Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42

HIGH COURT OF AUSTRALIA

CRENNAN, KIEFEL, BELL, GAGELER AND KEANE JJ

ALPHAPHARM PTY LTD APPELLANT

AND

H LUNDBECK A/S & ORS RESPONDENTS

Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42 5 November 2014 S97/2014

ORDER

Appeal dismissed with costs.

On appeal from the Federal Court of Australia

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

Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.

CATCHWORDS

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".

Patents Act 1990 (Cth), ss 70(1), 71(2) and 223. Patents Regulations 1991 (Cth), reg 22.11(4)(b).

CRENNAN, BELL AND GAGELER JJ. The issue in this appeal is whether s 223(2) of the Patents Act 1990 (Cth) ("the Act") 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"). 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. 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. On the grant of special leave, 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"). The Commissioner filed an appearance submitting to the jurisdiction of the Court. Relevant provisions Before setting out the detail of the relevant provisions it is convenient to make two general observations. 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 6 (ss 70-79A) of the Act, entitled "Extension of term of standard patents relating to pharmaceutical substances" ("the extension of term scheme"), which came into operation on 27 January 1999. 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. It is (and has been) commonplace for the legislature to cast many such time limits in mandatory terms using the word "must", including those prescribed in respect of an application (once a petition) for an extension of term. 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. 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 5.10. Extension of time 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." 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 1989 (Cth) ("the 1989 Act")). In particular, s 223(2) follows closely the text and structure of s 160(2), but in plain English. 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 a time by which a relevant act is required to be done. Regulation 22.11(4) 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) ..." 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 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 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. For present purposes, the most important of the cumulative requirements are that goods "containing, or consisting of" a pharmaceutical substance per se must be included in the Australian Register of Therapeutic Goods ("the ARTG"), and the first regulatory approval for the substance must be at least five years after the date of the patent. Further, the term must not have been previously extended under Pt 3 of Ch 6 of the Act. 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." 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". 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 was granted and a first regulatory approval was obtained before the commencement date of Ch 6, being 27 January 1999, making the relevant date under s 71(2)(c) 26 July 1999. A notice must be placed in the Official Journal that a s 70(1) application has been made and that the application is open to public inspection. The Commissioner must accept a s 70(1) application if the Commissioner "is satisfied that the requirements of sections 70 and 71 are satisfied in relation to the application" and, if so satisfied, publish a notice of the acceptance in the Official Journal. Interested parties may oppose the grant of an extension of term on the ground that one or more of the requirements of ss 70 and 71 are not satisfied. The Commissioner must grant the extension of term if there is no opposition to the grant or if, in spite of opposition, the Commissioner's decision is that an extension should be granted. In that case a notice of grant must be published in the Official Journal. Section 77 provides for the calculation of any extension of term by reference to the period between the date of the patent and the earliest first regulatory approval date, reduced by five years, so long as that does not result in a figure below zero. However long the period of regulatory delay, the maximum extension of term permitted is five years. The Commissioner may not grant an extension of term if "relevant proceedings in relation to the patent are pending". It is important to note that the interests of persons who may be affected by an extension of term are protected. A competitor who exploits a pharmaceutical substance during the term of a patent (including an extended term) for "purposes connected with obtaining the inclusion in the [ARTG] of goods" (colloquially, "springboarding") will not, subject to the satisfaction