Pfizer
[2005] APO 38
•21 September 2005
ABSTRACTS OF DECISIONS
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Patents: No. 540769 in the name of Pfizer Corp.
No. 573123 in the name of Pfizer Ltd
No. 651637 in the name of Pfizer Inc.
No. 691005 in the name of Pfizer Research and Development Company, N.V/S.A
Titles : Dihydropyridine Derivatives
Amlodipine benzene sulphonate and pharmaceutical compositions thereof
Indole Derivatives
Salts of an anti-migraine indole derivative
Action: Objection to the Commissioner’s proposal pursuant to sub-regulation 10.7(7) to amend relevant entries in the Register to insert the correct extension of the term of the patents and a request for the Commissioner to provide a written assurance not to rectify the Register for 21 days following a decision that entries in the Register should be amended.
Decision: Issued 21 September 2005.
Abstract
Request by the patentees to stay any decision to amend the Register under subregulation 10.7(7) pending appeal.
On consideration of the balance of interests, decided that in such an event directions will be given that amendment of the Register will not occur before 28 days from the date of that decision or, in the event that the Commissioner is served in that period with a notice of appeal and 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 Numbers 540769 in the name of Pfizer Corp.
573123 in the name of Pfizer Ltd
651637 in the name of Pfizer Inc.
691005 in the name of Pfizer Research and Development Company, N.V/S.A,
Objection to the Commissioner’s proposal, pursuant to sub-regulation 10.7(7), to amend relevant entries in the Register to insert the correct extension of the term of the patents and a request for the Commissioner to provide a written assurance not to rectify the Register for 21 days following a decision that entries in the Register should be amended.
BACKGROUND
The subject patents have all been granted an extension of the patent term under Chapter 6, Part 3 of the Patents Act 1990 (Extension of term of standard patents relating to pharmaceutical substances). In this regard section 77 provides the term of extension:
“(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.
Note: Section 65 sets out the date of a patent.
(2)However, the term of the extension cannot be longer than 5 years.”
Sub-sections 70(5) and (6) of the Act provide that:
“(5)For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:
(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.
(6)For the purposes of this section, pre-TGA marketing approval, in relation to a pharmaceutical substance, is an approval (however described) by a Minister, or a Secretary to a Department, to:
(a) market the substance, or a product containing the substance, in Australia; or
(b) import into Australia, for general marketing, the substance or a product containing the substance.”
Patent numbers 540769 and 573123 relate to Norvasc, a drug used to treat hypertension, and 651637 and 691005 to Relpax, a treatment for migraine headaches. All four patent were granted extensions based on Australian Register of Therapeutic Goods (ARTG) registrations as indicated in the following table:
| Patent | Date of the Patent | ARTG Registration | 20 year Term Expires | Register Entry for Extension |
| 540769 | 10 Mar 1983 | 26 Feb 1993 | 10 Mar 2003 | 26 Feb 2008 |
| 573123 | 3 April 1987 | 26 Feb 1993 | 3 April 2007 | 26 Feb 2008 |
| 651637 | 8 Oct 1991 | 13 Oct 2000 | 8 Oct 2011 | 13 Oct 2015 |
| 691005 | 17 May 1995 | 13 Oct 2000 | 17 May 2015 | 13 Oct 2015 |
I will refer to the patentees collectively as “Pfizer”.
On 12 March 2003 Arrow Pharmaceuticals Ltd filed an application with the Federal Court (N299/2003) seeking revocation of patent 540769 on the basis that the patentee had obtained the patent extension on the basis of fraud, false suggestion or misrepresentation in that, inter alia, it had failed to disclose to the Commissioner that the first date of regulatory approval of Norvasc was 14 April 1992 and not 26 February 1993. Extracts of the ARTG showing an export only listing in the ARTG for Norvasc on 14 April 1992 were provided by Arrow to the Commissioner on 3 April 2003. The court proceedings were discontinued however Pfizer’s views on the listings were sought and on 11 November 2003 wrote to the Commissioner indicating that:
“.. our client is also of the opinion that, having regard to the policy and intent of the relevant legislation the subject of Part 3 of Chapter 6 of the Patents Act 1990 (and, in particular, Sections 70(5) and (6)), the “first regulatory approval date” for the purpose of Section 70(3)(b) is limited to the first such date for the purpose of marketing in or importing into Australia for general marketing and does not include the regulatory approval date for export purposes only”
Amendments were made to Regulation 10.7 of the Patent Regulations on 23 March 2005 with effect on both new and existing entries on the Patent Register. These added the following provisions:
“(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 sub-regulation 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 2 Subregulation 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.
