European Court of Justice rules
SPCs not available for certain combination products
On 4 May 2006, the European Court of Justice handed down its decision in Case C-431/04
in relation to the grant of Supplementary Protection Certificates (SPCs) for certain types of combination products.
Take home
An SPC can not be granted for these types of formulation patent. To paraphrase the European Court of Justice – an SPC will not be granted for a product which has a combination of two substances in which only one of the substances has a therapeutic effect while the other acts to make possible this therapeutic effect.
In other words, a substance which makes the therapeutic effect of another substance possible, but has no therapeutic effect of its own, is not an ‘active ingredient’ within the meaning of the regulation.
Comment
There has been a lot of controversy over this case. Many saw it as a chance for innovator companies to obtain SPCs for formulation patents. While this closes the door on one of the most promising attempts to broaden the classes of patents for which SPCs are granted, this is quite unlikely to be the end of such attempts.
Some countries outside Europe will grant patent term extensions based on the same policy rationale (see below). However, interestingly, in some circumstances the relevant patent need not be restricted to claiming only a pharmaceutical active ingredient. See for example the recent Australian Federal Court decision in Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305 (29 March 2006). (under 35 USC §156) are similarly uninhibited.
Background
Supplementary Protection Certificates
SPCs are designed to compensate developers of new drugs for delays in obtaining regulatory approval by granting a maximum of 15 years monopoly on marketed drugs.
An SPC is not a patent extension - it only comes into effect after expiry of the relevant patent. An SPC may last for up to a maximum of five years. The SPC is not an automatic right and has to be applied for in each individual state.
The length of an SPC period is calculated by calculating the time difference between the date of first marketing approval in the first EU State and the patent application date and then subtracting five years. If the result is more than five years, then the maximum five year term is granted.
The case
Massachusetts Institute of Technology holds a European patent for Gliadel Wafer
, which is implanted into the cranium for the treatment of recurrent brain tumours. The mechanism of action consists of slow release of carmustine, a highly cytotoxic active ingredient, by the action of polifeprosan, which acts as a bio-erodible matrix.
MIT has licensed the patent to Guilford Pharmaceuticals Inc., a
U.S. biotechnology company owned by
MGI Pharma Inc.
The case concerned interpretation of Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992. Article 1 provides:
‘For the purposes of this regulation:
(a) “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) “product” means the active ingredient or combination of active ingredients of a medicinal product;
(c) “basic patent” means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
(d) “certificate” means the supplementary protection certificate.’
Article 3 sets out the conditions for obtaining an SPC and provides:
‘A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate …;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.’
Click here for a handy guide to SPCs from the UK Patent Office.
For the IPKat’s thoughts and associated comments, click here.
For commentary from Patent Baristas, click here.
Duncan Bucknell
May 2006
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