The flip side of the coin

Pharma-savvy readers are probably well aware of the pan-European pemetrexed litigation.

Eli Lilly’s patent No.EP1313508 is probably one of the most litigated patents in Europe. A nice summary, which is a little bit more than one year old, can be found here but there have been more recent developments, in particular in the Netherlands and in Germany.

In this context, France was late in the game, but here we are, with a remarkable judgment by the Paris TJ (tribunal judiciaire) issued a few days ago. Many thanks to Loïc Lemercier at Clifford Chance for providing a copy!

The French decision seems to be overall aligned with the rulings issued in most other jurisdictions: in a nutshell, it is a (big) win for Eli Lilly.

The patent was upheld as valid and infringed. A permanent injunction was ordered against the defendant, Fresenius, and provisional damages amounting to 28 million euros were awarded – pending final determination.

There are certainly several noteworthy aspects in this decision, but the most interesting one is probably the interpretation of the claims and the infringement finding.

Claim 1 of EP’508 is a Swiss-type claim, which is drafted as follow:

Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

The claimed invention thus relates to a cancer combination therapy based on the administration of pemetrexed disodium, the main active substance, in association with vitamin B12 (or the like).

As summarized by the court in the judgment, pemetrexed disodium is a known anticancer agent marketed by Eli Lilly under the trade name Alimta®. This agent is toxic and has significant side effects. According to the patent, these undesirable side effects may be reduced owing to the co-administration of vitamin B12, which lowers the level of methylmalonic acid (a predictor of toxic events in patients) without impairing the efficacy of pemetrexed. The two substances may be administered as a single composition or separately.

Fresenius obtained a marketing authorization for a generic of Alimta®, called Pemetrexed Fresenius Kabi®, in 2016, and has been marketing this generic in France.

According to the summary of product characteristics of Pemetrexed Fresenius Kabi® (NB: for some reason, you have to use another navigator than Google Chrome to open this link), there is a mandatory pre-medication regimen: “patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter“.

In other terms, Pemetrexed Fresenius Kabi® is intended for the combination therapy recited in EP’508.

But there is a hitch: the active substance in Pemetrexed Fresenius Kabi® is not in the same saline form as Amlita®. The generic drug contains pemetrexed diacid, whereas the originator’s contains pemetrexed disodium. And, most importantly, claim 1 of EP’508 refers to pemetrexed disodium. Fresenius’ non-infringement defense was based on this difference.

When analyzing the scope of the patent, the court made reference to article 69 EPC (the claims must be interpreted in the light of the description and drawings) and its protocol on interpretation. As a reminder, according to this protocol, claim interpretation must stay away from the extremes of an excessively literal interpretation and an excessively extensive interpretation. Besides, any element equivalent to an element specified in the claims must be taken into account.

A claim is like an iceberg: there is more to it than you can see.

Interestingly, the court cited the file history as an additional source of interpretation:

The scope of the claims is determined in the light of the description and drawings, and also if appropriate by taking into account elements from the file wrapper of examination proceedings, such as the amendments and arguments made by the patentee, which are factual elements, to be considered among others. 

The court turned to the description of the patent and noted that it makes reference to the general class of antifolate drugs, of which pemetrexed disodium is an example. This seems to be because, in the application as filed, an antifolate was originally claimed, which was later restricted to pemetrexed disodium.

The court then noted that the crux of the invention is the combination of pemetrexed with vitamin B12, and that the disodium form of the active is inconsequential:

The skilled person knows that the active part of the pemetrexed active substance is the anion (which causes the therapeutic effects as well as the unwanted side effects) combined with vitamin B12 […] and understands, without focusing on the literal wording of the claims, that the invention resides in the combined administration of the active agent, whatever its form, with the other substances claimed in the patent. 

The court added that the existence of other patents owned by the same company and claiming an active in more general terms (with the notion of “pharmaceutically acceptable salts“) is irrelevant.

The court also added that the file wrapper, in the present case, did not need to be taken into account. Anyway, it merely showed that the restriction to the disodium salt form was not necessary to distinguish the invention from the prior art. It was necessary because there was no support in the application as filed for pemetrexed in general, therefore omitting the disodium feature would have resulted in an extension of subject-matter by intermediate generalization:

[…] The examination procedure in front of the office [provides] a simple optional tool of interpretation, it has no effect on the scope of the patent, and is not binding on the court or the patent proprietor. The behavior of the patent proprietor, who accepted a modification requested by the examiner, cannot be interpreted as an admission which is binding on the court and it has no consequence on the scope of the claim. […] Especially so in the present case, as Lilly meant to designate a preferred embodiment, without intending to modify the scope of its right, even if they did not object to the examiner’s argumentation. In fact, this modification due to added matter under article 123(2) EPC was not meant to overcome a prior art prejudicing the validity of the patent, and was only made for purely formal reasons. The modification due to added matter may not prevent the patent proprietor from relying on infringement by equivalence, since it is a formal condition relating to the substance of the inventive contribution and the literal content of the specification, prohibiting the patentee from adding any element which cannot be directly and unambiguously derived from the patent [sic]. It does absolutely not alter the base on which the interpretation must be performed, and it has no bearing on the extent of protection which is conferred. 

