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 be 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.

Competence? Competence!

When international private law meets patent law, things never fail to get interestingly complex.

Today’s case pits a German plaintiff, TerraNova Energy GmbH & Co. against a French defendant, Suez International SAS, and the litigation involves a number of patents and patent applications worldwide.

The background of the case is the following (according to the summary provided by the judge in the order to be discussed).

TerraNova developed a technology for recycling organic waste recovered from sewage sludge. Suez International, originally Degrémont, is now part of the Suez group, a major actor in the water and waste treatment industry.

Between April 2011 and October 2012, TerraNova presented its so-called “Ultra” technology to Suez in a demo plant in Germany. A non-disclosure agreement (NDA) was signed in November 2012. Both companies continued to cooperate, which led to the execution of a second, partnership agreement in April 2013. According to this partnership agreement, Suez had an exclusive right to the Ultra technology in France, and had a preemption right on the technology in other countries.

In 2013 and 2014, the Ultra technology was implemented in a sewage treatment plant in Compiègne, France and then in another facility in Maribor, Slovenia. In May 2014, the parties began negotiating a license agreement. November 2014 is the point in time when things started going south, as Suez informed TerraNova that they wanted to improve the Ultra technology, and to work on this new process in China. Then, they announced that they no longer intended to get a license, having developed their own improved process.

In January 2015, Suez offered to pay royalties for the ongoing Chinese project and for a potential second one, and requested exclusive rights in China. TerraNova refused. In October 2015, Suez opened a renegotiation of the 2013 partnership agreement and mentioned the development of its own, distinct technology. TerraNova then realized that Suez had filed three PCT applications, based on three French priority applications filed respectively in May 2013, July 2013 and November 2014. A number of granted patents and pending applications were later filed from these PCT applications, in Europe, China, the U.S., Canada, Australia and Brazil.

TerraNova was of the opinion that the patent applications disclosed confidential information communicated to Suez under the 2012 NDA. They filed a complaint with the Paris Tribunal de grande instance (TGI) in October 2016, claiming damages as well as the transfer of the various patents / applications.

Patent law meets international law.

As a legal defense, Suez argued that the Paris TGI lacked jurisdiction over this dispute. As an auxiliary argument, they said that the court lacked jurisdiction at least regarding the requested transfer of patent rights deriving from Suez’ PCT applications.

This legal defense was debated in front of the case management judge, which gave rise to the order discussed today. The merits of the case are not addressed in this order.

Let’s first deal with Suez’ general argument of lack of jurisdiction. The difficulty here is that the parties were bound by two successive agreements: the 2012 NDA and the 2013 partnership agreement.

Now, the NDA contained a jurisdiction clause, per which any dispute in connection with the agreement should be tried by the Paris courts. But the partnership agreement contained an arbitration clause, per which any dispute in connection with the agreement should be brought to the Swiss Chambers’ Arbitration Institution.

Suez claimed that, according to the competence-competence principle, only the arbitral tribunal had jurisdiction to decide on which forum had jurisdiction.

The court referred to article 1448 of the Code de procédure civile. According to this provision, if a lawsuit subjected to an arbitration agreement is filed in front of a national court, the court must decline jurisdiction unless (1) the case has not yet been brought to an arbitral tribunal, and (2) the arbitration agreement is manifestly null or inapplicable. These conditions (1) and (2) are cumulative.

In this case, condition (1) was fulfilled, as the case had not been brought to an arbitral tribunal. As to to condition (2), the court came to the conclusion that it was also fulfilled. The arbitration clause of the partnership agreement was manifestly inapplicable to the dispute, said the court. If there was the slightest doubt as to whether the arbitration clause was applicable, my understanding is that the judge had no other choice but to decline jurisdiction. Yet, in this situation, there was apparently no doubt at all.

Indeed:

  • It was clear that the parties to the NDA intended to subject this agreement to the jurisdiction of the Paris court.
  • The later partnership agreement did not state (be it implicitly or explicitly) that this jurisdiction clause in the NDA was no longer applicable.
  • The NDA contained a mention that the agreement would expire 3 years after the execution date, except some provisions which would still apply for 5 years after the end of the agreement. The jurisdiction clause was not cited among the surviving provisions. But the judge held that a jurisdiction clause was autonomous with respect to the rest of the agreement and necessarily continued to apply to disputes arising from the agreement.
  • Finally, the complaint did relate to an alleged breach of the non-disclosure provisions of the NDA, and not to an alleged breach of the partnership agreement.

Therefore, the overarching competence-competence principle in this particular instance did not apply, and the judge refused to decline jurisdiction.

