The UK Intellectual Property Office (IPO) has recently published revised examination guidelines for patent applications relating to medical inventions. The revisions are to take into account amendments to patent law made by the provisions of the Patents Act 2004, which came in force on December 13 2007 following the implementation of the European Patent Convention 2000. As always, the guidelines are a comprehensive explanation of the practice of the IPO and all practitioners in this field are advised to consult them.

In brief, the changes brought about by the Patents Act 2004 in the field of medical inventions are:

• The introduction of a new Section 4A to the Patents Act 1977 which states in section 4A(1) that the invention of a method of treatment of the human or animal body by surgery or therapy, or a method of diagnosis practised on the human or animal body, is not patentable. This replaces the former section 4(2), and thereby removes the so-called legal fiction that such methods lack industrial application. From December 13 2007, they are regarded as unpatentable in their own right.
• A new Section 4A states that patents may be granted for a known substance or composition for use in medicine (section 4A(3)), or for a specific medical use (section 4A(4)). These provisions therefore explicitly allow patent protection for the first medical use of a known substance or composition (previously allowed under section 2(6)) and a second or further medical use. Prior to December 13 2007, inventions relating to second medical uses could only be protected using the Swiss-type claim form of "the use of substance X for the manufacture of a medicament to treat disease Y". Section 4A(4) now allows for a more straightforward second medical use claim: "substance X for use in the treatment of disease Y."

The guidelines make it clear that the changes introduced by the Patents Act 2004 do not lead to any substantive change in what is and what is not patentable in this field. For example, existing case law under repealed sections 4(2) and 2(6) of the Patents Act 1977 will continue to govern the IPO's practice under sections 4A(1) and 4A(3) respectively.

The guidelines are available on the UK Intellectual Property Office's website.

Scott Foster

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