of various conditions, infringe the patentee's exclusive rights. A patentee is protected against the circumstance that an extension of term is granted after a patent term has expired. Regulations 6.8 to 6.11 are directed to the Commissioner's power to extend the term of certain patents under Pt 3 of Ch 6 of the Act and prescribe the "information" and documents which must "accompany" a s 70(1) application (that is, which must be "filed" with the s 70(1) application). The issue The issue mentioned at the outset of these reasons comes down to competing constructions of reg 22.11(4)(b). Does reg 22.11(4)(b) exclude from s 223(2)(a) both of the time requirements in s 71(2) (Alphapharm's construction), or only the first time requirement – that an application for an extension of term must be made "during the term of the patent" (Lundbeck's construction)? There was no dispute that the regulation excludes the first time requirement from s 223(2)(a). These reasons will show that Lundbeck's construction is correct and that the appeal should be dismissed. Notwithstanding an awkwardness in its reasoning, the Full Court was correct to conclude that the Commissioner has power under s 223(2) to extend the time requirement calculated by reference to s 71(2)(a), (b) and (c). The background facts A little more needs to be said about the Escitalopram Patent. Lundbeck, a Danish pharmaceutical company, applied for the Escitalopram Patent on 13 June 1989 (the expiry date of which became 13 June 2009), for an invention entitled "(+)-Enantiomer of citalopram and process for the preparation thereof". There are six claims – claims 1 to 5 are product claims and claim 6 is a method claim, which, for present purposes, can be put to one side. Claim 1 claims a compound (an enantiomer) known as "(+)-citalopram" and its non‑toxic acid addition salts, and claims 3 and 5 claim a pharmaceutical composition comprising, as an active ingredient, that compound. The pharmaceutical substance disclosed in the complete specification, (+)-citalopram, is used to treat depression. Citalopram, a racemate, also an invention of Lundbeck's, is the subject of the Citalopram Patent, dated January 1977 (the term of which was originally 16 years from that date). A racemate, or racemic mixture, comprises two enantiomers in equal measure. Enantiomers are non‑superimposable mirror images of each other and are designated (+) or (-) based on how they rotate polarised light. On 9 December 1997, Lundbeck's local subsidiary successfully obtained the inclusion of a pharmaceutical product called CIPRAMIL in the ARTG based on the Citalopram Patent. CIPRAMIL comprises two enantiomers: (+)-citalopram; and the mirror image enantiomer (-)-citalopram. On 16 September 2003, Lundbeck's local subsidiary successfully obtained the inclusion in the ARTG of a second pharmaceutical product, LEXAPRO, based on the Escitalopram Patent, which consisted of (+)-citalopram. In the complete specification of the Escitalopram Patent, it was explained that the isolated enantiomer (+)-citalopram is "therapeutically more active" and "more than 100 times more effective" in treating depression than the racemate. Lundbeck's first application to extend the term On 22 December 2003 (thus, "during the term"), Lundbeck made a s 70(1) application for an extension of the term of the Escitalopram Patent based on the inclusion of LEXAPRO in the ARTG three months earlier, on 16 September 2003 (which appeared to conform with the time limit in s 71(2)(b), set out above). Any application to extend the term of the Escitalopram Patent based on the earlier inclusion of CIPRAMIL in the ARTG was required to be made by 26 July 1999 so as to conform with the time limit in s 71(2)(c), also set out above. On 27 May 2004, the Commissioner granted the extension of term sought, based on the inclusion of LEXAPRO in the ARTG. Pursuant to s 77, the term was extended by five years to 13 June 2014 and an entry was made in the Register of Patents ("the Register") to that effect. On 7 July 2005, Alphapharm notified the Commissioner of the earlier inclusion of CIPRAMIL in the ARTG. On 13 July 2005, the Commissioner determined that Lundbeck's application to extend the term of the Escitalopram Patent should have been based upon the inclusion of CIPRAMIL, not LEXAPRO, in the ARTG. This had the effect (when s 77 was applied) of reducing the extension of the term of the Escitalopram Patent from 13 June 2014 to 9 December 2012. Alphapharm's proceedings for revocation One day earlier, on 6 July 2005, Alphapharm commenced proceedings in the Federal Court of Australia seeking revocation of the Escitalopram Patent or, alternatively, rectification of the Register by removal of the entry recording the extension of term (the latter on the basis that Lundbeck's application for the extension of term had been incorrectly founded upon the inclusion