Supplementary Protection Certificates: Court of Justice provides answers ... but more questions too!

We have reported previously on the progress of two cases (“Medeva” and “Georgetown”) concerning the requirements for an SPC (supplementary protection certificate) to protect a combination medicinal product (see here).  These cases were ultimately referred to the Court of Justice of the European Union (CJEU) and the Decision has now been handed down.

Background

In the European Union, an SPC can extend the period of protection of a patent relating to a new drug by up to five years.  The extension is based on the length of time that it takes to obtain regulatory approval to market the product and is intended to compensate the patent holder for the erosion of effective patent term during the pre-approval period.  An SPC can only be obtained for a medicinal product if:

 a. the product is protected by a patent, known as the “basic” patent; and
 b. the product is the first to receive a marketing authorisation for the particular “active ingredient or combination of active ingredients” contained therein.

The Medeva case

Medeva B.V. was the owner of European patent number EP(UK) 1666057.  This patent protected its Pertussis family of vaccines - four vaccines in total - each of which contains several active ingredients (antigens), including peractin and filamentous haemagglutinin.

The patent claimed methods of making vaccines containing peractin and filamentous haemagglutinin.  As patent expiry approached, Medeva filed five SPC applications with the UK Intellectual Property Office in order to extend the term of protection for these vaccines.

Medeva had defined the “product” for the purposes of the first SPC application as the combination of peractin and filamentous haemagglutinin only; the remaining four applications carried a product definition which required the presence of peractin and filamentous haemagglutinin and further active ingredients.

The SPC application was rejected by both the English High Court and the Court of Appeal, who referred questions to the CJEU requesting clarification as to what the term “protected by the basic patent” was intended to mean.

The Georgetown case

The facts of the Georgetown case are very similar to those of the Medeva case in that the basic patent claimed an antigen, whereas the marketing authorisation was for a multi-antigen vaccine including additional antigens which had not been specifically claimed.  The SPC applications were refused by the UK High Court for reasons analogous to those in the Medeva case.

Decision of the CJEU

In cases of this type, many SPC applicants have argued that the product is “protected” by the basic patent if manufacture of the product would infringe the basic patent (the so-called “infringement test”).  The CJEU has now stated that this test does not apply.  Instead the CJEU says that the product is “protected” by the basic patent if the active ingredient or combination of active ingredients, are “specified in the wording of the claims”.  In an interesting twist, it was also indicated that an SPC relating to a given active ingredient (or combination) would cover, for the purposes of infringement, a third party product containing that ingredient or ingredients, even if it contained other active ingredients as well.

The CJEU has also confirmed that the mere fact that a marketing authorisation covers a product including several active ingredients does not preclude it being used as the basis for an SPC where the basic patent claims only one or a combination of only some of those active ingredients.  The marketing authorisation concerned must still, however, be the first authorisation to place the active ingredient(s) in question on the market.

These aspects of the decision may allow cautious optimism for those seeking SPCs.  However, the CJEU also addressed the question of whether more than one SPC can be granted for one basic patent, and apparently concluded that this should not be possible.  This may therefore preclude the granting of multiple, separate SPCs to protect multiple drugs covered in a single basic patent.  In view of this aspect of the decision it may be necessary in future for innovators to file multiple patent applications intended to protect specific products. 

Whilst this decision improves certainty in some areas, it does raise further questions.  In particular, it remains to be seen to what extent the active ingredient must be “specified” in the wording of the claims of the basic patent.  Many pharmaceutical patents claim products in terms of classes of compounds and it is not yet clear whether the identification of a generic class of compounds will be regarded as “specifying” the relevant compounds sufficiently for SPC purposes.

It remains to be seen how this decision will affect SPC and patent filing practice in the pharmaceutical sector.  It seems possible that more patent applications will be filed in view of the requirement that only one SPC may be granted per patent.  It may also be the case that, to ensure a product is “specified” in the patent, there will be an increase in the filing of applications which are of narrow scope and intended purely to cover the anticipated commercial product.  In practice, however, this will pose difficulties since it is often well after the filing of initial patent applications in a development project that important candidate compounds will be identified by the innovator.

There are undoubtedly positive aspects of this decision for pharmaceutical innovators.  However, doubts have been left (or even raised) in certain key areas, and it will now be important for the national courts to determine how the CJEU’s decision should be implemented in practice.

Joanna Westwood
Nicholas Jones
Life Sciences & Chemistry Group