Following Seattle Genetics, Swedish Appeal Court opens for re-examination of SPC term; overturning lower court
On 4 October 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions.
The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. In the judgement, the CJEU held 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) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation.
The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law.
The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions.
The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term.
The decisions then differ depending on when the patentee filed its request – in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun.
Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above.
Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court.
5 October 2017