Source: http://patentmyfrench.com/author/r3n4ud/
Timestamp: 2019-04-23 12:18:43+00:00

Document:
Renaud, Author at Patent my French!
France has a funny bicameral system.
Both chambers of the parliament, the Assemblée nationale and the Sénat, get to debate on, amend and vote bills. But if they fail to agree on the same version of a bill, in the end the Assemblée nationale has the last word.
And so it is with the so-called “Loi Pacte“, first discussed on this blog post. There was some suspense as to what the bill would finally contain, as it bounced back and forth, being amended and dis-amended from one chamber to the other. But now the suspense has come to an end as the bill has been finally adopted and will become the law of the land.
Well, unless there is a last minute surprise, as the constitutionality of the bill will likely be challenged in front of the Conseil constitutionnel (our constitutional supreme court) by disgruntled members of parliament.
The final text is here and it is 408 pages long (yes, that is some packed Pacte). It has many different aspects, including some controversial ones – like the privatization of ADP (the company that runs Paris’ airports). It also contains some provisions on IP, including just a few ones on patent law – but they are very important provisions indeed.
The maximum duration of utility certificates will be brought from 6 years to 10 years (article 118).
It will be possible to convert a utility certificate application into a patent application within a deadline which still needs to be determined, whereas only the opposite is possible as of today (article 118).
The government is authorized to rule by way of an ordonnance in order to set up a procedure for third parties to oppose a granted patent (article 121).
The INPI (French patent office) will be able to refuse a patent application if its subject-matter is not an invention or is excluded from patentability, in contrast with the current formulation, per which its subject-matter is “manifestly” not an invention or is “manifestly” excluded from patentability (article 122).
The INPI will be able to refuse a patent application if its subject-matter is not novel or not inventive, in contrast with the current formulation, per which an application may be refused if it was not modified despite a “manifest” lack of novelty (article 122).
Infringement actions will be time-barred five years after the day the right owner knew or should have known the last fact allowing them to act, as opposed to the current formulation, which is five years “from the facts” (article 124).
The statute of limitations will no longer apply to patent nullity actions (article 124).
So, there you have it, I don’t know if it is spring or winter, but a new season is definitely coming.
In the year 2525 – if patents can survive.
So what next? Well, first we will have to carefully look at transitional provisions.
The new provisions on utility certificates shall enter into force when the implementing decree is published, or one year from the publication of the law at the latest.
The timeline for the introduction of the opposition proceedings is still unclear, as it will depend on the regulations (ordonnance) that the government will issue.
Provisions extending the scope of examination of patent applications by the INPI shall enter into force one year from the publication of the law.
The new provision on the statute of limitations for nullity actions will immediately enter into force – but will have no effect on decisions that have become res judicata. It remains to be seen how this will be interpreted in practice.
The bottom line is that, regarding the biggest changes for patent applicants, patent attorneys and the patent office, we have some time to get prepared – but we all know how that usually flies.
The nitty-gritty of the new system is still unclear and will require our full attention.
Moreover, another question mark is how the INPI will adapt to this upheaval.
The projected date of entry into force of the patent opposition proceedings is January 1, 2020 (this is quite ambitious).
The projected start of the examination of inventive step is mid-2021 (this is because the new law will only apply to newly filed applications, I presume).
In terms of HR efforts, 15 patent examiners currently working on a backlog of national search reports will be redeployed to deal with opposition cases, and 16 new patent examiners will be hired to deal in particular with the increased workload related to the examination proceedings.
We also learn from this report that the new French “provisional patent application“, that we have heard of a number of times, is not dead. It should be created soon by way of a government decree.
I am curious to know what such a provisional application will look like. So far, patent professionals have been extremely skeptical about this – to put it mildly.
According to one apocryphal anecdote, President Macron was told by a French start-upper a few years ago that U.S. law is much more favorable to innovators than French law, because they have provisional applications in the U.S.
