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.

Follow-up on priority and on SPCs

Dear readers, this is just a brief follow-up post on two topics previously addressed on this blog: partial priority at the EPO and vaccine SPCs.

First, partial priority at the EPO. This was already addressed in the past here and especially there, where I talked about the decision of the Enlarged Board of Appeal G 1/15.

Since then, another decision T 282/12 has been issued and has swiftly been presented on all good blogs (here, here and there).

In this decision, it was ruled that the priority of a claim was partially invalid because the alleged priority document was partially not the first application for the invention at stake.

As I have previously observed, although G 1/15 was almost unanimously welcome by the patent profession as a cure to the toxic divisional plague, the relatively flexible and generous approach of partial priority adopted in this ruling can also turn against patent proprietors when they file successive similar applications.

In this respect, T 282/12 is not really groundbreaking. The same already happened in T 1222/11, the decision which was the first one to theorize the “generous approach” later endorsed by G 1/15. In this earlier decision, the refusal of the patent application at stake was confirmed by the Board due to the invalidity of a priority claim in view of an earlier application (by the same applicant) which contained the same examples as the alleged priority document. I always thought that it was somewhat paradoxical that this decision considered as life-saving by many in fact killed the patent application at stake.

There is one remaining issue which may give rise to additional discussions, though.

T 282/12 states that the priority is only partially, and not fully, invalid if part of the claimed subject-matter was disclosed by the same applicant in an earlier application than the priority document. T 1222/11 was in my opinion not so clear in this respect. However, is it really certain that this is consistent with the Paris convention and the EPC? After all, these treaties do not expressly contain the notion of a “partial first application“.

So, it remains to be seen whether future decisions will be fully in line with this aspect of T 282/12 or not. It also remains to be seen what national courts will make of all this, as they are not bound by the Enlarged Board’s findings – least of all French courts if I may say so.

In the meantime, extreme caution should be exerted when filing successive applications on similar subject-matter, especially when the supporting examples are the same. 

Second topic, totally unrelated to the first one: vaccine SPCs.

Almost two years ago, Lionel Vial reported on this blog on the refusal of an SPC application filed by GlaxoSmithKline Biologicals (GSK) for the Cervarix vaccine by the INPI, and on the confirmation of this refusal by the Paris Cour d’appel.

Interestingly, another French SPC application was filed by a different applicant, namely the Loyola University of Chicago, still for the Cervarix vaccine, and based on the same marketing authorization as the GSK application.

The same causes often produce the same effects. Thus, this second SPC application was also refused by the INPI, and the appeal filed by Loyola was dismissed by the Paris Cour d’appel.

As explained by Lionel in the earlier post, the Cour d’appel considered that the active substance in the Cervarix vaccine was in fact the same product as the active substance in the earlier Gardasil vaccine, for which an SPC had already been granted to GSK.

The Cour d’appel did not change its mind in the Loyola case and reminded that only one SPC can be granted per product. The fact that the patent mentioned in the SPC application as well as the applicant were different did not change anything.

To Loyola’s credit, whether both active substances are actually the same is not straightforward here. This is because one critical protein in the Cervarix vaccine is obtained differently (via insect cells rather than yeast cells), and is truncated, relative to the same protein in the Gardasil vaccine. Therefore, it was probably worth giving it another try despite the previous negative decision.

An interesting variation of the insect pictured in the earlier Cervarix post.

Loyola made ample reference to its own patent and to a later scientific publication as evidence that the difference in protein structure had an impact on biological properties.

But the court said:

[…] The INPI rightly states that this change is minor […]. Even though the appellant claims a different structure and different properties, they do not show that these modifications are anything but minor, as the active substance remains the same and the preventive purpose remains the same. The INPI rightly states that an increase in the capacity to form VLPs, a higher yield, a higher purity level, a more regular shape, a reduction in the risk of cellular DNA encapsidation or even a better stability, are changes which do not alter the nature of the active substance or its preventive purpose; they do not make it possible to conclude that the products are different. 

So, once again, insects and yeast – same difference.


CASE REFERENCE: T 282/12, (Coated tablets / JOHNSON & JOHNSON), Board of Appeal 3.3.07, November 9, 2017, Pfizer Inc. v. Johnson & Johnson Consumer Inc.

CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, December 19, 2017, Loyola University of Chicago v. Directeur Général de l’INPI, RG No. 2016/17848.

Weaker together?

Best wishes to all readers of this blog!

I am sure most of them have made their list of new year’s resolutions. Among those, there might be the resolution of keeping up to date with SPC case law. And this is one which can just as easily be dropped by the end of January as the resolution of going to the gym three times a week.

Luckily, Patent My French! is happy to oblige, courtesy of Lionel Vial. He reports below on an interesting recent decision illustrating one further way in which an SPC application can be derailed.

