Dolce vita for Amgevita®

Judgments on preliminary injunctions are uncommon, and thus particularly interesting.

So are judgments on prior user rights. Thus, when a case combines both aspects, things get truly exciting.

Fresenius Kabi Deutschland acquired the biosimilars activity of Merck KgaA in April 2017. European patent application No. EP 3145487, filed in May 2015, was part of the deal. The patent was later granted, on August 22, 2018.

The patent relates to a pharmaceutical composition which is a biosimilar of the drug Humira®, based on the antibody adalimumab as an active ingredient.

Humira® is what people call a blockbuster drug. It has a number of therapeutic indications, including rheumatoid arthritis, psoriasis, Crohn’s disease and other inflammatory conditions.

Humira® was developed by Abbott and, according to the court, the SPC which protected the originator’s product expired in France on October 16, 2018.

Several biosimilar drugs were developed and obtained a marketing authorization (MA) from the European Medicines Agency (EMA), including the Californian group Amgen. See here for a news report on the Humira® biosimilar landscape. Amgen’s drug is called Amgevita®. It was the first biosimilar approved by the EMA in March 2017. Its price was set in France the day after the expiry of the Humira® SPC, and my understanding is that Amgevita® was then immediately placed on the market.

Meanwhile, as mentioned above, the EP’487 patent was granted to Fresenius on August 22, 2018. Fresenius was really on the starting blocks with this patent: looking at the EPO file wrapper, the communication under R. 71(3) EPC on the intent to grant was dated July 6, 2018, and the applicant replied by paying the prescribed fee and filing the claim translations… on July 6! This is as responsive as you can be.

But Fresenius’ impatience was quite understandable, in view of the imminent expiry of the Humira® monopoly; and because they were of the opinion that Amgevita® infringed EP’487.

A number of exchanges between Fresenius and Amgen took place in October-November 2018. And since Amgen would not bend, Fresenius initiated infringement proceedings in front of the Juge des référés, i.e. the judge in charge of urgency proceedings in the Paris Tribunal de grande instance, on November 14, 2018. Fresenius notably requested a preliminary injunction (PI) against Amgen.

In parallel, Amgen filed an opposition against the patent at the EPO in December 2018.

The French hearing took place on January 14, 2019, and the judge issued her decision one month later – ruling in Amgen’s favor.

Tutto bene per Amgen.

Amgen challenged Fresenius’ request for PI by stating that such a measure would be unwarranted given that Fresenius itself does not have a product on the market; and by arguing that the patent is invalid and that there is no infringement.

In the decision, the judge first summarized the standard to be applied as follows:

[The judge] must rule on the challenges raised by the defendant, including regarding the validity of the patent itself. She must appraise the seriousness of the challenges, and at any rate should assess the proportion between the requested measures and the infringement alleged by the claimant and take the decision to ban the marketing of the infringing product or not, in view of the risks taken on one side and the other. 

A few years ago, there was a controversy regarding the standard to be applied with respect to validity challenges to PIs. Was a “manifest” invalidity the only acceptable defense to a request for PI? Recent case law is much more defendant-friendly (and probably much more reasonable, for that matter), as the above quote shows, in particular with the reference to a control of the proportionality of the requested measures.

The judge then turned to the assessment of Amgen’s non-infringement defense, which, as mentioned in the introduction, was based on a prior user right. Or rather, on a “prior personal possession” of the invention, as it is known under French law.

The judge summarized the conditions to be met for such a defense to be effective:

          • the possession [of the invention must be] before the filing date of the patent or its priority date;
          • the possessed technology [must be] identical with the patented invention; 
          • the possession [must be] on the French territory; 
          • those claiming such possession [must have acted] in good faith.

The judge also clarified that, based on longstanding case law, the possession of the invention does not require a commercial exploitation of the invention. Possession, in this context, rather corresponds to the knowledge of the invention.

