Forsgren's SPC: what does the marketing authorisation have to say about the active ingredient?
In a recent judgment, Case C‑631/13, Arne Forsgren v Österreichisches Patentamt, the Court of Justice of the European Union (CJEU) had to again consider a referral about a Supplementary Protection Certificate (SPC). The judgment was about
Normally when a medicine is being developed a patent application is filed at a very early stage. It then takes many years to develop the medicine and to perform the tests necessary for obtaining regulatory approval (or ‘marketing authorisation’).The purpose of SPCs is to provide protection for specific defined medicinal products beyond the term of the original ‘basic patent’ as a way of recompensing the patentee for the time taken to obtain regulatory approval, during which commercialising of the medicinal product was not possible. In Europe SPCs for medicines are governed by Regulation 469/2009 and are obtained based on the patent and the granting of a marketing authorisation for the medicinal product. A separate, very similar, Regulation governs SPCs for plant protection products.
Previous SPC referrals to the CJEU
There have been a surprising number of referrals to the CJEU which concern clarification of the SPC Regulation (see Katpost here). The Regulation is very short and has little description of how the active ingredient, the claims of the basic patent, the marketing authorisation and the product protected by the SPC need to relate to each other. Some of the issues that have arisen have been due to combination products, such as whether a patent to product A can support an SPC to product A+B (see discussion of that here and a Katpost about whether that can be fixed by post grant amendment of the claims here). Essentially the case law is strict on the relationship between the claims of the patent and the definition of the product in the SPC, but there is more flexibility concerning how these relate to the specific medicine that was tested and described in the marketing authorisation. For example, a marketing authorisation which describes a combination product can support an SPC that relates to a single medicinal product which is part of the combination product. The marketing authorisation does not have to be your own. It can be any that relates to your product.
The CJEU has previously decided that an ‘adjuvant’ which enhances the therapeutic of another substance, but which does not have its own therapeutic activity, cannot be an ‘active ingredient’ as defined by the Regulation and therefore cannot be the subject of an SPC (see SPC Blog post here). However in the field of SPCs for plant protection products the CJEU has also decided that a ‘safener’ which protects a plant from the harmful effects of a herbicide can be the subject of an SPC (see Katpost here).
The facts of the present case
Mr Forsgren is the proprietor of European patent EP0594610B which claims as a product per se Protein D, an IgD binding protein of Haemophilus influenzae, and describes its use in a vaccine against this bacterium. He now wished to obtain an SPC in Austria to Protein D based on a marketing authorisation to ‘Synflorix’ filed by GlaxoSmithKline Biologicals. Synflorix is a vaccine against conditions caused by Streptococcus pneumonia and contains pneumococcal polysaccharides covalently bonded to Protein D, which is acting as a carrier molecule. The marketing authorisation specifically points out that there was insufficient evidence that Synflorix provided protection against Haemophilus influenza. The Austrian Supreme Patent and Trade Mark Adjudication Tribunal (the ‘referring court’) asked the CJEU to determine whether an SPC could be granted in these circumstances for Protein D per se, where in the marketing authorisation it is described as covalently bonded and only acting as a carrier protein, with no reference to its therapeutic activity against Haemophilus influenzae.
The arguments
Mr Forsgren argued that Protein D present in Synflorix would have two effects:
The referring Court argued that the covalently bound form of a substance would have different properties, and thus an SPC could only be granted for the covalently bound form of Protein D. It also argued against the granting of the SPC based on the fact the marketing authorisation did not refer to the independent activity of Protein D against Haemophilus influenzae.
The European Commission also made submissions, arguing that the SPC system needed simplicity and transparency, which would not be achieved if there was a need to look beyond the marketing authorisation to establish whether a substance was an active ingredient.
The CJEU’s response
The CJEU found that the ‘covalent bonding’ issue should not prevent the granting of an SPC.
