The show must go on

I have always been fascinated by the longevity of some soap operas.

As a teenager, I have memories of holidays at my grandparents’, with The Young and the Restless on TV. This show has been airing in the U.S. since 1973 and has recently reached its 12,000th episode milestone. (Un)fortunately for French viewers, the story started for them at episode 3,263 only. Anyway, sooner or later, even the oldest shows come to end. After 54 years of broadcasting, As the World Turns stopped in 2010.

As I have already mentioned a couple of times on this blog, one of the oddities of French patent litigation is that we have a few soap opera cases, which seem to go on and on for ages, fueled by a regrettable back-and-forth movement between the Cour d’appel and the Cour de cassation (i.e. the appeal court and the supreme court).

One such litigation, the numerous twists of which have given rise to many comments over the years, is the pravastatin case.

On May 21, 2021, the Paris Cour d’appel issued a batch of parallel judgments in this saga. Since they nicely and clearly summarize the main episodes of the dispute, I thought I might take this opportunity to present the updated facts to the readership.

The case revolves around SPC No. FR 92C0224 owned by the Japanese company Daiichi Sankyo Company Ltd. The SPC concerns the cholesterol-lowering drug pravastatin. It should have expired in August 2006. The SPC was filed by an IP law firm which can be referred to as L. But the renewal fees of the SPC were then paid by another IP law firm. Let’s call it W.

In 2004, the fourth renewal fee for the SPC fell due. It was duly paid by the W.  firm. However, the INPI (French IP office) made an extremely unfortunate mistake, and did not properly take the payment into account. On July 15, 2004, the INPI sent a warning communication to L., the first law firm which had filed the SPC application. The INPI received no response from the SPC proprietor or its representatives. It then issued a decision noting that the SPC had lapsed, on January 26, 2005. This decision was again sent to L., received the next day, and published in the official bulletin (BOPI) on March 25, 2005.

Nevertheless, it is apparently only a few weeks before the scheduled expiry of the SPC that the patentee realized what had happened.

On June 28, 2006, W. filed a request for cancellation of the decision of lapse on behalf of Daiichi Sankyo, explaining that the fourth renewal fee had been duly paid (as well as the following one in fact).

It took the INPI only a few days to dismiss this request for cancellation, in a decision dated July 3, 2006. The INPI’s position was that the deadline for challenging the decision had expired. Indeed, according to general rules of administrative law, an unlawful decision can only be canceled within 4 months from the date of the decision.

Daiichi Sankyo filed an appeal against both decisions (the decision of January 26, 2005 noting the lapse of the SPC, and the decision of July 3, 2006 rejecting the request to cancel this decision), in front of the Paris Cour d’appel. Teva intervened in these appeal proceedings, since they had launched their generic pravastatin drug on the French market in the meantime.

On March 14, 2007, the Paris Cour d’appel issued a first judgment, which canceled both INPI decisions, thereby reinstating the SPC.

The court reasoned that the decision of lapse was erroneous, and that it had not been properly notified to Daiichi Sankyo’s representative. Indeed, the law firm L. was only entrusted with filing the SPC application, whereas W. was in charge of handling the renewal fees.

Teva filed a cassation appeal (appeal on points of law), but the supreme court rejected it on July 1, 2008, holding that L.’s power of attorney was limited to filing the SPC application; that W. was not required to file a power of attorney with the INPI; that the communication of lapse was therefore not notified to the proprietor’s representative; and that the deadline for challenging the decision had accordingly never started running.

In April 2009, Daiichi Sankyo filed infringement actions not only against Teva, but also against a number of other generic drug companies that had similarly launched their respective pravastatin generics prior to the SPC expiry, namely Biogaran, Sandoz, EG Labo, Arrow, Mylan and Qualimed.

In an interesting turn of events, three of them, namely Sandoz, EG Labo and Biogaran, filed so-called third-party oppositions (“tierce oppositions“) to the 2007 judgment.

This is a procedure by which a person negatively affected by a judgment, although they were not a party to the proceedings leading to the judgment, may challenge this judgment.

In three parallel rulings dated February 20, 2012, the Paris Cour d’appel held that the oppositions were admissible but were not well-founded. It therefore let the 2007 ruling, which was favorable to the SPC proprietor, stand. Sandoz and Biogaran did not give up and filed respective cassation appeals.

In another stunning development, on June 25, 2013, the supreme court rejected Sandoz’ appeal but set aside the 2012 judgment involving Biogaran.

In the Biogaran ruling, the Cour de cassation reasoned that Daiichi Sankyo had not informed the INPI that the law firm W. was its representative. Therefore, the Cour d’appel should not have considered that the decision of lapse was not properly notified. In other words, a complete U-turn from the Cour de cassation’s own judgment issued five years earlier.

