Representatives don’t count

Being a representative myself, my feelings tend to get hurt when I am told that representatives do not matter. Except, that is, when this is in the best common interest of attorneys and their clients, as in the present case.

In December 2013, Spanish company Agromet Ejea SL filed a French utility certificate application through its local French representative.

This is already an unusual start, since utility certificates are a rare species. But wait until you hear about the rest of the facts, which are rather unusual as well.

The second renewal fee for the utility certificate was due on December 31, 2014, and was not paid in due time. It was not paid either by the end of the 6-month grace period. This led the Institut National de la Propriété Industrielle (INPI) to issue a decision of noting of lapse dated August 31, 2015. This decision was notified to the French representative on September 3, 2015.

When the INPI sends you flowers.

A request for restoration of right was filed on November 16, 2015. The INPI rejected this request as inadmissible as it was filed too late.

The French provision on restoration of right is article L. 612-16 of the Code de la propriété intellectuelle. It is very similar to article 122 and rule 136 EPC. In particular, it is specified in the French provision that the request for restoration must be filed within two months of the removal of the cause of non-compliance.

The INPI considered that the cause of non-compliance had been removed upon notification of the decision of noting of lapse to the French representative on September 3, 2015. Therefore, according to the position of the office, the request for restoration should have been filed by November 3, 2015 at the latest.

The owner of the utility certificate appealed the decision in front of the Paris Cour d’appel.

They did well, as the court set aside the decision of the INPI and offered a different computation of the time limit for filing the request for restoration:

Contrary to the position of the [INPI], the legitimate excuse and the removal of the cause of non-compliance […] are appraised with respect to the owner of the IP right and not their representative

In the present case, Agromet Ejea SL stated that they entrusted a Spanish patent law firm with the filing and handling of the utility certificate […], which appointed firm [X] for France. They proved the deficiencies of their representatives in their submissions and with their exhibits, which led to the non-payment of the renewal fee […]. In December 2014, the email reminders of the French representative to the Spanish representative did not reach their destination due to an error of electronic address. In 2015, the IP portfolio management software of the French representative broke, preventing a reminder of the time limit for late payment. The employee of the French firm in charge of the file made several mistakes, leading to the termination of her employment agreement on September 9, 2015, with an effective departure on October 20, 2015. Finally, the decision of noting of lapse of August 31, 2015, notified on September 3, 2015 to the French representative was only communicated to the Spanish representative on October 12 and 16, 2015. The latter only informed the right owner on October 19, 2015. 

Besides, Agromet Ejea SL established that they inquired about the status of their right. Their Spanish representative asked the [French] representative about this by email on July 6, 2015. In view of the above, it can be derived, on the one hand, that Agromet Ejea SL could rely on a legitimate excuse for not paying the renewal fees of its IP right within the prescribed time limits, due to its representatives’ faults; and on the other hand that the cause of non-compliance was only removed on October 19, 2015, when they were made aware of the decision of lapse, or at the earliest when it was published in the BOPI on September 25, 2015

Thus, on November 16, 2015, since the two-month time limit had not yet expired and the payment of the surcharge was made on the same day, the request for restoration of Agromet Ejea SL was admissible.

In summary, the court held that the request for restoration was admissible and well-founded.

It is well known that the notion of legitimate excuse is assessed in a much more lenient manner in France than at the EPO.

In fact, a mistake made by a representative is a legitimate excuse per se, as illustrated by the present case. There is no need to demonstrate that the omission was the result of an isolated mistake within a satisfactory system for monitoring time limits, as demanded by the EPO. Fortunately so for the applicant in the present case, in view of the large number of deficiencies noted by the court…

But today’s decision illustrates that this different perspective also extends to the computation of deadlines.

According to established case law of the Boards of appeal, “the removal of the cause of non-compliance is a matter of fact which has to be determined in the individual circumstances of each case“. More particularly, “the removal of the cause of non-compliance occurs […] on the date on which the person responsible for the application (the patent applicant or his professional representative) is made aware of the fact that a time limit has not been observed“.

Usually, the receipt of a noting of loss of rights or negative decision is considered by the EPO as making the person in charge aware of the non-observance. In most cases, the relevant person is the European representative; but in other cases, it can be the applicant, or even a foreign patent attorney (see here), depending on the specifics of the case.

