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8 October 2015Big PharmaNatalia Wegner-Cribbs and Daniel Wise

A clearer picture for SPCs?

On October 6, the Court of Justice of the European Union (CJEU) delivered its judgment in case C-471/14. It clarified that the term of a supplementary protection certificate (SPC) is determined with reference to the date on which a marketing authorisation is notified to that applicant. This means that in many cases SPC owners that do not already benefit from the maximum five-year term will get some additional term for their products, although it remains to be seen how and to what extent the judgment will be implemented from a practical point of view by the various national patent offices. The judgment may also have implications for aspects of SPC law other than the SPC term, on which the CJEU did not provide any guidance.

The relevant legal framework (article 13 of the Regulation [EC] No 469/2009—the SPC regulation) provides that the SPC term is calculated with reference to the “date of the first authorisation to place the product on the market in the Community”. The dispute arose around the interpretation of this provision. Does it refer to the date on which the decision to grant a marketing authorisation is taken, or that on which the applicant is notified of the decision? Notification typically takes place a few days later than the date of the decision and in the case of centralised authorisations the date of notification is recorded and published in the Official Journal of the European Union (OJEU).

In this case, the decision to grant a marketing authorisation for the medicinal product Adcetris was dated October 25, 2012, but the applicant (Takeda) was notified of the decision five days later, on October 30. The Austrian Patent Office issued the SPC to Seattle Genetics with a term calculated with reference to the decision date. Seattle Genetics challenged this and requested that the relevant date is that of notification, and so the SPC should expire five days later than calculated by the office. The Austrian proceedings were stayed and questions on the interpretation of article 13 were referred to the CJEU.

The CJEU’s view

The CJEU agreed with Seattle Genetics and Advocate-General Niilo Jääskinen, ruling that the relevant date is determined according to EU law and that it is “the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision”. The CJEU emphasised that any other view would go against the objective of the SPC regulation, which is to provide a sufficient period of protection to compensate for the regulatory delays before commercial exploitation of the patented technology can begin.

The time elapsed between the decision granting a marketing authorisation and its notification is an example of such a regulatory delay for which the SPC regulation intends to compensate so it would go against the objective of the regulation to ‘reduce’ the SPC term on that basis.

The CJEU also referred to EU legal provisions which specify that a centralised marketing authorisation takes effect only upon notification, again supporting its view that the SPC term should be determined with reference to the date of notification, as it is only from notification that commercial exploitation can begin.

Practical implications

All this seems good news for innovator companies, as even a few additional days of term can be extremely valuable. It is hoped that the judgment will harmonise the SPC term for any given product across Europe, as some patent offices (eg, in Belgium, the UK, Slovenia and Portugal) have already been using the notification date, while others were using the decision date. This will also provide legal certainty, something valuable for companies in the generics field, which often need to wait for SPCs to expire before launching generic versions of medicinal products. Many SPC applicants and owners will now be keen to obtain the additional term, unless the SPC term is already the maximum five years available.

“Many SPC applicants and owners will now be keen to obtain the additional term, unless the SPC term is already the maximum five years available.”

The likely procedure for new SPC applications seems straightforward when the first authorisation in the Community is a centralised authorisation and the deadline for filing the SPC application does not depend on whether the judgment also applies to article 7(1) of the SPC regulation (discussed in more detail below). The SPC application can presumably be filed indicating the notification date as the date of the first authorisation in the Community, accompanied by a copy of the relevant excerpt from the OJEU showing the date of notification. National patent offices should then automatically determine the SPC term based on the notification date.

The procedure is less clear for pending applications, as the CJEU did not provide any guidance on whether applications can be retroactively corrected to indicate the notification date. The practice at the UK Intellectual Property Office (IPO), which since November 2013 has been to use the notification date for centralised authorisations instead of the decision date, requires applicants to write to the office on a case-by-case basis and request that the relevant date provided on the SPC application form is amended, submitting a copy of the relevant OJEU entry. Presumably, a similar procedure can now be tried across Europe (some patent offices may make the corrections automatically).

It is unclear to what extent the judgment applies to already granted SPCs, and what procedural steps need to be taken so that those SPCs benefit from the longer term. The IPO uses a similar procedure for pending applications and issues a corrected version of the SPC certificate on request from the SPC owner. Such requests are accepted at any time post-grant. In contrast, some national patent offices have been reluctant to correct the term of granted SPCs, relying on national procedural law that is more restrictive in terms of the required justification for correction or the time period post-grant within which a correction must be requested.

What is the relevant date?

The CJEU’s judgment does not explicitly deal with the situation where the first authorisation to place the product on the market in the Community has been obtained via a national rather than centralised route. Such national authorisations may not have an established ‘notification date’, and unlike centralised authorisations may take effect from the date of the decision (for example, authorisations issued by the UK regulatory authority).

In its decision, the CJEU stated that the date of the first authorisation to place the product on the market in the Community must be determined by EU law, and not by the law of the member state in which the marketing authorisation took effect, as otherwise “the objective of establishing a uniform solution at EU level would be undermined”. However, this is difficult to reconcile with national authorisations that are governed by national law. It therefore remains to be seen according to which criteria national patent offices will determine the relevant date of a non-centralised authorisation when there is ambiguity over the correct date, and what type of supporting documentation, if any, will be required from SPC applicants.

Does the judgment affect SPCs in other ways?

The CJEU did not explicitly consider the meaning of the ‘date’ of an authorisation across the whole of the SPC regulation. Of particular practical importance is the question of whether the judgment affects the deadline for applying for SPCs under article 7(1), which is six months from the ‘date’ of the authorisation.

Similarly, article 7(4) of the SPC regulation sets a deadline for filing an application for a six-month ‘paediatric extension’ to the SPC term of no later than two years before expiry of the certificate. For those SPCs that can now benefit from a later expiry date, the deadline for filing a ‘paediatric extension’ may be similarly pushed back. SPC owners should also be vigilant as the later expiry date may affect the annual fees that are payable at certain patent offices.

In summary, this decision is likely to be welcomed by SPC applicants and owners. However, the CJEU has left them to work out how to apply the decision to existing SPCs and applications, and indeed other areas of SPC law.

Natalia Wegner-Cribbs is an associate at  Carpmaels & Ransford. She can be contacted at:natalia.wegner-cribbs@carpmaels.com

Daniel Wise is a partner at Carpmaels & Ransford. He can be contacted at: daniel.wise@carpmaels.com

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25 August 2016   In an exclusive interview with LSIPR, Stephen Bennett, partner at Hogan Lovells, talks about the implications of Brexit with a focus on supplementary protection certificates.

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Europe
6 October 2015   The Court of Justice of the European Union (CJEU) has ended the uncertainty over the term of supplementary protection certificates (SPCs) by ruling that they begin once a party is notified of a marketing authorisation for a drug.
Big Pharma
25 August 2016   In an exclusive interview with LSIPR, Stephen Bennett, partner at Hogan Lovells, talks about the implications of Brexit with a focus on supplementary protection certificates.