Pfizer Italia S.r.l.
[2007] APO 2
•12 January 2007
ABSTRACTS OF DECISIONS
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Patent: No. 598197 in the name of Pfizer Italia S.r.l.
Title : Injectable ready to use solutions containing an antitumor anthracycline glycoside
Action: Objection to the Commissioner’s proposal pursuant to subregulation 10.7(7) to amend the relevant entry in the Register to insert the correct extension of the term of the patent.
Decision: Issued 12 January 2007.
Abstract
The patentee notified the Commissioner of a number of other pharmaceutical products (Adriamycin, Daunorubicin, Pharmorubicin) that fell within the scope of the claims of the patent and had earlier first regulatory approval dates than the product which formed the basis of the patentee’s application for an extension of term. Based on this information the Commissioner proposed to amend the Register to insert the correct extension of the term of the patent but the patentee objected on the grounds that the application for an extension of term was validly based on the inclusion of Zavedos in the ARTG, that the extension of term is correctly calculated on the first regulatory approval date for that substance and that in any event that the Commissioner has no power under subregulation 10.7(7) to amend the Register as proposed.
Found that:
Each pharmaceutical substance disclosed and claimed in a patent can have only one first regulatory approval date;
The correct interpretation of s 77 is that the term of the extension is determined on the “earliest first regulatory approval date" that applies to the substances in the patent and not only with regard to the substance on which the application for an extension was based;
Whether multiple substances are involved or not, the relevant earliest first regulatory approval date is 13 November 1989 (the first regulatory approval date for Adriamycin) giving an extension of term equal to zero; and
Subregulation 10.7(7) is not limited only to the situation where the information for a specific substance forming the basis of the application was incorrect so that the Commissioner must under that provision amend the Register.
Direction given that the Register be amended to insert the correct extension of term of the patent but not before 28 days from the date of the decision or, in the event that the Commissioner is served in that period with a notice of appeal and an 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 Number 598197 in the name of Pfizer Italia S.r.l., and objection to the Commissioner’s proposal, pursuant to subregulation 10.7(7), to amend the relevant entry in the Register to insert the correct extension of the term of the patent.
BACKGROUND
Patent number 598197 was granted to Farmitalia Carlo Erba S.R.L. on 3 July 1991. By name change, merger or assignment the patent has subsequently been held in the name of Pharmacia S.p.A., Pharmacia & Upjohn S.p.A., Pharmacia Italia S.P.A., and finally Pfizer Italia S.r.l.
In Pharmacia Italia S.P.A v Mayne Pharma Pty Ltd [2005] FCA 1078, Justice Crennan considered the present patent in the context of infringement proceedings and summarised the background of the invention as follows:
“[5] The invention, the subject of the Patent relates to:
(a) a pharmaceutical product, being a stable intravenously injectable ready-to-use solution of an antitumor anthracycline glycoside, e.g. doxorubicin;
(b) a process for preparing such a solution, [providing] the same in a sealed container; and
(c) a method for treating tumours by the use of the ready-to-use solution.[6] The priority date of the Patent is 2 August 1985. Anthracycline glycosides are anticancer drugs which were well known at the priority date. It appears that at that time they were commercially available solely in the form of lyophilized preparations (in a solid form) that needed to be reconstituted into an injectable form (a liquid) before administration to a patient.
[7] Lyophilization is a process which is colloquially described as ‘freeze-drying’ whereby the temperature of the subject material is lowered to freeze it. A vacuum is drawn then the temperature is raised such that the frozen solvent (usually water) sublimates directly from a solid to a gas. Accordingly, a ‘lyophilizate’ is the dried or solid form of a product which was formerly in a liquid form and has undergone lyophilization.
[8] Anthracycline glycosides cannot be administered to a patient in their lyophilized solid form yet they are unstable in aqueous solution and degrade, resulting in both a loss of pharmaceutical activity and the precipitation of solid particles, which prevents them from being administered intravenously. Because of the problems related to instability, anthracycline glycosides were not manufactured in the form of ready-to-use solutions before the priority date. As mentioned above, they were only marketed in the form of a lyophilized solid in a vial, which was required to be reconstituted into a liquid form before the product could be injected into a patient.
