CJEU confirms the rules for rectifying SPC duration

The CJEU hands down its second judgment on SPCs in December 2017, clarifying the basis for rectifying SPC duration.

To bring last year to a close and hand down its second supplementary protection certificate (SPC) decision of December 2017, the Court of Justice of the European Union (CJEU) gave its answer to the referral from the Hungarian court in Incyte (Case C-492/16) concerning SPC duration.

The CJEU’s decision provides a means for SPC holders to amend the duration of their SPCs, whenever granted and prior to their expiry, in accordance with the provisions of Regulation 269/2009 (the SPC Regulation). In doing so, the CJEU has provided a pragmatic and uniform approach which should help patentees rectify the terms of SPCs which are shorter than they might otherwise be if calculated using the formula set out in the CJEU’s decision in Seattle Genetics (Case C-471/14).

Furthermore, this decision supports the case for SPC holders to be able to rectify SPC duration, notwithstanding that they may be time barred from doing so under timelines set by national administrative procedures. Given that such hurdles have arisen in a number of Member States, including at least the Netherlands and Sweden, the decision is likely to be welcomed by patentees as clarification in this area.

Background

As noted above, the circumstances of this case arose because of the CJEU’s decision in Seattle Genetics, in which it held that the duration of an SPC should be calculated according to the date on which the applicant is first notified of the decision granting the relevant “first” marketing authorisation (MA), as opposed to the date of the decision itself - see our article Court of Justice decision paves way for consistency in calculating SPC duration discussing this case.

As a result, the duration of many pre-existing SPCs across Europe was thrown into question where the term had been calculated using the wrong (earlier) date; thereby giving too short a term.

This posed procedural questions, including if and how such deficiencies may be corrected, and in particular the impact of being time-barred from "appealing" SPC grant in accordance with administrative procedures laid down by the laws of certain Member States.

Incyte’s SPC

This case concerned Incyte’s Hungarian SPC application for its pharmaceutical product Jakavi, used for the treatment of myelofibrosis. Incyte filed their application at the Hungarian Patent Office (HPO) in January 2013, which was duly granted in October 2013. Under the administrative rules in Hungary, Incyte had 30 days in which to appeal such decision, though, at that time, had no cause to do so.

Subsequently, in October 2015, the CJEU gave its decision in Seattle Genetics, providing a different formula for calculating SPC duration than that already applied by the HPO. If that decision had applied to Incyte’s SPC, its duration would have been extended by four days.

Incyte applied to the HPO seeking that extension, but its request was rejected on the basis that the original decision did not contain any miscalculations or clerical errors and so Incyte were simply out of time to appeal the decision (being by this time, far beyond the 30 day limit).

The referral

This created two issues for the Hungarian High Court in hearing Incyte’s appeal of the HPO’s rejection, namely: (i) did the Seattle Genetics decision apply retrospectively - ie meaning that Incyte’s SPC duration was incorrect at all; and (ii) if it was incorrect, was the HPO/Hungarian Court required to rectify the term (ie overriding the procedural deadline)?

Accordingly, the Hungarian court referred two questions to the CJEU, which may be summarised as follows:

  1. Does the decision in Seattle Genetics apply retrospectively to pre-existing SPCs, such that it is appropriate to rectify the date of those SPCs even when the time limit for appealing against a decision has already expired under national rules?
  2. Is the national authority that granted the SPC required to rectify ex officio the date of expiry of an SPC granted before the decision in Seattle Genetics?

The CJEU’s decision

Question one

In respect of question (1), the CJEU’s answer was narrower than the scope of the question and addressed the main issue of simply whether an SPC application not in accordance with the decision in Seattle Genetics (ie by having the wrong date for the first MA) was “incorrect”. In this way, the appropriateness of rectification and the conflict with national procedural rules were left for question (2).

The CJEU’s answer centred on the differences between Article 18 of the SPC Regulation and the parallel provisions for plant protection certificates under Article 17 of Regulation 1610/96 (the Plant Protection Regulation) in respect of appeals. Notably, the Plant Protection Regulation has a specific provision for rectifying the duration of certificates in Article 17(2):

SPC Regulation:
Article 18 / Appeals

Plant Protection Regulation
Article 17 / Appeals

 

The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.
  1. The decisions of the authority referred to in Article 9(1) or of the body referred to in Article 15(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.
  2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorization to place the product on the market in the Community, contained in the application for a certificate as provided for in Article 8, is incorrect.

