Clarity for SPCs
Recently, the Court of Justice of the European Union (CJEU) has addressed a number of issues relating to Supplementary Protection Certificates (SPCs) directed to combination products. Although some questions remain unanswered in full, a recent series of CJEU decisions have clarified the requirements for acquiring an SPC and the scope of protection afforded by one once granted.
An SPC is an intellectual property right, provided for by European Union (EU) law, that comes into effect after the expiry of a patent upon which it is based. SPCs are available in relation to various products that require authorisation before being allowed on the market, such as pharmaceuticals. This need to obtain market authorisation for such products often reduces the time available to a patent owner for exploiting their patent before it expires.
SPCs provide some compensation, up to a maximum of five years, for this potential loss. The fundamental objective of SPCs is to ensure that patents provide a sufficient period of protection in order to cover the investment put into research, and therefore encourage further research, in particular in the pharmaceutical area. SPCs must be applied for country-by-country and are based on a granted basic patent “protecting the product” and a supporting market authorisation relating to said product.
However, over recent years, we have witnessed a number of conflicting decisions regarding the granting of SPCs relating to products containing a combination of active ingredients. In particular, national patent offices and national courts from different EU countries have interpreted the requirements for granting an SPC directed to a combination product differently.
A number of referrals were made to the CJEU asking for clarification. These were Medeva (C-322/10), Georgetown (C-422/10), University of Queensland (C-630/10), Yeda (C-518/10) and Daiichi Sankyo (C-6/11). All five cases related to combination products and between them addressed three central issues.
1. Can an SPC be granted directed to a combination of active ingredients (A+B) based on a market authorisation referring to a combination of active ingredients (A+B) when the basic patent refers to/claims only a single active ingredient (A) and does not explicitly refer to/claim A+B?
2. Can an SPC be granted directed to a single active ingredient (A) when the market authorisation also refers to other active pharmaceutical ingredients (e.g. A+B)?
3. Can an SPC be granted directed to a single active ingredient (A) when the basic patent refers to/claims only a combination of active ingredients (e.g. A+B)?
These issues arose because some parties held that only the wording of the claims is relevant for the purpose of determining whether a product is protected by a basic patent, whereas other parties maintained that any combination of products that directly infringe the basic patent should be held to be protected. These conflicting positions were resolved by the CJEU decisions as follows:
1. An SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent should not be granted.
2. It is permitted to grant an SPC relating to a single active ingredient in circumstances where the supporting market authorisation refers not only to that active ingredient but also to other active ingredients; likewise it is permitted to grant an SPC directed to a combination of active ingredients in circumstances where the supporting market authorisation refers not only to that combination of active ingredients but also to other active ingredients.
3. An SPC cannot be granted directed to a single active ingredient if the wording of the basic patent refers to/claims only a combination of active ingredients. In other words, an SPC directed to a combination of active ingredients A+B cannot be based on a basic patent that claims only A, however an SPC directed to A may be based on a market authorisation that refers to A+B (and any other number of further active ingredients). In the latter case, such an SPC is permitted only if the wording of the basic patent refers to A alone; such an SPC cannot be based on a basic patent that claims only A+B.
The CJEU stressed that the decisions placed considerable weight on the fundamental objectives of the relevant EU regulations and the intent of the legislators when drafting them. In particular, it noted that if the holder of a patent relating to an innovative active ingredient or an innovative combination of active ingredients were to be refused an SPC on the ground that the active ingredient(s) coexist in the marketed product alongside other active ingredients, the fundamental objective of the EU regulation would be undermined.
The importance of SPCs was again highlighted when not long after the above decisions the CJEU was asked in Novartis v Actavis (C-442-11) to address an issue relating to the scope of protection afforded by an SPC relating to a combination product. The CJEU held that a medicinal product containing a combination of active ingredients does infringe an SPC directed to a single active ingredient contained within the medicinal product. The decision follows the same logic applied in the Medeva and Georgetown cases.
The rulings of the CJEU have provided increased clarity which is welcome news for the pharmaceutical industry, however some issues remain unresolved in light of the Medeva and Georgetown decisions. In particular, the CJEU essentially created a new test for determining what constitutes a “product protected by a basic patent”. The test is now that a product protected by a basic patent is one that is specified in the wording of the claims of the basic patent. However, what does “specified in the wording of the claims” actually mean? For example, does it cover generic classes of active ingredients or active ingredients defined by Markush formulae? Alternatively, it could mean that any active ingredient must be individually referred to in the claims. At present, the answers to these questions are not clear. This has an effect not only on pending and future patent/SPC applications but also on the validity of SPCs already granted. It seems that only further referrals to the CJEU will provide the additional clarification required. Until then, these issues will be decided by individual national patent offices and national courts across the EU. As we have seen previously, their approaches can vary significantly. There are however measures that can be taken now to ensure that your SPC protection across Europe is as effective as possible. Now may therefore be the time to review your SPC portfolio and if necessary take action to make it stronger and more robust.
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