Three strikes – you’re out

One, two, three strikes you’re out. Today, I will be discussing an invalidity decision again, and a rather remarkable one. It is not every day that three different grounds of nullity are held against a patent, including what some practitioners could consider as their white whale, namely… the lack of industrial application.

The origin of the case is a dispute between two inventors owning a French patent and a corresponding European patent relating to a cloth coated with mother-of-pearl, and their licensee, Van Robaeys Frères. As part of the dispute, the patent proprietors in particular requested from the Dunkerque Tribunal de grande instance (TGI) that the license agreement should be terminated. The disgruntled licensee retaliated by filing a nullity suit in front of the Paris TGI – which, as explained in a recent post, has exclusive jurisdiction in patent matters.

The first part of the judgment is dedicated to an inadmissibility defense based on an alleged lack of standing. This has actually been a serious defense since a famous Barilla case three years ago, in which a nullity claimant was found to lack standing because they had not demonstrated that they were preparing for carrying out acts prohibited by the patent.

Yet, in the present case, the nullity claim was quite logically found to be admissible:

With respect to patent nullity actions, those who can act are those who can establish that, at the time the complaint is filed, the claims which are sought to be revoked, are or may be an impediment for carrying out their economic activity, because they work or plan to work in the field of the patented invention. In this case, as a licensee in a license agreement on the exploitation of the French patent for which a termination is requested by the licensor, Van Robaeys Frères has an economic activity notably in the field of linen cloths, and thus has standing for seeking nullity of the patents of Mr. Thierry D’Arras & Albert Paoli, which it will no longer benefit from due to the termination. 

That being settled, let’s have a quick look at the two patents at stake, FR 2941712 (FR’712) and EP 2393979 (EP’979). Claim 1 of EP’979 reads very simply:

A cloth comprising a support and a light deconstructing layer characterized in that said layer comprises mother-of-pearl.

Claims 2 to 8 are dependent claims. Claim 9 relates to:

A method for preparing a cloth according to one of claims 1 to 8, comprising a step to impregnate a support in a mother-of-pearl solution.

Claim 10 depends on claim 9, and claim 11 is directed to

The use of a cloth according to one of claims 1 to 8 or of a cloth obtained with the method according to claims 9 to 10 to manufacture products which reflect away the infrared such as blind fabrics, tent fabrics and clothing.

The claims of FR’712 are identical to those of EP’979, except that claim 1 of FR’712 is somewhat broader as it also recites the alternative of using a substance equivalent to mother-of-pearl.

Mother and her pearls
Mother and her pearls

The first ground of nullity upheld by the court was a lack of novelty due to the inventors’ own activities before the priority date. More precisely, Van Robaeys argued that the invention was disclosed to the public in two ways: because of trials at the Centre européen du non-tissé (CENT) a couple of months before the priority date, and because of a meeting at the Ecole polytechnique a couple of weeks before the priority date.

The inventors’ defense was that both events were confidential. But the court held that this was not adequately proven. In particular, it seems that the court was of the opinion that explicit confidentiality agreements should have been in place, which was apparently not the case:

However, it can only be derived from the exchange of emails concerning the 2008 trials that a draft of confidentiality agreement was received by [the inventors]; and concerning the [meeting] of January 2009, it can be derived from the report dated January 19, 2009 on the meeting at Polytechnique that it was intended that all documents would be confidential, that “the university insists on the execution of a confidentiality agreement”, that “a draft of confidentiality agreement” was received by Mr. … from Polytechnique, but no confidentiality agreement was submitted by the parties. 

Yet, it is conventional to execute an agreement of this type […]. 

The court did not investigate whether it could be considered that there was an implicit obligation of confidentiality due to the circumstances of the two disclosures – and it is possible that the patent proprietors did not phrase the argument in this manner.

This is a defense that might have been successful in front of a Board of appeal of the EPO. There are not enough details in the judgment to really understand the full circumstances of the disclosures, but one could probably argue that there was a common understanding by the participants that the information made available during the trials and the meeting was provided in confidence.

So, are French courts more severe than the EPO on this issue? That’s very possible, as this is not the first decision that I have seen where an explicit confidentiality agreement is viewed as necessary in order to disqualify a disclosure as a public one. On the other hand, another decision issued by another section of the Paris TGI earlier in 2015 (and that I might comment on in a further post) accepted that the supply of prototypes to a lab for testing purposes implies a duty of confidentiality for the lab.

