Extension of subject-matter and/or of scope

Every profession has its own telltale expressions.

Let’s say you meet someone at an event who tells you that they will have some cheese “and/or” a glass of red wine; I would bet that you are talking to a patent attorney. Well, especially so if the event is hosted by the CNCPI.

But, as fond as we may be of the “and/or” language, in some occasions it can come back to haunt us. Just ask Nice. Not the city, but an Italian company specialized in automatic doors or gates.

Nice owns European patent No. EP 1509823 directed to an electrical system for controlling a gate or door.

In 2010, Nice filed a complaint for infringement of this patent against FAAC France and FAAC Nord in front of the Paris Tribunal de grande instance (TGI). There are three independent claims 1 to 3 in the patent, the others being dependent claims. Nice initially asserted claims 3 to 23. The two other independent claims 1 and 2 were not at stake. The defendants counterclaimed for nullity.

The following year, as the first instance lawsuit was ongoing, a request for central limitation was filed at the EPO. As a result, a limited version of the patent (B3-1) was published in 2012.

Nevertheless, all asserted claims were held invalid by the Paris TGI in its 2014 judgment. Sadly, the decision does not seem to be readily available online, so I am not sure what ground for nullity was entertained by the first instance court.

Nice appealed and filed a second request for central limitation at the EPO in 2015.

As a result, a second limited version of the patent (B3-2) was published in 2016. This leads us to the recent judgment of the Paris Cour d’appel, which confirmed the invalidity of all asserted claims and in particular independent claim 3. The court held that the subject-matter of the claim extended beyond the contents of the application as filed and that the scope of protection had been extended after grant.

Who needs an automatic door control system when you can have a frog do the job.

Here is claim 3 of the patent as initially granted (B1 version of the patent):

Electrical system for controlling at least one gate or door or similar element of the type moved by means of at least one corresponding electric motor, comprising:
a) an electric network consisting of two electric wires adapted to allow distribution of power supply and digital information;
b) a central control unit having two terminals adapted to be connected respectively but indifferently to the two wires of the network in order to transmit direct-current power supply and to transmit and receive digital information;
c) one or more peripheral units, each having two terminals adapted to be connected respectively but indifferently to the two wires of the network in order to receive direct-current power supply and to receive and/or transmit digital information;
wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements;
wherein a peripheral unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements.

The two last paragraphs of the claim are the important ones for the rest of the discussion. Note the four occurrences of “and/or“.

In the first limited version of the patent (B3-1), a number of features were added; and the two relevant paragraphs of claim 3 were modified as follows:

[…] wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and to a device for entering requests of movement of the gate or door or to a safety device for gates or doors;
wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

In the second limited version of the patent (B3-2), yet further features were added; and the two relevant paragraphs of claim 3 were modified as follows

[…] wherein the central unit is adapted to be electrically connected to the electric motor for controlling operation thereof and to a safety device for the gate or door;
wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

Let’s turn to the appraisal of extension of subject-matter of the final version of the patent, namely B3-2.

In original claim 3 in the patent application as filed, the two relevant paragraphs were the same as in the B1 patent, namely:

[…] wherein the central unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements;
wherein a peripheral unit is adapted to be electrically connected to an electric motor for controlling operation thereof and/or to a device for entering requests of movement of the gate or door or similar element and/or to a safety device for gates or doors or similar elements.

“And/or” is usually taken to mean either “and”, or an exclusive “or”.  So, at first sight, one could think that claim 3 in B3-2 was obtained by simply deleting some options from original claim 3, without giving rise to any added matter concern. And one would be wrong, at least according to the Cour d’appel.

Indeed, the court did not simply rely on original claim 3 but turned to the description of the application in order to understand what the subject-matter of the invention, or more specifically of the “third embodiment” of the invention (corresponding to claim 3), actually is about.

The court held the following:

The invention relates to the use of an electric network made of only two electric wires for the entire system, which are designed so as to deliver DC current and numerical information, and so as not to impose constraints on the connection between system equipment and the network. 

This electrical system, intended to control at least a gate or door, must be connected to at least three main devices: 

– an electric motor which sets the gate in motion, 

– a device for entering requests of movement of the gate, 

– a safety device (for example based on a photoelectric cell).

According to the court, claim 3 as filed (or as granted) thus required the presence of all three devices – although they could be connected either to the central unit or a peripheral unit. This was not explicitly stated in claim 3, but the court held that this could be inferred from the description.

The court quoted in particular the following sentence, which is just before the presentation of the various embodiments in the application:

Such an electrical control system must be connected to at least three essential devices: an electric motor for moving the gate, a device for entering requests of movement of the gate (for example a key-operated selector, a command keypad, a remote control receiver, etc.), a safety device (for example a photocell system, a sensitive edges system, a mat presence detector, a radar presence detector, etc.).

