Some comments on the Medeva, Georgetown Opinion

The Advocate General delivered his Opinion last week in the Medeva and Georgetown references for a preliminary ruling to the Court of Justice of the European Union (see earlier SPC Blog post here, which has attracted a record-breaking number of comments).

Since then we have received this link to a comment by Niklas Mattsson (Partner, Awapatent AB, Sweden). He succinctly observes:

"The opinion contains a very detailed analysis of the EU law on the subject, and is interesting reading. To summarize the AG’s position in relation to the ultimate question, however, does not take more than a few words: the AG is of the opinion that the infringement test is definitely not the correct test, but that national law still has to be applied in order to determine whether a combination product forms the subject-matter of the basic patent".

We have also received a briefing from Tim Powell and Rebecca Lawrence (Powell Gilbert LLP, London) who comment as follows:

"The references concerned SPC applications for vaccines. For public health reasons, it is desirable to have vaccines against multiple diseases combined in a single shot. However, this poses an issue for a patentee that has a patent against a component or sub-set of components of a multi-disease vaccine. If the "product" that is authorised in Europe is the multi-disease vaccine containing components A+B+C+D can an SPC be granted for a patent that only claims components A+B? The approach of the UKIPO and the UK courts has been to deny SPC protection in such cases, on the basis that there is a mis-match between the totality of the active ingredients of the authorised combination product and the subject matter of the patent. 

The Advocate General recognised that applying a literal interpretation of the SPC Regulation would lead to a conclusion that such SPC's should be refused. However, she was concerned that taking such a literal approach would not be in accordance with the aims of the Regulation as it would lead to the denial of SPC protection for extremely valuable combination products. In some therapeutic areas manufacturers find themselves obliged to include multiple components for legal or practical reasons. The Advocate General therefore adopted a "teleological" interpretation of the Regulation, concluding that it was possible to select a sub-set of components of a multi-component medicinal product as forming the subject matter of the certificate. A certificate could issue on this sub-set and would extend to all medicinal products containing that sub-set of active ingredients authorised before the certificate expires. However the abuse of "evergreening" (which had been of concern to the UK courts) would be avoided because a patentee could not apply for further SPC's of longer duration under the same patent even if later product approvals issue to the sub-set which is the subject of the SPC in combination with different active ingredients. 

On balance, this Opinion seems favourable to the research based pharmaceutical industry in that the Regulation has been interpreted to avoid an unduly harsh refusal of SPC protection".

Marjan Noor and Andrew Hutchinson (Simmons & Simmons LLP, London) comment thus:

"The AG notes the risk that a manufacturer could seek to obtain successive SPCs on the same patent based on differing combinations containing the same patented active (or combination of active), for example a first covering the patented active ingredient and a second SPC covering the patented active in combination with another active. To avoid 'such an undermining of the system', the AG states that the manufacturer must designate the patented active or patented combination of actives as its product and then only one SPC can be granted with respect to that product, consistent with Article 3(c) which requires that the product must not already be the subject of an SPC. 

The knock on effect is also seen in Articles 4 and 5 which concern the scope of an SPC. Articles 4 and 5 were also not the subject of the referral but the AG states that the SPC for a single active or combination of actives gives protection against unauthorised production and distribution of all subsequent medicinal products that contain that active or combination of actives. This issue has been the subject of pan-European litigation relating to Losartan, which have resulted in inconsistent decisions from the French and Belgian courts.

The Opinion creates confusion with respect to whether or not the number of SPCs linked to the basic patent is restricted to one. This would be a departure from current practice where there are examples of more than one SPC per patent. In the context of combinations, if a patent 'protects' both active A and combination A+B, currently the patentee can obtain SPCs on A and A+B on the basis that each would be interpreted as a different 'product'. However, the Opinion (at para 103) suggests that a patentee would need to pick either A or A+B, even if they are both protected by the basic patent. In light of the preceding paragraphs of the Opinion, it may be the case that the AG is considering the situation of combinations consisting of the patented product alongside other non-patented actives. In other words where a patent covers A+B and the patentee has an authorisation for A+B+C and one for A+B+D, an SPC would not be available for both as they would be with respect to the same product (ie A+B) - again consistent with Article 3(c). The AG may also have made these comments under an assumption that a patent does not cover A and A+B.

Though clearly influenced by the importance of vaccines in the medical field which appears to have led the AG to adopt her teleological approach, the AG states that there is no special case for multi-disease vaccines under Article 3.

If the ECJ follows the AG Opinion, SPCs on combination products will no longer need to mirror the exact combination the subject of the marketing authorisation. Instead a patentee would match its SPC product to the product the subject of its patent. A knock on effect is that the scope of the SPC would then be more commensurate with the scope of the patent, ie the SPC could be enforced against any unauthorised use of a product containing the product the subject of the SPC rather than be limited to the product the subject of the SPC. 

Interesting follow-on issues include:
1. How will the subject matter test be applied in practice? The Daiichi case referral may provide useful guidance in the absence of any harmonised European legal test for determining the subject matter of a patent.

2. Despite the AG's opinion in the context of combinations and the commentary on one SPC per patent, (a) where a basic patent protects A and A+B, would obtaining an SPC on A prevent a subsequent SPC on A+B on the same patent and (b) where a basic patent protects A and separately B (eg as part of a markusch formula - no combination intended), can the patentee have an SPC on each of A and B based on the same patent? 

3. Whether a combination product A+B the subject of its own separate patent is entitled to an SPC where the same patentee has already obtained an SPC on A based on an earlier patent and which would have been enforceable against A+B, given the AG's comments on Article 4?
As is customary with SPC law, no doubt many further questions will arise".