By the way, why did the Cour de cassation allow only Biogaran’s appeal but not Sandoz’ appeal? Simply because only Biogaran raised the winning legal argument, and the court is strictly bound by the parties’ submissions.

The Biogaran case was thus remitted back to the appeal stage.

Smelling blood in the water, three more generic companies filed their third-party oppositions to the 2007 judgment at this point, namely Mylan, Qualimed and Arrow.

Teva, who had lost the very first round, joined the proceedings (all three in fact). As a result, the Paris Cour d’appel issued three more parallel judgments on October 27, 2017.

In these new judgments, the Paris Cour d’appel (in a different composition) modified its 2007 ruling and held that the decision of lapse should stand after all (in keeping with the guidance offered by the Cour de cassation in 2013). Of course, Daiichi Sankyo filed a cassation appeal. Once again, on December 4, 2019, the cassation judges partly set aside the three 2017 judgments, but due to a mere technicality. Indeed, the 2017 judgments modified the reasoning of the 2007 ruling but failed to formally issue a new order.

And so, there we are again in front of the Paris Cour d’appel, with three brand new parallel judgments issued on May 21, 2021.

The show must go on.

In these judgments, the Cour d’appel once again reevaluated the facts.

The court focused in particular on the provision which is now known as article R. 612-2 Code de la propriété intellectuelle, per which applicants having their seat overseas must appoint a representative in order to act in front of the INPI. It is specified that “unless otherwise mentioned, the power of attorney extends to all acts and to the reception of all communications“.

The court then noted that the law firm L. was appointed as a representative by Daiichi Sankyo, without any express mention according to which L. was not empowered to receipt communications on behalf of Daiichi.

The court further stated:

The payment of the renewal fees as from 2001 by W. and not by L. cannot in itself justify a change of the representative in charge of receiving communications. Thus, the intervention of a second patent attorney, who did not have to justify their quality for the acts that they carried out, namely paying renewal fees, did not amount to informing the INPI of a change of representative, especially because the renewal fee receipts issued until May 2005 did not mention that W. was the representative. 

Therefore, only L. was properly registered as Sankyo’s representative when the warning before lapse was issued by the […] INPI […] on July 15, 2004 […]. The same applies to the notification […] of the decision of lapse issued on January 25, 2005 […]. 

Since the notification of these communications was proper, the request for cancelation of the INPI’s (unlawful) decision was filed too late. Therefore, the original 2007 judgment must be canceled, and the decision of lapse must stand.

Most importantly, the court noted the following:

The effect of the [INPI] decisions of January 26, 2005 and July 3, 2006 is that the ‘224 SPC has lapsed. This lapse can only be effective with respect to all. It cannot be divided. Indeed, an SPC cannot lapse with respect to some and remain valid with respect to all parties. Therefore, Daiichi’s auxiliary request that only the third-party opponent […] should benefit from the cancelation cannot be granted. 

End of the story? I would not bet on it, unless a general settlement takes place. First, Daiichi Sankyo may still file a cassation appeal. Second, regardless of this possibility, there may be a couple of spin-off proceedings still pending regarding other aspects of the case (such as infringement and liability of the INPI).

Anyway, these latest rulings seem to bring at least some sanity back to a crazy case.

The situation was difficult to handle for the judges from the onset, since all parties, to some extent, acted in good faith. On the one hand, the SPC should never have been declared lapsed, as the renewal fees were paid in time. On the other hand, the third parties were entitled to rely on the lapse of the SPC.

That said, the theory that, by stating ex post facto that there was a change of representative, and that a deadline never started running because the INPI communications were not properly notified to the new (unannounced) representative, was a severe blow to legal certainty. It is thus reassuring that this reasoning finally seems to have been set aside.

Furthermore, it would have been quite unfair if there had been winners and losers among the generic companies, depending on who raised which legal argument and when. It is therefore fortunate that the Cour d’appel has now clarified that the lapse of the SPC must have an erga omnes effect.

Now we just have to wait and see how this plays out next time, as the world turns its attention to the pravastatin case again – no longer young but seemingly forever restless.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, May 21, 2021, SAS Biogaran v. Daiichi Sankyo Co. Ltd., RG No. 20/02952 & 20/04838.

A pro-choice ruling

Once in a while, a complex and long-lasting patent case gives rise to a simple and straightforward ruling.

Only longtime readers having an exceptional memory will remember that, a few years ago, I reported on a first cassation ruling in a Time Sport International v. Décathlon France et al. case. This ruling dealt with a priority issue.