The court also quoted the following characterization of the third embodiment:

In other words, according to this third embodiment, two of the essential devices are connected electrically directly to the central unit, while the third essential device is connected electrically to a peripheral unit.

In contrast, according to claim 3 of the B3-2 patent, the second device was mentioned only in connection with the peripheral unit, and not in connection with the central unit, and the mention in question was the following:

[…] wherein a peripheral unit is adapted to be electrically connected to a safety device for gates or doors or to a device for entering requests of movement of the gate or door; […]

Therefore, according to the amended claim, the device for entering requests of movement can be omitted altogether. This, the court said, is not supported by the application as filed.

Nice argued that, if the claimed peripheral unit is connected to a safety device, then the device for entering requests will be connected to yet another peripheral unit so that the system can work. But the court discarded the argument and said it was an inventive step-type of argument.

Thus, the court declared that the subject-matter of claim 3 extended beyond the content of the application as filed.

Furthermore, since the granted patent was similar to the application as filed and was thus interpreted by the court as not covering the option wherein the device for entering requests is absent from the system, the B3-2 limited patent was also found to suffer from extension of the scope of protection, since this limited patent no longer required the presence of the device for entering requests.

Once again, we are reminded that French courts have a tendency to extensively interpret claims (not just granted claims, but also original claims) in the light of the description.

How would the extension attack have flown with an opposition division at the EPO? I am quite sure that they would have focused more on the exact language used in original claim 3. That said, they could theoretically have reached the same conclusion as the French judges, for instance by noting that going from original claim 3 to amended claim 3 required multiple selections in the “and/or” options, and that there was no pointer to such a multiple selection (or combination of features).

In summary, “and/or” is nice and broad, but beware of what the teaching of the invention actually is.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, November 9, 2018, Nice v. FAAC France, RG No. 16/11888.

The “pays” of the PIs?

A hardly understandable question, I know.

“Pays” is the French word for “country”. As for PIs, this term refers of course to preliminary injunctions. A PI is the most dreaded weapon of right holders.

But this legendary prize is also famous for being extremely hard to seize, notably in France. Although… could the trend have recently changed?

One ruling in particular which was issued last June in a prominent pharma case gave rise to a lot of comments. But another ruling issued just one month later also followed a somewhat similar path.

French chemical company Minakem sued two companies of the M2i group, namely Melchior Material and Life Sciences France (MMLS) and M2i Salin (M2i). MMLS owns a patent family on a method for making bromo methyl cyclopropane and bromo methyl cyclobutane. Minakem claimed ownership of this patent family and also complained that MMLS and M2i infringed its own patent No. FR 3010997, filed a few months before the priority date of the MMLS patent family. The two actions were joined as a consolidated case.

The ruling reported today does not contain much information on the context of Minakem’s ownership claim. It is an order issued by the judge in charge of case management, who was presented with a motion for PI by the plaintiff. MMLS and M2i raised invalidity and non-infringement as means of defense – but both grounds of defense were rejected.

Let’s start with validity first. The defendants argued that claim 1 of the Minakem patent lacks inventive step over a so-called Bayer document.

Now seems like a good time to have a look at the claim, which is quite straightforward:

A method of preparing bromo methyl cyclopropane comprising a step a) of reacting cyclopropylcarbinol with a complex of triphenylphosphite and bromine. 

Making reference to the problem and solution approach for the inventive step reasoning, the judge first noted that all parties agreed that the Bayer document was the closest prior art. According to this document, bromo methyl cyclopropane is prepared by reacting triphenylphosphine with cyclopropylcarbinol, and, after cooling, adding bromine.

The judge then held that there are two differences between the claimed invention and the teaching of the Bayer document, namely:

  • The use of triphenylphosphite instead of triphenylphosphine as a reactant: this is a one-letter difference in the name, and more importantly, three additional oxygen atoms in the molecule.
  • The use of a complex of triphenylphosphite and bromine, instead of adding bromine in a subsequent step.

Two documents were offered as secondary references, designated as D.G. Coe and Eli Lilly.

D.G. Coe teaches that triphenylphosphite can be used as a reactant to make alkyl halides (a class which encompasses the bromo methyl cyclopropane at stake here). But the judge noted that, according to the document, the reaction does not work similarly with all alcohols, and in particular that it provides very unsatisfactory results with cyclohexanol. Since cyclohexanol is a cyclic compound, just like cyclopropylcarbinol, the judge was convinced that the skilled person would have been dissuaded by D.G. Coe from reacting a triphenylphosphite complex with cyclopropylcarbinol, as claimed.

