Orange juices up its defense

The summer was relatively quiet – patent case law-wise, that is. Thus, now may be a good time to go back on some interesting decisions issued during the first semester which I did not have time to comment upon.

In particular, and just in case you missed it a couple of months ago, I would like to showcase a procedural ruling issued by a case management judge, which addresses the evolution of the statute of limitations (for infringement claims) over time.

The lawsuit revolves around telecommunications equipment that was supplied by Alcatel-Lucent International to Orange SA, under a 2007 agreement. The equipment (called Network Analyzer 5530 or NA 5530) is believed by a U.S.-based company, Assia, to infringe two of its European patents. In July 2020, Assia had no fewer than four infringement seizures carried out at Orange, and then initiated infringement proceedings in front of the Paris tribunal judiciaire (TJ). Alcatel-Lucent was forced by Orange to join the lawsuit.

A procedural motion was filed by Assia to request access to some of the seized and sealed documents. As a counterclaim, the defendants requested that Assia’s infringement claims be declared time-barred, to the extent that they concern alleged infringement acts having taken place before August 6, 2015.

In order to address this request, the judge had to review the evolution of article L.615-8 of the Code de la propriété intellectuelle over time.

From 1992 to 2014, this provision was worded as follows:

Infringement actions […] are time-barred three years after the underlying facts.

As from March 12, 2014, the limitation period was increased to five years:

Infringement actions […] are time-barred five years after the underlying facts.

The limitation period of article L.615-8 was then further modified by the recent loi PACTE – not in terms of duration, but of starting point:

Infringement actions […] are time-barred five years after the day on which the owner of a right knew or should have known the last fact allowing them to act.

As you can see, patent infringement is not yet treated as seriously as crimes against humanity – which are not subject to any statutory limitation – but things are slowly moving in that direction.

Going way back in time – a patentee’s dream.

In the present case, the alleged infringement started in May 2010, when Orange began using the NA 5530 equipment. Therefore, the statute was amended twice between the start of the alleged infringement and Assia’s complaint.

In order to determine the proper limitation period, the judge applied two legal principles:

  • First, if a new statute makes a limitation period longer, the longer period immediately applies to any action which is not yet time-barred. But it does not apply to an action which has already been time-barred. This general principle is set in article 2222 of the Code civil.
  • Second, the entry into force of a new statute of limitations does not modify the starting point of a limitation period which has already started running based on the previous statute. This is based on established case law of the Cour de cassation.

In view of these principles, the judge ruled as follows:

  • Claims relating to alleged infringing acts dated between May 2010 and March 12, 2011 were already time-barred (under the three-year statute of limitations) on the day the increased five-year period entered into force, i.e. on March 12, 2014. Therefore, these claims remained and are still time-barred.
  • Claims relating to alleged infringing acts dated between March 13, 2011 and May 23, 2014 were already time-barred (under the five-year statute of limitations) on the day the modification of the starting point entered into force, i.e. on May 22, 2019.
  • Claims relating to alleged infringing acts dated between May 24, 2014 and August 5, 2015 are still subject to the pre-PACTE starting point, they are thus time-barred since the acts were more than five years old on the day the complaint was served, on August 6, 2020.

As a result, the only acts of alleged infringement which can still give rise to damages are those which took place on or after August 6, 2015.

Assia had argued that the loi PACTE was immediately applicable upon entry into force. This seems to be correct, but “immediately applicable” does not mean “retroactively applicable“. They had also argued that the infringement claim as a whole was not time-barred even under the previous statute, since the alleged infringement acts, namely using and keeping the equipment, were continuous acts; the limitation period in such a case only starts running once the continued acts have ceased – and in this case, Orange has never stopped using the NA 5530 equipment.

Remarkably, the judge did not have the same interpretation of the alleged infringement acts. She considered that the act of “keeping” the equipment (“détention” in French) corresponds to the one-time act of acquiring the equipment from Alcatel-Lucent. And that the use of the equipment should be considered as a succession of repeated, daily acts – not as a single, years-long continued act.

One practical takeaway is that the post-PACTE, patentee-friendlier starting point for the infringement limitation period only applies to infringement acts taking place as from May 23, 2019.

But I think the most controversial aspect of the ruling may well be the passage in which the acts of keeping and using equipment are said not to be of a continuous nature – I bet that not everyone would agree with this characterization.

The ruling contains a second part on the original subject of the procedural motion, namely how to deal with some of the documents taken during the infringement seizures and provisionally placed under seal, especially in view of the necessity to protect trade secrets.

This second part is also a must-read, since the new trade secret statute is still fairly recent (2018), and it is enlightening to see how it is applied by the courts in practice.

A few notable points in my opinion:

First, several successive versions of the Alcatel Lucent’s NA 5530 user guide were seized. In view of the judge’s finding on the statute of limitations, a number of the older versions of the user guide were deemed not relevant for the lawsuit (since the contemporaneous alleged acts of infringement were time-barred) and were thus ordered to be handed back to the seized party.

Second, concerning the more recent versions of the user guide (as well as a presentation by Orange on the user guide), the judge deemed that these documents could not be considered as trade secrets because they appeared to be easily accessible to the public, in particular on the collaborative scribd platform. This highlights the importance of putting effective restrictive measures of protection in place if a document is to be argued as relating to a trade secret.

On the other hand, the judge added that not the entirety of these documents were useful for the infringement suit. Therefore, the judge ordered that only redacted versions prepared by Alcatel Lucent be handed over to the plaintiff. In other terms, if some of the seized documents are not useful for the lawsuit, they should not be handed over to the patent proprietor, despite their unprotected nature – see articles R.153-5 to R.153-7 of the Code de commerce.

Third, another group of documents was held to relate to trade secrets. For those, the judge also ordered that only redacted versions prepared by Alcatel Lucent be handed over; but in addition, a confidentiality club was put in place for the access to the documents, comprising only one individual for each party, plus the attorneys at law and patent attorneys acting on behalf of the parties.

One question that can legitimately be raised, though, is how the plaintiff can react if too much information was redacted, in a case such as this one, as the redaction was not examined by an independent expert.


CASE REFERENCE: Tribunal judiciaire de Paris, 3ème chambre 1ère section, ordonnance du juge de la mise en état, Adaptive Spectrum and Signal Alignment Incorporated – Assia Inc. v. Alcatel Lucent International & Orange, RG No. 20/07066.

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.