In contrast, the position of the Cour d’appel seems to be that only the receipt by the applicant can be relevant. Interestingly, the Cour d’appel also offered another possible starting point for the time limit, namely the publication of lapse in the BOPI (Bulletin officiel de la propriété industrielle), which is the local equivalent of the European patent bulletin.

In this case, the time limit was found to have been complied with irrespective of the exact starting point. But if the request for restoration had been filed e.g. on December 1, 2015, it would then have made a world of a difference whether the starting point was October 19 or September 25. So, it is somewhat strange that the court did not more clearly state its position.

The one unfortunate thing about this case though is that one of the very few advantages of utility certificates as opposed to patents is their reduced cost. But in this instance, I would not bet that any money at all was ultimately saved, in view of all the efforts necessary to keep the certificate alive.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, April 25, 2017, Agromet Ejea SL v. Directeur général de l’INPI, RG No. 16/11489.

A true vade mecum to SPC law

A few days ago, a very interesting decision on the blockbuster drug Truvada® landed on my laptop courtesy of Matthieu Dhenne. According to the decision, Gilead’s request for preliminary injunction to halt the distribution of Mylan’s generic version of Truvada® on the French territory was denied on September 5, 2017.

Soon thereafter, a most interesting report on the decision reached my inbox courtesy of Lionel Vial.

Owing to both of them, my main remaining task was to find a title and a patent illustration for the post. So, if those are neither apt nor witty, that’s on me.

As you will see, this decision is a good opportunity to revisit the CJEU case law on combo SPCs, since there is a UK-based pending reference to the CJEU in connection with the Truvada® litigation.

I will now leave the floor to Lionel.

Today we report about France’s contribution to the ongoing pan-European litigation over generics of Truvada®.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC). It has received a relatively important media exposure since it became, in 2012, the first drug to be approved by the Federal Drug Agency (FDA) for Pre-exposure Prophylaxy (PreP) of HIV infection. As such, the TDF/FTC combination can be used to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. By way of example, the so-called IPERGAY clinical study has evidenced that this combination allowed 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.

As will be readily spotted by our trained readers, the main question of law arising from this wording 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 (hereafter the « SPC regulation »).

Intense litigation over the validity of the SPCs has ensued, which has notably led Justice Arnold of the High Court of England and Wales to request a preliminary ruling of the CJEU on the question of knowing “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” (yes, again). The case is pending as C-121/17.

The current status of selected SPCs is summarized in the following table:

Country Decision of the patent Office Validity status
Belgium Granted Ruling on the merits pending
Germany Granted Ruling on the merits pending
Great-Britain Granted Ruling of the High Court stayed pending C-121/17
Ireland Granted Ruling on the merits pending
Italy Granted Ruling on the merits pending
The Netherlands Rejected Ruling of the Court of Appeal stayed pending C-121/17
Spain Rejected Rejection overturned by the Administrative Court of Madrid
Sweden Rejected Rejection upheld by the Court of Appeal

It is now France’s turn to take position on the validity of the SPC.

French SPC No. 05C0032 was granted on December 21, 2006 and will expire on February 24, 2020. Mylan obtained a generic marketing authorization for the TDF/FTC combination on December 16, 2016. On July 13, 2017, Gilead requested a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic. The case was heard on August 11, 2017. Meanwhile, Mylan offered its generic for sale on July 26, 2017, i.e. one day after the term of the basic patent. The ruling was rendered on September 5, 2017.

As could be expected, the judge performed a quite thorough appraisal of the case law of the CJEU regarding Article 3(a) of the SPC regulation as applied to this case, notably:

  • C-322/10 (Medeva): active ingredients have to be specified in the wording of the claims;
  • C-443/12 (Actavis v. Sanofi): the basic objective of the SPC regulation is to compensate for the delay to the marketing of what constitutes the core inventive advance [i.e. the technical contribution] that is the subject of the basic patent;
  • C-493/12 (Eli Lilly): where the active ingredient is covered by a functional formula in the claims, Article 3(a) does not preclude the grant of a supplementary protection certificate for that active ingredient, on condition that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The French judge also noted that in cases C-443/12 and C-577/13 (Actavis v. Boehringer), the CJEU had considered that the core inventive advance forming the subject of the respective basic patents was limited to the compound the invention of which was sought to be protected, even though combinations with other compounds (which invention did not form the subject of the patent) were mentioned.

