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.

Easy as ACD

Even for those who know the ABCs of patent law, mastering the ACDs of SPC law may seem a daunting task. I am talking about article 3(a), 3(c) and 3(d) of the SPC regulation of course, a never-ending source of legal headaches. 

I am happy to once again host a contribution from SPC enthusiast Lionel Vial, reporting on the first of a series of three recent judgments. With his explanations, I am sure everything will look as easy as ACD.

Today we discuss the first of three recent decisions of the Cour d’appel (appeal court) of Paris rendered on appeal against decisions of the French patent office (INPI) to reject three SPC applications in view of Articles 3(a), 3(c) and 3(d) of the SPC Regulation (Regulation (EC) No 469/2009):

Date of the decision Parties SPC Product Article of the SPC regulation applied Main CJEU decisions applied Outcome
15/12/2020 Halozyme Inc. 15C0053 Trastuzumab and recombinant human hyaluronidase 3(d) C-631/13 (Arne Forgsen) SPC rejection sustained
19/01/2021 Ono Pharmaceutical Co. Ltd & Prof. H 15C0088 Nivolumab 3(a) & 3(c) C-482/07 (AHP Manufacturing) & C-650/17 (Royalty Pharma) SPC rejection sustained
09/02/2021 Wyeth LLC & the General Hospital Corporation 16C1004 Osimertinib 3(a) C-650/17 (Royalty Pharma) SPC rejection sustained
The ABC mouse is right: SPC law does feel like the teacher playing a joke on the class.

In the first case, Halozyme Inc. had applied for a SPC (FR15C0053) for a combination product of trastuzumab and recombinant human hyaluronidase on the basis of a marketing authorization (MA) granted on 26 August 2013.

The combination is indicated in the treatment of breast and gastric cancer. Trastuzumab is a monoclonal antibody targeting HER2 thereby inhibiting the proliferation of human tumor cells that overexpress HER2. Recombinant human hyaluronidase increases the dispersion and absorption of co-administered drugs when administered subcutaneously, by catalyzing the hydrolysis of hyaluronan, a constituent of the extracellular matrix.

A previous MA for trastuzumab was granted on 28 August 2000.

Problem: the summary of the product characteristics of the MA of 2013 mentions trastuzumab as the sole active ingredient and hyaluronidase is listed among the excipients.

As a consequence, the INPI rejected the SPC application on 7 March 2018 on the basis of Article 3(d) of the SPC Regulation, considering that recombinant human hyaluronidase was not an active ingredient having a therapeutic action of its own but that it was an excipient, as provided in the summary of the product characteristics of the MA. As such, hyaluronidase did not qualify as a product within the meaning of the SPC regulation, the product being none other than the active ingredient shown in the MA, i.e. trastuzumab, which had already been granted a MA in 2000.

Halozyme appealed the decision of the INPI in particular on the ground that, based on judgement C-631/13 (Arne Forgsen) of the CJEU, it was of no consequence that hyaluronidase was presented as an excipient in the MA, since the SPC regulation does not provide that a SPC should be only granted for active ingredients presented as such in the corresponding MA. Instead, it should be verified, based on all pertinent factual and scientific elements, whether the ingredient at stake could be considered an active ingredient. In this regard, recombinant human hyaluronidase should be considered as an active ingredient, since it has a therapeutic action on the organisms of patients allowing treating breast cancer.

As a reminder, judgement C-631/13 notably provides that:

Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorized as an “active ingredient” within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorization, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings. (emphasis added).

This is what the Court decided:

It results from the foregoing that it appears from the “summary of the product characteristics” of the MA that the active ingredient of the medicinal product is trastuzumab, that hyaluronidase is an excipient, and that no other element contained in the MA justifies that hyaluronidase alone, or associated to trastuzumab, would produce a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the MA (emphasis added).

