Hidden in plain sight

Sometimes, an object is best hidden in plain sight. Like the diamond in the crystal chandelier of Alfred Hitchcock’s classic motion picture Family Plot.

The same can be true of Easter eggs, which many readers may have hunted over the weekend – successfully, I hope.

And the same can be true of a teaching in a prior art document, based on a recent decision which left a number of us wondering whether Board of Appeal 3.3.10 may have discarded or at least amended a long-standing novelty test endorsed by the Enlarged Board of Appeal.

A well hidden technical disclosure in an Easter egg
A well hidden technical disclosure in an Easter egg

Lionel Vial reports on that case.

The decision we will discuss today relates to the difficult question of knowing under which conditions the chemical composition of a product is made available to the public.

Decision T 719/12 was rendered on October 29, 2015 on an appeal formed by the proprietor (appellant) of European patent No. 1539673 against the decision of the opposition division to revoke the patent. The decision of the opposition division was based on the lack of novelty of the subject-matter of claims 9 and 10 in view of the disclosure of document (1) (Blicke et al. (1942) J. Am. Chem. Soc. 64:451 to 454).

Claims 9 and 10 respectively claimed the compounds of formulae II and VI:

F2

wherein R1 can be a thienyl (i.e. the cycle shown in formula VI), R2 can be a C1-8 alkyl (i.e. a -CnH2n+1 group where 1 ≤ n ≤ 8) and R4 is methyl (-CH3), ethyl (-CH2CH3), isobutyl (-CH2CH(CH3)2) or tert-butyl (-C(CH3)3).

Document (1) identified the compound methyl-2-(α-thenoyl)-ethylamine by its chemical name. For those not versed in the chemical arts, here is what it looks like:

methyl-2-(α-thenoyl)-ethylamine
methyl-2-(α-thenoyl)-ethylamine

It can readily be seen that this compound falls within formulae II and VI of the opposed patent.

Indeed, this fact was contested by neither of the parties as is noted by the Board in point 2 of the reasons for the decision and the question was rather whether methyl-2-(α-thenoyl)-ethylamine had been made available to the public.

There the Board recalled that:

It is the established jurisprudence of the Boards of Appeal that the subject-matter described in a document can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Article 54(1) EPC, if the information given therein is sufficient to enable the skilled person, at the relevant date of the the [sic] document, to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at the time in the field to be expected of him (see T 206/83, OJ EPO 1987, 5) (point 2.2. of the Reasons).

However, even though document (1) aimed at synthesizing methyl-2-(α-thenoyl)-ethylamine through a Mannich reaction or the steam distillation of the corresponding tertiary amine, the authors of the document could neither isolate it nor obtain it when the reactions were actually carried out, in spite of the use of conditions which were considered favorable for its formation. The Board thus went on to consider that document (1) alone did not make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since the specific attempts to prepare it, which are described in said document, failed (see point 2.2 of the Reasons).

The opponent (Respondent) replied by arguing that document (1) did nonetheless make the compound methyl-2-(α-thenoyl)-ethylamine available to the public, since on repeating the preparation of the tertiary amine methyl[di-2-(α-thenoyl)-ethyl]amine 5 of document (1) in experimental report V1 it submitted, the compound methyl-2-(α-thenoyl)-ethylamine was indeed produced (but went unnoticed by the authors of document (1)).

This did not convince the Board:

[…] the Board holds that in view of the categorical statement in document (1) that despite attempts to synthesise it, the secondary amine could be neither isolated nor obtained, the skilled person, at the date of publication of document (1), would not have seriously contemplated repeating its teaching in order to undertake further investigations as to whether the secondary amine was formed after all. Thus, regardless of whether the report V1 repeats the method of document (1) exactly, the Appellant contesting this fact (see point IV above), the skilled person had no motivation to perform the steps in the experimental report V1 which are not disclosed in document (1), namely of analysing the product mixture obtained or of recrystallising from the mother liquor (point 2.3 of the Reasons, emphasis added).

