All eyes are on the Court of justice

A tout seigneur tout honneur, today’s decision, being about SPCs, was first reported on the SPC blog.

However, I would like to talk about it as well because, unlike British courts, it is not every day that the Paris Cour d’appel refers questions to the CJEU.

The case relates to a European patent owned by Santen, a pharmaceutical company specialized in ophthalmology.

Claim 1 of the patent is directed to a particular type of oil-in-water emulsion. According to a dependent claim, the emulsion may contain an active ingredient. According to another dependent claim, the active ingredient is cyclosporine A. Finally, another claim relates to the use of the emulsion for the preparation of an ophthalmic composition for the treatment of ocular diseases such as notably keratitis.

Santen obtained a Marketing authorization (MA) for the drug Ikervis®, which is an emulsion containing cyclosporine as an active ingredient and is indicated for the treatment of severe keratitis.

On June 3, 2015, Santen filed an SPC application at the French patent office (INPI) for “cyclosporine emulsion eye drops”. The SPC application was later amended to rename the product as “cyclosporine for its use in the treatment of keratitis”.

On October 6, 2017, the SPC application was finally refused by the INPI. The reason for the refusal was the existence of a prior MA dating back to 1983, for the drug Sandimmum®.

This drug is in the form of a drinkable solution, in which the active ingredient is also cyclosporine. The therapeutic indications range from the prevention of transplant rejection, to the treatment of endogenous uveitis (which is another ocular disease).

In the SPC business, you gotta always keep an eye out for the next CJEU case law.

Santen appealed the refusal in front of the Paris Cour d’appel. Instead of deciding on the merits of the case, the court referred some questions to the CJEU regarding the interpretation of article 3 (d) of regulation (EC) No 469/2009, nicknamed the “SPC regulation”.

Article 3 (d) lays down one of the conditions for obtaining an SPC, namely that the MA referred to in the SPC application should be the first authorization “to place the product on the market as a medicinal product”.

The most important ruling from the CJEU regarding the interpretation of this article is Neurim (C-130/11) of July 11, 2012.

According to this ruling, the existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which the MA 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 SPC.

In Neurim, an SPC application for a formulation of melatonin useful for the treatment of insomnia had been initially refused due to the existence of an earlier MA for melatonin in a veterinary product (more precisely for the regulation of seasonal breeding activity in sheep). The Court of justice clarified that, in such a situation, the SPC application should not have been refused for this reason.

However, with the Luxembourg Court, most clarifications usually raise additional questions.

Case in point, Neurim was widely interpreted as a reversal of earlier case law (in particular Pharmacia Italia C-31/03 and Yissum C-205/05) but the Court of justice did not say a word about this in the judgment. More importantly, people wondered how far the principle set out in Neurim should extend. That is, how should the expression of the Court “a different application of the same product for which [an MA] has been granted” be interpreted?

Does the expression refer to veterinary vs. human use only, like in the facts underlying the Neurim judgment? Or does it extend to the treatment of different human diseases? Or to different formulations or modes of administration?

In the Santen case, the INPI noted that there are various interpretations of Neurim across Europe. The French administration’s current position is that Neurim should be applied in a “measured” manner.

The INPI believes in particular that there are two reasons why Neurim does not apply to Santen’s SPC application:

  • First, the scope of the basic patent should correspond to that of the MA which is relied upon, like in the Neurim case (cf. the proviso that “the application is within the limits of the protection conferred by the basic patent” in the order of Neurim). This is not the case here, said the INPI, because the basic patent mainly relates to a particular emulsion. Keratitis is only one of the diseases that can be treated according to the patent. Uveitis (i.e. one of the diseases treated by the former drug Sandimmum®) is also mentioned in the dependent Swiss-type claim of the patent.
  • Second, the MA which is relied upon should relate to “a new therapeutic field”, i.e. a new medical specialty, or a drug, the active ingredient of which should have a different mode of action from that exerted in the drug of the previous MA. Again, this is not the case here, the INPI argued, since both MAs relate to the treatment of inflammations of the human eye, by the same mode of action of the same substance (cyclosporine). Thus, a new medical use is not sufficiently demonstrated. The INPI’s position seems to be that a “new medical use” in this context has to be appraised in a stricter manner than in the context of a patentability appraisal.

