Opposition guidelines – part 2

As promised by the INPI, the second and final part of their patent opposition guidelines has now been released. Here is the link to download the full pdf document. And as promised by me, here is now a summary of this new installment. As you will see, we now have a much clearer view of what the opposition à la française is going to look like. As a reminder, the presentation of the first part can be found here.

The opposition procedure consists of an admissibility phase, an instruction phase and a decision phase. I will pick up my comments again at the instruction phase, which starts after the expiry of the 9-month opposition time limit and after the end of the admissibility phase.

Notification of the opposition(s)

The INPI will “immediately” (French text: “sans délai”) notify all admissible oppositions to the patent proprietor and invite them to reply. As a side note, the admissibility phase seems to be ex parte, solely between the opponent and the INPI. I wonder whether the proprietor will be able to challenge the admissibility of the opposition after the so-called admissibility phase.

As to the notion of immediate notification to the patent proprietor, my understanding is that the notification will anyway not take place before the expiry of the 9-month time limit (even if an admissible opposition is filed a few days after the grant of the patent), as the instruction phase only starts after this expiry. Besides, in the case of multiple oppositions, the proceedings are supposed to be consolidated.

Overall timeline of the opposition proceedings

  • In its official communication to the patent proprietor, the INPI will invite the proprietor to respond to the opposition within a 3-month deadline, designated as “the first deadline“.
  • Within three months from the proprietor’s response, the INPI will communicate to all parties its preliminary opinion on the case, and invite all parties to file further observations within a 2-month deadline, designated as… “the second deadline“.
  • If one or more parties file observations within this second deadline, a so-called “written phase” begins. Each party will be invited to comment on the other parties’ submissions within another 2-month deadline  – yes, “the third deadline”, you nailed it!
  • Then the back and forth stops: no invitation to respond to submissions made within this third deadline will be sent.
  • An “oral phase” will take place upon request of one the parties, or on the INPI’s own motion (the expression “oral proceedings” was probably copyrighted).
  • If an oral phase takes place, summons to the oral phase will be issued, together with an additional opinion listing the main points to be addressed during the oral phase.

The first, second and third deadlines are not extendable. This means that the timeline is going to be tight, and the parties will have to be very quick.

Never play a game before carefully reading the rules.

Oral phase

The oral phase will take place at the INPI, in front of the “opposition commission” (the expression “opposition division” was probably copyrighted). As a reminder, this commission comprises three examiners. The chairperson can decide to add a legal member to the commission. The oral phase is public and will be conducted quite similarly to oral proceedings at the EPO. In particular, the opposition commission may interrupt the oral phrase for an interim deliberation, and the chairperson may then announce an intermediate opinion on one particular aspect. At the end of the oral phase, the chairperson will close the instruction phase of the opposition. It is not clear whether the final decision will be announced orally or not.

For the time being, the guidelines do not mention the possibility to conduct the oral phase by videoconference. I expect that the first hearings will likely not take place before approximately one year from now, which leaves some time for the INPI to decide to add this option, if they so wish.

Decision phase

If an oral phase takes place, the instruction phase ends once the oral phase is closed. In the alternative, the instruction phase ends:

  • at the expiry of the second deadline, if the parties have not replied to the invitation and have not requested to make oral observations;
  • or at least at the expiry of the third deadline, if the parties have not requested to make oral observations.

The end of the instruction phase is communicated to the parties. Then starts the decision phase, in which the INPI will draft and notify a reasoned decision on the opposition. If a decision is not issued within four months, the opposition will be rejected by default (the infamous “silence vaut rejet” principle). As already mentioned on this blog, the INPI will certainly make every effort so that this never happens.

The appeal deadline will be triggered by the receipt of the decision. As a reminder, the appeal will have to be filed in front of the Paris Cour d’appel, which is an entirely different kettle of fish. The appeal deadline is one month for a party residing in mainland France, two months for a party residing in the overseas territories, and three months for a party residing abroad – a rather unfortunate inequality. Appeal submissions must then be filed within three months after the notice of appeal.

Possible outcomes

The possible outcomes of the opposition are: the rejection of the opposition, the full revocation of the patent, the maintenance of the patent in amended form, but also… the partial revocation of the patent.

