Re: G.D.Searle LLC - [2008] APO 31

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 680635 in the name of G.D.Searle LLC

Title: Hydroxyethylamino sulfonamides useful as retroviral protease inhibitors

Action: Request for an extension of term under section 70

Decision: Issued 05 December 2008
Abstract

The patentee applied for an extension of term based on the substance darunavir. Another substance (known as amprenavir) within the scope of the claims had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG).

An application for extension of term must be made within six months of “the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist or, any of the pharmaceutical substances referred to in subsection 70(3)”. This provision was found to mean that an application for extension of term is to be made within six months of the earliest first inclusion in the ARTG.
The patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223.
Equally, the Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made.
Since the application was not made within six months of the date of the earliest first inclusion in the ARTG, the application is refused.
It was noted that regulation 10.7(7) operates when the full facts were not known to the patentee at the time of granting the extension of term.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 680635 by G.D.Searle LLC and a request for an extension of term under section 70

BACKGROUND

Patent number 680635 in the name of G.D.Searle LLC was sealed on 27 November 1997. The normal 20 year term of the patent will expire on 24 August 2013. On 29 August 2007, the patentee filed an application for an extension of term of the patent under section 70 of the Patents Act 1990. The extension is based on the substance darunavir. During examination of the application, a Senior Examiner reported that there was another substance (known as amprenavir) within the scope of the claims that had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG), and as a consequence the application for an extension of term was not made within six months of the commencement of the first inclusion in the ARTG of goods that contain a relevant pharmaceutical substance. The patentee requested a hearing, which was held in Canberra on 15 October 2008. The patentee was represented by Shahnaz Irani, patent attorney with Spruson & Ferguson.
DECISION
Extension of the term of a patent relating to pharmaceutical substances is governed by Part 3 of Chapter 6 of the Patents Act. For present purposes, the only question relates to when an application for an extension of term must be made. This is addressed in subsection 71(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 or, any of the pharmaceutical substances referred to in subsection 70(3);
(c)the date of commencement of this section.”
In the present case, the date the patent was granted is 27 November 1997, and the date of commencement of section 71 was 27 January 1999 (the section was inserted by the Intellectual Property Laws Amendment Act 1998). In Pfizer Corp v Commissioner [2006] FCAFC 190, 70 IPR 559 the Federal Court found that “first inclusion” refers to the first inclusion in any of the parts of the ARTG. Goods containing darunavir were first included in the ARTG on 15 March 2007 (as goods called PREZISTA, having registration number 127411). The sponsor of the goods is Janssen-Cilag Pty Ltd. Goods containing amprenavir were first included in the ARTG on 5 June 2001 (as goods called AGENERASE, having registration numbers 71482, 71483 and 71484). The sponsor of these goods is GlaxoSmithKline Australia Pty Ltd. I am satisfied, and the patentee agreed, that both darunavir and amprenavir satisfy the criteria in subsections 70(2) and 70(3). The only question is which of these pharmaceutical substances is relevant for the purposes of paragraph 71(2)(b)?
The Senior Examiner and the patentee place emphasis on different words in paragraph 71(2)(b). The Senior Examiner took the view that “the first inclusion” is the key expression, and thus subsection 71(2) requires the application to be made within 6 months of the EARLIEST inclusion in the ARTG of a relevant pharmaceutical substance. The patentee submitted that “any of the pharmaceutical substances” can be relied upon for the purposes of subsection 71(2). In this case, the expression “first inclusion” refers to the fact that a substance can have several entries in the ARTG with respect to different goods, or different listings. Thus the patentee asserts that the 6 month period is started afresh by EACH first inclusion in the ARTG.
Plain meaning of subsection 71(2)
The present case is simply an exercise in construction. The starting point of construction is to read the words of the subsection. Both interpretations of subsection 71(2) can fairly be read out of the words that are used. Emphasis could be placed on either the word “first” or “any”. The definition of “any” does not help either. The word “any” is used to qualify the term “the pharmaceutical substances”, and is either a determiner or a pronoun. The relevant definitions in the Macquarie Dictionary are “one, a, an, or some, whatever or whichever it may be” and “every”. As examples of the two definitions, the dictionary gives “if you have any witnesses, produce them” and “any schoolboy would know that”. Both constructions find support in the different definitions of “any”. It follows that there is an ambiguity in the wording of the subsection, which must be resolved.
Consideration of the Acts Interpretation Act
