02 April 2007
Key Points:
The Full Federal Court has recently held that the term "first regulatory approval date" when used in determining the eligibility for, application filing deadline for, and length of a patent term extension, is not limited to the date the substance was first registered on the ARTG but includes the date of the first listing of that substance. The Full Federal Court has recently held that where the Patent Register records an incorrect extension, the Commissioner of Patents must correct it.
In the December edition of Life Sciences Insights, we examined a series of cases that are likely to have a significant impact on the length of some patent term extensions already granted, the eligibility of some patents for extension, and the regulatory approval path pursued. Since those articles, the Full Federal Court has issued a decision upholding one of the lower court decisions.
The patent term extension process
For an overview of the patent term extension process please click here.
The decision in Pfizer Corp v Commissioner of Patents ("Pfizer")
In Pfizer, the Full Court held that:
Pfizer had applied for and been granted patent term extensions for patents relating to Norvasc (amlodipine), a drug to treat hypertension, and Replax (eletriptan hydrobromide), a drug to treat migraine headaches. These extensions had been applied for on the basis of the respective dates of first registration in the ARTG. They ranged from five months to almost five years in length.
On 12 March 2003, Arrow Pharmaceuticals Ltd ("Arrow") filed an application seeking revocation of the Norvasc patent on the basis that Pfizer had obtained the patent extension by fraud, false suggestion or misrepresentation in that, inter alia, it had failed to disclose to the Commissioner that the first regulatory approval date of Norvasc was 14 April 1992 and not 26 February 1993. Arrow provided the Commissioner with extracts of the ARTG showing an export-only listing for Norvasc on 14 April 1992. The Court proceedings commenced by Arrow were subsequently discontinued.
The Commissioner then however wrote to Pfizer stating that in her view a first regulatory approval date existed for each of the patented substances that was earlier than the date provided in support of the patent term extension application, and that she, therefore, intended to amend the Register under Reg. 10.7(7) to reflect the correct term of extension.
Pfizer opposed amendment of the Register, arguing that the "first regulatory approval date" referred to in the Act is limited to the first such date for the purpose of marketing in or importing into Australia for general marketing and does not include the regulatory approval date for export purposes only. Pfizer also argued that Reg. 10.7(7) was invalid.
Following a hearing, the Deputy Commissioner held that the term "first regulatory approval date" includes the first listing date as well as the first registration date. He also held that Reg.10.7(7) was valid and that he was, therefore, required to direct that the Register be amended to reflect the correct term of extension for each of the patents.
On appeal to the Full Federal Court, the question of the validity of Reg.10.7(7) was raised but all parties accepted that, for the purposes of the appeal, the regulation would be valid in accordance with the earlier decision of that Court in Lundbeck II (discussed here), prior to any determination to the contrary by the Full Court.
The main point argued by Pfizer was that the "first regulatory approval date" for the purposes of determining the length of an extension was limited to the date of registration in the ARTG. They argued that "pre-TGA marketing approval", defined by section 70(5)(b) as the date of the "first approval", refers to approval for marketing in Australia and thus to Registered Goods.
Concluding that the provisions were not so limited, the Full Court dismissed the appeal and upheld the decision of the lower court.
The Full Court rejected Pfizer's argument that Reg.10.7(7) was invalid. The Full Court held that "[i]t is unexceptionable that the Commissioner should be authorised to amend the Patent Register to reflect the extensions that were authorised by the Patents Act in lieu of extensions that were not authorised by the Patents Act."
On the issue of the construction of section 70, the Full Court held that "[a]s a matter of ordinary English, ‘first inclusion in’ the Therapeutic Register means the first time when goods are included in the Therapeutic Register..., irrespective of the part of the Therapeutic Register in which they are included."
The Full Court rejected Pfizer's contention that "‘first inclusion in’ the Therapeutic Register" should be understood as referring only to inclusion for marketing in Australia. It held that, irrespective of whether or not it is more difficult to have goods included in the part of the Register relating to registered goods than the part relating to listed goods, if goods are included in either part, they are included in the Register.
The Full Court also rejected Pfizer's contention that inclusion of goods in the part of the Register relating to listed goods does not permit exploitation of the invention, and is thus inconsistent with the legislative purpose of the patent extension regime, which is to provide an additional effective term for the exploitation of a patent. The Full Court held that "export of goods is clearly commercial exploitation."
Pfizer has sought special leave to appeal to the High Court. No changes are to be made to the Register until the resolution of the High Court appeal.
For further information, please contact Mary Still.