It turns out that another cassation ruling has recently been issued in the same litigation. So this is one of these few never-ending cases in which the judiciary pingpong seems to go on eternally. Is it a bug or a feature of the French legal system? We may never know for sure.

Anyway, there is probably no need to go over the entire case in detail: as I said, the point made in this new ruling is quite simple and straightforward.

Suffice it to say that Time Sport International owns European patent No. EP 0682885 on a device for the adjustable occipital fixing of a helmet, and that Décathlon France and DHG Knauer were found to have infringed the French part of this patent. The only outstanding question is the computation of damages.

More innovation in the helmet business.

Damages were awarded to Time Sport by the Paris Cour d’appel in a judgment dated September 22, 2017 (corrected on May 4, 2018). Several amounts were awarded in consideration of different periods of time and defendants. The total amounted to more than 800,000 euros for Décathlon France, but (only) approximately 71,000 euros for Knauer.

The Cour de cassation, which only rules on points of law and does not reassess the facts, let the 2017 ruling stand for the most part, but took issue with one amount in particular, namely the one supposed to address Knauer’s infringement for the period running from November 1, 2007 to September 8, 2012.

Time Sport’s claim amounted to 1,754,483 euros. But the 2017 appeal ruling only granted them 28,620.90 euros. If the staff mathematicians are correct, this means that the court granted Time Sport 1.6% of what they asked for – obviously quite a disappointment for them.

The amount claimed by Time Sport was based on an expert’s report and was said to correspond to the profit made by Knauer. It seems that Knauer refused to communicate its sales figures relating to the infringing helmets to the expert, so that he made an estimate based on a minimum number of helmets sold by Knauer to Décathlon, on Décathlon’s average unit price and on Décathlon’s gross margin (not Knauer’s gross margin).

But the appeal judges noted that Knauer and Décathlon have different activities. Knauer is a manufacturer and wholesaler while Décathlon is a retailer. Therefore, the expert’s estimate based on Décathlon’s gross margin did not correctly reflect Knauer’s profits. As a result, the court decided that the damages should rather be computed by applying a 6% royalty rate to a certain turnover – how exactly this turnover figure was obtained is unfortunately not very clear to me when reading the judgment.

Time Sport argued in front of the Cour de cassation that this approach was incorrect.

The key provision here is article L. 615-7 Code de la propriété intellectuelle.

In the relevant version which was in force between October 30, 2007 and March 13, 2014, the article read:

To set the damages, the court takes into consideration the negative economic consequences suffered by the harmed party, including lost profits, the profits made by the infringer, and the moral prejudice caused to the right owner due to the infringement. 

However, the court may, as an alternative and upon request of the harmed party, award a lump sum as damages, which cannot be lower than the amount of royalties or rights which would have been due if the infringer had asked for a permission to use the right which was infringed.  

The amended version of the article currently in force is not much different from this one.

In summary there are at least three modes of computation laid out in the statute (leaving aside the moral prejudice aspect, which rarely gives rise to significant indemnification): the first one based on negative economic consequences for the IP right owner, the second one based on the infringer’s profits and the third one which is royalty-based.

The Cour d’appel applied the third one.

But these different modes of computation are not equally available to the court. In particular, the phrase underlined above shows that the third modality has to be requested by the plaintiff.

The Cour de cassation confirmed that there is no getting around the underlined phrase, and that the plaintiff indeed has the right to choose whether or not to be indemnified by way of a royalty:

The Cour d’appel, by ruling thusly, by refusing to take into account the indemnification claim based on one of the evaluation criteria set in article L. 615-7, first paragraph […] and by awarding the amount of royalties which would have been due to Time Sport if there had been a permission to work the patent, although a claim for enhanced royalties had not been filed, violated this provision by refusing to apply the first paragraph and by wrongly applying the second paragraph. 

The case is therefore again remitted to the (regular) appeal level to have this portion of the damages award reassessed.

This cassation ruling can be viewed as a useful clarification – although, frankly, I would say the provision at stake in the Code de la propriété intellectuelle was in fact clear enough.

What remains fuzzy to me is how the court should “take into account” both the first and second modes of computation (negative economic consequences and infringer’s profits). I am not sure the case law is crystal-clear in this respect (see also this previous post on the same topic).

What is also somewhat fuzzy is what happens if the defendant refuses to open its account books, as seems to have been the case here. Wouldn’t it be logical in such a situation for the court to simply follow the plaintiff’s estimate?


CASE REFERENCE: Cour de cassation, chambre commerciale, March 17, 2021, Time Sport International v. DHG Knauer GmbH et al., appeal numbers 17-28.221 & 18-19.206.

