Pfizer Italia S.r.l. - [2007] APO 2

ABSTRACTS OF DECISIONS

DECISION OF A DEPUTY COMMISSIONER OF PATENTS

Patent: No. 598197 in the name of Pfizer Italia S.r.l.

Title : Injectable ready to use solutions containing an antitumor anthracycline glycoside

Action: Objection to the Commissioner’s proposal pursuant to subregulation 10.7(7) to amend the relevant entry in the Register to insert the correct extension of the term of the patent.

Decision: Issued 12 January 2007.
Abstract

The patentee notified the Commissioner of a number of other pharmaceutical products (Adriamycin, Daunorubicin, Pharmorubicin) that fell within the scope of the claims of the patent and had earlier first regulatory approval dates than the product which formed the basis of the patentee’s application for an extension of term. Based on this information the Commissioner proposed to amend the Register to insert the correct extension of the term of the patent but the patentee objected on the grounds that the application for an extension of term was validly based on the inclusion of Zavedos in the ARTG, that the extension of term is correctly calculated on the first regulatory approval date for that substance and that in any event that the Commissioner has no power under subregulation 10.7(7) to amend the Register as proposed.

Found that:

Each pharmaceutical substance disclosed and claimed in a patent can have only one first regulatory approval date;
The correct interpretation of s 77 is that the term of the extension is determined on the “earliest first regulatory approval date" that applies to the substances in the patent and not only with regard to the substance on which the application for an extension was based;
Whether multiple substances are involved or not, the relevant earliest first regulatory approval date is 13 November 1989 (the first regulatory approval date for Adriamycin) giving an extension of term equal to zero; and
Subregulation 10.7(7) is not limited only to the situation where the information for a specific substance forming the basis of the application was incorrect so that the Commissioner must under that provision amend the Register.

Direction given that the Register be amended to insert the correct extension of term of the patent but not before 28 days from the date of the decision or, in the event that the Commissioner is served in that period with a notice of appeal and an application for a stay of the decision, until the stay application is determined by the Court.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Number 598197 in the name of Pfizer Italia S.r.l., and objection to the Commissioner’s proposal, pursuant to subregulation 10.7(7), to amend the relevant entry in the Register to insert the correct extension of the term of the patent.

BACKGROUND

Patent number 598197 was granted to Farmitalia Carlo Erba S.R.L. on 3 July 1991. By name change, merger or assignment the patent has subsequently been held in the name of Pharmacia S.p.A., Pharmacia & Upjohn S.p.A., Pharmacia Italia S.P.A., and finally Pfizer Italia S.r.l.

In Pharmacia…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2007] APO 2
Decision Date: 12 January 2007

CaseChat Overview and Summary

Pfizer Italia S.r.l. sought to amend the Australian Register of Therapeutic Goods (ARTG) to include an extension of the term of a patent. The patent, number 598197, relates to injectable solutions containing an antitumor anthracycline glycoside and was granted to Farmitalia Carlo Erba S.R.L. on 3 July 1991. The patent was subsequently held by Pharmacia Italia S.P.A. before being transferred to Pfizer Italia S.r.l. Pfizer applied for an extension of term under the Patents Act 1990, based on the registration on the ARTG of Zavedos, idarubicin hydrochloride 5mg/5mL injection vial. The Commissioner of Patents granted the extension on 6 April 2004 and the term was recorded as 19 June 2011. However, Pfizer informed the Commissioner that the patent also related to other products (Adriamycin, Daunorubicin, Pharmorubicin) with earlier first regulatory approval dates. The Commissioner proposed to amend the Register to insert the correct extension of the term of the patent but Pfizer objected on the grounds that the application for an extension of term was validly based on the inclusion of Zavedos in the ARTG and that the extension of term is correctly calculated on the first regulatory approval date for that substance. The court had to determine the correct interpretation of s 77 of the Act and whether the Commissioner was required and empowered under subregulation 10.7(7) to amend the Register. The court found that each pharmaceutical substance disclosed and claimed in a patent can have only one first regulatory approval date. The correct interpretation of s 77 is that the term of the extension is determined on the “earliest first regulatory approval date” that applies to the substances in the patent and not only with regard to the substance on which the application for an extension was based. Whether multiple substances are involved or not, the relevant earliest first regulatory approval date is 13 November 1989 (the first regulatory approval date for Adriamycin) giving an extension of term equal to zero. The court also found that subregulation 10.7(7) is not limited only to the situation where the information for a specific substance forming the basis of the application was incorrect. The Commissioner must under that provision amend the Register when it becomes aware of an earlier first regulatory approval date for any substance in the patent. The court directed that the Register be amended to insert the correct extension of term of the patent but not before 28 days from the date of the decision or, in the event that the Commissioner is served in that period with a notice of appeal and an application for a stay of the decision, until the stay application is determined by the Court.

Orders