A guide to the UPC and the UP - Flipbook - Page 64
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SPCs can be invalidated on the ground that the basic patent is invalid and additionally on the
ground that the SPC should not have been granted in the first place. Art.15(1) MP SPC
Regulation states: 20
“The certificate shall be invalid if:
(a) it was granted contrary to the provisions of Article 3;
(b) the basic patent has lapsed before its lawful term expires;
(c)
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the basic patent is revoked or limited to the extent that the product for which the
certificate was granted would no longer be protected by the claims of the basic patent or,
after the basic patent has expired, grounds for revocation exist which would have justified
such revocation or limitation.”
The issues of validity and infringement of SPCs have previously been dealt with at a national
level under the laws of the country in which the SPC was granted, subject to references to the
CJEU in cases where the law is uncertain or differs as between Member States. In those cases
before it which involve SPCs such jurisdiction will now fall to the Court.
Challenges for the SPC System in the EU
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References concerning SPCs from national courts to the CJEU and EFTA Court have been
numerous over the past two decades, with some of the issues referenced in the footnotes to
preceding paragraphs in this chapter. This has created a degree of legal uncertainty and lack of
predictability, and in some instances led to the same issue being referred several times with the
consequent delay in reaching a decision at national level.
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There have also been divergent practices amongst national IP offices. While the MP SPC
Regulation provides the substantive requirements for the grant of an SPC, the grant procedure
is left to national laws. Importantly, the national IP offices in some Member States substantively
examine the SPC application, therefore refusing grant in some instances based on their
interpretation of the law, while others check only formal requirements. The proposals for
introducing a centralised granting route for national SPCs, in respect of European patents
and Unitary patents outlined at paragraph 4-03 above seeks to address such differences.
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During the 30 years that have now passed since the introduction of the MP SPC Regulation,
the pharmaceutical industry has changed significantly with biological products becoming an
increasingly important part of the market. This raises new challenges, such as, should an SPC
based on a particular authorised biological product extend to protect an authorised variant of
that product.
European and Unitary SPCs
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20
As noted above, the MP SPC Regulation provides for the grant by individual Member States of
national SPC rights. There is as yet no unitary European SPC right available but as outlined in
paragraph 4-04 above one was proposed in April 2023. There is however nothing to stop the
grant of a bundle of national SPCs which designate a Unitary patent having effect in those
Member States as a basic patent, and over which SPCs, despite their national origins, the Court
will have exclusive jurisdiction. The Court will also have exclusive jurisdiction over Unitary SPCs.
Art.3(b) UPCA specifies that the UPCA applies to SPCs issued for a product protected by a patent
which in turn is defined in Art 2. UPCA to mean a European patent (that is not subject to an optout) or a Unitary patent and art 32 UPCA provides the Court has exclusive jurisdiction to the
following actions relating to such SPCs for: actual or threatened infringements and related
defences; actions for revocation; actions for declarations of non-infringement and invalidity;
Although this list may not be exhaustive: Hässle AB v Ratiopharm GmbH (C-127/00) [2003] ECR I-14781.
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 54
