Pharmaceutical patent term extension regimes are of critical importance to innovators in the pharmaceutical industry, for whom an ability to exploit a monopoly to a patented invention is often subject to lengthy delays because of the time it can take to obtain the necessary regulatory approvals to market a pharmaceutical product. 

In Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42, the majority of the High Court of Australia has confirmed that where a patentee fails to apply for an extension of a pharmaceutical patent term within the prescribed timeframe of six months from either the date the patent was granted or the date of inclusion on the Australian Register of Therapeutic Goods (ARTG) because of a genuine error or omission, the Commissioner of Patents may grant the patentee an extension of time to do so.

EXTENDING THE TERM OF THE ESCITALOPRAM PATENT

Enantiomers are molecules that are non-superimposable mirror images of each other, and are designated (+) or (-) based on how they rotate polarised light. In 1997, Lundbeck successfully obtained inclusion on the ARTG of CIPRAMIL, a “racemic” mixture of the (+) and (-) enantiomers of citalopram, used to treat depression.

In September 2003, Lundbeck obtained ARTG inclusion for its related LEXAPRO product, comprised of only the (+)-citalopram (known as escitalopram). Lundbeck also held a patent directed to escitalopram (the Escitalopram Patent), which noted that escitalopram was therapeutically more active and more than 100 times more effective in treating depression than the racemic mixture of CIPRAMIL.

In December 2003, Lundbeck applied to extend the term of its Escitalopram Patent under s 70(1) of the Patents Act 1990 (Cth) (Act). Section 70(1) allows a patentee to apply for an extension of term of a pharmaceutical patent by up to five years to compensate the patentee for delays in obtaining regulatory approval to market the patented product.

Importantly, s 71(2) of the Act provides that such an application under s 70(1) must be made:

  • during the term of the patent (Patent Term Timeframe); and
  • within the later of six months from either the date the patent was granted or the date of inclusion on the ARTG (Grant or ARTG Timeframe).

Believing its application satisfied the above requirements of s 71(2), Lundbeck filed an application under s 70(1) three months after the inclusion of LEXAPRO on the ARTG. However, in 2009 the Full Federal Court held that Lundbeck’s application to extend the term of its Escitalopram Patent should have been based upon the inclusion of CIPRAMIL on the ARTG because the racemic mixture of CIPRAMIL “contained” the pharmaceutical substance disclosed in the Escitalopram Patent. As a result, Lundbeck’s application under s 70(1) was deemed not to have been made within the Grant or ARTG Timeframe.

Following the Full Court’s decision but before the 20 year term of its Escitalopram Patent was due to expire, Lundbeck made a second application under s 70(1) to extend the term of its Escitalopram Patent based on the inclusion of CIPRAMIL on the ARTG. As its application could not satisfy the Grant or ARTG Timeframe requirement of s 71(2), Lundbeck made a concurrent application for an extension of the Grant or ARTG Timeframe under s 223(2)(a) of the Act. 

Section 223(2)(a) of the Act confers the Commissioner of Patents with a general remedial power to extend the time for doing a ‘relevant act’ that was not done in time because of an error or omission by the person concerned or his or her agent or attorney. The Commissioner considered that Lundbeck’s genuine misunderstanding of the law led to its failure to apply for an extension of the term of the Escitalopram Patent within the Grant or ARTG Timeframe, and that such an error warranted the exercise of discretion under s 223(2)(a) to grant Lundbeck an extension of time to apply to extend the term of the patent.

Alphapharm, who had begun marketing a generic version of escitalopram, appealed the Commissioner’s decision to the Administrative Appeals Decision and subsequently the Full Federal Court, both of which upheld the Commissioner’s decision. Alphapharm subsequently appealed the Full Federal Court’s decision to the High Court.

THE QUESTION BEFORE THE HIGH COURT

The central question before the High Court was whether s 223(2) of the Act conferred the power upon the Commissioner to extend the time within which Lundbeck could apply under s 70(1) of the Act to extend the term of its Escitalopram Patent, having regard to the statutory limitations applicable to the provision.

Certain “prescribed actions” are unable to be extended under s 223(2) of the Act. In particular, under reg 22.11(4)(b) of the Patents Regulations 1991 (Cth) one such “prescribed action” is the “filing, during the term of a standard patent under s 71(2) of the Act, an application under s 70(1)”.

Alphapharm argued that reg 22.11(4)(b) operated to limit the Commissioner’s power to grant an extension of time in relation to both the Patent Term Timeframe and Grant or ARTG Timeframe requirements of s 71(2), because the filing of an extension of term application was the very “action” for which an extension could not be granted.

Lundbeck, however, contended that the express reference to “the term of a standard patent” in reg 22.11(4)(b) rendered the provision operable only to prohibit extensions of time in relation to the Patent Term Timeframe requirement.

THE HIGH COURT’S DECISION

The majority of the High Court considered the legislative history and context of the extension of patent term regime in Australia, noting that its purposes were to balance the competing interests of:

  • a patentee whose ability to exploit his or her monopoly had been delayed by the regulatory process; and 
  • the public interest in the unrestricted use of an invention after the expiration of a patent term.

Their Honours noted that there was nothing in any of the extrinsic materials, or in the long policy debates on simplifying extensions of term that suggested any rationale for excluding the Grant or ARTG Timeframe requirement from the general remedial power to extend time under s 223(2)(a). 

The majority considered text of reg 22.11(4)(b) as a whole, including its syntax and immediate context, concluding that Alphapharm’s arguments provided an “incomplete and inadequate foundation” for construing the provision that was inconsistent with the objects of the extension of term regime. The majority therefore held that the only time requirement that was excluded from the general remedial power to extend time in s 223(2)(a) was the Patent Term Timeframe requirement.

IMPLICATIONS OF THE DECISION

The High Court’s decision confirms that where a patentee fails to apply for an extension of a pharmaceutical patent term within the Grant or ARTG Timeframe because of a genuine error or omission, the Commissioner may grant the patentee an extension of time to do so. The decision is consistent with the Australian Patent Office’s longstanding practices, and will reassure innovators that Australia has an effective pharmaceutical patent term extension regime with adequate protections to ensure patentee rights are not prejudiced by genuine errors or omissions or delays in obtaining regulatory approval.