A flayed patent

We have one saying which goes “Vérité en-deçà des Pyrénées, erreur au-delà, which could be translated by: “What holds true on one side of the Pyrenees may be false on the other“. Well, the same can probably be said of the Rhine.

In a previous post, I discussed a recent decision by the Paris Cour d’appel, in which medical device claims were found novel due to a purpose feature – in keeping with the well-established French novelty standard. This approach is at odds with the practice of the EPO, where purpose features are only taken into account if they can be translated into structural limitations.

Yet, the greater generosity of French courts with patentees with respect to novelty is counterbalanced, it seems, by greater severity in particular with respect to sufficiency of disclosure, as the same case shows.

As a reminder, claim 1 of the patent was directed to:

A device for selectively disrupting lipid rich cells in a non-infant human subject by cooling, comprising:

– cooling means for cooling a local region of the subject’s skin to selectively disrupt lipid rich cells of the region, while, concurrently therewith, maintaining the subject’s skin at a temperature whereby non-lipid rich cells are not disrupted, wherein the cooling means are adapted to cool the lipid rich cells to a temperature between about -10°C and about 25 °C, 

– a temperature control unit for controlling the temperature of the cooling means, and temperature measuring means which are adapted to measure the temperature of the subject’s skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin; characterized in that 

– the temperature control unit is further adapted to control the temperature of the cooling means such that the temperature of the subjects skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin does not fall below a predetermined minimum temperature on the basis of the temperature of the subjects skin and/or the temperature in the subject’s skin and/or the temperature on the surface of the subject’s skin.  

The court started the sufficiency assessment by defining the skilled person, in a plural form:

[…] In this case, the skilled in the art is a team composed of a specialist in skin biology and a specialist in the field of cryogenics (cryolipolysis as regards the destruction of fat by the cold).

Then, the court recalled the general purpose of the claimed invention (which, as a reminder, was duly taken into account in the novelty analysis):

[…] The cryolipolysis device disclosed by claim 1 of the patent at stake must be able to selectively break lipid-rich cells by cooling, owing to cooling means which make it possible to maintain, at the same time, the skin of the subject at a temperature such that the other cells of the dermis and the epidermis are not broken […]. 

The sufficiency question at stake was thus whether there was enough information in the patent to achieve this general purpose.

In this respect, three parameters came into play, according to the court: cooling temperature, cooling time, and the surface area of the patient’s skin subjected to the cooling.

The patent proprietor’s position was that:

  • the temperature to be applied was from -10 to 4°C, or from -2 to 15°C;
  • the optimal time of application was from 5 to 20 minutes;
  • the surface of treatment should be at least 1 cm2 and preferably from 3 to 20 cm2;
  • the determination of the optimal values for the various parameters was a matter of routine implementation for the skilled person;
  • the examples in the patent would direct the skilled person to specific cooling parameters of -6°C for 5 minutes or -7°C for 10 to 20 minutes.

In order to assess the merits of this defense, the court analyzed the contents of the description of the patent in great detail.

They noted a number of extremely generic and vague statements.

Regarding the temperature to be applied, the court noted that

[…] at paragraph [0024] of the description, a temperature range for the cooling means is mentioned which is excessively broad, since it goes from the temperature of liquid nitrogen (-196°C) to human body temperature (37°C); at paragraph [0025], preferential ranges are provided, but they are still very broad and imprecise, since they encompass from “approximately” -15°C to “approximately” 35, 30, 25, 20, 15, 10 or 5°C, or from “approximately” -10°C to “approximately” 35, 30, 25, 20, 15, 10 or 5°C, or also from “approximately” -15°c to “approximately” 20, 15, 10 or 5°C […]. 

The court continued to analyze the rest of the description of the patent and remarked that many other indications were provided for the temperature of cooling of lipid-rich cells as well as for the cooling time. In particular, the court noted the disclosure of preferred temperature ranges of -10 to 37°C, -4 to 20°C, -8 to 33°C, -2 to 15°C, -10 to 35°C, -5 to 10°C, -5 to 5°C, -10 to 20°C, -8 to 15°C, as well of many exemplary values.

Turning to the cooling time, the court stated that

[…] paragraph [0026] starts by teaching an application time for the cooling means of up to two hours, while retaining a preferred time of between one and thirty minutes, but without specifying for each temperature level of the cooling means what the corresponding preferred application time is, except for the sole example of liquid nitrogen application, although on the one hand liquid nitrogen temperature does not correspond to the preferred temperature ranges mentioned in the previous paragraph and on the other hand the duration of application (one tenth of a second) does not correspond to the time range indicated as preferential. 

The court also noted that various cooling patterns were disclosed, such as continuous cooling, multiple cooling cycles, and cooling with intermediate warming up periods (which, said the court, are not specified). Time intervals between cooling applications ranged from 1 minute to 1 hour or from 12 to 24 hours.

The court’s conclusion was that

[…] it cannot be derived from such broad and imprecise – or even contradictory – temperature and time indications that, for the skilled person, the cooling temperature range for achieving cryolysis of lipid cells would vary between -2 and 15°C and the optimal application time would vary between 5 and 20 minutes (all the more so that this time mentioned at paragraph [0045] does not relate to the application time but to the preferred interval between each application).

