Southern Cross Pharma Ltd v Euro-Celtique S.A.
[2016] APO 1
•8 January 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1
Patent No.:2002300863, 2004229058, 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Opponent: Southern Cross Pharma Pty Ltd
Hearing Officer: Dr B. Akhurst
Decision Date: 8 January 2016 (Corrected on 21 January 2016)
Hearing Date: 1 December 2015
Catchwords: PATENTS – extensions of term – s 71(1)(c)/reg 6.8(3) – the substance as it occurs in the goods – insufficient information where the amount of an ingredient is provided as a broad range –s 71(1)(c)/reg 6.8(2) – no information provided showing that the listed goods have a required polymer content – insufficient information to show that a relevant goods is listed on the ARTG –s 70(3)(a) – insufficient information to establish that the listed goods do in fact contain, or consist of, a pharmaceutical substance falling within the scope of the claims of two patents – opportunity provided to file further information under reg 6.11
Representation: Patentee: Philip Kerr, solicitor, and Linda Govenlock of Allens Patent & Trade Mark Attorneys, Sydney.
Opponent: Kate Beattie of counsel
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Nos.:2002300863, 2004229058, 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Date of Decision: 8 January 2016 (Corrected on 21 January 2016)
DECISION
The opposition to grant of an extension of the term of patent 2004229058 is unsuccessful. Costs for this opposition are awarded according to Schedule 8 against Southern Cross.
The oppositions to grant of an extension of the term of patents 2002300863 and 2009243527 are successful. Costs in these oppositions are awarded according to Schedule 8 against Euro-Celtique S.A.
Pursuant to reg 6.11, the patentee has two (2) months from the date of this decision to provide further information as follows:
(i) for the 2009243527 patent, more precise information regarding the weight for weight proportions (% w/w) of cellulose ether and polyalkylene glycol(s) as these occur in the goods TRAMAL®SR 100, and
(ii) for the 2002300863 patent, precise information regarding the weight for weight proportion (% w/w) of hydrophilic or hydrophobic polymer(s) as these occur in the goods TRAMAL®SR 100.
At the end of that period the oppositions to an extension of term for patents 2002300863 and 2009243527 will be finally determined.
REASONS FOR DECISION
Background
This opposition relates to applications by Euro-Celtique S.A. (the patentee) to extend the term of three related patents - 2002300863 (‘863), 2004229058 (‘058) and 2009243527 (‘527). The original standard patent application 61963/94, and serial divisionals 39957/97 and 65526/99, lapsed without gaining acceptance. Patent ‘863 is a divisional of 65526/99. Patents ‘058 and ‘527 are both divisionals of patent ‘863. Patent application ‘527 was granted on 20 March 2014 after Sandoz Pty Ltd withdrew its opposition to grant of a patent. Patent applications ‘863 and ‘058 were granted on 6 May 2014 after Federal Court appeals by Sandoz Pty Ltd. under s 60(4) of the Patents Act 1990 (the Act) were discontinued. The date of these patents is 9 May 1994 and their maximum 20-year term expired on 9 May 2014.
On 7 May 2014, Euro-Celtique S.A. filed the applications for an extension of the term of patents ‘863, ‘058 and ‘527. The applications were accepted by the Commissioner on 26 May 2014 and advertised on 12 June 2014. If granted on the basis asserted by the patentee, the term of each patent would be extended until 21 September 2015.
On 10 September 2014, Southern Cross Pharma Pty Ltd (the opponent) filed notices under s 75 opposing grant of the extensions, followed by statements of grounds and particulars (SGP) on 10 December 2014. Evidence in support, answer and reply was filed on 10 March 2015, 10 June 2015 and 17 August 2015, respectively. The matter was heard in Canberra on 1 December 2015.
The Evidence
Evidence in support of the oppositions consisted of a declaration by Duncan Bucknell dated 10 March 2015 accompanied by Exhibit DB-1A, DB-1B or DB-1C for patents‘863, ‘058 and ‘527 respectively. The exhibits in each case consisted of copies of documents on the Patent Office file relevant to grant and expiration of the patent, and prosecution and acceptance of the associated request for an extension of term. Also included was a 1-page summary sheet listing such documents in chronological order.
