What

In its recent decision of 6 October 2015 in Case C-471/14, Seattle Generics, the Court of Justice of the EU (the “CJEU”) has provided helpful clarification of the duration of a national supplementary protection certificate (“SPC”) in an EU member state where the human medicinal product to which it relates was authorised via the centralised procedure (i.e by a decision of the European Commission, following a positive opinion of the European Medicines Agency).

The CJEU ruled that:

  • the “the date of the first authorisation to place the product on the market in the Community”, which is used in calculating the duration of an SPC, must be given a uniform EU interpretation (rather than being left to national law); and
  • where such first authorization was granted via the centralized procedure, the date in question is the date on which the Commission decision formally granting the authorization was notified to the applicant, rather than the date of the Commission decision itself.

This may appear to be a mere point of detail, as the difference between the two dates is usually only 2-5 days. However, even a short increase in the length of an SPC can have substantial commercial value in the case of a pharmaceutical product (not least because the typical product lifecycle usually means that peak sales are achieved around the time of SPC expiry).

Background

Seattle Generics is a leading biotech company specialising in the development and commercialization of antibody-drug conjugates (“ADCs”), a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Its leading product, brentuximab vedotin (trade name ADCENTRIS®) is an ADC directed to the protein CD30, which is expressed in classical Hodgkin lymphoma (“HL”) and systemic anaplastic large cell lymphoma (“sALCL”). The active substance is made up of a chimeric monoclonal antibody brentuximab (cAC10, which targets the cell-membrane protein CD30). It is attached, using Seattle Generics’ proprietary technology, to monomethyl auristatin E, a cytotoxic (cell killing) molecule. The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, which eventually kills the cancer cells.

Seattle Genetics is the holder of European Patent No EP 1 545 613 (‘the basic patent’), entitled‘Auristatin conjugates and their use for treating cancer, an autoimmune disease or an infectious disease’. The basic patent was applied for on 31 July 2003 and granted on 20 July 2011.

In 2009, whilst the brentuximab vedotin was still in phase IIb trials for the treatment of relapsed and refractory HL and sALCL, it was designated as an ‘orphan medicinal product for human use’ by the European Medicines Agency. In the same year, Seattle Genetics entered into a strategic collaboration with Millennium Pharmaceuticals/Takeda Oncology jointly to develop and commercialize brentuximab vedotin. Under the terms of the collaboration agreement, Takeda had rights to commercialize the product outside North America.

Accordingly, in May 2011, Takeda submitted an application under the centralised procedure for a conditional marketing authorisation for a brentuximab vedotin

By Implementing Decision C(2012) 7764 final of 25 October 2012, the European Commission granted Takeda a conditional marketing authorisation under number EU/1/12/794/001 for that brentuximab vedotin. On 30 October 2012, Takeda was notified of that decision.

On 2 November 2012, Seattle Genetics filed an application with the Austrian Patent Office for an Austrian SPC, based on the basic patent. The Austrian Patent Office granted the application.

Article 13 of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”), entitled ‘Duration of the certificate’, provides in paragraph 1 that:

“[t]he certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community reduced by a period of five years”.

Taking the view that the “date of the first authorisation to place the product on the market” in the European Union within the meaning of Article 13(1) of the SPC Regulation was the date of the Commission’s decision on marketing authorisation (i.e. 25 October 2012), rather than the date of notification to Takeda (i.e. 30 October 2012), the Austrian Patent Office fixed the expiry date for the Austrian SPC as 25 October 2027.

On 22 April 2014, Seattle Genetics brought proceedings before the Oberlandesgericht Wien (Higher Regional Court, Vienna, Austria) against the decision of the Austrian Patent Office, requesting rectification of the Austrian SPC so that it will expire on 30 October 2027 (i.e. an increase in duration of 5 days).

The Austrian Court observed that divergent practices had developed between the national patent offices of the EU Member States (who are responsible for receiving and examining SPC applications) when calculating duration of an SPC. The standard practice of many national patent offices in Europe at that time (including the offices of Germany, France, Italy, Ireland, Sweden, the Czech Republic and the Netherlands) was to set the SPC term based on the date that the European Commission decided to issue the centralised authorisation (for those products where the first marketing authorisation in the EEA for a medicinal product is obtained via the centralised procedure) used the date of notification of that marketing authorization to the applicant.

In light of this discrepancy, the Austrian court referred the issue to the CJEU for a preliminary ruing.

The decision of the CJEU

The CJEU had no difficulty firstly in finding that the relevant wording in Article 13(1) have to be given a uniform EU wide meaning, rather than being left up to national law. Indeed the CJEU observed that, where a provision of EU law makes no reference to the laws of the Member States with regard to a particular concept, that concept must be given an independent and uniform interpretation throughout the European Union. It referred in this regard to its decision Brüstle, C-34/10 (concerning the meaning of the words “human embryo”).

In choosing between the two dates in question, the CJEU observed that it is not possible on the basis of either the wording of that provision in its various language versions or the other provisions of that regulation to give an unequivocal answer. It therefore turned to the objective of the Regulation No 469/2009, which is to is to re-establish a sufficient period of effective protection of a basic patent, by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent. This is to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for that patent was filed and the date on which the first marketing authorisation in the EU was granted (recitals 3 to 5 and 8 and 9). It was common ground between the parties that a holder of an SPC is entitled to market his product only from the date on which he is given notification of the decision granting the marketing authorisation in question, not from the date on which that decision was adopted. In light of this, a purposive construction required the date of notification to be used to calculation the duration of the SPC.

This conclusion was also supported by a general provision of EU law, the third subparagraph of Article 297(2) Treaty on the Functioning of the EU. This Article provides that decisions of the EU institutions, which specify to whom they are addressed (which would cover Commission Decisions granting a centralised marketing authorisation following a positive opinion of the EMA) are to be notified to those to whom they are addressed and take effect upon such notification.

So what?

This decision affects only a subset of SPCs: those which were granted by reference to a product authorised in the EEA under the centralised procedure (as opposed to the mutual recognition or decentralised procedure), and which do not already qualify for the maximum duration of 5 years.

It is nevertheless significant because it brings a welcome degree of harmonisation between the practices of the national patent offices of the EEA Member States regarding duration of SPCs.

Moreover, it will be welcomed by innovator pharmaceutical companies, as it has given them a windfall which could have substantial commercial value (when multiplied across all EU member states, and every relevant portfolio product).

It also brings useful clarity for generics companies, who often plan their launch strategies so that their products become available as soon as the SPC has expired.

Whilst national patent office of the EEA Member States are bound by this decision, and are obliged to bring their national granting practices in line with it for pending and future SPC applications, it remains to be seen how existing SPCs will be treated. Will the national patent offices of the Member States which formerly applied the “date of authorisation” rather than “date of notification” approach carry out a review of their own motion, and rectify the expiry dates of the relevant SPCs? Or will the SPC holders still be required to bring proceedings to rectify the SPC(s) (which are provided for under Article 17(2) Regulation 406/2009)? Another interesting question is whether SPC holders of now-expired SPCs whose duration was too short will be able to claim compensation from the national patent offices of the Member States in question? In general, a failure to properly implement EU law can give rise to a claim against the Member State in question for compensation. That might add up to many millions of Euros of compensation, and cause a real headache for Member States already looking to bring their healthcare spending under control and trim drug budgets. In light of the amounts at stake, we may well see a test case before too long.