Clarity on methods of diagnosis

Thursday 11th September 2008

As discussed in Managing IP’s March edition, it was becoming increasingly unclear whether method of diagnosis claims were allowable in New Zealand. However, Biosite Incorporated, a recently released decision of the Commissioner of Patents [P31/2007], may assist in clarifying practice in New Zealand.

The Biosite application was rejected under section 2 of the New Zealand Patents Act 1953 on the basis that the claims did not provide patentable subject matter. The claims are directed to a method for determining a patient’s prognosis using antibodies against a sample from the patient. The claimed method can be used to select between alternative therapeutic regimens.

Several areas of the law regarding method of prognosis claims were considered in the Commissioner’s decision. Firstly, the Assistant Commissioner stated that “on the basis of the Bio-Digital Sciences decision alone, I believe the present claims are allowable”. The Bio- Digital Sciences [Bio-Digital Sciences Inc’s Application [1973] RPC 668] decision specifically supports the allowability of method of diagnosis claims that produce information.

The application of the Commissioner’s decisions in George N Haddad [P8/2000] and Hughes Aircraft Company [P3/1995] to method of prognosis claims was also considered. These decisions held that method claims that provide a tangible result (Haddad) or commercially useful effect (Hughes) are allowable. The applicant’s argument in Biosite that the claimed method provided both a tangible result and a commercially useful effect was accepted.

The Assistant Commissioner noted that the benefit of the doubt should go to the applicant and that clear doubt exists about whether method of prognosis claims should be allowed. In addition, the Assistant Commissioner made a strong statement that:

"Claims should only be rejected under section 2 at the examination stage where it is manifestly clear that a New Zealand Court would refuse the claims as not falling within the definition of ‘invention’ of section 2. Given the decisions of the Courts in New Zealand and in overseas jurisdictions with similar definitions of invention, and the liberal approach taken over many decades by the Courts as to what is to be regarded as properly falling within the definition of invention in section 2, it cannot be said that the present claims would clearly be refused by such a Court."

The claims were held to be acceptable.

This article was published in Managing Intellectual Property, September 2008.

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