In Eli Lilly Company v Human Genome Sciences Inc, [2008] EWHC 1903 (Pat), the English High Court of Justice recently clarified the law relating to the industrial application requirement, a case which addressed the patentability of nucleotide sequences discovered through bioinformatics. It involved an attack by Eli Lilly Company (Lilly) on the validity of European Patent No 0,938,804 (the "˜804 Patent) owned by Human Genome Sciences Inc (HGS), which disclosed the nucleotide and amino acid sequences of the cytokine Neutrokine-alpha. Lilly alleged that the "˜804 Patent lacked industrial applicability as required by Section 1 of the UK Patents Act 1977. Justice Kitchin reviewed a number of European Patent Office (EPO) and UK cases and he concluded that the Court should construe Section 1 so that it had the same effect as Article 52 of the European Patent Convention (EPC), as interpreted by the EPO. Article 52 of the EPC provides that for an invention to be patentable it must be "susceptible of industrial application". At paragraph 226 of the decision, Justice Kitchin summarized the industrial application requirement as follows:
  1. the notion of "˜industry' should be construed broadly;
  2. the capability of industrial exploitation must be derivable by a person skilled in the art from the description of the patent, read having regard for the common general knowledge;
  3. the description must disclose a practical way of exploiting the invention in at least one field of industrial activity;
  4. the requirement will not be satisfied if what is described is merely an interesting research result that might yield an unidentified industrial application;
  5. if a substance essential for human health is disclosed, its identification will immediately suggest a practical application, but if its function is not known or understood and no disease has been identified which is attributable to an excess or deficiency of the substance, then the requirement of industrial application is not satisfied;
  6. using the claimed invention to find out more of its own activities is not itself an industrial application; and
  7. it is no bar to patentability that the invention has been found by homology studies using bioinformatics.
Applying these principles, Justice Kitchin found that the "˜804 Patent was not susceptible of industrial application, as it merely identified a nucleotide sequence and protein, and speculated as to their industrial application. The principles may serve as guidance for Canadian courts, as the Canadian utility requirement is roughly analogous to the UK industrial application requirement. For the full reasons for judgment, see: http://www.bailii.org/ew/cases/EWHC/Patents/2008/1903.html For commentary on the judgment, see: http://tinyurl.com/58xrdp http://tinyurl.com/5hywrs Summary by: Michael Migus

E-TIPS® ISSUE

08 08 27

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