The decision Seattle Genetics CJEU decision C-471/14 from the 06 May, 2009 concluded 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 Regulation of the European Parliament of the Council (EC) No 469/2009 is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. Many countries in the EU, including Sweden, had until then used the date of grant of said marketing authorisation to calculate the SPC term.
Since the two dates referred to above are often a few days apart, a potential extension of the SPC term was available, if a re-calculation and amendment of the term of the SPC was allowed by the national patent offices. As for many other SPC decisions from the CJEU, the implementation of the Seattle Genetics decision C-471/14 varies throughout the EU. This is an effect combined of diverging interpretation of the decision and national law.
The Swedish Patent and Market Appeal Court ruled on the 04, October 2017 how the Seattle Genetic decision is to be implemented in Sweden. The ruling should shed more light on the SPC holders’ right after a period of uncertainty on the implementation and interpretation of Article 13(1) of the Regulation of the European Parliament of the Council (EC) No 469/2009 in Sweden. However the ruling of the Swedish Patent and Market Appeal court is appealable at the Swedish Supreme Court.
Change of practice usually does not provide basis for re-examination under the Swedish Administrative law, and thus at the Swedish Patent and Registration Office (Swedish PTO), the Swedish PTO refused to change the term of already issued SPCs in accordance with CJEU decision C-471/14, unless the re-calculation was requested within the time limit of appeal; 2 month after the decision to grant the SPC.
This decision was subsequently supported by the Patent and Market Court. The judges argued that regardless of the fact that no further parties are involved in the decision to grant SPCs, such decisions should be viewed as being similar to civil actions, because the grant of SPC, according to the Patent and Market Court, does not affect the SPC holder alone, but also 3rd parties who may have commercial interests in competition with the SPC holder.
The above decision was appealed to the Swedish Patent and Market Court, which lead to the recent decision outlined below.
Decision of the Swedish Patent and Market Appeal Court of 04 October, 2017
The Swedish Patent and Market Appeal Court did not agree with the Patent and Market Court on the belief that the decision to grant SPC is comparable to a civil act. The judges here argue that economic consequences for 3rd parties should not lead to deviations from a general administrative law. The interest of 3rd parties should however be considered in the re-examination procedure. Thus, the Swedish Patent and Market Appeal Court ruling represents a balance between the interests of the SPC holder and 3rd parties. As a general rule, the SPC term should be re-calculated and amended according to the CJEU C-471/14 upon request from the patent holder, if the request is filed before the supplementary protection has commenced. In the case where the SPC has commenced, the judges argue, that the interest of 3rd parties, who have adapted their efforts to prepare for market entry after expiry of the original SPC date, has to be protected by maintaining the foreseeable term.
In conclusion, if the SPC holder files the request for re-calculation and amendment of the term before the SPC commences, the Swedish PTO should allow the amendment of the SPC term according to CJEU decision C-471/14 . If they file after the SPC period has started, the rejection of the Swedish PTO should be maintained.
The current decision can be appealed to the Supreme Court, which means that the implementation of Seattle Genetics CJEU decision C-471/14 in Sweden may be revised one more time.