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). US patent term extensions (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.