Patentee schussing down

Are you getting tired of automotive equipment technology and anti-hypercholesterolemic drugs?

This would be understandable. Cheer up, as today I give you a seasonal alternative, with this ruling which involves a patent directed to a “method of securing, monitoring and management of the ski area of wintersportplaces“.

As if this technical field weren’t unconventional enough, the ruling is also unusual in that it was issued by the Lyon Cour d’appel.

The Paris courts have had exclusive jurisdiction over patent matters for a number of years now, so it is increasingly infrequent to come across a judgment issued in another forum. Who knows, this could actually be the very last one.

Mr. Costa, who lives in the Rhône département, owns European patent No. EP 1048789, filed in 2000 and which claims a French priority. The patent was licensed to a local company, Construction Moulage Fabrication Polyester (CMFP).

The patent was granted in 2003. Shortly thereafter, the patentee and the licensee initiated infringement proceedings against Perception and Guidance Embedded Systems (now Perguisys), Kässbohrer Engins au Service de l’Environnement as well as SA Aménagement Touristique de l’Alpe d’Huez et des Grandes Rousses. Already from the name of the third defendant, it can be inferred that the alleged infringement takes place in the Alps area.

As this was 15 years ago, the complaint was filed with the Lyon Tribunal de grande instance (TGI), which had jurisdiction at that time.

Two oppositions were filed at the EPO, one by Sabatier SA and a joint one by the defendants Perguisys and Kässbohrer. This led the Lyon TGI to stay proceedings pending the outcome of the opposition. Hence the extraordinary length of the proceedings.

The oppositions were rejected by the opposition division in 2006 and the rejection of the oppositions was confirmed by the Board of appeal in 2009. Only then were the infringement proceedings resumed. But it took 6 more years for the Lyon TGI to issue its judgment, in 2015. This is amazingly long but (1) we don’t know all the details, and it is possible that all parties did their best to delay the proceedings; and (2) now that patent litigation is centralized in Paris, my understanding is that there are no longer cases that drag on forever to this extent – except when the Cour de cassation successively sets aside appeal judgments four times, like in the Nergeco case discussed last week.

In the first instance judgment, the infringement claim was dismissed, and so was the defendants’ nullity counterclaim. The plaintiffs appealed, which now brings us to the appeal judgment.

Here is claim 1 of the patent at stake, again, not a conventional one, as you will see:

Method for protecting, following up maintenance and managing the field intended for skiing in a winter sports resort using mobile protection, control and maintenance means equipped with means for marking the position and guiding vehicles from a satellite network or from fixed markers, using fixed devices which need to be controlled and maintained, using a digitized cartography, as well as radio or remote transmission cables for transmitting digital data between at least one computer situated in a central station and computer terminals situated in intervention services or on mobile means fully or partially associated with automatic or manual coding means, characterized in that the computer system situated in the central station is able to divide the site of the winter sports resort into homogeneous zones with respect to at least one criterion from a series of coherent criteria zones stored in said computer system connected by remote transmission means to the mobile means and the intervention services so that when a mobile element is positioned in an homogeneous zone of the skiing field, the computer system of the central station is able to immediately be aware of the criteria applied to this homogeneous zone so as to deduce from this task orders, observations or action to be taken by the central unit and/or by the mobile element and/or by the intervention or maintenance services.

Peter Rabbit managing the ski area.

The validity discussion is extremely short in the decision.

Apparently, the defendants raised the same arguments of lack of novelty and lack of inventive step that they had already raised in first instance. The appeal judges thus simply stated that they agreed with the first instance judges and had nothing to add.

The infringement discussion is more interesting. The plaintiffs alleged that there was infringement by equivalence.

According to the court, the patented method comprises numerically mapping a ski resort site in the form of points according to coordinates, and then storing the information in a computer of a central station so as to provide a virtual grid in the form of planar polygones (cf. the claimed “digitized cartography“).

Fixed and mobile devices are deployed in the ski area and supply positional information to the central station using transmission means.

Still according to the court, the alleged infringement does not make use of virtual mapping and of a central station. Thus, the court held:

[…] Even though the [allegedly infringing] system uses GPS technical means, it does not achieve the sophistication of the patented system, in that it does not make it possible to provide a division of the area into homogeneous zones in real time on the screen, based on predefined and modifiable criteria.  Contrary to what the appelants state, this sophistication […] prevents infringement by equivalence from being acknowledged, as the Snow Sat system is of a lesser quality and lesser efficiency. 