The evidence in answer and reply for the three oppositions was identical. Evidence in answer consisted of declarations by: Angelo Mario Morella dated 29 May 2015 with Exhibits AMM-1 to AMM-6; and Linda Jane Govenlock dated 5 June 2015 with Exhibit LJG-1. Evidence in reply consisted of a declaration by Ian Hamilton Pitman dated 31 July 2015 with Exhibits IHP-1 to IHP-2.
The Govenlock declaration brings into evidence a copy of a Product Information Sheet for TRAMAL® formulations which were first included in the Australian Register of Therapeutic Goods (ARTG) on 7 August 2008, 8 years later than the TRAMAL® goods relied on in the extension requests. As a consequence, this evidence appears to be of little relevance to the oppositions. Since the Pitman declaration is wholly in reply to the Govenlock declaration and its Product Information Sheet, it also appears to be of little relevance.
I advised the parties at the hearing that the Commissioner did not intend to invoke reg 5.23 to consult the documents filed by the patentee on 27 November 2015.
The Law
Part 3 of Chapter 6 of the Patents Act 1990 (the Act) provides a statutory framework for an extension of the term of standard patents relating to pharmaceutical substances.
Section 70 relevantly provides:
(1)The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(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) … .
(3)Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) … .
(4)The term of the patent must not have been previously extended under this Part.
(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) … .
Section 71 prescribes the form and timing of an application, 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 regulation; 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), as worked out under subsection 70(5A) (if applicable);
(c)the date of commencement of this section.
The term “pharmaceutical substance” is defined in Schedule 1 of the Act as follows:
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 in vitro diagnosis or in vitro testing.
Regulations 6.8 and 6.9 prescribe the information required by paras 71(1)(c) of the Act.
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.
Note: For providing a copy of a certificate mentioned in paragraph (2)(a), see the definition of document in subsection 71(1) of the Act.
Regulation 6.11 permits the Commissioner to request further information where the application for an extension of term is deficient:
6.11 Further information
(1) This regulation applies if the Commissioner needs further information to decide whether he or she is satisfied that the requirements set out in sections 70 and 71 of the Act are satisfied for an application for an extension of the term of a standard patent.
(2) The Commissioner may give the applicant a notice requesting the further information within the period mentioned in the notice.
(3) The period must not be shorter than 2 months or longer than 6 months from the day the notice is issued.
Note:The period for giving the further information can be extended—see section 223 of the Act.
(4) If the applicant does not give the further information within that period, the Commissioner must decide whether he or she is satisfied that the requirements set out in sections 70 and 71 of the Act are satisfied.
(5) For subsection 71(2) of the Act, further information given within the period mentioned in subregulation (2) is taken to have been filed with the application for extension of the term of the standard patent.
Grounds of opposition
The grounds of opposition pressed at the hearing were that the requirements of paragraphs 70(3)(a) and 71(1)(c) of the Act are not satisfied in relation to the applications for an extension of term.
Standard of proof
There was no dispute that the standard of proof in opposition proceeding under s 75 is the civil standard on the “balance of probabilities”. The application of this standard is consistent with the explicit provisions of s 74 of the Act, which govern the Commissioner’s acceptance of, or refusal to accept, an application for a patent term extension for patents granted on or after 15 April 2013. It is also consistent with the standard of proof applied by the Commissioner in other opposition proceedings (Explanatory Memorandum for the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 page 9).
Onus of proof
It is generally incumbent on an opponent to establish their case. The opponent disputed that it bore the onus of proof to make out its grounds of opposition, referring to principles provided by Buckley LJ in Dunlop Holding Ltd’s Application [1979] RPC 523 at 542-543, which are set out more fully below:
“It seems to me that in principle [the legal burden of proof] should lie on the opponents to prove all the necessary elements of a valid ground of opposition ... Knowledge of the relevant facts may lie mainly, or exclusively, with either the opponents or the applicants, or be to a greater or lesser degree available to either of them. Notwithstanding that the legal burden may lie upon the opponents, the evidential burden may shift according to the state of the evidence from time to time. The ease with which it may do so may depend upon the circumstances of the case and the likelihood of the facts being within the knowledge of, or more readily available to, one side or the other. Thus, if the relevant facts are likely to be within the exclusive knowledge of the applicants ... very little evidence on the opponent’s side might be sufficient to shift the evidential burden ... to the applicant. Failure to produce convincing evidence ... at any stage at which the evidential burden rests on the party who fails to do so, may prove fatal to that party’s case; but when all the evidence has been adduced the question must be whether [the particular ground of opposition relied on] has been established.”
