Patenting of Human Gene Sequences and the EU Draft Directive.

Statement by the British Society for Human Genetics, September 1997

1. The application of existing patent law has created uncertainty over what is and what is not patentable, resulting in a culture of defensive patenting applications being made for apparently trivial inventions and for discoveries which are quite unlikely to be patentable.

    

2. Interpretation of patentability varies between countries, including between member states of the EU. The granting of preliminary applications in the fields of biotechnology and human genetics has often been liberal, increasing the confusion as to where the boundaries of patentability may lie.

    

3. Patenting is a valuable means of protecting intellectual property and promoting investment in developing products for the diagnosis and treatment of genetic disease. The EU Directive is an important step forward in creating a framework for this to happen, by harmonising and clarifying decisions about patentability within the EU.

    

4. In the medical field there is however remaining confusion about the apparent patentability of human gene sequences. arising from the wording of Article 5. This Article appears both to permit and to exclude the patenting of human gene sequence.

    

5. The discovery of gene sequence has for some little time been a well understood process. There is nothing novel or inventive about this in principle, and as such new gene sequences should not be patentable, even where a straightforward utility e.g. diagnostic testing has been specified, unless there has been real progress towards the design of a specific commercial product.

    

6. Rigidity in an area of science that is changing very rapidly is undesirable. To avoid this, and to maximise opportunities for progress, primary legislation may be relatively non-specific. In this case, authoritative guidance, regularly updated, should be issued from time to time to ensure both consistency of approach and the application of knowledge current at the time of the patent application.

    

7. Such guidance would have to address the following points:
   • Novelty.
     This cannot reside in the mere description of a nucleotide sequence. It must rest in either novel methodologies for discovering the sequence or a novel use or application of the sequence. Conventional technology, conventionally applied, should not result in patents on newly isolated sequences.

      

   • Utility.
     A claim for utility must describe a utility specific to the sequence in question, and not simply rehearse those possible applications of any known gene sequence which are part of the general public state of the art. The following should not be acceptable claims for utility of a gene or partial gene sequence:
     • use for isolating the full gene sequence
     • use for detecting mutations in the gene (without specifying the clinical indication, see below)
     • use for studying expression or function of the gene.
     Utility requires:
     • some meaningful indication that the sequence being patented has a reasonable prospect of being developed into a marketable product (which may be a diagnostic test).
     • a proposed specific use - for example, diagnosis of mutations in people with a specified clinical indication.

     Undue difficulty in gaining patent protection will deter investment by reducing the prospect of a reasonable return. This is not in the interest of patients, or of industry. On the other hand, too free an availability and excessive breadth of protection will give undue reward for prosaic contributions and may inhibit the speed of exchange of basic knowledge and the likelihood of development of useful products.

      

   • Breadth.
     If a gene sequence can be discovered using methods well known in the field, then patent protection should only be conferred on it in respect of specified applications which meet the novelty and utility criteria. We endorse the recommendations of the House of Commons' Select Committee on Science and Technology, that a gene sequence is only patentable in the context of a specific utility, and that the same sequence should be available for further patents by others in the context of other utilities.

    

8. Regular and continuing mechanisms for communication between scientists in the public and private sectors, patent lawyers and patent offices must be developed to ensure understanding and a consistent application of the law within the EU. The system must be fair, it must be open, and it must carry conviction in the eyes of those who have to use it to best advantage in the pursuit of improved services and products for the diagnosis and treatment of genetic disease.

    

9. The UK government should take a lead in promulgating guidance as to the intended interpretation of Article 5 of the Directive, and the mechanisms whereby this will be reviewed in the light of scientific progress.

    

British Society for Human Genetics, September 1997