Alphapharm Pty Ltd v H Lundbeck A/S

• Jurisdiction: Australia Federal only
• Judge: Crennan,Bell,Gageler JJ.,Kiefel,Keane JJ.
• Judgment Date: 05 November 2014
• Neutral Citation: [2014] HCA 42
• Docket Number: S97/2014
• Court: High Court
• Date: 05 November 2014

[2014] HCA 42

HIGH COURT OF AUSTRALIA

Crennan, Kiefel, Bell, Gageler and Keane JJ

S97/2014

Alphapharm Pty Ltd

Appellant

and

H Lundbeck A/S & Ors

Respondents

Representation

S C G Burley SC with C Dimitriadis for the appellant (instructed by King & Wood Mallesons)

R M Niall QC with K J Howard SC for the first respondent (instructed by Corrs Chambers Westgarth Lawyers)

Submitting appearance for the second to fifth respondents

Patents Act 1990 (Cth), ss 70(1), 71(2) and 223.

Patents Regulations 1991 (Cth), reg 22.11(4)(b).

Alphapharm Pty Ltd v H Lundbeck A/S

Intellectual property — Patents — Extension of term — Application to extend time for applying for extension of term of patent — Section 71(2) of Patents Act 1990 (Cth) required application for extension of term of patent to be made during term of patent and within six months after latest of three specified dates — First respondent made application for extension of term of patent during term of patent but more than six months after latest of three specified dates — Whether Commissioner of Patents had power to grant extension of time.

Words and phrases — ‘filing, during the term of a standard patent’, ‘prescribed action’, ‘relevant act’.

ORDER

Appeal dismissed with costs.

1 Crennan, Bell, Gageler JJ. The issue in this appeal is whether s 223(2) of the Patents Act 1990 (Cth) (‘the Act’) 1 conferred power upon the second respondent, the Commissioner of Patents (‘the Commissioner’), to extend the time within which the first respondent, H Lundbeck A/S (‘Lundbeck’), may apply under s 70 of the Act for an extension of the term of its Australian Patent No 623144 (‘the Escitalopram Patent’) 2.

2 The appellant (‘Alphapharm’) appeals from a decision of the Full Court of the Federal Court of Australia dismissing an appeal from a decision of the Administrative Appeals Tribunal (‘the Tribunal’). There were two questions before the Tribunal concerning s 223(2). The first was whether s 223(2)(a) conferred power on the Commissioner to grant an extension of time in respect of an application for an extension of term filed during the term of the patent. The second, which depended on the first question being answered ‘yes’, was whether the Commissioner's delegate erred in exercising the discretion to grant Lundbeck an extension of time within which to make an application for an extension of the term of the Escitalopram Patent 3. By its decision, the Tribunal affirmed the delegate's decision to grant Lundbeck an extension of time within which to apply for an extension of the term of the Escitalopram Patent, notwithstanding opposition to that extension of time from Alphapharm and the third to fifth respondents in this appeal 4.

3 On the grant of special leave 5, the appeal was limited to the question of whether the Full Court erred in finding that s 223(2)(a) of the Act conferred power on the Commissioner to extend the time within which Lundbeck could apply under s 70(1) for an extension of the term of the Escitalopram Patent,

having regard to the provisions of s 223(11) of the Act and reg 22.11(4)(b) of the Patents Regulations 1991 (Cth) (‘the Regulations’) 6.

4 The Commissioner filed an appearance submitting to the jurisdiction of the Court.

Relevant provisions

5 Before setting out the detail of the relevant provisions it is convenient to make two general observations.

6 First, the statutory context is provided not only by s 223 of the Act and reg 22.11, both of which concern extensions of time, but also by Pt 3 of Ch (ss 70–79A) of the Act, entitled ‘Extension of term of standard patents relating to pharmaceutical substances’ 7 (‘the extension of term scheme’), which came into operation on 27 January 1999.

