“Protection” is all about Article 69 EPC
On 18th July 2014 the High Court handed down its judgment in Eli Lilly v Human Genome Sciences Ltd  2404 EWHC (Pat) which concerned the interpretation of Article 3(a) of the SPC regulations. The judgment follows a referral to the Court of Justice of the European Union (“CJEU”) (C-493/12) in which Mr Justice Warren asked for clarification of the meaning of the requirement that a product must be “specified” or “identified” in the claims in order to be “protected” by a basic patent, as required by Article 3(a). In its decision, the CJEU had not provided any specific guidance on how these words were to be interpreted. It did say, however, that there was no requirement for the product to be identified by structure in the claims; a functional definition of the product could be enough.
Warren J has now interpreted this CJEU judgment in a seemingly pro-patentee manner. He suggests that a product is protected by a basic patent in the sense of Article 3(a) if the product falls within the scope of the claims when interpreted by Article 69 EPC and the corresponding Section 125 of the UK Patents Act. This means that compliance with Article 3(a) may become a simple matter of interpreting the claims and determining whether the product falls within their scope. This test would apply to claims whether they define the product structurally or functionally.
Nevertheless, Warren J felt the need for a proviso in the situation where the product is protected solely by claim language which extends the claim scope beyond its “principal scope”. Following the logic of the CJEU’s judgment in Medeva v Comptroller General of Patents (C-322/10), he said that the open-ended wording “comprising” in a claim directed to a composition comprising an active substance A was not suitable under Article 3(a) for an SPC for a product containing active ingredients A and B. He reasoned that B was not specified in the claims even though the word “comprising” meant that such compositions were encompassed by the claims.
This ruling is largely good news for SPC applicants because it suggests that UK courts are willing to interpret the requirements of Article 3(a) broadly, and to allow SPCs based on product claims which define the product structurally or functionally. Warren J’s broad test may also mean that SPCs will be allowable for other claim types, for example process and product-by-process claims, provided they can be interpreted to encompass the product for which the SPC application is filed.
It is uncertain though how other jurisdictions will interpret the CJEU’s judgment. We have already seen the patent offices in jurisdictions like Germany, The Netherlands, Spain and Sweden being stricter on the requirements of Article 3(a), requiring the product to be described in detail in the claims. It remains possible, even likely, that the various other national courts will interpret the CJEU’s decision differently from Warren J.
Are SPCs available to parties who have not themselves obtained the marketing authorisation?
Warren J also commented on the so-called third party MA issue. This issue has come up in various cases, including the Lilly case: can a party obtain an SPC based on a marketing authorisation granted to an entity that has developed the product with no connection to that party? The point being made is that if the purpose of an SPC is to compensate a patentee for its unavoidable delay in obtaining regulatory approval, then a patentee who has played no part in obtaining a particular marketing authorisation has not suffered from that delay, and so is arguably not entitled to an SPC.
Importantly, Lilly did not pursue this point in this case but the CJEU nevertheless commented on it in its decision. It noted that the refusal of an SPC application may be justified when the patentee had not made any investment in research to bring the product to market:
“[T]he refusal of an SPC application for an active ingredient which is not specifically referred to by a patent [. . .] may be justified [. . .] where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto.”
Warren J expressed concern with the CJEU’s comments, pointing out that an approach which attaches different weights to different types of research would be unsatisfactory. He reasoned that it cannot be the correct approach to grant SPCs only for later patents which cover specific products whilst no SPCs are available for the fundamental research which allowed the development of these products in the first place. Again, Warren J seems to be taking a pro-patentee approach here, questioning the suggestion that SPCs should be granted only for an applicant’s own marketing authorisation.
The facts underpinning the dispute
Human Genome Sciences, Inc. (“HGS” – now part of GSK) is the proprietor of European patent no. 0 939 804 which describes and claims neutrokine-alpha, a protein which is involved inter alia in inflammation. The patent also has claims directed to antibodies which specifically bind to neutrokine-alpha. Of particular importance for the proceedings was claim 13 which reads:
13. An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-alpha polypeptide (amino acid sequence of residues 1 to 285 of SEQ ID NO: 2); or (b) the extracellular domain of the Neutrokine-alpha polypeptide (amino acid sequence of residues 73 to 285 of SEQ ID NO: 2).
This claim was held to be valid by both the European Patent Office’s Board of Appeal as well as the UK Supreme Court. In the above judgment, the UK High Court has refused Lilly’s request for a declaration that the patent would be unsuitable for HGS to obtain an SPC for Lilly’s antibody tabalumab, which binds to neutrokine-alpha and falls within the scope of the patent’s claims.
Lilly was initially granted leave to appeal this case to the Court of Appeal, but we understand the parties have since settled the dispute and so no appeal will be heard. It will therefore be some time before Warren J’s relatively generous approach to Article 3(a) is tested by a higher court.