As for the second reference, Eli Lilly, it also discloses complexes of the type triphenylphosphite / halogen (e.g. bromine), as well as their potential use for a reaction with aliphatic alcohols, for making alkyl halides. But the document also emphasizes a new use for making vinyl halides by reacting these complexes with enol compounds. The judge concluded that Eli Lilly rather teaches to react the claimed complex with other compounds than aliphatic alcohols such as cyclopropylcarbinol. I am not sure I quite understand why the fact that the document both refers to a traditional use and to a new use of a chemical complex makes the traditional use less obvious than the new use. But on the other hand, it is true that the focus of the document is not on the preparation of alkyl halides.

What I actually found to be perhaps the most instructive in the judge’s reasoning is a mention of two side arguments.

First, the judge noted the following, regarding the sequence of steps in the claimed invention (first, formation of the bromine / triphenylphosphite complex, and then reaction with cyclopropylcarbinol):

This sequence is all the more important as MMLS and M2i precisely insisted on it in order to justify the inventive step of their own patent application filed in the United States, so as to discard the Bayer document which was cited as a prior art, since it disclosed a different order of introduction of reactants. They notably argued that “the particular order of the steps is essential to avoid a side reaction resulting in the opening of the tight ring, thus leading to the formation of a brominated alkene (bromobutene)” and that “this method is advantageous relative to the state of the art”.

This has the flavor of a file wrapper estoppel, and one based on a foreign file wrapper, at that.

But as is usually the case, this only comes as an additional consideration at the end of the reasoning in the ruling.

Second, the judge emphasized that both of the proposed secondary references were fairly old. D.G. Coe was dated 1954, and Eli Lilly was dated 1980.

A strong flavor of secondary indicia of inventive step, if you will.

Some fairly old prior art.

The other defense raised by MMLS and M2i was non-infringement.

The judge in charge of case management thus had to decide whether the existence of infringement was likely or not.

The process implemented by the defendants was known owing to an infringement seizure report.

The main non-infringement argument was that, in the defendants’ process, bromine is used in excess in the reaction with triphenylphosphite (TPP). This leads, they said, to the formation of bromo triphenoxy phosphonium bromide as an intermediate. This is not a TPP / bromine complex as recited in claim 1 of the Minakem patent, they argued, because of the presence of the bromide ion in the intermediate. In contrast, the TPP / bromine complex does not comprise a bromide ion and, according to the description of the patent, it is obtained with an excess of TPP (rather than an excess of bromine). They also insisted that the difference is significant, as their own process leads to a lower proportion of bromo butene by-product than the claimed one.

The judge was not convinced. He noted that the starting materials of the MMLS / Mi2 process are the same as those of the Minakem patent. So is the order of the reaction steps. The judge was not convinced either by the alleged difference in molar proportions of reactants:

[…] The scope of claim 1 of the FR’997 patent is not limited by any proportion, so that it does not necessarily and only cover a process limited to equivalent amounts of bromine and [TPP], and anyway the bromine excess alleged by MMLS and M2i is only low in view of the figures which were communicated. 

It is noteworthy that Minakem filed an affidavit from a chemistry professor that challenged the influence of the relative amount of bromine on the purity of the product.

The judge also noted that the different bromo triphenoxy phosphonium bromide intermediate relied upon by the defendants was not mentioned by the employees who were interrogated during the infringement seizure. And that this intermediate is not mentioned in MMLS’s own patent applications either.

As a conclusion, the infringement of the Minakem patent was found to be likely. The judge thus granted Minakem the PI that they requested, without security in view of Minakem’s financial health. However, the judge rejected Minakem’s request for provisional damages. This is because the evidence for the proposed computation of damages offered by Minakem, based only on an affidavit of their CFO without any external auditing corroboration, was insufficient.

To be continued on the merits! MMLS and M2i have their work cut out for them: it seems like they need to find new arguments if they want to turn the tables and ultimately prevail. I am especially curious to see how the ownership claim in relation to the defendants’ patent family will unfold.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance du juge de la mise en état, 3ème chambre 2ème section, July 6, 2018, Minakem v. Melchior Material and Life Science France & M2I Salin,RG No. 17/15019.

It-which-must-not-be-named

Some pharma cases are somewhat delicate to discuss in a blog post.

Case in point, if I provide the commercial name of the drug at stake in today’s litigation, I am afraid that this post may be classified as a spam and may thus never reach my email subscribers.

You see, it is the sort of drug which is prescribed for the treatment of erectile dysfunction, and which keeps coming up in these pestering unsolicited email messages that you may receive on a daily basis.

