EU legal and regulatory update October 2022

Judgment of the court (ninth chamber) irnova ab v flir systems AB

ECJ 8 September 2022, Case C-399/21

In a judgment of 8 September 2022, the Court of Justice rules on the determination of the scope of application of Article 24 (4) of the Brussels Ia Regulation, in the presence of patent applications filed in States outside the Union and patents obtained in one of them.

A dispute in front of a Swedish court between two Swedish companies concerning contested rights on inventions protected by American patents or which have given rise to patent applications in the United States and in China.

The court before which the case was brought declared that it lacked jurisdiction to determine the inventor, but its decision that it lacked jurisdiction was challenged.

The case was referred to the Court of Justice, which led it to consider the scope of Article 24 (4) of Regulation (EU) No 1215/2012 of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters: “Only the following courts of a Member State shall have jurisdiction, irrespective of the domicile of the parties: (...) in matters relating to the registration or validity of patents, trademarks, designs and other similar rights which are the subject of an application or registration, whether the question is raised by way of an action or a defense, the courts of the Member State in which the application or registration has been made, has been effected or is deemed to have been made under an instrument of the Union or under an international convention (...) ".

The question is whether Article 24 should be interpreted as applying to a dispute to determine, in the context of an action based on alleged inventorship or co-inventorship, whether a person is the owner of the right to inventions covered by patent applications filed and patents granted in third countries.

In order to answer this question, it is necessary to determine whether the dispute in question falls within the scope of the Regulation, when the only foreign elements concern States outside the Union, namely patents applied for or granted in the United States and in China, the rest of the dispute relating to two companies having their seat in the same Member State.

The Court states that:

“27 In that regard, it should be recalled that the Court has already held that for the jurisdictional rules laid down by the Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (‘the Brussels Convention’) to apply at all the existence of an international element is required (judgment of 1 March 2005, Owusu, C-281/02, EU:C:2005:120, paragraph 25).

The Court considers that the dispute falls within the scope of the Brussels 1a Regulation.

The Court then considered whether or not Article 24 (4) was applicable to the case.

The Court reminds that the question here in this case is to determine whether one of the Swedish companies involved is to be considered the owner of the right to the inventions concerned or to a part thereof:

“42 In this case, the main proceedings relate not to the existence of the deposit of a patent application or the grant of a patent, the validity or lapse of a patent, or indeed an alleged right of priority by reason of an earlier deposit, but to whether FLIR must be regarded as being the proprietor of the right to the inventions concerned or to a portion of them.”

The Court remind the three following points:

“43 It must be pointed out, first, that the question of who owns the inventions concerned, which encompasses the question of who is their inventor, relates not to an application for an intellectual property right or that right as such, but to their subject matter. Although the Court has found, as has been recalled in paragraph 41 of the present judgment, that the question of the individual estate to which an intellectual property right belongs is not, generally, closely linked in fact and law to the place where that right has been registered, which would justify the application of the rule of exclusive jurisdiction laid down in Article 24(4) of the Brussels Ia Regulation, that consideration also applies, at the very least, where that question relates solely to the subject matter of that right, namely the invention.

The Court answers to the question ruling that “Article 24(4) of Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, must be interpreted as: not applying to proceedings aimed at determining, in the context of an action based on alleged inventor or co-inventor status, whether a person is the proprietor of the right to inventions covered by patent applications deposited and by patents granted in third countries.”

Facts and procedure

The company Janssen-Cilag markets an originator medicinal product constituting a fentanyl transdermal device called « Durogesic ».

According to the judgment under appeal (Paris, 11 July 2019), by decision no. 17-D-25 of 20 December 2017, the French Competition Authority considered that Janssen-Cilag had, during 2008, unduly interfered in the national procedure for examining marketing authorisation (MA) applications for the specialties produced by Ratiopharm.