Betting the farm on inventive step

After several posts dealing with the intricacies and oddities of SPC law, I thought we might as well take a break, look at a simple, straightforward case for a change – yes, there are some – and get a post completed in fewer than 1,500 words .

I don’t know whether this will be a breath of fresh air, but the patent in suit, EP 0899518, relates to a ventilation system for a building containing (especially porcine) livestock.

The patent proprietor, I-Tek, based in Saint-Malo, sued Heughebaert Danièle et Philippe, in Evreux, for alleged infringement of the patent. Bretons and Normans: little wonder this got contentious.

In November 2018, the Paris TGI granted the defendant’s invalidity counterclaim and revoked claims 1-4 of the patent for lack of inventive step. I-Tek appealed, so that the issue was revisited by the Paris Cour d’appel.

Here is claim 1:

Ventilation system for a building containing at least one row of compartments intended to be occupied by at least one animal, the said system including at least one air intake interconnecting, beneath the said compartments, with lower intake apertures for each of the shafts, at least one air outlet in the said building connected to air suction devices intended to create negative air pressure inside the building so as to provide for the suction through the said shafts of air let in through the said or each inlet, the said or each air outlet being positioned above the said compartments, an outlet aperture from each shaft being positioned beneath a ceiling of the said building and each shaft being fitted with means of regulating the velocity of the air sucked through its outlet aperture to a set value so that the said value provides for ventilation of the said ceiling above each shaft, the system is characterized in that the outlet aperture from each shaft is located appreciably above the floor.

The court started with recalling that the question is whether

[…] taking into account the state of the art, the skilled person, in view of the problem that the invention purports to solve, would achieve the technical solution claimed in the patent using their professional knowledge and making simple operations. Inventive step is defined relative to the specific problem with which the skilled person is confronted.

A less intensive form of farming not requiring any ventilation system.

The court added:

The closest prior art to be selected must be relevant, i.e. it must correspond to a similar use and require the minimum of structural and functional modifications to achieve the claimed invention. This closest prior art must therefore aim at reaching the same objective or achieving the same effect as the invention or at least belong to the same technical field as the claimed invention or a field which is closely related. 

Most readers have probably recognized an almost verbatim quote of the EPO’s case law and guidelines on the problem and solution approach.

The next sentence in the judgment is thus somewhat surprising:

Article 56 EPC does not necessitate, in order to determine if a patent involves an inventive step, to proceed according to a problem and solution approach requiring first defining a closest prior art […], as this is specific to the EPO’s Boards of appeal and is not mandatory for French courts.

There is some contradiction here, but I think the message may be: please do not tell us what we should do; but we will do it anyway.

The court then identified three relevant prior art documents, designated as G, D and S.

Document G discloses a ventilation system according to claim 1, except that it fails to disclose that each shaft is fitted with means of regulating the velocity of the air sucked through its outlet aperture to a set value.

Document D discloses a ventilation system for avian livestock comprising lateral active air inlets equipped with closing means adjusting the air inflow rate to a constant value, based on measurements made by a detector.

Document S discloses a ventilation system for porcine livestock including an axial shutter and shafts having motor-controlled openings.

The court identified G as the closest prior art, which confirms that they did apply the problem and solution approach.

The problem to be solved, they said, was the provision of a ventilation system comprising shafts and air flow regulation means, to achieve good ventilation of the entire building. This formulation could be criticized as already containing a pointer to the solution – but I am not persuaded that this really had a bearing on the outcome.

The important point, I think, is that the court found that documents D and S were combinable with G, “by simple technical operations and based on common general knowledge“.

It seems that I-Tek argued that document D would not have been taken into account as the regulation of air flow is different in this prior art. In particular, the air flow is horizontal in D but vertical in G (and the claimed invention). The court disagreed. They concluded that claim 1 corresponds to a mere juxtaposition of known means, not to an inventive combination having a novel function – thus confirming the findings of the court below. Dependent claims 2-4 shared the same fate as claim 1.

Interestingly, the patent was opposed at the EPO by another third party, more than fifteen years earlier.

The opposition was quite minimal, and it was rejected without oral proceedings. Document G was also considered as the closest prior art in the opposition decision but another document was cited as a secondary reference instead of D and S. The opposition division held that the skilled person starting from G would not achieve the claimed invention as this secondary reference did not teach the distinguishing feature.

The court therefore simply discarded this decision by noting that the opposition division was not presented with prior art D and S. Based on a very quick look at the documents, it does seem that D may indeed be more relevant than the secondary reference filed by the opponent at the EPO. The latter mentions some regulation means but D seems more specific in that it calls for a regulated constant air flow.

