Supplementary Protection Certificates (SPCs) – which extend the patent life of a medicine for up to five years - are a valuable prize in the lucrative pharmaceutical market. It is not surprising, therefore, that the conditions for grant of an SPC under EU Regulation 469/2009 have been subject to intense scrutiny by the courts. An Advocate General’s (AG’s) opinion issued in September this year seeks to clarify the circumstances in which an active ingredient that is not specifically mentioned in the patent claim can qualify for an SPC.
Functional and Markush claims
The reference to the Court of Justice (CJEU) combined questions from the German Bundespatentgericht and the UK Court of Appeal. The German case (Royalty Pharma v German Patent Office)[i] related to a method for using “DP IV inhibitors” to lower blood glucose levels. Royalty Pharma’s application for an SPC for Sitagliptin had been refused by the German Patent Office because, although it satisfied the functional definition of the basic patent, it was not specifically disclosed in it. The English case (Sandoz v Searle[ii]) related to Searle’s SPC for “Duranavir”, used in the treatment of AIDS. Searle’s basic patent claimed a Markush formula covering a very large class of compounds which were not listed in the patent. In both cases, therefore, the question arose as to whether an active ingredient which was covered by the patent claim but not specifically mentioned in the patent could qualify for an SPC.
A two stage test
The Advocate General advises that active ingredients covered by a functional definition or Markush formula can qualify, provided the two-step test set out in the leading case of Teva v Gilead[iii] is met. He also advises that this test applies both to combination products (as in Teva) and to single active ingredient products as was the case here. Under the two-step test:
- the active ingredient(s) to be protected by the SPC must “necessarily” fall within the patented invention in the light of the description and drawings, and this test will not be satisfied unless the claims in the patent relating to the active ingredient(s) are “required for the solution of the technical problem disclosed by the patent”, and also
- each of the active ingredients must be specifically identifiable in the light of the information disclosed in the patent, and this test will not be satisfied unless a person skilled in the art is able to derive the product in question in the light of the information contained in the patent.
These two steps are to be judged through the eyes of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent.
Implications of the case
One can detect a certain exasperation on the part of the AG – he indicates that he believes that the test in Teva was clear and that the English and German courts had no real need to refer these questions. He also emphasises that the two step test is enough, and that the question whether the active ingredient embodies the “core inventive advance”, which has been applied by the English courts and the courts of some other Member States is irrelevant. The Opinion also highlights that an SPC will not be available to cover the results of research carried out after the priority date of the patent – compliance with the two steps is to be judged as at the priority date of the basic patent rather than at the time of application for the SPC. Overall, on the assumption that the Opinion is followed by the Court, it provides welcome clarification, particularly in relation to the point about the core inventive advance. However, ominously, commentators are already pointing out that ambiguities remain; for example, how will the requirement that the active ingredient must be “required for the solution of the technical problem disclosed by the patent” be interpreted in applications for SPCs for combination products where one of the active ingredients is “merely as an optional component” [iv]. Patent practitioners and their pharmaceutical clients now await the CJEU’s judgment with interest.