CJEU clarifies law on SPC term calculation and EU accession

Summary

In October 2016, following a referral from the Estonian Supreme Court, the Court of Justice of the European Union (CJEU) handed down a decision (Hoffman-La Roche - Case C-572/15) on Supplementary Protection Certificate (SPC) duration and the effect of EU law on pre-accession Member States. The decision, finding that SPC term should be consistent throughout the EU, emphasises the CJEU’s desire to take as simple and unambiguous an approach to the legislation as possible to try to reach fair protection across Member States.

The underlying facts are an important factor in this decision, because, despite the SPC in question being granted before Estonia joined the EU, the SPC came into force after Estonia had acceded. This timeline is relied upon by the CJEU to find that there is no question of retroactive effect on the national SPC. In effect, this applies EU law prospectively and automatically to amend the national SPC (or to provide basis for the same), notwithstanding the information detailing a longer term presumably contained both in the national decision granting the SPC and the national register.

Background

The case relates to Xeloda, Roche’s anti-cancer treatment whose active ingredient is chemotherapeutic agent capecitabine.

The timeline for Estonia is as follows:

As Estonia was not a member of the EU at the time of grant (joining later on 01 May 2004), Roche’s SPC was granted under national legislation, granting Roche 15 years’ protection from the date of the Estonian authorisation. However, the SPC came into force after Estonia had joined the EU, which appeared to be an important factor in the CJEU’s decision (discussed below).

Accord obtained an abridged marketing authorisation based on Xeloda and planned generic launch on the Estonian market on 15 December 2014. On 08 December 2014, just before Accord’s intended launch, Roche brought an action in the Estonian District Court enforcing its SPC, obtaining an order against Accord including seizure of all infringing products and prohibiting marketing and sales of their product.

Accord challenged the decision on grounds that Roche did not have a valid SPC, arguing that now Estonia had joined the EU, the Estonian SPC should be limited in duration according to Regulation No 469/2009 (the SPC Regulation), under Article 13, which limits SPC duration to the first authorisation in the EU:

“..the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.”

In this case, the first authorisation for Xeloda was granted on 10 June 1998 (based on a Swiss authorisation), which would mean Roche’s SPC would have already expired on 10 June 2013.

The key question was therefore whether the SPC Regulation should apply to the Estonian SPC granted pre-accession, including specifically as to its duration.

Accord argued that Article 13 applied pursuant to Article 21(2) of the SPC Regulation (introduced following the 2003 Treaty of Accession), which provides that:

“This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Croatia, Cyprus, Latvia, Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to their respective date of accession.”

Accord also argued that to afford protection of more than 15 years in the EU would contravene the SPC Regulation (as held in Merck Canada - Case C-555/13).

The District Court referred the case to the Estonian Court of Appeal, which set aside the order of the District Court and its associated protective measures. Roche then appealed to the Supreme Court of Estonia, seeking to have the initial order reinstated.

Roche argued that the SPC was valid because it was issued at a time when Estonia was not a member of the EU, and hence the duration granted according to the Estonian authorisation applied. Roche argued that Article 21(2) of the SPC Regulation did not expressly state that the duration of SPCs granted pre-accession should be retroactively governed by the SPC Regulation, and therefore re-calculated. Such an interpretation, Roche contended, would infringe the principle of legal certainty. Further, Roche argued that Merck Canada could be distinguished on the basis that Article 21(2) was not at issue in that case.

Questions referred to the CJEU

The Estonian Supreme Court decided to stay the proceedings and referred two questions to the CJEU for a preliminary ruling.

The first question asked whether Article 21(2) applies to duration, as well as subsistence, of SPCs so as to shorten the duration of SPCs granted under national law with a first authorisation date after the earliest date of authorisation in the EU.

An affirmative answer to the first question would mean that the duration of the SPC would be shortened retroactively, and so the second question asked whether that was compatible with EU law.

CJEU’s decision

Addressing the second question first, the CJEU adopted a strict approach to interpreting the legislation and indicated that it did not have jurisdiction to rule on the validity of Article 21(2) under the referral procedure. This is because Art 267 TFEU (under which referrals are made) applies to acts of the European Union institutions; but Art 21(2) of the SPC Regulation was inserted by an Annex to the 2003 Treaty of Accession which was an agreement between Member States and not an act of an EU institution.

In respect of the first question, the CJEU started by confirming that an authorisation granted in Switzerland qualified as the first authorisation for the purposes of Article 13 due to the automatic recognition in Liechtenstein (per AstraZeneca, Case C-617/12). The CJEU went on to rule that the Swiss authorisation was in this case the relevant authorisation for Article 13, not the Estonian authorisation. The date at which the relevant legal regime was to be assessed was the date when the SPC came into effect, not the date when it was granted. Therefore, the relevant date of authorisation to be used for determining the duration of the SPC was 10 June 1998, and not the 08 June 2001.

Interestingly, the CJEU pointed out that in this case there could be no question of retroactive application of the SPC Regulation, because by the time the basic patent had expired, and therefore when the SPC in question took effect, Estonia had already acceded to the EU. In this respect, the decision refers to submissions from the Estonian government and Commission, suggesting they both supported the outcome of the CJEU’s decision. This emphasises the importance of the facts underlying this decision, and the ruling may have been different had the SPC in question come into force before Estonia’s accession to the EU.