of LEXAPRO in the ARTG, as opposed to CIPRAMIL). The revocation proceedings initiated by Alphapharm included a sustained attack on the validity of the Escitalopram Patent, including attacks based on want of novelty and obviousness, citing as prior art the Citalopram Patent. Lundbeck established the validity of claims 1, 3 and 5 of the Escitalopram Patent, which is important in the context of infringement. Relevantly, on 24 April 2008, as part of those proceedings, the primary judge (Lindgren J) held that Lundbeck's application to extend the term of the Escitalopram Patent should have been based upon the inclusion of CIPRAMIL in the ARTG. The essential reason was that the racemate "contained" the pharmaceutical substance disclosed in the Escitalopram Patent. The consequence was not merely that the term of the extension should be shorter (as the Commissioner's delegate had found), but rather that the Register needed to be rectified by removing the record of extension of term of the Escitalopram Patent as being void ab initio. Lundbeck's subsequent appeal to a Full Court of the Federal Court on that point was dismissed, with final orders made on 12 June 2009. A subsequent application for special leave to appeal to this Court by Lundbeck was dismissed on 11 December 2009. Lundbeck's second application to extend the term Meanwhile, on 12 June 2009, after final orders had been made by the Full Court, and one day before the 20 year term of the Escitalopram Patent was due to expire, Lundbeck made a second s 70(1) application to the Commissioner to extend the term of the Escitalopram Patent, this time based upon the inclusion of CIPRAMIL in the ARTG, coupled with an application under s 223(2) for an extension of time as required. Following the expiration of the 20 year term of the Escitalopram Patent (13 June 2009), Alphapharm and the third to fifth respondents launched generic pharmaceutical products containing (+)-citalopram, the pharmaceutical substance disclosed in the complete specification. On 9 February 2010, the Commissioner amended the Register by removing the entry relating to the extension of term until 9 December 2012. Consideration of the background facts shows: (1) Lundbeck experienced a relevant regulatory delay based on CIPRAMIL of nearly eight and a half years; (2) the Federal Court litigation occupied the last four years of the term of the Escitalopram Patent, as extended by the 1994 Act; and (3) the extension of time sought by Lundbeck is from 26 July 1999 to 12 June 2009, being the date ("during the term") on which the second s 70(1) application was made. The upshot is that if the extension of term sought is granted (which depends significantly on the grant of an extension of time), infringers will, subject to any defences, be liable for damages for infringement from 13 June 2009 until 9 December 2012 in respect of any sales of products containing the pharmaceutical substance disclosed in the Escitalopram Patent. Without objection, this Court was informed, on the oral hearing, that Alphapharm is exercising its rights to oppose the grant of an extension of term to Lundbeck. The proceedings Alphapharm and the third to fifth respondents opposed Lundbeck's application for the grant of an extension of time in respect of Lundbeck's second s 70(1) application. These four oppositions were heard by a delegate of the Commissioner, and on 1 June 2011 the delegate granted Lundbeck the extension of time sought. That decision was then appealed to the Tribunal. Tribunal decision On 4 December 2012, the Tribunal affirmed the decision of the Commissioner's delegate to grant the extension of time sought. The Tribunal construed reg 22.11(4)(b) as identifying the first of the two time requirements in s 71(2) – that is, "filing" an application for an extension of term "during the term of the patent". The Tribunal described Lundbeck's submission, which it accepted: "Lundbeck submits that the second time requirement that an application be filed within 6 months of the latest of the dates in s 71(2)(a)‑(c) is not excluded by the definition in the regulation and is a relevant act in respect of which time can be extended. This time requirement in which to seek an extension of term is therefore capable of being extended. It is the requirement that an application for the extension of term must be made during the term of the patent that is not capable of extension." (emphasis in original) This led to the conclusion that since reg 22.11(4)(b), in its terms, operates only on the first time requirement referred to in s 71(2), the regulation does not preclude the grant of an extension of time from the due date (26 July 1999) to the later date sought (12 June 2009). As will be explained, that reasoning is correct. Full Court On 18 November 2013, the Full Court (Jessup, Jagot and Yates JJ) dismissed an appeal from the Tribunal