The bottom line is that, even if French courts may not draw the line at exactly the same position as the Boards of appeal of the EPO, in the end the question of whether a disclosure is considered as a confidential one or a public one is extremely fact-dependent, and there are never two exactly similar situations.

With that, claims 1 to 5 and 11 were found to lack novelty, which left claims 6 to 10 still standing.

Lack of inventive step was the next ground of invalidity tackled by the court, and it was quickly discarded. Indeed, it seems that none of the documents relied on by the claimant disclosed the use of mother-of-pearl on a cloth for filtering infrared and ultraviolet rays without interfering with visible light, which was the technical problem at stake.

Thus, the court turned to insufficiency of disclosure, which as readers may know is not a ground of invalidity that patent proprietors should take lightly in this country.

At this point, the judgment gets very surprising.

The court started by examining claim 6, which recites that “the light deconstructing layer is continuous“. According to the court, the description sets out that a continuous layer can be obtained by dipping or spraying, so that there is no insufficiency issue.

But then, the court turned to method claims 9 and 10 and explained that the notion of “mother-of-pearl solution” recited in these claims raises significant difficulties:

It is only mentioned in claim 10 that the mother-of-pearl solution comprises 10 to 20% mother-of-pearl, and it is mentioned in the description […] that “said mother-of-pearl is a powder of mother-of-pearl. Among the powders of mother-of-pearl which can be used in the invention, the one obtained by grinding the inside of mollusk shells can be cited.” 

Yet, the patent does not provide any indication on the formulation of the mother-of-pearl solution, although this element is essential since it defines the composition of the “layer” which needs to be homogeneous during preparation, its condition, its ability to penetrate or not the support or its ability to adhere to said support. 

Thus, it can be derived from the opinion drafted by Prof. D. […] that “the possibility to implement the invention depends on the possibility to implement the method of claims 9 and 10 […]. On the chemical standpoint, the term ‘solution’ is not sufficient to make it possible to carry out the invention and it raises many questions. Mother-of-pearl is mainly formed of calcium carbonate in the aragonite crystalline form, and it is very poorly soluble in water. One needs to know exactly what the solution is made of.”

The technical opinion of the engineer Mr. V. […] is consistent with this and adds that the composition the solution should probably vary depending on the fiber which is used […]. 

Therefore, the court held that method claims 9 and 10 are invalid due to insufficiency of disclosure and then added that “the product of claims 6 to 8 is also invalid because the methods for making the cloth are invalid“.

To say the least, this wording is clumsy. After stating that there was no defect of insufficiency of disclosure in claim 6, the court sort of changed its mind and held that the claim was invalid because the method of claims 9 and 10 is insufficiently disclosed.

It would certainly have been much clearer to start with claims 9 and 10, and then explain that since the skilled person does not know how to carry out the claimed manufacturing method, and in the absence of another readily available method, the product claims necessarily suffer from the same defect.

This clumsy wording notwithstanding, the court’s reasoning seems to make perfect sense. The analysis relies on experts’ opinions and it is true that the description of both patents is quite short and does not provide very detailed information, and in particular no example – in contrast to another recent case discussed here.

And finally, the white whale, i.e. the court’s position on the lack of industrial application of the patent:

It can be derived from the exchanges of emails in June 2011 between the parties as well as from the affidavit of Mr. J in charge of the project […] that the inventors faced unresolved difficulties of implementation of the non-woven linen cloth awnings coated with mother-of-pearl solution in a continuous layer, and it is not demonstrated that these difficulties only concerned roller awnings [as alleged by the defendants]. 

The inventors claimed that products according to the patent were manufactured and marketed, but only photographs and invoices were provided as evidence, which did not make it possible for the court to determine whether the invention was actually implemented in those products or not.

This lack of industrial application is in fact very similar to an insufficiency of disclosure. So, the whale may not be so white after all, upon closer inspection. But it is true that if an invention cannot be carried out by the skilled person, then it is not possible to make it or use it “in any kind of industry, including agriculture” as Article 57 EPC puts it.

And that was the last nail in the patents’ coffin.

As a final word, we should always bear in mind that French court are strictly bound by the parties’ submissions; therefore, surprising court’s findings may sometimes only reflect unusual parties’ submissions. But to some extent, it seems like this judgment is really a pearl.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, September 10, 2015, SA Van Robaeys Frères v. D’Arras & Paoli, RG No. 13/12618.