[…]

It follows that, in the combination of trastuzumab and recombinant human hyaluronidase, forming the subject-matter of the SPC at stake, only trastuzumab is the active ingredient, while a MA has already been granted for trastuzumab alone. Therefore the invoked MA is not the first MA for the product pursuant to article 3(d) of the regulation. Accordingly, the director of the INPI rightly decided that the SPC application did not comply with the requirements of the regulation and that it had to be rejected.

Even though the appeal was eventually rejected, it should be noted that the Cour d’appel did consider other parts of the MA than the summary of the product characteristics to assess the action of hyaluronidase and establish whether it could be considered as an active ingredient.

Accordingly, there is still some hope for combination SPCs in France when one of the ingredients of the combination is not mentioned as an active ingredient in the summary of the product characteristics of the MA, provided, of course, that data showing a therapeutic action of its own within the indications of the MA is available.

To be continued with the second of the three decisions!


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, December 15, 2020, Halozyme Inc. v. Directeur Général de l’INPI, RG No. 18/14332.

This is not a pipe

A regular patent law blogging activity comes with a number of serious pitfalls. Rambling may be one of them.

I hope readers will amicably warn me if this blog ever gets there – unless this point has already been reached?

A couple of weeks ago, when commenting on the recent pemetrexed decision of the Paris TJ, I lamented that French courts have a tendency to rely on the detailed choice of words in the description of a patent to draw dramatic conclusions concerning its scope of protection – either to restrict it or to broaden it beyond the literal wording of the claims.

I would like to continue this conversation today, but with a different perspective, namely an SPC angle; the case I would like to look at is the latest judgment in the Inegy® litigation (already reported on by others here and there).

Merck Sharp & Dohme Corp. (MSD) owns SPC No. FR05C0040 (FR’040) based on European patent EP 0720599 (EP’599) for the product “ezetimibe optionally in the form of its pharmaceutical acceptable salts in combination with simvastatin”. The originator’s product has been marketed as Inegy®.

At least four different lawsuits have taken place in France concerning this SPC, some of which have already been mentioned on this blog:

  • One involving Biogaran. MSD’s request for preliminary injunction was rejected in April 2018, and this rejection was confirmed in June 2018 (see this post), the reasons being that the SPC appeared to be invalid.
  • One involving Mylan and one involving Sandoz, in parallel. Here, MSD surprisingly obtained a preliminary injunction in March 2019 (see this post). This was however overturned on appeal in February 2020 (see this post), as the SPC appeared to be invalid.
  • One involving Teva, not yet mentioned on this blog.

Teva launched a generic version of Inegy® in April 2018 and initiated nullity proceedings against EP’599 and the FR’040 SPC. What was still known as the Paris TGI at that time rejected Teva’s nullity claim in October 2018, on the merits this time. By the way, this could be why a preliminary injunction was initially ordered against Mylan and Sandoz in March 2019 although it had been previously denied with respect to Biogaran in April-June 2018 (this piece of the puzzle was missing the last time I wrote on this topic).

Today’s decision is the ruling by the Paris Cour d’appel on Teva’s appeal against the October 2018 judgment. The first instance judgment has now been overturned, and the Cour d’appel has declared the FR’040 SPC invalid – consistently with its previous rulings of June 2018 and February 2020, but this time on the merits.

In the decision, the court rejected Teva’s objections to the validity of the basic EP’599 patent, but entertained Teva’s claim that the SPC itself is invalid under articles 3(a) and 3(c) of the SPC regulation. The reasoning is mostly in line with the February 2020 ruling already discussed here, so I may as well be brief.

EP’599 specifically claims:

  • a very broad family of compounds in claim 1 (in the form of a Markush formula);
  • ezetimibe as a specific compound in dependent claim 8; and
  • a pharmaceutical composition for the treatment or prevention of atherosclerosis, or for the reduction of plasma cholesterol levels, comprising an effective amount of the above compounds, alone or in combination with a cholesterol biosynthesis inhibitor selected from the group consisting of lovastatin, pravastatin, fluvastatin, simvastatin, CI-981, DMP-565, L-659,699, squalestatin 1 and NB598, in a pharmaceutical acceptable carrier (claim 17).

