The second defendant Aventis Pharma SA held a patent in New Zealand relating to pharmaceutical compositions containing taxane derivatives, including docetaxel, for the treatment of cancer. The patent was due to expire in July 2012. The third defendant Sanofi Aventis New Zealand Limited was licensee of the patent in New Zealand.

In late 2007, the plaintiff, InterPharma, responded to a general invitation from Pharmac (New Zealand’s pharmaceutical purchasing agency) to tender for the supply of various products including docetaxel. In anticipation of obtaining a contract, InterPharma applied to register a generic product Docetaxel EBEWE under the Medicines Act. By early 2009, this registration was complete. 

In 2009, Aventis wrote to InterPharma expressing its concern that Docetaxel EBEWE might infringe various New Zealand patents including the composition patent. Aventis did not reply to InterPharma’s suggestion that the parties meet to discuss patent issues. 

In September 2009, Pharmac announced that InterPharma had won a tender to supply docetaxel in New Zealand. In November 2009, Aventis applied to amend its patent on the grounds of disclaimer or explanation. Advertisement of the amendment went unnoticed by InterPharma and its patent attorneys. The Commissioner of Patents allowed the amendment with effect from 1 March 2010. Immediately following the amendment on 5 March 2010, Aventis’ patent attorneys wrote to InterPharma asserting infringement by InterPharma of the Amended Claim 2 of the patent and threatening infringement. The letter did not make any mention of the recent amendments to the patent but InterPharma’s enquiries revealed these. 

On 18 March 2010, InterPharma filed these proceedings for judicial review seeking to quash the amendments made on the grounds that:

1. There was no jurisdiction to amend because the amendments enlarged the scope of the patent in breach of s40(1) Patents Act 1953.
2. The Commissioner had made an error of law in failing to adequately inform himself as to the factors relevant to exercise his discretion to allow the amendments.

Aventis then filed separate infringement proceedings against InterPharma and sought an interlocutory injunction. For its part, InterPharma (in its judicial review proceedings) sought interim orders restraining infringement proceedings until determination of the judicial review application. In an interim decision, Harrison J refused the Aventis interlocutory injunction application. 

This decision then dealt with InterPharma’s application for judicial review. 

Did the amendments enlarge the scope?

S40(1) of the New Zealand Act provides that after acceptance no amendment shall be effected, the effect of which would be that the specification claims or describes matter not in substance disclosed in the specification before amendment or that any claim within the specification as amended would not fall wholly within the scope of a claim before amendment.

After reviewing the claims in their original and amended form, Courtney J held that the amendments (which added the word ‘perfusion’ to claim 2) did enlarge the scope of the claims and were not by way of disclaimer or explanation. As a result, the Commissioner did not have jurisdiction to allow it.

Did the Commissioner err in not satisfying himself as to the reasons for the amendment application?

Under s38(2) of the Act, the patentee is required “to give full particulars of the reasons for which application is made”. InterPharma contended that Aventis had not provided the necessary particulars when applying for amendment. Therefore it was asserted that the Commissioner made an error of law in exercising his discretion without being adequately informed as to the relevant considerations to be taken into account.

In its application, Aventis had stated:

“These amendments are made to exclude from the claims embodiments where there is a possibility of a validity argument due to prior art. While this point is disputable, we wish to make the amendment to remove all doubt.”

However, the prior art was not identified and the possible validity argument not explained by Aventis. The Commissioner did not request further information. Documents produced by the Commissioner to the Court showed that the Commissioner’s internal process was not followed and a checklist containing the box “full particulars of reasons provided by applicant” went unmarked. In an affidavit filed with the Court, the Commissioner admitted that, in not identifying the prior art, he (through his examiner) did not have the necessary information to determine the application. Further, because of that failure of process, the Commissioner could not properly have formed the view that the application for amendment met the criteria in the Act before making his final decision.

Courtney J held that the Commissioner had indeed made an error of law in exercising his discretion without the necessary information.

Did s40(2) preclude judicial review of the decision to allow amendment?

A critical part of the case was the contention by Aventis that InterPharma was precluded from challenging the Commissioner’s decision by s40(2) which states:

“Where, after the date of the publication of a complete specification, any amendment of the specification is allowed or approved by the Commissioner or the Court, the right of the patentee or applicant to make the amendment shall not be called in question except on the ground of fraud; and the amendment shall in all Courts and for all purposes be deemed to form part of the specification.”

Courtney J conducted a consideration of the antecedents to this provision in both the UK and in New Zealand. Her Honour considered that the clear restrictions on amendment imposed by s40(1) would be undermined if s40(2) were to be construed so as to permit an amendment that was not allowed by s40(1) to stand unchallenged. The Court accepted that what is put beyond question by s40(2) is not the amended specification per se but the right of the patentee or applicant to make the amendment.

Further, the Court was not impressed by the possible interpretation of s40(2) as a privative clause which would exclude the Court’s inherent jurisdiction to judicially review matters of administrative conduct or omission. The New Zealand courts have presumed that Parliament did not intend to empower statutory authorities conclusively and indeed this approach had hardened into a binding rule of application. [68] Courtney J did not accept that the context of the Commissioner’s decision making power suggested any intention by Parliament to exclude judicial review. Accordingly, the Court could judicially review the Commissioner’s decision.

Was InterPharma’s failure to utilise the opposition an impediment to the grant for relief?

Courtney J held that the existence of a right of appeal in patent law did not preclude judicial review.  Further she did not regard InterPharma’s failure to identify the application to amend as indicating ‘undue slackness’. The patent had at most two years to run and the likelihood of amendments based on prior art to such a patent would be low, much less an amendment that impermissibly enlarged the scope of the patent. Further, although InterPharma had failed to spot the advertisement, it had acted promptly when the fact of amendment was brought to its attention by bringing the judicial review proceedings.

As a result, an order was made quashing the Commissioner’s decision to allow amendments to the specification.