As a reminder, filing a French patent application without claims and without paying any taxes gives you a filing date, which is all you need to later claim priority. So, if there is any truth to this anecdote, it probably means that our President never met a French patent attorney – or at least that such a meeting did not leave as strong an impression as the ones he had with start-up folks. Which, let’s face it, is quite understandable.
Regular readers of this blog are probably aware that Lionel Vial is a frequent contributor.
I am grateful for his thorough reporting on pharma / biotech case law. Today, he once again keeps us apprised of the latest SPC tidbit. As he even provided the illustration, I really have nothing to add but say thanks!
While we are all waiting for the decision of the CJEU in the Santen case (C-673/18) to finally know if, in application of the Neurim (C-130/11) case law, a patented novel medical use in humans of a product having already been authorized for a previous different medical use in humans deserves a supplementary protection certificate (SPC), the decision discussed today will take us back to the pre-Neurim era, a time of uncertainty as we will see.
At that time, the prevailing case law regarding further medical use consisted in Pharmacia Italia SpA (C-31/03) rendered on October 19, 2004, and Yissum (C-202/05) rendered on April 17, 2007.
Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products […] is to be interpreted as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product.
The DeLorean remains the best way to travel in time with style.
The Regents of the University of Colorado (hereafter the University) was granted European patent No. 1658858 on November 18, 2009 for the use of a botulinum toxin, in particular botulinum toxin type A, in the preparation of a pharmaceutical composition for treating a recalcitrant voiding dysfunction, in particular urinary incontinence.
A corresponding marketing authorization was then granted on August 22, 2011.
The University had six month (that is until February 22, 2012) to file an SPC application. However, since botulinum toxin type A had benefited of previous marketing authorizations and in view of the then prevailing case law, the University considered it impossible to have an SPC granted and therefore no SPC application was filed.
Neurim has often been considered as a complete reversal of the previous case law.
Besides, for many commentators, it opened the door to SPCs for novel medical uses in humans of products having already been authorized for a previous different medical use in humans.
The University therefore filed an SPC application on September 19, 2012, i.e. within 2 months of the publication of the Neurim judgment, but about 7 months after the end of the deadline for doing so.
Where an applicant has not complied with a time limit as regards the Institut National de la Propriété Industrielle, it may submit an appeal for reinstatement of it rights if it is able to give a legitimate reason and if the direct consequence of the hindrance has been refusal of its patent application or of a request or the loss of any other right or means of appeal.
However, the INPI (French patent office) was not convinced and rejected the appeal for reinstatement on June 30, 2015.
The University and Allergan (to whom the SPC application and the basic patent had then been assigned) appealed the decision of the Director of the INPI before the Paris Cour d’appel on September 18, 2015.
In a first decision dated September 16, 2016 the Cour d’appel confirmed the decision of the INPI. However, the decision was invalidated by the Cour de cassation, the French Supreme court, on April 5, 2018, for procedural reasons, as the Cour d’appel had neglected notifying observations made by the INPI to the University and Allergan.
Even considering that the case law of the CJEU, before the Neurim judgement, did not allow the University to expect obtaining an SPC and could therefore discourage it to file an SPC application, the director of the INPI rightly observes that this situation does not characterize a hindrance according to the previously cited provision, given that the case law, be it that of the Court of justice, evolves, that even with the Pharmacia Italia and Yissum case law other operators have indeed filed SPC applications in relation to further medical uses, one of which having given rise to the Neurim judgment, and that the lack of filing of an SPC application by the University was the result of its free appreciation of the latter and not of an objective impossibility, independent of its will.
As such, the decision of the director of the INPI is exempt from criticism in having retained that the lack of respect of the deadline imparted to the University for filing its SPC application was not due to a hindrance for which it would benefit from a legitimate reason, but to its will not to proceed with a filing that it did not consider appropriate and this in spite of the reference for a preliminary ruling submitted to the Court of justice duly published on June 18, 2011.