Santen challenged this position, and stated that the conditions demanded by the INPI cannot be derived from the Neurim judgment. Santen insisted on the fact that Sandimmum® and Ikervis® have different therapeutic indications, and treat different diseases in different parts of the eye. Their respective formulations, dosages and modes of administration also differ.

The court considered both positions and came to the conclusion that “when reading the Neurim judgment it is not possible to interpret this notion of different application, which is essential for deciding the case, with any certainty”.

Thus, the Cour d’appel stayed the proceedings and referred the two following questions to the Court of justice:

1. Should the notion of different application under the CJEU Neurim judgment C-130/11 of July 19, 2012:

– be understood in a strict manner, namely be limited to the sole case of a human application following a veterinary application;

– or relate to an indication pertaining to a new therapeutic field, namely a new medical specialty, relative to the previous MA, or to a drug in which the active ingredient has a different action from the one it has in the drug of the first MA;

– or more generally, in view of the purposes of Regulation (EC) No. 469/2009 aiming at setting up a balanced system taking into account all the interests at stake, including those of public health, be appraised according to more demanding criteria than those applied for appraising patentability of the invention;

– or on the contrary be understood in an extensive manner, i.e. as including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration.

2. Does the notion of application within the limits of the protection conferred by the basic patent under the CJEU Neurim judgment C-130/11 of July 19, 2012 imply that the scope of the basic patent should correspond to that of the MA relied upon, and consequently be limited to the new medical use corresponding to the therapeutic indication of said MA?

In other words, some very precise and extensive questioning of the scope of article 3 (d) of the SPC Regulation. That said, the likelihood that the Court of justice will clearly answer by yes or no as to whether Neurim applies to different diseases, different formulations, etc. is probably close to zero. It is much more likely that the Luxembourg judges will offer a new general test which will still leave room for interpretation. This is indeed the game that has been played quite extensively in the past few years.

The other thing is that there is also another referral pending on the interpretation of Neurim, namely the Abraxis case (C-443/17).

Unsurprisingly, this is a referral by the High Court in the UK. The question asked is the following:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the MA referred to in Article 3(b) is the first authorization within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

In Abraxis, an SPC application was filed based on an MA for paclitaxel bound to albumin nanoparticles, but the issue was the existence of an earlier MA for solvent-based paclitaxel.

The Advocate General’s opinion in Abraxis is expected to be released on October 25, 2018. Will the Santen referral remain useful or relevant once Abraxis is decided?

As always with the SPC saga, to be continued.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, October 9, 2018, SAS Santen v. Directeur Général de l’INPI, RG No. 17/19934.

The new patent frontier

Out of sheer laziness, I am usually reluctant to report on bills that are still in the legislative process.

After all, you never know whether your report will still be consistent with what comes out of the process in the end. You may call that the UPC syndrome.

But the reform of the French patent granting procedure currently in gestation represents such an upheaval of the world as we French patent attorneys know it that it is getting more and more difficult to ignore it on this blog.

So, today, I will update readers on the “Projet de loi relatif à la croissance et la transformation des entreprises“, also known as the PACTE bill. Don’t ask me what the A in the acronym stands for. It is probably just easier to pronounce than “PLRCTE“, that’s all.

This is a very complex and long (some would say catch-all) bill that spans labor law, tax law, commercial law, etc. And there are a few provisions on patent law, which are rather far-reaching.

The bill, updated as of today, can be found here. All provisions have now been approved by the Assemblée nationale (the lower chamber of our parliament), which prompted today’s post. Please bear in mind that these provisions can still be modified during the rest of the legislative process though, but by now it is more likely than not that they will indeed become law.

The first relevant part of the bill is article 40, which deals with utility certificates. That’s the local name for utility models. These are seldom used in this country and probably not very well known. The three current main features of the utility certificate are the following:

  • no search report is established for a utility certificate;
  • the maximum duration of the utility certificate is 6 years from the filing date; and
  • a patent application can be converted into a utility certificate application but not the other way around.