These principles have been consistently applied in deciding oppositions and other proceedings before the Commissioner (see for example: Deputy Commissioner Spann in Amadeus Global Travel Distribution v SA Sabre Inc [2004] APO 21 at [26] and Acting Deputy Commissioner Herald in Cameco Industries Inc. v Austoft Industries Ltd [1996] APO 26; 35 IPR 140 (both s 59 oppositions to grant); Polemate Pty Ltd and Ors v Trevor Julius Falkenhagen and Ors [1995] APO 32 and Wimmera Industrial Minerals Pty Ltd v Iluka Midwest Limited [2001] APO 58 (s 36 and 32 disputes, respectively); Garden City Planters Pty Ltd v Vivre Veritas Pty Ltd [2012] APO 133 (opposition to grant of a licence under reg 22.21).
The opponent nevertheless submitted that to place the burden of proof on the opponent in an opposition to an extension of term involves a fundamental misunderstanding of an opposition under s 75. It argued that the authorities relied on by the patentee for that proposition dealt with oppositions to grant of a patent under s 59 of the Act, which was drafted in fundamentally different terms to s 75.
Section 60 governs the hearing and decision in an opposition under s 59. The opponent concluded from s 60(3A), which permits the Commissioner to refuse a patent application if she is satisfied that a ground of opposition exists, that a s 59 opposition depends on proof of fact by the opponent. In the absence of a similarly worded provision in s 75, the opponent argued that s 75(2) does not require the opponent to prove fact, but instead requires the Commissioner to more broadly “decide the case”, by deciding whether she is satisfied that the requirements of ss 70 and 71 have been met. The opponent submitted that it had enlivened the opposition with the notice of opposition, SGP and evidence in support, and that to be successful, it did not need to prove that the requirements of ss 70 and 71 are not satisfied; it just had to persuade the Commissioner that she could not be satisfied, on the balance of probabilities, that the requirements of ss 70 and 71 are satisfied.
In my view, the provisions relating to an opposition to grant of a patent (ss 59-60) and an opposition to grant of an extension of term of a patent (s 75) are not so markedly different as the opponent would have them. Sections 59 and 75(1) permit the Minister or any other person to oppose the grant of a standard patent or grant of an extension of term, respectively, on the grounds that one or more of the specified requirements for grant are not satisfied. Most relevant to the opponent’s submission, ss 60(1) and 75(2) prescribe in identical terms that in the event of an opposition, “the Commissioner must decide the case in accordance with the regulations”. There was no dispute that both provisions refer to Chapter 5 of the Patents Regulations 1991, which sets out the requirements for the opposition process, but does not prescribe the manner in which oppositions are decided.
Subsection 60(3A) of the Act does explicitly provide the standard of proof for deciding the case under s 60(3). However, construed in the context in which they appear in s 60, subsections 60(3A) and 60(3B) essentially govern the Commissioner’s powers to refuse the patent application in the event that the Commissioner “decides the case” against the applicant. Any differences there may be between the provisions of ss 59-60 and 75 are not so great that they set up a framework which reverses the onus of proof to the extent asserted by the opponent. It follows that where a party asserts under s 75(1) that “one or more of the requirements of ss 70 and 71 are not satisfied in relation to the application” then, as in a s59 opposition, the burden of proving that assertion rests, at least initially, with the asserting party.
The opponent further submitted that an opposition under s 75 should be dealt with in the same manner as an opposition to an extension of time to file evidence under reg 5.9, which “is decided on the basis that the applicant for the extension must establish that the extension is justified”. However, these latter oppositions are distinguished because they involve the Commissioner deciding, for the first time, whether she is satisfied that the extension is justified; they are not an opposition to grant of an application where the Commissioner has previously examined and accepted that application.
The patent specifications
As is common with divisional applications, the ‘863, ‘058 and ‘527 specifications are substantially similar. Each states on page 1 that, in particular, the invention relates to a controlled release preparation comprising tramadol or a pharmaceutically acceptable salt thereof. Tramadol is an orally active opioid analgesic, and an object of the invention is to provide an oral controlled release tramadol preparation suitable for at least twelve-hourly administration for the treatment of pain (page 1).
