Dutch Supreme Court ends second medical confusion…for now
03 November 2017
Today, the Dutch Supreme Court held that both direct and indirect infringement of Swiss-type claims is possible, in a case between MSD and Teva. A summary of the main points of the decision can be found below. Keep watching this space for a more detailed analysis. The Dutch version of the decision can be found here. An earlier article on the Life Sciences Hub on the opinion of the Attorney-General in this case can be found here.
With regard to direct infringement of Swiss-type claims, the Supreme Court confirmed its earlier decision in the Sun/Novartis case of 14 April 2017. This means that Swiss-type claims can be infringed if the generic foresees or should have foreseen that the generic substance will intentionally be used for the patented indication. To avoid a finding of infringement a generic will have to take all reasonable precautions to avoid use of the substance for the patented indication. A carve out is unlikely to be enough.
On the question of whether a Swiss-type claim can be indirectly infringed, the Supreme Court seems to aim for a convergence of the scope of protection of Swiss-type claims and EPC 2000 claims. Since indirect infringement of EPC 2000 claims is possible, the same should apply for Swiss-type claims, according to the Supreme Court.
On direct infringement (par. 3.4.4-3.5):
Regarding direct infringement of Swiss-type claims, the Dutch Supreme Court confirms the rule of its earlier decision in Sun/Novartis of 14 April 2017:
- A Swiss-type claim will only be directly infringed if the generic foresees or should have foreseen that the generic substance will intentionally be used for the patented indication;
- For this it is required that a person skilled in the art believes, in light of the circumstances, that the generic substance is (also) meant to be used or suitable for the patented indication;
- The generic will then have to take all reasonable precautions to prevent that the generic substance will be used for the patented indication. Generally, a carve-out in the SmPC or PIL will not be enough.
The Supreme Court dismisses any distinction between different types of second medical use claims as incorrect (par. 3.5):
- The Supreme Court holds that the distinction, made by the Court of Appeal in this case, between the scope of protection of “classic” second medical use claims and “sub-group” medical use claims, is incorrect. All second medical use claims have the same scope of protection: in the EPC-system there is no room for a categorical distinction between the two types of second medical use claims;
- The Attorney-General also thought that a general distinction would be too restrictive.
On indirect infringement
The Supreme Court holds the following on the point of indirect infringement (par. 3.6.1-3.6.4):
- After EPC 2000, art. 54(5) EPC 2000 allows the protection of substances for second medical indications by product claims (the EPC 2000 claims). According to the Supreme Court, EPC 2000 aimed not to deviate from the case law in relation to patentability of substances by Swiss-type claims (confirmed in G2/08);
- This is (sort of) in line with the opinion of the Attorney-General, who made explicit that one should aim for a convergence of the scope of protection of Swiss-type claims and EPC 2000 claims;
- According to the Supreme Court this means that, in light of a reasonable protection for patentees, the acts that constitute indirect infringement of EPC 2000 claims should also constitute indirect infringement of Swiss-type claims. The Supreme Court refers to the Bundesgerichtshof in Eli Lilly/Actavis and the UK Supreme Court in Actavis/Eli Lilly;
- Therefore, as is the case with EPC 2000 claims, indirect infringement of Swiss-type claims is possible if the generic offers the substance with the knowledge, or if it is obvious to the generic given the circumstances, that the substance is suitable for and will be used for the patented indication;
- The Attorney-General came to the same conclusion.