In order to make the utility certificate a more attractive option for innovators, the maximum duration of the certificate will be brought to 10 years instead of 6. Its duration will thus be on a par with that of utility models in foreign countries, notably Germany.

A second change is that it will now be possible to convert a utility certificate application into a patent application. The conditions for this conversion will be further specified by way of an executive order.

If we assume that flexibility is always appreciated by applicants, these changes will indeed make the utility certificate more palatable to them. While we are at looking at what the Germans do, we might as well have imported the “Abzweigung“, i.e. the possibility to file a utility model application as a split-off from a patent (including European) application. This can be quite a powerful tool for applicants. Maybe next time – together with a (much awaited) re-opening of the French national phase PCT route?

The second topic addressed in the bill is a much bigger prize, though.

Article 42 authorizes the government to create national opposition proceedings, so as to allow third parties to request the revocation or modification of a French patent, by way of an “ordonnance”. 

An “ordonnance” is a special kind of executive order which has the same effect as a law passed by the parliament, provided that it is later ratified by the parliament.

There are absolutely no details as to this future opposition in the bill, as the parliament has precisely surrendered its prerogative to set rules on this matter to the government, by way of this article 42. So we will have to wait until we see the “ordonnance”. 

For what it is worth, a survey was conducted by the French patent and trademark office (INPI) on this topic a few months ago. Among the questions which were addressed in the survey, were the following:

  • Should any person be allowed to file an opposition, like at the EPO, or should an opposition be reserved to persons and entities having standing? (And, boy, we know that the appraisal of standing in nullity suits can be tricky.)
  • Should the opposition period be set to 6, 9, or 12 months?
  • What should the grounds for opposition be?
  • Should it be possible to file an opposition against a granted utility certificate?
  • Should the decision on the opposition be open to appeal in front of the Paris Tribunal de grande instance (first instance court) or in front of the Paris Cour d’appel (appeal court)?
  • What should the effect of an opposition be on parallel litigation, in particular concerning a possible stay of proceedings?
  • Should oral proceedings be summoned?
  • Should an accused infringer be able to intervene in opposition proceedings?
  • Should the examiner who granted the patent be part of the panel of three examiners who will decide on the opposition?
  • Etc.

As you can see, things were (still are?) very open. Rumor has it that the INPI is contemplating a rather extensive alignment of the future French opposition proceedings on the EPO model.

As a side note, article 42 of the bill specifies that the future “ordonnance” should make sure to prevent abusive oppositions. I have no idea what they mean by this, but I do hope that there will be no standing required to oppose a patent. This would certainly lead to useless complexity and legal uncertainty.

PACTE, the final frontier?

Now, the third topic of interest in the bill is as big as the second one – if not bigger.

At present, the INPI has limited power to refuse a patent application. Basically, a French examiner can raise objections (such as lack of clarity or unity) before the issuance of the search report. Then the search report and a complete written opinion are drafted, either by the EPO or directly by the French examiner. Then the applicant files observations as a response – which can very well be very brief. And a refusal can only take place in exceptional circumstances, e.g. if it is “blatant” that the application relates to subject-matter which is not an invention (such as discoveries, aesthetic creations, etc.); or if there is a “blatant” lack of novelty.

There are further (more minor) grounds for refusal, such as lack of unity. But the major fact is that lack of inventive step is not a ground for refusal – although of course it is a ground for nullity of the issued patent in front of a court. And lack of novelty or lack of patentability are grounds for refusal only insofar as the objection is crystal clear and there is no possible defense.

Well, it seems like this fundamental peculiarity of French patent law is about to become a thing of the past.

Article 42bis of the bill will make it possible for the INPI to refuse an application for lack of novelty or non-patentability, period (i.e. the objection will no longer need to be blatant); and also for lack of inventive step.

A huge change indeed. Hailed by some, as it is believed to increase the value of French patents. Lambasted by others, as applicants (especially local ones) may be less incentivized to file national applications if the local granting procedure becomes similar to the European one.

To me, the success or failure of the above reforms will mostly depend on their implementation by the INPI.

Tremendous efforts will have to be undertaken to hire and properly train new examiners to perform these tasks. Let’s hope that this aspect has not been underestimated by the government and that sufficient funding will be available to support these efforts.