As a reminder, the FR’040 SPC is directed to the combination of ezetimibe and simvastatin.

The test of article 3(a) of the SPC regulation is whether the product was protected by the basic patent; and the test of article 3(c) of the SPC regulation is whether the product protected by the basic patent had already been the subject of a certificate.

In this case, MSD had already obtained an earlier SPC (No. FR03C0028) for ezetimibe itself.

The court reviewed the relevant case law of the CJEU, placing special emphasis on Sanofi, also known under the name of the other party, Actavis (C-443/12). In that case, based on a same patent, Sanofi had obtained a first SPC on the drug irbesartan based on a first MA, and then a second SPC on the combination of the drug irbesartan with a diuretic substance, HCTZ, based on a second MA. The CJEU ruled that, in this case, the grant of the first (mono) SPC prevented the grant of the second (combo) SPC.

The court found that the facts of the present case are very close to those of Sanofi – which, I think, is quite convincing.

Merck countered that, in Sanofi, the second compound HCTZ was not explicitly recited, only the therapeutic class (diuretics) was. But the court cited paragraph 30 of Sanofi: “it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent“. The court deemed that this reasoning applies in the present case.

Merck relied on two more recent CJEU rulings, namely Gilead (C-121/17) and Royalty Pharma (C-650/17), but the court found that these concern different situations and are not applicable.

The court then investigated “whether, from the perspective of the skilled person, based on common general knowledge at the filing date of the basic patent, and in the light of the description used to interpret the claims, according to article 69 EPC and its interpretative protocol, the product of the combination of ezetimibe and simvastatin, which is the subject-matter of the second SPC, is a product different from ezetimibe alone, protected by the patent as such“.

The court then turned to the description of the patent. Here is the central part of the reasoning:

The description of the patent, which uses the singular form to designate the invention, and uses the formulation “in yet another aspect” to present the combination of a hydroxy-substituted azetidinone, which is the subject-matter of the invention, with a cholesterol biosynthesis inhibitor, indifferently refers for hydroxy-substituted azetidinones alone and for their combination with a cholesterol biosynthesis inhibitor, to an effect “for the treatment and prevention of atherosclerosis or for the reduction of plasma cholesterol levels” without any indication of the specific therapeutic effect that distinguishes the product composed of ezetimibe alone from that comprising the combination of ezetimibe and a cholesterol biosynthesis inhibitor such as simvastatin. Therefore, the skilled person, who was aware in the prior art of the possibility of combining two anticholesterolemic drugs having different mechanisms of action (paragraph 8 of the patent – an HMG CoA reductase inhibitor and a bile acid sequestrant), and who was familiar with statins, and in particular simvastatin, which have been commonly used since the late 1980s for the treatment of hypercholesterolemia, will not consider that the combination of ezetimibe with simvastatin, or with the 9 other active ingredients also covered by claim 17 (in particular atorvastatin, for which Merck, on the basis of the same reasoning, filed a third SPC on September 12, 2014), constitutes a distinct product protected by the basic patent as such.

The underlying idea is that there is only one invention in the patent, namely ezetimibe itself (or the other compounds of the same class). The combination of ezetimibe with another, well-known, anticholesterolemic drug, is not patentably distinct from that invention, I would say (using U.S. vocabulary).

The court’s conclusion, as far as it is based on a review of the therapeutic effect of the products at stake, and of the actual contribution of the basic patent to the art, seems to make a lot of sense.

There is one portion of the reasoning that I do not feel comfortable with, though, namely the first part of the paragraph, in which the court pays attention to the expressions “the invention” (singular) and “in another aspect” – which, to me, do not really mean anything one way or the other.