This fourth possible outcome is ambiguous in the statute and has given rise to some speculation. The guidelines give the example of an opposition challenging only claim 1, and a proprietor not filing any claim amendment. The INPI could then revoke claim 1 only. I wonder if this situation of partial revocation would also occur if the opponent challenges all claims, but the INPI concludes that only claim 1 is invalid.

In case of a partial revocation, the patent proprietor will be invited to file a request for modification of the patent in keeping with the decision of partial revocation. However, there is no deadline for doing so and no negative consequence if the patent proprietor remains inactive.

Commentators’ suspicions are thus confirmed: the partial revocation procedure does seem kind of messy.

Modifications of the patent 

The patent proprietor may file a modification of the patent at at least three stages: within the first deadline, the second deadline and the third deadline set out above. Any modification filed later, especially during the oral phase, will be deemed late-filed. Once the instruction phase is over, no more modification will be allowed.

Any modification of the patent must be occasioned by a ground for opposition raised by the opponent. This is more restrictive than at the EPO, where a modification may be filed to address a ground for opposition not raised by an opponent.

Naturally, amended claims will have to comply with all of the requirements of the Code de la propriété intellectuelle.

Interestingly, the description can only be amended to address the ground for opposition of insufficiency of disclosure. This provision is surprising. I do not expect that an objection of insufficiency of disclosure can frequently be overcome by amending the description – without adding new matter. What this also implies is that the description will not need to and actually cannot be adapted to amended claims. This is partly consistent with the examination guidelines, which do not require – but allow – an adaptation of the description when claims are amended in response to the search report.

Claim amendments can be filed in the form a main request and one or more auxiliary requests, which will be assessed in the order of preference stated by the proprietor, provided that their number is reasonable.

Late-filed submissions

The scope of the opposition and the grounds for opposition cannot be extended after the 9-month opposition deadline. This is more severe than at the EPO, wherein a late ground for opposition may be taken into account by the opposition division if it is prima facie relevant.

Facts and evidence which are not filed in due time by the parties may be admitted into the proceedings, at the INPI’s discretion. Factors to be taken into account include the relevance of the late-filed submission, the circumstances of the late filing and the possibility for all parties to debate it. This will apply in particular to new requests filed on the day of the oral phase.

A new submission made in the instruction phase as a direct and timely reaction to a submission of another party will not be considered late-filed.

It seems that new arguments may not be considered as late-filed. There is even a statement in the guidelines per which the parties should not merely repeat arguments already made in writing, during the oral phase – which sounds like an invitation to submit new arguments on the day of the oral phase.

That said, the boundary between new facts and new arguments probably remains to be determined. For instance, if a novelty objection based on D1 and an inventive step objection based on D2+D3 are raised within the 9-month period, will a new novelty objection based on D2 be considered as a late fact or a late argument (which would therefore be necessarily admissible)? How about an inventive step objection based on D2+D1? or based on D1+D3?

Language 

The language of the proceedings is French. Submissions must be filed in this language, otherwise they are inadmissible. French will also be the language used in the oral phase. The parties may bring their own interpreters to the oral phase.

Any exhibit or evidence should in principle be in French or translated into French. Otherwise, the INPI can invite a party to provide a translation within a deadline. It will be interesting to see how this provision will be implemented in practice. The majority of evidence filed in French opposition proceedings will likely be in English (or be translated into English). And it is a fact that all patent professionals, including INPI examiners, are able to read technical documents in English. We will see whether a French translation will be required for documents in the English language.

Stay of proceedings

There are several circumstances in which the opposition proceedings may be stayed: notably in case an ownership claim is filed in court, or if a nullity action is pending (although the judge may order a stay of the nullity suit, in which case the opposition can proceed).

As a more uncommon feature, the INPI may stay the proceedings if information is expected which may impact the outcome of the proceedings; or upon joint request of the parties, for a duration of four months, which can be renewed twice (thus for a total duration of 1 year). This may be useful in case the proprietor and the opponent need time to negotiate.