Let’s now turn to claim 1 of Fresenius’ patent:

An aqueous pharmaceutical composition comprising:
(a) adalimumab;
(b) an acetate buffering agent (or acetate buffer system);
(c) a sugar stabiliser, wherein the sugar stabiliser is a non-reducing disaccharide selected from the group including trehalose and sucrose; and
(d) polysorbate 80; and
wherein the composition:
• has a pH between 5.0 and 5.5;
• is either free of arginine or comprises arginine in a concentration of at most 0.1 mM;
• is either free of phosphate buffering agents or comprises a phosphate buffer system in a concentration of at most 0.1 mM;
• is either free of amino acids or comprises one or more amino acids in a (collective) concentration of at most 0.1 mM; and
• is either free of surfactants, with the exception of polysorbate 80, or comprises one or more of surfactants excluding polysorbate 80 in a collective concentration of at most 0.001 mM.

The other claims depend on or otherwise indirectly refer to claim 1.

Amgen Inc. had applied for an authorization to run clinical trials on the product designated as ABP 501, in front of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), and the authorization was granted on August 13, 2013. This was before the priority date of EP’487.

The ABP 501 formulation was described in the request for authorization as adalimumab “at 50 mg/ml […] formulated with 10 mM sodium acetate, 9.0% (weight/volume) sucrose, 0.1% (w/v) polysorbate 80, pH 5.2“.

The judge noted that those are the essential features of the claimed invention – which seems to be a reasonable conclusion to draw; and that Amgen’s good faith did not appear to be questionable.

Thus, the only remaining point to be discussed, which in my view was the most tricky one, was whether the possession was “personal” and had taken place on the French territory.

This is potentially a major stumbling block to a prior user right defense in this country, especially in large group of companies. Under French law, a very strict distinction is usually applied between various companies, even if they are affiliated. Therefore, if company A “possessed” the invention, this does not necessarily imply that its affiliate B also “possessed” it. Even more so if A is a foreign company, and B a French one.

In this case, the request for authorization to run clinical trials was filed by the U.S. company Amgen, Inc. But the defendant to the lawsuit was a different company, namely the French subsidiary Amgen SAS.

Here is how Amgen passed the hurdle:

In view of the specific organization of the Amgen group, it is reasonable to consider (especially in urgency proceedings) that Amgen SAS, like the other European subsidiaries of the group, had direct access to the document relating to the clinical trials, and thus to the formulation of the biosimilar product ABP501, owing to the “EPIC” platform of the group, as early as March 2013. In fact, part of the clinical trials were performed in France. It must therefore be held that the possession of the formulation which is identical to the patented one, although originating from the U.S., was realized in France. 

Thus, the judge concluded that the prior user right defense raised by Amgen was a serious challenge to the likelihood of infringement.

By way of overkilling, the judge noted that the lack of novelty argument based on prior art document US 2014/0086930 was also serious.

Consequently, Fresenius’ request for PI was dismissed.

I often conclude my posts by stating how much I look forward to the next developments in the litigation (judgment on the merits, appeal…). But in this particular instance, I don’t think there is anything to look forward to, really.

Indeed, we can see on the online European patent register that Amgen withdrew its opposition a few days ago on May 8, 2019. This certainly means that a settlement has been reached. We thus likely will not hear about this dispute anymore.

By the way, the 9-month opposition time limit has not expired yet – it will on May 22. I’m somewhat curious to know whether others will oppose.

One take-away message from this ruling is that the sharing of information between the various companies of the Amgen group via a dedicated platform was crucial in securing the French affiliate’s right to use the invention despite the patent. This may be a point to keep in mind for other multinational companies.

Although on the other hand it may also be difficult to put into place as a general rule, in view of the necessity to actively protect trade secrets.


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, February 14, 2019, Fresenius Kabi Deutschland GmbH v. Amgen SAS, RG No. 19/50489.

Paris, Texas

Sometimes, French patent litigation can have the distinct flavor of a road movie.

OK, you may not get to travel that much: the plot usually takes place in Paris all along, from one courtroom to the next, from first instance to appeal and then cassation and sometimes back down to appeal. In fact, until very recently, all of these courtrooms used to be concentrated in a very small area – the Ile de la Cité.

