Pfizer - [2005] APO 38

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 and a request for the Commissioner to provide a written assurance not to rectify the Register for 21 days following a decision that entries in the Register should be amended.

Decision: Issued 21 September 2005.
Abstract

Request by the patentees to stay any decision to amend the Register under subregulation 10.7(7) pending appeal.

On consideration of the balance of interests, decided that in such an event directions will be given that amendment of the Register will not occur before 28 days from the date of that decision or, in the event that the Commissioner is served in that period with a notice of appeal and 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,

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 and a request for the Commissioner to provide a written assurance not to rectify the Register for 21 days following a decision that entries in the Register should be amended.

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). In this regard section 77 provides the term of extension:

“(1) If the Commissioner grants an extension of the term of a standard patent, the term of the extension is equal to:
(a) the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70) in relation to any of the pharmaceutical substances referred to in subsection 70(2);
reduced (but not below zero) by:
(b) 5 years.
Note: Section 65 sets out the date of a patent.
(2)However, the term of the extension cannot be longer than 5 years.”

Sub-sections 70(5) and (6) of the Act provide that:

“(5)For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:

(a) if no pre-TGA marketing approval was given in relation to the substance—the date of commencement of the…

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 38
Decision Date: 21 September 2005

CaseChat Overview and Summary

The case involves Pfizer, represented by its various entities, objecting to the Commissioner’s proposal to amend the patent register to reflect a corrected extension of the term for several patents related to pharmaceutical substances. The patents in question are numbered 540769, 573123, 651637, and 691005, and they cover dihydropyridine derivatives, amlodipine benzene sulphonate, indole derivatives, and salts of an anti-migraine indole derivative. The dispute centres on the interpretation of the regulatory provisions concerning the extension of patent terms for pharmaceutical substances and the appropriate timing for implementing any corrective amendments to the patent register.

The legal issues at hand pertain to the interpretation of sub-regulation 10.7(7) of the Patent Regulations 1991, which mandates the Commissioner to amend the patent register if an earlier date of first regulatory approval for a pharmaceutical substance is identified. Additionally, Pfizer sought written assurances that no amendments to the register would be made for 21 days following any decision, pending the outcome of an appeal. The court had to balance Pfizer's request for delay against the public interest in maintaining an accurate and timely patent register.

In reaching a decision, the court considered the practices of other administrative bodies and the public interest in ensuring the patent register accurately reflects the current status of patents, especially concerning pharmaceuticals. The court concluded that while there is a strong public interest in the register being kept current, immediate implementation of an adverse decision could prejudice Pfizer's rights if ultimately found incorrect on appeal. The court decided that if an amendment to the register was necessary, it should not be implemented until 28 days after the decision, or until the court determined any stay application filed by Pfizer. This period allows Pfizer sufficient time to appeal and seek a stay, while also addressing the public interest in the accuracy of the patent register.

The court’s decision ensures that Pfizer’s rights are protected pending the outcome of any appeal, while also safeguarding the public interest in an accurate and timely patent register. The court’s directions provide a balanced approach, allowing Pfizer to seek judicial review without immediate prejudice to its rights, while ensuring the register reflects the correct patent status.

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