brought pursuant to s 44 of the Administrative Appeals Tribunal Act 1975 (Cth). In the Full Court, Yates J (with whom Jessup J and Jagot J agreed) said: "Properly understood, reg 22.11(4)(b) distinguishes between separate actions and prescribes one, not the other. The result is that the action of filing the application under s 70(1) during the term of the patent is prescribed and cannot, therefore, be a relevant act to which s 223(2) refers. On the other hand, the action of filing the application within six months of the applicable date is not prescribed and is taken to be a relevant act to which s 223(2) can respond." An awkwardness appears in that reasoning in the first sentence, in describing the two time requirements as "separate actions" – especially as the whole of the paragraph in which this passage can be found indicates that the expression "separate actions" operates as a trope for separate time requirements. Once that is recognised, the reasoning is not relevantly different from that of the Tribunal. The awkwardness reflects the drafting of s 223(11) and reg 22.11(4), which exclude time requirements from the general remedial power to extend time under s 223(2)(a) by excluding "prescribed actions" from "relevant acts" covered by s 223(2)(a). Arguments The parties did not contest the established principle of statutory construction that, while it may be useful to read regulations together with the statute under which they were made in order to understand a legislative scheme, it is not legitimate to construe a statute by reference to the wording of regulations made under it. Further, in conformity with the approach to statutory construction explained most recently by this Court, the parties' primary arguments were directed to the text of the relevant provisions. However, both parties went on to draw support for their arguments on the meaning of the text of reg 22.11(4)(b) from the wider context – the legislative history, extrinsic materials and changes in legislative direction – as indicative of the general purpose and policy of the Act. Alphapharm Alphapharm submitted that the power of the Commissioner to extend time under the general remedial provision, s 223, was "specifically excluded" by reg 22.11(4)(b) in respect of a s 70(1) application. That argument was underpinned by the major premise that the correct construction of s 223(2) and (11) and reg 22.11(4)(b) required: first, an identification of a "relevant act" (or "action"); and, second, a determination of whether that "relevant act" (or "action") is "prescribed" under the regulation. The minor premise was that the "relevant act" (or "action") permitted by s 70(1) in relation to a patent was "filing an application to extend the term" of the patent. It was a short step then to a conclusion that reg 22.11(4)(b) was directed, in terms, to the single action of "filing" and, in particular, to contend that the words "as required by subsection 71(2) of the Act" (as they occurred in reg 22.11(4)(b)) comprehended both the first and second time requirements in s 71(2). Alphapharm relied on the awkwardness in the Full Court's reasons referred to above as demonstrative of error. Lundbeck Lundbeck submitted that s 71(2) involved two separate and independent time requirements and that reg 22.11(4)(b) should not be applied as if s 71(2) were concerned with a single time requirement. Lundbeck also relied on the different purposes of the first and second time requirements. The first was directed to the expiration of the term of the patent, and the second, it was said, was directed to delay in obtaining regulatory approval. The first time requirement was said to reflect an aspect of the law concerning extensions of time in extension of term applications (once petitions), which had subsisted since 1903. In contrast, the second time requirement was new and reflected the novel aspects of the extension of term scheme, in which delay in obtaining regulatory approval functions as a proxy for inadequate remuneration, which once needed to be proven. Emphasis was laid on the text of the regulation as limited, in terms, to the first time requirement. This was said expressly, alternatively implicitly, to not exclude the second time requirement from s 223(2)(a). The pre‑existing law The pre‑existing law and the legislative history should not deflect the Court from its duty to resolve an issue of statutory construction, which is a text‑based activity. However, both parties recognised that the task of statutory construction in this case required some appreciation of the pre‑existing law and the legislative history of relevant provisions. Undoubtedly, questions of policy can inform the Court's task of statutory construction. Long historical developments in the United Kingdom concerning extensions of term for patents were reflected in the 1903 Act and the 1952 Act. These