In particular, Janssen-Cilag intervened in an unfounded legal manner with the French Health Products Safety Agency (AFSSAPS), which has since become the National Agency for the Safety of Medicines (ANSM), in order to convince the latter to refuse to grant generic status at national level to Durogesic’s competing specialities, despite the fact that it had obtained this status at European level.

According to the competition authority, once these authorizations granted, Janssen-Cilag, until mid-August 2009, disseminated a discourse denigrating Ratiopharm’s specialties to health professionals working in hospitals and in towns.

In view of these elements, the French competition authority imposed a financial penalty on Janssen-Cilag and Johnson and Johnson, as parent company, for abuse of a dominant position falling within the scope of Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article L. 420–2 of the French Commercial Code.

The Paris Court of Appeal reduced the amount of the penalty.

The French Supreme Court confirms the analysis made by the Paris Court of Appeal on the legality of the behavior of the laboratory princeps which intervened in the process of the authorization of a generic medicinal product with the aim of delay the entry on the market of the medicinal product.

The French court sets out to identify the limits of a dominant company’s freedom of expression in order to sanction a phenomenon of capture by the regulator in the pharmaceutical sector.

The arguments

On the first plea

Janssen-Cilag and Johnson and Johnson complained that the judgment rejects the plea for annulment of the Authority’s decision on the grounds that the Authority lacked jurisdiction to assess the legal arguments developed by Janssen-Cilag before AFSSAPS and, by way of reversal of that decision, that it imposes on them a financial penalty of 21 million euros, on the grounds that: “1°/that the Director General of AFSSAPS, to whom Articles L. 5121–10 and R. 5121–5 of the Public Health Code confer exclusive competence to decide on the identification of a medicinal product as a generic speciality and on its registration in the register of generic groups, has sole competence to assess, under the control of the administrative judge, the validity, in the light of the standards of the Public Health Code, of the legal and scientific arguments raised by a pharmaceutical company in the context of the preparatory investigation for the issuing of such decisions”.

The Court’s response

The judgment recalls that the Authority, which may be seized of any practice likely to constitute an infringement of the competition rules, whatever the sector of activity concerned, has the duty, in order to assess their possible anti-competitive nature, to place the offending practices in their legal context - which differs according to the market on which the practices take place - and in their factual context. He concluded that the Authority had not exceeded its powers by determining, in advance, the legal and factual framework in which Janssen-Cilag’s intervention with the AFSSAPS took place, without considering itself bound by the legal analysis that the AFSSAPS or its Director General had followed in the case, the question of whether, in so doing, it had misinterpreted the applicable provisions or misjudged the factual context relevant to the assessment of the internal legality of the contested decision.

In light of these statements, findings and assessments, which show that scientific assessments were not required, in the case in point, to analyze the legal regulations in question and that the Authority had not made any such assessments, the Court of Appeal, which did not disregard either the powers and duties of AFSSAPS and its Director General, nor the separation of powers, nor the case law of the CJEU on the respective competences of the health authorities and the competition authorities, rightly decided that the Authority was competent to qualify the conduct of which Janssen-Cilag alone was accused, in the light of Article 102 of the TFEU and Article L. 420–2 of the Commercial Code, of which it was the only authority competent to do so. 420–2 of the French Commercial Code, whose compliance it is responsible for verifying and, where appropriate, sanctioning practices that contravene them.

The plea is therefore unfounded.