A patented robot to help you find your way through SPC case law.

In the case at hand, the French judge thus considered that the SPC was “in all likelihood invalid”, because none of the conditions defined the case law of the CJEU were apparently fulfilled.

Here is the relevant part of the decision (based on the English translation distributed by cabinet Schertenleib):

It appears that claim number 27 is drafted so broadly that it does not describe any specific active ingredient that should be combined with tenofovir disproxil [NB: this a reference to C-322/10]; it thus does not protect a combination that is likely to result in entitlement to the grant of a patent.

Moreover, the combination claimed as active ingredient “tenofovir disoproxyl + emtricibatine” is not implicitly but necessarily and specifically taught in the description [NB: this is a reference to C-493/12], there is no indication whatsoever that would enable the person skilled in the art to choose emtricibatine and it quite evidently does not constitute the core of the invention [NB: this is a reference to C-443/12].

If tenofovir disoproxil indeed constitutes the subject matter of the basic patent, the combination of tenofovir disoproxil with any other therapeutic ingredient cannot constitute a separate invention.

On the one hand, this combination as claimed in claim No. 27 is not a functional claim because it does not describe the structure that should be produced and the function that the second product should fulfill in order to build this structure. [NB: this is a reference to C-493/12]. On the other hand, assuming that this claim was functional, the steps defined by the Dutch Patent office in order to determine whether emtricibatine was sufficiently taught by the patent as being the necessary therapeutic ingredient of claim number 27 are relevant:

1 – Upon reading the phrase formulation in the context of the patent and in the light of their general knowledge, would the person skilled in the art think of the active therapeutic ingredient (biological)?

2 – Would the person skilled in the art think immediately of antiviral agents?

3 – Would the person skilled in the art immediately deduce that these antiviral agents designate anti-HIV agents?

4 – At the priority date, would the person skilled in the art have immediately thought of emtricitabine as anti-HIV agent?

Based on the description and as was perfectly highlighted by the Dutch Office of Industrial Property, no specific combination has been claimed, no relevant element has been reported so as to induce the person skilled in the art to select emtricitabine especially as there is no indication leading one to select a second antiviral agent as the “other therapeutic ingredient” let alone an antiviral anti–HIV agent.

As a consequence, Gilead’s request for preliminary injunction was refused. It now remains to be seen if this preliminary conclusion will be upheld when the case will be tried on the merits.

Finally, we would like to go back to Justice Arnold’s request for further guidance of the CJEU on the question “what are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”. Apparently, Justice Arnold’s goal was to get a ruling establishing that, pursuant to Article 3(a), SPCs for combinations of active ingredients should be reserved for cases where the combination, as distinct from one of the active ingredients, embodies the inventive advance of the basic patent. But perhaps the Truvada® case was not the best one for such a reference to the CJEU.

Indeed, as emtricitabine is only purported to be specified by the expression “other therapeutic ingredients”, there is a chance the CJEU will not feel it necessary to go beyond its previous ruling according to which active ingredients have to be specified in the wording of the claims.

Well, to Lionel’s latter point, UK courts have always been quite prolific in asking SPC-related questions to the CJEU. As we know, this will probably soon come to an end. So maybe this was something of a last chance for them to try and get a final answer to a longtime puzzle?


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, September 5, 2017, Gilead Sciences Inc. et al. v. SAS Mylan, RG No. 17/57112.

No claim is etched in stone

The appeal ruling reported on today kept people waiting for a very long time, but the wait was worthwhile for case law observers, as it contains a number of interesting aspects.

The patent at stake is EP 0570484. It was filed on February 4, 1992 and claimed a priority back to February 4, 1991. The patent proprietor, Trikon Technologies Inc., had an infringement seizure conducted in September 2006 and then sued Alcatel Vacuum Technology France (AVTF) for infringement of the patent.

In case you are wondering what the usual pun in the title of this post is about, the patent relates to high density plasma machines for depositing or etching a substrate.

Over the course of the litigation, the original companies disappeared, the patent was sold, so, in order not to get lost, I will simply refer to the parties as the plaintiff and defendant, or similar designations.