included developments in the curial jurisdiction to extend the time for presenting a petition to extend the term of a patent after the term had expired. The extension of term regimes considered in In re Robinson's Patent and Sanofi v Parke Davis Pty Ltd [No 2] (under the 1903 Act and the 1952 Act respectively) permitted an extension of term in respect of standard patents, covering any subject matter, on the grounds of inadequate remuneration (or, after 1921, on the grounds of war loss). Each regime contained a statutory time requirement, within which a petition to extend the patent term was required to be brought. In Robinson's Patent, Isaacs J found that, notwithstanding the mandatory language of the 1903 Act's statutory time requirement, the time could be extended because subsequent wartime legislation and regulations gave the Solicitor‑General a general power to extend time for "doing any act under the [1903 Act]". Decades later, a majority in Sanofi (Mason ACJ, Wilson and Dawson JJ) rejected an argument that the statutory time requirement under the 1952 Act precluded the grant of an extension of time to bring a petition for an extension of term after the expiration of the term. In their joint judgment, their Honours observed that a consistent Australian practice, for over 80 years, to permit a petition for an extension of term to be presented after the term of a patent expired was not inimical to the purposes of extension of term legislation. The purposes identified were to balance the interests of an inadequately remunerated inventor against the public interest in unrestricted use of the invention after expiration of the monopoly (that is, the term). To the extent that permitting an application to be made after the term of a patent had expired might prejudice a competitor, the court had jurisdiction under the 1903 Act and the 1952 Act to resolve the problem by imposing conditions on any grant of an extension of term or re‑grant. Because of the way in which the balance was struck under the extension of term regimes in the 1903 Act and the 1952 Act, patentees bore a heavy onus, as inadequate remuneration alone was not necessarily sufficient to warrant an extension. All the circumstances of the case were relevant, including the nature and merits of an invention in relation to the public. Extensions of term were rare (at least until the 1970s) and proceedings for extensions of term (particularly if the patentee sought an "exceptional" term) were complex and expensive. As a result, extensions of term (and the need to balance the competing interests of patentees and the public (including competitors)) became the subject of sustained policy debates in Australia (and elsewhere) for some 20 years before the extension of term scheme relevant to this appeal came into operation on 27 January 1999. The extension of term scheme for pharmaceuticals is simplified by comparison with the pre‑existing law. As observed succinctly and correctly by senior counsel for Alphapharm, regulatory delay is now the proxy for inadequate remuneration and merit is now assumed for a pharmaceutical substance suitable for human use. Once the Commissioner is satisfied that the conditions in s 70 and the procedural time requirements in s 71 have been met (subject to opposition), the Commissioner can directly proceed to consider the date of the patent and the date of the first regulatory approval and apply s 77 to calculate an extension of term. The legislative history When first enacted, the Act introduced significant changes to Australian patent legislation, as recommended by the 1984 report of the Industrial Property Advisory Committee ("the IPAC"), but not those relevant to extension of term provisions. Relevantly, in the IPAC Report, Recommendation 11 (in two parts) recommended retaining the standard patent term (then 16 years under the 1952 Act) and went on to recommend that procedures for "granting of extensions of the terms of standard patents be eliminated in toto". The federal Minister for Science responded in 1986. He said the Government approved the proposal in principle but was aware of special circumstances with pharmaceutical products where delays in obtaining regulatory approval eroded "the effective patent lives of these products". As foreshadowed, the 1989 Act (substantially re‑enacted in the Act (as first enacted)) repealed Pt IX of the 1952 Act and substituted a new Pt IX, entitled "Extension of Certain Patents", limited to patents for pharmaceutical substances. The primary objects of a more limited extension of term scheme were explained in the second reading speech of the Minister for Justice for the relevant Bill: "The Bill abolishes the present complex procedures for extending the term of a patent and replaces them with more straightforward procedures applicable only to pharmaceuticals ... This Bill implements the