The second plea

Janssen-Cilag and Johnson and Johnson complain that the judgment rejected the plea for annulment of the Authority’s decision on the grounds of failure to notify the Minister for Health of the investigation and, by way of reversal of that decision, imposed on them a financial penalty of EUR 21 million, on the grounds that: “1°/that the judge must, in all circumstances, observe the principle of contradiction; that after having noted that the Authority’s decision had been taken at the end of an irregular procedure with regard to the provisions of Article L. 463–2 of the French Commercial Code, the judge must also observe the principle of contradiction. 463–2 of the French Commercial Code, as the rapporteur or deputy rapporteur general had not notified the report to the Minister for Health, the Court of Appeal raised the defence of its own motion based on the application of Article 70 of Law No 2011–525 of 17 May 2011 and the principle established by the Conseil d'Etat according to which “a defect affecting the conduct of a prior administrative procedure, followed on a compulsory or optional basis, is likely to taint the decision taken with illegality only if it emerges from the documents in the file that it was likely to influence, in the case in point, the meaning of the decision taken or that it deprived the interested parties of a guarantee” (CE, Ass., 23 December 2011, [P], No. 335,477), and then considered that the failure to notify the report to the minister in charge of health had not deprived the parties involved of any guarantee and had not been able to influence the meaning of the decision since the Authority already had the fullest possible insight into the legal and scientific framework following the hearing of the AFSSAPS and ANSM officials, so that the absence of an opinion from the Minister of Health could not, in this case, have deprived it of elements of understanding of the said framework or, consequently, have an impact on its interpretation; that by refraining from reopening the debates to provoke contradictory explanations from the parties on this plea raised ex officio, the Court of Appeal violated Article 16 of the Code of Civil Procedure.”

The Court’s response

Firstly, having found that the Minister for Health was an interested minister within the meaning of Article L. 463–2 (1) and (2) of the Commercial Code and that the procedure followed was, in the absence of notification to that minister of the report drawn up by the services of the Commission, a breach of the law. 463–2, paragraphs 1 and 2, of the Commercial Code and that the procedure followed was irregular because the minister had not been notified of the report drawn up by the investigating authorities, the Court of Appeal, which was seized of a plea concerning the external legality of the Authority’s decision arguing that the penalty for this failure to notify was nullity, Without indicating the text from which this resulted, the Court of Appeal noted that no legal or regulatory provision of the Commercial Code specified the consequences of this irregularity, from which it rightly deduced that it was up to the Court to determine them itself.

Since the sanction for the procedural defect noted was therefore part of the debate, it was without disregarding the principle of contradiction that, having held that the failure to notify the report could be analysed as a failure to carry out a mandatory consultation within the meaning of Article 70 of Law No. 211–525 of 27 May 2011, which was applicable at the time, it applied the rules set out in the Conseil d'Etat’s judgment of 23 December 2011 [P], req. No. 335,477, and sought to ascertain whether the omission of the formality in question was likely to have had an influence on the decision taken.

Secondly, the judgment states that the hearings of AFSSAPS and ANSM officials, which were held during the investigation, had sufficiently enlightened the Authority on the legal and scientific framework in which the practices in question had been identified, so that the absence of an opinion from the Minister for Health could not, in this case, deprive the Authority of elements of understanding of this framework or have an impact on its interpretation.

On the basis of these statements and assessments alone, leaving aside the excessive grounds criticized in the fourth part, the Court of Appeal took the view, in its sole discretion, that the omission of the required formality could not have affected the meaning of the Authority’s decision, from which it concluded that there was no reason to annul it.

The remainder of the plea is unfounded and partly inoperative.

On the third plea

Janssen-Cilag and Johnson and Johnson complain that the judgment rejected the grounds for annulment of the Authority’s decision on the grounds that the Authority had committed errors of law in determining the regulatory framework in which the intervention of the Janssen-Cilag laboratory with AFSSAPS had taken place, resulting in an inaccurate characterization of that intervention as ‘legally unfounded’, and that it imposed a financial penalty on them, on the grounds that:"1°/under Article 168 (7) of the TFEU, “Union action shall be taken with due regard for the responsibilities of the Member States for defining their health policy and for the organisation and delivery of health services and medical care” and “the responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them”; that, moreover, Article 10 of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, in its consolidated version resulting from Directive 2004/27/EC, gives a definition of the concept of “generic medicinal product”, substituted for that of “essentially similar speciality”, which is valid only “for the purposes of this Article”, i.e. for the sole purpose of determining the content of the dossier to be submitted to the health authorities with a view to obtaining marketing authorisation, Article 4 (3) of the Directive also specifies that the provisions it contains “shall not affect the powers of the authorities of the Member States as regards either the pricing of medicinal products or their inclusion in the scope of national health insurance systems on the basis of health, economic and social conditions, in particular as regards reimbursement";”.