Okay. This is kind of frustrating as it is very far from being a clear and complete infringement reasoning. But again, you probably cannot expect too much from a court that may not have seen any other patent case in a number of years.

But there is possibly one interesting take-away message though.

The established standard for assessing infringement by equivalence under French law is the following: two means are equivalent when, although they are of a different form, they perform a same function for a result of a same nature, if not of the same degree.

Lyon’s position is that, since the defendants’ method is not as efficient as the patented one, it does not infringe.

This is clearly confirmed by the court’s following statement:

[…] A means is not equivalent when its different implementation leads to a result of a same nature but of a different quality or efficiency. 

This is not a common aspect of equivalence discussions. But it is not unheard of. In fact, in a previous post, I reported on a similar analysis by the Paris Cour d’appel.

Thus, if anything, today’s judgment confirms that assessing infringement by equivalence is tricky. You cannot just look at the function of the means at stake – and at whether the function was known from the prior art. You also have to look at how effective the means is and what the quality of the end result is.

CASE REFERENCE: Cour d’appel de Lyon, 1ère chambre civile A, September 20, 2018, Antoine Costa et al. v. Perguisys et al. (RG No. 2015/06635).

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.

For your eyes only

No, this post has nothing to do with the famous 007 spy.

It rather deals with the restriction of the accessibility of evidence filed during patent litigation to protect trade secrets. With such an exciting topic, who needs car chases, double agents and half-naked bodies?

A while ago, I reported on the first instance judgment in the Core Wireless Licensing v. LG  litigation. As a reminder, this is an SEP (standard essential patents) infringement action brought by Core Wireless (Core) against the Korean giant LG, which was handled super fast by the Paris Tribunal de grande instance, upon the claimant’s request for accelerated proceedings. Not that it worked out for them though, as there was no finding of infringement by the court for any of the five asserted patents.

As swift as the first instance case was, I have not heard about any appeal proceedings since the judgment of April 17, 2015 – until very recently, that is. Now, owing to LG’s lawyers and via the AIPPI French group (thank you), here are tidings of Core’s appeal.

It turns out that the appeal case has been moving at a much slower pace, with already three orders on procedural motions issued by the appeal judge in charge of case management. The third order, dated October 9, 2018, is of particular interest.

First of all, the order of the judge mentions that “what is at stake in the litigation is now the determination of a FRAND royalty rate applicable to the patents in suit“.

This is somewhat surprising, since the first instance judgment dismissed all infringement claims brought by Core. I can only assume that a partial agreement between the parties must have been reached, that LG must have agreed to take a license from Core and that the only remaining contentious issue must be the royalty rate.

Now, a major difficulty in a FRAND royalty rate-setting lawsuit such as this one is how evidence relevant to the royalty rate determination should be handled.

For instance, similar license agreements granted by the right holder, or even third party license agreements may be of relevance to the determination, but these are also highly sensitive documents.

Eyeing towards the right royalty rate.

The first point addressed in the October 9 order is a dispute regarding one exhibit filed by LG, namely a license agreement between Nokia and Qualcomm.

Core’s patent portfolio was originally owned by Nokia. Nokia licensed the patents to the chip manufacturer Qualcomm. The LG devices comprise Qualcomm chipsets. As a result, LG contends that they benefit from pass-through rights under the Nokia / Qualcomm agreement (by exhaustion of the Nokia patent rights). A recurring debate in many SEP lawsuits.

LG had made repeated official requests for being granted access to the Nokia / Qualcomm agreement, to no avail. But on October 31, 2017, LG finally filed a redacted version of this agreement in front of the Paris Cour d’appel, which they apparently originally obtained from parallel proceedings in the U.S.

Core protested and stated that this filing was illegal. They argued in particular that, under article 21 of the agreement, Nokia’s consent is a prerequisite for filing the agreement in the French proceedings, and that Nokia did not consent. Core thus requested that the exhibit should be dismissed.