[9] In the body of the Patent specification it is noted that the manufacturing and reconstitution of such preparations expose the personnel involved to risks of contamination which are particularly serious because of the toxicity of the antitumour substances. The complete specification states:
‘To administer a lyophilized preparation, double-handling of the drug is required, the lyophilized cake having to be first reconstituted and then administered and, moreover, in some cases, the complete dissolution of the powder may require prolonged shaking because of solubilization problems.’ (p2)
[10] The complete specification indicates that the invention is targeted at circumventing the problems of handling cytotoxic material safely:
‘As the risks connected with the manufacturing and the reconstitution of a lyophilized preparate would be highly reduced if a ready-to-use solution of the drug were available, we have developed a stable, therapeutically acceptable intravenously injectable solution of an anthracycline glycoside drug, e.g. doxorubicin, whose preparation and administration does not require either lyophilization or reconstitution.’ (p2)”
While doxorubicin is particularly preferred, the specification indicates at page 3 that the anthracycline glycoside may be chosen from the group consisting of “doxorubicin, 4'-epi doxorubicin (i.e. epirubicin), 4'-desoxy-doxorubicin (i.e. esorubicin), 4'-desoxy-4'-iodo-doxorubicin, daunorubicin and 4-demethoxydaunorubicin (i.e. idarubicin)”.
The invention claimed in claim 1 of the patent is as follows:
“1. A sterile, pyrogen-free, anthracycline glycoside solution which comprises a physiologically acceptable salt of an anthracycline glycoside dissolved in a physiologically acceptable aqueous solvent therefor at an anthracycline glycoside concentration of from 0.1 to 50 mg/ml, which has not been reconstituted from a lyophilizate and the pH of which has been adjusted from 2.5 to 5.0 solely with a physiologically acceptable acid.”
Subject to the payment of renewal fees, the normal term of the patent was due to expire on 19 June 2006. However, a request for an extension of term of the patent under s 70 of the Act was filed on 14 March 2001 together with an application for an extension of time for filing that request under s 223. The basis for the request for extension of term was the inclusion in the Australian Register of Therapeutic Goods (ARTG) of Zavedos, idarubicin hydrochloride 5mg/5mL injection vial which was subject to an ARTG registration commencing on 19 August 1999. The extension of term was granted by the delegate on 6 April 2004 and 19 June 2011 was entered in the Register as the date for the extension of term of the patent. Subsequently the grant of the extension of term by the Commissioner was considered in Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305 where Justice Weinberg found that the invention claimed in claim 1 was directed to a pharmaceutical substance per se as required by s 70(2) of the Act and consequently dismissed an application for judicial review.
On 6 June 2006 solicitors for Pfizer Italia S.r.L (Pfizer) wrote to the Commissioner of Patents indicating that Pfizer markets a number of products other than Zavedos that fall within the scope of the claims of the present patent. These include solutions of doxorubicin hydrochloride (Adriamycin), daunorubicin hydrochloride (Daunorubicin) and epirubicin hydrochloride (Pharmorubicin) in different presentations and each having a different first regulatory approval date. Pfizer then indicated its view that the “earliest first regulatory approval dates” were:
Daunorubicin (20mg/10mL) 13 August 1991
Adriamycin (10mg/5mL, 20mg/10mL, 50mg/25mL) 13 November 1989
Pharmorubicin (10mg/5mL) 15 July 1992
For Daunorubicin and Pharmorubicin this was said to be the date recorded in the Australian Register of Therapeutic Goods (ARTG) and for Adriamycin the date of approval for importation by the Secretary of the Department of Health.
Pfizer requested that the Commissioner consider this information along with the following statement:
“Pfizer considers that the extension was validly applied for and granted (under section 70 of the Patents Act) based on the registration on the ARTG of Zavedos. Further, Pfizer considers that the term of the extension was correctly calculated (under section 70 of the Patents Act) based on the above earliest first regulatory approval date for Zavedos. Section 77 expressly permits the extension to be based on the earliest first regulatory approval of ‘any’ (rather than ‘all’) of the compounds within the patent.”
In a letter dated 13 July 2006 a delegate of the Commissioner responded by referring to section 77 of the Act and stating that:
“The extension of term is defined in respect of the earliest first regulatory approval date in relation to any of the pharmaceutical substances. If the earliest first regulatory listing of a pharmaceutical substance within the scope of the present claims was 13 June 1989 (daunorubicin hydrochloride) [sic], then the extension of term should be calculated on that date.”
Consequently the delegate advised that the Commissioner was obliged under subregulation 10.7(7) to amend the Patent Register. However, Pfizer was invited to provide further reasons why the Commissioner should not do so or to request to be heard.