Following consistory clauses that reflect the claims of each patent, on pages 2-5 preferred in vitro release rates (dissolution rates) are provided to allow for controlled release of tramadol over at least a twelve hour period following oral administration, facilitating once or twice daily dosing. On page 6, the controlled release preparation preferably contains an analgesically effective amount of tramadol or salt thereof, in the range 50-800 mg calculated as tramadol hydrochloride (tramadol HCl) per dosage unit. On pages 6-14, it is stated that the controlled release preparation may be presented in a variety of forms, and suitable means and materials are broadly described for effecting controlled release of the active agent. Illustrative examples are provided on pages 15-23.
The extension of term applications
The patentee’s applications for an extension of term of the patents were all based on the inclusion on the ARTG of the goods TRAMAL® SR 100 on 21 September 2000 with indications for the relief of moderate to severe pain. The extension requests were filed in the approved form and were each accompanied by a covering letter and a copy of a Public Summary for “ARTG Entry: 75947 TRAMAL SR 100 tramadol hydrochloride 100 mg modified release tablet blister pack” downloaded from the Therapeutic Goods Administration’s (TGA’s) website.
In its covering letters, the patentee advised that it is not the sponsor of TRAMAL® SR, and could not provide the ARTG Certificate. Thus, for the purposes of s 71(1) and regs 6.8 and 6.9 it relied on the TGA’s Public Summary to confirm that a relevant goods is registered on the ARTG and its date of first inclusion.
The pharmaceutical substance
The parties were broadly in agreement that, for each patent, the pharmaceutical substance per se is an oral controlled release preparation of tramadol hydrochloride with a composition and pharmacokinetic parameters encompassed by claim 1 of that patent, and that such a substance is disclosed in the complete specification and in substance falls within the claims. In each case, this is a multiplicity of pharmaceutical substances.
Claim 1 of the ‘863 and ‘527 patents are similarly drafted and are reproduced below:
‘863 claim 1:
“A controlled release, oral pharmaceutical preparation suitable for dosing every twelve hours containing 50 to 400mg of tramadol or pharmaceutically acceptable salt thereof (calculated as hydrochloride) in a controlled release matrix, the preparation containing between 1 and 80% w/w of one or more hydrophilic or hydrophobic polymers and having the following dissolution rate in vitro when measured using the Ph. Eur. Paddle Method at 100rpm in 900ml 0.1N hydrochloric acid at 37°C and using UV detection at 270nm:
between 5 and 50% (by weight) tramadol released after 1 hour,
between 10 and 75% (by weight) tramadol released after 2 hours,
between 20 and 95% (by weight) tramadol released after 4 hours,
between 40 and 100% (by weight) tramadol released after 8 hours,
more than 50% (by weight) tramadol released after 12 hours,
more than 70% (by weight) tramadol released after 18 hours,
more than 80% (by weight) tramadol released after 24 hours,characterised in that at least one of the hydrophilic or hydrophobic polymers is a cellulose ether.”
‘527 claim 1:
“A controlled release, oral pharmaceutical preparation suitable for dosing every twelve hours containing 50 to 400mg of tramadol or pharmaceutically acceptable salt thereof (calculated as hydrochloride) in a controlled release matrix, the preparation containing between 1 and 80% w/w of a cellulose ether and up to 60% w/w of one or more polyalkylene glycols and having the following dissolution rate in vitro when measured using the Ph. Eur. Paddle Method at 100rpm in 900ml 0.1N hydrochloric acid at 37°C and using UV detection at 270nm:
between 5 and 50% (by weight) tramadol released after 1 hour,
between 10 and 75% (by weight) tramadol released after 2 hours,
between 20 and 95% (by weight) tramadol released after 4 hours,
between 40 and 100% (by weight) tramadol released after 8 hours,
more than 50% (by weight) tramadol released after 12 hours,
more than 70% (by weight) tramadol released after 18 hours,more than 80% (by weight) tramadol released after 24 hours.”
Each of the above claims defines a controlled release, oral pharmaceutical preparation, wherein the preparation contains specified weight for weight proportion(s) (% w/w) of one or more hydrophilic or hydrophobic polymers (‘863 claim 1) or cellulose ether and polyalkylene glycol(s) (‘527 claim 1). Properly construed, these claims define the weight of the specified ingredients as a proportion of the total weight of the preparation.
