No gift from Santen for SPC holders this year

Why on earth has Patent my French! not reported yet on Santen, I am sure dozens of readers have silently but reproachfully wondered.

After all, SPCs are a frequent topic on this blog, and it is not every day that a CJEU ruling shatters previously established practice. And based on a French referral, no less. Well, you may probably blame it on summertime torpor.

Luckily, Matthieu Dhenne does not mind heatwaves and has kindly sent me a contribution, which I am happy to reproduce below.

Santen owns European patent No. EP 057959306 for an ophthalmological emulsion in which cyclosporin is an active ingredient, plus a marketing authorization (“MA”) for the drug IKERVIS®, an eye drops emulsion containing said cyclosporin, which is intended for the treatment of severe keratitis in adult patients.

On the basis of these patent and MA, Santen filed an application with the INPI for a supplementary protection certificate (“SPC”) for a product entitled “cyclosporin for the treatment of keratitis“. The Director General of the INPI rejected this application, considering that the marketing authorisation on which it was based was not the first for cyclosporin, since another authorisation had already been previously issued for a SANDIMMUN® drug, which included this same active ingredient, in the context of post-graft medication. Faced with the applicant’s appeal against this rejection, the Paris Cour d’appel referred two questions to the CJEU, with a view to determining, in substance, whether an SPC could be granted for a new therapeutic application of a known drug.

The European High Court firstly considered that the definition of the notion of “product” in Article 1 b) of Regulation (EU) No. 469/2009 on SPCs is independent of the approved therapeutic application of said product, which therefore implies that it has a therapeutic effect of its own.

The Court concluded, secondly, that this strict interpretation of the concept of product implies that Article 3(d) of the Regulation must be understood as relating to the first marketing authorisation of any medicinal product incorporating the active ingredient.

The Santen judgment is thus an important turnaround.

As a reminder, an SPC extends the term of protection of a product that is a component of a medicine and is covered by a patent. Its purpose is to compensate for the length of time it takes to obtain a marketing authorization for a drug, because it is particularly significant. The central question raised in the Santen case was therefore whether this certificate only rewards the development of new active substances or whether it also rewards the search for new treatments for known substances.

Initially, the Court of Justice had consistently adopted a literal interpretation of the texts by excluding the grant of SPCs for new therapeutic applications (C-31/03, Pharmacia Italia; C-431/04, MIT; C-202/05, Yissum). However, it reversed its position with its judgment in the Neurim case on 19 July 2012 (C-130/11). It then held that an SPC could be granted despite an earlier marketing authorisation for the same active ingredient, so that the mere existence of a marketing authorisation for the veterinary medicinal product did not prevent an SPC from being granted for a different application of the same product, provided that the said application fell within the scope of protection of the basic patent. However, the Court later restricted the scope of this reversal in Abraxis (C-443/17), by rejecting the protection of new formulations of a known product.

Nevertheless, the interpretation of the Neurim case law has given rise to considerable debate as to whether its application was limited to the case at hand, i.e. from veterinary use to human use or vice versa, or whether Neurim meant that any new therapeutic application was protectable by a SPC. National patent offices took different positions on this question.

In Santen, the Court of Justice unambiguously put an end to SPCs for second therapeutic applications and thus to the legal uncertainty surrounding them.

SPC case law is like a Moebius strip: sometimes, a long and winding path may bring you back to where you started from.

The judgment is thus part of a trend towards a literal reading of Regulation (EU) No 469/2009, in particular after the Abraxis case mentioned above, and should be reaffirmed in the pending Novartis case (C-354/19), which relates to the question whether a new SPC can be granted to the holder of a first SPC concerning the same active ingredient.

This ultimately brings us back to the idea, once developed by Michel de Haas in connection with patents, that a new treatment is not protectable because it was already inherent in the first product.

While legal certainty undoubtedly remains the first social value to be attained, it should not be overlooked that it is achieved here at the cost of a significant reduction in the incentive for research in the pharmaceutical sector. However, despite the insecurity, many SPCs have been granted and exploited in accordance with previous case law and some companies have been built based on the economic model of re-using known drugs (developers of personalized drugs or orphan drugs, or companies using data and artificial intelligence to identify new therapeutic uses, for example). Therefore, although it increases legal certainty, this judgment is nonetheless a loss for many players in the sector, who will ultimately no longer have the incentive to invest in the development of new applications for known medicines.