Lyon’s share

It has been almost seven years now since patent litigation in France has been fully centralized in Paris. Patent cases used to be heard in various Tribunaux de Grande Instance (TGIs) in the entire country. The number of TGIs having jurisdiction for patent matters was progressively reduced and finally all cases were consolidated in Paris.

Similarly, at the appeal level, the Cour d’appel de Paris has now exclusive jurisdiction in all patent cases. We can still see from time to time decisions issued by other Cours d’appel in relation with legal actions started a number of years ago before the centralization was completed.

But new cases do not normally end up in a court outside of Paris, save if the plaintiff makes the unfortunate mistake of filing its writ of summons with the wrong court.

The present case is an exception, but certainly not one due to an ill-informed litigant. On the contrary, this was certainly the result of a sophisticated (although, in the end, unsuccessful) strategy by Swedish pharmaceutical company AstraZeneca AB.

AstraZeneca owns European patent No. EP 0907364 covering the active substance quietapine for treating schizophrenia, and markets a corresponding pharmaceutical product called Xeroquel.

Generic company Mylan filed a nullity action in connection with the French part of the patent on April 28, 2015, in front of the Paris TGI – which, as recalled below, has exclusive jurisdiction for patent matters, including nullity actions of course. Apparently, another nullity action had already been started earlier in 2014 by Accord, and Mylan filed an intervention so as to be part of that nullity action. How Mylan can be part of two different actions having the same purpose is an interesting question which is however not addressed in the decision that I am reporting on today.

Mylan launched its generic version of Xeroquel at risk, without waiting for the outcome of the nullity action. Accordingly, AstraZeneca filed a counterclaim for infringement of the French part of the European patent on June 9, 2015, still in front of the Paris TGI.

Now comes the interesting part.

AstraZeneca attempted to obtain interim relief against Mylan. The usual way to do this, if an infringement claim is already pending in front of the Paris court, is to file a motion with the judge in charge of case management, who then decides on the motion pending the full trial on the merits. But AstraZeneca did not take the usual path.

Instead, AstraZeneca filed a motion for interim relief in front of the “juge des référés“, i.e. the judge in charge of urgency proceedings, at… the Tribunal de commerce (sometimes nicknamed T. com.) in Lyon. In this motion, AstraZeneca did not submit a patent infringement claim, but rather a claim for unfair competition.

Why apply to the juge des référés of the T. com.? Because, AstraZeneca stated, this is the judge having general jurisdiction for granting interim relief in situations of unfair competition. But why a judge in Lyon? Because, the defendant having its seat close to this city, this is the judge who had territorial jurisdiction – still in keeping with general, non-patent rules of judicial organization.

The Lyon judge accepted to hear the case and issued an order prohibiting Mylan from marketing the quietapine generic drug until the expiry of the French part of the European patent, i.e. May 27, 2017, or until a final decision of revocation is issued; a recall of the products was also ordered, as well as a publication of the decision.

In summary, AstraZeneca obtained the most positive result that they could ever have hoped for.

The order was issued on November 12, 2015. Mylan reacted by immediately filing an appeal and by requesting accelerated appeal proceedings. The entire process was, I must say, particularly fast and efficient, since the decision of the Cour d’appel de Lyon on this matter is dated December 17, 2015 – so the complete appeal process took only one month. The Cour d’appel set aside the first instance order and declared that the motion filed in front of the juge des référés in Lyon was in fact inadmissible because the judge had no jurisdiction.

A word must probably be said here of the differences between a TGI and a T. Com.:

  • TGIs are general courts dealing with civil matters. T. com.s, on the other hand are specialized in handling disputes between commercial companies (or persons).
  • TGIs are exclusively composed of government-appointed judges, while T. com.s are composed of elected judges.
  • Accordingly, TGI judges are professional judges, who are civil servants, while judges in T. com.s are company managers.

I have heard some lawyers familiar with T. com.s say that these courts are somewhat unpredictable and can sometimes render pretty wild decisions. What is almost certain is that the juge des référés was not fully aware of the subtleties of IP law, which is very far from his or her everyday practice.

Judicial organization in France shown on a simplified diagram.
Judicial organization in France shown on a simplified diagram.