An interesting problem, but also one that the appeal judge did not solve. Indeed, the judge noted that it is not within her prerogatives to dismiss an exhibit. This is a matter for the three-judge court to decide. So, Core’s request was rejected – for the time being at least. It will be decided in the judgment on the merits.

As a second point addressed in the order, various requests for additional evidence were filed by both LG and Core.

LG requested that Core be ordered to file a number of contracts: 1) a purchase and sale agreement between Intellectual Property Asset Trust and Core dated 2011, 2) a royalty participant agreement between Intellectual Property Asset Trust, Core, Nokia and Microsoft dated 2011, and 3) all further agreements between Core and any third party regarding the patents at stake, and in particular an agreement of 2015 between Core and Microsoft.

The judge deemed that these agreements were indeed relevant to the determination of the FRAND royalty rate. Besides, Core did not frontally object to the submissions of these documents but requested that confidential information be protected (more on that below).

On the other hand, Core requested that LG be ordered to file license agreements between LG and Nokia, Interdigital, Ericsson and Blu Products.

LG objected, and the judge held that the LG agreements are in fact not relevant to the lawsuit because they do not relate to the patents in suit. Also, the judge did not like that this request by Core was submitted only a few days before the scheduled hearing on the parties’ motions.

As a summary, Core was ordered to file a number of agreements in relation with the patent portfolio at stake, but LG was not ordered to filed its own license agreements regarding other patents.

But the most interesting part of the order is probably that the judge made use of a brand new provision, introduced by law No. 2018-670 of July 30, 2018 into the French statute.

This is the transposition of the so-called “trade secret directive” (aka Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure).

Among others, this law created a new article L. 153-1 in the Code de commerce, which reads as follows (my own translation):

When, in civil or commercial proceedings relating to a motion for taking of evidence before a trial on the merits or during litigation on the merits, the communication or supply of an exhibit is relied upon or requested, and a party or a third party contends, or it has been held, that it may breach a trade secret, the judge can, on his/her own motion or upon the request of a party or a third party, if the protection of this secret cannot be otherwise safeguarded and without prejudice of the rights of the defendants: 

1. Read the exhibit alone and, if deemed necessary, order an expertise and ask for the opinion, for each party, of a person authorized to assist or represent them, in order to decide whether the protection measures provided in the present article should be applied; 

2. Decide to limit the communication and supply of this exhibit to some elements only, order the communication or supply in the form of a summary, or restrict access, for each party, to at most one person and another person authorized to assist or represent them; 

3. Decide that the debates will take place and the decision will be handed out in private; 

4. Adapt the reasons of the decision and modalities of publication thereof to the necessities of protecting trade secrets. 

The judge thus decided that the documents at stake should be first communicated for LG’s attorneys’ eyes only. The attorneys of both parties should then tell the judge which parts of the documents may or may not infringe a trade secret, in their view. The judge will then, if necessary, issue another order to implement some of the measures under 2, 3 and 4 above.

I think it is very positive that the range of options to preserve trade secrets during litigation has been broadened by the transposition of the trade secret directive. This will hopefully make it easier for judges to order relevant evidence to be communicated – knowing that guarantees can be put in place in order to prevent the misuse of such evidence, if it is highly confidential and sensitive. This is essential in the French system which does not provide for a broad discovery / disclosure procedure.

Turning back to this Core v. LG case, I personally hope that the judge will not issue an order under paragraph 3 of article L. 153-1, and will make moderate use of paragraph 4. This is because the judiciary determination of the FRAND royalty rate in a case such as this one will be of major interest to all stakeholders in the industry, as it could provide some eagerly awaited general guidance.

Cour d’appel de Paris, pôle 5 chambre 1, October 9, 2018, Core Wireless Licensing SARL v. LG Electronics France SAS & LG Electronics Inc., RG No. 15/17037.

Standard or not standard?

Traditionally, non-practicing entity patent infringement suits have been  relatively few and far between in France.

Without the huge financial stakes of U.S. litigation, and without the lure of German bifurcation, the French legal system has, to some extent, resisted the trend so far. There are a few counter-examples, though.

Like the case discussed today, between famous Intellectual Ventures (IV) and SFR, one of the major French telecommunications companies.

Among the many patents owned by IV is EP 1304002, entitled “Arranging Data Ciphering In a Wireless Telecommuncation System” and originally filed as a PCT application by Nokia Mobile Phones Ltd, in Finland.