7 Secondly, like all Australian patent legislation since 1903, the Act and the Regulations prescribe many time limits within which an act permitted to be done is required to be done. A measure of the complexity of some of the time limits can be gauged by the types of cases in which an extension of time has been found to be justified 8. It is (and has been) commonplace for the legislature to cast many

such time limits in mandatory terms using the word ‘must’ 9, including those prescribed in respect of an application (once a petition) for an extension of term 10. However, the potential for inflexibility to occasion serious injustice is (and has been) addressed both by the general power to extend time, as in s 223 of the Act (and, before it, s 160 of the Patents Act 1952 (Cth) (‘the 1952 Act’)), and by specific discretionary provisions to extend times — especially those cast in permissive terms 11. Regulation 22.11(4)(a) provides a handy example of the different ways of extending times: the time requirements cast in mandatory terms in regs 5.3, 5.3AA, 5.4(a), 5.8(1)(a)(i) and 5.9A can be extended under the general power to extend times in s 223(2); whereas the time requirements cast permissively for the ‘prescribed actions’ in reg 22.11(4)(a) can be extended by the specific discretionary power in reg 5.1012.

Extension of time

8 Section 223, headed ‘Extensions of time’, is a provision of general application. It is found in Ch 22 (ss 212–230), and relevantly provides:

‘(2) Where, because of:

• (a) an error or omission by the person concerned or by his or her agent or attorney; or

• (b) …;

  a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may, on application made by the person concerned in accordance with the regulations, extend the time for doing the act.

…

(3) The time allowed for doing a relevant act may be extended, whether before or after that time has expired.

…

(6) … a person may, as prescribed, oppose the granting under subsection (2) … of the application.

…

(11) In this section:

relevant act means an action (other than a prescribed action) in relation to a patent, a patent application, or any proceedings under this Act (other than court proceedings), and includes the making of a Convention application within the time allowed for making such applications.’

9 Section 223 resembles, without duplicating, s 160 of the 1952 Act (as amended by s 28 of the Patents Act 1960 (Cth) and s 7 of the Patents Amendment Act 198(Cth) (‘the 198Act’)). In particular, s 223(2) follows closely the text and structure of s 160(2), but in plain English.

10 Regulation 22.11 is directed to the Commissioner's power to grant an extension of time under s 223. The expression ‘relevant act’ is employed in sub-ss (1), (2), (2A), (3), (3A), (7), (9) and (11) of s 223, invariably to identify atime by which a relevant act is required to be done. Regulation 22.11(4) 13 isolates ‘prescribed actions’ so as to exclude certain time requirements from the remedial power under s 223 to extend times:

‘For the definition of relevant act in subsection 223(11) of the Act, each of the following actions is prescribed:

• (a) an action or step prescribed in Chapter 5, other than an action or step taken under regulation 5. 3 or 5.3AA, paragraph 5.4(a), subparagraph 5.8(1)(a)(i) or regulation 5.9A;

• (b) filing, during the term of a standard patent as required by subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of the term of the patent;

• (c) …’

11 It should be noted that the period for which an extension of time is needed may be considerable, particularly if the application is opposed.

The extension of term scheme

12 As mentioned, Pt 3 of Ch 6 contains the statutory scheme for an extension of term. Section 70 governs applications for an extension of term. Relevantly, s 70(1) permits a patentee of a standard patent to apply to the Commissioner for an extension of the term 14 of a standard patent if ‘requirements’ set out in sub-ss (2), (3) and (4) are satisfied (‘a s 70(1) application’). In essence, a patentee is not permitted to make a s 70(1) application until a patent for a pharmaceutical substance is granted and regulatory approval for marketing relevant goods has been obtained.

13 For present purposes, the most important of the cumulative requirements are that goods ‘containing, or consisting of’ a pharmaceutical substance per se15 must be included in the Australian Register of Therapeutic Goods (‘the

ARTG’) 16, and the first regulatory approval 17 for the substance must be at least five years after the date of the patent 18. Further, the term must not have been previously extended under Pt 3 of Ch 6 of the Act 19.

14 Section 71(1) prescribes the form, and s 71(2) prescribes the timing, in respect of a s 70(1) application. Section 71(2) provides:

‘An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:

• (a) the date the patent was granted;

• (b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);

• (c) the date of commencement of this section.’

15 The requirement that a s 70(1) application be made during the term of the patent will be referred to in these reasons as ‘the first time requirement’. The requirement to make such an application within six months after the latest of the dates specified in s 71(2)(a), (b) and (c) will be referred to as ‘the second time requirement’.

16 Paragraphs (a) and (b) of s 71(2) cover the circumstance of a patentee whose patent is granted on or after 27 January 1999, who may not apply for an extension of term under s 70(1) until a patent has been granted and a regulatory approval obtained. The order in which these two conditions are satisfied may vary from patent to patent. Paragraph (c) is directed to patentees whose patent...