Just to be clear, today’s drug-which-must-not-be-named is not the famous one that starts with a V (containing sildenafil as an active compound), but the other famous one that starts with a C (containing tadalafil as an active compound).

He-who-must-not-be-named.

Icos Corporation (of the Eli Lilly group) is the owner of a number of European patents in connection with the C. drug.

First, there is EP 0740668, which was the basic patent for a French Supplementary Protection Certificate (SPC No. FR 03C0017), which expired in November 2017. Second, there are EP 1173181 and EP 1200092, designated as “secondary patents” by the Paris Tribunal de grande instance (TGI).

In November 2014, generic drug company Mylan obtained a marketing authorization (MA) related to the C. drug. In January 2016, Mylan initiated nullity proceedings with respect to the EP’181 and EP’092 patents in front of the Paris TGI. The parties later reached a settlement agreement with respect to EP’092, so that only the fate of EP’181 remained to be decided upon. Icos Corporation and the French distributor Lilly France counterclaimed for infringement of EP’181. The first instance judgment was issued in May 2018.

EP’181 or equivalents thereof were or are also litigated in other countries. According to the summary provided by the court, the patents were revoked in Germany, the United Kingdom, Canada and Japan. It may thus come as little surprising that the same outcome was achieved in this country. On the other hand, the ground for nullity that the TGI took into consideration is relatively unexpected, as will be apparent below.

But before getting there, let’s first look at the statute of limitations defense raised by Icos.

Mylan argued that the statute of limitations is not applicable to patent nullity suits. This argument was rejected by the court, in keeping with earlier decisions.

Turning to the determination of the starting point for the limitation period, the court recalled its now established principle of an in concreto determination.

The court thus explained that the grant of the EP’181 patent was not the starting point for the limitation period. The general principle is the following:

The starting point for the limitation period must thus be set at the date, determined in concreto, at which Mylan was or should have been aware of EP’181, due to its intent to market a generic of the drug [C.], which led to the MA obtained on November 21, 2014, since this patent is an impediment to its exploitation.  

In this case, a determining factor to be taken into account was the date at which Icos obtained its own MA:

In this case, the first MA for [C.] was granted in November 2002. By way of application of article R. 5121-28 of the Code de la santé publique, the generic company can only apply for an MA as from the eighth year after the grant of the originator’s MA, and cannot be granted one before the tenth year. Therefore, Mylan could not file an MA application before November 2010.

This reasoning is fully consistent with that applied in another recent case which already involved Mylan.

However, this is not the end of the story here. The court further held:

In this case, an additional fact should be taken into account in the in concreto analysis of standing and the starting point for the limitation period. […] [Namely, Icos corporation] filed a request for limitation of the EP’181 patent on February 14, 2014 with the European patent office, and the limitation of the patent was published on March 25, 2015. 

Thus the patent enforceable against Mylan could only be known on this date, so that the starting point for the limitation period is March 25, 2015. 

In another recent case, the starting point of the limitation period was postponed by a court to the date of the decision of the Board of appeal of the EPO in the opposition appeal regarding the patent at stake. The relevant paragraph of this decision may be worth quoting again here:

[…] It is only on [July, 7, 2014, i.e. the date of the Board of appeal’s decision] that the drafting of the patent which is sought to be revoked was stabilized and that Ethypharm was able to precisely know the content of the claims of said patent as well as all the facts making it possible for them to act, so that the action is not time-barred and is admissible. 

We now have a confirmation that limitation proceedings, just like opposition proceedings, may result in a postponement of the limitation period for nullity actions.

It remains to be seen how general this principle is and in particular whether it extends e.g. to the impact of other lawsuits involving third parties.

Turning now to the merits of the case, claim 1 of EP’181 as limited reads as follows:

A pharmaceutical unit dosage composition comprising 1 to 5 mg of [tadalafil], said unit dosage form suitable for oral administration up to a maximum total dose of 5 mg per day.

Independent claim 10 is a Swiss-type claim containing similar features.

Mylan raised all classical grounds for nullity, but the court focused on insufficiency of disclosure.

After reviewing the description of the patent, the court noted the following facts:

  • There are several molecules belonging to the class of type 5 phosphodiesterase (PDE5) inhibitors.
  • Among them, particular reference may be made to sildenafil, the active compound of V., marketed at the priority date of the patent in doses of 25, 50 and 100 mg.
  • However, sildenafil generates a number of side effects, such as facial red patches, or a lowering of blood pressure.
  • The invention thus relates to a low dosage of the known alternative drug tadalafil, in order to provide an effective treatment of erectile dysfunction without the side effects associated with sildenafil.
  • The patent also contains a number of examples showing the efficacy and the absence of side effects of low dosage forms of tadalafil.