The matter came to hearing in Canberra on 25 October 2006. Pfizer was represented by Mr B Caine of Counsel, instructed by Allens Arthur Robinson, Melbourne. In the absence of objection by Pfizer I also heard Mayne Pharma Limited (Mayne) as an interested party. It was represented by Mr S Burley of Counsel, instructed by Clayton Utz, Melbourne.
DECISION
The provisions of Part 3 of Chapter 6 of the Act provide for the extension of term of standard patents relating to pharmaceutical substances. These provisions have now been considered in a number of decided cases and perhaps more relevantly for the current circumstances in H Lundbeck A/S v Commissioner of Patents [2006] FCA 163, in Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176 and on appeal to the full bench in Pfizer Corp v Commissioner of Patents [2006] FCAFC 190. The latter also outlines in some detail the relevant provisions of the Therapeutic Goods Act.
Subsection 70(1) of the Patents Act provides that a patentee may apply for an extension of term if the requirements of subsections (2), (3) and (4) are met. Relevantly s 70(2)(a) provides that:
“one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification”
According to Schedule 1 of the Act a “pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
(b) action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in vitro diagnosis or in vitro testing.”
The conditions set out in s 70(3) are also particularly relevant to the present case and are that:
“goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods” and
“the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years”
The term first regulatory approval date is defined in subsection (5) as being, in relation to a pharmaceutical substance:
“(a)if no pre‑TGA marketing approval was given in relation to the substance—the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b)if pre‑TGA marketing approval was given in relation to the substance—the date of the first approval.”
with pre‑TGA marketing approval being defined in subsection (6).
Sections 71 to 76 deal with matters concerning the application for and grant of the extension of term. Significantly s 71 provides the form and timing of an application for an extension of term as follows:
“Form of application
(1) An application for an extension of the term of a standard patent must:
(a) be in the approved form; and
(b) be accompanied by such documents (if any) as are ascertained in accordance with the regulations; and
(c) be accompanied by such information (if any) as is ascertained in accordance with the regulations.
For this purpose, document includes a copy of a document.
Timing of application
(2) 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.”
For s 71(1) the regulations prescribe the following:
6.8 Information to accompany application
(1) This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance.
(2) For paragraph 71 (1) (c) of the Act, the application must be accompanied by information showing that goods containing, or consisting of, the substance are currently included in the Australian Register of Therapeutic Goods.
(3) The application must also be accompanied by information identifying the substance, as it occurs in those goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent.
6.9 Application without pre-TGA marketing approval
(1) This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance for which pre-TGA marketing approval has not been given.
(2) For paragraphs 71 (1) (b) and (c) of the Act, the application must be accompanied by:
(a) a certificate under paragraph 25 (3) (b) or subsection 26 (4) or 26A (9) of the Therapeutic Goods Act 1989 stating the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) if the patentee does not have a certificate mentioned in paragraph (a) — information showing the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance.
6.10 Application with pre-TGA marketing approval
(1) This regulation applies to an application under section 70 of the Act for an extension of the term of a standard patent for a pharmaceutical substance for which pre-TGA marketing approval has been given.
(2) For paragraphs 71 (1) (b) and (c) of the Act, the application must be accompanied by:
(a) a written statement by the person who gave the approval showing:
(i) that approval has been given; and
(ii) the date of the first approval; or
(b) if the patentee does not have a written statement mentioned in paragraph (a) — information showing:
(i) that approval has been given; and
(ii) the date of the first approval.”
Pursuant to s 74 the Commissioner must accept an application that she is satisfied meets the requirements of ss 70 and 71 and in the absence of an opposition under s 75 must grant the extension of term. If an extension is granted, s 77 then provides for the calculation of the term as follows:
“(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.
(2)However, the term of the extension cannot be longer than 5 years.”
The key issues in the present matter are what is the correct term of the extension of the patent provided by s 77 and, if that term is different than the term currently reflected in the Register, is the Commissioner required and empowered under reg 10.7(7) to amend the Register? Primarily Pfizer argue that the Commissioner has incorrectly interpreted s 77 such that the word “any” has been taken to mean “all of” the pharmaceutical substances disclosed and claimed in the patent. It says this is inconsistent with the scheme of the Act and particularly s 70 which it says allows an application to be made in respect of any pharmaceutical substance. It also says that consistent with the scheme of the Therapeutic Goods Act (TGA) “the first inclusion” in the ARTG must be read as a reference to the first entry in the ARTG in respect of any presentation of a therapeutic good that contains or consists of the pharmaceutical substance in question. Hence “earliest” in s 77 refers to the first among the “first regulatory approval dates” that apply to a particular substance.
