Darunavir in Swedish Preliminary Injunction Proceedings

Recently, the Paris High Court decided for a preliminary injunction against the commercialisation of Darunavir by Sandoz, the SPC Blog report can be found here. In parallel proceedings, the Swedish Patent and Market Appeal Court has come to the opposite conclusion, and found that that the contested SPC would most likely be found invalid and thus denied a request for a preliminary injunction. Hampus Rystedt from Zacco has kindly provided the following summary of the case.

The first instance Patent and Market Court, which is quite experienced in SPC appeals originating from the examination at the Swedish Patent Office, granted a preliminary injunction. The Patent and Market Appeal Court however reversed the decision. The PMAC specifically referenced the Teva case from the CJEU (C-121/17; EU:C:2018:585) and found that the criteria set out in Teva should be applied when assessing the plausibility that an SPC will be considered valid. The PMAC finds that darunavir is not specifically identified in the claims, and indeed appears to have been first synthesized only after the priority date. The PMAC therefore finds that it is likely that the SPC will be considered invalid in the main proceedings and that a preliminary injunction cannot be granted.

Of interest to note is that the decision in PMAC was split 3 to 2, with the chairwoman and the only chemical expert dissenting. The two dissenting judges found that the case law is not clear on how Art 3(a) of 469/2009 should be applied when the basic patent defines the invention by means of a Markush-formula. These judges were thus of the opinion that it had not been sufficiently shown that the SPC would likely be held invalid, and that the preliminary injunction granted by the lower court should be upheld.

The main proceedings will now continue in the first instance court.

Many thanks Hampus!

Swedish Appeal Court opens towards re-examination of Swedish SPC terms

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:

"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."