Southern Cross Pharma Ltd v Euro-Celtique S.A
[2016] APO 44
•6 July 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 44
Patent No.:2002300863, 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Opponent: Southern Cross Pharma Pty Ltd
Hearing Officer: P M Spann, Deputy Commissioner of Patents
Decision Date: 6 July 2016
Hearing Date: 19 May 2016 by written submissions
Catchwords: PATENTS – reg 4.3(2)(b) – whether there are reasonable grounds for believing that evidence proposed to be filed should not be open to public inspection – order made – inspection allowed subject to undertakings as to confidentiality.
Representation: Patentee: Philip Kerr, solicitor, and Linda Govenlock of Allens Patent & Trade Mark Attorneys, Sydney.
Opponent: Kate Beattie, counsel, instructed by Duncan Bucknell Company.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Nos.:2002300863, 2009243527
Title:Controlled Release Formulation
Patentee: Euro-Celtique S.A.
Date of Decision: 6 July 2016
DECISION
I direct that:
a)Evidence of the weight for weight proportions (% w/w) of cellulose ether and polyalkylene glycol(s), and of hydrophilic or hydrophobic polymer(s), as these occur in the goods TRAMAL® SR 100, when filed, is not Open to Public Inspection (OPI);
b)The period in which the evidence is to be filed in response to the delegate’s direction in Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1 is extended to 1 month from the date of this decision; and
c)The non-OPI evidence is available for inspection by the opponent’s Australian legal representatives on them giving undertakings to the patentee that the information contained in the evidence will be used only in relation to the present opposition and not be disclosed to any other person.
REASONS FOR DECISION
This matter concerns whether there are reasonable grounds for believing that evidence proposed to be filed in the opposition should not be open to public inspection. It is to be determined under the Patents Regulations as amended on 15 April 2013 by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1).
BACKGROUND
On 7 May 2014, Euro-Celtique S.A. (the patentee) applied for extensions of the term of related patents 2002300863 (‘863), 2004229058 (‘058) and 2009243527 (‘527). 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 instead expire on 21 September 2015.
On 10 September 2014, Southern Cross Pharma Pty Ltd (the opponent) filed notices under s 75 opposing grant of the extensions. The oppositions were heard and on 8 January 2016 the delegate in Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1 decided that the opposition to ‘058 was unsuccessful (and the extension has been granted) but upheld oppositions to ‘863 and ‘527. Nevertheless she provided the opportunity for the patentee to provide further information in support of these applications:
(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 relevance of this is that the delegate found that there was insufficient information provided to be satisfied that the product TRAMAL® SR 100 contained or consisted of the pharmaceutical substances disclosed and claimed in the patents.
The product was developed by Grunenthal GmbH (Grunenthal) and is manufactured by them under licence from the patentee. The patentee and Mundipharma International Limited (Mundipharma) are “independent associated companies”.
On 15 February 2016 the patentee advised that it possessed the further information requested by the delegate but stated that it was proprietary and confidential and requested a reg 4.3(2)(b) order to ensure that the information was not publicly available once it was provided to the Commissioner. The patentee further agreed to make the information available to the opponent’s solicitor on the basis of an undertaking of confidentiality.
A delegate of the Commissioner objected to this request resulting in the patentee seeking to be heard. The opponent also requested and was granted the opportunity to be heard and, together with its submissions, filed a declaration made by Dr Russell Kinghorn concerning methods of chemical analysis of pharmaceutical products.
The patentee on 7 April 2016 filed a declaration by Mr Kevin Bill of Mundipharma stating that he has responsibility for present patents and that in January 2016 he requested information about the product from Grunenthal. This included the % w/w proportion of excipients in the product and confirmation that the product as currently listed in the Australian Register of Therapeutic Goods (ARTG) has the same formulation as when originally listed. Mr Bill states this information was provided on a confidential basis in line with existing agreements between Mundipharma and Grunenthal and exhibits supporting documentation.
Mr Bill further states that:
“I have personally reviewed the information relating to the TRAMAL® SR 100 mg tablet
formulation provided by Grunenthal in the 22 January 2016 email and I affirm that:(a) the amount of hydroxypropyl methyl cellulose is between 1-80 % w/w;
(b) the amount of microcrystalline cellulose is between 1-80 % w/w;(c)the combined amount of hydroxpropyl methyl cellulose and microcrystalline cellulose is between 1-80 % w/w; and
(d) the amount of polyethylene glycol is between 0-60 % w/w.”
A delegate considered this evidence but considered that it did not meet the terms of the direction to supply further information on the specific composition of the product.
THE LAW
The Patent Act and Regulations do not provide for a disclosure and confidentiality regime specific to opposition proceedings. Rather documents filed in proceedings are subject to the general public inspection and publication provisions of Chapter 4. These essentially provide for standard patents that, from 18 months after the earliest priority date or, if earlier, acceptance of the application, the patent specification and all documents associated with the application and in possession of the Patent Office are open to public inspection.
