New Dosage Regimes for Pharmaceuticals now Patentable in New Zealand

Wednesday 23rd April 2008

The Intellectual Property Office of New Zealand (IPONZ) has just released a decision of particular significance to the pharmaceutical industry. The decision follows a hearing at IPONZ on the patentability of Swiss claims where the novelty of the claimed subject matter resides in a dosage regime, rather than the active ingredient or the disease to be treated.

The patent application is jointly owned by Genentech Inc. and Washington University. The active ingredient of the claims, insulin-like growth factor-1 (IGF-1), was previously known for treating various diseases, but patients suffered from side effects and the particular problem that continuous treatment rendered IGF-1 ineffective over time. The applicants had found that intermittent treatment using IGF-1 maximised efficacy and minimised side effects.

New Zealand does not allow patents for methods of medically treating humans.This position is in line with the vast majority of countries, the notable exceptions being the United States and Australia. However, following a decision of the Court of Appeal in 2000, known as the Pharmac case (Pharmaceutical Management Agency Ltd v The Commission of Patents [2000] RPC 857), Swiss claims have been allowable in New Zealand. Swiss claims effectively protect a new use of a known pharmaceutical ingredient.

However, the interpretation of relevant case law by IPONZ has been rather restrictive and is reflected in its “Guidelines For the Examination of Swiss-type Claims” that issued in September 2006. The Guidelines considered the conflicting positions of the UK and Europe. The UK Court of Appeal in the Bristol-Myers Taxol case (Bristol-Myers Squibb v Baker Norton Pharmaceuticals [2001] RPC 1) refused to allow a Swiss claim having a faster administration rate as its novel feature. In contrast, the decision of the EPO in the Genentech Inc. case (T1020/03) allowed claims equivalent to those that were the subject of the New Zealand decision. The Guidelines controversially concluded that the novelty must reside in the newly discovered purpose (of the known pharmaceutical) and not the mode of administration or the amount, timing or frequency of dosage.

The New Zealand decision reviewed the UK and European decisions, as well as earlier IPONZ decisions on the issue, and disagreed with the statement in the Guidelines that claims of this type are not valid Swiss claims. The IPONZ decision noted that the applicants had produced a means of overcoming or alleviating problems associated with the continued use of IGF-1 and that it was proper that they should be able to obtain patent protection for their contribution. The decision went on to explain that the only contrary view was that expressed by the UK Court of Appeal in the
Bristol-Myers Taxol case, and that case, although persuasive, was not binding in New Zealand nor had it been followed by later European Board of Appeal cases.

The decision represents a positive step forward for many in the pharmaceutical industry, and reflects the continued expansion of areas of pharmaceutical innovation that can be patented in New Zealand.

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