Perhaps, this case is an illustration that too much knowledge is sometimes dangerous, and that we, as counsels, should always be careful when giving opinions on the likely outcome of a filing on the basis of our knowledge of established case law, bearing in mind that there is always a possibility, even a remote one, that a case law can be overturned.
In any case, the University and Allergan should refrain from nourishing regrets on their missed filing at least until the result of the Santen referral (C-673/18) is known, as this latter case precisely arises from a decision of rejection of an SPC application by the INPI in relation to a further medical use.
Well, the way I see it, getting SPC law 100% right is a little bit like having to hit a wire with a connecting hook at precisely eighty-eight miles per hour the instant a lightning strikes a tower. Everything will be fine.
CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, February 12, 2019, The Regents of the University of Colorado & Allergan Inc. v. Directeur de l’Institut National de la Propriété Industrielle, RG No. 18/14291.
In a rather exceptional move, two patent attorneys professional organizations took sides in a lawsuit between two private companies.
In fact, the CNCPI (Compagnie nationale des conseils en propriété industrielle) and the ACPI (Association des conseils en propriété industrielle) filed an intervention in an appeal on points of law in front of the Cour de cassation.
I know this may sound like a nerdy and rather unamusing April Fools’ day prank, but it is not. I have temporarily given up on those since reality has started catching up with the imagination of jesters on a daily basis (anyone up to a Brexit joke these days?).
So, yes there was indeed such an intervention, in the litigation pitching British company JC Bamford Excavators Ltd. (JCB) against Manitou BF.
How did we get there and how did this all end?
JCB specializes in the production of manufacturing equipment e.g. for construction and agriculture. Manitou is a French manufacturer of fork lifts and other heavy equipment.
JCB owns in particular two European patents (EP 1532065 and EP 2263965) that it believes have been infringed by Manitou on the French territory.
On April 26-27, 2017, JCB rented a telehandler called Manitou MT 1840 and had tests performed on this device by two JCB employees, in the presence of two French patent attorneys. These tests were aimed at demonstrating infringement of the patents at stake. The two patent attorneys involved in this testing issued a report for JCB.
On May 5, 2017, JCB filed a complaint for patent infringement against Manitou.
A few weeks later, on June 1, 2017, JCB filed a request for an ex parte order to be authorized to carry out an infringement seizure in Manitou’s premises. It is somewhat unusual for an infringement seizure to be requested after the infringement proceedings have already been initiated, but it is certainly possible to proceed in such a “reverse” order. The ex parte order was granted the next day.
The bailiff was assisted during the seizure by two patent attorneys – as is almost always the case. But the important point here is that the two patent attorneys at stake were those who had assisted JCB with the April testing.
One week later, Manitou filed a motion for canceling the infringement seizure order. The judge rejected the motion in another order dated October 5, 2017. Manitou appealed.
On March 27, 2018, the Paris Cour d’appel set aside the October 2017 order, and canceled the infringement seizure order of June 2017 – thus also canceling at the same time the bailiff’s infringement seizure report.
[…] The right to a fair trial set out in article 6 of the European Convention on Human Rights [ECHR] requires that the expert assisting the bailiff should be independent from the parties […].
Mr. […] and Mr. […] were designated twice in the same infringement lawsuit between [JCB] and Manitou; a first time on April 26, 2017, upon [JCB]’s request, to perform tests on a Manitou MT 1840 vehicle, and to hand out on May 4, 2017 a private expert report describing the features of the material which was examined; and then by way of an order dated June 2, 2017, in which they were designated as judicial experts to assist the bailiff during the infringement seizure relating again to the MT 1840 model, already examined during the private expertise, as well as to further Manitou models. Obviously, and regardless of their status which requires compliance with rules of ethics, patent attorneys cannot be designated as experts by a judicial authority while they have previously been involved as experts on behalf of one of the parties in the same case […], without violating the impartiality principle required by article 6 [ECHR]. Their designation was illegal, so that the June 2, 2017 order shall be canceled, and the October 5, 2017 order shall be set aside.
JCB filed an appeal on points of law in front of the Cour de cassation.