The appeal decision we discuss today was rendered by the Paris Cour d’appel on December 19, 2017 in a case of rejection of a supplementary protection certificate (SPC) application by the Institut National de la Propriété Industrielle (INPI).

Was this decision an advance Christmas present for the appellant or rather a late visit from the Père Fouettard (aka Father Whipper)? This is what we are going to see.

Good old Indy – the best approximation of Père Fouettard that can be found in a patent.

French SPC application No. 14C0081, in the name of Medivir AB (bear in mind the name of the holder, it is important in the present case!), was filed on November 14, 2014, on the basis of European patent EP 1713823 and of marketing authorization (MA) No. EU/1/14/924. The MA is held by Janssen-Cilag International N.V. and is for simeprevir (Olysio®), a medicinal product indicated for the treatment of chronic hepatitis C.

According to the decision (online file inspection is not available for this SPC), during the examination procedure, Medivir AB received a communication from the INPI, probably stating that it contemplated rejecting the application in view of co-pending SPC application No. 14C0076.

French SPC application No. 14C0076, held by Medivir AB and Janssen Sciences Ireland UC (here again, mind the name of the holders), was filed on October 7, 2014, on the basis of European patent EP 1912999 and of the same MA for the same product (i.e. simeprevir).

In response to the communication, Medivir AB requested a stay in the examination procedure of SPC application No. 14C0081 until a decision was rendered for co-pending SPC application No. 14C0076.

French SPC No. 14C0076 was then granted on July 28, 2015 and SPC application No. 14C0081 was rejected on January 13, 2017 on the ground that EU regulations 469/2009 (the pharmaceutical SPC regulation) and 1610/96 (the phytosanitary SPC regulation) forbid that several SPCs be granted to a same holder (Medivir AB) in regard of a same product (simeprevir). The INPI stressed that Medivir AB did not justify why the fact that it was a co-holder of SPC n°14C0076 would warrant the grant of a further protection (for SPC application No. 14C0081).

Medivir AB appealed the rejection decision on April 12, 2017 and notably argued that the holder of a first SPC as sole proprietor is a different entity from the co-holders, taken as a whole, of a second SPC, because the rights of a co-holder are under the control of the other holders, and that it is of no importance in this regard that the sole proprietor of the first SPC is also a co-holder of the second SPC.

The INPI responded that a holder of several patents on the same product cannot have several SPCs granted for the same product.

The INPI stated that, according to the case law of the CJEU, several SPCs can be granted for a same product on the basis of several patents, provided the patent holders are different (see e.g. C-181/95 Biogen and C‑482/07 AHP). In the present case, Medivir AB having already been rewarded by the grant of SPC No. 14C0076, a second SPC cannot be granted to it.

The time has now come to open the Christmas present. Will it be a shiny SPC or a dreadful whip? Let’s see what the Court had to say:

Medivir has made the choice to team up with Janssen Ireland UC to commonly develop patent EP 1912999 and, even though Medivir knew of the difficulties associated with applying for two SPCs on the same products, it chose to favor the application based on patent EP 1912999, of which it is a co-holder, over the application based on patent EP 1713823.

Co-ownership of patent EP 1912999 does not prevent it from being worked by Medivir, pursuant to Article L. 613-29 of the Code de la propriété intellectuelle [on the co-ownership of patent applications and patents].

As such, in view of the choices made by Medivir, co-holder of patent EP 1912999 which forms the basis for a SPC, it cannot apply for another SPC for the same product on the basis of patent EP 1712823 of which it is the sole holder.

Accordingly, its appeal will be rejected.

Well, a whip it is then!

To sum up, the Court decided that when considering ownership of an SPC or SPC application, the different holders of a same SPC or SPC application should not be considered as a single entity but individually.

Although this decision may appear to be in line with recent case law of the CJEU stressing that a patent holder should not be afforded a compensation for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity when he was already afforded one (see e.g. C‑443/12 Irbesartan, paragraph 40), it does not appear entirely coherent to us.

Indeed, as was noted by Medivir AB during the appeal proceedings, if the same reasoning was applied to a situation where the SPC No. 14C0081 had first been granted to Medivir AB alone, it would have probably led to the rejection of SPC application No. 14C0076, thereby depriving Janssen Sciences Ireland UC of the right to be compensated for the delay to the commercial exploitation of its invention.

That is, unless the Court would have considered that the situation was different and called for another appraisal because Janssen Sciences Ireland UC did not have the possibility to choose between two SPC applications.

In any case, considering that (i) Medivir AB and (ii) Medivir AB + Janssen Sciences Ireland UC are different patent holders appears to be a more coherent solution to conciliate the principles that SPC protection should be made available to different patent holders in regard of a same product on the one hand, and that SPC protection should not be made available more than once for a same patent holder in regard of a same product on the other hand.

