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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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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
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 (C-322/10)
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, Gavin Margetson
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 Ashleigh Owens
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 April 2011
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 June 2011
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. IP in M&A Transactions – Key Issues 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 October 2011
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
November 2011
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, December 2011
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 January 2012
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
Valsartan Valsartan Combination (Valsartan + Conclusions
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 Herbert Smith, 41st Floor, Midtown Tower,


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