In my opinion this decision is an illustration of how flexible the problem and solution approach can be.

Criticisms have been raised against the problem and solution approach over time, including on this blog. But I would submit that the unconvincing inventive step reasonings that we sometimes see in EPO decisions are not really due to the approach itself, but rather to an objectionable, sometimes overly rigid, application of the approach.

In this respect, the selection of the closest prior art and the formulation of the objective technical problem are more often than not hotly debated.

But let’s not forget the third stage of the approach, namely the appraisal of (non-)obviousness, which probably gives the most leeway to the deciding body.

Case in point: for a narrow-sighted skilled person, the airflow rate regulation means of document D would not be obvious to incorporate into the ventilation system of the closest prior art G, as the positioning of the openings and direction of airflow are different. But if the skilled person has just a little bit more imagination, then the modification of the closest prior art becomes perfectly obvious.

In summary, IP courts have full discretion in deciding how high or low the inventive step bar should be, even if they follow the problem and solution framework, which can thus be viewed, at its core, as a convenient common language for the entire European patent profession.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, January 19, 2021, I-Tek v. Heughebaert Danièle et Philippe, RG No.18/28089.

Third time’s not a charm

Welcome to the third and final part of the SPC drama miniseries on Patent my French, still courtesy of guest blogger Lionel Vial.

Spoiler alert: I would never have thought that the fate of an SPC application would be at least partly decided based on a number of bibliographic citations – and yet…

The Easter egg which was missing from the latest post has finally been found again.

The last of the three decisions we discuss today was rendered by the Paris Cour d’appel on February 9, 2021 following an appeal against a decision of the French patent office (INPI) to refuse SPC application No. FR16C1004.

The SPC application was filed by Wyeth and the General Hospital Corporation on the basis of European patent No. EP 1848414 filed on February 2, 2006 and of marketing authorization (MA) No. EU/1/16/1086 granted in 2016 to Astrazeneca for Tagrisso® (osimertinib mesylate).

Tagrisso® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations (i.e. mutations of EGFR which cause cancer), and in particular for treating those patients who harbor a T790M mutation-positive EGFR (i.e. the amino acid threonine (T) in position 790 of the EGFR is substituted by a methionine (M)).

Osimertinib

Osimertinib is a Tyrosine Kinase Inhibitor (TKI) which irreversibly inhibits EGFRs harboring sensitizing-mutations (EGFRm) (i.e. mutations causing cancer) and the TKI-resistance mutation T790M.

Astrazeneca obtained an SPC for osimertinib on the basis of the MA and of European patent No. EP 2736895 filed on July, 25, 2012, which claims osimertinib as such.

The SPC application of Wyeth and the General Hospital Corporation was based on claim 23 of the basic patent which relates to a pharmaceutical composition for use in treating cancer in a subject with a cancer having a mutation in EGFR, wherein the mutation is a substitution of a methionine for a threonine at position 790; and wherein the pharmaceutical composition comprises an irreversible EGFR inhibitor.

Claim 24, which depends from claim 23, further gives a list of irreversible EGFR inhibitors: EKB-569, HKI-272 and HKI-357, which are structurally related to gefitinib, an EGFR inhibitor sensitive to the T790M mutation.

The SPC application was refused by the INPI on August 1, 2019 pursuant to Article 3(a) of Regulation (EC) No. 469/2009 (hereafter the “SPC regulation”). The INPI in particular considered that while the claims of the basic patent did implicitly and necessarily relate to osimertinib, they did not specifically relate to it, since osimertinib was neither mentioned in the specification of the patent nor identifiable as such.

The Cour d’appel essentially based its reasoning on the judgement handed by the CJEU on April 20, 2020 in case C‑650/17 (Royalty Pharma):

1. Article 3(a) of Regulation (EC) 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 is protected by a basic patent in force, within the meaning of that provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualized form as a specific embodiment of the method of that patent, provided that it is specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.

2. Article 3(a) of Regulation No. 469/2009 must be interpreted as meaning that a product is not protected by a basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition given in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step. (emphasis added by the Cour d’appel).

Regarding the first part of the Royalty Pharma test the Cour d’appel considered that:

To demonstrate that the person skilled in the art could specifically identify osimertinib as an irreversible inhibitor of the EGF receptor, the appellants only put forward allegations, arguing that the skilled person needed only perform standard enzymatic inhibition assays distinguishing EGFR irreversible inhibition from the reversible inhibition of EGFR, said assays being comprised in the basic knowledge of a biochemist […], without submitting any evidence, such as scientific publications or declarations from persons skilled in the art in support of their thesis.