But perhaps this restrictive approach of the CJEU should be seen as an appeal to the Commission since, as the Advocate General pointed out in Santen, it is for the European Union legislator alone, and not the Court, to decide to extend the scope of protection of SPCs?

Thank you Matthieu for this nice summary. There is no doubt that this ruling must have disappointed a number of stakeholders.

Now, on a purely legal standpoint, I am struck by the unusual clarity of the ruling.

CJEU judgments on SPCs have had this tendency to form an undecipherable patchwork of rules. When a new one is issued, it is generally not an easy task to figure out whether it reverses or qualifies a previous one, or whether it should be interpreted as being limited in scope to very specific facts. This was in particular the problem with Neurim, which was difficult to reconcile with Yissum et al.

Contrast this with the quasi-crystal-clear order in Santen:

[…] A marketing authorisation cannot be considered to be the first marketing authorisation, […] where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.

Even more remarkable is the way the court explicitly repelled its previous ruling at paragraph 53:

It follows that, contrary to what the Court held in paragraph 27 of the judgment in Neurim, to define the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of Regulation No 469/2009, there is no need to take into account the limits of the protection of the basic patent.

This got me thinking though.

Now that we know for a fact that the CJEU sometimes sets aside rules that it previously laid out itself, isn’t this an incentive for litigants to try to challenge other seemingly well-established rules?

Neurim was issued only eight years ago, and it has now already gone the way of the dodo, so why not try this approach again in the future? In other words, is it at least conceivable that an unusually clear ruling may have ultimately increased overall legal uncertainty?

Let’s hope that the next SPC regulation will be intrinsically clearer and leave less room for diverging interpretations.


CASE REFERENCE: CJEU, July 9, 2020, C-673/18, Santen SAS v. Directeur général de la propriété industrielle

Time for the third round

The postman may always ring twice, but Lionel Vial, as a seasoned post-writing man, always rings three times. Here is thus his third foray into the Truvada® litigation.

As our faithful readers surely remember, there have already been two rounds in the Truvada® litigation in France (reported here and here). For the less faithful readers, here is a short 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 EP 0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) expiring 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).

The essential question repeatedly asked to the French courts was 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).

Round one saw the rejection, on 5 September 2017, of Gilead’s request for a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic, because the SPC was considered “in all likelihood invalid” by the French judge in charge of the case.

Round two saw the Paris Tribunal de Grande Instance confirm this preliminary ruling by invalidating the SPC on 25 May 2018.

Which brings us to round three, which took place before the Paris Cour d’Appel.

Bam! Wham! … and Pow!

In our previous post on the subject, we had expressed the thought that there was not much suspense left, especially in view of the opinion of the Advocate General (AG) of the CJEU delivered on April 25, 2018 in the then pending case C-121/17, relating to the corresponding UK SPC, and according to which 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.

Referral C-121/17 yielded a decision on 25 July 2018:

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision 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. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

            • the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
            • each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.” (emphasis added)

Let’s see what the Cour d’Appel made of it in its decision handed down on 19 June 2020:

The court, which studied the consultations and scientific articles submitted by the parties, retains that if it is not contested that the person skilled in the art knew that for treating HIV a therapy combining several active principles was more effective than a mono-therapy, nothing establishes that in 1996 the person skilled in the art, given the the general state of its knowledge, necessarily and specifically thought of emtricitabine to combine it to TD upon reading claim 27 which is drafted in very general terms.

The [first instance] judgement will be therefore confirmed in that it retained that no functional formula necessarily and specifically related to emtricitabine and that consequently the combination of the two products TD and emtricitabine could not be made the subject of an SPC on the basis of the EP 894 patent […]” (emphasis added)

Thus, not much suspense indeed, as round three also ends in a knock-down. Time to throw in the towel?


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, June 19, 2020, Gilead Sciences Inc. et al. v. SASU Mylan, RG No. 18/15906.

Karmic retribution

Or should that be cosmic irony?

Today’s tale is that of an inventor applicant who is successful in obtaining the grant of a European patent – which is no small feat for a self-represented individual; and who then loses the French part of his European patent due to a minor misstep.

But he does not give up and is fully reinstated by the Paris Cour d’appel… due to what might also be a procedural error by the French patent office (INPI). Tit for tat.

