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  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 , 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  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  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  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.
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.