It is to be noted that in the Netherlands both corresponding SPCs have been granted.

In the meantime, before the situation above eventually gets clarified in France, it is advised to avoid such ownership configurations.

In this regard, for the sake of a witty conclusion, a mechanism could be imagined whereby Medivir AB’s SPC application No. 14C0081 would have been assigned to a third party under an agreement granting an exclusive license to Medivir AB. Looking for such a third party, the Saint Regis Mohawk Tribe would appear to be just the right candidate to consider…

As always, thank you Lionel for this report.

I guess the other side of the coin is that, if the Cour d’appel had ruled in favor of Medivir, it might then have been possible to circumvent the prohibition of several SPCs to the same holder by putting together various co-ownership agreements.

Definitely a thorny issue then, which means that it will end up in front of the CJEU sooner or later.

By the way, did the CJEU also make some new year’s resolutions to make SPC law more simple and predictable for everyone? For sure, we will soon find out.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, December 19, 2017, Medivir AB v. Directeur Général de l’Institut National de la Propriété Industrielle, RG No. 17/07741.

One-two-three

Still warm from the press and courtesy of Matthieu Dhenne, come tidings of the fall of another important pharma IP, namely the Atripla SPC (Supplementary Protection Certificate).

Atripla is marketed as a pink tablet with “123” impressed on one side. It contains a combination of three anti-HIV drugs, namely efavirenz, emtricitabine and tenofovir.

The U.S. pharmaceutical giant Merck Sharp & Dohme Corp. (MSD) owns European patent No. EP 0582455, entitled “benzoxazinones as inhibitors of HIV reverse transcriptase“. The patent was filed on August 3, 1993.

Two SCPs were filed and granted in France based on the EP’455 patent, and on two successive marketing authorizations (MAs):

  • The first one, FR01C0012, was filed on April 10, 2001 and granted on May 18, 2001. It protected the active efavirenz per se. This SPC expired on November 20, 2013.
  • The second one, FR08C0021, was filed on May 27, 2008 and granted on November 20, 2009. It protects the triple therapy combination of efavirenz, emtricitabine and tenofovir (marketed as Atripla) and is set to expire on August 2, 2018.

On September 20, 2016, Mylan initiated legal proceedings against MSD in France, claiming that the FR’021 SPC is invalid. The Paris Tribunal de grande instance (TGI) issued its judgment on November 30, 2017.

The judgment is interesting both regarding the admissibility of the action and  the merits.

As far as admissibility is concerned, the nullity defendant claimed that Mylan was time-barred from requesting the nullity of the SPC.

As a first line of response, Mylan argued that the general statute of limitations in our Code civil, which provides a five-year limitation period for “personal or movable actions“, is not applicable to actions for nullity of an IP right. Unsurprisingly, the court disagreed, in keeping with recent case law at the first instance and appeal levels. The TGI made in particular reference to a trademark ruling by the Cour de cassation dated June 8, 2017. For the court, applying this ruling by analogy leads to the conclusion that an action for revocation of an SPC is indeed subject to the limitation period under ordinary law.

That being said, the real interesting point is the determination of the starting point for the five-year limitation period. Although there has been a lot of discussion (including on this blog) concerning the starting period for patent nullity cases, there has been no clear guidance for SPC nullity actions, as far as I am aware of.

MSD’s case was that the starting point for the limitation period was the publication of the SPC application. The court disagreed and set the following principles.

The starting point for the limitation period must be set to the day, determined in concreto, when Mylan knew or should have known, because it intended to market a generic version of the drug which received an MA on December 13 [2007], for the combination of [the] three actives, which is protected by the SPC, which represents an impediment for its business.

So, we all get the idea there – although a couple of words may be missing, which happens from time to time when your sentences are too long, and this is probably why my blog software keeps blaming me for using more than the recommended threshold of 25% of sentences containing more than 20 words.

The general principle of an in concreto assessment is in keeping with the TGI’s previous decisions in patent revocation cases. The court went on:

[…] Only the SPC matters as an impediment, and not the patent. 

One should not refer to the date of grant of the patent, since the validity of the patent is not challenged by Mylan, which acknowledges that the efavirenz active compound is the subject-matter of the invention protected by the EP’455 patent and then by the [FR’012] SPC which expired on November 20, 2013. 

Only the validity of the [FR’021] SPC […] is challenged […]. 

Thus the publication of the grant of the patent cannot be set as the starting point for the limitation period, as it would in fact require an unrealistic watch from stakeholders and is unrelated to the development of the project which gives standing to sue. 

Mylan’s standing does not derive from the publication of the title, be it the patent or the SPC, but from its concrete intent to market the same drug. 

In this case, they have to check that this intent to market the product does not infringe any IP, and if this is the case, to seek its revocation before launching. 

