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February 2020

On 23 January 2020, the Advocate General issued his opinion in the case Santen SAS/Directeur général de l’Institut national de la propriété intellectuelle (INPI) in the case C-673/18.

The opinion is a very interesting and valuable read – although currently only available in French and some other languages – as it calls on the CJEU to either strictly follow its case law as most recently expressed in Abraxis (C‑443/17; see our previous article) and to completely abandon Neurim (C‑130/11), or to be brave enough to follow Neurim by redefining some definitions.

The facts

Santen SAS (Santen) is a pharmaceutical laboratory specialising in ophthalmology. Its patent EP 057959306 (basic patent) relates to oil-in-water emulsion with low concentration of cationic agent and zeta-positive potential and has 27 claims. It will expire on 11 October 2025.

Santen obtained a marketing authorisation issued by the European Medicines Agency (EMA) on 19 March 2015 for the medicine Ikervis, an emulsion eye drops with the active ingredient cyclosporine, for the treatment of severe keratitis in adult patients with dry eyes which do not improve despite the instillation of tear substitutes.

On 3 June 2015, on the basis of this basic patent and the marketing authorisation (MA), Santen filed a SPC application in France for a product called "Ciclosporine collyre en emulsion", which it subsequently renamed "Ciclosporine for use in the treatment of keratitis".

By decision of 6 October 2017, the Director of the French patent office (INPI) rejected that application, on the ground that a marketing authorisation had already been issued on 23 December 1983 for a medicinal product called 'Sandimmun' – the active substance of which was also cyclosporine – and, consequently, that the marketing authorisation at issue in the main proceedings was not the first marketing authorisation according to Article 3(d) of Regulation No 469/2009.

The INPI argued that the conditions of the Neurim judgment, relied on by Santen to argue that the medicinal product Ikervis included a "new application" of cyclosporin allowing the grant of a SPC, are not met.

Firstly, the basic patent relied on did not only protect a new application of cyclosporin (claims 23 and 24), but also (and principally) did not protect a new application of cyclosporin, an oil-in-water ophthalmic emulsion of submicronic type comprising an active substance, including cyclosporin (claims 1 to 21, 25 and 26).

Secondly, that it had not been shown that the medical application of the marketing authorisation constituted a 'new therapeutic application', within the meaning of the Neurim caselaw, in relation to the Sandimmun features, both relating to the treatment of inflammations in the ophthalmological field.

Santen in contrast argues that the drug Ikervis is a different and novel application of cyclosporin, within the meaning of the Neurim judgment, because:

• none of the earlier formulations of the medicine Sandimmun is an oil-in-water emulsion as claimed in the basic patent
• the medicinal products Sandimmun and Ikervis do not have the same therapeutic indication and they treat different diseases
• even if, in both cases, the cyclosporin exerts, inter alia, an anti-inflammatory function, it is to treat different parts of the eye and different diseases, and
• their dosage and mode of administration are different and not interchangeable.

Santen appealed against the decision of the INPI.

Referral by the Cour d’Appel de Paris

In the following, the Cour d’appel de Paris (Appeal Court, Paris) referred the following questions in its decision of 9 October 2018:

Must the concept of 'different application', within the meaning of the Neurim judgment, be understood to mean strictly:

• That it is limited to the sole case of human application following veterinary application?
• Does it relate to an indication falling within a new therapeutic field, in the sense of a new medical application, compared to the previous MA, or a medicinal product in which the active ingredient has a different mode of action compared to the earlier drug being subject to the first MA?
• More generally, in the light of the objectives of the SPC Regulation to implement a balanced system that takes into account all the interests at stake, including health interests, are more demanding criteria needed than those used to assess the patentability of the invention?
• Or, on the contrary, should it be understood broadly (ie including not only different therapeutic indications and diseases, but also formulations, dosages and/or different modes of administration)?

Does the concept of "application falling within the scope of protection conferred by the basic patent" in the sense of the Neurim decision imply that the scope of the basic patent should be consistent with that of the MA and, consequently, be limited to the new medical use corresponding to the therapeutic indication of the said MA?

The opinion of the Advocate General

The Advocate General (AG) explains in a very well founded analysis that the Neurim decision is not in line with the previous and subsequent CJEU case law with the result that new therapeutic indications are not suitable for being granted supplementary protection.

However, if new therapeutic indications should benefit from supplementary protection in order to fulfil the purpose of the SPC Regulation to promote health and pharmaceutical research, several terms of the SPC Regulation will need to be construed and applied differently compared to the CJEU case law so far.

The inconsistency in the present case law

The AG argues the three earlier decisions Farmaitalia ((C‑31/03), MIT (C‑431/04) and Yissum (C‑202/05) have set up a strict line of interpreting the term "product" which has been circumvented by the Neurim decision. However, the most recent Abraxis decision (C‑443/17; see our previous article) in contrast confirms the earlier strict case law.

The AG continues to explain that he does not believe that Neurim could be read as an exception and that the inconsistency in the case law to which he gave place can be solved by restricting its scope to a kind of empty shell. Such an operation would betray the spirit and the wording of that judgment, without eliminating any contradiction within the case law of the Court. The Court is therefore called upon, in the context of the present case, to carry out a clear choice, either by revising the Neurim judgment or by widening the tight meshes of the notion of term "product" currently retained in the case law.

Giving up on Neurim and strictly interpreting "product" – the preferred option of the AG

On the one hand, the teleological approach adopted in the Neurim judgment may also apply to Article 3(c) of Regulation No 469/2009, the purpose of which is to avoid the same product being subject to several successive SPCs, with a risk of going beyond the total period of protection provided for in Article 13 of the SPC Regulation. This question is currently subject to another referral case from the Stockholm Court of Appeal (C354/19 – Novartis).

