Otsuka Pharmaceutical Co (Otsuka) and Bristol Meyers Squibb (BMS) are the patentee and exclusive licensee of a patent relating to aripiprazole (an antipsychotic used to treat schizophrenia). In 2009, the patentee proposed certain amendments to the patent. This request was made following an adverse report by the Commissioner of Patents during re-examination of the patent under section 97(2) of the Act.
The proposed amendments were allowed by the Patent Office and subsequently opposed by Apotex Pty Ltd (Apotex). After Apotex's opposition was lodged, Otsuka and BMS commenced infringement proceedings against Apotex. Apotex cross-claimed for revocation of the patent. Under sections 104 and 112 of the Act, because proceedings were now pending in relation to the patent, the Commissioner no longer had the power to deal with the amendment application. It was in this context that Justice Yates had to consider the allowability of the proposed amendments, and therefore whether the requirements of section 102 of the Act had been satisfied.
His Honour confirmed several important principles when assessing the allowability of amendments under section 102:
Section 102(1)
- When applying section 102(1), a comparison is required between what would be claimed as a result of the proposed amendment and what is disclosed in the specification as filed.
- The words "as a result of the amendment" in section 102(1) should not be confused with the expression "after the amendment".
- The correct approach is to first identify the amendment. To identify what matter results from the amendment, the specification should then be compared to how it would stand after the proposed amendment. The next step is to read the specification as a whole (i.e amended in the manner proposed) and compare this to what is "in substance disclosed" in the specification as filed.
Section 102(2)(a)
- When applying section 102(2)(a), a comparison is required between the proposed new claims and the claims of the specification immediately prior to amendment.
- The reference to "within the scope of the claims" before amendment is important. It is incorrect to compare a particular amended claim to that claim before amendment, rather, the comparison must take into account all the claims.
- Yates J referred to a useful practical test from previous authority: "A practical test is to ask whether an amendment makes anything an infringement which would not have been an infringement before the amendment. If the answer is 'yes', the amendment is proscribed by s 102(2)(a) of the Act".
Yates J was satisfied that the proposed amendments to all but two claims (claims 33 and 34) were allowable under section 102. Turning to the court's discretion to allow the amendments, Yates J noted the delay by Otsuka in seeking to make the amendments, but decided that the delay was not such as to disallow the amendments as a matter of discretion. His Honour confirmed that any delay would need to be coupled with some improper conduct or detriment to a particular person or the public more generally, in order to trigger this exercise of the Court's discretion.
The patentee was invited to propose a further limitation on claims 33 and 34 (which it subsequently did), and the allowability of the amendments to these claims will now be heard at a later date.
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