One good point is that the new, beefed up, granting procedure will only come into force two years from the entry into force of the PACTE law. This transition period will certainly be necessary in order for everyone to get ready for this new enterprise, in other words “to explore strange new worlds, […] to boldly go where no man has gone before“.

And by the way, who said the unitary patent and the UPC would be the kiss of death for national patent rights?

PS: for those eager to know everything about the debates that took place in the Assemblée in connection with the above provisions, here is the link to the full transcript. Don’t hold your breath though, it is fairly high level and there was no discussion on the nuts and bolts of the new system.

For the sake of the argument

As I have already mentioned here, one reason why I do not often comment on decisions from the Boards of appeal of the EPO on this blog is that any interesting decision that comes out is instantly shot at by all good bloggers around the place before I even get a chance to draw my metaphorical gun.

So, sorry folks, no breaking news from me today, as Laurent Teyssèdre has already been here, as well as others.

But I could not let this one decision T 1914/12 go without a comment or two.

First, because it is highly interesting. Second, because it is in French (so, maybe some non-French speaking colleagues would benefit from further highlights). Third, because I was involved in the case at hand in the first instance proceedings, so this one brings back a number of memories.

The catchword of the decision can be translated as follows:

Boards of appeal do not have any appraisal power with respect to the admissibility of late arguments which are based on facts that are already part of the proceedings (decision diverging from T 1621/09).

A brief presentation of the facts of the case will probably suffice, before summarizing the very thorough legal discussion in the decision.

The patent at stake is entitled “Method of adhesively bonding a strip of flexible fabric to a substrate“. It was opposed after grant and revoked by the opposition division, for lack of inventive step (as well as extension of subject-matter as far as some of the auxiliary requests are concerned).

In the course of the appeal proceedings, the opposition was withdrawn, and the patent was transferred to the previous opponent. Not that this circumstance is really critical.

The key issue is that, for the first time on appeal, the new patent proprietor identified a further distinguishing feature relative to one of the main cited prior art references.

In a written communication, the Board expressed the preliminary opinion that this was a late argument and that its intention was not to admit it into the proceedings. But the Board, for once presided by the legal member, later changed its mind and came to the opposite conclusion. As a result, the first instance decision was set aside, and the case remitted to the first instance for further prosecution.

But before reaching this conclusion, the Board performed a very thorough analysis of the law pertaining to late facts and arguments.

A fancy EPO appeal clock.

The starting point for the discussion is article 13(1) of the Rules of procedure of the Boards of appeal (RPBA), per which:

Any amendment to a party’s case after it has filed its grounds of appeal or reply may be admitted and considered at the Board’s discretion. The discretion shall be exercised in view of inter alia the complexity of the new subject matter submitted, the current state of the proceedings and the need for procedural economy. 

So the question is: does the discretionary power of the Board apply to a situation such as the one at hand, where a new distinguishing feature is identified by the proprietor at a late stage?

As a first step (section 7.1 of the reasons), the Board reviewed in great detail the notions of “facts” and “arguments” and their respective definitions, based on the common understanding of the terms, of the legal understanding of the terms, and on the specific use of the terms in the EPC and case law.

Clearly distinguishing between facts and arguments is not just a matter of hair-splitting. Depending on whether a late submission is viewed as a fact or an argument, the fate of the submission may differ – even in first instance.

As a side note, in one opposition I have handled, a new inventive step attack based on a timely filed document only later identified as a possible closest prior art document was considered by the opposition division as pertaining to a “new fact” and not merely a “new argument” and it was thus not admitted into the proceedings. The Board set aside the first instance decision – but I don’t know yet if this point will be discussed in the reasons or not.

Anyway, the definition offered by the present Board (reasons, 7.1.4) is the following (in my own translation as always):

A “fact” can be understood as a factual (or allegedly factual) element or a circumstance on which a party bases its case, whereas an “argument” designates a proposition that a party bases on one or more facts and which supports the case that it puts forward. 