The question in this case is whether the aim of encouraging research into new applications products already known, underlying inter alia, the Neurim judgment, could not justify that an applicant who has already been issued a SPC for a product protected as such by a patent in force is granted a certificate for a new application of that product if this new application constitutes a new protected therapeutic indication specifically protected by a new basic patent.

On the other hand, the interpretation of the concepts of "product" and "first marketing authorisation for the product" which emerges from a reading of Article 3(d) of Regulation No 469/2009, as adopted in Neurim necessarily affects other fundamental provisions of this Regulation:

"In Article 13 SPC Regulation, it is ruled that the mechanism for calculating the duration of the SPC from the first MA in the Union, in order to allow the simultaneous termination of any SPC issued for the same product.

Also, Article 4 of the SPC Regulation, sets out the subject matter of the protection conferred by the SPC specifying that it extends only to the "product" covered by the marketing authorization of the corresponding drug, "for any use of the product, in as a medicinal product, which has been authorised before the expiry of the certificate".

Furthermore, Article 5 of the SPC Regulation according to which a SPC issued in connection with a covered product as a medicine subject of a MA confers, "upon expiry of the patent, the same rights as those that were conferred by the basic patent for that product, within the limits of the protection of the basic patent conferred by that patent as set out in Article 4 [of] Regulation [No 469/2009]"."

However, in the cases envisaged by Neurim, where a SPC is issued for a new use of an already known active ingredient, the concept of "product covered by the marketing authorisation" (Article 4) must necessarily be interpreted as covering only the new use of that active ingredient. In such case, the purpose and effects of the SPC must be delimited, which does not appear to be in accordance with Article 4 and which seems to complicate the application of the test emerging from Article 5 of the SPC Regulation.

Finally, the grounds of the Neurim decision are likely to apply also in cases where the subject-matter of the basic patent is not a new use of an old product, but a process of an already known product or a new composition containing a novel already known product.

Although such transposition is theoretically possible, it would, on the one hand, broaden the scope of application of Article 3 (d) of the SPC Regulation by rewording that provision and, on the other hand, it would be contrary to the position taken by the Court in its judgment in BASF (C‑258/99), as regards process patents, and in MIT (C‑431/04), as regards composition patents.

The AG continues to carefully examine the holding of the Neurim decision against the background of the purposes of the SPC Regulation. It aims at preventing the creation of obstacles to the free movement of medicinal products in the internal market and encouraging the pharmaceutical research, creating a uniform system based on simple and transparent rules and finally achieving a proper balance of the interests at stake. He asserts that the Neurim decision is not in line with these aims, particularly because it introduces new uncertainties and shifts the balance in favour of pharmaceutical manufacturers.

He therefore concludes that the CJEU should answer the referred questions in that a MA for a new use of an already known active ingredient cannot be considered to be the first MA of the medicinal product if the active ingredient has already been the subject of an MA as such.

Broadly applying Neurim and giving new life to the SPC Regulation – alternative observation of the AG

On the first question referred – whether the term "different application" in Neurim is to be read strictly or broadly – the AG explains that there are two different views: Either the scope of this term is limited to the sole case of human use versus veterinary use, or one equally applies the patentability criteria.

The latter would consequently also include new formulations, dosage regimes and/or ways of administrations as a different application. The AG carefully elaborates that the holding of Neurim must be identified between these two extremes.

In this regard, two cases should be considered according to the AG’s view: The first case is that of a new therapeutic application, namely where the invention protected by the patent on which the SPC application is based is suitable for treating a new disease. If the Court were to decide to accept this reading of Neurim, it would have to go back on the MIT ruling.

The second case is one where the old active ingredient has a "pharmacological, immunological or metabolic action", different from that previously known. In the presence of such a new action, the old active ingredient would, in substance, be assimilated to a new product.

The AG underlines that such interpretation will lead to significant efforts of the national patent offices that have to decide about the grant of SPCs and they will need to be correspondingly equipped.

The AG therefore suggests the CJEU to answer the first question that the issuance of a SPC for a different application of an active ingredient for which an MA has been granted in the Member State concerned, within the meaning of the Neurim judgment, requires that the MA which serves as a basis for the application for MCC covers a new therapeutic indication for that active ingredient, or relates to a use of the latter in which the active ingredient has a new action pharmacological, immunological or metabolic own.

On the second question – whether "application falling within the scope of protection conferred by the basic patent" in the sense of the Neurim decision, implies that the scope of the basic patent should be consistent with that of the MA and, consequently, be limited to the new medical use corresponding to the therapeutic indication of said MA – the AG points out that the Neurim judgment itself states that the scope of such an SPC can, in any event, only cover the new use of the active ingredient already known, as protected by the basic patent and covered by the AM that serves as the basis for the SPC request. Under no circumstances the scope of this SPC could be extended to the active ingredient as such or other uses of this active ingredient.

In the present case, the referring court would therefore have to assess whether the new use of ciclosporine is protected by the basic patent in the sense of the TEVA decision (C‑121/17, see our previous article)

Ultimately, the AG concludes on the second question that the Court should answer that Article 4 of the SPC Regulation must be interpreted as meaning that, where the SPC relates to a different application of an active ingredient, the term "product" means only the said particular application. It does not extend to the active ingredient itself or to other applications of that active ingredient.

Our comment

The opinion of the Advocate General Giovanni Pitruzella is very well founded and argued. He clearly analyses the inconsistencies of the existing CJEU case law and he makes two suggestions – one reflecting his opinion and one in the event that the CJEU would dissent – regarding how to align the existing case law with a correct interpretation of the SPC Regulation.

If the CJEU followed one of these suggested routes, it would ensure legal security for pharmaceutical companies as well as the public in the future. However, as always, it remains to be seen whether and to which extent the CJEU will follow his opinion.

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