Hence, even if methyl-2-(α-thenoyl)-ethylamine were inevitably produced by a method described in document (1), since its presence remained undetected by the skilled person, it had not been made available to the public (point 2.3 of the Reasons, emphasis added).

Well so long for the astute novelty attack, but doesn’t that ring a bell? G 1/92 of course:

The chemical composition of a product is state of the art when the product as such is available to the public and can be analysed and reproduced by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition (emphasis added).

Except that the Board appeared to favor an opposite view to that of the Enlarged board of appeal. Unfortunately, the Board did not discuss the particulars of this case with respect to G 1/92, leaving us in uncertainty as to the interpretation of this decision: is it to be understood as going against G 1/92 or can it be reconciled with it?

Let’s try to see by ourselves.

A reminder of the case behind G 1/92 might be useful at this stage.

G 1/92 followed from a question referred to the Enlarged board of appeal by the President of the EPO pursuant to Article 112(1)(b) EPC which arose as consequence of decision T 93/89. It was held in this latter decision that if the composition of a commercially available product (e.g. aqueous polyvinyl ester dispersion) can be established only by a chemical analysis, the ingredients of the product (e.g. polyvinyl acetate, native starch, polyvinyl alcohol) have not been made available to the public unless there was a reason for experts to investigate it (see Headnote and point 8.2 of the Reasons).

The case at hand thus differs from the case at the origin of G 1/92 in that the product is not “directly” available to the public since it has to be manufactured before it can submitted to a chemical analysis (as opposed to a commercially available product). As such, decision T 719/12 could be interpreted as meaning that when a product is not commonly available to the public and needs to be manufactured to become so, then it would become relevant that one of skill in the art should have a special motivation to perform the manufacture and the analysis of the product.

However, this point of view is not totally satisfying as this would amount to making a distinction between the different means by which any information is made available to the public under Article 54(1) EPC, i.e. public use vs. written description, which is something G 1/92 specifically warned against (see point 1.2 of the Reasons).

Accordingly, even though the Board in decision T 719/12 does not explicitly take position against G 1/92, one might wonder whether after more than 23 years of good service the latter has not been silently euthanized.

Thank you Lionel. It is indeed somewhat strange to read about the absence of motivation for the skilled person in the context of a novelty analysis.

Of course, the facts of the case were very specific, with on the one hand a prior art document explicitly stating that a compound is not obtained, and on the other hand a recreation of the prior art by the opponent showing that the compound is indeed obtained.

Such recreations are always heavily criticized by the patent proprietor, as there are inevitably some details missing in the prior art disclosure, which need to be completed by the experimenter – and this case is no exception (see section IV of the Summary of Facts and Submissions).

With that in mind it does not really come as a surprise that the Board preferred to rely on the explicit statement in the prior art document rather than on a posterior, disputed, demonstration. But the reasons put forward by the Board do come as a surprise.


CASE REFERENCE: Board of Appeal 3.3.10, T 719/12, Lonza AG v. Merck Patent GmbH, October 29, 2015.

A fishy appeal?

It is not an easy task to report on case law from the EPO Boards of Appeal, as there are so many commentators in the blogosphere (and elsewhere) poised to jump on any fresh decision that being original is tricky, unless you do high frequency posting. Nevertheless, I am wondering whether decisions drafted in French might as a general rule fly a little bit more under the radar, since French is certainly the official language of the EPO which is the least spoken by the European patent profession.

With that in mind, here is a report on one of these low flying decisions, which I find noteworthy for two reasons. The first reason is that the main claim of the patent in suit was directed to a container containing precooked tuna fish, which opens up an ocean of possible aquatic puns for this blogger. And the second reason is that the decision deals with an interesting point of law regarding the burden of proof in appeal proceedings.

The patent owned by Brittany-based Etablissements Paul Paulet had been revoked by an opposition division due to insufficiency of disclosure.

Claim 1 as granted was the following:

A rigid container containing foodstuff, the container comprising a receptacle and a cover and being made of a material selected from aluminum, steel, glass, or a plastics material that is oxygen-proof, the foodstuff being constituted by pre-cooked fish that is in solid form, eventually comprising an additive, a preservative, or a small amount of water or oil, characterized in that

– the closed container presents substantially no liquid after sterilization, such that the liquid content is less than 10% of the total weight of the content, and

– the container contains only the foodstuff and a gas, wherein the volume content of dioxygen in the gas is less than 15%, the gas being nitrogen.

