On 15 January 2015, the Court of Justice of the European Union (CJEU) delivered a potentially favourable judgment on the question of whether a molecule such as a carrier protein, which is covalently bonded to an active ingredient (in this case a polysaccharide antigen), can be the subject of a Supplementary Protection Certificate (SPC).

SPCs are an extremely valuable form of IP, providing additional protection, beyond patent expiry, for "products" (active ingredients of medicinal or plant protection products) that require a marketing authorisation (MA).

Arne Forsgren v Österreichisches Patentamt (C-631/13)

Arne Forsgren is the owner of a European patent covering protein D, an immunoglobulin receptor for human IgD. Protein D is found in many strains of Haemophilus influenzae and related species, and is capable of providing protection against infections caused by Haemophilus influenzae. The vaccine that was the subject of the MA contained several polysaccharide serotypes which were each covalently bonded to protein D, with the therapeutic indications relating primarily to immunisation against diseases associated with Streptococcus pneumonia in children.

The main question that was referred to the CJEU by the Österreichisches Patentamt (Austria) concerned whether an SPC could, in principle, be granted for a first active ingredient when that active ingredient is present in an authorised medicinal product in a form in which it is covalently bonded to another active ingredient. Further questions were also referred on whether the MA needs to relate to the therapeutic effect that is associated with the first active ingredient.

The CJEU concluded that an SPC may potentially be granted for a first active ingredient which is present in an authorised medicinal product in a form in which it is covalently bonded to another active ingredient. However, it is necessary for the therapeutic effect of the first active ingredient in isolation (i.e. in its unbound form) to fall within the therapeutic indications covered by the wording of the MA in order to comply with Article 3(b) of Regulation 469/2009.

The CJEU also appears to suggest that, where a carrier protein is chemically bonded to a polysaccharide antigen when present in a medicinal product, that carrier protein (in isolation) may be categorised as an active ingredient for the purposes of Article 1(b) of the Regulation if it can be shown (to the satisfaction of the national patent office or court) that it produces a "pharmacological, immunological or metabolic action" of its own which is covered by the therapeutic indications of the MA.

Commentary

Article 1(b), which defines the product that is the subject of the SPC, has been interpreted narrowly in the past, notably in Massachusetts Institute of Technology (C-431/04) in which the CJEU decided that the concept of a "combination of active ingredients of a medicinal product" did not include a combination of two substances, only one of which has therapeutic effects of its own for a specific indication. Nevertheless, the CJEU felt able to suggest a more expansive interpretation under the present circumstances.

The CJEU looked to the definition of "active substance" (also termed "active ingredient") in Directive 2001/83/EC (the legislation concerning MAs for medicinal products for human use), as amended by Directive 2011/62/EU, and indicated that in order for a substance to be an active ingredient it must at least produce a pharmacological, immunological or metabolic action of its own. This is in line with the CJEU's recent decision in Bayer CropScience AG v Deutsches Patent- und Markenamt (C 11/13) which required that a substance must have a toxic, phytotoxic or plant protection action of its own for it to be an active substance under the plant protection product regulation. However, the present decision seems to require that the therapeutic effect associated with a given substance falls within the therapeutic indications covered by the wording of the MA if that substance is to be considered a "product" (active ingredient) that can be the subject of an SPC. This gives rise to further unanswered questions.

As existing MAs can be varied to refer to new therapeutic effects once suitable clinical trial data become available, this may result in the relevance of an MA changing over time. This in turn will affect how compliance with Articles 3(b) [the requirement for an MA to support the SPC] and 3(d) [the requirement that there is not an earlier MA for the same "product"] is assessed, and precisely what documentation needs to be considered in the context of a "marketing authorisation".

As with the Bayer CropScience decision, the CJEU has offered no specific guidance on how to ascertain whether a substance can be classified as an active ingredient (i.e. whether it produces a pharmacological, immunological or metabolic action of its own), and it has stated that it is for the relevant national court to make this determination.

The CJEU also reaffirmed the decision in GlaxoSmithKline Biologicals (GSK) v Comptroller-General of Patents (Case C 210/13), in that how the substance is defined in the MA can also influence whether it may be classified as an active ingredient. Significantly, it appears that the CJEU considered that if the MA refers to the substance as an "adjuvant" or an "excipient" then this would preclude the substance from being considered an "active ingredient" for which an SPC could be granted. Indeed, the CJEU distinguished the Forsgren case from the GSK decision after finding that the active ingredient in question (protein D) is not an adjuvant based on the wording in the MA.

Thus, it is becoming increasingly important for patent holders and their licensees to carefully consider how to define each substance in an MA if an SPC is likely to be sought for any of those substances in the future.

Action Points

Patent holders and licensees should be aware that how individual components of a pharmaceutical product are defined in a marketing authorisation (in terms such as active ingredients, adjuvants, stabilisers, etc.) may impact upon the prospects of obtaining SPC protection for those components. Therefore, it is important for the regulatory department that is seeking the MA to obtain advice from the company's internal or external patent advisors before the MA application is submitted.