Watching patent or SPC registers cannot be required from stakeholders before they intend to develop a competing product. 

[…] In the present case, the first MA for Atripla […] was granted on December 13, 2007. In view of article R. 5121-28 of the Code de la santé publique, the generic company can only apply for an MA starting from the eighth year after the grant of the MA for the original drug, and cannot be granted one before ten years. 

Therefore, Mylan could not apply for an MA before December 13, 2015, and could not obtain it before December 13, 2017. As a consequence, the date at which Mylan’s standing can be taken into account is December 13, 2015, which is the date starting from which it could apply for an MA. Thus, Mylan is not time-barred as it had until December 13, 2020 to start legal action.

What is somewhat paradoxical is that the TGI calls for an in concreto appraisal but then defines what could possibly be a general rule for SPC cases, namely that the starting point for the limitation period is the date at which third parties may start applying for their own MAs.

We will need to wait for further cases to know for sure whether this is indeed a general rule or not.

Turning to the merits of the case, the discussion and the ultimate reasoning of the court are extremely similar to what can be found in the recent decision on Truvada, also reported on this blog a few weeks ago. 

Truvada is another anti-HIV drug based on the combination of tenofovir and emtricitabine. The SPC at stake in today’s decision relates to the combination of the same compounds, plus a third one, efavirenz. And the problems raised by this other combination are analogous.

According to article 3(a) of the SPC regulation (regulation (EC) No. 469/2009 of the European Parliament and of the Council), an SPC “shall be granted if, […] (a) the product is protected by a basic patent in force“.

How to determine whether a product can be considered as being “protected” by a basic patent has been the subject of intense litigation and numerous rulings from the CJEU, which are mentioned in the TGI’s judgment. Again, readers of this blog can refer to the Truvada post, which contains a short summary of the most important CJEU case law prepared by Lionel Vial.

CJEU case law on the interpretation of the SPC regulation: each ruling always leads to more referrals.

In the present case, none of the claims of EP’455 explicitly recites the combination of the three active compounds of the combination. Instead:

  • efavirenz is covered by a generic formula in claims 1 and 5 and is singled out in claims 2 and 12 (as well as in claims 8 and 9 but in combination with other drugs different from tenofovir and emtricitabine);
  • tenofovir and emtricitabine are not cited in the patent;
  • claims 7 and 16 relate to the combination of a generic formula (covering efavirenz), or of efavirenz specifically, together with a nucleoside analog;
  • tenofovir and emtricitabine belong to this category of nucleoside analogs.

According to the court, this is insufficient to consider that the combination of the three active compounds is protected by the EP’455 patent pursuant to article 3(a).

Says the court:

It turns out that the description never explicitly cites either tenofovir or emtricitabine which are not identified in the EP’455 patent, be it individually or collectively in a composition. And in addition the specific combination claimed as an active product “efavirenz + emtricitabine + tenofovir” is not implicitly but necessarily and specifically taught in the description, and no indication makes it possible for the skilled person to select emtricitabine and tenofovir as nucleoside analogs. 

In fact, if I understand correctly, emtricitabine and tenofovir were not even identified and known yet as anti-HIV drugs at the filing date of the EP’455 patent.

Furthermore, the court refused to consider the claims relied upon by MSD (reciting nucleoside analogs) as “functional claims” because “they do not describe the structure which should be present nor the function that the second and third products should have in this structure“.

For the sake of completeness, the court stated that even if the claims were considered as functional, the four-step test established by the Dutch patent office would then not be satisfied. Again, this same test was discussed in the previous Truvada post, so I will not describe it again here.

As a consequence, the SPC was found to be invalid under article 3(a).

By way of overkilling, the court added that the SPC was also invalid in view of article 3(c) of the SPC regulation, per which an SPC “shall be granted if, […] (c) the product has not already been the subject of a certificate“.

In this case, another SPC had been granted based on the same EP’455 patent, namely the efavirenz SPC. MDS relied on the Georgetown CJEU decision (C 484/12). According to this decision, article 3(c) does not preclude the grant of one SPC for a combination of active ingredients, and another SPC for a single active ingredient, based on the same patent.

Nevertheless, according to the TGI, Georgetown is only applicable if the mono and combo products are separate inventions.

In one brief paragraph, the court then held that:

the combination of efavirenz with emtricitabine and tenofovir does not represent a separate invention which may give the right to a second SPC. For this second reason, SPC [FR’021] is invalid under article 3(c) of the regulation. 

Those readers in favor of pan-European consistency (which probably means most readers of this blog) will be happy to know that the TGI’s decision mirrors a similar ruling in the UK handed down on March 21, 2017, per which the corresponding UK SPC was declared invalid by Mr. Justice Arnold.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, November 30, 2017, Mylan SAS v. Merck Sharp Dohme Corp., RG No. 16/14466.