Author: Birute Dauderiene, Senior Patent Consultant and Patent Attorney at METIDA
Good news for pharmaceutical companies trading in proprietary medicinal products and granted with Supplementary Protection Certificate (SPC) is that the term of the SPC may be extended for 2-5 days and the start for the suppliers of generic products will be postponed.
On 6 October 2015, the Court of Justice of the European Union (EU) adopted a particularly important decision, i.e. the term of the Supplementary Protection Certificate shall run from the date of decision or notification of the first authorization to place the product on the market (marketing authorization). The term shall run from the date of notification of the marketing authorisation. This decision is important for the companies issued with pharmaceutical patents, since according to the EU Regulation No 469/2009, the Supplementary Protection Certificate may be granted for such patent for additional period not exceeding 5 years. The SPC is granted in separate countries according to national legal acts; nevertheless, the Court of Justice of the European Union is addressed for interpretation of certain statements.
Adoption of such decision has been motivated by pending proceedings concerning calculation of the term of the SPC in different countries. Already at the beginning of 2014, a decision on calculation of the SPC term not from the date of the decision to grant the marketing authorisation for the medicinal product, but from the date of notification it has been delivered in Great Britain. Later on, Seattle Genetics instituted proceedings against the Austrian Patent Office for recalculation of the SPC term, since the marketing authorization for the medicinal product was granted on 25 October 2015 and notification was issued on 30 October 2015, i.e. 5 days. According to the estimates, when the Supplementary Protection Certificate is valid, trade in the pharmaceutical product brings around 80 percent of income. Thus, each additional day allowing marketing in the pharmaceutical product is extremely valuable to pharmaceutical companies.
Different terms of the SPC in different countries would result in great confusion and be contrary to the EU principle of uniformity provided for in the Regulation concerning the Supplementary Protection Certificate for medicinal products. Therefore, the Higher Regional Court of Vienna applied to the Court of Justice of the European Union for interpretation of Article 13(1) of the Regulation No 469/2009 concerning the SPC. In addressing this issue it has been recognised (except for the Government of Italy) that the date of the authorisation to place the product on the market is set not according to the national legislation, but to the Community legislation. The date from which the term of the SPC should run has been considered. The member states, for example, Greece, Latvia and Lithuania, who were involved in the discussion were in favor of calculation of the term as of the date of granting of the marketing authorization.
The Court of Justice was of a different opinion and grounded its decision on the aim of the SPC to extend the patent protection term so that the patent proprietor could recover investments made in clinical trials of medicinal products. After adoption of the decision, the SPC term shall run in the whole European Economic Area on a uniform basis. In the countries where the SPC term was running from the date of issuance of the marketing authorisation till today the SPC term will be extended.
Nevertheless, it is still not clear how this decision will be applied to the Supplementary Protection Certificates that have already been granted. Currently this issue is dealt with at national level.
The Court of Justice of the European Union has not addressed all issues concerning the SPC yet. One of such issues is the date till which the application for granting of the Supplementary Protection Certificate should be filed. Pursuant to Article 7(1) of the Regulation concerning the Supplementary Protection Certificate for medicinal products, the application for a Supplementary Protection Certificate shall be filed within six months of the date of granting of the first authorisation to place the product on the market. Nevertheless, the date from which the term should run, i.e. the date of the decision or the date of notification thereof, still raises some questions.