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Thursday 15 January 2015

Synflorix: SPC can be based on covalently bound active ingredient -- in principle ...

This morning the Court of Justice of the European Union (CJEU) delivered its judgment in Case C‑631/13, Arne Forsgren v Österreichisches Patentamt, a request for a preliminary ruling under Article 267 TFEU from the Oberster Patent- und Markensenat, Austria. The CJEU obviously didn't consider this a tough case to decide, since it dispensed with an Opinion from Advocate General Bot.

The factual background runs as follows. Forsgren owned a European patent (EP0594610B1, ‘the basic patent’) relating to ‘Protein D ‒ an IgD-binding protein of Haemophilus influenzae’.  Protein D is present in a pneumococcal vaccine for paediatric use, ‘Synflorix’, the marketing of which was authorised by Commission Decision C(2009) 2563 for ‘Synflorix — Pneumococcal polysaccharide conjugate vaccine (adsorbed)’. From the wording of the marketing authorisation (MA) for Synflorix, it appears that Synflorix was composed of 10 pneumococcal polysaccharide serotypes which were conjugated to carrier proteins and adsorbed on to aluminium phosphate. In eight of those serotypes, Protein D was the carrier protein. The therapeutic indications set out in the MA were for
‘Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age’. 
According to the MA, the excipients of that vaccine were sodium chloride and water for injections.

In September 2009 Forsgren applied to the Österreichisches Patentamt for an SPC for Protein D. No, said the office, since Protein D was just an excipient. On appeal, the Board of Appeal of the Österreichisches Patentamt agreed: while Protein D had a therapeutic effect against the Haemophilus influenzae bacterium, it wasn't present as such in Synflorix, being covalently bonded to other active ingredients. Accordingly, Protein D couldn't be authorised as a medicinal product within the meaning of the SPC Regulation. Forsgren appealed further to the Oberster Patent- und Markensenat, which decided to stay proceedings and to refer to the CJEU the following questions for a preliminary ruling:
‘1. Under Article 1(b) and Article 3(a) and (b) of [Regulation 469/2009], provided that the other conditions are met, may [an SPC] be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is present in a medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains an effect of its own?

2. If Question 1 is answered in the affirmative:

(a) Under Article 3(a) and (b) of [Regulation No 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against the Haemophilus influenzae bacterium) but the marketing authorisation for the medicinal product does not relate to that effect?

(b) Under Article 3(a) and (b) of [Regulation 469/2009], may [an SPC] be granted for the substance protected by the basic patent (in this case, Protein D) where the marketing authorisation describes that substance as a ‘carrier’ for the actual active ingredients (in this case, pneumococcal polysaccharides), where the substance, as an adjuvant, enhances the effect of those substances, but where that effect is not expressly mentioned in the marketing authorisation for the medicinal product?’
This morning the CJEU (Eighth Chamber) ruled:
1. Articles 1(b) and 3(a) of Regulation 469/2009 ...  must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

2. Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised 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 authorisation, 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.
There may be some further comment from the blog team but, in the meantime your comments are most welcome.


Anonymous said...

Can anyone explain to me how the CJEU reached its conclusion in the final sentence of paragraph 35?

As far as I can see, the conclusion most definitely does NOT follow as a logical consequence of the points that the CJEU makes prior to that conclusion.

Anonymous said...

The judgment leaves me unconvinced about whether a distinction between

(i) a Glaxosmithkline Biologicals-type of scenarios involving an enhancement adjuvant; and

(ii) a Question 2(b)-type scenario under Forsgren

is the right way to go.

I must look into this judgment in more detail, anyway. It is indeed difficult to read, particularly the last question.


A fellow in the galleys of SPC litigation