As you have probably already guessed, IV initiated legal proceedings in front of the Paris Tribunal de grande instance (TGI), alleging infringement of the EP’002 patent. The alleged infringement mainly relates to the WiFi technology.

You will not know who won at the end of the post, because no one did – the lawsuit is not over yet. In fact, the pleadings hearing is presently scheduled to take place on November 23, 2018. So there is still plenty of time left for you to take your morning off at the new courthouse.

The decision discussed today is only an interim order issued by the judge in charge of case management (JME in the local jargon).

Can you believe there are actually patent applications on methods for identifying patent troll activity? Do some of them get acquired by NPEs, just for the irony of it?

Among the various defenses raised by SFR, there is a rather interesting one, which is that the EP’002 patent is a standard essential patent (SEP).

Two standards were mentioned by SFR: 3GPP TS 33.234 (a 3G standard issued by ETSI – short for European Telecommunications Standards Institute), and 802.11.2012 (a WiFi standard issued by IEEE – short for Institute of Electrical and Electronics Engineers). According to SFR, the EP’002 patent was not declared as essential by its then owner Nokia – a member of both ETSI and IEEE – although it should have been. Due to this omission, they argued, the infringement action should be deemed inadmissible.

Now, apparently SFR did not have all the necessary evidence at hand.

They thus wrote both to ETSI and IEEE and requested the “travaux préparatoires” (one of the most well-known French expressions among lawyers, ranking third after “bonjour” and “merci”) for the relevant standards, as well as relevant correspondence between Nokia and both organizations.

France-based ETSI replied that they would provide the requested documentation, but IEEE turned down SFR’s request.

Thus, SFR filed a motion with the JME, requesting a stay and further requesting that IEEE be ordered to hand down the relevant documents. 

IV fought this motion.

First, IV claimed that SFR’s motion was inadmissible.

Indeed, IEEE is based in the U.S., and the French judge has no jurisdiction to directly order a third party to the litigation to hand down evidence, they argued. The only possible procedure would be the letter rogatory, i.e. the French judge should ask U.S. authorities to issue the order.

The judge closely looked at the written response made by IEEE further to SFR’s request. The first part of this response was the following:

Please be advised that it is IEEE’s policy not to provide information that may be used in litigation without a subpoena. This is to protect IEEE’s neutrality in any dispute. If that is necessary, please feel free to let me know and we can arrange the details of service. 

The JME deduced from this response that IEEE was willing to hand down the evidence at stake, and that they just required a formal judicial order for doing so. The judge was happy to oblige, and the formal and cumbersome process of the letter rogatory could thus be avoided.

I note that IEEE’s response does not specify whether the requested subpoena should be specifically issued by a U.S. court, or whether any subpoena would do. It was probably the judge’s understanding that, in the absence of any specific mention, they were open to any form of subpoenaing.

As a second defense against the motion, IV argued that SFR’s request was useless and unjustified.

SFR raised the SEP argument late in the case management procedure, IV said, and only they should have the burden of providing their own evidence. Besides, the second part of IEEE’s written response to SFR reads as follows:

However, a subpoena may not be necessary in this instance as IEEE 802.11 does host a public website that contains a wide variety of working group materials. The IEEE 802.11 website is located

But the judge held that SFR was free to raise a new defense at any point within the case schedule (which, in case you are wondering, is nothing like the extremely tight schedule envisioned for the future UPC). Besides, SFR stated that they could not find the relevant documents on the IEEE website, and that in particular the correspondence with Nokia is not supposed to be available on this site. Finally, the supply of evidence by the standard organizations should not take long.

As a result, the judge granted SFR’s request and issued an order for IEEE to send SFR all documents and reports of the working group relating to the relevant part of IEEE 802.11, as well as the relevant correspondence with Nokia, within one month.

On the other hand, the request for stay of proceedings was dismissed – probably because this timeline is supposed to be still compatible with the planned date for the main hearing.

Access to evidence can be challenging in this country especially in the absence of discovery / disclosure. French judges are often reluctant to order a taking of evidence, such as the provision of documents. But in a case such as this one, it does seem rather fair that a defendant should be allowed to explore a particular line of defense by requesting third party-held documents.