Apportionment of costs

For reasons of equity, for instance in the case of unjustified late submissions leading to additional expenditure, the INPI can order an apportionment of costs. However, the maximum amount to be apportioned is limited according to the following schedule:

  • 600 euros for costs incurred in the written phase.
  • 100 euros for costs incurred in the oral phase.
  • 500 euros for representation costs.

So the grand total would be 1200 euros, and it would likely only be possible to reach this amount in rather exceptional circumstances.

Therefore, it seems fair to say that parties may just as well completely forget about apportionment of costs, which will not be a factor – except for natural persons. The mere fact of requesting and arguing apportionment of costs may cost more than what may be finally apportioned.

* * *

These are the salient points that I have noted in the second part of the new guidelines.

Now that the first few oppositions have been filed – extremely few in fact, as far as I can tell based on recent issues of the Bulletin Officiel de la Propriété Industrielle – the opposition system is live. I hope readers will share updates on how it goes in practice.

This is not a pipe

A regular patent law blogging activity comes with a number of serious pitfalls. Rambling may be one of them.

I hope readers will amicably warn me if this blog ever gets there – unless this point has already been reached?

A couple of weeks ago, when commenting on the recent pemetrexed decision of the Paris TJ, I lamented that French courts have a tendency to rely on the detailed choice of words in the description of a patent to draw dramatic conclusions concerning its scope of protection – either to restrict it or to broaden it beyond the literal wording of the claims.

I would like to continue this conversation today, but with a different perspective, namely an SPC angle; the case I would like to look at is the latest judgment in the Inegy® litigation (already reported on by others here and there).

Merck Sharp & Dohme Corp. (MSD) owns SPC No. FR05C0040 (FR’040) based on European patent EP 0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin”. The originator’s product has been marketed as Inegy®.

At least four different lawsuits have taken place in France concerning this SPC, some of which have already been mentioned on this blog:

  • One involving Biogaran. MSD’s request for preliminary injunction was rejected in April 2018, and this rejection was confirmed in June 2018 (see this post), the reasons being that the SPC appeared to be invalid.
  • One involving Mylan and one involving Sandoz, in parallel. Here, MSD surprisingly obtained a preliminary injunction in March 2019 (see this post). This was however overturned on appeal in February 2020 (see this post), as the SPC appeared to be invalid.
  • One involving Teva, not yet mentioned on this blog.

Teva launched a generic version of Inegy® in April 2018 and initiated nullity proceedings against EP’599 and the FR’040 SPC. What was still known as the Paris TGI at that time rejected Teva’s nullity claim in October 2018, on the merits this time. By the way, this could be why a preliminary injunction was initially ordered against Mylan and Sandoz in March 2019 although it had been previously denied with respect to Biogaran in April-June 2018 (this piece of the puzzle was missing the last time I wrote on this topic).

Today’s decision is the ruling by the Paris Cour d’appel on Teva’s appeal against the October 2018 judgment. The first instance judgment has now been overturned, and the Cour d’appel has declared the FR’040 SPC invalid – consistently with its previous rulings of June 2018 and February 2020, but this time on the merits.

In the decision, the court rejected Teva’s objections to the validity of the basic EP’599 patent, but entertained Teva’s claim that the SPC itself is invalid under articles 3(a) and 3(c) of the SPC regulation. The reasoning is mostly in line with the February 2020 ruling already discussed here, so I may as well be brief.

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).

As a reminder, the FR’040 SPC is directed to the combination of ezetimibe and simvastatin.

The test of article 3(a) of the SPC regulation is whether the product was protected by the basic patent; and the test of article 3(c) of the SPC regulation is whether the product protected by the basic patent had already been the subject of a certificate.

In this case, MSD had already obtained an earlier SPC (No. FR03C0028) for ezetimibe itself.

The court reviewed the relevant case law of the CJEU, placing special emphasis on Sanofi, also known under the name of the other party, Actavis (C-443/12). In that case, based on a same patent, Sanofi had obtained a first SPC on the drug irbesartan based on a first MA, and then a second SPC on the combination of the drug irbesartan with a diuretic substance, HCTZ, based on a second MA. The CJEU ruled that, in this case, the grant of the first (mono) SPC prevented the grant of the second (combo) SPC.