Conversely Mayne submits that while there is a close intersection between the operation of s 70 and s 77 it is the latter that governs the period of the extension of term separately from the application process provided by other provisions of Part 3 of Chapter 6 and for this relies significantly on the findings of Justice Lindgren in Lundbeck. Consequently it says s 77 provides unambiguous direction for the calculation of the period of extension by reference to any of the substances which satisfy the conditions of the s 70(2). Mayne also asserts that what is involved in this case is a single pharmaceutical substance, that is, an anthracycline glycoside solution as claimed in claim 1. Despite this submission, the assumption that more than one pharmaceutical substance is disclosed and claimed in the patent is essential to the case put by Pfizer and accordingly I will consider it on that basis but revisit the issue if it becomes necessary in light of my findings below.
It is also fundamental to Pfizer’s case that each pharmaceutical substance may have more than one first regulatory approval date and hence meaning is given to “earliest” in Pfizer’s interpretation of s 77. However turning to the definition in s 70(5), I note that while “the first regulatory approval date” is determined by “the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance” or, “if pre‑TGA marketing approval was given in relation to the substance—the date of the first approval”, it is defined for, or in relation to, a pharmaceutical substance and not the goods that contain it. As such it appears plain to me that logically each pharmaceutical substance can have only one first regulatory approval date. This is even more evident when one considers the wording of s 70(3)(b) which refers to “the period beginning on the date of the patent and ending on the first regulatory approval date for the substance” [my emphasis]. Clearly this provision would not make sense if each substance was to have more than one first regulatory approval date.
As a consequence I reject Pfizer’s submission that each distinct presentation of a product relating to a pharmaceutical substance will have associated with it a first regulatory approval date such that the relevant pharmaceutical substance may as a result have multiple first regulatory approval dates. This view is said by Pfizer to flow from the fact that under the TGA different presentations will be treated as distinct goods and to this end has provided a declaration made by Dr Brian Hewitt setting out various inclusions in the ARTG for the substances identified above and the reason why several inclusions may be required for the same substance. However it seems to me that the possibility of multiple inclusions under the TGA for the same pharmaceutical substance is the very reason why it is necessary under the Patent’s Act to distinguish the first inclusion or approval in relation to a substance from later inclusions or approvals whether they relate to different presentations, different types of inclusions or otherwise.
In Re Pfizer Corporation 67 IPR 201 I also came to the view that s 70(5) has the effect that a pharmaceutical substance may have only a singe first regulatory approval date and addressed a similar argument on multiple first regulatory approval dates and the interpretation of s 77 in the following way:
“[25] Before looking to section 70(5) in detail, it is further said in relation to section 77 that the wording "earliest" in "earliest first regulatory approval date" implies a number of first regulatory approval dates in different categories for a particular substance. To my mind this does not particularly assist the case pressed by Pfizer but in any event I do not think this is the correct interpretation. The effect of subsection 70(5) seems to me to be that a pharmaceutical substance may only have only a single "first regulatory approval date" and this appears perfectly logical. What then is the purpose of prescribing the "earliest" first regulatory approval date in subsection 77(1)? This subsection provides:
(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);
[26] The key part of this for understanding the import of "earliest" is the latter part of the paragraph, that is, "... in relation to any of the pharmaceutical substances referred to in subsection 70(2)" (my underlining). Subsection 70(2) states:
(2) Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
[27] Thus it can be seen that the issue is that a patent specification may disclose and include within the scope of its claims more than one pharmaceutical substance. Under subsection 70(5) each pharmaceutical substance has only one "first regulatory approval date" so, since a patent can involve more than one substance with possibly different first regulatory approval dates, the only reasonable interpretation of subsection 77(1) is that it is intended that the term of the extension must be based on the earliest of the approval dates that may apply to the patent.”
On appeal to the Federal Court, Justice Bennett (Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176) appears to have affirmed that interpretation, indicating that:
“34 Section 77 refers to the ‘earliest first regulatory approval date’ (emphasis added). This recognises that the patent may cover more than one pharmaceutical substance and provides that the term of the extension is based on the earliest of the approval dates that apply to the patent.”
