SWITZERLAND Trends and Developments Contributed by: Simon Holzer, Ulrike Ciesla, Louisa Galbraith and Michael Ritscher, MLL Legal
parties could comment within the short dead- lines appropriate for PI proceedings. In the present case, the Federal Patent Court dismissed Bayer’s ex parte PI request after hav- ing involved two technical judges and after a period of 14 days. No inter partes PI proceed- ings were conducted in this case. It remains to be seen whether this new prac- tice of the Federal Patent Court will prevail in Switzerland. Bayer’s appeal is currently pend- ing before the Federal Supreme Court (second and highest instance court in Switzerland). The authors will likely be able to provide an update on this matter next year. Apart from that, there are also nullity proceedings concerning EP 916 currently pending before the Federal Patent Court. The judgment of the Federal Patent Court in those proceedings is expected in Q1 2025. Confirmation of validity of the SPC for apixaban (O2022_007, judgment of 5 March 2024) Another case that attracted particular attention in Switzerland and beyond concerns the Swiss SPC for apixaban owned by Bristol-Myers Squibb (BMS). This is another case that was or still is litigated in several parallel national pro- ceedings, either in PI proceedings or nullity pro- ceedings, with mixed results on both the ques- tions of priority and inventive step. On 26 September 2024, the Swiss Federal Supreme Court dismissed Mepha’s appeal against the first instance decision of the Swiss Federal Patent Court of 5 March 2024. As a result, the Swiss Federal Patent Court and the Federal Supreme Court confirm the validity of the Swiss SPC for apixaban. No further appeal is possible.
In Switzerland, Mepha had filed a nullity action against the Swiss SPC for apixaban, challenging the validity of the Swiss part of the basic patent EP 1 427 415 (EP 415). The main issues were the alleged lack of validity of the priority claim and the technical effect of the invention for the assessment of inventive step (previously called “plausibility”). The first-instance judgment of the Swiss Federal Patent Court, issued by an extended panel of five judges (three of them with a scientific back- ground), is a landmark decision as it is the first case in Switzerland to examine the reliance on a purported technical effect for inventive step and an allegedly invalid priority since the decisions of the Enlarged Board of Appeal of the EPO in G 2/21 (“plausibility”) and G1/22 and G2/22 (“enti- tlement to priority”) were published. Decisions of the EPO’s Boards of Appeal are considered persuasive authority in Switzerland, but they are not binding on the Swiss courts. The Federal Patent Court considered the two decisions of the Enlarged Board of Appeal and discussed them in detail in its judgment on BMS’ basic patent for the Swiss SPC for apixaban. Regarding the priority claim, Mepha argued that BMS cannot rely on the priority document US 165 because, at the date of filing of the EP 415 application, the applicant (BMS Company, the predecessor of BMS) was not the holder of priority document US 60/324,165 (US 165). In 2001, group companies of Bristol-Myers Squibb Company (“BMS Company”) acquired DuPont Pharma, which was later renamed “BMS Phar- ma”. The inventors transferred their rights to the provisional US patent application to BMS Pharma. In 2002, BMS Company submitted an international patent application for the same
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