The Court’s response

The judgment states first of all that Union law merely provides for the possibility of granting a marketing authorisation to a medicinal product recognised as the generic of a reference medicinal product or of recognising, under a mutual recognition procedure, a marketing authorisation issued by a Member State in accordance with the abridged procedure laid down for generic medicinal products.

On the basis of these statements and assessments alone, leaving aside the excessive grounds criticised in the third part, the Court of Appeal, which did not disregard any of the principles or texts relied on by the plea, but on the contrary, in accordance with the principle of the effectiveness of Union law, interpreted national texts in the light of that law in such a way as to ensure that all the legislation in question was consistent, ruled correctly.

The remainder of the plea in law is unfounded and partly unfounded.

On the fourth plea

Janssen-Cilag and Johnson and Johnson complain that the judgment rejected the pleas for annulment of the Authority’s decision on the grounds that the conditions required for an intervention before a public authority to constitute an abuse of a dominant position had not been met and that Janssen-Cilag’s intervention before AFSSAPS was legitimate, and that it imposed a financial penalty on them, on the grounds that:"1°/that the simple fact, on the part of an undertaking in a dominant position, of submitting, under conditions excluding any manipulation by the provision of misleading factual information, a legal argument contrary to existing or supposedly positive law to an administrative authority that is fully competent to assess the merits of the argument itself is merely the normal exercise of the fundamental freedom of expression that must govern the dialogue between undertakings and the administrations to which they belong and cannot be regarded as an abuse within the meaning of Article 102 of the TFEU and Article L. 420–2 of the French Commercial Code; that by affirming, however, that the fact that a dominant company supports before an administrative authority a legal analysis whose falsity is already apparent from the state of the law is likely to constitute an abuse of a dominant position and does not fall within the legitimate exercise of the aforementioned fundamental freedoms, since it turns out that the debate thus opened before the said authority is likely to hinder the free play of competition, the Court of Appeal violated Articles 102 of the TFEU and L. 420–2 of the Commercial Code, together with Article 10 of the Convention for the Protection of Human Rights and Fundamental Freedoms and Articles 11 and 13 of the Charter of Fundamental Rights of the European Union;”.