In the first instance judgment dated March 3, 2009, the patent claims asserted by the proprietor were revoked by the Tribunal de grande instance for lack of novelty.

The plaintiff appealed, and this is when the case got dormant for a very long time. Presumably both sides dragged their feet. Well, when I say the case got dormant, this is not entirely accurate, as a lot actually happened.

First, the proprietor initiated central limitation proceedings at the EPO – and later abandoned it.

Then, a national request for limitation was filed at the French patent office (INPI), and was finally granted in September 2012, after a number of objections by the patent office and the defendant acting as a third party.

In May 2014, the defendant filed a motion for canceling the order for infringement seizure. Never too late! The appeal judgment does not mention what the objection was, but it was certainly a serious one, as the plaintiff gave up and withdrew its seizure exhibits from the record. Finally, the appeal went to trial in December 2016.

As I said, there are several interesting aspects in the ruling, but I will focus on the appraisal of the limited claims by the appeal judges.

First, an unconventional objection was raised by the defendant. According to article 564 of the Code de procédure civile, “new claims” may not be filed on appeal. By “new claims” is meant legal claims, not patent claims of course. The question is which claims filed on appeal are really new and which ones are not so new. In particular, according to article 566:

Parties may also make requests explicit if they were virtually comprised in the claims and defenses submitted to the first judge, and add thereto any claims which are an accessory thereto, a consequence thereof, or a complement thereto.  

In this case, claim 1 of the patent as limited comprised new features which had thus not been debated in first instance. The defendant then argued that the infringement case based on claim 1 as limited was a “new claim” according to article 564 and thus inadmissible. A very interesting argument indeed, but a long shot, as the court noted that the patent proprietor was entitled to limit its claims “at any time“, and that the limitation was retroactive, pursuant to article L. 613-24 of the Code de la propriété intellectuelle.

Therefore, this inadmissibility defense was rejected. It is true that if it had been successful, the benefits of limitation during litigation would have been considerably affected.

The second way the defendant challenged the limitation was by asserting that the subject-matter of the limited claims extended beyond the contents of the application as filed.

Here is claim 1 as limited, wherein the highlighted portion represents the main changes relative to claim 1 in the application as filed:

A system for generating a high density plasma comprising:

a plasma confinement chamber of cylindrical form;

means for injecting a gas to be ionized into the chamber;

means disposed adjacent the chamber for generating a longitudinal magnetic field in the chamber; and

means for generating high frequency energy at a frequency of 13.56 MHz and at power in the range of 100 W to 5 kW, comprising an impedance adaptation circuit;

the system being characterized in that an antenna forming means comprises:

a single loop element encompassing the cylindrical chamber, the loop element being disposed in a plane at an angle of in excess of 45° to the central axis of the chamber, and positioned in an intermediate region along the length of the chamber, said single loop element being coupled to the means for generating high frequency energy. 

State of the art etching… in 1899. For a bit of nostalgia: the patent was granted 4 months after filing.

The court started by restating the standard to be applied, which was accurately imported from the EPO doctrine:

The content of the application as filed must be interpreted as encompassing the description, the claims and drawings, as well as any teaching, even implicit, directly and unambiguously deriving therefrom, as understood by the skilled person.

This was followed by a long and complex discussion of the teaching of the application, which I will not attempt to fully reproduce here.

In a nutshell, the value of a frequency of 13.56 MHz was mentioned in claim 4 of the application, but (1) this value was not disclosed in association with a power range of 100 W to 5 kW, and (2) claim 4 depended on claims 2 and 3 which recited further features not included in claim 1 as limited.

So one issue was whether the value of 13.56 MHz was generally applicable to the power range of 100 W to 5 kW. And another issue was whether this value could be isolated from the other features disclosed in original claims 2 and 3.

Regarding the first issue, the court considered that the application generally taught a power range of 100 W to 5 kW and a frequency range of 2 to 50 MHz. One sentence in the description read: “to effect wave coupling and establish a high plasma current density, measured in mA/cm2, the antenna loop 12 is driven at 13.56 MHz and with RF energy of the order of 2.0 kW (in the range of 100 W to 5 KW) by the RF energy source 19“. This was interpreted as meaning that the whole power range could be achieved with the preferred frequency of 13.56 MHz, and that the value of 2.0 kW was only an example. The interpretation was confirmed by looking at the examples and figures.

