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.
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