And now, the somewhat more complete account of these events.

Mr. F (as he is referred to in the redacted version of the ruling) filed a PCT application in 2007, claiming the priority of a French patent application. The invention is a gas turbine engine. Based on this PCT application, a European patent was granted in 2011. If you have a look at the European patent register, you will see that the examination proceedings were mostly conducted by phone, the applicant being instructed which taxes he should pay and being advised as to which modifications would be acceptable for the examining division. Kudos to the EPO for explaining what needed to be explained – and for documenting these explanations in the record accessible to the public (more on this topic below).

Then, Mr. F started paying renewal fees at the INPI to keep the French part of his patent in force.

In 2015, the 9th renewal fee became due. That year, there was an increase in the schedule of fees, and the new rate was 180 euros. But Mr. F paid only 170 euros.

At the EPO, this would (presumably!) not have been a major difficulty, as “the EPO may, where this is considered justified, overlook any small amounts lacking without prejudice to the rights of the person making the payment (Art. 8 RFees)” (Guidelines, A-X, 7.1.1).

But the INPI was not lenient. “Un sou est un sou” – every penny counts. Thus, the French part of the patent was declared lapsed on May 31, 2016.

There are two ways to challenge a declaration of lapse. One is a request for restoration of rights. The other one is a “recours gracieux which I would probably not translate into a gracious appeal, but rather a petition for reconsideration.

The INPI dismissed this petition for reconsideration in a decision dated February 6, 2018. It is against this decision that Mr. F filed an appeal with the Paris Cour d’appel.

And then what?

For starters, the INPI argued that the appeal was inadmissible because the notice of appeal neither specified the date and object of the decision under appeal, nor the professional occupation and birthplace of the appellant. As you can guess, Mr. F did not hire an attorney at the appeal stage either. Usually, this is not a good idea, but in this case the court was satisfied that the decision under appeal could be properly identified by the mention “I hereby appeal the INPI decision for the lapse of my patent“, and the appellant was allowed to simply provide the missing information at the hearing.

On the merits, the INPI argued that the procedure had been clean. Admittedly, no reminder of the grace period was issued after the due date for the renewal fee – but the INPI is not required to send such a reminder.

As for Mr. F, he claimed that he was never informed that his payment was insufficient; that he moved in 2012; and that, although he duly received all correspondence from the INPI, as an exception he did not receive the communication on the declaration of lapse and he only became aware of it more than one year and a half afterwards.

By the way, this is reminiscent of the infamous pravastatin case, in which an SPC was considered lapsed and then had to be reinstated due to a correspondence problem.

Here is now the court’s position:

The court notes that, based on the patent datasheet submitted by the INPI, Mr. F residing in Palluau is mentioned as the patent proprietor, but Mr. F residing in Le Pallet is indicated as the representative. It is at this “representative” address that the INPI sent him each year from 2012 to 2018 the renewal fee receipts, including that of November 12, 2015 for the amount of 170 euros.  

However, it has been established that the decision of declaration of lapse of May 31, 2016 was not sent to Mr. F at his address in Le Pallet, but at the one in Palluau; and that the registered letter came back with the mention “unknown recipient at this address”; and that these circumstances have prevented him to exert his rights to maintain or restore the patent in time.

It can be deduced from all of this that Mr. F’s appeal must be granted so that the decision to reject his petition for reconsideration is set aside. 

A rescue operation by the Cour d’appel.

Let me now express some conflicting observations.

First, the court’s reasoning may rest on shaky legal grounds.

Even if the declaration of lapse had been properly notified to Mr. F, it would still have been too late for him to pay the missing amount. Actually, declarations of lapse are only issued after the grace period is over, i.e. when it is already too late to redress the situation. A proper notification of this declaration of lapse would have enabled him to file a request for restoration – but it would not per se have entitled him to a reconsideration of his case.

Second, despite this somewhat shaky reasoning, I have a lot of sympathy for Mr. F – and thus for this judgment.

What happened to this inventor strikes me as mostly unfair. The INPI did not take any step to let him know that a minor amount of the recently increased renewal fee was still due, then messed up with the patentee’s contact information (how and why being unclear based on the judgment), and finally, as far as I understand, continued to bank the following renewal fees for several years despite the lapse.

Third, I assume that one of the reasons why the INPI stood its ground when Mr. F finally complained is the protection of the interests of third parties.

