UK High Court approves SPCs for functionally defined products
06 August 2014
SPCs provide additional protection, beyond patent expiry, for products (medicinal, veterinary or plant protection) that require a marketing authorisation (MA).
A central requirement for the grant of an SPC is that the Product (i.e. the active ingredient or combination of active ingredients of a medicinal or plant protection product) must be "protected by a basic patent in force" (see Article 3(a) of the SPC Regulation, EC 469/2009).
The meaning of "protected" has been the subject of several cases before the Court of Justice of the European Union (CJEU), most recently in Medeva (C-322/10), Actavis (C-443/12) and Lilly (C-493/12) (see our previous reports here and here).
The present judgment stems from the Lilly reference.
Eli Lilly had sought a declaration to stop Human Genome Sciences (HGS) from receiving an SPC based on Lilly's MA for its antibody, tabalumab . HGS's patent contained a claim directed to an isolated antibody that binds specifically to Neutrokine-alpha, and it was common ground that (a) tabalumab would infringe the patent and (b) it was not sufficient for tabalumab to infringe the patent in order to be "protected" by the patent in the sense necessary to secure an SPC. Central to the case, therefore, was whether abalumab is "protected" by the patent in which the claim defines the antibody solely by its ability to bind Neutrokine-alpha (the target antigen), there being no description of any specific antibodies in the patent. The CJEU's ruling stated that where an active ingredient is covered by a functional formula in the claims of a patent, this does not preclude grant of an SPC provided that the claims "relate, implicitly but necessarily and specifically, to the active ingredient in question".
The case came back to the UK High Court this year and the High Court observed that the CJEU had failed to give the clear guidance that was sought. It was therefore left to the UK High Court to interpret the CJEU's ruling.
Decision of the High Court
The UK High Court has now held that the functional claims of HGS's patent do "relate" to Lilly's antibody, tabalumab, and that they do so "implicitly but necessarily and specifically". The requirements for "protection" in the sense of Article 3(a) would therefore be fulfilled.
The UK High Court concluded that the proviso that claims must "relate, implicitly but necessarily and specifically, to the active ingredient in question" does not call for any further detailed definition elsewhere in the patent specification. Rather, it simply means that, when the claims are interpreted in view of the description and drawings under Article 69 of the European Patent Convention (which deals with the "extent of protection"), the active ingredient in question must be covered by the claims.
The Court's decision means that a functional definition of an active ingredient in the claims is sufficient to fulfil the requirements of Article 3(a), even in the absence of any structural definition elsewhere in the patent. What is important is that the functional definition covers the active ingredient in question.
Interestingly, the Court does not appear to consider the CJEU's judgement in Lilly to introduce any further requirements beyond those set out in Medeva (C-322/10), namely that the active ingredients are "specified" or "identified" in the wording of the claims. In the absence of further guidance from the CJEU on the meaning of these terms, the UK Court seems to suggest that, provided there is some wording in a claim that encompasses the active ingredient in question (be it structural and/or functional), the active ingredient would be so "specified" or "identified".
The Court sets out one proviso to this in the context of products comprising a combination of active ingredients. In particular, the Court stated that if a patent were to claim a product comprising A, only A would be considered "protected" in the sense of Article 3(a). The use of the language "comprising" was said not be sufficient to make such a claim relate "implicitly but necessarily and specifically" to a combination of A and another active ingredient, B.
Thus, it appears that each and every active ingredient in a product must fall within a structural and/or functional definition present in the claims in order for the product to be protected. How general this definition may be, however, remains unknown. For example, it is unclear whether the Court would consider a claim along the lines of "a product comprising A and another active ingredient" to be sufficient for this purpose. It also remains unclear whether, for example, a claim directed to "a composition of specific pharmaceutical carrier X and a protein" would allow for an SPC to specific protein Y based on an MA to a composition of specific pharmaceutical carrier X and specific protein Y, if specific protein Y is not mentioned in the patent.
The Court was also invited to comment on whether the question of "protection" under Article 3(a) would be affected where the holder of the MA is not the same as the patent holder. The Court stated that the question of "protection" should not depend on the identity of the party that funded the research leading to the MA. To consider otherwise would, in the eyes of the Court, give preference to holders of patents covering later stage research, and so would be contrary to the objectives of the SPC Regulation, which is intended to cover all types of research.
Lilly has been granted leave to appeal this decision, and so it is likely that these issues will be reviewed further in due course. Watch this space...
Please contact us if you are interested in filing SPCs, particularly where the patents in question relate to active ingredients that are defined largely in functional terms. At least in the UK, this decision would indicate that such active ingredients clear the hurdle for "protection" in an SPC sense.
If you require any further information, please contact David Carling, Michael Pears or Stephanie Pilkington of our SPC and Regulatory group.