Government's response to recommendation 11 of the [IPAC Report] ... The arrangements acknowledge that the effective patent life for pharmaceuticals for human use is reduced by the stringent and time‑consuming evaluation procedures that the Department of Community Services and Health is required to conduct to ensure both the safety of patients and the efficacy of drugs." The extension of term scheme enacted by the 1989 Act permitted a patentee to apply to the Commissioner "not later than 12 months before the end of the term of the patent". An extension of term of four years from a 16 to a 20 year term was permitted. Competitors were permitted to springboard in the last two years of any extended term. An application to extend the term had to be advertised and could be opposed. Neither the 1989 Act nor the Act (as first enacted) contained any equivalent to s 71(2)(a), (b) and (c), for reasons which will become obvious. The immediate predecessor to s 223, s 160 of the 1952 Act, was also amended by the 1989 Act. Section 160(4A) was added in order to limit any relevant extension of time within which to apply for an extension of term. The practical effect of that amendment was that, even if granted an extension of time under s 160(2), a patentee had to make the application expeditiously, no later than nine months before the expiration of the term. By comparison with the time requirements considered in Robinson's Patent and Sanofi, these provisions obviated any gap in the records of the Register. Such a gap could previously arise where a patent lapsed on expiration of the term but a patentee subsequently obtained an extension of time within which to petition for an extension of term. This was a matter commonly dealt with under the pre‑existing law by imposing conditions, as explained. Policy debates which continued in relation to the desirable term of a standard patent in Australia (and elsewhere) raised the suggestion that the term of all standard patents should become 20 years (rather than 16 years) with the possibility that patents for pharmaceutical substances be extended beyond a 20 year term because in the pharmaceutical industry research and development costs were high, imitation costs low, and regulatory delays significant. As events transpired, the 1994 Act provided for the extension of term of all standard patents to 20 years and repealed Div 2 of Pt 3 of Ch 6 of the Act, as it had operated since the 1989 Act (as substantially re‑enacted in the Act). Transitional provisions in the 1994 Act permitted a patentee who had been granted an extension of term beyond 16 years under the repealed provisions to take advantage of that extension to 20 years. Because the term was extended to 20 years, the extension of term scheme limited to standard pharmaceutical patents, first instituted in 1989, was repealed. The extension of term scheme relevant to reg 22.11(4)(b) was instituted by the Intellectual Property Laws Amendment Act 1998 (Cth) ("the 1998 Act"). The principal objects of the 1998 Act were summarised in the Revised Explanatory Memorandum for the relevant Bill: "The Bill amends the Patents Act 1990 to give effect to the government's decision to provide for an extension of term scheme for pharmaceutical patents. An extension of up to five years will be available for a standard patent relating to a pharmaceutical substance that is the subject of first inclusion on the [ARTG]. The scheme will apply to all existing 20 year patents, as well as those patents granted after the commencement date. The new arrangements make provision for 'spring‑boarding' activities. This allows manufacturers of generic drugs to undertake certain activities at any time after the extension is granted solely for the purposes of meeting pre‑marketing regulatory approval requirements." The rationale for reintroducing extension of term legislation was explained in detail: "The development of a new drug is a long process, estimated to average around 12 years, which requires a new chemical entity to be patented early in the process in order to secure its intellectual property rights. However, considerable research and testing is still required before the product can enter the market. As a consequence, patentees of new drugs usually have considerably fewer years under patent in which to maximise their return. It is expensive to bring a drug to market, around US$380 million, and involves considerable risk. As such, research based pharmaceutical companies rely heavily on patents to generate the substantial cash flows needed to finance the development of new drugs from the discovery stage, through the pre-clinical and clinical development phases, to eventual marketing. A country's patent system is also an important factor in contributing to a company's decision on whether to invest or not. If Australia has a weak patent system, relative to it's [sic] competitors, there is a risk that investment in research and development will be lost to those offering stronger patent protection. The objective of this proposal is to provide an 'effective patent life' – or period after marketing approval is obtained, during which companies are earning a return on their investment – more in line with that available to inventions in other fields of technology. It is also intended to provide a patent system which is competitive with other developed nations." Section 223 was noted in the following terms: "Section 71 sets out the requirements of the form and timing of the application. The extension of time provision under section 223 of the Patents Act 1990 will apply to all acts required to be done under the extension of patent term scheme provided that the relevant criteria are satisfied." The purposes of the extension of term scheme are to balance the competing interests of a patentee of a pharmaceutical substance whose exploitation of monopoly has been delayed (because of regulatory delay) and the public interest in the unrestricted use of the pharmaceutical invention (including by a competitor) after the expiration of the monopoly (that is, the term). Construction of reg 22.11(4)(b) It is not always appropriate to dissect a composite legislative expression into separate parts, giving each part a meaning which the part has when used in isolation, then combine the meanings to give that composite expression a meaning at odds with the meaning it has when construed as a whole. Alphapharm makes errors of this kind. First, Alphapharm relies on words forming part only of the parenthesis in reg 22.11(4)(b) – "as required by subsection 71(2) of the Act" – to "read up" the regulation to encompass both the first and second time requirements in s 71(2). Time is critical to ss 223(2)(a) and 71(2) and reg 22.11(4)(b). The critical expression in the regulation is "during the term of a standard patent", which must be construed in its immediate context in accordance with the principles expressed by this Court in Project Blue Sky Inc v Australian Broadcasting Authority. The part only of the parenthesis upon which Alphapharm relies so heavily merely identifies the statutory source of the critical time requirement. The text, syntax and immediate context of reg 22.11(4)(b) show that the natural and ordinary meaning of the "prescribed action" identified is the "filing (or making) of a s 70(1) application during the term of the standard patent" (that is, before the term of the patent has expired). Secondly, Alphapharm bases its preferred construction of reg 22.11(4)(b) on the proposition that it is only necessary to ask whether there is a "relevant act" (or "action") for the purposes of s 223(2)(a), then to ask whether it is "prescribed" under the regulation. That proposition detaches reg 22.11(4)(b) from its immediate context, and falls well short of establishing that reg 22.11(4)(b) encompasses both the first and second time requirements in s 71(2). The immediate context of reg 22.11(4)(b) is to be found in ss 223 and 71(2) of the Act. It can be observed generally that, subject to reg 22.11, there is no reason to suppose that s 223 of the Act lacks the broadly protective and remedial operation accorded to its immediate predecessor by numerous courts, including this Court. As a general remedial provision, s 223 is concerned only with extensions of time. Section 223(2)(a) empowers the Commissioner to extend the time for doing a relevant act which has been required to be done within a certain time and has not been so done because of an error or omission by the person concerned or his or her agent or attorney. Section 223(11) limits the power to extend time under s 223(2)(a) by excluding a "prescribed action" from a "relevant act". Regulation 22.11 is likewise concerned only with extensions of time. All "prescribed actions" in reg 22.11(4) are subject to time requirements, which are to be excluded from the general remedial power to extend time. To focus on a single "relevant act" (or "one action") to the exclusion of time requirements, and to ask only whether that "relevant act" (or "one action") is "prescribed", as Alphapharm does, is to misapprehend the real purpose of s 223(2)(a) – to confer a general remedial power to extend time – and the derivative purpose of reg 22.11(4) – to exclude a limited number of times from that general power to extend time. Alphapharm's arguments, which depend only on asking whether a "relevant act" (or "action") is "prescribed", provide an incomplete and inadequate foundation for construing reg 22.11(4)(b). The correct description of the prescribed "relevant act" (or "action") under s 223(2)(a), for present purposes, is "making (or filing) a s 70(1) application in the time within which that is required to be done under s 71(2)". Section 71(2), which is