This is a very legitimate concern. It is true that reinstating a patent further to a procedure initiated a couple of years after the lapse (and thus initiated after the one-year restoration time bar) can also be very unfair – to third parties.

But I think one way to address this concern would be to make the office’s records more fully and readily available to the public, so that third parties can make their own assessment of the actual situation of any patent or application.

Progress has recently been made, but this is still not enough. If you look up the patent in suit on the INPI’s website, you will see that the only documents available for download are… the publication of the PCT application, and the B1 patent!

The declaration of lapse cannot be downloaded – let alone the no-delivery mailing receipt. The full renewal fee records cannot be checked – so that third parties cannot see that the patentee paid the major part of the 9th renewal fees and continued to pay the following ones. Last but not least, the “datasheet” mentioned by the court, in which the “representative address” is supposed to be indicated, can also not be retrieved from the website.

Some documents can probably be more or less easily obtained upon request – at least the communication on the declaration of lapse and hopefully the patentee’s petition for reconsideration and the INPI’s decision to refuse this petition. But I am pretty sure that not all of the relevant information can be obtained. Besides, this is 2020 – everything should be made available online.

Anyway, congratulations to Mr. F, and let’s hope he gets the next steps right when his patent is reinstated, especially regarding the payment of the various renewal fees.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, June 19, 2020, Mr. F v. Directeur général de l’INPI, RG No. 19/06949.

Back to the old normal?

Let me first start by wishing that all readers are safe and well, in these exceptional and difficult times.

As so many of us have to remain home all day in the foreseeable future, with the dreadful pandemic newsfeed as a main distraction, I said to myself, what better way to take my mind off it than to write about… a pharma case?

And so, here is an update on the Inegy® patent dispute (judgment kindly provided by Denis Schertenleib).

Difficult to think about anything else these days.

One year ago, Lionel Vial and I reported on a preliminary injunction ordered against Mylan due to the likely infringement of SPC FR05C0040 owned by Merck Sharp & Dohme Corp. (MSD).

In that post, we expressed some surprise at the decision since, back in April 2018, a judge in charge of emergency interim proceedings had refused to issue a preliminary injunction against another generic drug company, Biogaran, based on the same SPC, because the latter was considered likely invalid, which was confirmed on appeal on June 26, 2018 (see this post).

We wondered whether there was thus a new, more patentee-friendly trend in France with respect to preliminary injunctions in general and pharma patent litigation in particular, which is why the March 2019 post was entitled The new normal.

But now, we seem to be back to the old normal, as the Cour d’appel has overturned the preliminary injunction, and effectively re-raised the bar for pharma patent holders. 

As a reminder, Inegy® is a combination of ezetimibe and simvastatin, which is prescribed for reducing cholesterol levels.

Ezetimibe reduces intestinal absorption of cholesterol while simvastatin (belonging to the family of statins) is an HMG-CoA reductase inhibitor which inhibits cholesterol biosynthesis.

MSD’s SPC protecting Inegy® 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”.

EP’599 specifically claims:

  • a very broad family of compounds in claim 1 (in the form of a Markush formula);
  • ezetimibe as a specific compound in dependent 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 the above compounds, 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 initiated nullity proceedings, to which MSD responded by requesting, on November 30, 2018, that a preliminary injunction to stop selling Mylan’s ezetimibe/simvastatin combination and to pay provisional damages be issued against Mylan.

On March 7, 2019, the judge in charge of case management (JME) granted the preliminary injunction. Mylan appealed, and the JME’s judgment has now been overturned by the Paris Cour d’appel on February 14, 2020.

Like in first instance, Mylan argued that the SPC was invalid because:

  • 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 does 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 was already the subject of a certificate (i.e. SPC FR03C0028 granted for ezetimibe) in breach of Article 3(c) of the SPC regulation.
  • As is usual in SPC-related cases, the court analyzed the relevant case law from the CJEU. But the court interpreted the Gilead decision (C-121/17, Teva UK Ltd. et al. vs. Gilead Sciences Inc.) differently from the JME at first instance.

According to Gilead:

Article 3(a) of [the SPC regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision 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. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

The Cour d’appel held that the conditions of Gilead are not automatically met merely because the claims of the patent explicitly mention the active ingredients of the combination product. Something more is required.