We will thus stay tuned, and I am sure the decision on the merits will be most interesting to read – if the lawsuit goes all the way of course.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 7, 2018, Intellectual Ventures LLC v. Société française du radiotéléphone, RG No. 16/16346.

An infringement theory to be taken with a grain of salt

In a previous post entitled The salt of the judgment, I reported on an order issued in July 2016 and rejecting a request for preliminary injunction against Biogaran’s generic version of the drug rosuvastatin.

The judgment on the merits has now been issued, so this is an opportunity to go back to this interesting case. The problem with this approach is that finding a good title for a blog post in relation with a given case is difficult enough once, and it is even more difficult the second time. By the time I may get to report on a possible appeal ruling, I am afraid I may run short of salty idioms.

So, yes, everything in this case is about salt, or rather salts.

Claim 1 of the patent at stake (EP0521471, owned by the Japanese pharmaceutical company Shionogi, and licensed to the Swedish group AstraZeneca), on which the SPC is based, reads as follows:

The compound (+)-7-[ 4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl-N-methylsulfonylamino)pyrimidin-5-yl)-(3R,5S)dihydroxy-(E)-6-heptenoic acid or a non-toxic pharmaceutically acceptable salt thereof.

The compound in question is rosuvastatin, in its acid or salt form.

The active substance in Biogaran’s generic drug is the zinc salt of rosuvastatin. The zinc salt is not cited in the patent at stake.

As a reminder, the judge in charge of emergency proceedings ruled that the zinc salt of rosuvastatin was in fact excluded from the scope of the patent, when the claim was properly interpreted in view of the description.

Now this preliminary view has been confirmed by the three-judge panel of the Tribunal de grande instance (TGI). As a side note, the judge who issued the interim order (Ms. Courboulay) was not part of this panel.

Here is the relevant part of the judgment (as usual, I took the liberty of cutting excessively long sentences into shorter ones):

[…] [In the patent,] the patentee has mentioned in a clear and precise wording at paragraph [0007] what is meant by “a non-toxic pharmaceutically acceptable salt”, namely “a salt wherein the cation is an alkaline metal ion, an alkaline earth metal ion or an ammonium ion”. [It] does not comprise any indication allowing [the skilled person] to select a salt in another family. [Besides,] the patentee, even if it did not expressly exclude a specific salt, did not, unlike in other paragraphs of the patent, add the expressions “which are not to be considered as limiting”, [0029] […] or “and the like”, [0006] and [0024] […]. [Thus, the skilled person] understands that the salts protected in the patent are defined in a limiting manner as a salt wherein the cation is an alkaline metal ion, an alkaline earth metal ion or an ammonium ion. 

Therefore, and as decided by the judge in charge of emergency proceedings, it derives that the non-toxic pharmaceutically acceptable salts protected by claim 1 are salts wherein the cation is an alkaline metal ion, an alkaline earth metal ion or an ammonium ion.

A very interesting example that claim interpretation in view of the description can be used both ways: not only for broadening the scope of protection of the patent beyond what is literally claimed, but also in some situations for restricting said scope.

As a result of this claim interpretation, the necessary conclusion was that Biogaran’s zinc salt of rosuvastatin did not literally infringe the SCP.

Shionogi and AstraZeneca argued that zinc could be considered as an alkaline earth metal at the filing date. They said that the exact classification of zinc was a matter of debate.

However, the court was not convinced. Based on a 1978 dictionary and on Mendeleev’s table, it appeared that zinc could not be considered as an alkaline earth metal.

Non-toxic salts are useful for other purposes than drugs: salt sculptures for instance.

Another auxiliary argumentation by the plaintiffs was one of contributory infringement: once ingested, the zinc salt of rosuvastatin dissociates, and the anionic active molecule recombines with sodium or hydrogen, to form the sodium salt or the acid form of rosuvastatin. Thus, the zinc salt of rosuvastatin should be considered as an essential means for carrying out the claimed invention.

This bold argument failed – just as it had in the interim proceedings:

[…] The fact that the zinc salt of rosuvastatin, after ingestion, would dissociate in the patient’s body under a neutral acid form may not characterize contributory infringement […]. First, the third party mentioned in article L. 613-4 Code de la propriété intellectuelle [CPI], namely the patient, is not aware of the mechanism of decomposition of the drug within the body, so that he/she does not know under this provision that the ingestion of the drug at stake is intended for implementing the claimed invention. Second, this drug ingestion by the patient is carried out in a private and non-commercial context, so that the patentee’s rights do not extend to such acts. 

