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Interpharma (NZ) Ltd v Commissioner of Patents

(CIV 2010-485-506, 7th October 2011)

Interpharma sought judicial review of the Commissioner of Patents decision in 2010 to allow amendments to a patent held by Aventis Pharma SA. Aventis amended its patent after it lost (to Interpharma) the tender it had with Pharmac for the supply of Docetaxel injections. The advertisement of the amendment went unnoticed by Interpharma, and once the amendments were allowed and included in the specification, Aventis immediately sent Interpharma a cease and desist letter. Interpharma argued that the amendments were allowed in error because they enlarged the scope of the patent.

The judge noted that the amendment sought was only allowable by way of disclaimer, correction or explanation. An amended specification must not claim or describe matter that is not, in substance, disclosed in the original specification, and everything covered by an amended claim must have fallen within the scope of at least one claim prior to the amendment.
The Judge followed the Supreme Court approach in Lucas v Peterson Portable Sawing [2006] SC 20 of interpreting the specification primarily by the meaning the claims would convey to a skilled addressee. The description of the invention can assist in interpreting the claim, but it does not dictate that meaning.

The invention relates to compositions that make it possible to greatly reduce or eliminate ethanol or Cremophor concentrations from perfusions used in injections relating to the treatment of cancer. While this purpose of the invention remained unchanged, the pre-amendment claim 1 did not refer to perfusions. While the Judge accepted that some elements of the amendments were by way of disclaimer, the post-amendment requirement that the composition be a perfusion was held to be an enlarging of the scope of the invention. In particular, the Judge agreed with the plaintiff’s expert witness and found that the skilled addressee would not have interpreted the pre-amendment claim 1 as including perfusions, as to do so would result in an unacceptably high concentration of ethanol in the stock solution used to make the perfusion.

Interpharma also contended that the Commissioner erred in allowing the amendment since his discretion was exercised in the absence of the full particulars of the reasons for the amendment that the applicant is required to provide. The stated reason for the amendment was to avoid the possibility of validity attacks due to prior art, although no particulars of the prior art or possible validity attacks were given. The Judge agreed that the Commissioner erred in not requiring those particulars before allowing the amendment. Such particulars are required to determine whether the amendments are made by way of disclaimer, correction or explanation. Hence, the Commissioner erred in proceeding to amend the patent without requiring those amendments.

Despite the above findings, Aventis nonetheless sought to retain the amendments on the basis that section 40(2) precludes judicial review of the patentee’s right to make the allowed amendments except on the ground of fraud. Following extensive analysis of inconsistent UK case law, the Judge held that the prohibition on judicial review in section 40(2) needs to be read in light of section 40(1). Namely, if an amendment ought not to have been allowed under section 40(1), then it cannot be retained on the basis of section 40(2). Further, the Judge agreed with the plaintiff counsels submissions that section 40(2) only puts beyond question the right of the patentee to make the amendment rather than the specific amendment made.
Finally, the Judge held that Interpharma’s failure to object to the amendments during the opposition period allowed was not prejudicial to its case. The fact that the amendments were made late in the patent’s life and Interpharma’s prompt action upon realizing that amendment had been made were sufficient for the Judge to exercise discretion in that regard.