Die Marktexklusivität als absolutes Recht (Teil II), GRUR 16/2024

Although market exclusivity for orphan drugs (drugs for rare diseases) and the related non-indication-related document and marketing protection are crucial for ensuring investment and innovation protection in the pharmaceutical industry, it has not yet been clarified how and against whom the first marketing authorization holder can assert these rights. On 4 August 2023, the Munich Regional Court I in its “Eculizumab“ decision (21 O 6235/23) was the first German court to deal with the legal nature of regulatory market exclusivity for orphan drugs, categorizing it as an “other right“ within the meaning of Section 823(1) BGB. The Munich Regional Court subsequently affirmed a claim for injunctive relief enforceable under civil law based on Section 1004 BGB by analogy. On appeal by the defendant, the Munich Higher Regional Court has now rejected this categorization and, in its ruling of 1 February 2024 (6 U 3303/23e), revoked the interim injunction issued by Munich Regional Court I. In Part 2 below, the two Munich decisions will first be discussed and the different legal opinions of the Regional Court Munich I and the Higher Regional Court Munich will be compared. The last part of the article looks at the implications of the Munich Higher Regional Court’s decision for non-indication-related document protection regarding the authorization and marketing of generics.