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.