So, again, it was a bold and clever move for AstraZeneca to request the preliminary injunction far from the Ile de la Cité in Paris. The judge in charge of case management at the TGI would likely have made a more severe assessment of the patentee’s case – not least because the European patent was already revoked in six other countries, including Germany, the UK and the Netherlands, as we learn in the Cour d’appel decision.

Now, going back to the issue of jurisdiction, article L.615-17 of the Code de la propriété intellectuelle provides that

Civil actions and motions relating to utility patents, including […] when they also concern a connected issue of unfair competition, are exclusively heard by [TGIs] mentioned in a decree […].

The decree in question names the Paris TGI as the one having exclusive jurisdiction for the purposes of article L.615-17.

Therefore the central issue, which was revisited by the Cour d’appel, is to which extent the claim brought by AstraZeneca in Lyon was related to a patent, or a connected issue of unfair competition.

The answer to this question prima facie seems pretty obvious, so how did the patent proprietor defend its position?

Again, they were rather creative, in that they stayed away from the Code de la propriété intellectuelle (which contains the definition of patent infringement), and rather argued that Mylan had committed other torts, and more specifically:

  • violated articles L.4113-6, L.4163-2, L.5122-10 and R.5122-17 of the Code de la santé publique, article 1382 of the Code civil and article 1.2.2.1 of the rules of ethics applicable to pharma labs, by offering free unsollicited samples of generic quietapine to pharmacists;
  • violated articles L.5122-1 and L.5122-2 of the Code de la santé publique, article 1382 of the Code civil as well as the recommendations issued by the ANSM (i.e. the regulatory authority in charge of pharmaceutical products), by inserting the mention “identical to the original drug” on its ads; and
  • violated article 1382 of the Code civil by committing passing off, in view of the aspect of the generic quietapine packaging and tablets.

But such creativity did not pay off in front of the Cour d’appel, which held that:

the facts and evidence submitted to the judge for defining a manifestly illicit breach caused by disloyalty in free competition are necessarily linked to the rights that AstraZeneca derives from their patent, which confers a monopoly to them until its expiry or until its revocation by a court, the effect of which is retroactive, so that the civil action started in front of the juge des référés of the Tribunal de commerce de Lyon is necessarily a connected unfair competition action, so that he does not have jurisdiction due to the subject-matter and the exclusivity of jurisdiction imparted by statute to the Paris TGI. 

Said otherwise, all torts possibly committed by Mylan in this case are closely related to the alleged patent infringement. Patent infringement is a matter for the Paris TGI to rule upon, not for the Lyon T. com., and so are any side claims linked to this patent infringement (such as the passing off claim).

The court also stated that the various violations of the Code de la santé publique alleged by the patentee were not relevant, because this is a law which does not regulate competition between pharma companies:

All the violations of the Code de la santé publique which are alleged do not aim at protecting competition but rather public health, notably by imposing rules of ethics to pharmaceutical labs and by imposing advertising rules protecting drug consumers. 

The alleged violations are not within the ambit of jurisdiction of the juge des référés of the tribunal de commerce, for deciding measures of injunction […] similar to those that the infringement judge could take, because these violations, if they existed, would not constitute a manifestly illicit breach of free competition. 

And thus the logical conclusion was that:

[…] although it is certain that the juge des référés of the tribunal de commerce has in principle jurisdiction with respect to proven unfair competition, when there is a manifestly illicit breach, in order to take preliminary and injunction measures, even if there is a serious defense, because he is the natural judge between two commercial companies, […] the special provisions of the Code de la propriété intellectuelle prevail when, as in the present case, commercial parties are opposed in a lawsuit relating to intellectual property, the judge of which, having jurisdiction for ruling on the validity of the title or on infringement, has been previously applied to, before the urgency unfair competition claim. 

The judge of the Lyon tribunal de commerce has thus in this case no jurisdiction for ruling as he did and committed abuse of power.

Last but not least, the court ordered AstraZeneca to pay 100,000 euros of attorney fees to Mylan, which looks like a fairly high amount in the context of urgency proceedings. Courts have an almost complete discretion in terms of reimbursement of attorney fees, which they decide on as a matter of equity. Usually, when the amount is remarkably high, there is a sense that the court may have wanted to punish the losing party and to send a warning message.


CASE REFERENCE: Cour d’appel de Lyon, 1ère chambre civile, section A, December 17, 2015, Mylan SAS v. AstraZeneca SAS & AstraZeneca AB,
RG No. 2015/08783.

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