The court found that the facts of the present case are very close to those of Sanofi – which, I think, is quite convincing.

Merck countered that, in Sanofi, the second compound HCTZ was not explicitly recited, only the therapeutic class (diuretics) was. But the court cited paragraph 30 of Sanofi: “it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent“. The court deemed that this reasoning applies in the present case.

Merck relied on two more recent CJEU rulings, namely Gilead (C-121/17) and Royalty Pharma (C-650/17), but the court found that these concern different situations and are not applicable.

The court then investigated “whether, from the perspective of the skilled person, based on common general knowledge at the filing date of the basic patent, and in the light of the description used to interpret the claims, according to article 69 EPC and its interpretative protocol, the product of the combination of ezetimibe and simvastatin, which is the subject-matter of the second SPC, is a product different from ezetimibe alone, protected by the patent as such“.

The court then turned to the description of the patent. Here is the central part of the reasoning:

The description of the patent, which uses the singular form to designate the invention, and uses the formulation “in yet another aspect” to present the combination of a hydroxy-substituted azetidinone, which is the subject-matter of the invention, with a cholesterol biosynthesis inhibitor, indifferently refers for hydroxy-substituted azetidinones alone and for their combination with a cholesterol biosynthesis inhibitor, to an effect “for the treatment and prevention of atherosclerosis or for the reduction of plasma cholesterol levels” without any indication of the specific therapeutic effect that distinguishes the product composed of ezetimibe alone from that comprising the combination of ezetimibe and a cholesterol biosynthesis inhibitor such as simvastatin. Therefore, the skilled person, who was aware in the prior art of the possibility of combining two anticholesterolemic drugs having different mechanisms of action (paragraph 8 of the patent – an HMG CoA reductase inhibitor and a bile acid sequestrant), and who was familiar with statins, and in particular simvastatin, which have been commonly used since the late 1980s for the treatment of hypercholesterolemia, will not consider that the combination of ezetimibe with simvastatin, or with the 9 other active ingredients also covered by claim 17 (in particular atorvastatin, for which Merck, on the basis of the same reasoning, filed a third SPC on September 12, 2014), constitutes a distinct product protected by the basic patent as such.

The underlying idea is that there is only one invention in the patent, namely ezetimibe itself (or the other compounds of the same class). The combination of ezetimibe with another, well-known, anticholesterolemic drug, is not patentably distinct from that invention, I would say (using U.S. vocabulary).

The court’s conclusion, as far as it is based on a review of the therapeutic effect of the products at stake, and of the actual contribution of the basic patent to the art, seems to make a lot of sense.

There is one portion of the reasoning that I do not feel comfortable with, though, namely the first part of the paragraph, in which the court pays attention to the expressions “the invention” (singular) and “in another aspect” – which, to me, do not really mean anything one way or the other.

Every patent attorney, sometimes every firm, has their own drafting style. This should have no impact on the extent of monopoly granted to a patent proprietor.

Let’s take an example. Imagine that, in the EP’599 patent, the combination of ezetimibe with another anticholesterolemic drug had been presented as being “a second invention“, or “a number of further inventions“. Should this have made a difference? Of course not. Simply naming a product as a distinct invention does not make it so.

“This is not a pipe” – can words change reality?

My fear is that some patent owners may take advantage of the judges’ over-reliance on contingent aspects of the specification to unduly extend the scope of their legal monopoly. Conversely, some may be hurt by innocuous, if unfortunate, syntactic structures.

Going back to the judgment at hand, the court decided that the case was clear and that there wasn’t any need for a reference to the CJEU. The FR’040 SPC was thus formally revoked.

According to reports published on other blogs, this is not the end of the story yet, as a final appeal in front of the Cour de cassation is already pending, at least in connection with the refusal to grant a PI against other generic companies. Presumably, this judgment is also going to be appealed.

As a final note, this seems to be one of these instances of fragmented European landscape. The decision acknowledges that preliminary injunctions have been granted and sometimes confirmed on appeal in Norway, the Czech Republic, Portugal, Belgium and Austria; and have been rejected (with sometimes a confirmation on appeal) in the Netherlands, Germany and Spain.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, September 25, 2020, SAS Teva Santé et al. v. Merck Sharp & Dohme Corp., RG No.18/23642.

