Intellectual Property & Technology, Media and Telecommunications newsletter number 18, March 2012 European patent term extensions – recent developments in relation to Supplementary Protection Certificates for fixed-
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combination medicinal products
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issues outlined in this newsletter, or any other legal issues that may be
Japanese companies holding patents in European Union ("EU") member countries
relevant to your business, please do not hesitate to contact us.
may be aware of the possibility of obtaining Supplementary Protection Certificates ("SPCs") for various regulated, biologically active agents, including human medicaments. The purpose of an SPC is to encourage innovation by compensating Contacts
for the lengthy time needed to obtain regulatory approval of such products: SPCs allow companies to enjoy an additional five-year monopoly that comes into force
after expiry of the upon which it is based.
However, there has until now been uncertainty surrounding the application of SPCs to combination products. The most common example of a combination product is a vaccine which, for public health reasons, is normally administered as a biological preparation that contains several different active ingredients to target multiple diseases. In addition, national courts throughout Europe have reached inconsistent
views on the question of whether an SPC for one active ingredient is infringed by a
Dr Frederick Ch'en
(commercial) product that combines that active ingredient with another (or others).
Senior Associate – Intellectual Property Registered Foreign Lawyer
Two recent decisions of the Court of Justice of the European Union ("CJEU"),
namely Medeva (C-322/10)1 and Novartis v Actavis (C-442/11)2, have clarified these
difficult issues and provide a reasonably workable solution to those who wish to obtain and enforce SPC protection for vaccines and other combination products.
Obtaining an SPC for a Combination Product
Article 3 of the EU SPC Regulation3 states that an SPC may only be granted in respect of a product if the product is:
(a) protected by a basic patent in force; and
Graeme Preston Senior Associate – Technology, Media
(b) subject of a valid marketing authorisation, that is, an authorisation to place
Registered Foreign Lawyer Tel: +81 3 5412 5485
Compliance with these requirements of Article 3 has proved difficult in the case of
those who develop vaccines and other combination products, as can be illustrated
Medeva had a patent directed to a vaccine that contained two active ingredients, namely pertactin and filamentous haemagglutinin, that can be used for vaccination against whooping cough. Medeva filed five SPC applications based on its patent,
Four of the five SPC applications listed all of the active ingredients in the marketed
product (which contained pertactin and filamentous haemagglutinin in combination
with additional antigens as active ingredients). The United Kingdom Intellectual
Property Office decided that these SPC applications did not comply with Article 3(a) because not all of these active ingredients were specifically claimed by the basic patent. On the other hand, the fifth SPC application listed the products that were protected and claimed by the patent, but omitted some of the active ingredients in the marketed product. Although this fifth SPC application satisfied Article 3(a), it was
For the full text of the Medeva judgment, see
2 For the full text of the Novartis v Actavis order, see.
3 Regulation 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products.
Index of previous newsletters
found not to be compliant with Article 3(b) because it did not contain the same active
ingredients as the product on the market. Therefore, Medeva found itself in the
Further update on the prospects of a unitary patent system for Europe
impossible position of being unable to comply with both Articles 3(a) and 3(b).
The question of how properly to interpret Article 3(a) and Article 3(b) was referred by
the English Court of Appeal to the CJEU. The CJEU decided to construe Article 3(a)
strictly, and held that the product (active ingredient) must be specified in the wording of the claims of the basic patent. Therefore, where the subject matter of a
patent is A, then an SPC for A + B cannot be obtained due to Article 3(a) (in other
words, because A + B is not specified in the wording of the claims of the patent for
A). This is so even if the combination of A + B will have infringed, under national law,
the basic patent due to the presence of A.
Conversely, if a patent claims a combination of two products (A + B), an SPC July 2011
cannot be granted for either A or B individually on the basis of such a patent.
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The operation of Article 3(a), as decided in the Medeva judgment, may be illustrated
August 2011 Basic Patent Claim September 2011 L'Oréal v eBay – clarification of online
marketplace operators' liability for its
Since Article 3(a) had been construed strictly, the CJEU had to adopt a more flexible
interpretation of Article 3(b) if it were to allow SPCs for vaccines. Essentially, the
question that the CJEU addressed was whether an SPC can be granted for a
product or combination of products on the basis of a marketing authorisation for both
that product/combination of products and others that fall outside the scope of the
Patentability of stem cells: the Brüstle
The CJEU acknowledged that medicines for complex diseases and vaccines often
consist of a combination of active ingredients. Companies that produce vaccines,
often at the request of health authorities, must be incentivised to perform research.
