On 12 December 2013, the Court of Justice of the European Union (CJEU) delivered its judgments in three important cases relating to Supplementary Protection Certificates (SPCs).
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.
The SPC may only relate to a product that is "protected by a basic patent in force" (Article 3(a) of the SPC Regulation, EC 469/2009). In addition, obiter comments of the CJEU relating to Article 3(c) of the SPC Regulation have suggested that only one SPC may be granted for each basic patent (regardless of how many products are claimed or disclosed in that patent).
Georgetown University v Octrooicentrum Nederland (C-484/12), Actavis v Sanofi (C-443/12) and Lilly v HGS (C-493/12): references by the Dutch and UK courts
Article 3(a): the wording of the claims
In prior decisions, most notably Medeva C-322/10, the CJEU has stated that the test for assessing whether a product is protected by a patent is to ask if the product is "specified" (or "identified") in the wording of the claims of the basic patent.
In the Lilly and Actavis cases, the English court sought further clarity on what is meant in Article 3(a) by "protected by the basic patent" and implicitly found it difficult to apply the "specified in the wording of a claim" test from the earlier Medeva judgment.
In Lilly the issue arose in relation to antibodies which were defined in the claims of the basic patent in the functional terms of an antibody binding to a particular target antigen. As an aside, HGS had not filed an SPC under the basic patent; rather, the reference to the CJEU arose from a request from Lilly for a declaration that HGS would not be eligible for an SPC under their patent for an antibody product that Lilly has under development.
Sanofi's SPCs related to a combination therapy comprising an antihypertensive agent (irbesartan) together with HCTZ, a diuretic. The claims of the basic patent included one directed at irbesartan in combination with a diuretic, but nowhere in the claims (or the patent) was HCTZ disclosed as such.
Article 3(c): limitations of the number of SPCs per patent
The CJEU has previously made certain obiter comments, notably in Biogen C-181/95, which suggest that only one supplementary protection certificate may be granted for each basic patent (regardless of how many products are claimed in that patent). However, many national patent offices have accepted an interpretation of the SPC Regulations that allows one SPC per product per patent.
In Georgetown, the Dutch court sought clarity from the CJEU on whether the issuance of multiple SPCs for a single patent was prohibited by Article 3(c) of the SPC Regulation, and the extent to which an applicant may surrender an earlier granted SPC if only one SPC per patent were allowable. In Actavis, the English court also referred questions to the CJEU on the primary issue in the Georgetown case.
Georgetown's SPC applications related to cervical cancer vaccines (Gardasil® and Cervarix®) comprising multiple antigens, each of these antigens being described for the first time in the basic patent. Several SPC applications were filed based on the same basic patent, and were directed to either individual antigens or combinations thereof based on the same marketing authorisation.
Sanofi's SPCs related to (i) irbesartan (Aprovel®) and (ii) a combination of irbesartan and HCTZ (CoAprovel®), both SPCs being based on the same basic patent but on different marketing authorisations. The authorisation for the combination was granted some time later than that for irbesartan alone such that the combination SPC expired 14 months later than that to irbesartan alone.
The CJEU has decided the following.
In order for an active ingredient to be regarded as "protected by a basic patent in force":
- it is not necessary for an active ingredient to be identified in the claims of a patent by a structural formula; and
- the use of a functional definition for an active ingredient will be sufficient provided that the claims "relate implicitly but necessarily and specifically" to the active ingredient in question when interpreted in accordance with Article 69 EPC.
Article 69 EPC indicates that the extent of protection conferred by a European patent shall be determined by the claims, and that the description and drawings should be used to interpret the claims.
- Where a basic patent protects more than one product, then more than one SPC may be granted for that patent, under most circumstances, including those of the Georgetown University case.
- However, where a basic patent protects both a first active ingredient and a combination of that active ingredient together with another, and an SPC has been granted for the first active ingredient on the basis of a relevant marketing authorisation, an SPC for the combination product cannot be granted under the same basic patent on the basis of a subsequent marketing authorisation. Thus, Sanofi's combination SPC is invalid.
The judgment in Lilly C-493/12 attempts to build upon the Medeva decision (C-322/10) and provides further insight into what is meant by "protected by a basic patent". While the ruling clearly indicates, for the first time, that the use of functional definitions for products may potentially satisfy the requirements of Article 3(a), it arguably leaves many other aspects of this question open for interpretation
For many cases, it is difficult to see whether the situation is any clearer for the national courts as a result of the reference to Article 69 EPC and the indication that claims should relate implicitly but necessarily and specifically to the active ingredient in question. For example, although it did not ultimately have to be determined in the Actavis case, it is not completely clear whether the claim to the combination of irbesartan and a diuretic "relates implicitly but necessarily and specifically" to the combination of irbesartan and HCTZ.
In addition, the CJEU considered itself unable to provide any substantive comment on the interpretation of Article 69 EPC on the grounds that the EU is not a party to the European Patent Convention.
The interpretation by national courts of the new test for compliance with Article 3(a) will be eagerly awaited and it remains to be seen whether they will find it sufficiently clear or whether further references to the CJEU will be needed.
The CJEU has finally clarified the statements made in previous judgments (most notably the Biogen C-181/95 and Medeva C-322/10 decisions) which suggested that only one SPC may be granted for any basic patent, regardless of the number of products that were claimed.
As a result of the present decisions, under most circumstances, it is clear that more than one SPC may be granted for a basic patent where that patent protects more than one product.
The CJEU outlined an exception to this general principle, which applies to the circumstances surrounding Sanofi's SPCs. In cases such as this, a second marketing authorisation cannot be used as the basis for an SPC for a combination product where one component of that combination was already the subject of an SPC based on the same basic patent, but the remaining product(s) are not protected as such by that patent.
At first, it may appear possible to circumvent this specific issue by ensuring that new active ingredients and related combination products are claimed in separate (e.g. divisional) patents. However, the CJEU states that, in such cases, each separate patent can only confer entitlement to a new SPC insofar as it covers "a totally separate innovation". In principle, this could mean that the claims of parent and divisional patents would need to be examined by each national office to determine whether the relevant products are "totally separate innovations" for SPC purposes, in a manner akin to the assessment of double patenting that is made for continuation and divisional patent applications at the USPTO.
Where such patent filing strategies are adopted, it remains to be see to what extent patentees will be given the opportunity to present arguments and evidence to justify that a combination of active ingredients represents a "totally separate invention" for SPC purposes.
With the exception of certain circumstances, such as those of Sanofi's combination SPC, the ruling confirms that multiple SPCs may be obtained for a single patent.
In cases where a pending application discloses a new active ingredient together with a specific, and separately inventive, combination of active ingredients, divisional applications may be required.