The defendant argued that generating helicon waves required matching a certain frequency with a certain power, but the court did not agree that the invention was only about generating such helicon waves.

Regarding the second issue, original claim 2 mentioned a magnetic field of les than 1000 gauss, a plasma density of more than 1013/cm3 and a loop element at an angle of about 90° relative to the magnetic field; and original claim 3 mentioned a first plasma current and density peak in the grange of about 50 gauss and a second plasma and density peak in the range of about 400 gauss.

The court analyzed the application in detail again and came to the conclusion that these various features were not mandatory or essential, and not inextricably linked with the frequency value of 13.56 MHz.

Thus, there was no extension of subject-matter beyond the content of the application as filed. 

Why on earth original claim 4 was then exclusively dependent on claim 3, which itself depended on claim 2, and why this claim did not directly depend on the broadest claim 1, is unclear to me. Generally, this is a hint that the various technical features at stake are probably interconnected. Not in this case, apparently – but as I said, the technical discussion was quite complex.

Anyway, the patent as limited survived the added matter challenge. It also successfully passed novelty and inventive step challenges.

On the other hand, the court found that there was no evidence of infringement, and this is another interesting aspect of this case. As explained above, the evidence seized in 2006 was no longer part of the record, further to the late challenge brought by the defendant against the seizure order.

The plaintiff relied on technical manuals and technical specifications of the defendant’s various machines. The court did not even examine whether the technical information contained in these documents reproduced the subject-matter of the patent claims.

In fact, it was sufficient for the court to note that there was no clear evidence of any potentially infringing act (such as manufacturing, marketing or the like). The new assignee of the patent filed an affidavit by its vice president and CFO, but this affidavit did not convince the court:

The affidavit […] contains tables originating from Alcatel’s documentation and states that “Alcatel made and sold 129 litigious machines during the litigious time period”. This does not make it possible to identify the machines at stake. And, due to the quality of its author, it cannot represent objective evidence of the manufacturing or marketing of machines reproducing the features of the EP’484 patent. The court notes that, in view of the documents relied on by SPTS as to the number of machines allegedly manufactured and marketed, they did not undertake any effort making it possible to physically identify any one of the allegedly infringing machines. 

Technical documents do not demonstrate the actual manufacturing of the machines that they describe. And even if they were indeed manufactured, it is no possible to determine the date of manufacturing nor the manufacturer. 

Remarkably, the court also rejected a request for the appointment of an expert to assess the extent of infringement and the corresponding damages. 

The take-away message here is that infringement seizures are a powerful tool for IP right holders in this country. But if for some reason the infringement seizure falls apart, it becomes much more difficult for them to prove their case, and courts are generally unwilling to help them complete it.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 – chambre 2, March 10, 2017, TTI Liquidating Inc. et al. v. Pfeiffer Vacuum et al., RG No. 15/01226.

Sunset for Cynrise

Easter always brings back chocolaty memories. The question as a child growing up in the Northeastern part of France on Easter morning was whether eggs had been brought by the Easter bunny. And the question as a child also growing up in the Southeastern part of France was whether eggs had been brought by the Easter bells.

It has been a while since the Easter bunny and the Easter bells stopped feeding me with chocolate. But this year there was an even better surprise on Sunday morning, in the form of an SPC-related guest post by Lionel Vial. And as all readers will probably acknowledge, SPCs are a delicacy of their own.

Rush of nostalgia: Easter eggs are no longer what they used to be.

Here is to Lionel.

The case discussed on this Easter day relates to a ruling of the Paris Cour d’appel dated January 20, 2017 which upheld a decision of the French patent and trademark office (INPI) to reject an application for a supplementary protection certificate (SPC) for a biological medicinal product.

French SPC application No. 11C0054 was filed on December 14, 2011 by Laboratoire Français du Fractionnement et des Biotechnologies (hereafter LFB), a French company specializing in medicinal products purified from human blood. The SPC application was based on French patent No. 2722992 filed on July 28, 1994, which claimed a method for the manufacture of a C1-esterase inhibitor concentrate (claim 1), as well as the concentrate obtained by the method (claim 11).

