Following a reference from the Higher Regional Court of Vienna, the CJEU has issued a decision in Seattle Genetics Inc. v Österreichisches Patentamt (Case C‑471/14) clarifying the meaning of "date of the first authorisation to place the product on the market in the [European Union]" in the SPC Regulation (Regulation 469/2009). The CJEU held that the date on which a centralised marketing authorisation ("MA") holder is notified of the grant of that MA is the relevant date for calculating the term of a Supplementary Protection Certificate ("SPC"), and not the earlier date of the decision to grant that MA. This agrees with the conclusion of Advocate General Jääskinen's Opinion, and confirms the approach to the calculation of an SPC's term previously followed by the UK-Intellectual Property Office and several other national Patent Offices.
Given that the date of notification of grant follows the date of the decision to grant a centralised MA, this will mean that in certain cases (i.e., where the term of the SPC is less than the maximum 5 year term when calculated using the earlier date of the decision to grant that MA) the SPC will expire at a later date. This will give many SPC holders a longer period of exclusivity in countries which had previously calculated the SPC's term from the date of the MA decision.
Although the longer duration will usually be a matter of a few days, the decision is likely to be of financial significance to the pharmaceutical industry given the high revenues for its blockbuster drugs.
Summary of Decision
The reference to the CJEU concerned an SPC application made by Seattle Genetics. This SPC application was based on a patent held by Seattle Genetics and a centralised MA granted to its partner, Takeda, for Brentuximab vedotin, the antibody-drug conjugate of Adcetris. The term of an SPC, up to the maximum term of five years, is calculated under the formula contained in Article 13 of the SPC Regulation. This can be summarised as:
Duration = ["date of the first authorisation to place the product on the market in the Community"] – [date of patent application] – [5 years]
The Austrian Patent Office granted Seattle Genetics' SPC, but calculated its term using the date of the decision to grant the centralised MA for Adcetris, which was 25 October 2012. Given this, Seattle Genetics brought proceedings before the Higher Regional Court of Vienna seeking rectification of the SPC such that it had a later expiry date calculated using the date on which Takeda was notified of the grant of its centralised MA, which was 30 October 2012. Under the calculation in Article 13 of the SPC Regulation, this change would extend the duration of Seattle Genetics' SPC by five days.
The CJEU noted that the SPC Regulation makes no reference to national laws for the interpretation of "date of the first authorisation to place the product on the market in the [European Union]", such that its meaning must be interpreted in a uniform manner as an autonomous concept of EU law. This was also consistent with the objective of the SPC Regulation to create a uniform system across Europe. As the meaning could not be unequivocally determined from a reading of the SPC Regulation itself, the CJEU held that it must be interpreted in light of the objectives of the SPC Regulation. The CJEU held that in order to give effect to the legislator's intention that the SPC holder has adequate effective protection, the term of an SPC must take account of the date on which the SPC holder is in fact able to benefit from the grant of the relevant MA. As a consequence, the date a centralised MA holder is notified of the grant of that MA was the relevant date. This was even more so given the fact that the procedural steps between the grant of the centralised MA and the date of notification that would reduce the term of the SPC are outside the control of the SPC holder.