Claim 1 of the ‘058 patent is relevantly as follows:
“An oral controlled release preparation of tramadol or a pharmaceutically acceptable salt thereof, effective for the treatment of moderate to severe pain for 12 hours or more, wherein:
(A) the oral controlled release preparation comprises the tramadol or a salt thereof incorporated in a controlled release matrix which includes one or more materials selected from (a) digestible C8-C50 substituted or unsubstituted hydrocarbons such as; fatty acids, fatty alcohols, glyceryl esters of fatty acids, mineral or vegetable oils or waxes and (b) polyalkylene glycols; or
(B) …; or
(C) … .”
The opponent construed part (A) of the ‘058 claim 1 as requiring the controlled release matrix to include one or more materials selected from each of (a) and (b). However, for reasons that follow, I am of the view that the normal and natural construction of claim 1 part (A) is that the matrix includes one or more materials selected from: group (a) alone; group (b) alone; or groups (a) and (b) in combination. Claim 1 part (A) essentially requires the controlled release matrix to include one or more materials selected from digestible C8-C50 hydrocarbons and polyalkylene glycols. An embodiment having only one such material must necessarily have either a digestible C8-C50 hydrocarbon or a polyalkylene glycol. This construction is consistent with the exemplified tramadol preparations which include a digestible C8-C50 hydrocarbon in the form of hydrogenated vegetable oil, but no polyalkylene glycol (Examples 4, 5 and 6).
The applications for an extension of term in each case clearly comply with s70(2).
It is convenient to first address the grounds of opposition relating to the form of the application (s 71(1)(c)), and then whether a relevant goods is included in the ARTG (s 70(3)(a)).
Section 71(1)(c)
Paragraph 71(1)(c) of the Act prescribes that an application for an extension of term of a standard patent must “be accompanied by such information (if any) as is ascertained in accordance with the regulations”. Subregulations 6.8(2) and (3) set out the information required by paras 71(1)(c) of the Act, as follows:
“(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.”
“information”
The parties differed as to the meaning of “information” in the statutory provisions. The opponent submitted that since it is required to satisfy the Commissioner, on the balance of probabilities, that the requirements of ss 70 and 71 are satisfied, the word “information” should be construed to mean “evidentiary material and documentation” consistent with the High Court in SZBYR v Minister for Immigration and Citizenship (SZBYR) [2007] HCA 26 at [18], (2007) 235 ALR 609 at [18]. In SZBYR, in the passage at [18] on which the opponent relies, the High Court expressly confined its definition of “information” to the context of that case, which involved a statutory requirement that an applicant for a visa under the Migration Act 1958 (Cth) be given written notice by the tribunal of particulars of certain matters that may be adverse to its interests.
The context and circumstances in SZBYR are not analogous to the present circumstances and in my view, to construe the word “information” in s 71(1)(c) and reg 6.8 to necessarily require evidentiary material or documentation is unwarranted and unduly restrictive. I agree with the patentee’s submission that that the word “information” in s 71 and reg 6.8 should be accorded its plain meaning - “knowledge communicated or received concerning some fact or circumstances” (Macquarie Dictionary, 3rd Ed. 1997). It follows that s 71(1)(c) and reg 6.8 permit the provision of information in the form of unsworn statements. Nevertheless, the information must be sufficient for the purpose for which it is provided. That is, it must be of sufficient probative value to satisfy the Commissioner that the statutory requirements for grant of an extension of term have been met. In this regard, the nature and quality of the information, and the form in which it is communicated to the Commissioner, may affect the weight it is accorded during examination and any opposition proceedings in which its veracity may be challenged.
“accompanied by”
Section 71 prescribes that an application for an extension of term of a patent must be accompanied by certain information and documents and filed within strict time limits. The High Court has observed that to “accompany” a s 70(1) application means ““filed” with the s 70(1) application” (Alphapharm Pty Ltd v H Lundbeck A/S & Ors [2014] HCA 42 at [20]). On this basis the opponent submitted that any information provided by the applicant after the application was first filed, including Dr Morella’s evidence in answer, must be disregarded in deciding the opposition. For the reasons that follow, this is incorrect.