Besides, the court observes that several years of research were necessary to precisely and specifically identify osimertinib as an active product, since osimertinib was only claimed in a patent on July 25, 2012 by Astrazeneca, which confirms that upon reading all the information contained in the [basic] patent in the light of its knowledge, this product was unknown to the person skilled in the art at the filing date in 2006. The skilled person could not directly and unequivocally infer [osimertinib] from said patent, its discovery being the result of several years of complex research.

Regarding the second part of the Royalty Pharma test the Cour d’appel considered that:

The appellants however argue, in the light of the Royalty Pharma judgement, that while osimertinib was developed after the filing date of the basic patent application, the inventive activity which led to the authorized product was not ‘independent’ since the inventors of the Astrazeneca patent relating to osimertinib based their work on the EP’414 basic patent and on scientific publications, in particular a KWAK publication of 2005 (Mr. Eunice KWAK being one of the inventors of the EP’414 basic patent), since an AVIZIENYTE publication of 2008, of which Mr. Richard WARD was a co-author (and also a co-inventor of Astrazeneca’s EP’895 patent in which osimertinib is identified) referred to the KWAK publication of 2005 […].

While these elements demonstrate that the EP’414 basic patent has undoubtedly enriched the state of the art and contributed to research relating to EGFR inhibitors, they do not establish that the active product osimertinib, which has led to the Tagrisso medicinal product, would not be the result of an independent inventive activity.

In this regard, the Cour finds that while Astrazeneca also filed two US patents US 8946235 and US 9732058 on July 25, 2012 and on December 19, 2014, relating to this active product, which mention the basic patent as prior art, fifteen other patents are also cited as prior art, which counterbalances the appellants’ allegations.

Similarly, it should be noted that if the AVIZIENYTE publication of 2008 mentioned the KWAK study of 2005, it also mentions thirty-one other bibliographic references.

Accordingly, the refusal of the SPC application was upheld by the Cour d’appel.

We must say that we are not entirely convinced by the simple quantitative approach adopted by the Cour d’appel for determining if the work underlying Astazeneca’s EP’895 patent is independent from the work which yielded the basic patent EP’414. Indeed, simply counting the total number of references cited by a patent or a scientific publication does not take into account the fact that not all cited references relate to the subject of interest, e.g. some of the cited references may only relate to minor experimental procedures, nor that not all cited references have the same scientific weight. In our opinion, it could be more relevant to establish the influence exerted by a publication/patent on following publications/patents, which can be estimated by counting the number of times the publication/patent has been cited by others, that is to say its impact factor. In this regard, it should be noted that the KWAK 2005 publication was cited more than 1000 times (Google Scholar count) which is a huge number. By comparison the AVIZIENYTE publication of 2008 was cited 93 times (Google Scholar count). We are not sure if this establishes whether the inventive activity leading to osimertinib depends from the work forming the subject-matter of the landmark KWAK 2005 publication and of the EP’414 patent, as the CJEU is rather elusive as to what constitutes an independent inventive activity, but in our opinion it is likely that this seminal work gave birth to a new field of research, i.e. searching for irreversible EGFR inhibitors useful to circumvent the T790M mutation, which eventually led to osimertinib.

With this decision we end our series of three recent decisions of the Paris Cour d’appel rendered on SPC refusals by the INPI. The final score is a spectacular hat trick (3 – 0) in favor of the INPI against SPC applicants.

Strikingly, if we perform a rapid statistical analysis of the decisions of the Paris Cour d’appel rendered on refusals of SPC applications by the INPI and discussed on this blog since 2016, we find that the Paris Cour d’appel upheld 100% (10/10) of the SPC refusals.

The odds of obtaining a reversal of a refusal decision are therefore clearly not in favor of SPC applicants. As such, if this trend were to continue, the best thing that could be expected from an appeal against a refusal of an SPC application by the INPI would be a reference for preliminary ruling by the CJEU, as e.g. in the Santen case (C-673/18). And indeed, all three decisions we discussed attempted to obtain a reference for a preliminary ruling, which the Cour d’appel however refused to pursue.

Thanks again Lionel for making my life easier reporting on this recent SPC case law – and for incidentally teaching me a sports-related idiom (definitely not my forte).

Is it fair to generally consider that, if a second patent filed after the publication of the basic patent gets granted and if it specifically claims an active ingredient which is generally covered by the basic patent, then there is almost no way the basic patent can be validly relied upon for an SPC application on that active ingredient?

Anyway, we will make sure to do something special on this blog next time an SPC refusal is overturned on appeal.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, February 9, 2021, Wyeth LLC & The General Hospital Corporation v. Directeur général de l’INPI, RG No. 19/19410.

