Landmark Decision: Nucleic Acids still Constitute Patentable Subject-Matter in Germany

In the recent judgment Rezeptortyrosinkinase of January 19, 2016 (X ZR 141/13), the Federal Court of Justice had to decide on the validity of claims, which wereinter alia directed to nucleic acid molecules.

In short

The Court discusses in detail the question whether nucleic acid molecules constitute patentable subject-matter.

The Court confirms the established German case law that nucleic acid molecules constitute patentable subject-matter in Germany, and stresses the clear differences to the US case law on patent-eligible subject-matter, as decided in the judgment Mayo von Prometheus (566 U.S. 2012).

Further, the Court confirms the established practice in Germany and Europe that it is notnecessary to specify a nucleic acid in a claim as being “isolated” or “obtained by a technical process”.

The case

The case underlying the present judgment relates to an appeal in the context of a nullity suit against the German part of a European patent. The claims as defended in the appeal proceedings were inter alia directed to a nucleic acid of a tandem duplication mutant encoding a specific receptor tyrosine kinase. Further independent claims were directed to corresponding subject-matter, such as a polypeptide encoded by the nucleic acids, a cell, an antibody, a method of detecting the nucleic acid molecule, kits, as well as uses thereof.

As summarized by the Court, the invention relates to the provision of the claimed nucleic acid molecule which is a tandem duplication mutant. The nucleic acid is defined on the one hand as encoding a specific receptor tyrosine kinase (FMS-like tyrosin kinase 3), and on the other hand by a specific nucleotide sequence, which is a specific tandem duplication mutation. The detection of the presence of a tandem duplication mutation in a sample is an indicator for leukemia in human patients.

Among other nullity grounds, the plaintiff of the nullity action argued that the claimed nucleic acid molecules merely relate to a discovery and therefore constitute non-patentable subject-matter pursuant to Art. 52(2) a (3) EPC.

The Court did not follow the argumentation: A technical teaching which relates to the application of a discovery in order to achieve a technical effect represents patentable subject-matter both according to European and German law. This principle applies independent of whether there is “an additional inventive contribution” (“erfinderischer Überschuss”), in addition to the discovered relationship according to the law of natures. This highlights the clear distinction between the principles applied for the determination of non-patentable subject-matter in Germany on the hand and the corresponding case law of the US Supreme Court in Mayo v. Prometheus on the other hand.

The Court further states that the recognition of a physical, chemical or biological relationship, which represents the basis for the technical teaching has to be taken into account in the assessment of inventive step. In this context, the Court indicates that the same considerations apply to computer-implemented applications.

According to the Court, it is, moreover, immanent to any product claim that the claimed technical teaching is specified by the description of the product. Accordingly, a further specification of a nucleic acid in claim directed to such nucleic acid as being “isolated” or “obtained by a technical process” is not required.

The Court finally comes to the conclusion that the provision of a nucleic acid molecule and, therefore, a claim directed to a nucleic acid as such, constitutes patentable subject-matter. This confirms established German case law.