The Board then gave the example of a lack of novelty attack:

  • The party’s case (“moyen” in French) is that the claimed subject-matter is comprised in the state of the art.
  • One argument is e.g. that the subject-matter is disclosed in paragraph [0017] of D1.
  • Another argument is e.g. that the skilled person understands the paragraph in a certain manner, in view of common general knowledge, and thus views a certain feature as implicitly disclosed.
  • The textual content of the paragraph is a fact.
  • The copy of the document or of its translation is a piece of evidence.

As a next step, the Board addressed the central issue of whether late arguments can be disregarded or not.

Here, the first interesting remark is that the text of the EPC is not the same in the three official languages.

The English version of article 114(1) reads:

In proceedings before it, the European Patent Office shall examine the facts of its own motion; it shall not be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought. 

Note the term “arguments” here. But the French version is in fact quite different, as it solely refers to “moyens invoqués” and “demandes présentées“. I would tend to translate the general term “moyens invoqués” by “the party’s case“. The German version does not specifically mention arguments either.

The Board noted that the English version seems to more accurately express the intentions of the drafters of the EPC (is that generally the case? the Frenchman asks), and therefore adhered to this English version in the rest of the reasoning.

Now the key part of the reasoning is that the English version of the second paragraph of article 114, on which the discretionary power of the EPO to disregard late submissions is based, does not refer to arguments:

The European Patent Office may disregard facts or evidence which are not submitted in due time by the parties concerned. 

This is in contrast to the first paragraph mentioned above, which deals with examination of the EPO’s own motion.

Based on the difference between the two paragraphs, the Board concluded that the discretionary power of the EPO is strictly limited to facts and evidence and does not extend to arguments.

Now going back to article 13(1) RBPA, there is a reference here to an “amendment to a party’s case“, which is not very explicit. But the notion of a party’s case is further defined in article 12(2):

The statement of grounds of appeal and the reply shall contain a party’s complete case. They shall set out clearly and concisely the reasons why it is requested that the decision under appeal be reversed, amended or upheld, and should specify expressly all the facts, arguments and evidence relied on. […]

So, on the face of it, it can be surmised that article 13(1) RPBA, via its implicit reference to article 12(2), empowers the Board with the right not to admit a late modification of the arguments of a party on appeal.

But, reviewing the Travaux préparatoires for the current version of the RPBA, the Board found that a proposed article 13(1) containing an explicit reference to arguments was rejected in the drafting process.

Thus, the Board held, the intent seems to have been in fact not to encompass arguments within the purview of article 13(1). See section 7.2.1 of the reasons.

Then, the Board reviewed the relevant case law in detail (section 7.2.2 of the reasons), and found a number of decisions pursuant to which arguments are not subjected to the Boards’ discretionary power.

But then there are T 1069/08 and above all T 1621/09, which decided otherwise. Especially in T 1621/09, an analysis of the travaux préparatoires was performed but the deletion of the word “arguments” in the drafting process of new article 13(1) was not noted.

In the wake of these two decisions, the Board counted 17 later decisions which relied on the principles set out in T 1069/08 and T 1621/09 without questioning them. A couple of recent decisions have however decided the other way around.

As a conclusion, the Board expressed its disagreement with the approach of T 1069/08 and T 1621/09 (section 7.2.3 of the reasons).

The final reason put forward by the Board for such disagreement is that the RPBA should not “lead to a situation which would be incompatible with the spirit and purpose of the Convention” (article 23), which would precisely be the case if article 13(1) RPBA were to be interpreted as encompassing arguments, although article 114(2) EPC, which prevails, does explicitly not refer to arguments, among the late submissions which may be disregarded.

One first question immediately comes to mind: is this question ripe for a referral to the Enlarged board of appeal?

After all, there are a number of diverging decisions, it seems. I guess the answer may depend on whether the Boards which issued T 1069/08 and T 1621/09 will stand their ground or change course.

The second question that I have is: what about the upcoming revised version of the RPBA?

A few months ago, there was a public consultation at the EPO on a draft. I do not know where this project stands right now. But, for what it is worth, there was a new paragraph 2 in article 12 in this proposal, which reads:

In view of the primary object of the appeal proceedings to judicially review the decision under appeal, a party’s appeal case shall be directed to the requests, facts, objections, arguments and evidence on which the decision under appeal was based.