The provisions of reg 6.11 permit the Commissioner to have regard to information filed later than the original extension request when deciding whether to accept or to grant an extension of term. Similarly, in an opposition to grant of an extension of term, the parties are permitted to file evidence in support of their respective cases. The outcome of the opposition depends on the facts of the case, which are determined having regard to all relevant information available to the Commissioner at the time of making the decision. To do otherwise would lead to the curious result that the patentee could be refused an extension of term because information required to justify the extension was on file but could not be considered. In this opposition to grant of a patent term extension, I will have regard to any relevant information available on the patent office file, under the evidentiary provisions, or those of reg 6.11 or reg 5.23. Furthermore, the effect of reg 6.11(5) is that further information filed within the period provided in a notice under reg 6.11(2) is taken to have been filed with the application for an extension of term.
The opponent submitted that reg 6.11 does not apply during opposition proceedings. I do not agree. Subregulation 6.11(1) sets out the circumstances in which the regulation applies and does not confine its operation to pre-acceptance matters.
Section 71(1)(c) & reg 6.8(3)
For the purposes of paragraph 71(1)(c) of the Act, reg 6.8(3) requires an application for an extension of term of a patent to be accompanied by information identifying the substance, as it occurs in the listed goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent.
Submissions
The patentee submitted that the language of the definitions in each extension of term request substantially reflect the language of the specification, which is precisely what is required by reg 6.8(3). In contrast, the opponent submitted that even on the broadest meaning of the word “information”, the applications were not accompanied by information identifying the pharmaceutical substance as it occurs in the TRAMAL® SR 100 tablets, in the same way, as far as possible, as that pharmaceutical substance is identified in the complete specification of the patents. Using the ‘863 request as an example, the opponent submitted that in particular, the pharmaceutical substance as it occurs in these tablets must:
· contain the active ingredient in a particular form, not neutral or salt form;
· contain a particular amount of active ingredient not a range;
· have a specific dissolution profile when measured according to rather than the ranges provided; and
· contain a specific amount of hydroxypropyl methyl cellulose not a range of 1 and 80% w/w.
The form of the active agent (patents ‘863, ‘527 and ‘058)
The three extension of term requests at item 1 and item 2 para 2, explicitly identify the active ingredient in the ARTG-listed goods as the tramadol hydrochloride salt. This is consistent with the TRAMAL® SR 100 Public Summary and is not contradicted by the additional references in the extension of term requests to “tramadol or pharmaceutically acceptable salt thereof”.
The amount of tramadol hydrochloride (patents ‘863 & ‘527)
Although the extension of term requests for the ‘863 and ‘527 patents repeat the words of claim 1 of the patent in identifying an amount of the active agent between 50 and 400 mg, the information in the Public Summary confirms that the listed goods, TRAMAL® SR 100, contains 100 mg of tramadol hydrochloride.
The dissolution profiles (patents ‘863 & ‘527)
The dissolution rates provided in the original extension requests for patents ‘863 and ‘527 are broadly defined and do not reflect the dissolution rate as it occurs in the listed goods. This is apparent from Dr Morella’s evidence in reply, which provides information regarding the in vitro dissolution rate of TRAMAL® SR 100 sustained release tablets (paras 21, 25 and 34 of the Morella declaration and Exhibit AMM-6, specifically sample no 38542 designated “Tramal long 100 mg tbl”).
The opponent disputed whether the dissolution data for “Tramal long 100 mg tbl” relates to TRAMAL® SR 100. However, Dr Morella identified it as such at para 34 of his declaration, and the opponent has adduced no evidence to the contrary. At para 34, Dr Morella tabulates the mean, minimum and maximum values for the in vitro dissolution of tramadol hydrochloride from TRAMAL® SR 100 mg tablets, measured in 6 replicates using the Ph. Eur. Paddle Method at 100rpm in 900ml 0.1N hydrochloric acid at 37°C and using UV detection at 270nm (sections 4.1 and 4.2 of the Morella declaration). This more precise information regarding the TRAMAL® SR 100 in vitro dissolution rate can be summarised as follows:
between 33-34% (by weight) tramadol released after 1 hour,
between 49-51% (by weight) tramadol released after 2 hours,
between 69-73% (by weight) tramadol released after 4 hours,
between 90-94% (by weight) tramadol released after 8 hours,
equal to or more than 96% (by weight) tramadol released after 12 hours,equal to or more than 98% (by weight) tramadol released after 18 hours (by inference from minimum’s of 98% at 16 and 24h),
equal to or more than 98% (by weight) tramadol released after 24 hours.