The SPC application was further based on marketing authorization (MA) No. EU/1/11/688/001 for Cinryze® comprising “C1 inhibitor, human (INN)” as active ingredient.

For those whose curiosity goes beyond patent law, C1 is one of the proteins forming the complement system, which itself is part of the innate (i.e. non-adaptive) immune system. The C1 inhibitor is a natural protein, found in blood, the role of which is to regulate the activation of the complement system. The C1 inhibitor is especially useful for individuals suffering from a rare autosomal dominant disease, caused by a deficiency of functional endogenous C1 inhibitor, which manifests itself in the form of angioedema attacks.

The SPC application was rejected on December 22, 2014 by the INPI for not complying with Article 3(d) of Regulation (EC) No. 469/2009 (hereafter the SPC regulation), i.e. the MA for Cinrize® was considered not to be the first authorization to place the product on the market as a medicinal product.

This was because a prior MA had been issued on June 28, 1999 for Esterasine comprising “human C1 esterase inhibitor” as active ingredient.

LFB lodged an appeal against the decision of the INPI before the Paris Cour d’appel and essentially argued that the human C1 inhibitors of Cinrize® and Esterasine were in fact two different products.

The precise arguments used by LFB are not very clearly summarized in the decision.

But it appears that LFB stressed that the way biological medicinal products, such as Cinrize®, are manufactured has an impact on their molecular structure, which, in the present case, was evidenced by a half-life of 56 hours for Cinrize® vs. 30 hours for Esterasine.

This did not convince the Cour d’appel which considered that:

The regulation relating to SPCs does not provide for exceptions to the definitions of a “product” and a first MA for biological medicinal products or blood products which would allow defining them as a function of their methods of manufacture or under their commercial names; it is therefore irrelevant that the SPC application is based on an MA for the “Cinryze” drug since the product protected by the basic patent is “the C1 inhibitor, human”; [besides] if LFB, after having initially claimed the latter, has amended the application by claiming “the C1 esterase inhibitor of the Cinryze drug”, this limitation made after the objections of the INPI cannot be effective since either the patent or the MA only relate to the “C1 inhibitor” as active ingredient of the Cinryze drug. 

To put it more clearly, the Cour d’appel took a very formal approach of Article 3(d) of the SPC regulation and simply considered that, if the names of the active ingredients mentioned in two different MAs are the same, then both MAs in fact relate to the same product, without further consideration as to the true physicochemical identity between the two products, as in the case of biological medicinal products obtained by different methods of manufacture.

LFB also argued that, in the assessment report of the European Medicines Agency (EMA) which led to the MA, the purified and concentrated C1 INH (i.e. C1 inhibitor) after pasteurization and nanofiltration is considered as the active substance.

The Cour d’appel responded that

the subject matter of this report was a marketing authorization application for Cinryse, so that, if [the report] specifies what its active ingredient is, it does not conclude that it would be a new product, the novelty of the medicinal product being different from that of its active ingredient; accordingly this does not contradict the decision of the INPI.

Moreover, the Cour d’appel noted that this latter argument was not submitted to the INPI which, therefore, could not do otherwise than decide that the MA for the drug Cinryze was not the first one for the active ingredient which is the “C1 inhibitor, human”.

It is to be noted that the latter argument was however decisive in overcoming the objection of the Dutch patent office based on Article 3(d) of the SPC regulation for the corresponding SPC application in that country (NL SPC application No. 300510), thereby securing the grant of an SPC.

It is therefore tempting to imagine that the fate of the French SPC application could have been changed for the best had the attention of the INPI examiner been drawn to the definition of the active substance in the assessment report of the EMA.

As a final note, this case reminds us of the ruling of the Paris Cour d’appel of April 12, 2016 which upheld the decision of the INPI to reject SPC application No. 08C0003 covering Cervarix®(GlaxoSmithKline Biologicals) which was discussed here.

In that case also the Cour d’appel refused to take into account the impact of the manufacturing process of biological products (production in yeast cells vs. insect cells) on their structure, sticking to the definition of the product given in the MA.