Beside the fact that there is a new concept here (namely “objections“), this provision seems to introduce a limitation to what kind of arguments a party is allowed to file on appeal – namely, those on which the decision under appeal was based.

If one follows the reasoning of T 1914/12, wouldn’t this proposed provision breach article 114 EPC?


CASE REFERENCE: T 1914/12, Board 3.2.05, June 13, 2018, Gaztransport et Technigaz.

The single question

When you come to think about it, most of the issues that are discussed on a daily basis in patent cases seem to always boil down to one single question: same or different?

Take novelty: is the claimed subject-matter the same as that of the prior art or is it different? Or take infringement: does the allegedly infringing product or process differ from the claims of the patent? The list continues with extension of subject-matter, priority, etc.

Nevertheless, we patent attorneys or lawyers do not get bored, because this multifaceted single question is in fact extremely complex and gets renewed all the time. The most perfect example is probably supplementary protection certificates (SPCs), an area of law in flux if there ever was one.

Spot the differences – a patent attorney’s favorite game.

Merck Sharp & Dohme Corp. (MSD) is the owner of European patent No. EP 0720599. The patent is directed to the treatment and prevention of atherosclerosis and more particularly to a class of compounds called hydroxy substituted azetidinones, among which the molecule known as ezetimibe.

Ezetimibe is in fact explicitly recited in claim 8 of the patent.

Of note are also claims 9, 16 and 17, which are worded as follows:

9. A pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of a compound as claimed in any one of claims 1 to 8, alone or in combination with a cholesterol biosynthesis inhibitor, in a pharmaceutically acceptable carrier.

16. A pharmaceutical composition of any of claims 9, 12 or 15 wherein the cholesterol biosynthesis inhibitor is selected from the group consisting of HMG CoA reductase inhibitors, squalene synthesis inhibitors and squalene epoxidase inhibitors.

17. A pharmaceutical composition of claim 16 wherein the cholesterol biosynthesis inhibitor is selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, Cl-981, DMP-565, L-659,699, squalestatin 1 and NB-55 598.

Two SPCs were successively granted by the French patent office (INPI) based on this European patent, namely:

  • First, SPC No. 03C0028, for a medicament comprising ezetimibe as an active, based on a marketing authorization (MA) for the drug Ezetrol®.
  • Second, SPC No. 05C0040, for a medicament comprising a combination of the active compounds ezetimibe and simvastatine, based on an MA for the drug Inegy®.

The European patent expired in 2014. The first (mono) SPC expired on April 17, 2018. The term of the second (combo) SPC is April 2, 2019.

In August 2017, the generic drug company Biogaran obtained an MA for a combination of ezetimibe and simvastatine and began preparing for the launch of this generic version of Inegy®.

In December 2017, Biogaran filed a nullity action against the combo SPC in front of the Paris Tribunal de grande instance (TGI). In February 2018, the U.S. MSD company and its French subsidiary initiated urgency proceedings and requested an injunction against Biogaran in view of an imminent infringement threat.

On April 5, 2018, an order was issued per which MSD’s request for injunction was denied. An appeal was filed, and the Paris Cour d’appel dismissed MSD’s appeal on June 26, 2018.

French legal proceedings are, as a general rule, not extremely quick. But sometimes they can be, as the present case shows. In fact, I did not even have time to become aware of and report on the first instance order, before the appeal ruling came out. Well, the fact that this blog has been somewhat slow in the past few months does not help, I will grant you that.

The reason why the President of the Paris TGI denied MSD’s request in the order of April 2018 is that the combo SPC was considered as invalid. This was confirmed on appeal.

Before delving into the details of the ruling, we need to go back, as always, to article 3 of the SPC regulation (officially known as Regulation (EC) No. 469/2009 of the European Parliament and of the Council):

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. 

Biogaran contended that the combo SPC was invalid for non-compliance with articles 3(a), 3(c) and 3(d). Their position was that:

  • regarding article 3(a), simvastatine is not claimed “as such” in the EP’599 patent, but merely as a substance known from the prior art, which can be used together with ezetimibe, which is claimed “as such“;
  • regarding article 3(c), an SPC had already been granted for the product at stake (namely the mono SPC), because the combination of the drug Ezetrol® with a statine such as simvastatine was already contemplated notably in the summary of product characteristics (SmPC) for this drug; and
  • regarding article 3(d), the MA for Inegy® was not the first MA for the product at stake, for the same reasons.

