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.

Prior art to no purpose

French courts and the Boards of appeal of the EPO are supposed to apply the same validity rules to European patents. But in fact a patentee’s chances to withstand a validity challenge differ between Paris and Munich depending on the nature of this challenge. So much so that one could go as far as saying that, depending on which strongest arguments a third party may have against a patent, either an opposition at the EPO or a nullity action before the Paris Tribunal de Grande Instance (TGI) would be a better option.

Some previous posts have illustrated that French courts tend to have an extremely restrictive, and actually rather surprising, approach concerning patentability of therapeutic inventions or computer programs (see e.g. here or here).

One recent decision illustrates another interesting discrepancy, with a patent found novel but insufficiently disclosed in France, whereas it could very well have been held sufficiently disclosed but lacking novelty by a Board of appeal – although this assumption will never be tested, since no opposition was filed.

I will address the novelty aspect in the present post and the sufficiency aspect in a next post.

The patent at stake is European patent No. EP 1490005, assigned to The General Hospital Corporation (hereafter General Hospital). General Hospital, together with its exclusive licensee Zeltiq Aesthetics Inc., sued a small business named Clinipro for infringement of the patent, both in Spain and in France. It seems that the patent was held invalid in Spain (although a preliminary injunction had been obtained first). Unfortunately, the French judgment does not explain on which grounds the patent was found invalid by the Spanish judges (it would have been interesting to be able to make a comparison with the French approach).

In first instance, the Paris TGI held that the patent was valid and infringed. At that time, only lack of novelty and lack of inventive step had been raised as an invalidity defense by Clinipro. On appeal, Clinipro added an insufficiency challenge, which carried the day.

By the way, this is yet another difference, a procedural one, with respect to EPO proceedings, since an opponent would not be allowed to introduce a new ground for opposition at the appeal stage – unless the patentee agrees to it, said the Enlarged Board of Appeal with a deadpan sense of humor.

Claim 1 of the patent reads as follows:

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.  

Let’s now examine the novelty attacks against this claim, which failed.

The novelty standard applied in France, which is invariably cited in each decision including this one, is that

[…] in order to be comprised in the state of the art and thus lack novelty, the invention must be entirely found in a single piece of prior art in all certainty, with the same elements which make it up, in the same form, the same arrangement and the same mode of operation in order to achieve the same technical result

The last part of the sentence is very noteworthy: a prior art disclosure will take away novelty of a claim if and only if, not just the structure of the invention is taught in the prior art disclosure, but also the function and technical result of said invention.

This is particularly significant in a case such as the present one which deals with a claim directed to a “device for” – here, “a device for selectively disrupting lipid rich cells in a non-infant human“.

The court not only fully relied on this feature in the novelty analysis, but in fact also took into account the general purpose stated in the patent, which is to reduce orange-peel skin by destroying subcutaneous fat tissue without damaging the dermis or the epidermis.

Thus, when analyzing a first prior art reference called Thorner, the court stated that:

[…] The invention thus disclosed by this patent application is only intended for treating diseased or injured animal tissues, for instance inflamed limbs, by cooling the limb to a temperature of between 13 and 18°C or skin cancer by cooling the limb to temperatures below zero. 

[…] This prior art therefore does not disclose a set composed of the same means having the same function and leading to the same result as the patent at stake, namely selectively cooling lipid-rich cells in a non-infant human subject so as to break those up and reduce the excess of fatty cells without causing damage to other tissues. 

Turning to another prior art reference called SI Industries, the court used a similar reasoning:

[…] The invention thus disclosed by this patent application is only intended for cooling (or warming up) a limb in a controlled manner below the normal temperature of the body in a medical treatment, in order to eliminate the excess of fluid stored in muscular compartments further to a wound so as to avoid the occurrence of the compartment syndrome related to excessive pressure on nerves and blood vessels. 

[…] Similarly, this prior art does not disclose a set composed of the same means having the same function and leading to the same result as the patent at stake. 

Fat and cold are not always incompatible.
Fat and cold are not always incompatible.

This approach is very different from the EPO’s, which is well summarized in section F-IV, 4.13 of the Guidelines for examination:

If a claim commences with such words as: “Apparatus for carrying out the process etc…” this must be construed as meaning merely apparatus suitable for carrying out the process. Apparatus which otherwise possesses all of the features specified in the claims but which would be unsuitable for the stated purpose or would require modification to enable it to be so used, should normally not be considered as anticipating the claim.