Pfizer contend that this is not a correct interpretation and that, given the different circumstances in that case, her Honour’s statement is not binding in this matter. More particularly it asserts that “any” in s 77(1)(a) means “any one of” rather than “all of” the pharmaceutical substances referred to in subsection 70(2) and hence only the first regulatory approval date in relation to Zavedos is relevant for determining the term of the extension. However, having concluded that a substance can have only one first regulatory approval date, it appears impossible to escape the clear meaning of s 77 that it is the earliest of the first regulatory approval dates that can apply to the substances of the patent that is relevant to the calculation of the term of the extension.
Pfizer asserts that this interpretation is inconsistent with the policy intent of the scheme which was to provide an “effective patent term” after regulatory approval which is more in line with that available in other fields of technology. Hence they say that it is reasonable that an extension be granted, and the term calculated, on the basis of any substance under the patent for which regulatory approval is sought. This argument seems not to appreciate that in Australia the deliberate policy approach was not to limit the term extension to a particular substance or drug but rather to allow a single extension of the entire patent of up to five years and that the effect of Pfizer’s approach would be that for some drugs covered by the patent, the effective patent term would exceed even the normal 20 year patent term. This is the case in the present matter since, on Pfizer’s reasoning, the effective patent term for Adriamycin would be in excess of 21 years and this would seem to be entirely inconsistent with the policy objectives reflected in the extrinsic materials and of the patent system generally.
Rather as was found by the full bench in Pfizer Corp v Commissioner of Patents [2006] FCAFC 190 at [67] “it is tolerably clear that the policy that underlay the introduction of the regime for the extension of the term of the patent was to provide an additional effective term for the exploitation of a patent.” Exploitation of a patent for a pharmaceutical substance or substances can commence when any of them achieve regulatory approval, or in other words, at the earliest first regulatory approval date. Hence the plain meaning of section s 77 seems to be entirely consistent with the policy intent of the legislation.
In relation to submissions on the process for applying for an extension of term it is true that the Act and Regulations do not explicitly prescribe a requirement that information concerning the substance with the earliest first regulatory approval date must be provided. It does however seem to me that there is a clear assumption in the operation of the Act that information concerning the first inclusion in the ARTG for goods that contain or consist of any of the pharmaceutical substances will be provided or otherwise the earliest first regulatory approval date (if different) and will be the basis of the application under s 70. In this regard I do not take s 70 to mean that an application can be made on the basis of any substance covered by the patent and which complies with s 70(3) but that the right to apply generally arises from the first relevant inclusion in the ARTG and this is why the timing permitted for the application is set with reference to this date under s 71(2). Consequently it appears that to satisfy the requirement of s 70(3) each substance meeting the requirement of paragraph (a) must also meet meets the requirements of paragraph (b). If this were not the case the Commissioner would unnecessarily be led to grant extensions of term based on applications made out of time and where the term of the extension provided under s 77 is zero. Again it should be noted that the intent of the scheme is that an extension of up to five years is given for delays due to regulatory approval up to the point when exploitation of the patent becomes possible. Hence the “earliest first regulatory approval date” is critical to the operation of the scheme.
The logic of this interpretation of the Act is also apparent when one considers the terms of s 77 and the relatively simple administrative scheme which was established for the grant of an extension. Under s 74(1) all the Commissioner is required to do before acceptance of the application is to be satisfied that the requirements of ss 70 and 71 are met. She is not required to examine the ARTG to set or establish definitely the correct term of the extension. Rather this is provided separately to the Commissioner’s consideration by the operation of s 77 and, as discussed in Lundbeck at [36], the relevant extension of term is not necessarily the period applied for. However this does not mean that the intention of the legislation is to allow the Commissioner to put inaccurate or misleading particulars on the Register when more relevant information is known to and available from the patentee. Indeed in those circumstances for the Commissioner to grant an extension when to the knowledge of the patentee the term of that extension is actually zero would seem entirely contrary to the public interest. Rather the legislative intention is that the Register should not contain false entries (Lundbeck at [49]) and, subject to information that comes to light subsequently, it should be assumed that the information required to accompany the application will be such as to allow compliance with ss 70 and 71 to be determined and accurate particulars entered on the Register. Hence I take reference in reg 6.8, 6.7 and 6.10 to “a pharmaceutical substance” and “the substance” to be to the substance relating to the first relevant inclusion in the ARTG. Accordingly I do not find this line of argument supports Pfizer’s contention on s 77 and the clear meaning and intent of that section prevails.
