Patent amendments struck down in court

27 January 2012

A recent High Court decision, Interpharma (NZ) Limited v Commissioner of Patents, considered the question of whether a patent amendment after acceptance is open to judicial review.

Aventis Pharma's patent concerns pharmaceutical compositions containing taxane derivatives, a generic form of Docetaxel used in cancer treatment. Aventis made amendments after acceptance to its specification and claims in November 2009. The amendments were advertised for opposition purposes, and no opposition occurred. Shortly after this, Aventis wrote to InterPharma (NZ) Limited alleging infringement of the claims. InterPharma had recently won a tender for supply of its generic Docetaxel to the Pharmaceutical Management Agency of New Zealand, a government agency that manages subsidised medicines.

Amendments after acceptance are permitted by section 38(1) of the Patents Act 1953, subject to the requirements of s 40(1). Amendments must be by way of disclaimer, explanation or correction and cannot broaden the scope of the claims. InterPharma submitted the Commissioner did not have jurisdiction to allow the amendments because they did not meet these criteria. The Court construed the amendments and held they were outside the scope of s 40(1) because they enlarged the scope of the claims.

The Court then considered whether the Commissioner erred by allowing the amendments without enough information. Section 38(2) of the Act requires the patentee to provide "full particulars" of the reason for the amendment. The Court found the Commissioner was not adequately informed of the reasons for the amendment and made an error in law by exercising his discretion without the necessary information.

Aventis argued the Commissioner's decision was not reviewable because s 40(2) of the Act states "the right of the patentee…to make the amendment shall not be called into question except on the ground of fraud". The Court concluded that judicial review of a decision to allow amendments outside the scope of s 40(1) is not precluded by s 40(2). InterPharma's failure to oppose the amendments was not considered detrimental to the application for review and the Commissioner's decision to allow the amendments was quashed.

Fiona Pringle

Baldwins
Level 14, Baldwins Centre
342 Lambton Quay, Wellington
New Zealand
Tel: +64 4 472 1094
Fax: +64 4 473 6712
enquiries@baldwins.com
www.baldwins.com


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