On the contrary, with respect to assessing the scope of the patent, article 69 EPC […] demands that equivalents be taken into account. Therefore, adding matter during examination proceedings is not a bar to relying on infringement by equivalence, provided that the specifically claimed means or combination of means (here, the combined used of vitamin B12 […] with the active substance) have a novel function (namely the reduction of toxic effects without impairing therapeutic efficacy) […]. 

The technical problem to be solved consists in reducing the toxicity of the pemetrexed antifolate, without impairing therapeutic efficacy. The solution recommended in the patent, despite the restrictive formulation of the claims, is the combined administration of the pemetrexed anion and the other substances mentioned in the patent, the form in which this antifolate is administered being irrelevant. The scope of the patent thus extends to all forms of pharmaceutically acceptable forms of pemetrexed (salt or others) employed in combination with the […] other substances

There is a lot to digest here.

First, although the file history was generally presented as a source of interpretation, it is rated as a secondary, “optional” one.

My take is that file history is duly taken into account when it confirms the interpretation that the court wants to adopt, but it is disregarded when it does not fit the court’s reasoning.

Second, a primary reason for accepting that the patent covers more than pemetrexed disodium is the fact that the description of the patent generally refers to an antifolate drug.

What if the description had been more thoroughly adapted to the amended set of claims during prosecution, and if all generic mentions of the antifolate class had been removed? Would the court have reached a different conclusion, or would it have made it harder for the court to reach this conclusion? If so, this is a red flag for patent attorneys: do not underestimate the importance of this sometimes boring phase of examination proceedings at the EPO, namely the adaptation of the description.

Third, the court draws a clear distinction between two types of amendments made during prosecution: amendments introduced to distinguish the claimed invention from the art and amendments which are not necessary to distinguish the invention from the art.

Only the former type of amendment affects the actual scope of the patent.

Let’s now turn to the assessment of infringement:

Fresenius’ generic drug is composed of the same active substance pemetrexed, and its administration must be combined, as recommended in the EP’508 patent, with vitamin B12 […]. It is therefore irrelevant whether the [incriminated] compound uses a diacid solution so as to enable its administration, since this does not have any specific technical effect. It should be added that it has been admitted that a formulation specialist is able to offer a number of possible counter-ions other than sodium, to form a free acid or a number of well-known pharmaceutically acceptable salts. The selection of the salt form is thus irrelevant. Only the therapeutic effect of the pemetrexed anion combined with the other substances matters. The defendants claimed that it was not obvious to use this particular salt, which ranks 10th among frequently used salts. This is a criterion for the validity of an invention, not for the assessment of infringement. Fresenius obtained patents […] on this form of salt. But all of this is immaterial. 

The variant directed to the use of a different salt is totally incidental. Pemetrexed Fresenius Kabi® is administered according to the use provided in the invention. It is meant to treat the same cancer conditions, with the same technical effect. It was authorized as a generic drug of the originator’s drug. 

Infringement by reproduction is established. 

Since infringement by reproduction is established, in view of the scope of the patent as determined above, infringement by equivalence does not need to be decided upon. 

This latter part is a bit confusing. By “infringement by reproduction” is probably meant “literal infringement“. So the court seems to say that there is literal infringement when the claims are properly interpreted in the light of the description, so that “pemetrexed disodium” is understood to actually mean “pemetrexed“.

On the other hand, the court did cite the French equivalence test (different means, same function, function must be novel) when determining the scope of the patent (see the passages quoted above). This wavering is mostly inconsequential, though.

I personally think it would be much cleaner to consider that there is no literal infringement because the wording of the claims is crystal-clear, but that there may be infringement by equivalence when considering that the claims could have been drafted in a broader manner in view of the inventive concept. That said, literal infringement and infringement by equivalence both mean infringement, and it does not make any difference in terms of outcome or legal consequences.

To finish this post, I would like to go back to the rosuvastatin case commented on this blog a couple of years ago. In this case, the main claim was directed to the active compound rosuvastatin in the form of an acid or a non-toxic pharmaceutically acceptable salt thereof. The alleged infringement was a zinc salt of rosuvastatin. The court decided that there was no infringement because the claim, when properly interpreted in the light of the description, only covered salts in which the cation is an alkaline metal ion, an alkaline earth metal ion or an ammonium ion – and therefore excluded the zinc salt.

Rosuvastatin and pemetrexed are two sides of the same puzzling coin. On the one hand, an embodiment literally covered by the wording of the claims is found to be excluded from the patent’s scope. And on the other hand, an embodiment explicitly excluded from the claims during prosecution is found to still be covered.

