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The topic of pharmaceutical patent term extensions has again recently been the subject of consideration before the Patent Office and the Federal Court. In two separate proceedings, the issue of whether the Commissioner is entitled to amend the Register to reflect a new (shorter) extension period was considered by the Federal Court. The issue arose when it came to light that the actual first regulatory approval date was earlier than the first regulatory approval date supplied by the patentee in the original application for extension. This also raises the question of whether the identification of an earlier first regulatory approval date can lead to a finding that the application for extension was filed out of time and that the extension was therefore invalidly granted in the first place. The latter is yet to be determined.
18 September 2006 decision of a delegate of the commissioner Each of the patents had been extended on the basis of registration in the Australian Register pfizer corp, pfizer ltd, pfizer inc. and pfizer of Therapeutic Goods (ARTG). However, it research and development company, n.v/s.a subsequently came to the Commissioner’s (“pfizer”) (re pfizer corporation (2005) 67 ipr attention that earlier “export only” listings were included in the ARTG. The Commissioner accordingly notified Pfizer that she intended to amend the Register to reflect extensions of term decision of the federal court of australia calculated on these earlier dates. This would pfizer corp v commissioner of patents (no 2) have the effect of reducing the currently recorded extensions by some ten or thirteen months, and in the case of AU 691005, reducing the five Australian Patent Nos 540769 and 573123, relating to Norvasc (amlodipine) and 651637 and 691005, relating to Replax (eletriptan Section 70(3) of the Act sets out that in order for hydrobromide), (“the patents”) had all been granted an extension of the patent term under (a) goods containing or consisting of the the pharmaceutical extension provisions of pharmaceutical substance (as disclosed and the Patents Act 1990 (Cth) (“the Act”). The claimed in the patent) must be included in extensions varied from about 5 months to almost 5 years and were recorded in the patent (b) the period beginning on the date of the patent (usually the filing date) and ending on the first regulatory approval date for the On 23 March 2005, amendments were made to the Patents Regulations, with effect on both new and existing entries on the patent Register, that The first regulatory approval date, as given by if the Commissioner becomes aware that the s 70(5), is the date of commencement of the first first regulatory approval date in relation to the inclusion in the ARTG of goods that contain, or pharmaceutical substance is earlier than that supplied with the application for extension, then the Commissioner must amend the Register to The extension of term is calculated according to insert the correct extension of the term of the s 77 and is the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by s 70); reduced of the Patentee’s rights and amount to a reduction by five years (but not below zero). The maximum term in the term of the extension. The Hearing Officer pointed out that the Register was merely prima facie evidence concerning patent rights but that it does not Pfizer contended that the relevant first regulatory establish those rights. Before granting an extension, approval date for calculating the extension of term the Commissioner only has to determine that ss 70 and is limited to the first such date for the purpose of 71 are satisfied. The term of the extension is calculated marketing in, or importing into, Australia for general by s 77 and is not decided or set by the Commissioner. marketing of the pharmaceutical substance, and does Accordingly, while the Commissioner may be functus not include the regulatory approval date for export officio on the decision to grant the extension, she is not so merely in amending particulars on the Register that are intended to correctly reflect the term of the The Hearing Officer noted that the Therapeutic Goods Act 1989 (“the TGA”) provided for the ARTG to contain two parts, one relating to goods to be The decision was appealed to the Federal Court. known as registered goods and the other relating to goods to be known as listed goods. In this context Before the Court, two issues were considered: the the Hearing Officer concluded that the meaning validity of reg 10.7(7); and the date from which an of the “first inclusion in the Australian Register of extension of term of a pharmaceutical patent is Therapeutic Goods” must take into account the plain meaning of “inclusion” or “include” (“to contain, embrace or comprise”) and the nature of the ARTG With regard to the first point, Pfizer submitted that reg and the inclusions provided for under the TGA. It was 10.7(7) is invalid but limited its submissions to that therefore clear that at all relevant times goods included contention. It was accepted by all parties that for the on the ARTG have encompassed both registered and purposes of the appeal, Bennett J would follow the listed goods. As a result, export listings in the ARTG Lundbeck decision (discussed below) that reg 10.7(7) is are to be taken into account when determining the valid prior to any determination to the contrary by the first regulatory approval date. It was also noted that although most extensions have in the past been based on registered goods included in the ARTG, a small but In determining the second point, Her Honour first significant number have been based on ARTG listings. considered the structure of the ARTG, noting that On this basis it was assumed that the requirements of inclusion of a patented pharmaceutical substance as the TGA are clear and the concept of inclusion in the a Listed Good or a Registered Good both allowed the patentee, albeit to a different extent, to exploit the substance. Pfizer acknowledged this but submitted When the relevant export listings were taken into that the provision of data for Registered Goods is account, the dates of commencement of the first more onerous and extensive, resulting in a delay in inclusion in the ARTG that were supplied with the marketing in Australia and in full exploitation of applications for the extension of term were found to the patent. However, it was held that the extent to be later than the actual first regulatory approval date which the provision of data for Registered Goods is as determined under s 70(5). In such circumstances, more onerous than Listed Goods was not considered the Register must be amended in accordance with reg to be determinative of the issue. This turned on the construction of ss 70 and 77 of the Act. In response, Pfizer also submitted that reg 10.7(7) On its face, the meaning of the expression “first is invalid because it is ultra vires and that under the inclusion in the ARTG” as used in s 70(5)(a) was found to circumstances amendment would be a restriction be clear and unambiguous: “the entry, first in time, in a In conclusion it was held that an export only listing in the ARTG is an inclusion in the ARTG for the purpose of With regard to the meaning of “earliest first regulatory s 70 of the Act and