The court insisted on the the link between the claimed combination and the technical problem at stake, based in particular on reason 48 of Gilead, which reads: “it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent“.

The court also turned to earlier decisions of the CJEU, namely Sanofi (C-443/12, Actavis Group PTC EHF & Actavis UK Ltd v. Sanofi) and Boehringer (C-577/13, Actavis Group PTC EHF & Actavis UK Ltd v. Boehringer Ingelheim Pharma GmbH & Co. KG) and found that the facts of the present case are similar to those of these earlier decisions.

Here is the court’s summary of Mylan’s key argumentation:

Mylan argues that the basic patent lists a large number of products, namely all known cholesterol-lowering products to be combined with the new active compound ezetimibe, that it does not contain any information on the specific effects of these combinations, and in particular the one associating ezetimibe with simvastatin, and that this combination is therefore not a product distinct from ezetimibe alone, for which the patentee has already obtained an SPC, which would make it possible for them to prohibit the sale of ezetimibe combined with any other product, so that the [SPC] is likely invalid.  

And here is the summary of MSD’s rebuttal:

MSD argues that [the expressly designated] composition of ezetimibe and simvastatin necessarily pertains to the invention for the skilled person, in keeping with Gilead. They add that this combination product is not a mere juxtaposition of two known active substances; it effectively makes it possible to solve the technical problem stated in the patent, namely the development of more effective drugs in the treatment and prevention of atherosclerosis, avoiding side effects, in view of the complementary modes of action of ezetimibe and simvastatin; and that this is a second invention of the EP’599 patent, covered by this patent under article 3(a) of the regulation, so that this case is different from Sanofi and Boehringer. They add that the combination product of ezetimibe and simvastatin has not given rise to an SPC under article 3(c) of the regulation yet, that several products can be protected as such by a basic patent, and that the condition of article 3(c) is also met so that the SPC is valid. 

In summary of the summaries: for MSD, there are two inventions in the basic patent, namely ezetimibe on its own, and the combination of ezetimibe with other complementary drugs such as simvastatin; for Mylan, the patent is only about ezetimibe itself.

In order to decide between these two propositions, the court looked at the structure of the basic patent, and at the nature of the combined effect of the two active substances.

Concerning the structure of the patent, the court noted that the summary of the invention primarily focuses on the class of compounds to which ezetimibe belongs. And then:

[…] The next paragraphs 15 to 17 which disclose product compositions and notably the association of a hydroxy substituted azetidinone and a cholesterol biosynthesis inhibitor are introduced by the following wording: “in still another aspect, the present invention relates to a pharmaceutical composition” or “the present invention also relates to”, so that the skilled person could consider the combination […] as being another “aspect” of the invention relating to hydroxy substituted azetidinones, and not a distinct invention. 

That sounds like a fair point, but on the other hand, it should scare the hell out of all patent drafters that an apparently innocuous choice of wording can have such dramatic consequences more than 25 years after the patent was drafted.

Concerning the “combined effect” of the active substances (an expression used at paragraph 53 of the reasons of Gilead), the court noted the following:

MSD states in its submissions that the “combined effect” under Gilead of the association of ezetimibe and simvastatin lies in the fact of not having to administer the maximum dose of statin and reducing the risk of side effects. This is not mentioned in the patent, which indifferently mentions that the effect of both hydroxy substituted azetidinones alone and their combination with a cholesterol biosynthesis inhibitor is the “treatment and prevention of atherosclerosis”. Therefore, the skilled person, who knew from the prior art that it was possible to combine two anti-cholesterol substances having different modes of action […] and who knew statins and especially simvastatin, in use since the end of the 80s for the treatment of hypercholesterolemia, would not consider that this combination is a distinct product of the patent (in the absence of any indication at the filing date as to the combined effect of ezetimibe and simvastatin, and the results from later research not having to be taken into account) […].

Consequently, the court seems to consider that, in order for a combo drug to be considered as distinct from a mono drug in a patent, this needs to be stated in the patent itself, and there must be a specific effect for the combination disclosed in the patent.

It remains an open question whether a mere mention of a specific combined effect would suffice or whether the combined effect would have to be plausible at the filing date (by analogy with the requirements of sufficiency of disclosure).