The Court’s response

After recalling that it may be an abuse for an undertaking to support a legal analysis which is already wrong in the law, the judgment states that, while an undertaking in a dominant position is entitled to respect for its freedom of expression and must be able to propose a legal analysis to a public authority in a context where the interpretation of the legal and regulatory texts is still uncertain, the intervention by an undertaking in a dominant position in the decision-making process of a public authority, consisting in raising a legal analysis before that authority, is not a legitimate use of that freedom, The legitimate use of this freedom does not include intervention by an undertaking in a dominant position in the decision-making process of a public authority, consisting in raising before the authority a legal analysis which it knows or should have known is contrary to the interpretation of the applicable texts, when the debate thus opened before the authority concerned is likely to hinder the free play of competition on the dominated market. It noted that the delay in registering Ratiopharm’s specialities in the register of generic groups postponed the implementation of the right of substitution, which is one of the main factors in the acquisition of market share by generic manufacturers. It also notes that any challenge before a health authority, due to the responsibility of such an authority, in the context of a certain judicialization of health issues, almost inevitably leads to a slowing down of the decision-making process, which no pharmaceutical laboratory can ignore. He deduced that in this case, it was the very fact of raising a legally unfounded debate that was likely to produce an anti-competitive effect. In light of these statements and assessments, which show that the conduct in question was not part of a debate of general interest relating to the health consequences of the entry of a new medicinal product onto the market, but was part of a strategy aimed at delaying the development of competing products on the market, the implementation of which, in the circumstances specific to the context of which the Commission has noted the characteristics, could, on its own, produce this anti-competitive effect, regardless of the exclusive decision-making capacity of the health authority, while the state of the law that had to be known by the dominant operator resulted from a decision of the Conseil d'Etat, even if it had been a single decision, which established the consequences, as of right, of the registration of a product in the register of generic medicines, of a marketing authorisation for a generic drug, regardless of the fact that it was issued solely on the initiative of the national authority and not in execution of a decision of the European Commission, the law thus interpreted making no distinction as to this effect according to the nature of the authority that took such a decision, the Court of Appeal, which did not disregard the principle of free scientific research and did not infringe Janssen-Cilag’s right to freedom of expression in an unjustified and disproportionate manner in the light of the need to preserve public policy on competition, which guarantees the right of undertakings to undistorted competition, which is also protected by the Convention for the Protection of Human Rights (see, mutadis mutandis, Ashby Donald and Others v. France, No. 36,769/08, §§ 39–45, 10 February 2013), rightly held that the company’s conduct, which had not been limited to making scientific recommendations on how to substitute generics for originator drugs, which it was entitled to do, and regardless of whether the Director General of AFSSAPS had, the fact that the Director General of AFSSAPS had, pending further information, reserved his decision on the inclusion of the specialties concerned in the repertoire of generics, was, because of its particular responsibility arising from its dominant position on the market in question, an abuse of that position.

The sixth plea

Janssen-Cilag and Johnson and Johnson complain that the judgment imposes on them a financial penalty of 21 million euros, whereas “1°/the imposition of a penalty based on the retroactive application of a new interpretation of Article 102 TFEU and Article L. 420–2 of the French Commercial Code leading to the imposition of a fine of EUR 21 million is contrary to the principles of legality of offences and penalties and of legal certainty 420–2 of the French Commercial Code, which leads to consider as an abuse of a dominant position a behaviour which, at the time of its commission, the decisional practice of the EU Competition Authority could reasonably suggest did not fall under the prohibition set out in these texts; that at the time of the disputed facts, only the Commission’s AstraZeneca decision of 15 June 2005 had ruled on the question of whether interventions by a pharmaceutical laboratory before a national administrative authority could fall within the prohibition of abuses of a dominant position, and that in respect of the first abuse identified the Commission had determined that the pharmaceutical company had submitted factually inaccurate and misleading information to the administrative authority in charge of patents with a view to obtaining undue decisions to extend the duration of its industrial property rights, while for the second abuse the Commission had sanctioned the behaviour of a laboratory which consisted in submitting to health authorities, which had no room for manoeuvre to refuse to grant them, requests for cancellation of its own marketing authorisations with the sole aim of hindering the arrival on the market of generic medicines;”

The Court’s response

The judgment first states that the fact that a practice is new does not necessarily mean that its classification as an abuse of a dominant position and its punishment are based on a new, retroactive interpretation of Article 102 TFEU and Article L. 420–2 of the Commercial Code. It notes that it has been constant since the Commission’s decision of 15 June 2005 on the practices implemented by AstraZeneca that the intervention of an undertaking in a dominant position in the decision-making process of a public authority is likely to constitute an abuse of a dominant position and that, as it relates to the medicinal products sector, this decision was necessarily known to Janssen-Cilag. He also noted that a decision of the Competition Council of 3 November 2005 had qualified as an abuse of dominant position the fact that an economic operator in this situation had intervened with a public authority so that it would refuse a draft agreement that a competitor was negotiating with one of its clients, without being accused of having communicated erroneous information, but only of having exerted pressure on the supervisory authorities of its competitor. He concluded that any undertaking in a dominant position is on notice that its intervention in the decision-making process of a public authority may, depending on the circumstances of the case, be qualified as an abuse of a dominant position and that the conviction was not based on a new interpretation of the provisions on which the proceedings were based. It then notes that, with regard to the denigration of a competitor’s products, it is settled practice and case law that such behaviour by an undertaking in a dominant position may be qualified as an abuse of that position. It also holds that a pharmaceutical laboratory, which owns an originator drug on whose market it holds a dominant position, and which reopens, before an authority that is not competent to hear the matter, a debate that has been definitively closed as to the generic quality of competing products, but which it knows will delay competition with its originator by these specialities, is necessarily aware that it is employing means that are alien to competition on the merits and that it is committing an abuse of a dominant position.