The Cour de cassation: the Great Manitou of French litigation.
The March 2018 ruling sent some shock waves through the French patent profession as it seemed to establish new requirements for patent attorneys to be able to assist a bailiff during an infringement seizure.
Hit by these shock waves, the two abovementioned patent attorney professional organizations stepped in, in support of JCB’s case.
Hot from the dematerialized press, here is now the judgment issued by the cassation judges a few days ago, which the Cour de cassation set aside the March 2018 ruling of the Paris Cour d’appel.
The fact that the patent attorney of the seizing party had, on the initiative of the latter, established a report describing the features of the product at stake, does not prevent a later designation, upon request of the seizing party, as an expert to assist the bailiff in a patent infringement seizure. [Indeed], his mission is not subjected to a duty of impartiality since it is not an expertise under articles 232 and following of the Code de procédure civile. [Therefore], by ruling in this manner, the Cour d’appel breached the above legal provisions [i.e. article 6 ECHR and article L. 615-5 Code de la propriété intellectuelle].
I bet this ruling will come as a relief for most of the patent profession.
The mistake made by the Cour d’appel seems to have been to consider the patent attorneys assisting the bailiff as court-appointed judicial experts. They are not.
They are supposed to help the bailiff find evidence of infringement, they are not there to provide an impartial recommendation to a judge regarding the outcome of a discussion.
Calling upon patent attorneys to assist the bailiff, as opposed to employees of the infringement plaintiff for instance (which is prohibited), offers a number of guarantees for the seized party, due to the rules of ethics that patent attorneys have to follow. For instance, a patent attorney should not and will not communicate to the plaintiff any confidential information that he/she becomes privy to during the seizure.
But on the other hand there is no requirement for the patent attorney not to have advised the plaintiff in the past – including regarding the case at hand.
By the way, the CNCPI and ACPI’s intervention in the appeal was found admissible.
This may pave the way for similar interventions in the future in case the rights and prerogatives of patent attorneys are at stake in a litigation.
CASE REFERENCE: Cour de cassation, ch. commerciale, March 27, 2019, JC Bamford Excavators Ltd. v. Manitou BF, appeal No. H 18-15.005.
As promised last week, here is another episode of the ezetimibe SPC saga. Just like last week, Lionel Vial reports on the latest twists.
After having applied, on the basis of European patent EP0720599 (EP’599), for a first French SPC for ezetimibe alone (FR03C0028), then for a second one for ezetimibe in combination with simvastatin (FR05C0040), Merck Sharp & Dohme Corp. (Merck) has sought to secure a third one for ezetimibe in combination with atorvastatin (FR14C0068) corresponding to the medicinal product Liptruzet®.
However, if the first two SPC applications were granted by the INPI (French patent office), the third application was met with a decision for refusal that Merck appealed.
It is the appeal decision, rendered on January 22, 2019, that we will discuss today.
The 1960s, a decade of many twists – now, that’s a far-fetched one.
As a reminder from our previous post, EP’599 specifically claims ezetimibe in claim 8 and a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of ezetimibe, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).
Cl-981 is atorvastatin, a statin (i.e. an inhibitor of cholesterol biosynthesis) that was known before the filing date of the patent. The patent discloses results of biological tests obtained for ezetimibe alone (compound 6a in the last table of the example section of the patent) but does not disclose experimental results specifically obtained for a combination of ezetimibe and atorvastatin.
SPC application No. FR14C0068 was filed for ezetimibe in combination with atorvastatin or the pharmaceutical acceptable salts thereof, including the calcium salt of atorvastatin.
The INPI rejected the application on February 6, 2018 for lack of compliance with article 3(c) of Regulation (EC) No. 469/2009 (“the SPC regulation”) which provides that a certificate shall be granted if, at the date of the application for an SPC, “the product has not already been the subject of a certificate“.
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 [the SPC Regulation] 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.