I am satisfied that Dr Morella’s evidence is sufficient to identify the in vitro dissolution rate as it occurs in the TRAMAL® SR 100 goods in the same way, as far as possible, as it is identified in the complete specification of patents ‘863 and ‘527.
The additional components in the pharmaceutical substance of patent ‘058
The ‘058 extension of term request states in item 2:
“Tramadol HCl sustained release tablets [i.e. the listed goods] are an oral controlled release preparation of tramadol HCl wherein:
The oral controlled release preparation comprises the tramadol hydrochloride incorporated in a controlled release matrix which includes hypromellose, silica colloidal anhydrous, magnesium stearate and microcrystalline cellulose; the magnesium stearate falling within the scope of (a) digestible C8‑C50 substituted or unsubstituted hydrocarbons … in claim 1 (A).”
Claim 1 of the ‘058 patent encompasses a pharmaceutical substance in which tramadol hydrochloride is incorporated in a controlled release matrix which includes magnesium stearate (a digestible C8-C50 hydrocarbon). In the absence of evidence to the contrary, I conclude that the information in the patentee’s extension of term request satisfies the requirement to provide information identifying the pharmaceutical substance relevant to the ‘058 patent, as it occurs in the goods TRAMAL® SR 100, in the manner required by s 71(1)(c) and reg 6.8(3).
The additional components in the pharmaceutical substance of patents ‘863 and ‘527
The extension of term request for the ‘863 patent identifies the cellulose ether in the listed goods as hydroxlpropyl methyl cellulose in an amount “between 1 and 80% w/w”. However, claim 1 of this patent requires the pharmaceutical preparation to contain:
“between 1 and 80% w/w of one or more hydrophilic or hydrophobic polymers … characterised in that at least one of the hydrophilic or hydrophobic polymers is cellulose ether” (Emphasis added)
It would appear that the amount of hydroxlpropyl methyl cellulose is not necessarily the same as the total polymer content because TRAMAL® SR 100 contains at least the additional polymer microcrystalline cellulose (information provided in the ‘058 extension request). Thus the ‘863 extension of term request is deficient in that it provides no information whatsoever regarding the weight for weight proportion (% w/w) of hydrophilic or hydrophobic polymer(s) as it occurs in TRAMAL® SR 100.
The extension of term request for the ‘527 patent identifies the cellulose ether in the listed goods as hydroxlpropyl methyl cellulose in an amount “between 1 and 80% w/w” and the polyalkylene glycol(s) in the goods as polyethylene glycol in an amount “up to 60% w/w”.
Although it may be appropriate to identify the weight for weight proportions of hydrophilic or hydrophobic polymer(s), cellulose ether and polyalkylene glycol(s) in the goods using a range of values, I agree with the opponent that it is not reasonable to conclude that the very broad ranges specified in the extension requests could properly reflect the proportions of these ingredients as they occur in the goods TRAMAL® SR 100. Thus, I am not satisfied that the extension requests for patents ‘863 and ‘527 identify the pharmaceutical substance, as it occurs in the goods TRAMAL® SR 100, in the manner required by s 71(1)(c) and reg 6.8(3).
Section 71(1)(c) & reg 6.8(2)
For the purposes of paragraph 71(1)(c) of the Act, reg 6.8(2) requires the extension of term requests to be accompanied by information showing that goods containing, or consisting of, the substance are currently included in the ARTG. I have found above that the information required by reg 6.8(2) can encompass information in the form of unsworn statements.
As discussed above, the extension of term requests and accompanying documents provide information regarding the composition of the listed goods TRAMAL® SR 100. Most relevantly, these goods are said to contain 100 mg tramadol hydrochloride (relevant to patents ‘863, ‘527 and ‘058), digestible C8–C50 hydrocarbon (relevant to patent ‘058), between 1 and 80% w/w of the cellulose ether hydroxylpropyl methyl cellulose (patent ‘527), and up to 60% polyalkylene glycol (patents ‘863 and ‘527). Thus, the extension of term applications provide some information relevant to “showing that” goods containing, or consisting of, the pharmaceutical substance are currently included on the ARTG as required by reg 6.8(2).