The judgment then held that, since account had already been taken, at the stage of the assessment of the cyclical and structural consequences of Janssen-Cilag’s conduct, of the fact that the registration procedure had also been slowed down by the legitimate communication relating to the risks associated with substitution during treatment, the basic amount of the fine should be reduced by the amount of the fine, so that the basic amount of the penalty, set in consideration of the seriousness of the facts and the damage to the economy, had to be reduced compared to that set by the Authority, there is no reason to consider that the intervention, partly legitimate, of Janssen-Cilag with AFSSAPS constitutes a mitigating circumstance.

In the light of these findings and assessments, which show that the prohibition of the conduct at issue was accessible and reasonably foreseeable for an operator such as Janssen-Cilag, it is rightly and without disregarding the subject matter of the dispute, or any of the principles or texts invoked by the plea, and by applying the criteria for the imposition of the penalty defined by Article L. 464–2 of the Commercial Code, the Court of Appeal held that the novelty of an anti-competitive practice, the various possible manifestations of which, given their variety and complexity, are not exhaustively listed either in Union law or in domestic law, does not prevent it from being sanctioned.

The plea is therefore unfounded.

For these reasons, the Court dismisses the appeal and orders Janssen-Cilag and Johnson and Johnson to pay the costs; pursuant to Article 700 of the Code of Civil Procedure, orders Janssen-Cilag and Johnson and Johnson jointly and severally to pay the President of the Competition Authority the sum of EUR 3000.

The remainder of the plea is unfounded and partly inoperative.

SUPPLEMENTARY PROTECTION CERTIFICATE - ARTICLE 3 A AND 3C OF REGULATION EC N°469/2009 - PATENT CO-OWNERSHIP

Appeal Court of Paris (CA PARIS Pôle 5 1er ch 19 January 2021, n°18/10,540, ONO PHARMACEUTICAL CO Ltd and Tasuku H/INPI)

The Appeal Court of Paris seized by an appeal against a rejection decision of INPI dated of 2 March 2018 analysed Articles 3a and 3c of Regulation (EC) No 469/2009 (GDPR 2021, No 1154, III, p. 1) and relying on the case law of the CJEU (CJEU, 12 Dec. 2013, aff. C-493/12, Eli Lilly. - And CJEU, 30 Apr 2020, Case C-650/17, Royalty Pharma) dismisses the action.

ONO PHARMACEUTICAL, a company incorporated under Japanese law, and Mr H, a professor and researcher in medicine and winner of the Nobel Prize for Medicine (2018), jointly filed an application for a supplementary protection certificate (SPC) No 15C0088 for the product nivolumab on 15 December 2015 under Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products.

This application was based on European Patent No. EP 03741154.3 filed on 2 July 2003, published as EP 1 537 878 and granted on 22 September 2010, under the title “Immunostimulant compositions".

Patent EP 878 is co-owned by ONO and Professor H. By decision dated 2 March 2018, the Director General of INPI rejected the application for the SPC No. 15C0088, on the basis of Article 3, c) of the above-mentioned Regulation (in this sense INPI, dec, 10 June 2020, SPC No. 16C1009, registered in the GNI on 11 June 2020 under No. 0236294), on the grounds that the product, which was the subject of the SPC application, had already been the subject of an SPC for the benefit of the company ONO, and of Article 3, a) of the same regulation, on the grounds that the product was not protected by the basic patent No. EP 878.

