• Statement of potential utility in the treatment of rheumatoid arthritis, diabetes mellitus and multiplesclerosis is sufficient for ‘credible function’

    Gene sequences are patentable subject matter so long as they are isolated from the human body and are susceptible to industrial application.

    In ZYMOGENETICS INC.’S patent application (EPO Board of Appeal Decision T0898/05) a claim to the gene sequence of Zcytor1 protein was upheld as being subject matter susceptible of industrial application because data demonstrating an effect as well as a credible role in specific diseases was suggested in the specification. No mechanism of effect at the biochemical or cellular level is required.

    A vast number of patent applications were filed around the world for gene sequences identified as a result of the Human Genome Project, and the resulting furore created a need to define exactly when a gene sequence is patentable. In 1998, the European Union issued Directive 98/44/EC on the legal protection of biotechological inventions (the Biotechnology Directive), and in 1999 the US Patent and Trademark Office introduced its utility guidelines that call for a “specific, substantial and credible utility”.

    The position on patentability of gene sequences at the EPO has for some time been clear despite extensive controversy in the mainstream press and from various environmental groups regarding the idea of ‘patenting life’. The Opposition Division took the opportunity in RELAXIN (OJ EPO 6/1995, 388) to point out that “…DNA is not life…Even if every gene in the (human) genome were patented, it would be impossible to reconstitute a human being from the sum of its genes”

    A gene sequence as such is simply a discovery and as such is not patentable subject matter in the sense of Article 52(2)(a) EPC. Furthermore, a gene sequence in situ clearly is not novel or inventive and therefore as an element of the human body it will not be accepted. This is clearly stipulated in Rule 23 on the implementation of Article 53 Exceptions to Patentability (based on Article 5 of the Biotechnology Directive). However, biological material previously occurring in nature, which has been isolated using a technical process, may constitute patentable subject matter. This is limited by the requirement in Rule 23(e)(3) that the industrial application of a sequence or partial sequence of a gene must be disclosed in the patent application.

    Board of Appeal decision T0898/05 has helped to define exactly what is required in order to satisfy the requirement of Article 52(1) that a invention must be “…susceptible of industrial application”. ZymoGenetics Inc.’s patent application contained claims to the sequence for the protein Zcytor1. The application had been rejected by the Examining Division on the grounds that no function at a cellular or biochemical level had been disclosed and so the invention could have no industrial application in the sense of Article 57 EPC and Rule 23(e)(3) EPC.

    The decision was reversed on appeal. The Board of Appeal recognised that the patent application contained data showing stimulation of cell-mediated immunity and lymphocyte proliferation and suppression of immune system when molecules known to respectively stimulate or reduce Zcytor1 function were applied to cells. The patent application also clearly stated the potential utility of these effects in the treatment of rheumatoid arthritis, diabetes mellitus and multiple sclerosis. On this basis the gene sequence for Zcytor1 was deemed susceptible of industrial application.

     

    Comment

    It is well established that an explanation of the mechanisms or theories underlying the way an invention works is not necessary in order to render subject matter patentable. This decision confirms that this is also applicable to gene sequences. So long as an Applicant clearly discloses a credible envisaged use for the sequence, the biochemical mechanisms required to achieve the effect are unlikely to be required in order to demonstrate industrial applicability. Concrete data which demonstrates the effect is not strictly necessary; computer assisted modelling will suffice.