This is based on a talk given by Beatriz San Martin at the
CIPA Life Science Conference on 14 November 2013. Her talk had the title ‘SPC’s - Are they Fit
for Purpose?’
1. The SPC Regulation
have been around for 20 years, but a lot of uncertainties remain. Given that there is a strong commercial incentive
for innovators and competitors to challenge the Regulation, purposive
construction has been exploited to interpret it in different ways. The Regulation is drafted vaguely to allow
for new technologies which emerge subsequently, but that has led to a lot of
uncertainty and a lot of referrals to the CJEU.
Unfortunately the CJEU is guilty of not providing clear decisions and
national judges are now reluctant to make decisions based on the Regulation if
any degree of interpretation is required.
The SPC Regulation works well for traditional medicines,
i.e. those with single active ingredients, where it is the first marketing
authorisation (MA) and it is covered by basic patent. However, uncertainty quickly arises for
situations beyond this, e.g. combination products or where the product is being
used for another therapeutic indication.
2. Most people assume
that the objective of SPC’s is to compensate for patent protection which is
lost due to regulatory delay. However
the explanatory memorandums and recitals for the SPC regulations for pharmaceutical
and plant products do not refer to this.
Instead the objectives are stated to be protection for high levels of investment,
to maintain high levels of research in these areas and to maintain competitiveness.
3. What is the
product? Article 3 of the Regulation
refers to a product which is protected by a basic patent and which is the
subject of an MA and SPC. The assumption
would be that it is the same product in
these three cases. Article 1 defines the
product as an active ingredient or a combination of active ingredients. The explanatory memorandums and recitals
provide guidance and suggest a strict definition, so that different salts or
use of different excipients could not lead to a subsequent new SPC.
4. The question of
what the product can be was the subject of GSK C-210/13 concerning whether an
SPC was possible to an adjuvant on its own and or in combination with a flu
vaccine. Judge Arnold from the UK referred
this to the CJEU because the law was not clear and because there were diverging
decisions across the EU. The essential
question was ‘can an adjuvant be an active ingredient?’. The Neurim decision had previously caused a
lot of uncertainty as to defining a product.
Before Neurim, MIT C-431/04 had established a strict approach where an excipient
was not considered an active ingredient.
However Neurim used a purposive construction of the Regulation [Subsequent
to this talk the CJEU now said decided in GSK C-201/13 that an adjuvant is not
an active ingredient because it does not give a therapeutic effect when used on
its own]
5. There is a similar
situation in Bayer Cropscience C-11/13 for a plant protection product. The decision concerns lsoxadifen which is a safener
used to prevent the harmful action of herbicides. The question is whether a safener can be an
active substance. [Subsequent to the
talk the Advocate General has given the opinion that a safener can be an active
substance for the purpose of the SPC Regulation, but the CJEU has yet to decide]
6. Another issue
concerns the relationship between the product and the basic patent. In Medeva C-322/10 it was held that the SPC
product had to be specified/identified in the wording of the claims of the basic
patent. In that case the patent claim
referred to a product with 2 active ingredients, but the product in the MA and
SPC had in addition to those 2 ingredients other active ingredients. Thus the SPC could not rely on that
patent. The UK Court of Appeal criticised
the CJEU’s decision as not providing proper guidance and being unclear. The Medeva decision led to uncertainty in national
courts and notably in the case of the Irbesarten and HCTZ combination litigation
it led to different decisions across the EU.
7. In Actavis v
Sanofi C-443/12 the patent claims refer to Irbesarten and a diuretic, but not specifically
to HCTZ, which is specified as the diuretic in the SPC. [Subsequent to the talk
the CJEU decided that since there is already an SPC for the main product a
subsequent SPC is not possible for the combination]
In Eli Lilly v HGS C-493/12 the question was whether an
antibody can be sufficiently identified by simply referring to what it binds,
or whether the structure is needed. [Subsequent to the talk the CJEU has now
said that a structure does not need to be given for an antibody, and it can be
defined just by reference to what it binds]
8. In a pending
referral Actavis v Boehringer C-577/13 the question is whether a patent can be
amended post-grant to solve the issue of mentioning a specification combination
product in the claims.
9. Georgetown
C-422/10 concerns how many SPC’s are possible per patent. [Subsequent to the
talk the CJEU has decided that it is possible to have more than one SPC per
patent where the patent protects more than one product]. A previous decision on this point, Biogen
C-181/95, could be interpreted both ways.
In Neurim C-130/11 the CJEU surprisingly said that a
subsequent SPC was possible because the earlier MA did not fall within the scope
of protection of the later patent.
10. Is it time for
reform of the SPC system given new technologies such as biologics and gene therapy,
and given the increased cost of developing medicines? The European Commission has
indicated to the CJEU that reform of the SPC system is on the political agenda.
You may also wish to see related articles 10
Points on Regulatory Data Exclusivity and Advice
for Scientists Setting up a Company.
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