Subsidiarily, the INPI considered that even if the combination of ezetimibe with an HMG-coA reductase (i.e. a statin) could be considered to constitute a different innovation from ezetimibe alone, which the INPI denied, then SPC No. 05C0040 (for ezetimibe in combination with simvastatin) would be opposable to the grant of a new SPC.
Merck lodged an appeal against the decision of rejection before the Paris Cour d’appel on May 4, 2018.
During the proceedings, the INPI came to agree with the appellant that the combination of ezetimibe and atorvastatin complied with the requirements of article 3(a) of the SPC.
The only question that the Cour d’appel had to answer was therefore whether the combination of ezetimibe with atorvastatin is a different product from ezetimibe alone or from the combination of ezetimibe and simvastatin.
The combination of the statin atorvastatin with ezetimibe must constitute a product – within the meaning of the regulation – different from the combination of the simvastatin statin with ezetimibe, subject of SPC No. 05C0040, in order for the condition of article 3(c) of the regulation to be fulfilled.
However, claim 17 of the patent gives a list of the different statins with which ezetimibe can be combined indifferently and without distinguishing them, and the combination of ezetimibe with a statin as provided by [claim] 17 has already been the subject of SPC No. 05C0040 granted for the combination of ezetimibe and simvastatin; it is not justified within the terms of the patent that the result of the combination of ezetimibe with atorvastatin constitutes a different product from the combination of ezetimibe with simvastatin.
The 599 patent relates to “hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents in the treatment and prevention of atherosclerosis, and to the combination of a hydroxy-substituted azetidinone of this invention and a cholesterol biosynthesis inhibitor for the treatment and prevention of atherosclerosis” and SPC No. 05C0040 has been granted for the combination of ezetimibe with a cholesterol biosynthesis inhibitor, simvastatin, so that the combination of ezetimibe with another statin, atorvastatin, which is not protected as such by the patent, cannot justify the grant of anew SPC.
The condition of article 3(c) being unfulfilled because of SPC No. 05C0040 “ezetimibe in combination with simvastatin” the appeal of MSD against the decision dated February 5, 2018 of the Director of the INPI will be rejected.
To summarize, the Cour d’appel has decided that the EP’599 basis patent protected as such two different products: (i) ezetimibe and (ii) ezetimibe in combination with a statin.
Besides, the Cour d’Appel has also decided that the various particular statins cited in claim 17 were not protected as such, so that the combination of ezetimibe with atorvastatin could not be distinguished from the combination of ezetimibe with simvastatin, both of them being variations of the same product “ezetimibe in combination with a statin”. Therefore, the combination of ezetimibe with a statin, in particular atorvastatin was already the subject of an SPC (FR05C0040 for a combination of ezetimibe with a statin, in particular simvastatin).
In deciding so, and in relation to the preliminary injunction previously discussed based on SPC FR05C0040 (covering the drug Inegy®), it could be hypothesized that the Cour d’appel has acknowledged that the product ezetimibe in combination with simvastatin is protected as such by the EP’599 patent and is different from the product ezetimibe. However, this would be a dramatic change over the previous decision of the Cour d’appel regarding this SPC (discussed here).
Needless to say, we are eagerly awaiting the next decisions of the Cour d’appel to see more clearly which direction the French case law is taking in matters of combination SPCs.
Many thanks as always Lionel for the thorough summary. This truly is a murky subject.
Lionel’s working hypothesis on the decision is that the court may have acknowledged that the product ezetimibe in combination with simvastatin is different from the product ezetimibe. But this is really a matter of interpretation of the ruling. In my view the ruling states that the product ezetimibe in combination with atorvastatin is the same as the product ezetimibe in combination with simvastatin but does not take a clear position on the product ezetimibe in combination with (any) statin compared with the product ezetimibe alone.
The thing is, during the court proceedings, the INPI simply relied on the existence of the prior combo SPC FR05C0040 and not (i.e. no longer) on the existence of the mono SPC FR03C0028 as a reason for objecting to the second combo SPC. Thus, the court did not have to rule on the comparison with the mono SPC.