Note Regulations 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).”
On 7 April 2005 a Deputy Commissioner of Patents wrote to the Pfizer in relation to the patents indicating that, in the Commissioner’s view, a first regulatory approval date existed for each of them that was earlier than the date provided in support of the extension of term application. Consequently under subregulation 10.7(7) the Commissioner intended to amend the register to reflect a new date as the date to which the term of the patent was extended. The relevant dates are shown in the following table:
| Patent | ARTG Registration | Earlier ARTG Entry Cited | Current Register Entry | Proposed Register Entry |
| 540769 | 26 Feb 1993 | 14 Apr 1992 | 26 Feb 2008 | 14 Apr 2007 |
| 573123 | 26 Feb 1993 | 14 Apr 1992 | 26 Feb 2008 | 14 Apr 2007 |
| 651637 | 13 Oct 2000 | 10 Sep 1999 | 13 Oct 2015 | 10 Sep 2014 |
| 691005 | 13 Oct 2000 | 10 Sep 1999 | 13 Oct 2015 | 17 May 2015* |
*This is the normal 20 Year expiry date
Pfizer filed submissions and declaratory evidence in response to the Deputy Commissioner’s letters and the matter was set for hearing. On 17 August 2005, Pfizer’s patent attorney wrote to the Commissioner indicating that:
“In order to preserve our clients rights in the meantime (and if necessary, subsequently on appeal), we are instructed by our client to request the Commissioner’s assurance in writing that the reduction of term of each of the patents (as previously foreshadowed) will not be noted on the Register for a period of 21 days following any decision handed down by the Commissioner in connection with the above Hearing and, thereafter, without giving our client 14 days prior written notice.”
In response the Commissioner indicated that she did not think it appropriate to make any concluded view on the undertaking sought before hearing Pfizer. She did however indicate her view that if an error exists in the Register there seemed to be a clear public interest in having the Register rectified without delay and requested submissions be made on the weight that should be given to this consideration in determining the timing of the amendment to the register.
The matter came to hearing in Canberra on 6 September 2005. Pfizer was represented by Ms Katrina Howard and Ms Rhonda Bell of Counsel and were instructed by Ms Shahnaz Irani and Mr John O’Connor, patent attorneys of Spruson & Ferguson, Sydney.
After providing submissions both on the correct interpretation of subsection 70(5) and the validity of subregulation 10.7(7), Ms Howard addressed me on the question of Pfizer’s request for written assurances that a decision to amend the Register would not be implemented until after the time for lodging an appeal had expired. She indicated that if the Commissioner refused to provide such an undertaking Pfizer would immediately apply for a writ of prohibition. I indicated that I considered the matter of some importance relating to the public interest and that I would reserve my decision. However, in the circumstances, I proposed to first decide the question of how the Commissioner would proceed if the decision on the substantive points was against Pfizer and then separately to issue the substantive decision.
DECISION
The practice of the Commissioner in implementing decisions subject to appeal or review is reflected in Part 16.5 of Volume 3 of the Manual of Practice and Procedure. This states:
“When the Commissioner issues a decision, it will normally have immediate effect. Thus, for example, where the date of a decision is (either explicitly, or implicitly) the commencing date for some other action, that date is not somehow deferred on the 'possibility' of an appeal. On the other hand, if an appeal is filed then (and subject to the decision on appeal) the Commissioner will proceed on the basis of maintaining equity between the parties viz-a-viz before the decision and after the appeal. Where the effect of a decision is to substantially affect the rights of one or other party, such as the refusal of an application, or a direction that it proceed to sealing, the Office practice is generally not to implement the decision for 1 month, in case an appeal is filed, and if an appeal is filed, not implement the decision until the appeal is determined. Of course, if the appellant is dilatory in serving the Commissioner with the notice of appeal (or needs to obtain an extension of time to file an appeal), the Commissioner may have implemented the decision by the time the notice is served - in which case the appellant if successful will need to obtain a court order to rectify the matter.
