Southern Cross Pharma Ltd v Euro-Celtique S.A
[2016] APO 61
•21 September 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 61
Patents:2002300863 & 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Opponent: Southern Cross Pharma Pty Ltd
Delegate: Dr B. Akhurst
Decision Date: 21 September 2016
Hearing Date: Written submissions filed on 23 August and 6 September 2016
Catchwords: PATENTS – Final determination of oppositions to extensions of the term of two pharmaceutical patents – whether additional information provided by the patentee overcomes the deficiencies in the extension requests identified in the earlier decision – extensions granted.
Representation: Counsel for the patentee: Philip Kerr.
Patent attorney for the applicant: Allens Patent and Trade Mark Attorneys.
Patent attorney for the opponent: Duncan Bucknell Company.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2002300863 & 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Date of Decision: 21 September 2016
DECISION
The further information provided by Euro-Celtique S.A overcomes the deficiencies identified in the earlier decision published as Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1.
Subject to an appeal of this decision, I grant the extensions to the term of patents 2002300863 and 2009243527.
REASONS FOR DECISION
This matter concerns the final determination of applications by Euro-Celtique S.A. to extend the term of patents 2002300863 and 2009243527 and the oppositions by Southern Cross Pharma Pty Ltd. The date of these patents is 9 May 1994 and their maximum 20-year term expired on 9 May 2014. If extensions are granted the term of each patent would be extended until 21 September 2015.
Background
On 7 May 2014, Euro-Celtique S.A. (the patentee) applied to extend the term of three patents including 2002300863 (‘863) and 2009243527 (‘527). On 10 September 2014, Southern Cross Pharma Pty Ltd (the opponent) opposed grant of the extensions. The matters were heard and in Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1 (the earlier decision), I found the oppositions to extend the term of patents ‘863 and ‘527 were successful due to deficiencies in the extension requests. However, I allowed the patentee a period of time to provide further information in order to overcome the deficiencies.
As the basis for its extension request, the patentee relied on the product Tramal® SR 100, which was developed by Grunenthal GmbH and is manufactured by them under licence from the patentee. Thus, on 15 February 2016 the patentee advised that the further information it sought to file was proprietary and confidential and as a consequence it requested a confidentiality order. The opponent requested a hearing and in Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 44, the Deputy Commissioner directed under reg 4.3(2)(b) that the patentee’s evidence containing the further information, when filed, should not be open to inspection, but it would be available for inspection by the opponent subject to specified conditions. The patentee subsequently filed the further information on 17 August 2016. Note that the information in this decision which is subject to the reg 4.3(2)(b) order has been redacted.
The opponent filed submissions with respect to the further information on 23 August 2016. The patentee filed submissions on 6 September 2016.
Standard of proof
The standard of proof in opposition proceedings under s 75 is the civil standard on the “balance of probabilities”.
The Law
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) … .
Section 71 prescribes the form and timing of an application and relevantly states:
(1) An application for an extension of the term of a standard patent must:
(a)…; and
(b)…; and
(c)be accompanied by such information (if any) as is ascertained in accordance with the regulations.
Regulation 6.8 applies in the present circumstances, and prescribes 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.
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) …
(4) …
(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.
The claims
The extension applications were based on claim 1 in each of the ‘863 and ‘527 patents, which 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.”
The earlier decision
In the earlier decision, I found that the oppositions to grant of an extension of term of patents ‘863 and ‘527 both succeeded on s 70(3)(a) and 71(1)(c) grounds. The earlier decision identified specific deficiencies in the patentee’s extension requests, which can be summarised as follows:
·The ‘863 extension request does not provide the weight for weight proportion (% w/w) of hydrophilic or hydrophobic polymer(s) in TRAMAL® SR 100 (paras 50, 55-56 of the earlier decision);
·In the ‘527 extension request the very broad ranges provided for the cellulose ether and polyalkylene glycol(s) content of TRAMAL® SR 100, which merely recite the language of the claim, could not properly reflect the proportions of these ingredients in the goods TRAMAL® SR 100 (paras 51-52, 55-56 of the earlier decision); and
·In view of those deficiencies, I was 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 for the purposes of s 70(3)(a), having regard to the definition of the substance in s 70(2)(a) (paras 58-60 of the earlier decision).
Since I believed that these deficiencies could be overcome by further information, pursuant to reg 6.11, I invited the patentee to provide further information to address the deficiencies, 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.”