Therefore, if a Board of appeal had examined novelty of claim 1 of this patent, it would certainly have focused on whether the prior art devices were suitable, i.e. could potentially be used, for the claimed purpose, and not on whether the claimed purpose was disclosed per se in the prior art.

The Paris approach is thus much more lenient with patent proprietors than the Munich one.

I am not sure which one is the best one, but I can see two advantages with the French way of handling novelty.

First, it may provide increased legal certainty, as it may be easier to assess whether the function and result of a claimed device are disclosed in the prior art than to figure out whether a prior art device could potentially be used in the same way as the claimed invention. I think this latter question leaves more room for interpretation and discussion: is the new use simply a matter of changing the settings of the prior art device, or would structural redesign be necessary as well?

Second, especially in the medical device field, it makes it possible to more adequately reward innovation, taking into account the prohibition of therapeutic or surgical use claims. If we take the present case, a new method of disrupting lipid-rich cells might not be patentable, since it is probably considered as being of a therapeutic and/or surgical nature. However, it may make sense to grant a patent on an apparatus specifically designed to implement this new method, if there is an actual (novel and inventive) invention involved.

The real paradox however is that, in those situations where the EPO does fully take into account a claimed purpose in a novelty analysis, as is the case with second medical use claims, French courts tend to be reluctant to do the same. I am thinking in particular of dosage regimen features, which tend to be ignored by French courts if they are not considered as relating to a “different technical teaching” (see e.g. here).

Anyway, if General Hospital benefited from a liberal stance of the Cour d’appel in the first part of the judgment, alas the bad surprise for them came in the second part, which I will deal with in a next post.


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

One to rule them all (UPC breaking news)

A lot has already been written about the referendum in the UK scheduled on June 23, 2016 regarding a possible break-up with the European Union – nicknamed “Brexit. Many in the European patent profession have expressed concerns about the impact that a Brexit could have on the Unified Patent Court (UPC). One issue in particular is that Article 7(2) of the Agreement on a Unified Patent Court (A-UPC) specifies that “the central division shall have its seat in Paris, with sections in London and Munich”: should the UK no longer be part of the system, maintaining one third of the central division of the court in London would seem to be out of the question.

I am glad to report, thanks to a well-informed source at the European Commission, that a solution to this tricky problem has fortunately just been found. In fact, it seems that a special taskforce involving representatives from all participating states was secretly set up a few months ago in order to propose a protocol amending the A-UPC in case of a Brexit.

The initial draft, proposed by a Scottish member of the European Parliament (MEP), planned to simply move the London section of the central division to Edinburgh. However, it was rejected after the MEP was kindly reminded by his peers in the taskforce that Scotland was still part of the UK (in the absence of a Scoxit), so that the proposed move was in fact impractical.

Finally, after more than 2,000 hours of uninterrupted negotiations and 56 circulated drafts, it seems that a groundbreaking compromise has been reached, which effectively means that the UPC will be saved, irrespective of the outcome of the referendum.

Thus, the paramount aim of simplifying patent litigation in Europe without offending the sensitivity of any member state will not be jeopardized.

The proposed protocol (which will still need to be signed and ratified by member states) seeks to amend Article 7(2) as follows:

The central division shall have its seat in Paris, with sections in Munich, Luxembourg and The Hague. The section in Luxembourg shall have secondary offices in Monaco, Geneva, Jersey and Guernsey. The section in Munich shall have secondary offices at Erhardtstrasse, Bayerstrasse and Grasserstrasse. The section in The Hague shall have nine rotating offices which shall be allocated every three years to the nine cities of the Member States in which the highest amount of fish per inhabitant was consumed during the fourth month preceding the date of allocation.

A case brought before the central division shall be distributed to the office from the above list in which the last name of the presiding judge is alphabetically closest to the fifth word of the main claim of the European patent in suit. If this cannot be easily determined, the case shall be distributed to any office in Germany. 

As a spokesperson for the taskforce, probably exhausted after so many days at the negotiating table, told my anonymous source:

Three sections for the legally qualified judges under the Agreement,

Seven secondary offices for the technically qualified judges in their halls of justice,

Nine rotating offices for defendants doomed to litigate,

One seat for the President on his or her throne,

One seat to rule them all, one seat to find them,

One seat to bring them all and to EU law bind them.

I don’t know what readers think, but this sounds like a rather ominous statement to me…

The UBC board game
The UBC board game

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.