Court says no to Ono

Owing to my colleague and excellent friend Lionel Vial, it is SPC month on Patent my French!

After tackling the recent Halozyme judgment a couple of weeks ago, Lionel now goes one-on-one with Ono.

As promised last week, we are back to discuss the second of the third recent supplementary protection certificate (SPC) appeal decisions rendered on refusals of the French patent office (INPI).

This week’s decision, which was rendered by the Paris Cour d’appel on January 19, 2021, discusses not one but two articles (aren’t we lucky) of Regulation (EC) No 469/2009 (the “SPC regulation”): 3(a) and 3(c).

SPC application FR15C0088 was filed on December 15, 2015 by Ono Pharmaceutical Co. Ltd and Professor H., whom we are told in the decision is a Nobel prize winner, on the basis of (i) marketing authorization EU/1/15/1014 in the name of Bristol-Myers Squibb Pharma EEIG and of (ii) European patent EP 1537878 (which will give you the full name of Professor H. if you are curious or if you don’t know the names of all Nobel prize winners by heart). EP 1537878 was filed on July 2, 2003 and granted on September 22, 2010. The product forming the subject-matter of the SPC is nivolumab (Opdivo®), a human monoclonal antibody which blocks the PD-1 receptor and is indicated in the treatment of certain cancers.

Since the decision begins with article 3(c) of the SPC regulation, let’s do the same.

The SPC application was rejected on March 2, 2018 pursuant to article 3(c) of the SPC regulation because a SPC had already been granted to Ono Pharmaceutical Co. Ltd for nivolumab.

The SPC in question is FR15C0087, also filed on December 15, 2015, granted on January 6, 2017, and held by Ono Pharmaceutical Co. Ltd and E. R. SQUIBB & SONS, L.L.C on the basis of European patent EP 2161336.

The INPI based its decision in particular on the judgment of the CJEU of September 3, 2009 in case C‑482/07 (AHP Manufacturing), which notably provides that “it should be pointed out that the first sentence of Article 3(2) [of Regulation (EC) No 1610/96, i.e. the phytosanitary SPC regulation] precludes the grant, to the holder of more than one patent for the same product, of more than one SPC for that product. However, the second sentence of Article 3(2) allows such a grant to two or more holders of different patents for the same product. It is thus apparent that the special condition for the grant of two or more SPCs for the same product is that the relevant applications emanate from different holders of basic patents” (see paragraph 25 of the judgement).

Faithful readers will immediately be reminded of a previous decision discussed here on this blog, in which the Cour d’appel sustained the decision of the INPI to reject a SPC applied by Medivir AB for simeprevir pursuant to article 3(c) in view of a previous SPC for the same product held by Medivir AB and Janssen Sciences Ireland UC.

The INPI therefore appears to be consistent in considering that the different holders of a same SPC or SPC application should not be considered as a single entity but individually.

Is it also the case of the Cour d’appel?

In the appeal proceedings, Ono and Professor H. notably argued that the case law of the General Court of the European Union (EU) allows the EU judge who cannot find elements in the EU law which would allow her/him to specify the content and scope of an EU provision by an autonomous interpretation to rely on national law. In the present case, pursuant to French civil law ruling co-ownership, the “holder” within the meaning of the SPC and phytosanitary SPC regulations would thus refer to all the persons holding property rights on a patent, so that the two basic patents (and the corresponding SPCs) would be held by different holders.

The Cour d’appel ruled as follows:

In this regard, the reference made by the appellants to the rules of civil law relating to co-ownership to argue that the holders of the EP 336 and EP 878 patents are not the same – the co-ownership consisting of the ONO and SQUIBB & SONS companies, holders of the EP 336 patent, being in this regard different from the co-ownership consisting of the ONO company and Pr. H., holders of the EP 878 patent – so that the conditions of Article 3(2) (second sentence) of regulation (EC) 1610/96 are fulfilled, is inoperative. The rules governing patent co-ownership are specifically defined by articles L. 613-29 to L. 613-32 of the Code de la propriété intellectuelle. Article L. 613-30 expressly provides that the ordinary law governing co-ownership resulting from the civil code does not apply to co-ownership of a patent application or a patent. Article L. 613-29 provides that “Each of the co-owners may use the invention for its own benefit, provided the other co-owners are indemnified (…)”. It follows therefrom that ONO, which is a co-owner of both the EP 336 and EP 878 patents and which may use them alone under the conditions set forth in article L. 613-29 of the Code de la propriété intellectuelle, is a “holder” of these patents within the meaning of article 3(2) of previously cited regulation No. 1610/96.

The decision of the INPI was therefore sustained.

