• Embryonic Stem Cells

    DNA Sequence must show "credible function"

     

    European Patent Office Upholds "Edinburgh" Stem Cell Patent After Amendment to Exclude Embryonic Stem Cells

    Srem cells have the capacity to self-renew and to differentiate into mature cells of different body tissues and are immensely important for research into a wide range of incurable disorders.  For example, one study shows that it may be possible to use stem cells to repair widespread nerve damage in people (Single shot, New Scientist 6 November 2000).  Embryonic stem cells are the archetypal stem cell, being able to differentiate to form the whole gamut of cells in the body, but research through use of embryos is politically charged.

    In oral proceedings on 22 July 2002, the European Patent Office upheld the so-called "Edinburgh" patent issued to the University of Edinburgh and entitled "Isolation, Selection and Propagation of Animal Transgenic Stem Cells" in the face of oppositions by 13 Opponents, including the Governments of Germany, Italy and the Netherlands, as well as Greenpeace Deutschland.  The European Patent Office required amendment of the patent to exclude embryonic stem cells in view of the requirements of the EU Biotechnology Directive.

    European Patent No EP 0 695 351 granted to the University of Edinburgh and subsequently opposed included claims to methods of isolating and/or propagating animal stem cells based upon the presence of a selectable marker (e.g. an antibiotic resistant gene), claims to modified stem cells per se and claims to methods of preparing genetically modified animals using the stem cells.

    The patent came under great criticism and has been the subject of much media interest. Unusually even some European Governments decided to file oppositions against the patent.

    In the opposition proceedings, great attention was given to Rule 23(d) of the EPC Implementing Regulations enumerating the exceptions to patentability for biotechnological inventions. That Rule, in particular, precludes patenting of

    (a) processes for cloning human beings;
    (b) processes for modifying the germ line genetic identity of human beings;
    (c) uses of human embryos for industrial or commercial purposes;
    (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and
    (e) animals resulting from such processes.

    Rule 23(d) is derived from Article 6, paragraph 2 of Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions.

    In opposition, the proprietor amended the patent so that it no longer extended to human or animal embryonic stem cells. This amendment was necessitated by the European Patent Office's decision that the claims as granted would contravene Rule 23(d)(c). The patent was further amended to exclude human germ line intervention in view of objections from the opponents on grounds of insufficiency, with which the Opposition Division agreed.

    Provisions of German national law were held not to be relevant, because the European Patent Office is bound by the European Patent Convention, rather than the national laws of its member states.

    The University of Edinburgh has appealed.

     

    A DNA Sequence Including a Protein without a Credible Function is not a Patentable Invention

    Various media reports have described how biotech companies have rushed to find new DNA sequences to patent in the hope that therapeutic discoveries based on their sequences would prove rewarding (see for example Gene Patents Inhibit Innovation, New Scientist, 23 July 2002).  But the world’s patent offices have been moving to stem the tide of claims to DNA sequences being claimed without clearly identified functions.

    In December 1999, the United States Patent and Trademark Office published its Interim Utility Examination Guidelines which require that a patent claiming a DNA sequence (or indeed any other chemical compound) must disclose a specific, substantial and credible utility for the newly discovered sequence.  (The final Utility Examination Guidelines of 5 January 2001 are found at 66 Fed. Reg. 1092). The European Patent Office has now taken a step further to stem the tide of claims to DNA sequences which do not have a fully disclosed therapeutic or other function, by the recent refusal of European Patent No EP 0 630 405.

    The patent (issued to ICOS Corporation and opposed by SmithKline Beecham and Dufar International Research) disclosed a certain protein (V28 7TM protein) which was predicted to function as a receptor, but the proposed function of the receptor was not sufficiently disclosed in the specification. The specification did not demonstrate that V28 protein is a receptor.  Instead, it merely disclosed several methods which can be used to verify the prediction that the protein is indeed a receptor. The Opposition Division examined the plausibility of these tests finding that the protein is a receptor, but concluded that an undue burden would be placed on the skilled person to obtain a 7TM protein that is definitely a receptor. The specification also failed to identify a ligand for the V28 receptor among the tested candidate compounds.

    The European Patent Office concluded (EPOJ 6/2002) that the function of the protein was insufficiently disclosed in the absence of a disclosed compound, such as a ligand, for a predicted receptor protein.  The mere listing of speculative functions of the protein was not a reliable basis for acknowledging industrial application.

    Mere statements that the protein may be useful in complexes for immunisation or for purifying V28 peptides or for identifying cells producing the V28 polypeptides were insufficient.  Specific antibodies were not disclosed and, indeed, may not even be possible to be generated, due to a high sequence identity shared by a large number of other proteins. Proposed users were being directed to a substance that had not been disclosed and could only be considered as speculative.

    The European Patent Office held that a DNA sequence encoding a protein without a credible function is not a patentable invention and held that the requirement of an "indication of function" was a requirement for an indication which is more than speculative.

    In reaching its decision, the European Patent Office cited Recital 23 of the European Commission's Biotechnology Directive, which reads:

    whereas a mere DNA sequence without indication of a function does not contain any technical information and is, therefore, not a patentable invention.

    The proprietor filed notice of appeal but did not follow up with any statement of grounds of appeal, and the appeal has been ruled inadmissible (Decision T1191/01).

    This decision was taken by the Opposition Division at first instance and, while indicating how the wind is blowing at the EPO, it remains to be seen whether it is persuasive in the future.