The authors conclude as follows:
"The preamble to the SPC Regulation contains the following recital (10), which states that:See also The SPC Blog here.
All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should … be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.
The SPC Regulation thus seems to envisage a narrow scope of protection for SPCs, once they have been granted. But in his Erbitux® judgment, Lewison J seems to have used this reference in the preamble to justify a restrictive interpretation of the SPC Regulation when assessing eligibility, rather than the scope of protection. This is consistent with other judgments by the English courts, which have to date required correspondence between the product claimed in a basic patent as an active ingredient and the same product as an authorised medicinal product, before granting an SPC. Yet some active ingredients (such as cetuximab) are only ever authorised for use in combination therapies. In the field of biological medicines and in particular mAbs, by the time that an SPC can be applied for, there may no longer be a patent directly claiming the product itself, given the long development times of these products. A restrictive interpretation of the SPC Regulation (as seen in the Erbitux® decision) may exclude such valuable medicines from the possibility of supplementary protection in the future. Should then SPCs based upon the way in which a product is used be allowed (assuming that the granted patent protects, directly or indirectly, such use)? Whilst it is still possible for the ‘infringement’ test to prevail (given the Medeva reference), the answer to this question remains an open one. However, if a further development in the law was to allow SPCs to be granted on this basis, it will open up some further difficult questions, such as what happens when the use of the product
is changed after the initial marketing authorisation is granted, and how the issue of infringement of a certificate is to be resolved for any generic/biosimilar version of a product (given that the argument will be entirely about the question of indirect infringement). The SPC Regulation was drafted and introduced in the early 1990s, at a time when vertically integrated pharmaceutical companies relied upon novel chemistry, small molecule blockbuster products and patents to earn their revenues.
Today, the industry landscape has changed with the advent of biologics. Whilst it is interesting to observe that the English Court of Appeal has referred to the Court of Justice what is essentially a question of policy underlying the SPC Regulation (namely, whether there should be a stand-alone test for multi-diseases vaccines, in order to determine whether a product is protected by a basic patent in Article 3(a) of the SPC Regulation), we doubt whether the European Court will want to open Pandora’s box, by carving out exceptions to the SPC Regulation for novel products and treatments such as vaccines, combination therapies and even chemically-modified small molecules with improved pharmaceutical properties.8 For radical change of this kind, we suggest that there will need to be a more fundamental reform of the patent extension legislation for medicinal products in the EU.
Will the ECJ open the box?