The opponent acknowledged at the hearing that it has provided no information or evidence to establish that any of the statements by the patentee in its applications for an extension of term are incorrect, or that the applications do not otherwise satisfy the requirements of s 71. Nevertheless, in the absence of information establishing the weight for weight proportion of hydrophilic or hydrophobic polymer in TRAMAL® SR 100, the information provided by the patentee is insufficient to show that goods containing or consisting of a pharmaceutical substance falling within claim 1 of the ‘863 patent is currently included in the ARTG. Furthermore, as indicated above under the reg 6.8(3) ground, given the limited information regarding the precise amounts of cellulose ether or polyalkylene glycol(s) in the TRAMAL® SR 100 goods, I am not satisfied that the information provided by the patentee, which merely recites the language of the claims, is sufficient to show that a goods containing or consisting of a pharmaceutical substance falling within claim 1 of the ‘863 or ‘527 patent is currently included in the ARTG.
Summary s 71(1)(c)
I am not satisfied that the applications for an extension of term of patents‘527 and ‘863 meet the requirements of s 71(1)(c) insofar as the cellulose ether and polyalkylene glycol content of the goods TRAMAL® SR 100 is so broadly defined and information on its total polymer content is absent.
The opponent has not established that the application for an extension of term of patent ‘058 does not satisfy the requirements of s 71(1)(c).
Section 70(3)(a)
Paragraph 70(3)(a) prescribes that goods must be included in the ARTG that contain, or consist of, at least one pharmaceutical substance identified in, relevantly, s 70(2)(a).
Under this ground, the opponent’s submissions are essentially that there was no evidence filed with the applications for an extension of term that establishes that the TRAMAL® SR 100 product contains or consists of the identified pharmaceutical substance. However, the question under this ground is whether relevant goods are in fact included in the ARTG? In deciding this matter, I can have regard to any relevant information on file in the patent office, providing the opponent has sufficient notice and the opportunity to provide submissions and, where necessary, evidence with respect to that information.
The extension of term request for each patent states that Tramadol HCl sustained release goods obtained first regulatory approval on 21 September 2000 and are currently registered on the ARTG. The TGA’s TRAMAL®SR 100 Public Summary sheet is provided as confirmation. There is nothing on file that is inconsistent with these asserted facts. As indicated above, there was no dispute that the pharmaceutical substance, generally, is an oral controlled release preparation of tramadol or salt thereof with compositional and pharmacokinetic parameters falling within the scope of claim 1 of each patent. However, in view of the deficiencies identified under the s 71 grounds, I am not satisfied that the ARTG-listed goods TRAMAL® SR 100 contains or consists of a pharmaceutical substance that is disclosed in the complete specifications of the ‘863 and ‘527 patents and in substance falls within the claims of those patents.
The opponent has not established that the application for an extension of term of patent ‘058 does not satisfy the requirements of s 71(3)(a).
Conclusion
The opposition to grant of an extension of term for patent 2004229058 is unsuccessful.
The opposition to grant of an extension of term for patents 2002300863 and 2009243527 succeeds on the s 70(3)(a) and 71(1)(c) grounds. However, I believe that the deficiencies in these applications may be overcome by further information. Therefore, pursuant to reg 6.11, I will give the patentee the opportunity to provide further information to overcome the deficiencies in its extension of term applications, after which time the 2002300863 and 2009243527 oppositions will be finally determined.
Costs
Both parties sought its costs in this opposition. It is usual in proceedings before the Commissioner that costs should follow the event and I see no reason to depart from the normal practice. Southern Cross Pharma Pty Ltd has been successful in two oppositions and unsuccessful in the third, and it is appropriate to award costs accordingly.
For the oppositions in relation to patents 2002300863 and 2009243527 I award costs according to Schedule 8 against Euro-Celtique S.A. In the opposition relating to patent 2004229058 I award costs according to Schedule 8 against Southern Cross Pharma Pty Ltd. Where a cost item in Schedule 8 applies to the three hearings (eg. attendance by a solicitor and attorney) the amount is divided accordingly pro rata.
Dr Barbara Akhurst
Delegate of the Commissioner of Patents
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