A particular variation on the above concerns a decision to extend the term of a petty patent; in such decisions the Register will be annotated on the decision being issued.”
The manual goes on to indicate that where application is made to the AAT or the Federal Court under AD(JR) it is generally not the practice to implement the decision even though the AAT and AD(JR) Acts specifically provide that making an application does not affect the operation of the decision or prevent the taking of action to implement the decision. (See G & J Koutsoukos Holdings Pty Ltd v Capral Aluminium Limited [2003] APO 28 in relation to the AAT)
The practice of the Registrar of Trade Marks is reflected in the following from the TMO manual of Practice and Procedure:
“Registration of a trade mark or the removal, after opposition, of such a registration, will have drastic effects on the standing of the parties. Therefore, after deciding an opposition, a trade mark will not be registered until the decision has survived its appeal period. Similarly, where an application for removal is opposed, a decision to remove will not be effected until the appeal period has passed.”
However decisions on extensions of time, as in the Patent Office, are implemented immediately.
It seems to me that the question on whether a stay on proceedings or implementation of a decision is a matter of balancing the particular interests involved and this is reflected in the practices identified above. Other administrative bodies have been faced with similar issues and I note from Joan Margaret Martin on behalf of the Widi Mob/Western Australia/Westland Gold NL; ABC Resources Pty Ltd; WMC Resources Ltd; Resource Exploration NL and Gold Partners NL [1999] NNTTA 228 that, where an appeal or application for judicial review been made to the Federal Court:
“The Tribunal acknowledged that the decision to stay involved considering the public interest and whether failure to stay the applications would permanently defeat rights or cause injustice to one or other of the parties. It involved a weighing process involving considerations of fairness and of the public interest.”
I note also the considerations that have been applied by the AAT in determining whether a a stay should be ordered under section 41(2) of the Administrative Appeals Tribunal Act 1975. These include that the right of review not be rendered nugatory by implementation of the operative decision (Re Repatriation Commission and Delkou (1985) 8 ALD 454) the consequences for the administrative body carrying out its functions under the relevant legislation and the interests of those who are affected by the review of the decision if the stay were of were not granted.(“VBJ” and Australian Prudential Regulation Authority [2005] AATA 642)
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.
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.
Pfizer’s argument is essentially that if I ultimately find that an amendment of the Register under subregulation 10.7(1) is appropriate, an immediate implementation of that decision would not contribute to certainty because of the likelihood of appeal, that the action would directly impact on the patentee’s rights and prejudice it in future proceedings and that, in any event, there is still considerable time before the earlier proposed term extension date of 14 September 2007 for the matter to be resolved on appeal.
The suggestion that the earliest proposed date to be reflected in the Register is only 14 April 2007 and therefore the public and third party interests are diminished seems to me to ignore commercial realities. Decisions to develop and market competing products, particularly in the pharmaceutical industry, may need to be made many years before the normal term of the patent expires, let alone in the term extension period for pharmaceuticals. Court proceeding, if initiated, may also take a considerable period and add substantially to the uncertainty to decisions to enter the market with competing products. Consequently, I believe there remain critical public interest issues in relation to the currency of the Register and the speedy resolution of the status of the patents. As to other interests I am not convinced that in these circumstances that implementation of a decision under subregulation 10.7(7) would permanently defeat patentees’ rights or prejudice them in future proceedings. However, I recognise that there may be at least some detriment to the patentee if the Register is amended but that action is ultimately found to be incorrect on judicial consideration and a Court order is required to restore the Register to its original state.
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.
CONCLUSION
Pfizer has requested that I give undertakings or written assurances not to implement any decision to amend the Register under subregulation 10.7(7) pending appeal. I have decided that, if I make such a decision, I will direct that amendment of the register will not occur before 28 days from the date of that 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. A period of 28 days provides more than sufficient time both for the 21 day appeal period and 5 days for service on the Commissioner as prescribed by Order 58 of the Federal Court Rules.
Since I have decided not to immediately implement any decision to amend the register under subregulation 10.7(7), there appears to be no purpose in delaying my decision on the substantive matters and I will issue that decision as soon as is practicable.
Philip Spann
Deputy Commissioner of Patents
Patent attorneys for the Patentees: Spruson & Ferguson, Sydney
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