The above will probably be controversial enough, but an additional point made by the court, after concluding that the validity of the SPC was seriously challenged, may be even more controversial. To wit:

At any rate, the proportionality of the measures ordered at first instance is not justified in view of the respective interests relating to originator and generic drugs having obtained marketing authorizations. A financial harm cannot be seen as non-repairable or even poorly repairable, as long as it can later be cured by a damages award, unless under exceptional circumstances which are not justified in the present case, as the SPC at stake expired on April 2, 2019, i.e. less than two months after the preliminary injunction order.   

Just like in the latest post on this blog (in the context of telecom SEP litigation), the proportionality principle has thus been emphasized by the court, which seems to be a tendency on the rise. And just like in this other case, the fact that the expiry date of the IP at stake was nigh was a factor taken into account in the proportionality assessment.

This must be very worrying for originators, as preliminary injunctions have been a powerful deterrent for competitors, and as there are concerns that damages may never completely compensate for the competitive advantage gained by generic drug companies launching before expiry.

The case on the merits is probably going on in parallel, so we will probably get further updates on this case.

As a final note, a very similar decision was issued on the same day, with Sandoz instead of Mylan as the generic defendant.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, February 14, 2020, SAS Mylan v. Merck Sharp & Dohme Corp. & SAS MSD France, RG No. 19/06114.

The dead line

There is something ominous about the word “deadline” in English.

It makes you suspect some dire background. And rightly so, according to some online resources, which mention a line that you would cross at the risk of losing your life.

The French word “délai” sounds much less sinister, but the consequences of missing a “délai” are pretty much the same as those of missing a “deadline“, as a recent decision of the Paris Cour d’appel reminds us.

In this case, a French patent application was filed on November 6, 2015, claiming the benefit of the filing date of an earlier French application, namely April 1, 2015. This is what is sometimes conveniently referred to as an “internal priority claim“.

One of the requirements of claiming an internal priority is that you must provide a copy of the initial patent application (plus you must identify the modifications made in the later filing). As the applicant failed to do so upon filing the later application, the INPI issued a communication dated August 9, 2016 and notified on August 16 to the representative, inviting the applicant to submit the missing copy within a two-month period.

The applicant still did not file the requested document, so that a decision to refuse the application was issued on November 4, 2016, and notified on November 10, 2016 to the representative.

On January 8, 2018, the applicant filed a request for restoration of its rights. On August 17, 2018, the INPI issued a negative decision, holding that the request for restoration was inadmissible as it was filed past the statutory deadline.

The applicant lodged an appeal in front of the Paris Cour d’appel, which resulted in a judgment dated November 5, 2019.

The key provision in this case is article L. 612-16 Code de la propriété intellectuelle:

The applicant who failed to comply with a deadline set by the [INPI] may file a request for restoration of its rights, if it has a legitimate excuse and if the non-compliance directly resulted in a refusal of the patent application or of a request, in the lapse of the patent application or patent, or in the loss of any other right. 

The appeal must be filed […] within a two-month deadline from the removal of the cause of non-compliance. The missing act must be performed within this deadline. The request is admissible only within a one-year deadline from the expiry of the missed deadline.

[…]

The main question is that of the starting point of the one-year deadline. The INPI currently considers (and this is reflected in its Guidelines for examination, section E.3.3.1.b, Oct. 2019 edition) that the “missed deadline” starting point is the “initially missed deadline”.

As a side note, this did not appear in the previous versions of the Guidelines – I suspect that they may have been modified based on the present case.

Here, the applicant was notified on August 16, 2016 of the invitation to file the copy of the earlier filing. The deadline for filing this copy expired on October 17, 2016. The INPI thus deemed that the one-year restoration deadline expired on October 17, 2017.

The talking calendar – the must-have gadget for handling your deadlines this year.

The applicant’s defense relied on the fact that there was another possible legal remedy, namely a request for further processing. See article R. 612-52 Code de la propriété intellectuelle:

If a patent application is refused or may be refused due to non-compliance with a time limit set by the [INPI], the refusal is not issued or is revoked if the applicant files a request for further processing. The request must be filed in writing within a two-month deadline from the communication of the refusal decision. The missing act must be performed within this deadline. The request is admissible only if the required fee is paid. 

Thus, the applicant argued that the missed deadline was the two-month further processing deadline, and not the initial two-month deadline starting from the INPI communication. The request for restoration was thus filed with respect to the further processing deadline.

