"The use of vaccines in the prevention of disease is nothing new and they are often protected by patents and supplementary protection certificates ("SPCs"). However, in more recent times, two developments have taken place:
(i) guidance has come from regulators that treatment of populations with vaccine combinations is preferred to single vaccines, and
(ii) there has been an increased need to use adjuvants with vaccines to improve their efficacy.
Both of these developments have placed strain on the legislative regime governing SPC protection (the "SPC Regulation"), which whilst intended to supplement patents for the protection of investment in medicinal products, was not drafted with such combinations in mind.
Deciding whether certain classes of medicinal products should be protected by SPCs and, at the same time, maintaining a clear and consistent application of the SPC Regulation has been difficult for the courts. One UK Court of Appeal judge was forced to state that the SPC regime risks failing large areas of pharmaceutical research, making it 'not fit for purpose'. In addition, a UK High Court judge has said that it is "dysfunctonal'. However, until very recently, the interpretation of the SPC Regulation on the subject of SPC protection for combination, including vaccines, had achieved a measure of clarity for makers of combination products. However, an apprent attempt by the Court of Justice of the European Union in Nurim to respond to the commercial argument for wider protection by SPCs expressed by the Court of Appeal judge, has now caused disarray. In that case the court used a so-called teleological approach to theinterpretation of the SPC Regulation that appears to contradict earlier case that were thought to have settled on a strict approach. It is this disarray that caused the frustration expressed by the latter High Court judge and a further reference the the CJEU.
The case referred, GlaxoSmithKline Biologicals v Comptroller-General of Patents, is where these issues have now come to a head. It concerns vaccines again - adjuvant and vaccine combinations - and takes the SPC regime to a fork in the road: the CJEU can choose to go the new teleological route, or stick to the strict approach. Whichever way the CJEU chooses to go it is likely to have far-reaching commercial consequences for certain medicinal products, such as vaccines, and the pharmaceutical industry in general".This blog will use its good services to see if it can persuade the publisher -- who has been kind to us in the past -- to let us host the entire text of this piece.