The court was apparently quite puzzled by the patent as a whole:

The problem expressed in the description of the patent is to provide a principle which avoids the issues of red patches and side effects of sildenafil by a particular dosage of tadalafil. 

Indeed, and as rightly noted by Mylan, no side effect associated with tadalafil is mentioned in the patent, so that the dosage suggested for tadalafil curiously addresses a problem associated with another active compound. 

The court then referred to a standard mentioned in the so-called “finasteride” judgment of December 6, 2017 by the Cour de cassation, commented on this blog:

[…] When a claim relates to a [second] therapeutic application of a substance or composition, obtaining this therapeutic effect is a functional technical feature of the claim. Therefore, in order to meet the requirement of sufficiency of disclosure, it is not necessary to clinically demonstrate this technical effect; but the patent application must directly and unambiguously reflect the claimed therapeutic application, so that the skilled person can understand, based on commonly accepted models, that the results reflect this therapeutic application.

The court then came back to the technical problem presented in the patent:

Icos Corporation and Eli Lilly do not dispute that no prior art document describes any side effect related to the use of tadalafil.
And they cannot validly argue that the absence of documentation in this respect does not amount to the absence of a problem, because the onus is on them to show that there was a problem to be solved and that it is solved by the teaching of the patent.
It thus appears that the problem described in the patent relates to sildenafil and not tadalafil, and it cannot be extrapolated that both active compounds have the same side effects, unless one were to admit the resolution of artificial or speculative problems.
In fact, the examples cited in the patent demonstrate that the dosage mentioned in the patent does not address the listed “problems”. 

In summary, the problem to be solved cannot be considered as the reduction in the side effects of tadalafil, because such side effects were not known in the prior art – only side effects of sildenafil were known.

Most of the examples of the patent also do not demonstrate the existence of side effects of tadalafil associated with higher dosages, so that these were held not to “reflect” the alleged therapeutic application (using the wording of the Cour de cassation).

The conclusion reached by the three-judge panel will not doubt cause a stir, as the invention recited in claim 1 was found not to be sufficiently disclosed in the patent.

The finasteride case related to a second therapeutic application invention, for a known molecule. It is well accepted both at the EPO and in French national courts that the new therapeutic application has to be demonstrated in a plausible manner in the patent, otherwise the patent is insufficient.

Yet, in the present case, claim 1 is a classical product claim, with no functional feature. According to EPO case law, there should be no problem of insufficiency of disclosure, because the skilled person is able to manufacture the composition containing the active substance at stake in the claimed dosage range. The question of whether said claimed dosage range provides any technical benefit or not only pertains to the appraisal of inventive step.

Now, as regular readers of this blog are well aware, the French approach to validity is much more fluid than the EPO’s.

If a court is convinced that an invention does not properly solve the alleged technical problem, or that the technical problem is artificial, this can give rise to a number of invalidity objections, including insufficiency of disclosure. My understanding is that the technical problem tends to be viewed by French courts as an integral part of the claimed invention itself.

But there is yet another cause for controversy in the judgment.

I mentioned above that most of the examples of the patent do not demonstrate the existence of side effects of tadalafil associated with higher dosages. That said, there is one example, namely example 7, which does analyze in detail the occurrence of various side effects depending on the dosage of tadalafil. The table of results is in fact even reproduced in the judgment. The court first remarked that some side effects are not present at all at any dosage. So far so good. But, regarding those side effects which are indeed shown to be less frequent in the claimed dosage range than at a higher dosage, the court noted:

Regarding headache, back pain and myalgia […], the reasoning is the same because these effects were never previously observed.

This part of the judgment seems to imply that, at least in the context of drug dosage patents, the existence of the technical problem to be solved must be acknowledged in the prior art, and cannot be demonstrated for the first time in the patent itself.

The invention can thus not be a so-called “problem invention“.

Things should be put into perspective, though, and the present case may not necessarily be generalized. Maybe the court did not believe that example 7 was convincing at all. At the very least, the fact that the dosage originally claimed in the patent, namely from 1 to 20 mg, had to be later restricted to 1 to 5 mg, due to some relevant prior art, certainly contributed to the court’s perception of the patent being invalid.

In fact, the court reviewed all the following claims and concluded that they suffered from the same deficiencies as claim 1, mentioning a lack of inventive step in passing for some of them. Fluidity of the grounds for nullity indeed.

As a final note, this is probably one of the last judgments penned by Ms. Courboulay, who, given her seniority and her involvement in many conferences and events, was often considered as the leading judge in the 3rd (IP) chamber of the Paris TGI.

Ms. Courboulay has now officially retired; but given the large number of important rulings which she authored, there is little doubt that her influence will continue to be felt in the coming years.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, April 5, 2018, Mylan v. Lilly France & Icos Corporation, RG No.16/05073.