This reasoning will probably sound familiar to many European readers, as this is exactly the approach used at the EPO.

Applying this reasoning to the facts at hand, the deadline for requesting further processing expired on January 10, 2017 (date of notification of the refusal decision + 2 months), and therefore the one-year restoration deadline expired on January 10, 2018 – so that the request for restoration was timely filed.

But the appeal judges did not follow this argumentation. They stuck to the INPI’s interpretation of L. 612-16 and considered that the missed deadline used as a starting point must be the initial missed deadline, and not the further processing missed deadline. The INPI’s decision was accordingly confirmed.

Don’t ask me for the reasons why they chose one interpretation over the other. They just did, and there is no actual justification in the judgment.

This is all the more unfortunate as the summary of the facts reveals that two interesting case law decisions were discussed by the petitioner: a cassation ruling dated April 15, 1986, and a later judgment of the Paris Cour d’appel dated January 14, 1987.

The petitioner argued that the INPI misinterpreted the 1986 cassation ruling – from which it can be inferred that this ruling was the basis for the INPI’s position.

The facts underlying the 1986 ruling are that a patent application was refused for failure to pay the grant fee; a request for restoration was filed but it was held inadmissible as it was filed more than one year after the expiry of the time limit for paying the grant fee. The petitioner tried to take advantage of an additional two-month period corresponding to the filing of a request for further processing – to no avail.

The cassation judges stated the following: 

The non-compliance of the deadline for the request for further processing is not excluded from the provisions of [what is now art. L.612-16]. But the provisions of [what is now art. R. 612-52] do not result in extending the one-year deadline set in the second paragraph of [what is now art. L.612-16]. The Cour d’appel held that, irrespective of the grounds for the request for restoration, it is only admissible within a one-year deadline from the final date on which the initially omitted act had to be performed, and therefore rightly justified its decision. 

This is quite clear, right? The one-year deadline must be computed from the expiry of the initial deadline. Well, not so fast.

Looking at the specifics of the case that led to the 1986 cassation ruling, it turns out that, in that case, the request for restoration had been filed with respect to the initial time limit (i.e. the time limit for paying the grant fee). It had not been filed with respect to the (missing) request for further processing. 

Let’s now turn to the second case discussed by the petitioner. It is an appeal judgment which was issued after the 1986 cassation ruling. In this case, it was also the grant fee which was not paid in time. But the difference is that the applicant filed a request for restoration with respect to the (missing) request for further processing.

And the appeal judges computed the one-year deadline from the expiry of the period for requesting further processing, not from the expiry of the initial deadline for paying the grant fee: 

[…] The petition is admissible as to time limits. Indeed, according to [what is now art. L.612-16] the time limit for filing a request for restoration is one year from the expiry of the deadline not complied with. The request for further processing was due by April 17, 1982, so that the time limit for filing the request for restoration expired on April 17, 1983. The request for restoration was filed on April 15, 1983.

In summary, reading between the lines, we have:

  • On the one hand, a 1986 cassation ruling which could at first sight be seen as supporting the INPI’s position, except that the facts were different and that the relevant statement in the ruling is ambiguous. There is a reference to “the initially omitted act” but it is unclear what we should make of it. The cassation judges did simply not have to decide on a request for restoration with respect to a request for further processing.
  • On the other hand, a 1987 appeal decision based on facts similar to the present facts, and that is manifestly contradictory with the decision commented on today.

It is thus a real pity that the Cour d’appel did not seriously address these issues. 

I would also add that, one a purely pragmatic standpoint, it seems to me that there may be some contradiction in the INPI’s approach (and in the court’s present approach) to this matter. Indeed, the INPI acknowledges that a request for restoration may be filed with respect to a missed deadline for a request for further processing. This is stated in the table that you can find on the last page of the Guidelines for examination.

But what is the point in requesting restoration of right with respect to the further processing deadline, if the one-year time limit is to be computed from the initial missed deadline? I cannot think of any situation in which requesting restoration with respect to the further processing deadline would then be of any use.

I would not like to conclude this post without wishing all readers a very happy new year.

I hope that I have not missed the deadline for doing so – but hey, I have always heard that it is all right to send your best wishes until January 31. This may not be true elsewhere, but as you can see there is some cultural specificity about French deadlines.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, November 5, 2019, … v. Directeur Général de l’INPI, RG No. 18/20057.