One can wonder if this literal approach, which has the advantage of simplifying examination of SPC applications, is in keeping with the fundamental objective of the SPC regulation which is to make up for the insufficiency of the period of effective protection of a medicinal product under a patent to cover the investment put into pharmaceutical research as recalled by the CJEU in C‑130/11 (Neurim).

Indeed, in the present case, it appears from the assessment report of the EMA that new clinical data was produced for the C1 inhibitor of Cynrize® in support of the MA application. This is probably because the C1 inhibitor of Cynrize® is a biological product the structure of which depends on the manufacturing process, thereby making it impossible to rely on clinical data obtained with previous C1 inhibitors.

It is generally considered that clinical trials amount for the larger part of investment in drug development. It could therefore be considered that the active ingredient of Cynrize® is a new product the development of which necessitated investment entitling it to SPC protection.

As such, when assessing conformity with Article 3(d) of the SPC regulation, perhaps the necessity to generate specific clinical data in order to obtain an MA for a biological product should be the primary criterion for determining if an MA is the first one to place the biological product on the market, rather than simply determining if the name of the active ingredient is the same one as that of a prior MA.

Thank you Lionel. Easter being about resurrection even more than about chocolate eggs, it remains to be seen whether this SPC application may come back to life on cassation appeal.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, January 20, 2017, SA Laboratoire Français du Fractionnement et des Biotechnologies v. Directeur général de l’INPI, RG No. 16/08814.

Copy and paste

What is new in today’s post? Well, strictly nothing. Nope, nothing new under the sun. 

In fact, the recent ruling by the Cour d’appel de Paris in Avery Dennison RIS France & Avery Dennison Sytèmes d’étiquetage France v. Directeur général de l’INPI is pretty much a copy and paste of Free & Freebox v. Directeur général de l’INPI issued a few months ago and already reported on here.

So is there really a need to discuss it? After all, case law is more interesting when it tackles new issues or when it features a change in practice.

But the point is, sometimes even established case law can be somewhat questionable from a practitioner’s perspective. And in this case, I must say I struggle with fully understanding the court’s reiterated rationale.

Copying an IP judgment – a paradox?

The issue at stake is the limitation of a patent in front of the INPI (which is the French patent and trademark office), and which options are available to third parties to challenge this limitation. Appeals against decisions issued by the INPI are generally supposed to be lodged with the Paris Cour d’appel. Accordingly, a number of third parties have tried to challenge decisions of limitation of patents in front of the Cour d’appel, by directly appealing these decisions – oftentimes parallel to ongoing litigation. And they have lost, their appeals being deemed inadmissible. The present case is no exception.

In particular, the Paris Cour d’appel (with the support of the Cour de cassation in Teisseire v. Directeur général de l’INPI) has consistently held that challenges against the limited claims must be brought in the context of a nullity lawsuit. This means that such challenges have to be brought in front of the Paris Tribunal de grande instance (TGI), not the Cour d’appel.

But here is the thing. Grounds for nullity are supposed to be listed in a limitative manner in the law, be it in article L. 613-25 Code de la propriété intellectuelle (CPI) for French patents, or in article L. 614-12 CPI together with article 138 of the European patent convention (EPC) as far as French parts of European patents are concerned. These grounds of nullity notably comprise lack of novelty, lack of inventive step, insufficiency of disclosure, extension of subject-matter beyond the contents of the application as filed and extension of the scope of protection after grant.

What the statutory grounds for nullity do not comprise is lack of compliance with article 84 EPC (or its equivalent in the CPI), per which the claims “shall be clear and concise and be supported by the description” is not a ground for nullity. Just like a lack of clarity is not a ground for opposition at the EPO either.

Nevertheless, when the INPI examines a request for limitation, they are supposed to check whether the claims as limited are clear and concise and supported by the description. See article L. 613-45 CPI together with article L. 612-6 CPI.

The question is whether and how third parties may challenge the result of this part of the examination conducted by the INPI.

If we turn to the parallel situation of limitation proceedings at the EPO, the answer is clear. Only parties to the proceedings can file an appeal against a decision issued by the EPO. A third party, as its name indicates, is not a party to the limitation proceedings and thus cannot appeal the decision of limitation, even if they deem that the limited claims are e.g. unclear.

In France, third party appeals are not ruled out as a matter of principle. By way of example, it is relatively common for a third party to challenge a decision of restoration of a patent by the INPI. See an example here.