Regarding the surface area of the cooling means, the court referred to paragraph [0030] of the patent, which provided a general rule as well as preferred values. The relevant passage of the paragraph reads as follows:

[…] Generally, the dimension of the surface area (e.g., where the cooling agent is in contact with the skin) should be at least three times the depth of subcutaneous fatty tissue that is targeted for cooling. Preferably, the minimum diameter of the surface area is at least 1 cm2. Even more preferably, the diameter of the surface area is between 3 to 20 cm2. Determination of the optimal surface area will require routine variation of several parameters. For example, larger surface areas, such as those over 3500 cm2, can be cooled according to the methods of the present invention if hypothermia is prevented by additional means.

Again, the court was dissatisfied with this teaching. Actually, there seems to be a confusion in this passage between dimensions and surface areas. Moreover, “it is not taught how the skilled person could measure the depth of subcutaneous fatty tissue“, said the court; and the preferred ranges are very broad indeed.

If we stop at this point for a moment, the main problem of the patent’s description is not that there was too little information but rather that there was too much. Instead of providing a couple of relevant ranges of values for the various parameters at stake, the patent offered a huge number of variants within an extremely broad disclosure.

I take this as a serious warning against U.S.-style claim drafting. It is quite common to find extremely broad definitions in U.S.-originating patents, and the reader sometimes gets the impression that any term can mean anything and that each parameter can take any possible value under the sun. This drafting practice of course makes perfect sense in terms of affording the best scope of protection, especially in the U.S., but the present example shows that it may not always play well on this side of the Atlantic, where courts insist on finding an actual technical teaching which can be of practical use to the skilled person in the patent, in order for that patent to be deemed worthy of being upheld.

My feeling on this is that the Cour d’appel can probably not be blamed for looking for a real, practical teaching in the patent.

But then comes a more controversial part of the judgment. Indeed, the patent also contained a number of examples relating to experimental testing on pigs and showing a decrease in adipose tissue without damage to the dermis or epidermis.

At the EPO, “an invention is in principle sufficiently disclosed if at least one way is clearly indicated enabling the person skilled in the art to carry out the invention“, as the Case Law bible (Case Law of the Board of Appeal of the European Patent Office, 7th edition, 2013) puts it in section II.C.4.2.

So, shouldn’t we apply this standard, and conclude that the examples in General Hospital’s patent save it from falling for insufficiency of disclosure? Nope, and here’s why:

[…] Zeltiq and General Hsopital, based on the expert report of William E. […] state that these experimental results would direct the skilled person towards the application of a temperature from -6°C for 5 minutes to -7°C for 10 to 20 minutes.

[…] Domestic pig skin […] has morphological and functional characteristics similar to those of human skin, but William E. acknowledges that “of course in medical research, human testing is the reference standard”;

[…] Although this expert believes that the skilled person […] would have concluded in 2002 that the results observed in the three pigs of examples 1 and 2 would also apply to humans, it should be noted that this expert, who is an MD specialized in dermatology cannot be considered as the skilled person […] and that he relies on findings from more contemporaneous studies, whereas the priority date of the application […] is the reference for assessing the sufficiency of disclosure of the patent.

[…] It can be derived in particular from the article by Mr. M. entitled “the skin of domestic mammals as a model for human skin, with special reference to domestic pig” dated 1978 […] that “data from animal experiments cannot be transcribed without restriction to man”.

[…] Thus it does not appear that the skilled person in 2002 could have extrapolated the results of experiments 1 and 2 described in the patent and relating to pigs so as to select a cooling temperature application from -6°C for 5 minutes to -7°C for 10 to 20 minutes. 

With that, claim 1 as well as the dependent claims relied upon by the plaintiffs were held invalid.

 

The unfortunate result of excessive fat disruption due to an erroneous setting of the patented device.
The unfortunate result of excessive fat disruption due to an erroneous setting of the patented device.

Again, I think this part of the judgment is quite debatable.

Indeed, in the medical or medical-like field, there are usually in vitro studies first, then animal studies, and only then human studies. Actual experiments on human patients usually come late in the development process, so late that it does not make sense to wait for that stage before filing a patent application, in a first-to-file system.

This is certainly why the Boards of Appel of the EPO only require that the description of the application should make it plausible that a claimed technical effect can indeed be achieved (see e.g. here). My understanding is that animal studies are generally considered as making it plausible that a certain treatment can also be applied to humans, unless there are special reasons to come to the opposite conclusion. There is no denying that animal studies are less complete than human studies but stating that animal experiments are generally not sufficient for a skilled person to carry out an invention would mean tossing out most patents in the drug and medical device industries.

I have not had access to the exhibits filed by both parties in this lawsuit, so I do not have a complete opinion on the patent at stake. But let’s put it like this: absent any showing (1) that the selective disruption of lipid-rich cells in humans does not work, or (2) that the settings to make it work are very removed from those disclosed in the examples of the patent, I would say that the judgment was harsh with the patent proprietor.


CASE REFERENCE: Cour d’appel de Paris, Pole 5, chambre 1, January 12, 2016, Patrick M. & Clinipro v. The General Hospital Corporation & Zeltiq Aesthetics Inc., RG No. 13/13050.

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

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.