Section 15AB of the Acts Interpretation Act 1901 permits me to have regard to extrinsic materials to resolve ambiguity in legislation. The current extension of term provisions were introduced by the Intellectual Property Laws Amendment Act 1998. The Second Reading speech in the House of Representatives on 26 November 1997 states:
“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 Australian Register of Therapeutic Goods. The scheme will apply to all existing 20-year patents as well as those patents granted after the commencement of the scheme. An extension is not, however, automatic. Companies will need to apply within six months of the inclusion of the product on the ARTG or within six months of the date the patent is granted, whichever is the later. Transitional arrangements will be put in place to accommodate existing patents.”
The Explanatory Memorandum, Intellectual Property Laws Amendment Bill 1997 states at page 9:
“The Patents Act 1990 is to be amended to provide an extension of term scheme for pharmaceutical patents with the following features:
· Extensions of up to five years for standard patents in relation to a pharmaceutical substance that is the subject of the first registration as a therapeutic good on the Therapeutic Goods Act 1989 …”
Clearly the extrinsic materials provide only a simple overview of the scheme. The words used are consistent with a view that the application for extension of time was to be made within 6 months of the earliest inclusion in the ARTG. However, the brevity of language makes it unsafe to rely on this alone. Of equal significance is a consideration of whether either construction promotes the object of the scheme (see section 15AA of the Acts Interpretation Act). Purpose is commonly deduced from a close examination of the whole Act, which takes me to a consideration of the structure of the extension of term provisions of the Act.
Consideration of the internal structure of the Act
A patentee may apply for an extension of term within six months of the date of commencement of the first inclusion in the ARTG of relevant goods (see subsection 71(2)). The application must be accepted by the Commissioner if satisfied that the requirements of sections 70 and 71 have been met (subsection 74(1)). The application is then advertised in the Official Journal, and a person may oppose the extension of term (subsection 75(1)). If the Commissioner grants the extension of term, the term of the extension is calculated according to section 77. In Pfizer Corp v Commissioner of Patents (No 2) [2006] FCA 1176 at [34], (2006) 69 IPR 525 at 530 (Pfizer No 2), the Federal Court stated that section 77 is based on the earliest of the first regulatory approval dates that apply to the patent:
“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.”
The patentee pointed out that this would operate unfairly when the earliest of the first regulatory approval dates relates to goods sponsored by another party, as the patentee would not receive the full extension of term for their product. Ms Irani referred me to the Explanatory Memorandum at page 4 to show that the intention of the extension of term scheme was
“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”
Ms Irani submitted that this would not be achieved if the term of the extension was reckoned using a product sponsored by a competitor. Specifically, an extension based on AGENERASE would be approximately two years shorter than an extension based on PREZISTA. In this regard I also note the comment by Lindgren J in Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 at [23], 76 IPR 618 at 630 (Alphapharm):
“This provision reflects the view that, ordinarily, ARTG registration should mark the beginning of exploitation.”
While I understand Ms Irani’s concern about detriment to the patentee, Pfizer (No 2) is clear on the point and the term of the extension is based on the earliest inclusion, regardless of the identity of the sponsor. It is not open to the Commissioner to calculate the term of the extension only on the basis of goods sponsored by the patentee. I will return to this point in my conclusion.
Finally, if the term recorded on the Register is inaccurate, the Commissioner has the power to recalculate the term on the basis of the earliest of the first regulatory approval dates that apply to the patent (see Re Pfizer Italia S.r.l. [2007] APO 2 at [34] (Pfizer Italia)).
The extension of term scheme has two important elements for the present matter. First, the scheme reflects a concern that the term of the extension must be based on the earliest of the first regulatory approval dates that apply to the patent. It is this date that is central to the scheme. Second, only a limited window of time is provided for making an application for extension of term. This window is capable of extension only in the limited circumstances provided for under section 223.
Does subsection 71(2) reflect the central role of the earliest first regulatory approval date?
The first thing that needs to be noted is that subsection 71(2) does not use the expression “earliest first regulatory approval date” that is used in section 77. While the “date of commencement of the first inclusion” may be synonymous for the “first regulatory approval date”, there is clearly no reference to the “earliest”. The use of different wording normally implies a different meaning is intended.
