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.

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.

Time for the third round

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

As our faithful readers surely remember, there have already been two rounds in the Truvada® litigation in France (reported here and here). For the less faithful readers, here is a short reminder.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of tenofovir disoproxyl fumarate (TDF) and emtricitabine (FTC) approved for Pre-exposure Prophylaxy (PreP) of HIV infection, since it has been shown to allow for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP 0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) expiring between 21 and 24 February 2020 depending on the countries.

The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients. (Emphasis added).

The essential question repeatedly asked to the French courts was whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (i.e. the SPC regulation).

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

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

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

Bam! Wham! … and Pow!

In our previous post on the subject, we had expressed the thought that there was not much suspense left, especially in view of the opinion of the Advocate General (AG) of the CJEU delivered on April 25, 2018 in the then pending case C-121/17, relating to the corresponding UK SPC, and according to which it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent.

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

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

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

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

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

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

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


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

Karmic retribution

Or should that be cosmic irony?

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

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

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

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

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

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

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

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

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

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

And then what?

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

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

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

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

Here is now the court’s position:

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

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

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

A rescue operation by the Cour d’appel.

Let me now express some conflicting observations.

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

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

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

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

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

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

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

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

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

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

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


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