But imagination has journeys of its own. And when a litigant called Texas ends up being stuck in Paris for a number of years, what can you do, pictures of a desert come to mind. This is just how evocative some titles are.

So, two years ago, I wrote a post on this road movie of a sort, Carrera & Texas de France v. Muller. 

Can there be such a thing as free infringement, is the question I asked on that occasion. And I wondered whether the Cour de cassation would have to weigh in. Well it did, and the time has thus come to revisit the question.

As a reminder of the background of the case, Muller & Cie holds a European patent on a heating element for a heating or cooking apparatus. Carrera and Texas de France were found guilty of infringement of this patent by the Paris Tribunal de grande instance (TGI) in 2014. This verdict was confirmed on appeal. In parallel, the TGI issued a second judgment on the computation of damages: Carrera and Texas were condemned to pay Muller damages of respectively 327,733 euros and 280,130 euros for Muller’s commercial prejudice, plus 100,000 euros for moral prejudice.

The defendants appealed, and the Paris Cour d’appel completely changed course in December 2016, setting the amount of damages to zero euro.

The case went up to the Cour de cassation. The court dismissed various challenges of the appeal ruling regarding the appraisal of sufficiency of disclosure, claim interpretation and a request for information. But the real interesting part is the discussion on the damages award – or rather, on the lack thereof.

First, we need to go back to the reasoning of the Cour d’appel:

  • Muller claimed damages amounting to an apportionment of the entire infringer’s profits (successfully so in first instance).
  • However, the appeal judges held that infringer’s profits can only be taken into account in the context of the assessment of a commercial prejudice. The confiscation of the infringer’s profits is not an alternative option which would be available to the plaintiff instead of claiming the compensation of a commercial prejudice.
  • In the case at hand, Muller did not personally exploit the patent. The patent was rather exploited through six licensed subsidiaries, which were not parties to the proceedings.
  • Therefore, said the Cour d’appel, the sole proper methodology for assessing damages was the so-called indemnifying royalty, because the only profits lost by Muller were a lost royalty.
  • But since Muller did not ask for such indemnifying royalty, the court could not grant this remedy – and thus could not take into account infringer’s profits either.
  • Finally, Muller’s claim based on a moral prejudice was held to be insufficiently substantiated.

This last bullet point did not raise the cassation judges’ eyebrows. They simply noted that it was within the Cour d’appel’s power to determine whether the count of moral prejudice was sufficiently substantiated or not.

But the supreme court struck down the part of the judgment dismissing Muller’s claim based on the infringer’s profits.

The quest for infringer’s profits is not unlike that of Leprechaun gold.

Here is a working translation of the key paragraph of the judgment, broken down into shorter sentences as always:

[The court] refused to take into consideration the claim for damages based on one of the assessment criteria provided in article L. 615-7 par. 1 of the Code de la propriété intellectuelle. However, in view of the case law of the Court of justice of the European Union, Directive 2004/48/EC aims at providing a high level of protection of intellectual property rights, which takes into account the specificity of each case and is based on a mode of computation of damages corresponding to such specificity (CJEU, March 17, 2016, Liffers, C-99/15, item 24), the choice of which belongs to the harmed party. Therefore, the existence of an economic prejudice for the patent proprietor resulting from the infringement is not subject to the proviso that the proprietor personally exploits. Thus, the Cour d’appel breached the law. 

This is a rather important ruling. If we go back for a minute to article L. 615-7, there is no denying that its wording is not crystal clear in terms of which options are available to the plaintiff:

In order to set damages, the court separately takes into account:

1° Negative economic consequences of the infringement, including lost profits and losses suffered by the harmed party;

2° Moral prejudice inflicted to said party;

3° And profits made by the infringer, including savings on intellectual, material and promotional investments made owing to the infringement.

However, the court may, alternatively and upon request of the harmed party, grant a lump sum in terms of damages. This lump sum is higher than the amount of royalties or rights which would have been due if the infringer had asked for the authorization to use the right that it infringed. This sum does not exclude the further indemnification of the moral prejudice of the harmed party.  

