The Intellectual Property Office of New Zealand (IPONZ) has recently issued amended guidelines for the examination of claims directed toward both methods of medical treatment of humans and second medical use claims.
Under New Zealand patent law, a second medical use of a substance can be protected by a claim to the use of such substance in the manufacture of a medicament for a specified medical use. Such claims are termed Swiss-style claims, and usually take the form: "Use of (substance X) in the manufacture of
a medicament for the (therapeutic and/or prophylactic) treatment of (disease Y)".
Recent New Zealand case law, in which Swiss-style claims that are distinguished from the prior art by the way in which the medicament is administered, as opposed to the purpose of the administration, includes Abbott Laboratories (P16/2003) and Merck & Co v Arrow Pharmaceuticals (P3/2006). Unfortunately, these two decisions are conflicting: Abbott approves the UK case Bristol-Myers Squibb [2001] RPC 1 ("Taxol"), which essentially invalidates Swiss-style claims granted for novel and inventive dosage regimes of an existing medicament, whereas Merck follows a contrary European case, Genentech (T1020/03), which allowed Swiss-style claims directed to any new method of treatment.
IPONZ’s current position relating to Swiss-type claims, where the patentability resides in a new method, time, frequency or dosage, is unclear. Until the different approaches of Assistant Commissioners in Abbott and Merck are resolved, IPONZ have indicated that neither decision is necessarily and unequivocally binding upon New Zealand patent examiners.
IPONZ will proceed to implement their amended practice guidelines, notwithstanding that parts of this may be inconsistent with the Merck decision.
It is considered that the Swiss-style claims guideline represents the correct position, where the patentability resides in a new method, time, frequency or dosage.
Shelston IP would be pleased to offer further advice as to the allowability of claims directed toward both methods of medical treatment of humans and Swiss-style claims in New Zealand.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
