IPONZ examination guidelines for swiss-type claims updated
The Intellectual Property Office published an updated version of the examination guidelines for Swiss-type claims on 8 April 2009.
Swiss-type claims provide patent protection for new second therapeutic uses of known pharmaceuticals. Swiss-type claims have been allowable in New Zealand for some time, the allowability being confirmed by the Court of Appeal in Pharmaceutical Management Agency Limited v Commissioner of Patents & Others [2002] 2 NZLR 529 (Pharmac). Since the decision in Pharmac there has been uncertainty regarding the boundaries of what constitutes a new therapeutic use patentable by way of a Swiss-type claim.
In the past few years, there have been several cases heard by Assistant Commissioners regarding the type of subject matter that may be patentable by way of Swiss-type claims. The decisions in recent cases have confirmed the allowability of Swiss-type claims where the novelty lies in a dosage regime and Swiss-type claims where the novelty lies in the patient population to be treated. The decisions have tended to follow European cases.
The examination guidelines have been reviewed in light of the recent Assistant Commissioners’ decisions to allow Swiss-type claims where the novelty lies in the dosage regime and Swiss-type claims where the novelty lies in a patient group.
Novelty in a dosage regime
A decision of Assistant Commissioner Popplewell, in the case of Genentech’s Application (P1/2007), published on 28 March 2007, confirmed that claims in the Swiss-type format where the medical activity of the active ingredient is known, and novelty lies in the dosage regime used for administration, are allowable in New Zealand.
The examination guidelines have been updated to reflect the allowability of Swiss-type claims where the novelty lies in a new mode of administration or treatment regime.
The examination guidelines include a cautionary note that “mere novelty in a dosage regime or mode of administration will not automatically render a Swiss-type claim as a new invention unless the new use is a ‘new result’.” The guidelines require the new use which is purported to be a new mode of administration or treatment regime to be a new result in that it should be a “new and useful effect”, in accordance with NRDC’s Application [1961] RPC 134.
Novelty in a patient group
Two related decisions of Assistant Commissioner Hazlewood, AstraZeneca AB’s Application 533106 (P23/2007) and AstraZeneca AB’s Application 539603 (P24/2007), were both published on 28 September 2007. In both P23/2007 and P24/2007, Assistant Commissioner Hazlewood reviewed several decisions of the EPO Technical Board of Appeal relating to the allowability of Swiss-type claims where the novelty lies in the patient group and indicated that New Zealand law should also hold that such claims are an invention.
The two AstraZeneca decisions confirm that claims in the Swiss-type format where the novelty lies in the patient population to be treated are allowable in New Zealand. The examination guidelines have been updated to reflect these decisions.
The examination guidelines state that the patient group should be clearly defined to ensure that there is no overlap with an existing group in the prior art.
A general test for a new patient group, according to the examination guidelines, is that the group must be shown to possess a distinct physiological or pathological difference which is neither arbitrary nor overlapping with a known patient group. To determine whether a difference is arbitrary, the Intellectual Property Office will consider whether there is a functional relationship between the particular physiological or pathological status of the patient group and the therapeutic/physiological effect achieved, following Medco Research, T233/96.
Click here to view the examination guidelines on the Intellectual Property Office website.
Rachelle Beale - April 2009.