What this Texas ruling means is that a patent proprietor has the right to choose its mode of damages computation, and in particular has the right to rely on option 3° regardless of whether they work the patent or not.

Overall, this is good news for IP right holders, as it gives them more flexibility in their argumentation and assessment of damages.

But that’s not to say that all is said and done on this issue. Article L. 615-7 recites that the court should “take into account” various factors, including the “profits made by the infringer“. Does this mean that the plaintiff is entitled to recover the full profits made by the infringer? Or only part of those?

I am not sure this is settled law. So again, and just as I wrote two years ago, I am looking forward to the next scene of the movie.


CASE REFERENCE: Cour de cassation, chambre commerciale, January 23, 2019, Carrera & Texas de France v. Muller et Cie, appeals No. R 16-28.322 & A 17-14.673.

A core issue

I have already reported twice on the Core Wireless v. LG litigation in France: the first time to report on the first instance judgment, and the second time to report on a procedural ruling issued during the appeal proceedings.

Today’s post will be about Conversant v. LG… which is exactly the same litigation, since Core Wireless Licensing SARL has now become Conversant Wireless Licensing SARL.

So, the appeal ruling is out – and it basically confirms the first instance judgment.

As a reminder, Conversant (Core) holds a portfolio of Nokia-originating telecom patents. More than a thousand of these patents were declared essential for the 2G, 3G and 4G standards before the European Telecommunications Standards Institute (ETSI).

Core negotiated for several years with South-Korean giant LG Electronics in an attempt to reach a license agreement over this portfolio – but the negotiations failed. In September 2014, Core filed a complaint with the Paris Tribunal de grande instance (TGI), claimed damages and requested that the court should set a royalty rate for LG’s telecommunication devices. The complaint was based on a set of five European patents.

The TGI held that there was no evidence of infringement of the five patents by LG, and thus dismissed Core’s claims in April 2015.

The many traps of standard essential patent litigation.

Core appealed. When I commented on an interim case management ruling, I assumed that the only remaining issue on appeal was the determination of the royalty rate. This understanding was based on a somewhat misleading comment in the interim ruling – and it was thus incorrect.

In fact, similar issues were raised on appeal as in first instance. The main difference is that Conversant no longer asserted three of the patents initially discussed and preferred to focus on the remaining two.

Conversant still claimed that these two patents were infringed by LG and requested that the court should set a worldwide FRAND royalty rate for its portfolio. LG raised a number of defenses: invalidity of the two patents, absence of FRAND offer by Conversant, exhaustion of rights (based on a Nokia – Qualcomm license), absence of essentiality of the two patents, etc.

The first interesting part of the appeal ruling is a procedural one. The parties and the court made extensive use of the new provisions offered by the law of July 30, 2018 on the protection of trade secrets.

As already explained in the report on the interim ruling, the access to some of the exhibits (especially license agreements) was restricted to the parties’ lawyers and to some designated persons having signed confidentiality agreements (especially interpreters and economist experts).

Also, two versions of the written submissions, were filed, namely a complete one and a redacted one deprived of any reference to confidential information relating to the various license agreements at stake.

Finally, the hearing was scheduled over three days.

On the first day, Nokia’s FRAND commitment, an alleged abuse of dominant position and the exhaustion defense were debated. During part of the day, access to the courtroom was restricted to the lawyers of the parties as well as a couple of representatives from said parties. This closed session revolved around the most sensitive exhibit (the Nokia-Qualcomm agreement) and the exhaustion defense.

On the second day, the determination of the FRAND rate was discussed. Again, access to the courtroom was restricted to the above persons, plus a number of designated experts, during part of the day – when comparable license agreements were disclosed.

On the third day, validity, essentiality and infringement of the patents were discussed (without any access restriction).

The recent modernization of French procedural rules which has made this type of customized arrangement possible is most commendable – and was long overdue. It has probably put France on an equal footing with other major patent jurisdictions that have long been accustomed to such notions.