A clear judgment

For better or worse, lack of clarity is not a ground for opposition at the EPO. This is not to say that lack of clarity is not a frequent issue in granted patent claims. But there is not much you can do about it. Unless, that is, the lack of clarity also translates into a different type of defect which happens to be a ground for opposition. Such as insufficiency of disclosure, lack of novelty or extension of subject-matter.

So it is a very common game during opposition proceedings for patentees to claim that objections raised against their patents are disguised clarity attacks. And for opponents to reply that no, they are much more than that.

At which point do unclear things become so unclear that they can actually not be reproduced?

The same game can also be played in front of national courts, as lack of clarity is not a ground of nullity either. 

The game seems to be somewhat less popular there. But today’s judgment issued by the Paris Tribunal de grande instance (TGI) provides an illustration.

Guerbet is a French company specialized in medical imaging products. It owns a French patent No. FR 2927539 on a composition of contrast agent. Bayer Pharma (which I probably do not need to introduce) filed a nullity suit against this patent in July 2015. In May 2016, Guerbet’s patent was limited at the INPI.

Interestingly, this French patent is part of a much broader family including several European applications or patents, two of which were opposed by several competitors. But the litigation was restricted to this French priority patent.

The court nicely summarized the invention in the judgment. The patent at stake relates to an MRI (Magnetic Resonance Imaging) contrast agent formulation.

The formulation is based on a metal of the lanthanide series, such as gadolinium, which is complexed by a macrocyclic chelate, known as DOTA. Free lanthanide is toxic, therefore it needs to be bonded in the complex. In fact, a slight excess of chelate is desirable in order to prevent any risk of undesirable release of free metal within the patient’s body.

But the excess of chelate needs to remain small because the chelate itself is also toxic – although, I assume, less so than gadolinium. An amount of excess free chelate of 0.002 to 0.4% has been found to be optimal. One difficulty is how to accurately achieve this precise dosage on the industrial scale, and in a stable manner. The invention consists in a preparation process in which a certain concentration of free chelate or free lanthanide is achieved in an intermediate formulation, and then an adjustment is carried out in order to reach the proper concentration specifications.

There are two independent process claims 1 and 2 in the patent as limited at the INPI.

For once, let’s start with looking at claim 2:

A process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4% […], the macrocyclic chelate being DOTA and the lanthanide being gadolinium, said process comprising the following successive steps:
a) determination of a theoretical target concentration in free macrocyclic chelate Ctcl in the final liquid pharmaceutical formulation;
b) preparation of a liquid pharmaceutical composition containing the complex of macrocyclic chelate with a lanthanide, and free macrocyclic chelate and/or free lanthanide, by mixing free macrocyclic chelate and free lanthanide in a solution, so as to obtain complexation of the lanthanide by the macrocyclic chelate, the amounts of free macrocyclic chelate and of free lanthanide added being such that there is a deviation between the amounts of added free macrocyclic chelate and free lanthanide and stoichiometric proportions, and such that all the lanthanide is complexed and Ccl > Ctcl, […];
c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate Ccl, the concentration of free lanthanide Cll being equal to 0;
d) adjustment of Ccl so as to obtain Ccl=Ctcl and Cll being equal to 0, by suppressing free macrocyclic chelate and/or by adding free lanthanide and/or by modifying the pH. 

Claim 1 is very similar except that at step b) all the lanthanide is not complexed. The amount of free lanthanide is measured at step c) and more free marocyclic chelate is added at step d) to achieve the target concentrations.

This now leads us to the objection of extension of subject-matter raised by Bayer Pharma.

Bayer Pharma noted that there is a contradiction in step b) of claim 2, which refers to the preparation of a composition which may contain free lanthanide, although it is specified at the end of the step that all the lanthanide is complexed. Such a combination of features was not disclosed in the original application as filed, they said. They also added that the claim was the result of an intermediate generalization, since the feature that all the lanthanide is complexed at step b) was originally disclosed only in connection with a particular embodiment, called case B (involving in particular the use of an excess of macrocyclic chelate at step b)).

But the court was not convinced that this feature could not be generalized to other embodiments, and considered that the contradiction mentioned by Bayer Pharma was a mere lack of clarity, not an issue of extension of subject-matter:

Although this functional feature is made explicit for one of the three variants of the manufacturing process (case “B”), without being contemplated for cases A and C, it remains that it is indeed contemplated as an option disclosed in the initial application. Its title, related to a process for manufacturing a formulation, can lead the skilled person, who is a chemist used to combining different formulas, not to consider that this feature is excluded of all the other embodiments. The fact that this requirement […] can be in contradiction with another feature of this claim (namely the presence of free lanthanide) may potentially be a matter of lack of clarity but not of undue extension of the subject-matter of the patent. 

