. Indeed, French courts are strictly bound by the submissions of the parties, and we do not know in this case whether either party submitted that the French patent application had not proceeded to grant, and drew the proper legal consequences from this fact.

The second reason why the court’s finding is in my opinion problematic is that they applied the above “substitution test” differently from traditional case law.

According to said traditional case law, substitution takes place only to the extent that the scope of protection afforded by both patents is identical. So, if the French patent has a broader scope of protection than the European patent, which is actually very frequent, then the French patent partly survives, with respect to the subject-matter not covered by the European patent. This view is supported by the wording “insofar as a French patent covers an invention for which a European patent was granted […]” in Article L.614-13.

In Telecom Design, the Cour d’appel seems to have changed its tune.

The priority French patent application contains thirteen claims in total: twelve to a method for detecting a fall, and one to a device for detecting a fall. The European patent contains ten claims: nine method claims, and one device claim.

The court first noted that both descriptions are identical. Then, the court compared the two set of claims and found that

[…] claim 1 of the European patent is the contraction of claims 1 to 4 of the French patent [sic].

In fact, the features recited in claim 1 of the European patent are those of claims 1, 2 and 4 of the French patent application, but not claim 3. The features of French claim 3 were left out in European claim 1 as granted. But the court ignored this and considered that the limitations of French claim 3 are nevertheless implicitly present in European claim 1:

[…] it is true that claim 3 of the French patent [sic] […] is not expressly contained in claim 1 of the European patent, but nevertheless it is implicitly included in its scope due to the interpretation of this claim which must be made by reference to paragraph [0062] of the description, which expressly mentions it. It is reminded that according to Article 84 [EPC], claims define the protected subject-matter and must be supported by the description.

This is a bold statement. INS clearly voluntarily drafted a main European claim without the features of French claim 3. Stating that these features are implicitly contained in the main European claim in spite is a daring and non-obvious conclusion which would require at least some detailed explanations as to why the description makes it so clear that the missing features are implicitly present.

A fall can never be fully prevented, but at least it can be made more enjoyable.
A fall can never be fully prevented, but at least it can be made more enjoyable.

More importantly, it is plain to see that the scope of protection afforded by the European patent is (much) more restricted than the scope of protection of the French patent application. It is thus strange that the court finally held that

[…] the French patent [sic] and the European patent relate to exactly the same invention […].

For the sake of completeness, the device claims were also different, one limitation present in the French claim having been removed in the European claim. Again, the appeal judges took a shortcut and stated that

[…] although [claim 10 in the European patent] does not expressly contain the reference to the notion of battery life of the detection device in claim 13 of the French patent [sic], said reference is also implicitly included in its scope by the interpretation that needs to be made in view of paragraphs [0096] to [0099] of the description which expressly mention it.

Is this an isolated decision, or does it mean that the identity of invention (for the purpose of patent substitution) should now be appraised globally – basically checking only if the respective descriptions are the same? Maybe the Cour de cassation will shed some light on this, if a cassation appeal has been filed – which I do not know.

By the way, for those readers who are interested in the final outcome for Mr. M. and his employer, Mr. M. was indeed confirmed by the Cour d’appel as the sole inventor of the invention at stake. But the court decided that the invention was made in the course of Mr. M.’s inventive mission with his employer. So, the first instance decision was reversed and the court did not order the transfer of either of the French application or the European patent from INS to him. He was however awarded an amount of 50,000 euros as a retribution for his invention, and 20,000 euros of damages in relation to moral prejudice.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, 1ère chambre, June 30, 2015, Telecom Design SA & Info Network Systems SA v. Laurent M., RG No. 2013/10097.