The first reason mentioned by the court for rejecting this infringement theory is quite convincing. It is true that the patient has absolutely no idea what the drug becomes after ingestion.

The second reason looks much more challengeable on a legal standpoint. Admittedly, the rights conferred by a patent do not extend to acts carried out in a private and non-commercial context (article L 613-5 CPI). But here, the allegedly infringing act is not the ingestion of the drug by the patient, but the sale of the drug to patients, considered as the supply of essential means for implementing the invention to a third party. And article L. 613-4 CPI clearly states that a party benefiting from the exemption of article L. 613-5 CPI (such as a patient) is not regarded as a party authorized to implement the claimed invention for the purpose of the assessment of contributory infringement.

That said, one good reason was certainly enough to throw out Shionogi and AstraZeneca’s auxiliary infringement theory.

In addition to rejecting the plaintiffs’ infringement claims, the court also had to examine the validity of the EP’471 patent.

The interim order had already stated that there was no serious validity challenge. In the judgment now issued by the three-judge panel, the validity of the patent has been confirmed.

The grounds for nullity which were raised were extension of subject-matter, insufficiency of disclosure and lack of inventive step.

Regarding extension of subject-matter, original claim 1 in the application as filed was directed to a compound defined by a Markush formula with five variable groups X, R1, R2, R3 and R4.

Two examples of the application disclosed calcium rosuvastatin and sodium rosuvastatin.

The defendant argued that the acid form of rosuvastatin, on the other hand, was not directly and unambiguously disclosed in the application as originally filed.

But the court was satisfied that claim 1 of the patent was obtainable by the skilled person based on the examples of calcium and sodium rosuvastatin, and on a paragraph of the description which provided a broader definition for group R4 in the general formula, namely: hydrogen (corresponding to an acid form of the molecule), or a lower alkyl group, or a cation capable of forming a non-toxic, pharmaceutically acceptable salt.

What is not explicitly discussed in the court’s reasoning is the fact that the definition of group R4 was restricted to arrive at claim 1 as granted, since the option of a lower alkyl group is no longer covered in the patent.

Turning now to sufficiency of disclosure, Biogaran raised two objections:

  • there is no information in the patent how to select or use salts of rosuvastatin other than the exemplified sodium and calcium salts;
  • the patent does not sufficiently establish the existence of a therapeutic effect, as it only disclosed an in vitro test, and did not contain any precise indication on a possible dosage regimen.

Regarding the first objection, it is certainly relevant that only certain types of salts were held by the court to be covered by claim 1, namely alkaline metal, alkaline earth metal and ammonium salts. Therefore, it was immaterial for the appraisal of sufficiency that the zinc salt for instance is not discussed in the patent, since this salt is not covered by claim 1.

The court noted that the patent discloses a process for making various salts, and that Biogaran did not demonstrate any difficulty for carrying out the invention with the different forms of rosuvastatin that are claimed.

As for the second objection, the court was satisfied that, since the patent relates to new molecules, an assay comparing the biological activity (namely the activity of inhibition of HMG-CoA reductase) of rosuvastatin to that of the prior art drug mevinoline, is a sufficient disclosure of the therapeutic effect.

Lastly, inventive step.

Biogaran’s argument was based on two prior art documents, Bayer and Beck, which both disclose a broad family of compounds having an HMG-CoA reductase inhibitory activity. Biogaran argued that rosuvastatin can be obtained by way of a selection from the teaching of these documents, and that this selection is arbitrary, since the therapeutic effect of rosuvastatin is the same as that of the other compounds of the broad family explicitly taught in Bayer and Beck.

The court held that this reasoning is based on hindsight and thus impermissible. The court stated in particular that the skilled person would focus on options described as preferred in the prior art, and would thus not study all possible compounds at random. In this case, there was no pointer in the prior art leading the skilled person to rosuvastatin.

CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, February 9, 2018, Shionogi Seiyaku Kabushiki Kaisha, AstraZeneca & AstraZeneca UK Ltd v. Biogaran, RG No. 16/13292.