This clarity discussion then continues in the next part of the judgment dedicated to Bayer’s insufficiency objection.

Here is what the court had to say in this context (as usual, I am taking the liberty of slicing our beloved never-ending sentences into shorter phrases):

[…] It can be derived from common general knowledge that it is impossible for both free lanthanide to be present and for the complexation of the lanthanide to be total. Therefore, [the skilled person] will read the patent in a manner which will give it effect. [The patent] recites various steps for making the dissolution process, measuring and adjusting. [The skilled person] will understand that the total complexation of lanthanide can be performed later and that this circumstance does not result in an impossibility to reproduce the [invention], which requires to implement claim 2 as a whole, without focusing on one of its steps only without taking the other ones into account. 

Here, the approach of reading the patent in a constructive manner, with a “mind willing to understand“, as they are wont to say at the EPO, goes as far as making it possible to ignore an apparent contradiction in the wording of a claim.

In other words, the skilled person is presumed to resolve the contradiction by correcting and adding information to the claim.

It is not really surprising that the French court adopted this approach, in view of the longstanding tradition in this country of extensively relying more on the description for interpreting the claimed invention, instead of focusing on the exact wording of the claims.

Apart from this, the rest of the insufficiency discussion is also quite enlightening.

Regarding claim 1 in particular (the variant wherein there is some free lanthanide left at the end of step b)), Guerbet relied on example 2 of the patent.

But Bayer Pharma said that the example was not according to claim 1. Actually, when reproducing this example, a significant amount of free chelate was obtained at the end of step b). This is a problem because, at the following measuring step c), the concentration of free chelate is supposed to be zero, according to claim 1.

The TGI addressed this objection by stating that claim 1 does not require that all the chelate should necessarily be complexed at the end of step b). Otherwise, measuring step c) would actually be useless.

The court added:

Consequently, this step c) comprises a functional feature – achieving a total complexation of DOTA – in order to perform the measurement of free gadolinium which will precisely be made on a sample taken during step c), and which would be useless if the complexation of DOTA were total at the end of step b), as alleged by Bayer Pharma. 

Therefore, even if step c) of claim 1 does not explicitly mention that it requires a modification of the collected sample, this modification implicitly derives from the functional feature that it requires to perform the desired measurement, namely a concentration in free macrocyclic chelate Ccl that has to be equal to zero.

Here again, the court did not restrict the interpretation to what the claim actually recites.

Although the claim is silent as to the collection of a sample and the modification of the sample before performing the measurement, the court considered that these features are implicitly present in the claim in view of the description and in particular example 2.

The court also accepted Guerbet’s explanations that the modification of the sample at step c) could be performed by raising the pH through the addition of meglumine, and that the skilled person could rely on common general knowledge to perform such a modification.

Bayer Pharma further argued that the range of pH making it possible to achieve full complexation was not known. The court again sided with Guerbet on this aspect and accepted that a specialized scientific article and a university textbook discussing chemical equilibriums in general provided the skilled person with the necessary information.

Thus, the process of claim 1 was found to be sufficiently disclosed.

Turning again to claim 2, the patent in suit does not contain any example of implementation. But the court was satisfied that the process of claim 2 was analogous to the process of claim 1, so that it could also be carried out without undue burden.

In keeping with the case law of the Boards of appeal of the EPO, the presence of an example of a chemical invention in the patent is thus not an absolute requirement for sufficiency of disclosure to be acknowledged:

Thus, the skilled person, who may implement claim 1 as indicated above, for the same reasons […], is also able to implement claim 2 notably by relying on common general knowledge, so that the absence of an example to illustrate this claim does not make it insufficiently disclosed. 

The judgment then goes on with addressing an inventive step attack, which was also rejected.

Bayer Pharma’s nullity action thus failed. Who said pharma-oriented patents are always invalidated in this country?


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 23, 2018, Bayer Pharma Aktiengesellschaft v. Guerbet, RG No. 15/12348.

All out disclosure

I have already expressed the view several times on this blog that public prior use is usually a very difficult argument to prevail on, due to the extremely demanding standard of proof which is normally required.

And this can of course be frustrating for a third party that positively knows that there has indeed been a public prior use.

But from time to time, the argument does succeed, and it is then always instructive to see what made success possible.

In the present case, the German cosmetic company Beiersdorf AG (think NIVEA®) is the owner of European patent EP 1834630. They initiated legal proceedings against two French companies which are part of a U.S. group, namely Laboratoire Bioderma and DIPTA, which later became Naos and Naos Les Laboratoires respectively (hereafter “Naos“).