Pfizer admits that each of Adriamycin, Daunorubicin, Pharmorubicin and Zavedos meets the requirements of s 70(2)(a), that is, that they are pharmaceutical substances per se that are in substance disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification. Based on the admissions made by Pfizer, including the information contained in Dr Hewitt’s declaration, and the definition of s 70(5) I find the first regulatory approval date in relation to each of the substances is:
Adriamycin 13 November 1989
Daunorubicin 13 August 1991
Pharmorubicin 15 July 1992
Zavedos 19 August 1999and therefore the earliest first regulatory approval date based on this information is 13 November 1989.
The date of the patent is 19 June 1986 (s 65) and the period beginning on this date and ending on the earliest first regulatory approval date, ie 13 November 1989, is therefore less than five years. Consequently the effect of the calculation under s 77 is that the term of the extension granted is zero and the term of the patent expired on 19 June 2006. This then leads to the same result as if the patent was considered to claim only a single pharmaceutical substance, that is, the first regulatory approval date for the solution claimed is the date of commencement for the first inclusion in the ARTG of Adriamycin, 13 November 1989. As a result, and as perhaps might be expected in light of the legislative intention discussed above, the question of whether or not the patent relates to one or more than one pharmaceutical substance is not determinative of the correct extension of term.
The question that then remains is whether in this case the Commissioner can and should take action to amend the Register to reflect the correct extension of term. In this regard the relevant provisions of Regulation 10.7 are as follows:
“10.7 Correction of Register or patent
…..(7) If:
(a)an extension of the term of a standard patent for a pharmaceutical substance has been granted under section 76 of the Act; and
(b)the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance is earlier than:
(i) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods that was supplied, under subregulation 6.9 (2), with the application for the extension of the term; or
(ii) the date of the first approval that was supplied, under subregulation 6.10 (2), with the application for the extension of the term;
the Commissioner must amend the relevant entry in the Register to insert the correct extension of the term of the patent.
Note 1 Under section 77 of the Act, the term of the extension must be 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 of the Act) in relation to the pharmaceutical substance;
reduced (but not below zero) by:
(b)5 years.
The extension of the term of a patent is one of the particulars included in the Register under paragraph 19.1 (1) (c). If the earliest first regulatory approval date is earlier than the date that was used in calculating the term of the extension under section 77 of the Act, then the entry in the Register will be incorrect.
Note 2Subregulation 6.9 (2) refers to the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance. The date is supplied with an application for the extension of the term of a patent if pre-TGA marketing approval has not been given.
Subregulation 6.10 (2) refers to the date of the first approval of a pharmaceutical substance. The date is supplied with an application for the extension of the term of a patent if pre-TGA marketing approval has been given.
(8)If the Commissioner proposes to amend an entry in the Register under subregulation (7), the Commissioner must:
(a)give notice to that effect to the patentee; and
(b)act in accordance with regulations 22.22 to 22.24 as if those regulations applied to a decision to amend an entry.
NoteRegulations 22.22 to 22.24 apply to discretionary decisions made by the Commissioner. However, the procedures in those regulations will be used to allow the Commissioner to establish whether the grounds for a decision under subregulation (7) exist.
(9)An appeal lies to the Federal Court against a decision of the Commissioner to amend the Register under subregulation (7).”
While Pfizer challenges the validity of subregulation 10.7(7) it has been considered in Lundbeck, and on appeal to the full bench of the Federal Court in Pfizer Corp v Commissioner of Patents [2006] FCAFC 190 where it was said that:
“37 If the contentions of the Patentees concerning the construction of s 70(5) are rejected, the position is that the terms of the Patents were extended beyond the times authorised by the Patents Act. That is to say, extensions to dates were granted that should not have been granted. It is unexceptionable that the Commissioner should be authorised to amend the Patent Register to reflect the extensions that were authorised by the Patents Act in lieu of extensions that were not authorised by the Patents Act. Regulation 10.7 is a valid exercise of the power conferred by s228(2), which is itself a valid exercise of statutory power.”