As readers may already have noted, a three-day appeal hearing for a patent case, especially at the appeal stage, is truly exceptional in France. This duration was certainly justified by the complexity of the case.

Hence, it could legitimately be assumed that a significant decision would come out of this whole process, namely a worldwide FRAND rate-setting determination. It did not.

First, the court reviewed the two sample patents asserted by Conversant, and addressed the invalidity challenges brought by LG. The court concluded that both patents were valid.

Second, the court addressed whether these two patents, declared as essential, were indeed essential for the standards at stake. Walking in the footsteps of the first instance judges, they concluded that they are not.

Since the demonstration of infringement was solely based on the essentiality of these patents (and on the compliance of LG’s devices with the standards), and since no other patent from the portfolio was asserted in the lawsuit, the court was finally not aware of any actual Standard-Essential Patent (SEP) held by Conversant.

As a result, the court did not rule on exhaustion of rights, on the FRAND royalty rate and on all other exciting questions raised by the case.

Again, I guess that a number of stakeholders may be disappointed by this underwhelming decision, not so much because the plaintiff lost, but because legal certainty is currently relatively low when it comes to SEPs, FRAND royalty rates and exhaustion of rights.

Additional guidance from a French court would thus have been welcome.

That being said, looking at the non-essentiality finding in the ruling in more detail is rather interesting.

Claim 1 of the first patent, EP 0978210, is directed to a “method for selecting a base station in a mobile communication system“. One of the steps of the method consists in, “in response to recognizing the poor radio signal, measuring“, well, a certain something.

According to the relevant technical specifications of the UMTS (3G) and LTE (4G) standards, as explained by the parties and their experts, if a radio connection having a quality lower than a threshold is identified, a measuring step as claimed must be performed. But if the quality of the radio connection is higher than the threshold, the terminal may decide not to perform any measurement, which means that it may conversely decide to perform a measurement anyway.

The court concluded that a terminal which also performs the measurement when there is a good connection would be compliant with the standards but would not infringe the patent. Therefore, the patent is not an SEP.

Claim 1 of the second patent, EP 0950330, can be quoted in its entirety: “A user terminal comprising a wireless interface and a formatting device for formatting a signal for transmission over said wireless interface in accordance with a low level signal format protocol, characterised in that it comprises means for receiving a type signal, wherein said type signal is indicative of a high level signalling protocol to be used in transmitting said signal, and for formatting said signal in accordance with said high level signalling protocol“.

According to Conversant’s expert, LTE terminals can access both of the so-called IPv4 and IPv6 networks. If a network can work with only one of IPv4 or IPv6, the terminal will use it. If a network can work with both IPv4 and IPv6, the terminal will select one of those. Thus, the claimant argued, the subject-matter of claim 1 is implemented.

However, LG replied that IPv4 and IPv6 are just two versions of the same protocol, and not two different protocols. The court was quite sensitive to this argument, as the patent itself, although it was filed after IPv4 and IPv6 were established, does not distinguish between these versions and only broadly refers to the internet protocol (IP). Besides, the standard does not explicitly state that the terminal should select between IPv4 and IPv6 when both are available. It is thus not possible to consider that such a selection step would be demanded by the standard.

Again, the conclusion is that the patent is not an SEP.

Essentiality was thus the core issue throughout this litigation.

This appeal ruling should come as a warning that claim mapping of a standard is far from being straightforward.

Among the 1,000+ patents of the portfolio, it can be safely assumed that the five (later narrowed down to two) patents asserted in this case were rated as being among the “strongest” or “best” ones by their holder. And yet, even with these two particularly “strong” or “good” patents, the essentiality case was not clear-cut, as delicate issues of claim interpretation arose.

This is not completely surprising, as standards are elaborated quite independently from the patents which may be owned by members of the standard-setting body. Also, a standard contains a number of minimal rules but does not provide all implementation details. Even if, in practice, all implementations use a certain feature, it does not necessarily mean that this feature is required by the standard itself.