Here, we are of the opinion that the reasoning of the Cour d’appel might miss a point. Indeed, article L. 613-32 of the Code de la propriété intellectuelle provides that articles L. 613-29 to L. 613-31 apply in the absence of contractual provisions stating otherwise and that co-owners may decide otherwise at any time through a co-ownership agreement.

As such, before reaching its conclusion, the Cour d’appel should have checked whether co-ownership agreements had been set up between Ono & Squibb on the one hand, and between Ono & Professor H. on the other hand, and if both these agreements allowed Ono to use the patents for its own benefit, without requiring any authorization from the other parties.

Perhaps this missing piece in the reasoning of the Cour d’appel will be addressed by the Cour de cassation (the French Supreme court) in the future.

An Easter egg was supposed to be hidden in this post, but it went missing.

Notwithstanding, this may be irrelevant for the outcome of this case, as the rejection was also based on article 3(a) of the SPC regulation.

Claim 3 of the basic patent was relied on for the purpose of the SPC application:

Anti-PD-1 antibody which inhibits the immunosuppressive signal of PD-1 for the use in cancer treatment.

The INPI considered that while claim 3 did “implicitly” cover nivolumab, it could not be interpreted in the light of the description of the basic patent as relating “necessarily” and “specifically” to this active ingredient within the meaning of the judgement of the CJEU in case C‑493/12 (Eli Lilly), as the description of the patent did not contain any indication, such as a concrete embodiment or any other teaching allowing to specifically individualise nivolumab.

The appellants argued that nivolumab necessarily relates to the invention covered by the patent, because it implements the technical contribution brought by the basic patent. The appellants further argued that nivoluab was specifically identifiable by the person skilled in the art because patent EP 878 teaches all the necessary elements to identify the antibodies forming the subject-matter of claim 1, and describes in detail the steps for producing an anti-PD-1 antibody and how to screen these antibodies to identify those which inhibit the immunosuppressive signal of PD-1; as such, the person skilled in the art could obtain, at the filing date of the EP 878 patent, through routine operations, all the antibodies fulfilling the function recited by the EP 878 patent, including nivolumab.

The Cour d’appel essentially relied on the judgement handed by the CJEU on April 30, 2020 in case C‑650/17 (Royalty Pharma) to reach its decision.

The Royalty Pharma judgement provides:

1. Article 3(a) of Regulation (EC) 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 is protected by a basic patent in force, within the meaning of that provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualised form as a specific embodiment of the method of that patent, provided that it is specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.

2. Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is not protected by a basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition given in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step (emphasis added by the Cour d’appel).

The Cour d’appel agreed with the appellants that nivolumab is implicitly and necessarily within the scope of the invention covered by the basic patent. However, it came to a different conclusion as to whether nivolumab is specifically identifiable.

The Cour d’appel considered that the preparation of monoclonal antibodies requires more than routine operations. The fact that 3 years were necessary for Ono to file the EP 336 patent which specifically relates to nivolumab was a sound indication that an independent inventive step was needed from the EP 878 patent to arrive at nivolumab.

The decision of the INPI based on article 3(a) of the SPC regulation was therefore also sustained.

For our part, we are not certain that the article 3(a)-test should be applied in the same manner to functionally-defined antibodies on the one hand and small molecules on the other hand.

Indeed, given a protein target, it is generally considered that the level of difficulty for identifying small molecule inhibitors is higher than for antibody inhibitors. As such, this difference should also be reflected in the standard to apply for determining if a product is specifically identifiable from a patent specification. In this regard, it should be noted that the Royalty Pharma judgement arose from a small molecule case (sitagliptin). In contrast, the Eli Lilly judgement arose from a monoclonal antibody case (tabalumab). Accordingly, perhaps monoclonal antibody SPCs should be assessed on the basis of the Eli Lilly judgement, without applying the “independent inventive step” test added by the Royalty Pharma judgment, which should be reserved to small molecules, at least until the CJEU clearly states that this latter test is of universal application for functionally-defined products. In this regard, it should be noted that the UK intellectual property office did grant a SPC for nivolumab based on the EP 878 patent on June 25, 2018 (before the Royalty Pharma judgement was handed).

We will be back soon with the last of the three SPC appeal decisions rendered on refusals of the INPI, with yet another article 3(a)/Royalty Pharma case.

Thank you Lionel. Any decent SPC post is supposed to end with the expression of a wish for – or fear of – a future CJEU referral, and I am quite happy that this one is no exception.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, January 19, 2021, Ono Pharmaceutical Co. Ltd. et al. v. Directeur général de l’Institut national de la propriété industrielle, RG No. 18/10522.