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ES – Arne Forsgren v. SPTO / Protein D SPC

16 Apr 2015

Mr. Arne Forsgren v. Spanish Patents and Trademarks Office, High Court of Justice (Contentious-Administrative Chamber – 2nd Section) of Madrid, Spain, 9 July 2014, Docket No. 945/2012.

The wave of resolutions from the European Court of Justice (ECJ) concerning SPCs and the related interpretation of the provisions from the Regulation (EC) No. 469/2009 (hereinafter, “the Regulation”) recently brought the ECJ Judgment of 15 January 2015, in case C 631/13 (Arne Forsgren v. Österreichisches Patentamt), in reply to the request for a preliminary ruling submitted by the Austrian Supreme Patent and Trade Mark Adjudication Tribunal (Oberster Patent- und Markensenat) which concerned the request for grant of a SPC for Protein D present in the ‘Synflorix’ pneumococcal vaccine.

Before the rendering of the Judgment above, the High Court of Justice of Madrid had to decide upon the appeal filed by Arne Forsgren against the decision by the Spanish Patent Office (“SPTO”) not to grant an SPC for Protein D on the basis of the marketing authorization for ‘Synflorix’. It did so by means of a Decision dated 9 July 2014, where, accepting the patentee’s arguments, it revoked the previous rejecting resolution, and hence ordered to grant the requested SPC.


The factual background of is known: Mr. Forsgren was the owner of the European patent EP0594610, relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’ (hereinafter, “Protein D”), which was protected as such protein under claim 1 of the patent. The patentee sought extension of protection for Protein D under an SPC which he founded on the marketing authorization granted for GlaxoSmithKline’s ‘Synflorix’, a pneumococcal vaccine for paediatric use composed of 10 pneumococcal polysaccharide serotypes which are conjugated to carrier proteins and adsorbed on to aluminium phosphate. The Summary of Product Characteristics (SmPC) of ‘Synflorix’ specifies that 8 of those 10 polysaccharides are conjugated with Protein D, which acts as a carrier protein. ‘Synflorix’ is indicated for active immunization against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumonia in infants and children from 6 weeks up to 2 years of age.

The SPTO had twice rejected Mr. Forsgren’s application for an SPC for Protein D in Spain.

In assessing fulfilment of the requirements under Article 3 of the Regulation, the SPTO considered that, indeed, the patentee’s request complied with Article 3(a) (“the product is protected by a basic patent in force”) given that Protein D was indeed explicitly mentioned in claim 1 of the basic patent EP0594610 (ES2119776), in the terms required by the ECJ case law stemming from Medeva (C-322/10), University of Queensland (C-630/10), Daiichi Sankyo (C-6/11) and Yeda Research (C-518/10).

The SPTO concluded the opposite, however, when analyzing compliance with Article 3(b) (“a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate”). Basically, the SPTO understood from the information about the role that Protein D plays in the ‘Synflorix’ vaccine, according to both the SmPC and the Assessment Report for ‘Synflorix’ issued at the time by European Medicines Agency, that Protein D could not be deemed an active ingredient of that vaccine as such, given:

- that it merely acts therein as a carrier for certain active ingredients, - that it was expressly described in the Assessment Report as an “intermediate”, as opposed to the 10 polysaccharides described as active ingredients, and - the absence of any mention to Haemophilus influenza among the authorized therapeutic indications of ‘Synflorix’.

In this circumstances, the SPTO considered that Protein D was not “a medicinal product” having obtained a marketing authorization as required by Art. 3(b) of the Regulation, which caused rejection of  Mr. Forsgren’s request.

The patentee then appealed the SPTO decision before the High Court of Justice of Madrid. At that stage, the discrepancies between Mr. Forsgren and the SPTO lied on the consideration of Protein D, within ‘Synflorix’, as an active ingredient itself or as a mere intermediate molecule, for the purposes of compliance with Article 3(b) of the Regulation. The SPTO further noted that the marketing authorization for ‘Synflorix’ contained no statement about any activity of Protein D within the ‘Synflorix’ product .