This makes me wonder about the proportion of patents declared as potentially essential which would be viewed as actually essential by a court? I assume that proportion could in fact be rather low. Definitely some food for thought for all those involved in license negotiations.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, April 16, 2019, Conversant Wireless Licensing SARL v. LG Electronics France SAS & LG Electronics Inc., RG No. 15/17037.

A travel back in time

Regular readers of this blog are probably aware that Lionel Vial is a frequent contributor.

I am grateful for his thorough reporting on pharma / biotech case law. Today, he once again keeps us apprised of the latest SPC tidbit. As he even provided the illustration, I really have nothing to add but say thanks!

While we are all waiting for the decision of the CJEU in the Santen case (C-673/18) to finally know if, in application of the Neurim (C-130/11) case law, a patented novel medical use in humans of a product having already been authorized for a previous different medical use in humans deserves a supplementary protection certificate (SPC), the decision discussed today will take us back to the pre-Neurim era, a time of uncertainty as we will see.

At that time, the prevailing case law regarding further medical use consisted in Pharmacia Italia SpA (C-31/03) rendered on October 19, 2004, and Yissum (C-202/05) rendered on April 17, 2007.

According to the judgment in Pharmacia Italia SpA:

The grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by an authorisation to place the product on the market as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

On the other hand, the order in Yissum reads:

Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products […] is to be interpreted as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product.

The DeLorean remains the best way to travel in time with style.

The Regents of the University of Colorado (hereafter the University) was granted European patent No. 1658858 on November 18, 2009 for the use of a botulinum toxin, in particular botulinum toxin type A, in the preparation of a pharmaceutical composition for treating a recalcitrant voiding dysfunction, in particular urinary incontinence.

A corresponding marketing authorization was then granted on August 22, 2011.

The University had six month (that is until February 22, 2012) to file an SPC application. However, since botulinum toxin type A had benefited of previous marketing authorizations and in view of the then prevailing case law, the University considered it impossible to have an SPC granted and therefore no SPC application was filed.

Then the Neurim judgment was rendered on July 19, 2012. It notably provides that:

Articles 3 and 4 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 must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

Neurim has often been considered as a complete reversal of the previous case law.

Besides, for many commentators, it opened the door to SPCs for novel medical uses in humans of products having already been authorized for a previous different medical use in humans.

The University therefore filed an SPC application on September 19, 2012, i.e. within 2 months of the publication of the Neurim judgment, but about 7 months after the end of the deadline for doing so.

The University sought to benefit from the provisions of Article L. 612-16 of the Code de la propriété intellectuelle, according to which:

Where an applicant has not complied with a time limit as regards the Institut National de la Propriété Industrielle, it may submit an appeal for reinstatement of it rights if it is able to give a legitimate reason and if the direct consequence of the hindrance has been refusal of its patent application or of a request or the loss of any other right or means of appeal.

The appeal must be submitted to the Director of the Institut National de la Propriété Industrielle within two months of the cessation of the hindrance. The act that has not been carried out must be accomplished within that period. The appeal shall only be admissible within a period of one year from expiry of the time limit not complied with. […]

However, the INPI (French patent office) was not convinced and rejected the appeal for reinstatement on June 30, 2015.

The University and Allergan (to whom the SPC application and the basic patent had then been assigned) appealed the decision of the Director of the INPI before the Paris Cour d’appel on September 18, 2015.

In a first decision dated September 16, 2016 the Cour d’appel confirmed the decision of the INPI. However, the decision was invalidated by the Cour de cassation, the French Supreme court, on April 5, 2018, for procedural reasons, as the Cour d’appel had neglected notifying observations made by the INPI to the University and Allergan.

