Supplementary Protection Certificates unavailable for new formulations of known drugs

On 4^th May 2006, the European Court of Justice (ECJ) issued a judgement on case C-431/04 which essentially rules out Supplementary Protection Certificates (SPCs) for new formulations of active ingredients. In this decision, it was decided that a novel formulation, comprising the combination of a known active ingredient with an inactive excipient, was not entitled to SPC protection. This decision runs contrary to the opinion expressed by the Advocate-General of the ECJ who advised on this issue earlier this year.

The case concerned the product Gliadel which is used to treat recurrent brain tumours after surgery. Gliadel takes the form of a disc that is implanted into the cranium following surgery on the tumour. It comprises a combination of carmustine, a biologically active substance for treating tumours, and polifeprosan, a polymer forming a biodegradable matrix. The polifeprosan polymer matrix degrades in the brain causing the slow release of the carmustine; the slow release helps to avoid toxic side effects. This formulation was the subject of a patent held by Massachusetts Institute of Technology (MIT). Upon receiving a Marketing Authorisation for Gliadel, MIT applied for a SPC for the product.

In the European Union, a SPC extends 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. A SPC can only be obtained for a patented medicinal product if that medicinal product is the first to receive marketing approval for the particular "active ingredient or combination of active ingredients" contained therein (Council Regulation (EEC) 1768/92).

In this case, carmustine was already known and used intravenously in chemotherapy and was already the subject of a SPC. However, MIT applied for a SPC covering the combination of carmustine and polifeprosan. It claimed that Gliadel was different from the previously known product containing carmustine since Gliadel was, it submitted, a combination of active ingredients. It argued that polifeprosan was an active ingredient as it was an essential component of Gliadel - it enabled carmustine to be administered in a therapeutically relevant way, thereby contributing to the efficacy of the medicine. The meaning of the term "active ingredient" was therefore the key issue in deciding whether Gliadel should be allowed to be the subject of a SPC.

The ECJ decided that the term "active ingredient" should be given a pharmacological meaning, i.e. a substance that has a biological effect on the human or animal body. Therefore, a substance which does not have a therapeutic effect of its own, but is used to obtain a certain pharmaceutical form of the medicine, is not to be regarded as an "active ingredient". Accordingly, the ECJ decided that MIT was not entitled to a SPC for its product Gliadel since the only "active ingredient" was carmustine which had already received marketing approval.

This ruling means that products comprising the combination of a known active ingredient with an excipient to form a novel formulation are not entitled to SPC protection, however different the novel formulation may be in terms of characteristics in use. Some national patent offices have allowed SPCs on such products; however, following this judgement, this practice should stop. This will allow generic entry onto the market for such products to occur sooner. Innovators developing beneficial formulations of this kind should therefore focus even more on obtaining marketing approval as soon as possible in order to maximise the protection offered by their patent monopoly, since SPC protection now seems not to be available.

Justin Wilson
Nicholas Jones
25^th May 2006