I also note from the Explanatory Statement that accompanied the introduction of reg 10.7(7):
“Recently, the Commissioner has become aware that the extensions of term granted in respect of several patents are longer than the patentees are entitled to under the Act. This appears to be due to the Commissioner having been supplied with incorrect information by the patentees when these extensions of term were requested. However, the Principal Regulations did not provide a specific mechanism by means of which the Commissioner could amend the Register to insert the correct extension of the term of the patent in these circumstances.
The main purpose of the Regulations is to provide such a mechanism. Schedule 1 to the Regulations gives the Commissioner the power to amend the Register to insert the correct extension of the term of the patent when he or she becomes aware that the date of ‘first inclusion’ supplied by the patentee is incorrect. Before amending the Register, the patentee must be notified and given an opportunity to be heard. A decision of the Commissioner under these provisions is appellable directly to the Federal Court of Australia.
The effect of the Regulations is that the Commissioner can amend existing and future entries in the Register so that they accurately reflect the length of the extension of term of the affected patent as determined by section 77 of the Act. The correction of the Register under these provisions will not affect the patentee’s legal rights — it simply corrects an incorrect entry in the Register.”
Subject to any further judicial determination on the validity of the subregulation, there would seem to be no question that if only a single substance is claimed I am required to direct an amendment of the Register. Pfizer however contend in the case of multiple substances that the power to amend the Register does not exist unless it was shown that there is an earlier first regulatory approval date that applies to the particular substance on which the application for an extension of term was based. In this they rely on the decision in H.Lundbeck A/S v Alphapharm Pty Ltd [2006] APO 18 where the Delegate observed:
“[21] Lindgren J has recently found that reg 10.7(7) is valid (H.Lundbeck A/S v Commissioner of Patents [2006] FCA 163). The errors that are capable of correction under reg 10.7(7) relate to "the first regulatory approval date in relation to the pharmaceutical substance" (emphasis added). The pharmaceutical substance can only be the substance that was the basis of the extension of term (analogous to the interpretation of "the substance" above). Significantly reg 10.7(7) does not contain an equivalent to s 77(1), allowing amendment if there is an earlier date in relation to "any" pharmaceutical substance. Consequently, an amendment is required only if there is an earlier first regulatory approval date in relation to the substance which was used as the basis of the extension of term.”
Assuming again that multiple substances are in fact involved, I nevertheless do not believe the regulation can be read in the way the Delegate suggests and note that his comments were made only peripherally to the substance of the matter before him. Pfizer appear to again argue from the incorrect assumption that an extension of term applies to a particular substance being the substance referred to in its application. Clearly it does not but, as I have already discussed, applies to the patent as a whole. In relation to the information supplied with the application I have also concluded that it is information concerning the earliest first regulatory approval date that would normally be expected to be supplied with the application. Nevertheless where because of error or some other reason this does not occur it does not seem to me that reg 10.7(7) on its plain meaning limits corrective action only to the circumstances where the information provided for a specific substance in the application was incorrect. To read it otherwise would seem to ignore the clear policy intent as indicated above, that is, that the Commissioner is required to “amend the Patent Register to reflect the extensions that were authorised by the Patents Act in lieu of extensions that were not authorised by the Patents Act.”
Reg 10.7(7)(b) refers to “the first regulatory approval date in relation to the pharmaceutical substance”. This plainly means in relation to the “a pharmaceutical substance” in (a) that the patent is for. In the case that the patent is for more than one substance there does not seem to me to be any basis to assume that this is reference to the substance for which information is provided along with the application for an extension of term. Rather it more reasonably could be understood to be the substance with the earliest first inclusion date noting my comments above in relation to reg 6.8 – 6.10 and the similarity in wording with the current subregulation. It could also mean any or all of the substances since the patent is in effect for each one of them. In either case it can be said that an extension of the term of a standard patent for the substance with the earliest first regulatory approval date has been granted and the reference in (b) to “the pharmaceutical substance” therefore applies to that substance. Consequently if the Commissioner becomes aware of a first regulatory approval date in relation to that substance which is earlier than a date supplied with the application (whether for that substance or not) the subregulation requires the Commissioner to amend the Register. In this regard, if what is required for the operation of reg 10.7(7) is an error in information supplied about a particular substance, one may have expected that paragraphs (b)(i) and (ii) would have been limited to dates supplied in relation to “the substance”. They however only refer to the date of first inclusion, or of first approval, that was supplied and this clearly suggests that there was no intention to limit the provision as contended by Pfizer but it is intended to provide a general mechanism for correction of the Register where an earlier first regulatory approval date becomes apparent after grant of the extension.