Interestingly, two further SPC applications similar to the granted combo SPC, namely for the combination of ezetimibe with atorvastatine, and of ezetimibe with rosuvastatine, were rejected by the INPI in February 2018.

In their ruling, the appeal judges made extensive reference to the Actavis judgment of the CJEU, C-443/12.

According to this ruling:

[…] where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) 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 precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients.

The facts in Actavis were somewhat different from those of the present case. In Actavis, the patent at stake protected irbesartan and a first MA had been obtained for the mono drug. Then, a second MA was obtained for a combo drug comprising irbesartan and a diuretic, hydrochlorothyiazide (HCTZ). But HCTZ was not specifically named in the patent, whereas in the present case simvastatine is expressly designated in claim 17 of the patent.

That said, this different circumstance does not appear to be essential in view of the broad exclusionary language used in the order of Actavis. The Cour d’appel therefore directly applied Actavis as follows:

[…] MSD, based on the one hand on the EP’599 patent protecting the new active ezetimibe, and on the other hand of the MA […] for Ezetrol® containing ezitimibe as a single active compound, obtained […] SPC ‘028, making it possible to object to the use of said active, either alone or in combination with other actives.
MSD, based on the same patent but on a later MA […] for a different drug Inegy® containing the active ezetimibe in combination with another active, simvastatine, which is not, as such, protected by said patent, requested a second SPC on this combination of actives.
It should be added that the reasons of judgment C-443/12 specify that it is not allowable for the proprietor of a basic patent in force to obtain a new SPC […] every time it markets […] a drug containing, on the one hand, the active protected as such in its basic patent and constituting  […] the core inventive advance of this patent, and on the other hand, another active, which is not protected as such by said patent. 
It is not challenged in this case that simvastatine, which is an active of the category of statines or “HMG CoA reductase inhibitors” is not protected as such by this patent, nor in fact by another patent. 

As a result, the combo SPC was held invalid under article 3(c).

MSD’s defense was that there were two inventions in the basic patent. The first invention was a new class of compounds including ezetimibe. The second invention was the use of ezetimibe with statines.

The court replied that only ezetimibe is a novel active compound. The court also noted that, based on the description of the patent, the combination of compounds did not involve an inventive step (or should this be “inventive advance”? the French expression “activité inventive” can be used for both terms). Although MSD filed an expert declaration to support such inventive step, the court held that such declaration could not cure the lack of inventive step based on the patent itself.

The court also agreed with Biogaran’s auxiliary argument per which, assuming that the mono and combo drugs were considered as different products, the SPC would still be invalid, under article 3(d) this time, because the MA for Inegy® would not be the first MA for the product, because the SmPC for this drug mentioned the association with statine compounds, and in particular simvastatine.

On a procedural standpoint, the outcome of the judgment is thus that the rejection of MSD’s request for injunction is confirmed. The nullity action on the merits is still pending, although of course we now have a good indication of how this is likely to turn out.

Going back to the central question asked at the beginning of this post, “same or different?“, is a drug containing ezetimibe together with a statine compound “the same” as a drug containing ezetimibe as the single active, for the purpose of SPC law? 

The answer appears to be much more complex than the question.

As a Post Script to this report, Biogaran’s invalidity argument based on article 3(a) was not really discussed in the appeal judgment. However, it is notable that a new CJEU ruling has been issued in this connection, namely C-121/17. Since it has already been reported on many blogs (see e.g. here), I will not go over it in detail, but I just wanted to mention it, as Lionel Vial had previously reported on the opinion of the Advocate General in this case on this blog.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, June 26, 2018, Merck Sharp & Dohme Corp. & MSD France v. Biogaran, RG No. 18/52397.

The patentee’s tale

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

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

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

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

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

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

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

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

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

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

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

The future of TV shows envisioned in the 80s.

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

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

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

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

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


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