Both features of the characterizing part of the claim were viewed by the opposition division as raising implementation issues.

If we focus on the liquid content feature, the opposition division noted that the patent taught to place the precooked fish into the container, add liquid nitrogen which will be turned into gaseous nitrogen, then close the container and sterilize the product. Based on various statements made by the patent proprietor during the opposition proceedings and information contained in the patent itself, as well as in an experimental report referenced as T4 (filed – unfortunately – by the patent proprietor), it could be concluded that, during the sterilization step, the liquid content in the container can change, and in particular can increase or decrease. Many factors may influence this change in the liquid content, including the type of fish, the precooking procedure, the shape of the fish, the additives and the conditions of sterilization. The opposition division deemed that the patent did not teach how to control these various parameters.

A container for fish hopefully containing more than 10% of liquid
A container for fish hopefully containing more than 10% of liquid

With its statement of grounds of appeal, the patent proprietor filed a modified version of claim 1 as a main request (corresponding to one of the auxiliary requests discussed in first instance). In this modified version of claim 1, the material of the container was somewhat restricted, and the nature of the fish was further specified to be “pre-cooked tuna fish in solid form“.

With the summons to oral proceedings, the Board expressed the preliminary opinion that there was an issue of sufficiency of disclosure with the liquid content feature, although it did not share the view of the opposition division regarding the other feature of the nitrogen / oxygen content.

One month before the oral proceedings, the patent proprietor submitted a new document T18, which was an experimental report focusing on the processing of tuna fish. The admissibility of document T18 at this late stage of the proceedings was debated in front of the Board, in view of R. 13(3) of the Rules of Procedure of the Boards of Appeal.

The patent proprietor’s argument was that:

  • the first instance decision relied on experimental report T4, in which experiments were conducted on billfish product;
  • the main claim was now restricted to tuna fish, so that the first instance decision was no longer applicable;
  • the Board raised a new objection in the preliminary opinion by stating that even with precooked tuna fish the variations in liquid content were unpredictable;
  • therefore the patent proprietor had reacted in a timely manner by filing the new experimental report T18 focusing on tuna fish.

The Board rejected the argument by analyzing the first instance decision, which mentioned a number of ill-controlled parameters influencing the liquid content and not just the type of fish; and by noting that the main request in the appeal was the third auxiliary request in first instance and had thus also been rejected by the opposition division.

The most interesting part of the discussion relates to whether the admission of T18 into the proceedings would violate the opponents / respondents’ right to be heard – in view of the lateness of the filing. The appellant said no, because the respondents had failed to provided detailed justifications and evidence in their response to the statement of grounds of appeal; on the other hand, the appellant did not have to file additional evidence with its statement of grounds of appeal since:

the burden of proof of insufficiency of disclosure lies exclusively with the opponents, in all circumstances. This also applies on appeal further to a decision revoking the patent for insufficiency of disclosure, notably when the grounds of the decision at stake no longer adversely affect the appellant due to a modification of the claimed subject-matter (reasons, 1.4.1).

The Board rejected the argument in view of the very nature of the appeal proceedings.

The respondents brought forward elements during the opposition proceedings which were apparently sufficiently credible as to the impossibility to carry out the invention in a systematic and reproducible manner by relying on the information contained in the patent; moreover, this information would be too limited and contradictory. This led the opposition division to hand down the decision at stake, which was duly reasoned. This decision not only brings an end to the opposition proceedings, but also as a consequence assigns different roles to the parties for the appeal stage. Once the patent has been revoked, it is up to the patent proprietor as the appellant to take a more active part and present, firstly, a detailed argumentation in its statement of grounds of appeal, even if by filing a new set of claims the grounds for the challenged decision seem to be overcome. The appellant cannot simply wait for the respondents to demonstrate the invalidity of the patent.