Despite Article 18 of the SPC Regulation not being referred to in the Hungarian Court’s referral (which only referred to Article 17(2) of the Plant Protection Regulation), the CJEU used its discretion to answer referrals in any manner which it considered to assist in adjudicating an issue, and so included Article 18 in its analysis.

Relying on recital 17 of the Plant Protection Regulation, which applies, inter alia, Article 17(2) to the SPC Regulation mutatis mutandis, the CJEU essentially read Article 17(2) into the SPC Regulation via a teleological interpretation of Article 18; thereby incorporating its mechanism for appealing and rectifying SPC duration.

By apparent reference to the term as used in Article 17(2), the CJEU confirmed that any SPC calculated using a date other than that specified in Seattle Genetics was “incorrect”.

The CJEU also confirmed that its decision in Seattle Genetics applied retrospectively, emphasising that any clarification it provided about interpreting a rule of European law applied “from the date of [the rule’s] entry into force”.

Overall, therefore, the CJEU confirmed that Incyte’s Hungarian SPC (and any SPC with a duration calculated in the same way) was “incorrect”.

Question two

The CJEU then had to address the basis on which the HPO may be able (or be required) to rectify Incyte’s “incorrect” SPC.

Acknowledging the interests of public certainty afforded by the finality of decisions under national administrative law, the CJEU referred to the conditions under which an administrative body, under the principle of cooperation, has an “obligation to review a decision” in order to take into account interpretation of the relevant provision of European law. Notably, such conditions involve the assessment of the flexibility for review under the relevant national law and require the person concerned to act immediately.

However, the CJEU stated that the circumstances here were different and rather than considering this referral to be about the review of an administrative decision, viewed the issue at hand as purely the rectification of an SPC term. In doing so, the CJEU distinguished these circumstances and commented that they were “less capable of affecting legal certainty”.

This was consistent with the interpretation that the CJEU had already applied to Article 18, which meant that an appeal such as that made by Incyte simply “must be heard”. In light of the straightforwardness of the language of Article 17(2) (above), the CJEU applied only two conditions to such an appeal: (i) it must be made to the granting authority (and the CJEU declined to consider whether rectification could be effected without an application by the SPC holder); and (ii) it must be made before SPC expiry.

The CJEU held that this was consistent with the language of Articles 13 and 14, which dictated that an SPC’s duration is determined as a matter of law, without any discretion on the part of granting authorities. The CJEU also emphasised this outcome to be in line with two of the key objectives of the SPC Regulation, namely (i) the compensation to pharmaceutical companies for any delay in being able to market their invention; and (ii) a uniform, pan-European system allowing free movement of medicines and preventing the “heterogeneous development” of national laws.

Comment

As noted at the outset, this decision will be welcomed by rights holders wishing to correct any SPCs for which the term of protection was not calculated according to the formula set by Seattle Genetics.

The CJEU’s decision is consistent with the practice procedure adopted in the UK following Genzyme, which allows SPC holders to rectify SPC duration by writing to the UK IPO, and which would appear equivalent to the CJEU’s requirement for “appeal” set out here. Indeed, the UK register for Incyte’s SPC indicates that this procedure was followed resulting in the rectification of the duration of Incyte’s parallel UK SPC.

As also noted above, SPC holders in countries other than Hungary have also hit blocks under national administrative law when seeking to rectify SPC duration, notably in at least the Netherlands and Sweden. In the Syngenta decision, the Dutch Patent Office initially refused rectification before being overturned on appeal. A similar situation has been reported in Sweden last year, where the Swedish Patent Court refused to allow rectification, only to be overturned on appeal. We understand from commentary that both of these rejections were overturned on the basis of national administrative law, and in at least the Swedish case it was held that no appeal procedure was available under the SPC Regulation as Article 17(2) applied only to the Plant Protection Regulation. In these respects, while national administrative laws were overcome in these cases, the CJEU’s decision now provides a mechanism under the SPC Regulation itself, as a matter of European law, which should facilitate SPC duration rectification harmoniously across European Member States in accordance with the Seattle Genetics decision.

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.