This leads us to the second (auxiliary) part of Suez’ legal defense, i.e. that the judge should decline jurisdiction at least over the requested transfer of patent rights stemming from Suez’ PCT applications.

Indeed, the applications were filed after the execution of the partnership agreement, so that only this later agreement was applicable to TerraNova’s claim for ownership.

It is not perfectly clear to me when reading the order whether Suez also argued that the TGI had no jurisdiction over disputes regarding the ownership of foreign patent rights (as opposed to French patent rights) as a matter of principle. Anyway, in the past, French courts did not hesitate to rule on ownership claims regarding foreign patent rights, and the trend was not reversed in this case.

It is interesting to note, though, that TerraNova did not request that the foreign patent rights should be transferred to them by the court, but rather that the court should order Suez to perform the transfer of these patent rights to their benefit. The formulation of this claim probably makes it easier to avoid any potential argument that the French courts would encroach upon the prerogatives of foreign states.

As to the merits of Suez’ argument, the judge held that TerraNova’s transfer claim was analyzed as a remedy pertaining to the alleged breach of the NDA, so that the TGI did have jurisdiction also over this aspect of the case.

To summarize, Suez’ legal defense was rejected, and the proceedings will continue on the merits.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, ordonnance du juge de la mise en état, April 5, 2018, TerraNova Energy GmbH & Co v. Suez International SAS, RG No.16/16334.

The patentee’s tale

For some time, I wondered why the name “Gilead” in the trendy, horrifying, Margaret Atwood inspired TV show The Handmaid’s Tale sounded familiar to me. And then I realized that, yes of course, this is also the name of a famous pharmaceutical company, well known in the patent profession for being currently involved in a number of prominent litigation and opposition cases.

To some extent, patent disputes are like TV shows: they develop in episodes; sometimes unexpectedly, and sometimes not so much.

Lionel Vial reports on a recent decision (which was supplied courtesy of Matthieu Dhenne):

Following-up on our previous report on the refusal of Gilead’s request for preliminary injunction against Mylan in the Truvada® litigation in France based on SPC No. 05C0032, which was handed down on September 5, 2017, the judgement on the merits has now been rendered by the Paris Tribunal de Grande Instance on May 23, 2018.

A parallel decision was also handed down the same day (with the same outcome) with Biogaran as the generic drug manufacturer requesting the nullity of the SPC; it is commented upon here.

As a brief reminder, Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC) approved for Pre-exposure Prophylaxy (PreP) of HIV infection, since it has been shown to allow for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) which will expire between 21 and 24 February 2020 depending on the countries. The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients. (Emphasis added).

In summary, the essential question asked to the Tribunal is whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (i.e. the SPC regulation).

So has the Tribunal confirmed its previous provisional opinion on the invalidity of the SPC or has it changed its mind? Let’s see:

[…] The patent on the basis of which SPC No. 32 under litigation was granted neither mentions, in the wording of its claims, emtricitabine, the active ingredient to which the SPC relates in combination with tenofovir disoproxil, nor does it make it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically relating to emtricitabine, so that the product is not protected by the basic patent and that the condition laid down in Article 3 (a) of Regulation (EC) No 469/2009 is not fulfilled.

The future of TV shows envisioned in the 80s.

After the first round, the second round is also for Mylan then. Let’s wait for the third round (appeal), bearing in mind that by then the CJEU should have handed down its own decision on the subject (pending as C-121/17).

In this regard, it should be reminded that the Advocate General in his opinion delivered on April 25, 2018 has considered that the Court should answer the question referred for a preliminary ruling by the High Court of Justice of England and Wales as follows:

Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent. (Emphasis added).

Applied to SPC No. 05C0032, the Advocate General is thus of the opinion that “It would appear, subject once again to verification by the referring court, that, on 26 July 1996, the claimed priority date of the patent at issue in the main proceedings, it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent” (emphasis added).

Of course the opinion of the Advocate is not binding on the CJEU, but at present it appears there isn’t much suspense left for the third round.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 2ème section, May 25, 2018, SAS Mylan v. Gilead Sciences Inc. et al., RG No. 16/14214.

Judgment in the box

The burden of proof. A concept with a well-deserved name.

It can indeed be a real burden for a patent proprietor to find clear and convincing evidence that a patent is infringed; or for a defendant to find clear and convincing evidence that the invention was disclosed by the proprietor before the filing date.

The case discussed today illustrates both situations.

In this case, all litigants are from the Toulouse area. Construction Machines Automatiques Spéciales (CMAS) owns French patent No. FR 2755655, filed in 1996, which expired during litigation. The patent relates to a carton making machine.