Also, it can be noted that the January 22 ruling was issued by exactly the same panel as the one that held that the first combo SPC was likely invalid last June.
It is certainly possible that these judges may have changed their minds in this respect since then but to me the second ruling is inconclusive in this respect.
What the heck is going on with preliminary injunctions (PIs) in France right now?
Let’s face it, France is not particularly renowned for its patentee-friendliness. But different winds seem to be blowing these days over the Batignolles. Is this mere happenstance? Could it have anything to do with recent judicial appointments? Is there a feeling among our judges that the pendulum should swing back a little bit towards IP right holders? Or has there been a change in the behavior of third parties?
Preliminary injunctions in France: the new normal?
Hard to tell of course, so readers will have to make their own opinion based on a report kindly provided by Lionel Vial on a PI issued just a few days ago. I will now leave him the floor.
There has been a second high-penalty preliminary injunction in a row in the pharma field that we will comment on today after Renaud’s post on darunavir.
The drug at stake is a combination of ezetimibe and simvastatin (Inegy®, MSD France) which is prescribed for reducing cholesterol levels. Ezetimibe reduces intestinal absorption of cholesterol while simvastatin is a HMG-CoA reductase inhibitor (i.e. a statin) which inhibits cholesterol biosynthesis.
The case opposes Mylan, which has been marketing a generic version of the combination since April 18, 2018, and Merck (Merck Sharp & Dohme Corp. & MSD France) before the Paris Tribunal de Grande Instance (TGI).
Merck Sharp & Dohme Corp. holds French Supplementary Protection Certificate (SPC) FR05C0040, of which MSD France is a licensee. The SPC is based on European patent EP0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin” and is set to expire on April 2, 2019.
EP’599 specifically claims ezetimibe in claim 8 and a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of ezetimibe, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).
On October 17, 2017, Mylan started nullity proceedings against the SPC, to which Merck responded by requesting, on November 30, 2018, that a preliminary injunction to stop selling the ezetimibe/simvastatin combination and to pay provisional damages be issued against Mylan.
It was granted for a combination which is not protected as such by the basic patent, in breach of Article 3(a) of the SPC regulation (No. 469/2009), since it would not form the core inventive advance of the patent, which is centered on ezetimibe, in particular in the absence of any research conducted on the ezetimibe/simvastatin combination.
The product protected by the basic patent had already been the subject of a certificate (i.e. SPC FR03C0028 granted for ezetimibe) in breach of Article 3(c) of the SPC regulation.
The Court of Justice of the European Union thus considers that a product which is a combination of active ingredients is “protected by a patent in force” where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. The product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent and each active ingredient must be specifically identifiable.
As such, a product which is a combination of active ingredients pursuant to the first article of regulation (EC) No. 469/2009, necessarily relates to the invention covered by the patent if each of these ingredients is specifically identifiable according to the claims of the patent, without it being necessary that the second active ingredient of the combination be a new compound taught by the patent and protectable on that basis.
In this regard, in view of the GILEAD decision, the Court of Justice of the European Union does not require that the active ingredients, the combination of which is intended, should be an invention of the basic patent, provided [these ingredients] are identifiable. [The Court] only holds that the combination must necessarily relate to the invention covered by that patent.
This thus applies to a novel composition relating at least to an active ingredient taught by the patent.
Claim 17 of the patent claims a pharmaceutical composition according to claim 16 (which relates to the pharmaceutical composition according to any of claims 9, 12 or 15 wherein the cholesterol biosynthesis inhibitor is selected from the group consisting of HMG CoA reductase inhibitors), wherein the cholesterol biosynthesis inhibitor is selected from a group to which simvastatin belongs.
The association ezetimibe/simvastatin, which is thus taught, therefore necessarily relates to the invention deriving from the basic patent, simvastatin being specifically identified by the patent.