The case then came back in front of the Paris Cour d’appel which, albeit with different judges, again confirmed the decision of the INPI on February 12, 2019 in the following terms:

However, according to the terms of article L. 612-16 of the intellectual property code, the legitimate reason must be understood as a “hindrance”;

Even considering that the case law of the CJEU, before the Neurim judgement, did not allow the University to expect obtaining an SPC and could therefore discourage it to file an SPC application, the director of the INPI rightly observes that this situation does not characterize a hindrance according to the previously cited provision, given that the case law, be it that of the Court of justice, evolves, that even with the Pharmacia Italia and Yissum case law other operators have indeed filed SPC applications in relation to further medical uses, one of which having given rise to the Neurim judgment, and that the lack of filing of an SPC application by the University was the result of its free appreciation of the latter and not of an objective impossibility, independent of its will.

In any case, pursuant to article 7 of regulation No. 469/2009 concerning the supplementary protection certificate for medicinal products, the University had a six-month period expiring on February 22, 2012 to file its SPC application; the reference for preliminary ruling to the Court of justice of the European Union was received at the Court on March 16, 2011 and published in the OJEU on June 18, 2011; under these conditions, as is rightly observed by the director of the INPI, the University had to consider a possible reversal of the case law of the Court of justice;

As such, the decision of the director of the INPI is exempt from criticism in having retained that the lack of respect of the deadline imparted to the University for filing its SPC application was not due to a hindrance for which it would benefit from a legitimate reason, but to its will not to proceed with a filing that it did not consider appropriate and this in spite of the reference for a preliminary ruling submitted to the Court of justice duly published on June 18, 2011.

Perhaps, this case is an illustration that too much knowledge is sometimes dangerous, and that we, as counsels, should always be careful when giving opinions on the likely outcome of a filing on the basis of our knowledge of established case law, bearing in mind that there is always a possibility, even a remote one, that a case law can be overturned.

In any case, the University and Allergan should refrain from nourishing regrets on their missed filing at least until the result of the Santen referral (C-673/18) is known, as this latter case precisely arises from a decision of rejection of an SPC application by the INPI in relation to a further medical use.

Well, the way I see it, getting SPC law 100% right is a little bit like having to hit a wire with a connecting hook at precisely eighty-eight miles per hour the instant a lightning strikes a tower. Everything will be fine.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, February 12, 2019, The Regents of the University of Colorado & Allergan Inc. v. Directeur de l’Institut National de la Propriété Industrielle, RG No. 18/14291.

A ruling not so Great for Manitou

In a rather exceptional move, two patent attorneys professional organizations took sides in a lawsuit between two private companies.

In fact, the CNCPI (Compagnie nationale des conseils en propriété industrielle) and the ACPI (Association des conseils en propriété industrielle) filed an intervention in an appeal on points of law in front of the Cour de cassation.

I know this may sound like a nerdy and rather unamusing April Fools’ day prank, but it is not. I have temporarily given up on those since reality has started catching up with the imagination of jesters on a daily basis (anyone up to a Brexit joke these days?).

So, yes there was indeed such an intervention, in the litigation pitching British company JC Bamford Excavators Ltd. (JCB) against Manitou BF.

How did we get there and how did this all end?

JCB specializes in the production of manufacturing equipment e.g. for construction and agriculture. Manitou is a French manufacturer of fork lifts and other heavy equipment.

JCB owns in particular two European patents (EP 1532065 and EP 2263965) that it believes have been infringed by Manitou on the French territory.

On April 26-27, 2017, JCB rented a telehandler called Manitou MT 1840 and had tests performed on this device by two JCB employees, in the presence of two French patent attorneys. These tests were aimed at demonstrating infringement of the patents at stake. The two patent attorneys involved in this testing issued a report for JCB.

On May 5, 2017, JCB filed a complaint for patent infringement against Manitou.

A few weeks later, on June 1, 2017, JCB filed a request for an ex parte order to be authorized to carry out an infringement seizure in Manitou’s premises. It is somewhat unusual for an infringement seizure to be requested after the infringement proceedings have already been initiated, but it is certainly possible to proceed in such a “reverse” order. The ex parte order was granted the next day.