But when it comes to decisions of limitation, third party appeals are usually stroke out in view of the arguments raised by the appellant.

In the present case, the French part of a European patent was limited by Gemalto, parallel to ongoing patent infringement proceedings against two companies of the Avery Dennison group. Avery Dennison appealed the decision of limitation and argued (among others) that the claims as limited are unclear.

The Cour d’appel rejected the appeal as inadmissible and held in particular that: 

[…] The arguments by Avery Dennison supporting their request for cancellation of the decision of the general director of the INPI, per which the claims as limited are not clear and not supported by the description, are analyzed as arguments of invalidity of the patent enforced against them in the framework of the infringement suit. These arguments, which put into question the limitation itself, i.e. whether the modified claims comply with the law, pertain to the jurisdiction of the judge in charge of assessing the validity of the patent. In this case, there is a counterclaim for nullity of the claims of the […] patent pending in front of this judge. His jurisdiction extends to all patent validity challenges, be it arguments of extension of an absence of limitation or arguments of a lack of clarity of the claims or a lack of support in the description, which are indeed exceptions which can lead to the nullity of a patent

Just to be very clear on this: I perfectly understand that it may make a lot of sense for the same court (the TGI) to be in charge of assessing all challenges against the patent claims.

What I do not understand is the last sentence in the above quote. In other terms, why does the Cour d’appel deem that a lack of clarity of the claims or a lack of support in the description, can lead to the nullity of the patent? 

I can come up with three possible explanations. 

Option 1: the court simply did not (does not) understand that not all conditions to be examined before granting limited claims can be challenged after the limitation, based on the listed grounds of nullity. I think this is unlikely, because the point has certainly been explained to the court time and time again in this case and previous similar ones.

Admittedly, it is probably easy to confuse a lack of support in the description (not a ground for nullity) with insufficiency of disclosure (ground for nullity). Both concepts are quite close, as explained in section F-IV, 6.4 of the EPO guidelines for examination. Actually, lack of support can also be easily confused with extension of subject-matter.

But lack of clarity on the other hand is quite clearly different from insufficiency of disclosure, or any other ground for nullity for that matter.

Option 2: the court deems that judges have such a large discretion in examining the actual grounds for nullity, such as insufficiency of disclosure or even lack of novelty, that they can very well revoke a patent under one of these statutory grounds if there is a lack of clarity in the claims.

This would be a pragmatic approach but not a satisfactory one on the legal standpoint. The legislator purposefully set out a number of distinct requirements to be handled differently. So why should judges be allowed to blur the lines between them?

Option 3: the court believes that all statutory conditions may be examined in the context of a nullity claim or counterclaim, including clarity and conciseness mentioned in article 84 EPC or article L. 612-6 CPI.

This would be a very bold position, since, at least as far as European patents are concerned, article 138 EPC provides that “a European patent may be revoked with effect for a Contracting State only on the grounds that“, and then comes a list of grounds which does not contain lack of clarity and conciseness.

But let’s explore option 3 a little bit more.

If this is indeed what the court has in mind, is this situation specific to limited patents? Does it also extend to patents modified in opposition at the EPO? Or has lack of clarity now also become a ground for nullity for all patents, even those which were not modified after grant?

Dear readers, please feel free to provide more information or to speculate as to yet further possibilities not contemplated here…

One other argument which – as far as I understand – was raised in the appeal, was that the modified claims were not a limitation. Here, the court’s position seems to be that modified claims necessarily lead to a limitation of the scope (and thus are allowable) or to an extension of the scope (and thus can be revoked in a nullity challenge).

But aren’t there yet other situations in which the modified claims could result neither in a limited scope nor in an extended scope? What about for example claims which are modified only to provide some clarification? In such a scenario, shouldn’t a third party be allowed to challenge the decision of limitation per se? After all, the INPI is supposed to only grant actual limitations, not clarifications. And if no extension of scope results from the modification, it should not be possible to challenge it in a nullity suit, oder?

I must admit that this latter question is trickier. But at least the main point raised above really needs to be clarified once and for all.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 10, 2017, Avery Dennison RIS France & Avery Dennison Systèmes d’Etiquetage France v. Directeur général de l’INPI, RG No.15/25007.