The product sold under the trademark INEGY®, which is a combination of the active ingredients ezetimibe and simvastatin, therefore appears to be “protected by a basic patent in force”, pursuant to article 3(a) of regulation (EC) No. 469/2009.
It is reminded that pursuant to article 3(c) of this regulation, the SPC can only be granted if the product has not already been the subject of a previous SPC.
The condition provided by article 3(c) of regulation (EC) No. 469/2009 therefore also appears to be fulfilled.
As such, the arguments put forward by MYLAN to demonstrate that there is a doubt as to the validity of SPC No. 05C0040 appear to be lacking seriousness, this SPC obviously fulfilling the requirements of article 3 of regulation (EC) No. 469/2009. It can neither be seriously argued against the sufficiency of disclosure nor against the inventive step, since these conditions are not envisioned by article 3 of the regulation for obtaining a SPC, due note being taken that the disclosure of the ezetimibe/simvastatin combination allows the one skilled in the art to easily reproduce it, while this combination was not known at the filing date of the basic patent.
It follows that by marketing, since April 18, 2018, the generics “EZETIMIBE/SIMVASTATIN MYLAN” comprising a combination of ezetimibe and simvastatin, in violation of SPC No. 05C0040 granting the market exclusivity of this combination to MSD, MYLAN likely infringed.
Too bad for what appears to have been a test by Mylan of the application in France of Justice Arnold’s proposal that, in order to be granted an SPC, a product must infringe the basic patent because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent.
It is also very surprising that there has been a complete change of appreciation of the validity of this SPC, since on April 5, 2018 the judge in charge of urgency proceedings refused to issue a preliminary injunction against Biogaran on the basis of the same SPC because the latter was considered likely invalid, which was confirmed on appeal on June 26, 2018 (see Renaud’s post on the subject here). But then, C-121/17 (July 25, 2018) had not been issued yet and the Cour d’appel mostly relied on C-443/12 (Actavis Group PTC EHF & Actavis UK Ltd v. Sanofi).
However, perhaps the interpretation of the evolving case law of the CJEU by French judges is not the most notable part of this decision.
1,460,889 euros to Merck Sharp & Dohme Corp.
As a reminder, in the darunavir case (GD Searle LLC et al. v. SAS Sandoz) the judge in charge of urgency proceedings ordered on January 11, 2019 a preliminary injunction against Sandoz, under a 50,000 euro-penalty per violation of the injunction (Renaud’s post on the subject).
Before that, on June 7, 2018, the judge in charge of case management awarded 5,846,628 euros to Novartis Pharma AG and 7,308,285 euros to Novartis Pharma SAS as provisional damages in the valsartan/amlodipine patent infringement case (see here for a report).
Besides, a preliminary injunction was also recently issued on July 6, 2018 against a potential infringer in a chemistry case, but without provisional damages (see here for a report by Renaud).
Therefore, we may be currently observing a new trend setting in that could make France a very attractive forum for preliminary injunctions, in particular in the pharma field.
An open question is whether this trend could weigh in favor of Paris in relation to the still undecided relocation of the London UPC central division, which is in particular competent for pharmaceuticals.
Out of luck for the time being (the decision on the merits is yet to come) with the ezetimibe/simvastatin combination, maybe Mylan could consider a combination of ezetimibe with atorvastatin, since a recent decision from the Paris Cour d’appel rendered on January 22, 2019 has upheld the decision of the Director of the INPI (French Patent Office) to reject French SPC application No. 14C0068 for “ezetimibe in combination with atorvastatin or pharmaceutically acceptable salts thereof, including the calcium salt of atorvastatin”. But that will be our next post on Patent My French, so stay tuned for more on SPCs!
As always I would like to thank Lionel for this thorough report. The story does indeed need to continue with this appeal ruling of January 22, 2019, which in my view is closely connected to today’s decision – and (spoiler alert) there is a new twist in the saga.
CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 1ère section, ordonnance du juge de la mise en état, October 17, 2017, Mylan v. Merck Sharp & Dohme Corp. & MSD France, RG No. 17/14664.

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