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