Patent term extensions (SPCs) for combination products
Often marketed medicines in Europe are authorised as a combination product containing a combination of active ingredients. In some instances, combinations of active ingredients achieve marketing authorisation later than their individual counterparts. To maximise IP protection and compensate for the regulatory delays in bringing these innovative products to market, patentees often seek patent term extensions in Europe and the UK in the form of Supplementary Protection Certificates (SPC) for the specific combination product as well as the individual counterparts.
However, combination SPCs have been the subject of many referrals to the Court of Justice of the European Union (CJEU). A further set of questions has recently been referred to the CJEU seeking clarification on whether a second SPC to a combination of active ingredients can be granted to the holder of a first SPC protecting just one of the active ingredients.
The CJEU has already issued decisions outlining whether a combination SPC is protected by a basic patent as required by the SPC Regulation and outlining which marketing authorisation (MA) is deemed the “first” marketing authorisation for combination products. As outlined below, the divergence in the application of these decisions by the national courts suggests that there is still uncertainty regarding the interpretation of the SPC regulation with respect to combination SPCs.
When are combination products deemed “protected by” the basic patent?
The SPC Regulation requires that an SPC is granted if the product is “protected by” a basic patent that is in force.
Initially, the CJEU ruled in Actavis I and Actavis II that an SPC for a combination product is not protected by the basic patent where the “core inventive concept” of the patent only relates to one of the active ingredients in a monotherapy. Thus, SPCs for combination products must be based on basic patents where the core inventive concept relates specifically to the combination product.
However, more recent decisions of the CJEU have firmly rejected the “core inventive concept” test. In decisions, Teva and Royalty Pharma the CJEU took a broader approach and ruled that a combination product is protected by a patent if the combination is “specifically identifiable” in the patent. This interpretation can lead to
would result in combination products that arguably fall outside of a patent’s core inventive concept being deemed “protected”. For example, if the main claim is directed towards a single active ingredient, which is considered the core inventive concept, but there is a dependent claim towards the combination product, which would be deemed protected by the basic patent.
The conflicting tests laid down in these decisions have resulted in national courts coming to different conclusions on which combination products are protected by the basic patent. For example, various national courts have come to different conclusions on whether Merck’s combination product INEGY®, which contains the active ingredients ezetimibe and simvastatin, is protected by the basic patent. The basic patent relates to ezetimibe and states that ezetimibe may be administered with a list of known statins, including simvastatin. The combination of active ingredients was specifically identifiable in a dependent claim. However, simvastatin was well known at the priority date of the basic patent and the core inventive concept of the patent was directed to ezetimibe alone and not in combination with simvastatin.
The Irish, French, Spanish and German courts all found that the basic patent did not protect the combination product. Conversely, the Portuguese and Belgian courts came to the opposite conclusion since the combination is explicitly claimed.
Does the “one SPC per product per patent holder” rule apply to combination SPCs?
The SPC Regulation states that an SPC can only be granted if the product has not already been the subject of an SPC. In practice, this is interpreted to mean that different holders of basic patents can each be granted on SPC for the same product, but the same holder of several patents cannot be granted more than one SPC for the same product. Therefore, this has become known as the “one SPC pre product per patent holder” rule.
The considerations above on whether the product is “protected by” the basic patent also have an impact here on determining whether the product has already been the subject of an SPC.
Therefore, the diverging decisions of the national courts with respect to whether the basic patent protects the product also pose difficulties for the assessment of whether the same holder of several patents can be granted more than one SPC.
Referrals to the CJEU
Both the Finnish Market Court and Supreme Court of Ireland have referred questions up to the CJEU to clarify how they should be interpreting the previous case law in relation to combination products.
The Irish referral stems from Merck’s combination product INEGY® mentioned above. The Supreme court of Ireland referred 4 questions to the CJEU, which can be found here. The first question asks generally which test should be used and, if the narrower “core inventive concept” interpretation should be used, how should this be assessed. Questions 2-4 relate to combination products specifically, namely:
- whether an SPC can only be granted for active ingredient A, or whether the combination of active ingredients A+B may also be granted an SPC;
- if an SPC is granted for A, whether this precludes the subsequent grant of an SPC for A+B, and vice versa; and
- whether the grant of an SPC is limited to: (a) only A, if A is marketed as a product, (b) the first marketing of a product covered by the patent, regardless of whether this is A or A+B, or (c) whether both (a) and (b) are permitted at the discretion of the patent holder.
The specific questions referred by the Finnish Market Court are not available, but the referral stemmed from a challenge by Teva against Merck’s combination product JANUMET (sitagliptin and metformin) and the questions relate to specifically to the “one SPC pre product per patent holder” rule.
What is deemed the “first” marketing authorisation for a combination product?
The SPC Regulation also requires that the marketing authorisation (MA) must be the first MA to place the product on the market.
In Santen, the CJEU ruled out the possibility of an SPC for a product based on a second marketing authorisation of any form, regardless of whether the second authorisation was for a new formulation, route of administration or indication. This decision overturned the controversial Neurim decision, which had found that the first marketing authorisation is the first “relevant” authorisation i.e. the first authorisation for a product which falls within the claims of the basic patent.
It was thought that Santen would eliminate the possibility or having SPCs for combination products granted where one of the active ingredients is already the subject of an SPC. However, the Irish court of appeal in the Merck case highlighted above found that an SPC could be granted for the combination product INEGY®, which contains the active ingredients ezetimibe and simvastatin, despite the active ingredient ezetimibe being the subject of an earlier SPC. The decision issued by the Irish court of appeal thus raises questions over how to apply Santen in determining which is the “first” marketing authorisation for a combination product.
While we will have to wait for the CJEU’s judgment on these matters, the referrals add a further layer of uncertainty into how best to apply for SPCs where the product is a combination of active ingredients and conversely how best to attack an SPC granted for a combination product.
A further level of complexity is added for GB SPCs since the English Courts are not bound to follow decisions issued by the CJEU following the UK’s exit from the European Union, so it is unclear what test the UK-IPO will follow.
While we await these decisions, Forresters can advise you on how best to protect your SPC position for combination products. We have been expertly helping our clients navigate through the complexities.
If you have any questions concerning SPCs, please contact your usual Forresters attorney who will put you in touch with one of our SPC experts.
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