critical to the task of correctly construing reg 22.11(4)(b), is concerned only with the timing of a s 70(1) application. It imposes two cumulative time requirements, both of which need to be satisfied to establish the "certain time" (in Alphapharm's words, "the deadline") by which a s 70(1) application must be made. The first time requirement, namely that a s 70(1) application must be made "during the term" of the patent (that is, before the expiration of the term of the patent), imposes a time requirement having a recognisable origin in earlier cognate provisions and associated practices explained in Sanofi, which date back to 1903. As recognised in Sanofi, under the pre‑existing law, courts were wary of granting an extension of term which might prejudice or inhibit the public interest (including the interests of commercial competitors) in exploiting a disclosed invention on the expiration of the term. This reluctance was compounded by uncertainty in the Register which could occur if there was a gap between the lapse of a patent (due to the expiration of the term) and the presentation of a petition after the term had expired, as was permitted under the pre‑existing law. This could require the imposition of conditions on any extension of term or re-grant (as explained above). As correctly submitted by Lundbeck, were it not for reg 22.11(4)(b), the approach in Robinson's Patent, approved in Sanofi, may have authorised reliance on the general remedial power in s 223(2)(a) to extend the first time requirement in s 71(2) to a time after the term had expired. Regulation 22.11(4)(b), correctly construed, obviates the known problem of uncertainty in the Register which would follow if that were permitted. The second time requirement, which can be expressed using the formula "within six months of the latest of three specified dates" in s 71(2), has an entirely different and unrelated purpose, which is to require a patentee to make a s 70(1) application within six months of the satisfaction of all of the necessary conditions for the making of such an application, bearing in mind that the sequence of satisfaction may vary from patent to patent. The second time requirement has a rationale which is not dissimilar to the rationale for another discrete and distinct legislative requirement in relation to annual renewal fees (which must be paid to prevent a patent from lapsing). Those fees escalate sharply as the expiration date of the term of a patent approaches. The escalation is directed to encouraging a patentee to consider the utility of continuing its monopoly and discouraging the maintenance, on the Register, of patents which are not being exploited. The second time requirement is directed to requiring a patentee to decide about extending its monopoly as soon as the requisite conditions are aligned. There is nothing in any of the extrinsic materials, or in the long policy debates on simplifying extensions of term, which would suggest any rationale for excluding the second time requirement from the remedial power to extend time under s 223(2)(a). Alphapharm's senior counsel conceded, correctly, that if Alphapharm's construction of reg 22.11(4)(b) were correct, the remedial power in s 223(2)(a) could never apply to extend time in relation to the second time requirement, no matter what the quality or provenance of any "error or omission" made in respect of that time. Alphapharm's construction would introduce an inexplicable asymmetry between a patentee and a competitor opposing a s 70(1) application. An opponent can access the general remedial power to extend times cast upon it in mandatory terms. Had it been the legislature's intention to exclude the second time requirement in s 71(2) from the general remedial power in s 223(2)(a), that would have been simple to accomplish. Alphapharm's construction of reg 22.11(4)(b) gives the regulation an operation which is inconsistent with one of the principal objects of the extension of term scheme. Taking Lundbeck as an example of a patentee who has made a s 70(1) application during the term of the patent, a regulatory delay of nearly eight and a half years should give rise to a straightforward entitlement to an extension of term of nearly three and a half years. Conclusions For the reasons set out above, reg 22.11(4)(b) has the meaning which its text taken as a whole, its syntax and the immediate context support – the only time requirement which is excluded by reg 22.11(4)(b), from the general remedial power to extend time in s 223(2)(a), is the first time requirement in s 71(2). The Tribunal did not err in concluding that s 223(2)(a) conferred power on the Commissioner to extend the second time requirement in s 71(2) from 26 July 1999 to 12 June 2009 and the Full Court did not err in dismissing the appeal from the Tribunal. Orders The appeal should be dismissed with costs.