Beiersdorf deemed that Naos’ cosmetic products Photoderm AR SPF 50+, Photoderm Laser SPF 50+ and Photoderm Spot SPF 50+ infringed claims 1 to 3 of the EP’630 patent.

In the course of the proceedings, the French part of patent was limited in front of the INPI, as is very usual in patent litigation in this country.

Naos did not dispute that the allegedly infringing products implement the subject-matter of the EP’630 patent. But they argued that the patent claims are invalid because one of these products, Photoderm Spot SPF 50+, was publicly disclosed before the priority date of the patent.

Let’s now have a look at claim 1 of the patent as limited during litigation (the two other claims at stake are dependent claims):

Cosmetic preparations comprising active ingredient combinations comprising:
(i) glycyrrhizin and/or glycyrrhetic acid and
(ii) 2,4-bis{[9-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, 

characterized in that they contain from 0.001 to 0.5 % by weight of glycyrrhizin and/or glycyrrhetic acid, relative to the total weight of the preparation. 

The main purpose of the claimed “preparations” is to increase pigmentation of the skin and avoid UV damage to the skin. Compound (ii) is also known as Tinosorb S, which is much easier to write and read, thank you very much.

Naos explained that preparatory steps had been taken prior to March 1, 2006 (the priority date of the patent) to put Photoderm Spot SPF 50+ on the market. The body of evidence provided by Naos was the following:

  • A letter sent to a laboratory in Brazil on December 1, 2005.
  • A product datasheet certified by the Chamber of commerce of Lyon on November 31, 2005, intended for registering the product with the Brazilian administration.
  • Product datasheets sent to French and Portuguese poison control centers on December 6, 2005.
  • Various letters for the purpose of registering the product in Ukraine, Greece, Romania and Venezuela, sent in January-February 2006.
  • A pass for press sent to a printing company for printing the Photoderm Spot packages in December 2005-January 2006.
Sending letters all around the place.

Some of the evidence was discarded by the court.

In particular, the pass for press was deemed to be an insufficient disclosure because the packaging to be printed did not contain any information on the amounts of the ingredients in the product.

All of the other documents contained the complete information on the composition of the product. However, the letter sent to the French poison control center was also discarded because the center had to treat it in a confidential manner, under French law.

Regarding the rest of the documents, the court stated the following:

[…] On the one hand, as many as five pieces of evidence of a disclosure to third parties, on a number of territories, in France and abroad (Brazil, Portugal, Ukraine, Greece, Romania, Venezuela), of the qualitative and quantitative formula of the product at stake, were filed. These documents were sent between December 1, 2005 and February 23, 2006, which is before the priority [date]. On the other hand, these documents were sent to different recipients able to appreciate their contents, as they are used to processing this kind of information, since they were intended either for laboratories or for foreign people and/or authorities in order precisely to prepare the launch of the product and/or to obtain the required authorizations, thus aiming at a distribution to the public. Besides, some shipments were accompanied by a “free sale certificate” which precisely suggests that the communication made was specifically intended to be distributed to the public. 

Lastly and most importantly, none of these documents comprises any express mention of confidentiality by DIPTA, which carried out the shipments to these recipients, and thus any prior identification by this company of their confidential character. Only the one sent to the poison control center in Portugal made an implicit reference to this as it mentioned a shipment under “sealed envelope”, as well as the shipment for registering the product in Venezuela as it mentioned the “restricted use quali-quantitative formulas for actives and substances”. However, these mentions, which are not present in the other shipments and which are vague and unclear, do not make it possible to deduce an express request for confidentiality. 

The court concluded that the formula of the Photoderm Spot SPF 50+ product was indeed made available to the public before the priority date of the patent.

Since the formula comprises 0.1% of glycyrrhetic acid and 1.5% of Tinosorb S, claim 1 was found to lack novelty – the same conclusion applying to dependent claims 2 and 3. Therefore, Beiersdorf’s action failed.

Every public prior use case is unique. And I have the distinct feeling that the outcome of this one is closely related to the large number of (inter-related) disclosures of the cosmetic formula.

One or two shipments might have been possible to overcome, but multiple shipments were probably too high of a hurdle. Although the court recalled that the burden of proof lies with the nullity claimant, it was certainly more difficult for Beiersdorf to convince the judges that shipments carried out all over the place were all confidential – in the absence of an explicit mention on the letters.

It can be surmised that, even if the court had not concluded that there was a lack of novelty, Naos would then anyway have been in a quite good position for a non-infringement defense based on prior user’s rights – which was their auxiliary argumentation.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, March 9, 2018, Beiersdorf AG v. Naos & Naos Les Laboratoires, RG No. 14/08701.