Where an application is not based on the earliest first regulatory approval date that applies to the patent, this will likely lead to the Commissioner recording the wrong term of the extension on the Register, which is clearly undesirable. This was commented on by the Deputy Commissioner in Pfizer Italia at [27]:
“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.”
The Deputy Commissioner was clearly of the view that if the patentee is aware that the application is not based on the earliest regulatory approval date, they have an obligation to inform the Commissioner of this fact. Indeed, to do otherwise could be an offence under section 191.
After an extension of term has been granted, the remedy for such inaccuracies in the term of the extension is to amend the Register under regulation 10.7(7). But before acceptance of an application, the situation is quite different. As noted in Pfizer Italia, it would be entirely contrary to the public interest for the Commissioner to knowingly put inaccurate or misleading particulars on the Register, even if she could later invoke regulation 10.7(7) to correct the error. Instead, the application should be re-made on the basis of the earliest first inclusion, which is then the basis for the correct calculation of the term of the extension.
What is the implication of allowing only a limited window for applying for an extension of term?
The scheme envisages that an application for extension of term is made within 6 months of first inclusion in the ARTG. The application is then dealt with and entered on the Register. The short window provided by the Act ensures that recording an extension of the term of a patent closely follows inclusion in the ARTG, giving certainty in the marketplace. If an application for extension of term could be made using the timing of the inclusion in the ARTG of each relevant goods, the patentee would be able to sit on its hands until a later window opened. This is inconsistent with the existence of a limited window for making an application under section 71(2).
This was also recognised in Alphapharm at [22], where Lindgren J noted that it is an assumption that underlies the Act:
“Another assumption, however, is that the patentee should not be permitted to ‘sit on its hands’ once the patent has been issued and once the relevant goods have been listed on the ARTG.”
Conclusion
Based on the structure of the Act, I conclude that the intention of the Act is that an application for extension of term is to be made within 6 months of the earliest first inclusion in the ARTG. Consistent with this intention, when subsection 71(2) refers to the date of first inclusion of any pharmaceutical substance, it must be construed as a reference to the earliest first inclusion date. The Act does not intend an application for extension to be made on the basis of one inclusion, and the term of the extension calculated on the basis of another. Regulation 10.7(7) operates when the full facts were not known to the patentee at the time of granting the extension of term.
In a case such as the present, the patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223. Of course, it is also open to the patentee to withdraw the application for extension of term (for instance, if the true term of the extension is zero).
Equally, the Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made. In the present case the Commissioner has become aware of the listing of amprenavir, and has no option but to act on this information.
Ordinarily inclusion in the ARTG will be sponsored by the patentee, and this will mark the beginning of exploitation by the patentee (as noted in Alphapharm). Where the relevant goods are sponsored by a different party it is arguable that there is detriment to the patentee, as they will not gain the full effective patent life for their own product. Even though I have rejected this argument on the basis of Pfizer (No 2), it should be noted that it is a double-edged sword for the present patentee. The patentee seeks to deny the relevance of the goods AGENERASE (because it is not the sponsor), but to rely on the goods PREZISTA, of which it is also not the sponsor. This is clearly an untenable argument. I believe that the answer to the detriment question is that where earlier sponsored goods would infringe the patent rights of the patentee, the patentee can bring an action for infringement.
As the application does not comply with section 71, the application cannot be accepted. I have considered whether it would be more appropriate to allow the patentee to amend their application, or to refuse the application outright. As the amendment would materially alter the meaning or scope of the document, the amendment would have to be advertised for opposition purposes (regulation 10.5(2)). Further, the amendment would convert the application to an application made out of time, and thus require an extension of time under section 223 (which would also need to be advertised). I consider it would be more appropriate to refuse the application pursuant to subsection 74(3). This decision contains my reasons as required under subsection 74(4). Of course, the patentee can now make a new application based on amprenavir (or any earlier inclusion), accompanied by an application for an extension of time under section 223.
I note that even if the application had been found to comply with section 71, the term of the extension calculated under section 77 would be based on the goods AGENERASE, not PREZISTA.
I refuse the application.
Dr S.D.Barker
Delegate of the Commissioner of Patents
05 December 2008
Patent attorneys for the patentee : Spruson & Ferguson