According to the Court of Appeal, the SPC application for the product “nivolumab” was rightly rejected on the basis of Article 3(c) and (a) of Regulation (EC) No 469/2009 on SPC for medicinal products.

It follows from Article 3(c) of this Regulation and Article 3 (2) of Regulation (EC) No 1610/96 that if several SPCs can be obtained for the same product on the basis of different basic patents, it is on condition that these SPCs are issued to separate holders (in this sense, CA Paris, Pôle 5, first ch, 19 Dec. 2017, No 2017/07,741, Medivir AB c/INPI (B20170192): PIBD 2018, No 1087, III, p. 76).

The court, confirming INPI’s decision, considers that obtaining a first SPC, even based on a co-owned patent, is an obstacle to a second SPC application.

SUPPLEMENTARY PROTECTION CERTIFICATE - ARTICLE 3 A OF REGULATION EC N°469/2009 - NOTION OF “PRODUCT PROTECTED BY A BASIC PATENT

Appeal Court of Paris CA PARIS, Pôle 5, ch. 2, 15 oct. 2021, no. 17/04,327, 17/04,365, 17/04,366, 17/04,369 and 17/04,362

The Paris Court of Appeal ruled again on the notion of “product protected by a basic patent” within the meaning of Article 3, a) of Regulation (EC) No 469/2009.

This same court by judgments of 1 June 2018, decided to stay the proceedings until the judgment to be delivered by the Court of Justice of the European Union (CJEU) in a case C-650/17, following a preliminary question asked by the German Federal Patent Court.

According to the Royalty Pharma judgment (CJEU, 30 Apr 2020, Case C-650/17) when the product, subject of an SPC, is not explicitly mentioned in the claims of the basic patent, it is necessary to verify whether it is necessarily and specifically referred to in one of the claims.

Two cumulative conditions must be met:

The Court of Justice has clarified that a product developed after the filing or priority date of the basic patent, as a result of an independent inventive step, does not fall within the scope of protection conferred by the patent.

In this case, Royalty Pharma Collection Trust filed SPC applications based on Regulation 469/2009 for the products “sitagliptin”, “saxagliptin”, “linagliptin”, “alogliptin” and “vildagliptin”. The basic patent relied upon in this application is European Patent No EP00119496.8 filed on 24 April 1997, published as EP1084705 (EP 705) and granted on 25 June 2014 under the title “method for lowering blood glucose levels in mammals".

The application also refers to Community marketing authorizations (MA) granted in 2007, 2009, 2011, 2013 for pharmaceutical specialties belonging to the same family of inhibitors having as active ingredients “sitagliptin”, “saxagliptin”, “linagliptin”, “alogliptin” and “vildagliptin” respectively.

The examination procedure initiated by the INPI resulted in a decision to reject the SPC application on the grounds that the product, which was the subject of the application, is not protected by the basic patent and thus does not meet the condition for obtaining an SPC under Article 3(a) of Regulation (EC) No 469/2009: “sitagliptin”, “saxagliptin”, “linagliptin”, “alogliptin” and “vildagliptin”) is not mentioned in the claim wording of the invoked basic patent according to the case law of the CJEU (CJEU, 24 Nov. 2011, Case C-322/10, Medeva), as claims one and two do not address it in a necessary and specific manner (CJEU, 12 Dec 2013, Case C-493/12, Eli Lilly).

Applying the case law of the CJEU, the Court of Appeal on 15 October 2021 dismissed in all five judgments the appeals against the decision of the Director General of INPI which had rejected the SPC applications filed by Royal Pharma Collection Trust, relating to sitagliptin, “saxagliptin”, “linagliptin”, “alogliptin” and “vildagliptin".