More than one for the same product certainly - but who to? - and
what about the damages?
In the last patent review we reported the Advocate
General's Opinion in the European Court of Justice (ECJ) in Biogen
-v- SmithKline Beecham Biologicals (SBB). The Court has adopted the
Advocate General's Opinion.
The facts are as follows. Biogen is the holder of
two European patents. The relevant product, Engerix-B, is sold by
SBB under four Belgian marketing authorisations. Biogen required
copies of those authorisations in order to apply for a
Supplementary Protection Certificate (SPC). SBB refused to supply
those copies. However SBB did provide copies of the marketing
authorisations to the holder of other patents covering the
On application to it the ECJ held:-
- Where a product is protected by a number of basic patents held
by a number of patent holders each patent could be granted one SPC.
- The regulations did not require the holder of a marketing
authorisation to provide the patent holder with a copy.
- Where the holder of a basic patent and a marketing
authorisation were different and the product holder was unable to
provide a copy of the authorisation, the application for an SPC
could not be refused on that ground alone. It was open to the
national authority granting the SPC to get a copy of the marketing
authorisation from the national authority which issued
This decision raises the question as to what is the
position if a pharmaceutical group has made a number of inventions
which are embodied in a single pharmaceutical product and the
patents are held by a number of different companies in the group,
who have perhaps invented the different features, or just applied
for the individual patents, or into whose names the patents have
perhaps been transferred, simply so that a number of SPCs can be
sought? Would SPCs be granted to each company? Ones instinctive
reaction is "No" - but on reflection on the ECJ's decision "Why
not?" And for a valuable product in suitable circumstances the cost
of such an application might be well worthwhile, even if only
because the threat of the grant of an SPC might deter competition,
just as the existence of UK patent extension proceedings in the
past deterred competition.
But of course if they are worried about damages for
infringement the companies concerned will have to be careful to see
that appropriate licences or appropriate company structures are in
place to ensure that they will be able to recover damages, at least
in England, following the Court of Appeal's decision in Gerber -v-
Lectra (Reported in the 1997 UK Patent Review) confirming that the
patentee's loss must be strictly proved.
Supplementary Protection Certificates - but not
from a clinical trial
In the BTG Limited's Application the Comptroller
held that a clinical trial authorisation, which was only an
authorisation to carry out the particular trial, and which did not
comply with the requirements of Directive 65/65/EEC or 81/85/EEC,
as required by Article 3 of Regulation 1768/92, and did not contain
the required summary of product characteristics, was not an
authorisation which could be used as the basis of an application
for a Supplementary Protection Certificate.