Pfizer Research and Development Company, N.V/S.A - [2005] APO 41

ABSTRACTS OF DECISIONS

DECISION OF A DEPUTY COMMISSIONER OF PATENTS

Patents: No. 540769 in the name of Pfizer Corp.
No. 573123 in the name of Pfizer Ltd
No. 651637 in the name of Pfizer Inc.
No. 691005 in the name of Pfizer Research and Development Company, N.V/S.A

Titles : Dihydropyridine Derivatives
Amlodipine benzene sulphonate and pharmaceutical compositions thereof
Indole Derivatives
Salts of an anti-migraine indole derivative

Action: Objection to the Commissioner’s proposal pursuant to sub-regulation 10.7(7) to amend relevant entries in the Register to insert the correct extension of the term of the patents.

Decision: Issued 23 September 2005.
Abstract

The patentees’ objections relate firstly to the interpretation of “first inclusion in the Australian Register of Therapeutic Goods” in subsection 70(5) of the Act and secondly to the validity of subregulation 10.7(7) which requires the Commissioner to amend the register where she becomes aware that the first regulatory approval date in relation to a substance is earlier than the date of first inclusion supplied with the application for the extension of term.

Found as a matter of construction that “first regulatory approval date” in section 77 means, where no pre-TGA marketing approval is given, the date of first inclusion in the ARTG; that in this context “inclusion” takes its meaning from the ARTG and consequently the TGA and encompasses listed goods as well as registered goods; and that the Commissioner should proceed in that event on the assumption that subregulation 10.7(7) is valid.

Direction given that the Register be amended to insert the correct extension of term of the patents 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 Numbers 540769 in the name of Pfizer Corp.
573123 in the name of Pfizer Ltd
651637 in the name of Pfizer Inc.
691005 in the name of Pfizer Research and Development Company, N.V/S.A, and

Objection to the Commissioner’s proposal, pursuant to sub-regulation 10.7(7), to amend relevant entries in the Register to insert the correct extension of the term of the patents.

BACKGROUND

The subject patents have all been granted an extension of the patent term under Chapter 6, Part 3 of the Patents Act 1990 (Extension of term of standard patents relating to pharmaceutical substances).

Patent numbers 540769 and 573123 relate to Norvasc, a drug used to treat hypertension, and 651637 and 691005 to Relpax, a treatment for migraine headaches. All four patent were granted extensions based on Australian Register of Therapeutic Goods (ARTG) registrations as indicated in the following table:

Patent	Date of the Patent	ARTG Registration	20 year Term Expires	Register Entry for Extension
540769	10 Mar 1983	26 Feb 1993	10 Mar 2003	26 Feb 2008
573123	3 April 1987	26 Feb 1993	3 April…

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: [2005] APO 41
Decision Date: 23 September 2005

CaseChat Overview and Summary

In this case, the Deputy Commissioner of Patents considered Pfizer’s objection to the Commissioner’s proposal to amend the entries in the Register to insert the correct extension of term of the patents. The four patents in question related to Norvasc, a drug used to treat hypertension, and Relpax, a treatment for migraine headaches. The Commissioner had become aware that the first regulatory approval date for each of the patents was earlier than the date provided in support of the extension of term application and therefore sought to amend the Register accordingly. The Deputy Commissioner was required to consider Pfizer’s objections to the Commissioner’s proposal. The first objection was to the interpretation of “first inclusion in the Australian Register of Therapeutic Goods” in subsection 70(5) of the Patents Act 1990. The second was to the validity of subregulation 10.7(7) which required the Commissioner to amend the register where she became aware that the first regulatory approval date in relation to a substance was earlier than the date of first inclusion supplied with the application for the extension of term. The Deputy Commissioner found that “first regulatory approval date” in section 77 meant, where no pre-TGA marketing approval was given, the date of first inclusion in the ARTG and that in this context “inclusion” took its meaning from the ARTG and consequently the TGA. The Deputy Commissioner also found that Pfizer had not made out a case that subregulation 10.7(7) was invalid. The Deputy Commissioner directed that the Register be amended to insert the correct extension of term of the patents 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