that where that inclusion precedes approval date” as used in s 77, Pfizer contended that the registration that permits marketing in Australia and meaning given by s 70(5)(a) to “no pre-TGA marketing no pre-TGA marketing approval was given, it is the first approval” should be consistent with the meaning inclusion in the ARTG and the first regulatory approval given to “pre-TGA marketing approval”, which is defined by s 70(5)(b) as the date of the “first approval”. Pfizer submitted that this referred to approval for marketing in Australian prior to the commencement of the Therapeutic Goods Act 1989 (Cth) (“the TG decision of the federal court of australia Act”). Therefore, where no pre-TGA marketing approval h lundbeck a/s v commissioner of patents [2005] was given, the first regulatory approval date should be determined by the first inclusion in the ARTG which allows marketing in Australia, i.e. inclusion as Australian Patent No 623144 relates to the (S)- enantiomer of citalopram (escitalopram). The patentee, H Lundbeck A/S (“Lundbeck”), applied for and Her Honour, noted that s 70(6), which defines “pre- was granted an extension of term on the basis of the TGA marketing approval” as an approval to market registration of escitalopram oxalate in the ARTG on 16 the substance or a product containing the substance September 2003. Alphapharm Pty Ltd (“Alphapharm”) in Australia; or import into Australia, for general subsequently drew to the Commissioner’s attention marketing, the substance or a product containing the that goods containing the (S)-enantiomer had, in fact, substance, is restricted to the scenario where there is been included in the ARTG since 9 December 1997 an approval by the Minister or Secretary prior to the TG by way of registration of citalopram bromide, which Act. However, it was also noted that the TG Act further comprises both the (S)- and (R)- enantiomers. makes provision for the Secretary to grant approvals for importation into or supply in Australia of specified In accordance with reg 10.7(7), the Commissioner therapeutic goods in certain circumstances before the notified Lundbeck that on the basis of the earlier substance is included as Registered Goods in the ARTG, registration date, the patent Register did not reflect which is outside the scope of s 70(5). Her Honour then the correct extension of term and that she intended went on to state that if “the intention were to define to amend the Register to reflect the correct term. This “first regulatory approval date” as the date of approval revised term was some 18 months shorter than that to market in Australia or the date of entry in the ARTG as Registered Goods, it would have been easy to do so”.
Lindgren J set out the legislation concerning Her Honour also considered extrinsic materials which pharmaceutical extensions and observed that provided Pfizer contended evinced a clear legislative policy for ss 70 and 71 were satisfied, the Commissioner must granting the patentee at least 15 years of “unfettered grant an extension of term to the patent if there exploitation rights” commencing on the date of was no opposition to the grant. His Honour also approval enabling marketing in Australia and which noted that whilst the Commissioner must grant an should be relied upon to interpret the provisions of extension, she is not required to specify the term of the Act. However, it was held that the words “first that extension and that the actual extension of term inclusion in the ARTG” were neither ambiguous nor is not necessarily the period applied for, the period obscure and did not lead to a manifestly absurd or of the extension being defined in s 77. Finally it was unreasonable result, and thus the provisions of the Acts observed that since sub-s 195(1) provides that the Interpretation Act 1901 (Cth) did not apply. Register is prima facie evidence of any particulars registered in it, there is a general legislative intention that the Register be correct and reliable.
“The true extension is that brought about by the operation of s 77. The register does not give an Lundbeck referred to a number of authorities for the indefeasible title and is only prima facie evidence of proposition that a power to make regulations is not to any particulars registered in it: s 195(1). A patentee be construed as authority to make regulations which has no right to insist that the Register continue to widen, vary or depart from positive provisions of the record an extension greater than it truly is.” Act or extend the scope and general operation of the Act, and that reg 10.7(7) was therefore ultra vires with His Honour also dismissed the submission that to amend an entry in the Register to zero was inconsistent with s 76(1), pointing out that the notion that the However, His Honour did not think that it was extension might be zero is expressly contemplated by inconsistent with rights provided by the Act that a regulation should require the Commissioner to amend an entry in the Register which does not reflect the The timing of an application for an extension is set true extension of the term of a patent, where the by s 71(2) which, in this particular instance, required Commissioner has become aware that the entry in the the application to be made within 6 months of the Register fails to do so. His Honour considered s 228 date of commencement of the first inclusion in the and noted that sub-s 228(2)(e) did allow the making ARTG of goods that contain, or consist of, escitalopram. of regulations that make provision for, and in relation Whether the first regulatory approval date is 9 to, amendment of an entry in the Register for any December 1997 (as contended by Alphapharm) or 16 purpose. His Honour did not think that the expression September 2003 (as contended by Lundbeck) will be “for any purpose” signified a regulation made for considered in a currently pending revocation action literally any purpose, for example, for a purpose which between Alphapharm and Lundbeck. If it is held that demonstrated bad faith or for a purpose totally foreign the date is in fact the earlier of the two, this raises If you would like to be removed from our mailing list, please send an or antithetical to the concerns and objects of the Act, the question of whether the extension was invalidly but could not think of a purposive limitation to be read granted because the application for the extension telephone Melissa McLennan on + 61 3 9254 2777.
into sub-s 228(2)(e) which would have the effect that was filed outside the 6 month period from the first sheet are not intended to be, nor are they, a complete statement of the law on the particular subject matter and Lundbeck’s underlying submission, that by reason of are for information purposes only. This update is not a substitute for entry in the Register the Patentee has the benefit of the For further information or advice on patent term extension entered, was firmly dismissed. His Honour extensions or any other patent matters please contact: noted that the term is set by s 77 and amendment of the Register to show a shorter period would do no more than remove a false entry and ensure the Register reflected the true extension fixed by s 77. + 613 9254 2777 or [email protected] www.davies.com.au

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