It follows that the relevant conditions for the operation of the subregulation in this case are that:
An extension of the term of a standard patent for a pharmaceutical substance has been granted under section 76 of the Act – It has been assumed that the extension has been granted for a patent covering more than one substance and, if so, it can be said that an extension of a patent for Adriamycin has been granted even though the patent is also for other substances.
the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance… - The Commissioner has become aware that the first regulatory approval date for Adriamycin is 13 November 1989.
is earlier than:
(i) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods that was supplied, under subregulation 6.9(2), with the application for the extension of the term; - The date supplied under subregulation 6.9(2) was the date of commencement of the first inclusion for Zavedos, 19 August 1999. The date apparent for Adriamycin is earlier than the date 19 August 1999 and therefore the conditions for the operation of the subregulation are met and:
the Commissioner must amend the relevant entry in the Register to insert the correct extension of the term of the patent.
CONCLUSION
I have found that the “earliest first regulatory approval date” applicable to the patent is the first regulatory approval date for the pharmaceutical substance Adriamycin, 13 November 1989. Consequently under s 77 the term of the extension granted equates to zero. I have also found that the Commissioner is empowered and required by reg 10.7(7) to amend the relevant entry in the Patents Register to insert the correct extension of term.
In Re Pfizer [2005] APO 38 I considered submissions on the approach the Commissioner should take on implementing a similar decision contrary to the interests of the patentee and pending any appeal. In balancing the competing interests relevant to a decision to stay implementation I observed:
“[15] The purpose of subregulation 10.7(7) according to the Explanatory Statement to Select Legislative Instrument 2005 No.51 is to enable the Commissioner to insert the correct extension of the term of the patent where she becomes aware that the date of "first inclusion" supplied by the patentee is incorrect. Subregulations 10.7(1) and (6) permit the Commissioner to amend the Register to correct a clerical error or obvious mistake. Pfizer challenges the validity of regulation 10.7 but it is worth noting the general scheme of the Act that requires the Commissioner to add particulars and maintain the Register. These include the registration of particulars under section 187 and regulation 19.1 such as, for example, decisions to revoke and cessation of the patent.
[16] This is consistent with the purpose of the Register which is to inform (see section 190) and to provide a reasonable degree of certainty to the public as the nature, term and ownership of patent rights which may impact on their dealings and commercial interests or indeed a decision to acquire the patent or a license. The significance of the Register is further reflected by subsection 195(1) which provides that it is prima facie evidence of the particulars registered in it. Consequently it seems trite to observe that there is a strong public interest in the Register being kept current and, where circumstances change (such as revocation of a patent) that this be reflected in the Register as soon as possible. It should also be very apparent that where a pharmaceutical extension of term is involved the public interest will be in ensuring that proceedings to determine the correct date of extension be prosecuted diligently so that entry of generic manufacturers to the market is not unnecessarily delayed when the patent term ceases.”
And found that:
“[19] While the principle is that decisions of the Commissioner have immediate effect, it is also the case that an order of the Court can be sought staying the execution of a decision under appeal or review. The Commissioner in my view should not act in a way to circumvent a party’s right to seek such an order before implementing a decision and for that reason I believe it would be inappropriate in this case to immediately implement an adverse decision by amending the Register. However, considering the public interest in maintaining certainty in the Register, it seems to me that the stay on implementing the decision should only extend for a time sufficient for the patentee to seek and, if the Court finds it appropriate, obtain a stay on the implementation of the decision. In this regard the Court is well placed to hear submissions on the balance of the interests involved, including submissions by the Commissioner where appropriate, and to make any directions necessary for the timely prosecution of those proceedings. It is also the case that if a order staying execution is made and served on the Commissioner, it is a particular that must be registered (Section 187 and subregulation 19.1(1)(g)) and therefore this would also contribute to the Register better reflecting the current status of the patent or, in this case, patents.”
In the present circumstances I have found that the applicable term extension under s 77 is zero and the patent has expired. Hence the consequence of a stay here is even more significant. Nevertheless I believe the general principles expressed above apply and consequently I direct that the Register be amended to insert the correct extension of term of the patent, equating to zero, but not before 28 days from the date of this decision or, in the event that the Commissioner is served in that period with a notice of appeal and an application for a stay of the decision, until the stay application is determined by the Court.
Philip Spann
Deputy Commissioner of Patents
12 January 2007
4
6
0