The patent proprietor, as the appellant, must therefore act against the challenged decision, that is, must, in the present case, demonstrate that common general knowledge does make it possible to carry out the invention based on the patent. This demonstration must be complete and not selective, without waiting for the Board or the parties to invite it to develop it more. In this respect, the appeal proceedings are not a continuation of the opposition proceedings but a new procedure instituted by the appellant. Therefore, the principles which initially governed the opposition proceedings are no longer necessarily applicable at the appeal stage, and those stated in the Rules of Procedure of the Boards of Appeal replace them, notably the duty to provide the complete means in view of which the decision cannot be maintained. A patent proprietor who thinks that they can discard the basis for the challenged decision owing to grounds of appeal limited to only one aspect of said decision runs the risk of later being in a situation where the filing of additional grounds or evidence during the appeal proceedings may be considered late under articles 13(1) and/or 13(3) RPBA (reasons 1.4.2).

I think it is fair to say that the burden of proof of insufficiency of disclosure on the opponents is a very heavy one in opposition proceedings.

However, according to the present decision, the onus shifts on appeal, if the patent is revoked by the opposition division. More generally, it can be derived from the Board’s comments that the first instance decision is presumed valid until the contrary is proven – although I am not sure that this has often been stated in this way in the case law.

On the merits, the Board reached a similar conclusion as the opposition division regarding the unpredictability of the liquid content in the container after sterilization, and therefore dismissed the appeal.

The parties will have the opportunity to continue the discussion and fish for further arguments on the liquid content feature, since there are opposition proceedings pending in connection with the divisional patent, and since the same feature is present in the independent claims. My guess is it will be an uphill battle for the patent proprietor but at least they can hope to be able to rely on the additional evidence that the Board has refused to take into account in this case.


CASE REFERENCE: Board of Appeal 3.2.07, T 30/15, Etablissements Paul Paulet v. Princes Limited & Bolton Alimentari S.P.A, January 20, 2016.

Sufficiently suitable

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

As all Spider-Man fans know very well,

With great power comes great responsibility.

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


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

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

Wooly invalid patent

So, this is probably not a very good pun to start a new year with; but you have to admit that there are no easy puns with mineral wool, which was the subject-matter of today’s patent – a patent which was found to lack inventive step by Board of appeal 3.3.05.

The problem and solution approach is a must for any inventive step reasoning at the EPO. The first step of this approach consists in determining the closest prior art.

However, practically speaking, it is also very useful to run the approach backwards: if, as the patentee, you realize that, starting from prior art document A, it is much easier to arrive at a conclusion of non-obviousness than starting from prior art document B, then you know you need to push for the selection of A as the closest prior art, and thus come up with arguments disqualifying B. Of course, the opposite is true if you are an opponent.

One strategy sometimes used by patentees to get around a prior art reference which would make their lives miserable if selected as the closest prior art is to explain that this prior art reference is not a realistic starting point for the skilled person.

A typical example of a document which would not be a realistic starting point is one which has a lot of features in common with the claimed invention, but in a different context. As stated e.g. in T 870/96, the closest prior art should be a document

which [the] skilled person would have realistically taken under the “circumstances” of the claimed invention insofar as these circumstances can be retrieved in one item of the prior art. Consequently, among these “circumstances”, aspects as the designation of the subject matter of the invention, the formulation of the original problem and the intended use and the effects to be obtained should generally be given more weight than the maximum number of identical technical features (reasons, 4.1).

Now, in today’s decision T 2579/11, inventive step of the opposed patent had to be assessed in view in particular of two relatively similar prior art references, documents A5 and A6. These prior art references were in fact similar for a good reason: A5 was the priority document of patent application A6.

The patentee argued that the closest prior art was A6 and not the priority document A5. It is straightforward to guess why the patentee made such a submission: the claimed invention related to a mineral wool comprising a number of compounds within specific concentration ranges or concentration ratios. Both A5 and A6 disclosed mineral wools containing the same compounds as the claimed invention. But the examples disclosed in A6 differed from those of A5. In examples 2 and 5 of A5, only the concentration ratio MgO/CaO was outside of the claimed range. In contrast, in some of the examples of A6, not only was the MgO/CaO ratio outside of the claimed range, but in addition the alumine content was above the claimed maximum threshold. Or, in other examples, the alumine content was within the claimed range but then the MgO/CaO ratio was further away from the claimed values than in examples 2 and 5 of A5.