Every patent attorney, sometimes every firm, has their own drafting style. This should have no impact on the extent of monopoly granted to a patent proprietor.

Let’s take an example. Imagine that, in the EP’599 patent, the combination of ezetimibe with another anticholesterolemic drug had been presented as being “a second invention“, or “a number of further inventions“. Should this have made a difference? Of course not. Simply naming a product as a distinct invention does not make it so.

“This is not a pipe” – can words change reality?

My fear is that some patent owners may take advantage of the judges’ over-reliance on contingent aspects of the specification to unduly extend the scope of their legal monopoly. Conversely, some may be hurt by innocuous, if unfortunate, syntactic structures.

Going back to the judgment at hand, the court decided that the case was clear and that there wasn’t any need for a reference to the CJEU. The FR’040 SPC was thus formally revoked.

According to reports published on other blogs, this is not the end of the story yet, as a final appeal in front of the Cour de cassation is already pending, at least in connection with the refusal to grant a PI against other generic companies. Presumably, this judgment is also going to be appealed.

As a final note, this seems to be one of these instances of fragmented European landscape. The decision acknowledges that preliminary injunctions have been granted and sometimes confirmed on appeal in Norway, the Czech Republic, Portugal, Belgium and Austria; and have been rejected (with sometimes a confirmation on appeal) in the Netherlands, Germany and Spain.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, September 25, 2020, SAS Teva Santé et al. v. Merck Sharp & Dohme Corp., RG No.18/23642.

No gift from Santen for SPC holders this year

Why on earth has Patent my French! not reported yet on Santen, I am sure dozens of readers have silently but reproachfully wondered.

After all, SPCs are a frequent topic on this blog, and it is not every day that a CJEU ruling shatters previously established practice. And based on a French referral, no less. Well, you may probably blame it on summertime torpor.

Luckily, Matthieu Dhenne does not mind heatwaves and has kindly sent me a contribution, which I am happy to reproduce below.

Santen owns European patent No. EP 057959306 for an ophthalmological emulsion in which cyclosporin is an active ingredient, plus a marketing authorization (“MA”) for the drug IKERVIS®, an eye drops emulsion containing said cyclosporin, which is intended for the treatment of severe keratitis in adult patients.

On the basis of these patent and MA, Santen filed an application with the INPI for a supplementary protection certificate (“SPC”) for a product entitled “cyclosporin for the treatment of keratitis“. The Director General of the INPI rejected this application, considering that the marketing authorisation on which it was based was not the first for cyclosporin, since another authorisation had already been previously issued for a SANDIMMUN® drug, which included this same active ingredient, in the context of post-graft medication. Faced with the applicant’s appeal against this rejection, the Paris Cour d’appel referred two questions to the CJEU, with a view to determining, in substance, whether an SPC could be granted for a new therapeutic application of a known drug.

The European High Court firstly considered that the definition of the notion of “product” in Article 1 b) of Regulation (EU) No. 469/2009 on SPCs is independent of the approved therapeutic application of said product, which therefore implies that it has a therapeutic effect of its own.

The Court concluded, secondly, that this strict interpretation of the concept of product implies that Article 3(d) of the Regulation must be understood as relating to the first marketing authorisation of any medicinal product incorporating the active ingredient.

The Santen judgment is thus an important turnaround.

As a reminder, an SPC extends the term of protection of a product that is a component of a medicine and is covered by a patent. Its purpose is to compensate for the length of time it takes to obtain a marketing authorization for a drug, because it is particularly significant. The central question raised in the Santen case was therefore whether this certificate only rewards the development of new active substances or whether it also rewards the search for new treatments for known substances.

