(darts-ip reference: darts-246-093-G-en), 30 january 2019
Today, the ECJ gave its interpretation of Article 3(d) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate (hereinafter referred to as ‘SPC’) for medicinal products. Its strict interpretation of this article limits the granting of SPCs to fundamental innovations and excludes them for incremental innovations, as for example a new formulation of an active ingredient.
Summary of facts and proceedings
A request for a preliminary ruling was made by the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom in the context of a dispute between the company Abraxis Bioscience LLC (‘Abraxis’) and the Comptroller General of Patents. Abraxis is seeking from the national court the annulment of the Comptroller’s decision to reject – with regards to Article 3(d) of Regulation (EC) No 469/2009 – the SPC application made by Abraxis for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticles bound to albumin. Abraxis calls that combination of substances ‘nab-paclitaxel’ and markets it under the name of Abraxane.
For reference, Article 3(d) of the regulation requires that marketing authorisation (hereafter referred to as MA) be ‘the first authorisation to place the product on the market as a medicinal product’.
In the present case, the active ingredient in Abraxane, paclitaxel, had already been marketed under other brand names for use in eliminating cancer cells pursuant to earlier MAs. Nab-paclitaxel is a new formulation of that active ingredient and has the same use. That formulation is protected by the basic patent relied upon by Abraxis in support of its SPC application, it being understood that the protection conferred by that patent does not extend to paclitaxel as such.
In that context, the national court asked the Court, in essence, whether the conditions set out in Article 3(d) of Regulation No 469/2009 is fulfilled where, although the MA relied upon in support of the SPC application is for an active ingredient which has already been granted an earlier MA, that earlier MA did not concern the new formulation – protected by the basic patent and covered by the MA of the applicant for the SPC – of that active ingredient.
Opinion of the Advocate General
According to the Opinion of the Advocate General published last December, the present case provides the Court with an opportunity to clarify any possible links between the basic patent and the marketing authorisation relied upon in support of the SPC application.
The Advocate General concluded that this case raises the question of whether Article 3(d) of that regulation refers to the ‘the first authorisation to place the product on the market as a medicinal product’ without further qualification, or to the first MA covering the product as a medicinal product and falling within the scope of the protection conferred by the basic patent.
Hence, the Advocate General proposed to ECJ these two interpretations of the Article 3(d), while displaying his preference for the first.
First interpretation of article 3(d) : the ‘the first authorisation to place the product on the market as a medicinal product’ without further qualification
According to the Advocate General, the conditions set out in Article 3(d) of that regulation forms part of the effort to strike a balance between the interests involved by limiting the benefit of the SPC to products placed on the market for the first time as medicinal products. In that regard, the Explanatory Memorandum seems to indicate that the research which the establishment of the SPC regime was intended to encourage is that leading to the first marketing, as a medicinal product, of an active ingredient or combination of active ingredients.
Moreover, Paragraph 35 of the Explanatory Memorandum states: ‘It occurs very often that one and the same product is successively granted several authorisations to be placed on the market, namely each time a modification is made affecting the pharmaceutical form, dose, composition, indications, etc. In such a case, only the first authorisation for the product to be placed on the market in the Member State in which the application is presented is taken into account for the purposes of the proposal for a Regulation
It would be for the legislature, if it deems it appropriate, to modify the system so as to protect all patented inventions whose commercial exploitation requires the submission of a full application for marketing authorisation under that provision, or even to favour more generally all research leading to the placing on the market of a medicinal product incorporating for the first time a patented invention.
With regard to all the foregoing considerations, the Advocate General took the view that neither the objectives pursued by Regulation No 469/2009 nor its context supports an interpretation which departs from the wording of Article 3(d).
In the alternative, and in the event that the Court does not wish to adopt such an approach, he also examined the options which might allow it to limit the application of the scope of protection of the basic patent test to specific situations.
Second interpretation of Article 3(d) : the first marketing authorisation covering the product as a medicinal product and falling within the scope of the protection conferred by the basic patent
He proposed that the Court, in the alternative, hold that the scope of protection of the basic patent test applies only where a product was previously authorised pursuant to Directive 2001/82 for a therapeutic indication in veterinary medicine and is subsequently granted a marketing authorisation under Directive 2001/83 for a new therapeutic indication in human medicine. In such a situation, Article 3(d) of Regulation No 469/2009 does not preclude the grant of an SPC on the basis of that MA, provided it is the first to fall within the scope of the protection conferred by the basic patent relied upon in support of the SPC application, as the Court judged in the Neurim case.
Consequently, the test of the scope of the protection of the basic patent could not apply to the case in dispute, an SPC could therefore not be granted for a new formulation of an active ingredient that has already been the subject of a prior MA for the same therapeutic indication.
The Advocate General gave two main arguments to accept this limited application of the scope of protection of the basic patent test :
-where an invention leads to the first placing on the market of a product for a particular new therapeutic indication and as a human medicinal product, it does not seem unreasonable to me to consider that that invention may, in principle, be regarded as a basic therapeutic advance ;
-secondly, that solution would promote the coherence of the Court’s case-law.
Conclusion of the Court
The Court followed the first – most strict – interpretation of the Attorney General, the judge concluded that an MA relied on in support of an application for an SPC concerning a new formulation of an old active ingredient, cannot be regarded as being the first MA for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of an MA as an active ingredient.
The judges explained their decision by recalling first of all that Paragraph 11 of the Explanatory Memorandum of 11 April 1990 to the Proposal for a Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final) indicates that the term ‘product’ is understood to mean an active substance in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC.
They added that the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.
Finally, the judges completed their reasoning by stating that this decision is consistent with the Neurim case. They specified that the exception to the narrow interpretation of Article 3(d) as held in the latter case does not, in any event, refer to cases of a new formulation of the product at issue that has the same use. That exception cannot, therefore, in any event, be relied on in the case of an MA granted for a new formulation of an active ingredient which has already been the subject of an MA, even if the MA for that new formulation was the first to come within the scope of the basic patent relied on in support of the SCP application for that new formulation.
 In accordance with the SPC regime provided for by Regulation No 469/2009, if the commercial exploitation of a patent is delayed because of the regulatory procedures required to obtain marketing authorisation (‘marketing authorisation’, ‘authorisation to place on the market’ or ‘MA’) for a medicinal product incorporating the invention protected by the patent, the holder of that patent is permitted to enjoy an additional period of exclusivity on the expiry of the patent. That period of exclusivity compensates, at least in part, for the erosion of the period of effective exploitation of the exclusivity conferred by the patent.
 Judgment of 19 July 2012 (C-130/11, EU:C:2012:489).
 In the Neurim case, the Court considered that Article 3(d) does not preclude the grant of an SPC on the basis of the first marketing authorisation covering a new and inventive therapeutic use of an active ingredient that had already been the subject of an earlier marketing authorisation. It is clear from the order in Yissum (Order of 17 April 2007 (C-202/05, EU:C:2007:214, paragraph 18) that the concept of ‘product’ is also independent of the therapeutic use concerned: an active ingredient (or a combination of active ingredients) remains one and the same ‘product’ regardless of its therapeutic uses.