I am not questioning that the outcome in both cases might be the right or “fair” one. But frankly, this is a nightmare for legal certainty.

One can also wonder whether the gap between patent prosecution and patent litigation has not become too deep. In front of the patent office, you have to argue based on the claims, the whole claims and nothing but the claims. In front of a French court, you might as well forget about the wording of the claims: it is all about what the description teaches.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 3ème section, September 11, 2020, Eli Lilly and Company & Lilly France v. Fresenius Kabi France & Fresenius Kabi Groupe France, RG No. 17/10421.

Defendants empowered

Today, this blog is featuring a high-flying case. It started with Lufthansa Technik filing complaints against Astronics, Panasonic Avionics and Thales Avionics over a period of time ranging from December 2017 to June 2018.

The three complaints related to the alleged infringement of European patent No. EP 0881145 directed to an electrical power supply system for aircraft seats.

Since the allegedly infringing device targeted in the three complaints is the same, namely Astronics’ EmPower® high power USB in-seat power system, the three proceedings were joined in October 2018.

In parallel, Lufthansa Technik initiated discovery proceedings in the U.S. against the three defendants, for the purpose of gathering evidence for the French lawsuit. This would be under 28 USC § 1782, I presume.

Lufthansa Technik thus obtained confidential information and documentation from the defendants, and made reference to it in the French proceedings, as exhibits No.8.1 to 8.53.

This, however, caused a practical problem for the defendants. Indeed, the U.S. court had issued protective orders regarding some of the discovered documents. As a result, each of the three defendants, which are independent companies, are not entitled to review the exhibits originating from the other defendants.

In October 2019, Thales Avionics filed a motion with the judge in charge of case management in order to define how the confidential information was to be shared between the parties. In November 2019, Astronics and Panasonic Avionics also requested a ruling on confidentiality, but added, as a main request, that the court should rule on the invalidity defense first, before dealing with the infringement aspect of the case if needed.

The defendants argued that there was a real risk of trade secret breach, and that the confidentiality measures were complex to set up. However, these complex measures will anyway be useless if the patent is found invalid.

Lufthansa Technik countered that separating the validity and infringement discussions was contrary to the longstanding practice of the Paris court, and that this was just a delaying tactic.

No USB socket in this 1935 pneumatic airplane seat.

The judge in charge of case management noted that, indeed, the validity of the EP’145 patent could be addressed without any communication of the discovery exhibits. The judge also regretted that the parties were unable to reach an amicable agreement on a confidentiality club to handle these exhibits.

As a result, the judge deemed it appropriate to order that the validity of the patent should be decided upon first. Therefore, Lufthansa Technik should hold off from actually filing the discovery exhibits for the time being.

The ruling was issued on June 19, 2020, and the judge set a relatively tight mandatory schedule for the next steps, namely:

  • July 31, 2020: submissions of the defendants on the validity of the patent.
  • October 2, 2020: submissions of the plaintiff on the validity of the patent.
  • October 8, 2020: partial closing of the proceedings and hearing on the validity of the patent.

Once the court rules on this validity aspect,  the case will either stop or continue with a further discussion on how to deal with the confidential exhibits.

Overall, this looks like a rather reasonable and pragmatic ruling. Approximately one patent out of two is found invalid in court. An invalidity ruling is therefore not just a remote possibility, on a statistical standpoint, and it may be sensible to make sure that a patent is valid before addressing the infringement issue, if only from the perspective of procedural economy.

On the other hand, if the infringement side of the case does proceed, this sequencing will of course ultimately lead to a delay in the final resolution – although the schedule set by the judge is relatively tight, which was possible in this case since all parties had already filed submissions on the merits including on the validity issues.

Could the validity first / infringement second sequencing become commonplace in future cases?

Probably not – although this is not the first time, see this previous post.

The patent at stake in this case has already expired (it was filed in 1998). I assume this may have played a role in the judge’s decision: since an injunction is out of question, the negative impact of a delay for the plaintiff is probably less serious than usual.

In addition, the case has other very specific features. The defendants’ motion was caused by an unusual procedural mess resulting partly from the configuration of the parties (with three independent and competing defendants); and partly from the plaintiff’s original strategy. Instead of requesting access to the defendants’ confidential business information with the French court (this may be ordered prior to the ruling on the merits or after the ruling on the merits, in a second phase dealing with the assessment of damages), Lufthansa Technik opted for the nuclear option of opening a new front in the U.S.

Now, to end up on a less positive note on this ruling, setting up some sort of confidentiality club should not be viewed as an insurmountable task. If the parties cannot agree, it should be possible for the judge to solve this problem within a matter of weeks. As a general rule, too much time seems to be wasted dealing with procedural motions such as this one. I have a feeling that this significantly impacts the overall duration of French patent litigation – Covid crisis notwithstanding.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 2ème section, ordonnance du juge de la mise en état, June 19, 2020, Lufthansa Technik AG v. Thales Avionics Inc. et al., RG No. 18/04501.

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.