The main defendants are: LB Pack, a company created in 2012 a few kilometers away from CMAS; and two ex-employees of CMAS, who also happen to be the founders of LB Pack.

CMAS filed claims of patent infringement and unfair competition against these three defendants. The defendants counterclaimed inter alia for patent nullity.

The first notable question raised in this case is whether the nullity counterclaim was time-barred.

As reported last week, the statute of limitations will no longer be applicable to any patent nullity claim if and when the UPC Agreement enters into force. But in the meantime we have to continue dealing with it and the legal uncertainty that it entails.

Quite surprisingly, the court disposed of this issue in a short paragraph, briefly noting, as if it were self-evident, that the statute of limitations is not applicable to nullity claims when they are raised as counterclaims.

An interesting development indeed, as it was previously held in other cases that nullity counterclaims are to be treated in the same manner as direct nullity claims – with the caveat that, if a defendant is time-barred, nullity can always be raised as a defense (exception) to the effect that the patent should not be enforceable against them, even if the patent is not formally revoked.

Stay tuned to check whether this new approach will hold.

The wonderful things you can make out of cardboard.

The main invalidity argument raised by LB Pack et al. was that CMAS (formerly CMA) had disclosed the invention before filing by showing and selling so-called Minicompact machines.

By way of an interesting strategy, the defendants requested and obtained an ex parte order from a judge allowing them to perform an inspection by a bailiff with a third party, the company Stendhal, that had bought a Minicompact machine in 1995.

The bailiff’s report proved the acquisition of the machine before the filing date of the patent. But the court was not convinced that this machine anticipated the patent claims. The main reason for this was that the machine was subjected to several servicing operations since 1995, including an important compliance operation in 2004, performed by CMAS. In other terms, the court believed that the machine may have been altered, and that the copy inspected by the bailiff during litigation may not be representative of the machine bought in 1995. Thus, the benefit of the doubt was given to the patent proprietor – who was apparently not required to demonstrate that they had indeed modified the machine in a way which would be relevant to the patent in suit.

The patent was thus declared valid.

Turning now to infringement, the shoe was on the the other foot.

An infringement seizure report had been drawn up by a bailiff. This proved that LB Pack had sold one machine to a third party, Sicaf. But the issue was the description of the allegedly infringing machine.

In fact, the bailiff was only able to inspect an unfinished machine, not yet operational, and with some parts not yet assembled. But, said the court, analyzing whether the characterizing portion of the main claim of the patent was implemented by LB Pack could only be done based on a fully assembled machine.

The other documents and evidence found by CMAS did not make it possible to know whether the subject-matter of the patent claims was implemented or not.

As a result, the infringement claim was rejected.

That said, the defendants were not off the hook, as they were found guilty of unfair competition.

It turns out that the bailiff conducting the infringement seizure found evidence that the two ex-employees who founded LB Pack had extensively copied business and technical information belonging to CMAS before leaving. Also, at the time they left the company, they had accessed and taken advantage of one CAD license belonging to CMAS.

The assessment of the court as to the consequences of these illegal actions was then the following:

Even if it is not demonstrated that LB Pack makes and markets machines which infringe CMAS’ patent, it remains that all the saved technical data belonging to CMAS necessarily and unjustifiably made it easier to create new machines which could be very quickly put on the market by LB Pack as from 2013, on the same market, which conferred them an undue competitive advantage.

Finally, it can be derived from the invoices annexed to the infringement seizure report that, owing to the customer and prospect files copied on the laptop of Mr. […], it was easier for LB Pack to solicit customers and thus market its machine more easily notably with Schneider and Durlin which were already customers of CMAS. The misappropriation of customers is thus demonstrated and is an act of unfair competition and free-riding. In view of the invoices from LB Pack seized by the bailiff, the court knows that 3 machines were sold starting from July 2013 for an amount of 235,000 euros, notably to Sicaf, which was a prospect of CMAS, and that maintenance services were also sold to Schneider and Durlin, customers of CMAS. 

Therefore, the acts of unfair competition and free-riding are serious and repeated and the compensation for the harm caused should be set to 80,000 euros. 

One remark here is that an infringement seizure is a procedure specifically intended to gather evidence of patent infringement. However, even in the absence of patent infringement, the evidence found during the seizure can be used against the defendant with respect to other claims, notably in relation with unfair competition.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 4ème section, March 15, 2008, SARL Construction Machines Automatiques Spéciales v. SARL LB Pack et al., RG No. 14/16600.

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.