On June 16, 2017, the infringement seizure was carried out by a bailiff in Manitou’s premises. It must have been a rather exhausting one for all those concerned, as it lasted until 2:15 am the next day…

The bailiff was assisted during the seizure by two patent attorneys – as is almost always the case. But the important point here is that the two patent attorneys at stake were those who had assisted JCB with the April testing.

One week later, Manitou filed a motion for canceling the infringement seizure order. The judge rejected the motion in another order dated October 5, 2017. Manitou appealed.

On March 27, 2018, the Paris Cour d’appel set aside the October 2017 order, and canceled the infringement seizure order of June 2017 – thus also canceling at the same time the bailiff’s infringement seizure report.

The court expressed the following principle:

[…] The right to a fair trial set out in article 6 of the European Convention on Human Rights [ECHR] requires that the expert assisting the bailiff should be independent from the parties […]. 

The court then reasoned as follows:

Mr. […] and Mr. […] were designated twice in the same infringement lawsuit between [JCB] and Manitou; a first time on April 26, 2017, upon [JCB]’s request, to perform tests on a Manitou MT 1840 vehicle, and to hand out on May 4, 2017 a private expert report describing the features of the material which was examined; and then by way of an order dated June 2, 2017, in which they were designated as judicial experts to assist the bailiff during the infringement seizure relating again to the MT 1840 model, already examined during the private expertise, as well as to further Manitou models. Obviously, and regardless of their status which requires compliance with rules of ethics, patent attorneys cannot be designated as experts by a judicial authority while they have previously been involved as experts on behalf of one of the parties in the same case […], without violating the impartiality principle required by article 6 [ECHR]. Their designation was illegal, so that the June 2, 2017 order shall be canceled, and the October 5, 2017 order shall be set aside.

JCB filed an appeal on points of law in front of the Cour de cassation.

The Cour de cassation: the Great Manitou of French litigation.

The March 2018 ruling sent some shock waves through the French patent profession as it seemed to establish new requirements for patent attorneys to be able to assist a bailiff during an infringement seizure.

Hit by these shock waves, the two abovementioned patent attorney professional organizations stepped in, in support of JCB’s case.

Hot from the dematerialized press, here is now the judgment issued by the cassation judges a few days ago, which the Cour de cassation set aside the March 2018 ruling of the Paris Cour d’appel.

Locating the key part of a cassation judgment is a rather easy task. Such judgments are so brief that there is hardly any meat at all around the key part. So here it comes (broken down into shorter sentences):

The fact that the patent attorney of the seizing party had, on the initiative of the latter, established a report describing the features of the product at stake, does not prevent a later designation, upon request of the seizing party, as an expert to assist the bailiff in a patent infringement seizure. [Indeed], his mission is not subjected to a duty of impartiality since it is not an expertise under articles 232 and following of the Code de procédure civile. [Therefore], by ruling in this manner, the Cour d’appel breached the above legal provisions [i.e. article 6 ECHR and article L. 615-5 Code de la propriété intellectuelle].  

I bet this ruling will come as a relief for most of the patent profession.

The mistake made by the Cour d’appel seems to have been to consider the patent attorneys assisting the bailiff as court-appointed judicial experts. They are not.

They are supposed to help the bailiff find evidence of infringement, they are not there to provide an impartial recommendation to a judge regarding the outcome of a discussion.

Calling upon patent attorneys to assist the bailiff, as opposed to employees of the infringement plaintiff for instance (which is prohibited), offers a number of guarantees for the seized party, due to the rules of ethics that patent attorneys have to follow. For instance, a patent attorney should not and will not communicate to the plaintiff any confidential information that he/she becomes privy to during the seizure.

But on the other hand there is no requirement for the patent attorney not to have advised the plaintiff in the past – including regarding the case at hand.

By the way, the CNCPI and ACPI’s intervention in the appeal was found admissible.

This may pave the way for similar interventions in the future in case the rights and prerogatives of patent attorneys are at stake in a litigation.


CASE REFERENCE: Cour de cassation, ch. commerciale, March 27, 2019, JC Bamford Excavators Ltd. v. Manitou BF, appeal No. H 18-15.005.