It had a much more complex response to the issue of whether the marketing authorisation was adequate to support the grant of the SPC. The CJEU hinted at the fact that Protein D may be playing an important role when Synflorix was used to treat Streptococcus pneumonia which is different to that of an adjuvant. It ultimately decided that for Protein D to be an ‘active ingredient’ as required by the Regulation it must produce ‘a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation’. It left that determination for the referring court to carry out, and seems to have left the door open for Mr Forsgren to try to convince the referring court that Protein D does have some independent action within Synflorix. It seems to this Kat that, unless Mr Forsgren is able to provide additional material not referred to in the present decision, the referring court will decide against the granting of an SPC.
This Kat notes that the judgment does not require the marketing authorisation to ‘disclose’ the independent ‘actions’ required for a substance to be considered an active ingredient, but only that they must be ‘covered’ by the therapeutic indications the marketing authorisations refer to. That seems to give some leniency in the information which the marketing authorisation needs to provide, but presumably also leaves the door open for future referrals on the issue!
The specific questions that were referred to the CJEU together with the CJEU’s formal answers can be found in this SPC Blog post.
* whether an SPC could be obtained to a product per se in ‘separate’ form when the marketing authorisation was for a medicine in which the product is covalently bonded to other ingredients
* whether the SPC could rely on a marketing authorisation which only described the product as a ‘carrier protein’ and did not provide any information about an independent therapeutic effect (such as the one described in the patent on which the SPC was based).What are SPCs?
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| Using someone else's marketing authorisation can cause trouble |
Previous SPC referrals to the CJEU
There have been a surprising number of referrals to the CJEU which concern clarification of the SPC Regulation (see Katpost here). The Regulation is very short and has little description of how the active ingredient, the claims of the basic patent, the marketing authorisation and the product protected by the SPC need to relate to each other. Some of the issues that have arisen have been due to combination products, such as whether a patent to product A can support an SPC to product A+B (see discussion of that here and a Katpost about whether that can be fixed by post grant amendment of the claims here). Essentially the case law is strict on the relationship between the claims of the patent and the definition of the product in the SPC, but there is more flexibility concerning how these relate to the specific medicine that was tested and described in the marketing authorisation. For example, a marketing authorisation which describes a combination product can support an SPC that relates to a single medicinal product which is part of the combination product. The marketing authorisation does not have to be your own. It can be any that relates to your product.
The CJEU has previously decided that an ‘adjuvant’ which enhances the therapeutic of another substance, but which does not have its own therapeutic activity, cannot be an ‘active ingredient’ as defined by the Regulation and therefore cannot be the subject of an SPC (see SPC Blog post here). However in the field of SPCs for plant protection products the CJEU has also decided that a ‘safener’ which protects a plant from the harmful effects of a herbicide can be the subject of an SPC (see Katpost here).
The facts of the present case
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| Perhaps the CJEU simply enjoyed having lots of SPC referrals |
The arguments
Mr Forsgren argued that Protein D present in Synflorix would have two effects:
* as a vaccine against Haemophilus influenza, and
*as an adjuvant for the pneumococcal polysaccharides.For the first effect he argued there is nothing in the Regulation that requires the marketing authorisation to refer to the therapeutic effect. For the second effect he referred to the CJEU’s previous ruling that an SPC could be granted for a ‘safener’.
The referring Court argued that the covalently bound form of a substance would have different properties, and thus an SPC could only be granted for the covalently bound form of Protein D. It also argued against the granting of the SPC based on the fact the marketing authorisation did not refer to the independent activity of Protein D against Haemophilus influenzae.
The European Commission also made submissions, arguing that the SPC system needed simplicity and transparency, which would not be achieved if there was a need to look beyond the marketing authorisation to establish whether a substance was an active ingredient.
The CJEU’s response
The CJEU found that the ‘covalent bonding’ issue should not prevent the granting of an SPC.
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| Independent action is needed before an SPC can be granted |
This Kat notes that the judgment does not require the marketing authorisation to ‘disclose’ the independent ‘actions’ required for a substance to be considered an active ingredient, but only that they must be ‘covered’ by the therapeutic indications the marketing authorisations refer to. That seems to give some leniency in the information which the marketing authorisation needs to provide, but presumably also leaves the door open for future referrals on the issue!
The specific questions that were referred to the CJEU together with the CJEU’s formal answers can be found in this SPC Blog post.
