A guide to the UPC and the UP - Flipbook - Page 62
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Art.3 MP SPC Regulation sets out the conditions for grant of an SPC:
“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; 12
(b) a valid authorisation to place the product on the market as a medicinal product has been
granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c)
the product has not already been the subject of a certificate; 13 and
(d) the authorisation referred to in (b) is the first authorisation to place the product on the
market as a medicinal product.” 14
Scope
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Just as the grant of the SPC is to the “product”, the protection conferred by an SPC is also limited
to the “product.” In this respect the SPC differs from United States and Japanese patent term
extensions. By limiting the grant of the SPC to the “product”, the patent is not itself extended
but rather the term for the specific “product” protected by the “basic patent” (and not for
example to other compounds within the scope of the basic patent).
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The scope of the SPC includes any other use of the “product” as a “medicinal product”
authorised before expiry of the basic patent, such as an authorisation for a new indication or a
new formulation. 15 If a patent protects more than one product, separate SPCs may be granted
for each.16 However, where an SPC has been granted for a single active ingredient, it is unlikely
that a further SPC will be granted for a combination of this with another active ingredient unless
that combination is itself innovative (and the subject of a separate basic patent).
Term
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12
13
14
15
16
The SPC comes into force upon expiry of the basic patent. The applicant is compensated by way
of the SPC for the time beyond five years that it takes to obtain the relevant marketing
authorisation, for a maximum of five years.
There have been a number of references to the EU asking whether the basic patent protects the “product as such”. What is
clear from the case law of the CJEU is that the product must be specified in at least one claim of the basic patent, which is
therefore not the same test as for patent infringement (which has also been considered). The claims may also claim the
product via a functional definition, but in such a case must relate “implicitly but necessarily and specifically” (Eli Lilly & Co Ltd v
Human Genome Sciences Inc (C-493/12) ECLI:EU:C:2013:835) to the product in question. What is not clear, is what is meant by
this language, that is, what more is required from the claim to identify the product. This has become a particular issue for
combination products, where some of the case law under arts 3(a) and 3(c) is in tension, and is the subject of pending
references to the CJEU in Teva B.V. and Teva Finland Oy v Merck Sharp & Dohme Corp. (C-119/22) and Merck Sharp & Dohme Corp
v Clonmel Healthcare Limited (C-149/22).
The requirement in art.3(c) MP SPC Regulation, i.e. that the product must not already be the subject of an SPC in the same
Member State, has been clarified to mean that although a single entity cannot hold more than one SPC in respect of the same
product in a single Member State, separate legal entities may do this so long as each holds a basic patent for that product.
The issue of which marketing authorisation is the first to place the product on the market is particularly pertinent in many
cases as this directly effects the duration of the SPC (under art.13 SPC Regulation). In this regard, earlier marketing
authorisations which relate to different medical uses are disregarded.
art.4 MP SPC Regulation and Novartis AG v Actavis UK Ltd (C-442/11) ECLI: EU: C:2012:66.
Georgetown University v Octrooicentrum Nederland (Case AWB 10/4769), 11 July 2012 and (C-484/12) ECLI:EU:C:2013:828
and Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat)
and (C-443/12) ECLI:EU:C:2013:833.
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 52