Initially, the Court of Justice had consistently adopted a literal interpretation of the texts by excluding the grant of SPCs for new therapeutic applications (C-31/03, Pharmacia Italia; C-431/04, MIT; C-202/05, Yissum). However, it reversed its position with its judgment in the Neurim case on 19 July 2012 (C-130/11). It then held that an SPC could be granted despite an earlier marketing authorisation for the same active ingredient, so that the mere existence of a marketing authorisation for the veterinary medicinal product did not prevent an SPC from being granted for a different application of the same product, provided that the said application fell within the scope of protection of the basic patent. However, the Court later restricted the scope of this reversal in Abraxis (C-443/17), by rejecting the protection of new formulations of a known product.

Nevertheless, the interpretation of the Neurim case law has given rise to considerable debate as to whether its application was limited to the case at hand, i.e. from veterinary use to human use or vice versa, or whether Neurim meant that any new therapeutic application was protectable by a SPC. National patent offices took different positions on this question.

In Santen, the Court of Justice unambiguously put an end to SPCs for second therapeutic applications and thus to the legal uncertainty surrounding them.

SPC case law is like a Moebius strip: sometimes, a long and winding path may bring you back to where you started from.

The judgment is thus part of a trend towards a literal reading of Regulation (EU) No 469/2009, in particular after the Abraxis case mentioned above, and should be reaffirmed in the pending Novartis case (C-354/19), which relates to the question whether a new SPC can be granted to the holder of a first SPC concerning the same active ingredient.

This ultimately brings us back to the idea, once developed by Michel de Haas in connection with patents, that a new treatment is not protectable because it was already inherent in the first product.

While legal certainty undoubtedly remains the first social value to be attained, it should not be overlooked that it is achieved here at the cost of a significant reduction in the incentive for research in the pharmaceutical sector. However, despite the insecurity, many SPCs have been granted and exploited in accordance with previous case law and some companies have been built based on the economic model of re-using known drugs (developers of personalized drugs or orphan drugs, or companies using data and artificial intelligence to identify new therapeutic uses, for example). Therefore, although it increases legal certainty, this judgment is nonetheless a loss for many players in the sector, who will ultimately no longer have the incentive to invest in the development of new applications for known medicines.

But perhaps this restrictive approach of the CJEU should be seen as an appeal to the Commission since, as the Advocate General pointed out in Santen, it is for the European Union legislator alone, and not the Court, to decide to extend the scope of protection of SPCs?

Thank you Matthieu for this nice summary. There is no doubt that this ruling must have disappointed a number of stakeholders.

Now, on a purely legal standpoint, I am struck by the unusual clarity of the ruling.

CJEU judgments on SPCs have had this tendency to form an undecipherable patchwork of rules. When a new one is issued, it is generally not an easy task to figure out whether it reverses or qualifies a previous one, or whether it should be interpreted as being limited in scope to very specific facts. This was in particular the problem with Neurim, which was difficult to reconcile with Yissum et al.

Contrast this with the quasi-crystal-clear order in Santen:

[…] A marketing authorisation cannot be considered to be the first marketing authorisation, […] where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.

Even more remarkable is the way the court explicitly repelled its previous ruling at paragraph 53:

It follows that, contrary to what the Court held in paragraph 27 of the judgment in Neurim, to define the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of Regulation No 469/2009, there is no need to take into account the limits of the protection of the basic patent.

This got me thinking though.

Now that we know for a fact that the CJEU sometimes sets aside rules that it previously laid out itself, isn’t this an incentive for litigants to try to challenge other seemingly well-established rules?

Neurim was issued only eight years ago, and it has now already gone the way of the dodo, so why not try this approach again in the future? In other words, is it at least conceivable that an unusually clear ruling may have ultimately increased overall legal uncertainty?

Let’s hope that the next SPC regulation will be intrinsically clearer and leave less room for diverging interpretations.


CASE REFERENCE: CJEU, July 9, 2020, C-673/18, Santen SAS v. Directeur général de la propriété industrielle

Time for the third round

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

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

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

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

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

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

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

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

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

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

Bam! Wham! … and Pow!

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

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

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

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

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

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

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

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


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