The High Court of Justice of Madrid ultimately ruled for Mr. Forsgren in its Decision of 9 July 2014, where it essentially made the reasoning by the patentee’s appointed expert its own. In this sense, the Court subscribed the opinion that the decisive factor for determining whether a compound is an active ingredient or not within a medicinal product is whether or not it has a pharmacological activity. And, still following the arguments by the expert, the Court admitted that Protein D had indeed a pharmacological activity within ‘Synflorix’ (being hence more than a mere carrier molecule) to the extent that it enhanced the immune response by polysaccharides conjugated therewith, and that it protected against acute middle ear infection caused by non-typable Haemophilus influenzae bacteria, and this irrespective of not being such protective effect among the authorized indications of Synflorix’.

For the above, the Court found that Protein D was an active ingredient within such vaccine, and so it was a product having obtained a marketing authorization as a medicinal product, as required by Art. 3(b), in connection with Art. 1(b), of  Regulation (EC) No. 469/2009. As a result thereof, the Court revoked the previous decision by the SPTO and ordered the grant of the SPC for Protein D.

The findings by the High Court of Justice of Madrid were, however, later contradicted by the ECJ in its Judgment of 15 January 2015, with regards to the interpretation or Articles 3(a) and (b) of the Regulation in the same case raised before the competent authorities in Austria.

The first question referred to the ECJ by the Austrian Court aimed at clarifying whether under the Regulation an SPC could be granted for an active ingredient protected by a basic patent (such as Protein D) where that active ingredient is present in a medicinal product (such as Synflorix) merely as part of a covalent (molecular) bond with other active ingredients. The ECJ ruled that, as long as the active ingredient has a pharmacological, immunological or metabolic action of its own, it may be subject-matter of an SPC irrespective of whether or not it is covalently bound to other active ingredients in the medicinal product at stake, given that the Regulation contains no limitation in this regard. So the reading made by the High Court of Justice of Madrid seems aligned with the later findings by the ECJ on this point.

The Austrian Court further asked the ECJ to elucidate, in short, whether under Art. 3(b) of the Regulation an SPC could still be granted for the active ingredient above if, while retaining a therapeutic effect of its own, such effect is not comprised among the authorized indications in the marketing authorization.

And this is where we find a noticeable discrepancy between the ECJ and the High Court of Justice of Madrid. Whereas this latter had interpreted that, for the purposes of Art. 3(b), it was not relevant that the therapeutic effect of the active ingredient was not included within the drug authorized indications, the ECJ considered, quite the opposite, that Art. 3(b) precludes the grant of an SPC for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorization.

The High Court of Justice of Madrid had merely argued, in this regard, that the fact that the activity of Protein D was not expressly mentioned in the SmPC or in the Package Leaflet of ‘Synflorix’ does not deprive its protective immunizing action against Haemophilus influenza infections. Against this statement, the ECJ provided a more elaborated reasoning on the basis of the language of Art. 4 of the Regulation, pursuant to which an use of a product which has not been authorized as a medicinal product could not give rise to the grant of an SPC. It further added, with reference to previous case law, that an SPC can be enforced against the marketing of a medicinal product which comprises the same active ingredient after verifying that both medicinal products have been authorized for the same therapeutic indication. It is for the above that, ultimately, the ECJ ruled that Art. 3(b) precludes the grant of an SPC for an active ingredient whose effect does not fall within the authorized therapeutic indications, as was the case of Protein D in ‘Synflorix’.

The ECJ was also asked to clarify whether a carrier protein conjugated to a pneumococcal polysaccharide used in a vaccine for paediatric use could be regarded as a “product” within the meaning of Art. 3(b) of the Regulation. This question –which the Court replied by referring to the notion of active ingredient, has having a pharmacological, immunological or metabolic action of its own, and leaving to national Courts the consideration as to whether such action of the carrier protein was comprised or not within the authorized indications- exceeded already, however, the terms of the debate as raised before the Spanish Court.

So, ultimately, it was the SPTO, when first assessed Mr. Forsgren request for an SPC, and whose rejecting decision was later repealed by the High Court of Justice of Madrid, which actually came closer to the view taken by the ECJ afterwards, as that body already considered that the fact that protection against Haemophilus influenza infections provided by Protein D was not expressed within the authorized indications of ‘Synflorix’ was a relevant element to deny the requested SPC.

Read the decision (in Spanish) here.

Head note and summary: Luis Fernández-Novoa, Hoyng Monegier