Denying such persons SPC protection would act as a disincentive in this respect
and possibly lead to the marketing of products containing only one kind of antigen
(monovalent products), which is not in the interests of public health. For these
reasons, the CJEU decided that a product can be granted SPC protection even if the
marketing authorisation ("MA")for that product includes other active ingredients.
Therefore, the application of Article 3(b) in the case of a multi-disease vaccine may
February 2012 (update) Basic Patent Claim February 2012
The court reminded the national courts and offices that the other (though less
controversial) conditions of Article 3 must also be met, namely that the product must
not already have been the subject of an SPC and the marketing authorisation is the
first for the product as a medicinal product.
Scope of Protection of an SPC Japanese companies who have successfully obtained an SPC for their combination
product will be interested in Articles 4 and 5 of the SPC Regulation, which defines the scope of protection of an SPC. In particular, a key question is whether a Japanese company's SPC for A + B would be infringed by a competitor's commercial product for, say, A + B + C.
Article 4 of the SPC Regulation states that, within the limits of the protection
conferred by the basic patent, the protection conferred by an SPC shall extend only
to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product, as a medicinal
product, that has been authorised before the expiry of the SPC.
Article 5 of the SPC Regulation provides that, subject to Article 4, the SPC shall
confer the same rights as conferred by the basic patent and shall be subject to the
There had been some confusion as to whether an SPC for an active ingredient is
infringed by a product which combines that active ingredient with another (or
others). The CJEU had addressed this issue in the Medeva decision; however,
when it did so it was not answering a specific question referred to it, and so it was
unclear whether the matter had been fully settled. This has now been resolved in
the Novartis case, in which the CJEU answered a question referred to it by the
English High Court and clarified that where an SPC is granted for product A, the
SPC holder will have the right to bring infringement proceedings in respect of a
combination product comprising A and B, provided this would have been possible
Novartis v Actavis (C-442/11)
Novartis markets and sells a drug called Diovan, the active ingredient of which is a
chemical compound called valsartan. Valsartan is used to treat hypertension and it
was, until 12 February 2011, protected by a patent of which Novartis was the
proprietor. On the basis of that patent, a marketing authorisation for valsartan and
the results of a paediatric investigation plan, Novartis was granted an SPC for
valsartan. This SPC expired on 12 November 2011.
Novartis also markets and sells Co-Diovan, which contains valsartan in combination
with hydrochlorothiazide (a diuretic). However, Novartis did not apply for an SPC for
During November 2010, it became apparent that Actavis intended to launch a
generic product containing valsartan in combination with hydrochlorothiazide after
Novartis' valsartan patent had expired (but while its SPC for valsartan was still in
force). In other words, Actavis intended to launch A + B while Novartis' SPC for A
was still in force (here, A = valsartan and B = hydrochlorothiazide).
Novartis commenced infringement proceedings against Actavis. Novartis argued
that its SPC for valsartan conferred the same protection from which valsartan
benefited under Novartis' patent, and that any other interpretation of the SPC
Regulation would enable third parties to avoid infringing an SPC for an active
ingredient simply by launching a product that contained both that active ingredient in
combination with another. Actavis argued that its combination product was a
different product to the one protected by Novartis' SPC (i.e. valsartan) and that it
In its order, CJEU decided that Actavis' combination product would have infringed
Novartis' patent for valsartan (had it been in force). It is thus now clear that if an
SPC is granted for product A, the SPC holder will have the right to bring
infringement proceedings in respect of a combination product comprising A and B to
the extent that this would have been possible under the basic patent. This may be
Novartis Basic Patent Infringed By (Protected Against)
Valsartan Valsartan Combination (Valsartan +
Japanese companies seeking protection of the fruits of their endeavours in the field
of combination products in the EU will no doubt welcome the relative clarity that
these two decisions have brought to this complicated area of patent law and to the
interaction between the European regulatory system and the intellectual property
However, a number of uncertainties remain: for instance, it is not entirely clear what
is meant by the requirement to have a product "specified in the wording of the claims" of the relevant patent and, for instance, how this should apply to abstract,
generic or class claims.4 Also, it should be borne in mind that whilst all countries in
the EU are required to grant SPCs, no unified cross-recognition exists and
applications must be filed and approved on a country-by-country basis. As such,
further light will be shed as national courts apply these rulings to pending decisions
and new cases, as well as refer further questions to the CJEU for clarification. We
will aim to report on significant developments as they arise.
The contents of this publication, current at
the date of publication set out above, are for
constitute legal advice and should not be
relied upon as such. Specific legal advice
about your specific circumstances should
always be sought separately before taking
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