Opposition guidelines – part 1

Reading the BOPI (Bulletin Officiel de la Propriété Industrielle) is barely more entertaining than reading the phone book.

This weekly publication by the French patent office (INPI) contains the abstracts of all published patent applications, as well as tons of bibliographic information.

Well, I must confess that I used to flip through the phone book once in a while, when we used to have those, without any purpose really. But today, I skimmed through some recent BOPIs with a purpose in mind.

Remember that the patent opposition “à la française has entered into force on April 1, 2020. I was curious to know how many oppositions have been filed yet. Looking at the BOPIs issued since then, it turns out that there has been only one.

The winner is FR 3080526, which relates to a device for heating milk. It is not entirely surprising that only one opposition has been filed, though. Oppositions can only be filed against patents granted as from April 1, 2020. Since there is a 9-month time limit after grant for filing an opposition, and since opponents tend to file their oppositions toward the very end of the opposition period – at least that is what we typically see at the EPO – it can be expected that oppositions may surge at the very end of 2020.

For anyone interested in the new opposition procedure, there is a much more interesting read, though: the first part of the opposition guidelines recently released by the INPI.

The patent guidelines of the INPI currently comprise three sections: one on patent filing and examination; one on “other procedures” which is concerned  inter alia with renewal fees and SPCs; and one on post-grant procedures, directed to limitation and opposition proceedings.

Only the initial phase of the opposition is addressed in the first part which has been officially released. Meanwhile, a draft of the second part has been communicated to various professional associations and is currently being reviewed and commented on.

What does this first part teach us? Most of it is actually a digestible recap of the relevant provisions of the Code de la propriété intellectuelle, but there are a couple of interesting additional details as well.

So here is my recap of the recap.

An opposition can be filed only against a national patent. It cannot be filed against a European patent, a utility certificate or an SPC. Any person except the patent proprietor may file an opposition. There is no standing requirement for the opponent.

The opponent must be represented if its residence or seat is outside of the EU or EEA – which means that opponents from the UK will ultimately need to be represented.

Just like at the EPO, an opposition may be jointly filed by several persons or entities. In that case, a common representative also needs to be appointed, and the joint opponents will be treated as a single party. Otherwise, unrelated persons or entities may independently file oppositions against the same patent. In that case, the INPI will handle all oppositions together in single joint proceedings.

The opposition time limit expires 9 months after the date of grant of the patent (more precisely, the date of the publication of the grant in the BOPI). No reestablishment of right is possible if the opposition is not filed in due time.

The grounds for opposition are listed as follows, in a limitative manner:

  • Lack of novelty.
  • Lack of inventive step.
  • Insufficiency of disclosure.
  • Extension of subject-matter beyond the content of the application as filed or initial application as filed (in the case of a divisional patent).
  • Lack of industrial application.
  • Subject-matter of the patent not being an invention.
  • Subject-matter of the patent being excluded from patentability (i.e. methods of surgical or therapeutic treatment of the human or animal body; methods of diagnosis applied to the human or animal body; inventions contrary to ordre public, morality or dignity of human persons; inventions relating the human body, its elements and products; inventions relating to animal races, plant varieties, essentially biological processes for the production of plants or animals, processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and animals resulting from such processes).

On the other hand, lack of clarity, lack of support in the description, lack of unity of invention, non-entitlement to the patent or an inaccurate designation of the inventors are not grounds for opposition.

The guidelines specify that the priority of the patent can be challenged in the context of lack of novelty or inventive step.

The opposition can be filed against the patent as a whole or against only some claims.

This the pop up window that users will get on the INPI portal when one of their patents has just been opposed.

An opposition can be withdrawn at any time (the part of the guidelines explaining what the INPI will do in such a case is not in the released part).

There is no mechanism for the intervention of an alleged infringer in pending opposition proceedings after the 9-month period, and third party observations are not allowed.

The admissibility of each opposition application (demande d’opposition”) is verified by a formalities officer.