Exceptions to the general rule are provided by r 4.3. These include documents that would be privileged from production in legal proceedings and that are subject to orders of a court or tribunal that prohibit disclosure. Furthermore, for documents filed from the commencement of the Raising the Bar Regulation, r 4.3(2)(b) has provided as an exception “a document that the Commissioner has reasonable grounds for believing should not be open to public inspection”. This is a significant change to the provision which previously only applied in the circumstances of an order for production.
The relevant Explanatory Statement indicates:
“Item 38 – paragraphs 4.3 (2) (b) and (c)
This item amends the regulations to allow the Commissioner to keep a document confidential if it contains sensitive personal information, or in other appropriate circumstances.
Currently under sections 54 and 55 of the Patents Act, most documents related to a patent application become open to public inspection (OPI) 18 months after the priority date of the application. Occasionally patent applicants and others provide information to the Patent Office that is of a highly sensitive nature and which may not be appropriate for general public inspection. For example, information may be provided to the Commissioner to justify an extension of time and could include details of serious medical conditions, marital difficulties and resulting depression. In such circumstances, general availability to members of the public, with no direct interest in the matter, is not justified.
While documents may be prescribed for the purposes of subsection 55(2) of the Patents Act, so that they do not become OPI, the regulations only account for documents that are subject to legal professional privilege and documents that the applicant was compelled to provide under section 210(c) of the Patents Act via a Notice to Produce. Public access to sensitive information that is provided voluntarily to the Commissioner cannot be restricted or revoked.
This item broadens the Commissioner’s power to make a document non-OPI so that any information that is not appropriate for publication is not published or available to the public, regardless of whether it was subject to a Notice to Produce or not.”
Section 118 and Rule 53 of the UK Patents Act 2007 establish a similar regime. Rule 53 provides:
“53.—(1) Where a person files a document at the Patent Office or sends it to an examiner or the
comptroller, any person may request that the document be treated as a confidential document.(2) The comptroller must refuse any request where it relates to—
(a) a Patents Form; or
(b) any document filed in connection with a request under section 74A.(3) A request to treat a document as confidential must—
(a) be made before the end of the period of 14 days beginning immediately after the date on which the document was—
(i) filed at the Patent Office, or
(ii) received by the comptroller, an examiner or the Patent Office; and(b) include reasons for the request.
(4) Where a request has been made under paragraph (1), the document must be treated as confidential until the comptroller refuses that request or gives a direction under paragraph (5).
(5) If it appears to the comptroller that there is good reason for the document to remain
confidential, he may direct that the document shall be treated as a confidential document;
otherwise he must refuse the request made under paragraph (1).(6) But where the comptroller believes there is no longer a good reason for the direction under
paragraph (5) to continue in force, he must revoke it.(7) In this rule references to a document include part of a document.”
It is evident that the policy objectives of the UK and Australian legislation are the same and are intended to provide limited exceptions in circumstances where the public interest fundamentally lies in the disclosure of information supporting the grant of a patent. A summary of the considerations relevant to decisions under Rule 53 were cited by the hearing officer in Pilot Drilling Control Ltd and Smith International Inc [2011] UKIntelP o04611 with reference to the decision of the Court of Appeal in Lilly Icos Ltd v Pfizer Ltd (No2) [2002] EWCA Civ 2, [2002] 1 WLR 2253 and of the Patents Court in Diamond Shamrock Technologies S.A.'s Patent [1987] RPC 91.
Drawing from these sources I consider that principles apposite to the application of r 4.3(2)(b) are that:
- the Commissioner should order that a document not be OPI only if there are reasonable grounds for departing from the normal rule that all filed documents (after the relevant period) are available to the public;
- it is insufficient to merely assert that information contained in the document is commercial in confidence or otherwise sensitive;
- some real risk of harm must be identified that would follow from disclosure. That harm can be commercial or personal and can include “the indirect effect of inhibiting a party from putting forward their best case” (Pilot Drilling, supra);
- the Commissioner’s decision is to be based on a balancing of the relevant interests including the general public interest which strongly favours disclosure of information which goes to the validity of a patent if granted;
- the public interest also lies in the processes leading to grant, including opposition proceedings, be open and transparent. Where it is reasonable that some information in a document be not-OPI, the public interest will generally be served by requiring a redacted copy of the document be filed that is OPI;
- it follows that to the extent that information in a document relates to personal circumstances or is incidental or irrelevant it is more likely that an order will be made. In those cases the public interest may be met by requiring that a copy of the document with the information redacted be made open to public inspection; and
- on the other hand, it is less likely to be reasonable that documents directly relevant to validity including submissions and evidence rebutting grounds of objection or opposition should be not-OPI.
If a document is not OPI it may be made available for inspection by order of the Commissioner under section 56(1)(b). In the case of opposition proceedings it is normal for inspection to be allowed subject to conditions. These will include requiring undertakings of confidentiality and restrictions on the persons who may inspect documents.
