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| Will our correspondent be applying for a Supplementary Holiday Certificate ...? |
"Dear SPC Blog
Sorry for harking back to the Medeva AG opinion (but its holiday season and some of us have been away!)
As regards the first question in this reference - what is meant by "the product is protected by a basic patent in force", it seems to me (unless I have missed something) that the AG has -- in rather an off-hand manner -- answered this in passing somewhere around the late 60s (paras).
- In para 67 she makes reference to the "subject matter" of a patent when she states that the subject matter of each of the three categories of patent referred to in Art 1(c) (i.e. product, process and use) is always the "active" [not sure if this is correct -- but anyway].
- In para 68, she then appears simply to proclaim that "the subject matter" of a patent equates to the "extent of protection" of that patent. [So there we have her answer: "protected by a basic patent" = "the subject matter of a basic patent"]. Somewhat bizarrely, she then differentiates this concept of "extent of protection" from "the protective effect" of the basic patent (despite the obvious link in the word "protect" in both phrases). Whilst there may indeed be a distinction between these two concepts, there appears to me to be no reasoning behind her proclamation that "extent of protection" equates to "the subject matter". [and anyway -- what does that mean?]
Looking at this from a wider perspective of the legislation - what does Art. 4 now mean?
- In para 69 she fortifies her position by stating "The decisive consideration in that context is the fact that the definition of the basic patent in Art 1(c) of [the Regulation] takes as its basis the subject matter of the patent, and not its protective effect." (emphasis in original). Again, there seems to be no basis for this statement, despite the fact that Art. 1(c) uses the word "protects" and not "subject matter". Nevertheless, the entire remainder of the Opinion is built on this "rock" of principle - that "protects" in Article 1(c) actually means "is the subject matter of", and "protected by" in Art. 3(a) actually means "the subject matter of".
- That article is entitled "Subject matter of protection". Should this be construed (in the context of this Regulation) as "Subject matter of subject matter"?
- The substance of Art. 4 states: "Within the limits of protection conferred by the basic patent …". Does this therefore mean "Within the subject matter of the basic patent"?
As ever, readers' thoughts and comments are invited.Finally, does this mean we now have to refer to this Regulation as the 'Supplementary Subject Matter Certificate Regulation'?
- Art. 4 goes on: "the protection conferred by a certificate shall extend only to the product …". Does this mean "the subject matter of the certificate shall extend only to the product …"? If that is the case, how does her inference that SPCs for active(s) forming only part of multi-active medicinal products will protect those multi-active medicinal products stack up?
Back from Holiday and Confused".
"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".
"On 12 May 2011, the Court of Justice of the European Union (CJEU) heard the joined cases of Medeva (Case C-322/10) and Georgetown (Case C-422/10) - both references from the UK Courts on the interpretation of certain provisions of Article 3 of the SPC Regulation (EC Regulation 469/2009).For those readers who are not intimately familiar with the issues referred (and thus may have inadvertently stumbled across this blog), Article 3 of the SPC Regulation sets out certain conditions for an SPC to be obtained. Article 3(a) requires that at the time the SPC application is made, the product which is the subject of that SPC must be “protected by a basic patent in force”. Article 3(b) requires that “a valid authorisation to place the product on the market as a medicinal product” has been granted at the time that the application for the SPC is made.Representatives for Medeva, Georgetown, the UK and Portuguese Governments, and the Commission gave oral submissions to a panel of five judges: (Jean-Claude Bonichot (France), Lars Bay Larsen (Denmark), Camelia Toader (Romania), Alexandra Prechal (The Netherlands), and Egidijus JaraĊĦiunas (Lithuania)).Medeva and the UK Government advocated applying a so-called “infringement test” when considering Article 3(a), such that a combination of A+B would be protected by a patent for A because the patent would be infringed by the combination. For the UK Government, this represents a complete shift in thinking from the position previously adopted by the UK IPO on this issue. From the oral submissions made to the Court at the hearing, it was unclear what approach the Commission would prefer.On Article 3(b), Georgetown and the Commission both considered that this should be interpreted so that a marketing authorisation (MA) for A+B could be specified as a valid authorisation to obtain an SPC for A, if the MA for A+B represents the first approval for A. The UK Government was opposed to this idea.At the hearing, reference was made to questions submitted by the Court to the parties and the other bodies represented at the hearing on Article 4 (Subject Matter of Protection) and the Biogen decision (C-181/95). Those questions and the answers submitted to the Court have not been made public. However the representative for the Commission stated that an analysis of Article 4 was not necessary in order to be able to interpret Article 3.The opinion in these cases will be delivered on 13 July 2011 by Advocate-General Verica Trstenjak of Slovenia. The actual decision of the Court – which of course may follow the AG’s opinion or deviate from it - will follow several months later."
Just in case you're not immune to issues around SPCs for HPV vaccines, here's the latest juicy case (BL O/335/10) that was decided before the UK Intellectual Property Office (IPO):
The University of Queensland and CSL Limited filed 8 SPC applications at the IPO: 6 different applications to single Human Papilloma Virus (HPV) L1 protein virus-like particles (VLPs) (2 applications for HPV 16, 2 applications for HPV 18, 1 application for HPV11 and 1 application for HPV6), 1 application for a product comprising HPV16 and HPV18 L1 protein LPV, and 1 application for a product comprising HPV6, HPV11, HPV16 and HPV18 L1 protein LPVs. The applications were based on basic patents EP 0595935, EP 1298211 and EP 1359156. The marketing authorisations for Cervarix and Gardasil/Silgard were used to support the applications.
The issues raised here are similar to those in the Medeva and Georgetown et al. cases and concern the interpretation of Articles 3(a) and 3(b) of the Regulation. The IPO therefore proposed to defer further consideration of the applications until the outcome of the references to the Court of Justice of the European Union (CJEU) in relation to the Medeva and Georgetown cases. The applicant however requested a decision to be issued based on the papers on file so that, if the IPO were to refuse the applications, the decision could be appealed and a further referral to the CJEU could be made and considered at the same time as the other HPV-related cases.
The hearing officer, Dr. L. Cullen, found that the 6 SPC applications directed to single HPV L1 protein VLPs did not meet the requirement of Article 3(b) of the Regulation because neither of the MAs cited was a valid authorisation to place any of the single HPV L1 protein VLP products on the market as a medicinal product. Each MA related to a combination of active ingredients rather than a single active ingredient.
Moreover, the HPV combination applications did not meet the requirement of Article 3(a) of the Regulation because the basic patents did not protect combination HPV L1 protein VLP products, but only related a method for preparing single HPV L1 protein VLPs, HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in the patents suggested that the single HPV products could be used in combination with each other.
The applications were rejected in accordance with Article 10(4) after the application was provided with an opportunity to correct the irregularities of the application.
The complete decision is available here.