During the written phase of the opposition proceedings, the opposition is handled by a main technical examiner (“examinateur référent“), who is someone else than the examiner who worked on the case during examination. He/she is assisted by two other technical examiners, and if needed by a legal specialist. During the oral phase, an opposition commission (“commission d’opposition“) comprising the above persons hears the parties. The discussion is chaired by the main examiner. His or her opinion is said to be dominating.

The process is thus slightly different from that of EPO oppositions, wherein the primary examiner mainly in charge of examining the case is not the chairperson of the opposition division.

All documents pertaining to the opposition proceedings are made public on the INPI website, at the exclusion of internal documents, documents comprising personal information or pertaining to a trade secret, or third party observations (which are inadmissible).

As a side remark, I hope that access to this documentation will indeed be thorough and quick. I was not able to find the opposition application against FR 3080526 online, although the mention of the opposition was published on the French patent register on April 8, 2020. Such access will be in particular critical in order for stakeholders to get familiar with how the INPI handles oppositions in practice.

An opposition application as well as any subsequent material must be filed online, on the INPI portal.

The actual filing of the opposition is triggered by the payment of the opposition fee (EUR. 600). Each opposition application will be given a number starting with “DM” (does any reader know what these initials mean?).

If the INPI portal is down, and only in this case, a fax filing will be accepted, provided that it is confirmed online within two working days. I think this provision is not user-friendly and is detrimental to legal certainty. If an opposition application is indeed filed by fax and only confirmed online after the expiry of the 9-month period, there will likely be a difficult discussion between the parties and with the INPI as to what it means for the portal to be “down“, who has the burden to prove this, etc.

The opposition application must be signed and contain the identity of the opponent, the identity of the opposed patent, a declaration stating the scope of the opposition, the grounds for opposition, and the underlying facts and evidence, optionally the designation of a representative, and the justification of the payment of the opposition fee. A power of attorney must be filed unless the representative is a French patent attorney or attorney at law. The INPI portal will assist the opponent with the retrieval of the relevant information on the opposed patent.

The declaration must be in French. The exhibits must also be in French or translated into French. It will be very important in practice to see whether exhibits in English will be tolerated. This would be highly desirable since the vast majority of the prior art that French patent professionals work with on a daily basis is in English. The section relating to language will be in the second release of the guidelines, but according to the current draft, the INPI will have discretion to admit documents in a foreign language if there is no comprehension issue. How the existence of a comprehension issue would be appraised remains to be seen.

The opposition fee must be paid via a debit order on an INPI account, or by credit card.

An opposition application can be complemented during the 9-month period. After this period, the scope and basis for the opposition cannot be extended. New facts and evidence can be submitted but will be treated as late-filed.

The parties have access to the entire written proceedings on a private part of the INPI portal, and this is also where they must make any further submissions.

When there is an inadmissibility issue with an opposition application, the INPI may notify the opponent within the 9-month period, if there is still time to do so. In principle, the various causes for inadmissibility cannot be remedied after the 9-month period, and in this case an inadmissibility decision is issued. It seems that this would be done without oral proceedings.

The grounds for inadmissibility derive from the various requirements set out above: improper identification of the opponent, filing not made on the INPI portal, etc.

One point may deserve an additional word: the declaration in support of the opposition application must sufficiently set out the justification for each ground for opposition.

A generic statement will not be considered as sufficient; for instance, with respect to lack of novelty / inventive step, specific prior art documents and specific passages of these documents must be cited. If the justification is insufficient for one ground, this ground is deemed to be unsubstantiated – I understand that it will not be possible to provide the missing substantiation afterwards. If all grounds are deemed to be unsubstantiated, then the opposition is held inadmissible.

That’s it for now.

The second part of the opposition guidelines currently at the draft stage contains all the relevant information on how the opposition proceeds after the admissibility review.

There is therefore a lot to say, but let’s wait until the final version is established to review it here.

By the way – not sure whether I have mentioned this before, but English-speaking readers may be interested to know that there is an English translation of the section of the guidelines dedicated to patent examination at the INPI: see here. Maybe the other sections will be translated as well at some point.

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.