The further information
The patentee’s further information was contained in Exhibit KB-1 to a declaration by Kevin Bill dated 11 August 2016 and an accompanying letter. In Exhibit KB-1, Grunenthal’s confidential evidence relating to the TRAMAL® SR 100 mg tablet formulation establishes that, among other things, a Tramadol® SR 100 mg tablet contains the following ingredients:
mg/tablet
weight/weight % (w/w%)
Tramadol hydrochloride
100 mg
Microcrystalline cellulose
xxxxx
Hypromellose 105 mPa.s
xxxxx
Hypromellose 6 mPa.s
xxxxx
Macrogol 6000
xxxxx
In the accompanying letter dated 17 August 2016, the patentee relevantly states:
“In relation to the ‘863 Patent, Column C of Confidential Exhibit KB-1 provides evidence that TRAMAL® SR 100 tablets contain between 1 and 80% of one or more hydrophilic or hydrophobic polymers (microcrystalline cellulose, hypromellose 105 mPa.s, hypromellose 6 mPa.s, Macrogol 6000) as required by inter alia claim 1.”
“In relation to the ‘527 Patent, Column C of Confidential Exhibit KB-1 provides evidence that TRAMAL® SR 100 tablets contain between 1 and 80% w/w of a cellulose ether (microcrystalline cellulose, hypromellose 105 mPa.s, hypromellose 6 mPa.s) and up to 60% w/w of a polyalkylene glycol (Macrogol 6000) as required by inter alia claim 1.”
I will note here that the identification of microcrystalline cellulose as a cellulose ether is an obvious error by the patentee, which is subsequently corrected in its submissions for the hearing. Nothing turns on this error.
The opponent’s submissions
The opponent did not dispute that the deadline for complying with the Deputy Commissioner’s final notice to provide further information was 17 August 2016, or that the patentee filed its information on that date. The opponent’s submissions regarding the further information are reproduced below:
“The further information does not provide the weight for weight proportion of cellulose ether or polyalkylene glycol in the TRAMAL® 100 formulation
The Further Information provides no weight for weight proportion of polyalkylene glycol.
The Further Information does not mention cellulose ether at all and nor has the patentee provided any information to establish which of the listed compounds, if any, it alleges might meet such a description.
The Further Information does not provide the weight for weight proportion of hydrophilic or hydrophobic polymers in the TRAMAL® formulation.
The Further Information does not mention hydrophilic or hydrophobic polymers and the patentee has provided no information to establish which of the listed compounds, if any, it alleges might meet either description.”
Consideration
In my view, the opponent’s submissions do not take into account the totality of the information provided in the patentee’s evidence and accompanying letter.
Relevant to the ‘863 patent, the information provided by the patentee’s letter of 17 August 2016 and exhibit KB-1 establishes that TRAMAL® SR 100 contains the following (hydrophilic) polymers: microcrystalline cellulose (xxxxx w/w%); Macrogol 6000 (xxxxx w/w%); Hypromellose 105 mPa.s (xxxxx w/w%); and Hypromellose 6 mPa.s. (xxxxx w/w%). Thus, TRAMAL® SR 100 contains four hydrophilic polymers and has a combined polymer content of xxxxx w/w%, satisfying the requirement in claim 1 of the ‘863 patent for between 1 and 80% w/w of one or more hydrophilic or hydrophobic polymers.
Relevant to the ‘527 patent, the information provided by the patentee’s letter of 17 August 2016 and exhibit KB-1 establishes that TRAMAL® SR 100 contains the cellulose ethers Hypromellose 105 mPa.s (xxxxx w/w%) and Hypromellose 6 mPa.s (xxxxx w/w%), and the polyalkylene glycol Macrogol 6000 (xxxxx w/w%). Thus, TRAMAL® SR 100 satisfies the requirements in claim 1 of the ‘527 patent that the controlled release oral pharmaceutical preparation contains between 1‑80% w/w of a cellulose ether and up to 60% w/w of a polyalkylene glycol.
The patentee’s further information shows that the ARTG-listed goods TRAMAL®SR 100 contains, or consists of, the pharmaceutical substances defined by claims 1 of the ‘863 and ‘527 patents for the purposes of subreg 6.8(2). Relevant to subreg 6.8(3), in identifying the specific polymers, cellulose ethers and polyalkylene glycol in TRAMAL®SR 100 and the amounts of these ingredients, the patentee’s further information identifies the pharmaceutical 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 ‘863 and ‘527 patents, and in particular claim 1 of each patent.
As a consequence, pursuant to reg 6.11(5), I am satisfied that the applications to extend the term of patents ‘863 and ‘527 comply with s 71(1)(c) that they be accompanied by such information as is ascertained in accordance with regs 6.8(2) and 6.8(3). I am further satisfied that the patentee’s further information establishes that the ARTG-listed goods TRAMAL® SR 100 contains or consists of a pharmaceutical substance that is disclosed in the complete specification of the ‘863 and ‘527 patents and in substance falls within the claims of those patents, fulfilling the requirements of s70(3)(a) of the Act.
Conclusion
The further information overcomes the deficiencies identified in the earlier decision. The opponent’s submissions that the patentee is not entitled to further time to file additional information are therefore moot. In the circumstances, it is appropriate that the patentee’s applications to extend the term of patents 2002300863 and 2009243527 proceed to grant.
Dr Barbara Akhurst
Delegate of the Commissioner of Patents
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