Inspection will usually be limited to a party’s legal representative or an employee of the legal representative or an independent third party expert. In certain circumstances, such as ownership disputes, the other party would be granted restricted access if it could be shown that access was essential in the interests of justice and there would be no breach of duty of confidentiality. (See Davies v Eli Lilly & Co. (1987) 1 All ER 801).
CONSIDERATION
The patentee seeks to avoid the normal requirement for documents filed with the Commissioner to be OPI because it considers there is real risk of harm. This is said to be three-fold lying in:
a)a breech in the patentees obligation of confidentiality to Grunenthal and potential damage to their commercial relationship;
b)unfair commercial advantage to the patentee’s, Mundipharma’s and Grunenthal’s competitors in having access to proprietary information, ie the % w/w proportion of excipients in the product; and
c)being unable to present its best case if an order under reg 4.3(2)(b) is not made to the extent of the patentee being effectively denied its right to a patent term extension.
The Commissioner’s delegate in considering the request considered that while he could accept that the patentee would be in breach of its undertakings if it was to disclose the information, it appeared that the information was already available to the public. In this regard the delegate considered it was more likely than not that the composition of the product could be obtained by routine analysis. He therefore considered that the confidential character of the information had been removed when the product was made available to the public.
The opponent made submissions in support of the delegate’s position and has filed evidence concerning the availability of comparative quantitative excipient analysis. However the patentee has not objected to the opponent having access to the further information for the purpose of the proceedings and therefore it is not directly disadvantaged by a non-OPI order being made. Conversely it will be advantaged if the order is not made and as a result the patentee is unable to rely on the further information to support its applications for extensions of term.
The grant of an extension of term of a pharmaceutical patent is an important decision which significantly impacts on the interests of the public and potential generic drug suppliers. The relationship between the existence of patent rights and the cost of pharmaceuticals to government and consumers generally ensures that this will be the case. Consequently the balance of interests would generally weigh heavily against a patentee seeking to avoid public disclosure of information necessary to justify the extension of the patent rights.
The present case however presents some exceptional circumstances. The relationship between the patentee (and Mundipharma) and Grunenthal as the third party owner of the further information appears unusual and sensitive. While precise detail of the agreement between the parties has not been filed, there is sufficient evidence to indicate that the patentee has a contractual obligation not to make the further information publically available. It is also reasonable to infer that in being so bound the patentee risks significant consequences as a result of breaching this obligation or alternatively would not be able to provide information to satisfy the Commissioner that the extension should be granted. The risk of harm would at least include damage to the commercial relationship between the parties including the potential for the patentee and Mundipharma to be excluded from future collaboration or licencing arrangements with Grunenthal.
It is also appropriate to consider separately the effect of public disclosure on Grunenthal who may have nothing to gain in the grant of an extension to the patentee. Presumably it has entered a confidentiality agreement because the disclosure of its proprietary information will be commercially damaging, particularly in an environment where there are numerous competing controlled released products. Its interests as a non-party are very strongly in favour of the order being granted.
In seeking to overcome these difficulties the patentee has filed the evidence of Mr Bill including the statement reproduced above. While insufficient in itself to address the requirements of the extension delegate’s direction nevertheless it does provide secondary evidence that would, at least partially, address the requirement for transparency in relation to any further determination of the oppositions. It would remain the case that, if not-OPI, the further information would still be available to a party seeking to challenge the grant of an extension if the conditions for inspection are satisfied.
I further note that the precise formulation of the product is of public interest only to the extent that it may demonstrate the required link between a product listed on the ARTG and the patent. There is otherwise no requirement for, or public interest in, the public disclosure of the product formulation per se.
These considerations tend to favour the grant of the non-OPI order. Nevertheless if the further information is already in the public domain this would certainly suggest that any harm in making the information OPI would be minimal. There is however no suggestion that this is the case but rather it is argued that the composition could be readily obtained by chemical analysis. The patentee disputes this and on the whole I do not consider that there is sufficient certainty to assume the formulation is publicly available even considering Dr Kinghorn’s evidence. It therefore remains that there is a real risk of harm if the further information becomes OPI.
The considerations are finely balanced but in the circumstances I find that there is reasonable grounds for making a non-OPI order under reg 4.3(2)(b). The patentee agrees that the opponent should be given access to the further information when filed and I will therefore also make an order for inspection by the patentees Australian legal representatives on them making suitable undertakings to the patentee.
CONCLUSION
I am satisfied that it is reasonable in the circumstance for the evidence proposed to be filed not to be open to public inspection to the extent that it concerns the disclosure of the specific formulation of TRAMAL SR 100. I will make orders accordingly including to extend the time in which the information is to be filed and for inspection of the non-OPI evidence once filed.
COSTS
I make no award costs. While the patentee has been successful the requirement for a hearing arose primarily from the delegate’s objections rather than from the opponent. Therefore, in the circumstances, it appears appropriate for the parties to bear their own costs.
P M Spann
Deputy Commissioner of Patents
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