Further SPC Granting Guidelines
J.P. Hustinx, G. Kuipers en T. Douma, Further SPC Granting Guidelines, DeBrauw Legal Alert december 2011.
Bijdrage ingezonden door Jan Pieter Hustinx, Gertjan Kuipers en Tjibbe Douma, De Brauw Blackstone Westbroek. Zie onderaan voor een interessante tabel.
In addition to its recent judgments in the Medeva and Georgetown cases (24 November, click here for the legal alert) and the Merck case (8 December, click here for the legal alert), the Court of Justice ("CJ") of the European Union handed down three orders in Supplementary Protection Certificate ("SPC") cases which did not receive much attention. Nevertheless, the Yeda (C-518/10), Queensland (C-630/10) and Daiichi Sankyo (C-6/11) orders of 25 November 2011 provide some interesting clarification on the granting of SPCs by national Industrial Property Offices ("IPOs"), especially as regards product-by-process claims and combination products.
Yeda (C-518/10): if the patent claims only a combination, can an SPC be granted for an individual active ingredient?
Yeda owns a European patent that discloses a therapeutic composition A+B. The patent also claims the administration of both components separately, provided they are part of the same composition. Yeda applied for two SPCs, one for the composition A+B and one for active ingredient A only. The supporting Marketing Authorisation ("MA") only covered product A, but indicated that it should be administered together with B. Both SPCs were refused by the British IPO. Yeda appealed and, following a referral by the Court of Appeal, the CJ clarified that an SPC cannot be granted:
"(…) where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone."
Hence, no SPC for Yeda. This further narrows the "disclosure test" for Article 3(a): if the patent claims A + B in combination, an SPC cannot be granted for just A.
Queensland (C-630/10): One patent = one SPC? One MA = several SPCs?
Queensland is the owner of a parent patent and two divisional patents. The parent patent claims two active ingredients (by product-through-process claims), and the divisional patents claim additional active ingredients. The MA relied on for the SPC applications, contains a combination of active ingredients both from the divisional patents and from the parent patent. The actual CJ ruling regarding most questions referred is no surprise and a literal copy of the rulings in the Medeva case. However, an interesting paragraph in Yeda is:
"Moreover, where a product is protected by a number of basic patents in force, each of those patents may be designated for the purpose of the procedure for the grant of a certificate, but only one certificate may be granted for a basic patent (…)." (paragraph 35)
Although that case concerned a patent family, this consideration is worded in broader form. It implies that one MA concerning a combination of active ingredients can be relied on for several SPC applications, provided the constituting active ingredients are specified in the wordings of the claims of different basic patents (and provided the other requirements of Article 3 are also met). We are of the view that, contrary to the wording of the CJ, it should also be possible to obtain more than one SPC relying on the same basic patent in case the patent claims several active ingredients independently (i.e. not as part of a combination).
Queensland (C-630-1-): product-by-process claims and SPCs
A new question at issue in Queensland was whether in a case involving a basic patent relating to a product-by-process claim, it is necessary for the ‘product’ to be obtained directly by means of that process. The CJ clarified that it is irrelevant whether the product is derived directly from the process, but that an SPC can only be granted for a product identified in the wording of the claims of the patent. In other words, if the product is not specified, no SPC is possible for that active ingredient.
Daiichi: combination products
Daiichi owns a patent regarding an active ingredient A. It obtained an SPC for this product based on an MA containing A as sole active ingredient. Daiichi invested considerable time and resources in undertaking clinical trials and studies in order to secure an MA for a combination therapy of A+B. This was successful and Daiichi then sought an SPC relying on the MA for the combination product and on the same basic patent. The British IPO refused this second SPC for the combination therapy on the grounds that the active ingredients of the MA are not covered by the basic patent. In confirming the IPO's decision the CJ uses the exact wording of the Medeva case, clearing all doubts that Medeva is not limited to multi-disease vaccines but applies to all combination products.
Summary of the present situation for easy reference: what do the decisions mean in practice
CASE | Basic Patent Claims: | MA in place for: | SPC |
Medeva | Combination A+B | A +B +C+D multi-disease vaccine | A+B |
Yeda | Combination A+B | A (+C) | No SPC possible |
Queensland Several basic patents | 1. A+B 2. C 3. D | A+B+C+D | 1. A+B (based on patent 1) 2. C (based on patent 2) 3. D (based on patent 3) |
Queensland Product through process | A claimed in the wording as (in)direct product of the process claim | A (+B + C) | A |
Queensland a contrario Product through process | A product of process but A not specified in the wording of the claim | A (+B + C) | No SPC possible |
Daiichi | A | A+B combination therapy | A |