As a result, it was easier to arrive at a finding of lack of inventive step starting from A5 than starting from A6, since fewer modifications needed to be made starting from A5.

Artificial sheep from which mineral wool can be sheared
Artificial sheep from which mineral wool can be sheared

In order to try to disqualify A5 as the closest prior art, the patentee offered the following argumentation:

A5 is accessible only in the examination file wrapper of A6. The skilled person has no reason to start from priority document A5 since he/she has a more elaborate text available, which was filed after one year of additional research. The fact that examples 2 and 5 of A5 were not included in A6 shows that they were not valid examples. Therefore, document A6 is the closest prior art (facts and submissions, VII).

But this did not fly with the Board. The Board first of all noted that both A5 and A6 had the same purpose (which was also the purpose of the claimed invention), namely providing mineral wool which can be dissolved in a physiological medium, and which can be fibered by centrifugation (reasons, 2.2.5). Second of all, in terms of features in common with the claimed invention, it was concluded that, for the reasons already set forth above, “the wools according to examples 2 and 5 of A5 request fewer structural modifications than the wools of A6” (reasons, 2.2.6).

Finally, the Board addressed the patent proprietor’s argumentation as follows:

Once a priority document has been made accessible to the public, it belongs to the state of the art under article 54(1)(2) EPC like any other publicly available document. The papers of a patent application on the one hand and a priority document on the other hand are then entirely distinct documents, even if the latter is made accessible to the public through the publication of this application. The fact that a later application generally has a more detailed description than the priority application can therefore not, by itself, justify that the priority document should be discarded in favor of the later application when the closest prior art is selected. The fact that an embodiment and/or an example contained in the priority application are not included in the application claiming the priority does not by itself allow one to conclude that such embodiment and/or example were less preferred, or less valid. 

[…] Even assuming that the later application A6 contains results of complementary research, nothing indicates that examples 2 and 5 of A5 which are not included in A6 would be invalid or of poor quality or insufficiently disclosed (reasons, 2.2.7).

Thus, examples 2 and 5 of A5 were deemed to represent the closest prior art, and the rest of the problem and solution approach analysis led the Board to the revocation of the patent due to lack of inventive step.

To some extent, it seems to me that a parallel could be made with other cases such as T 741/91 or  T 334/92, where an old prior art document was rejected as a candidate closest prior art because said document had been ignored in the relevant field and had not given rise to further development.

Here, the priority document A5 was dated at most one year prior to the subsequent application A6, so this was not a very”old” document by any means. But the common trait is that, in both situations, an argument was made that a prior art reference should be disregarded as the closest prior art, not because of its intrinsic contents, but rather because of extrinsic evidence that the reference would not count in the eyes of the skilled person. In T 2579/11 the argument failed, whereas it succeeded in T 741/91 or T 334/92. This may just be a matter of the extrinsic evidence being persuasive enough or not.

As a side remark on a procedural aspect of the present decision, the Board skipped the novelty objections and only took position on inventive step as this was sufficient to reach the conclusion that the patent should be revoked. Similarly, the Board focused on inventive step of the most restricted claims defended by the patent proprietor, namely auxiliary request No.3, the conclusion on this request also applying to the previous, broader requests.

This is a reminder that Boards of appeal have a lot of leeway for dealing with submissions of the parties in the order that they see fit, and for getting to the final decision in the most efficient manner. However, shortcuts such as the present one may seem somewhat unorthodox. In particular, there was an objection of lack of novelty of the main request and the first auxiliary request over A5 (as well as over another document A3). This means that the Board decided that these requests involved no inventive step over A5 without ruling whether the claims at stake were even novel over A5.


CASE REFERENCE: Board of Appeal 3.3.05, T 2579/11, Laine minérale / Saint-Gobain, March 10, 2015