Apotex Pty Ltd v Eli Lilly and Company
[2012] APO 131
•5 December 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v Eli Lilly and Company [2012] APO 131
Patent Application: 2004231254
Title:Methods of preventing breast cancer
Patent Applicant: Eli Lilly and Company
Opponent: Apotex Pty Ltd
Deputy Commissioner: Philip Spann
Decision Date: 5 December 2012
Hearing Date: 15 November 2012
Catchwords: PATENTS – notice to produce – whether lawful excuse – scope of notice – confidentiality – lawful excuse in relation to certain documents pending a further notice or direction.
Representation: Patent applicant: A Lang, Counsel, S Irani, Patent Attorney, Spruson & Ferguson
Opponent: H Bevan, Counsel, N Hyde, Solicitor, Freehills
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004231254
Title:Methods of preventing breast cancer
Patent Applicant: Eli Lilly and Company
Date of Decision: 5 December 2012
DECISION
The applicant has a lawful excuse and is not required to produce the documents referred to in paragraphs 2 and 5 of the notice to produce subject, in the case of category 5, to a further notice or direction of the Commissioner. Under regulation 4.3(2)(b) I order that all documents produced in relation to the notice are not to be open to public inspection and, in relation to section 56, direct that Apotex may inspect the documents subject to undertakings of confidentiality agreed between the parties.
I make no award of costs.
REASONS FOR DECISION
Background
The current application relates to methods of treating breast cancer by the administration of the drug Raloxifene. Apparently the invention arises from, or is at least supported by, the results of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial initiated in 1994. The clinical trial involved several thousand postmenopausal women and was carried out in a number of countries including Australia. It was intended to assess the effect of Raloxifene on osteoporosis, however the incidence of breast cancer was a secondary end point.
The application was filed on 23 November 2004 as a divisional of patent application 54106/01 which is in turn a divisional of application 43647/97. Its earliest possible priority date is 30 October 1996. The application was advertised accepted on 23 February 2009 and opposed by Apotex Pty Ltd (Apotex). A statement of grounds and particulars was filed on 18 September 2009 and on 9 May 2012 the opponent requested the issuing of a notice for the applicant to produce 5 categories of documents related to the MORE trial. Consequently on 17 May 2012 a notice was issued under section 210(c) by Deputy Commissioner Bokil.
The applicant objected to the notice describing it as a “fishing exercise” and oppressive on the basis of the very large amount of material involved. Efforts to resolve the matter between the parties were unsuccessful and the matter was set for hearing on 15 November 2012. On the day before the hearing the Commissioner was notified that Lilly did not dispute production of documents in categories 1, 3, and 4 of the notice subject to a confidentiality order under regulation 4.3(2)(b). I subsequently ordered that submissions on confidentiality be filed within 2 weeks of the date of the hearing and the documents within categories 1, 3 and 4 be produced within 1 month of the hearing.
Applicable Law
The power for the Commissioner to require production is provided under section 210 of the Act:
The Commissioner may, for the purposes of this Act:
(a) summon witnesses; and
(b) receive written or oral evidence on oath or affirmation; and
(c) require the production of documents or articles; and
(d) award costs against a party to proceedings before the Commissioner.
The current practice of the Commissioner in dealing with a request to issue a Notice Requiring Production is to issue the notice if and to the extent that it appears to serve a legitimate forensic purpose in the context of the opposition. Objections by the affected party are not heard before the issuance of the notice but it is expected that objections arising will be dealt with as a matter of lawful excuse for not complying with the Notice.
While a number of decisions have been cited concerning the practice of the Federal Court and are instructive, particularly as goes to the question of relevance, it should not be forgotten that the Commissioner’s powers under section 210 are discretionary. As a result a range of considerations apply including the nature of proceedings before the Commissioner which are not subject to the rules of evidence that apply to the Court and, in the case of pre-grant opposition, are intended to allow a relatively prompt and inexpensive consideration of the merits of an application.
The Notice
The documents ‘within the custody, power or possession of Eli Lilly and Company’ sought by the notice of production are:
“1 The Protocol and Investigation Brochure for the Multiple Outcomes of Raloxifene Evaluation (MORE) study, including any Phase III clinical trials commenced in Australia before 30 October 1996.
2 Master labelling showing the label texts of the vials and the packs used in the Phase III clinical trials referred to in point 1.
3 One example of a Master Patient Information and Informed Consent Form used in the Phase III clinical trials referred to in point 1.
4 Any agreement on the Protocol between the investigators carrying out the Phase III clinical trials referred to in point 1 and Eli Lilly and Company (subject to redaction of financial information, if any).
5 Interim and final reports of the Phase III clinical trials referred to in point 1 together with:
a)All Case Report Forms (as per section 16.3 of the ICH Harmonised Tripartite Guidelines), or equivalent documents having substantially the same information, of the earliest treated, non-placebo, Australian resident participants who commenced treatment before 30 October 1995;
b)20 (or all if less than 20) Case Report Forms (as per section 16.3 of the ICH Harmonised Tripartite Guidelines), or equivalent documents having substantially the same information, of the earliest treated, non-placebo, Australian-resident participants who commenced treatment between 30 October 1995 and 30 October 1996.
If there were no treated, non-placebo, Australian-resident participants who commenced treatment before 30 October 1996, then the Case Report Forms, or equivalent documents having substantially the same information, of the first 20 (or all if less than 20) such participants treated whenever treatment commenced.”
The relevance of the documents sought is said to lie particularly in relation to the asserted grounds that the claimed invention is not novel or does not involve an inventive step or was secretly used as a result of the MORE trial. As indicated above, Lilly has advised that it does not dispute production of the documents in categories 1, 3 and 4 of the notice. For its part Apotex advised at the hearing that it did not press production of the documents in category 2. Therefore what remains in dispute is the documents in category 5.
Objection and excuse
Both parties referred me to the decision in Eli Lilly & Company v Novo Norodisk [1999] APO 45. This is relevant because it concerned a notice for production of documents relating to clinical trials and resulted in a modified requirement for production that recognised that confidentiality should be maintained in relation to the documents produced and irrelevant material excluded by redaction. Apotex rely on the decision as supporting a requirement for production while Lilly relies on it for the maintenance of confidentiality. Nevertheless the present case needs to be considered on its merits.
10.It seems to be accepted that the documents within category 5 are very extensive and to include much information that is irrelevant to the potential case asserted by Apotex. I consider production in the circumstances to be oppressive but understand that Apotex is not in a position to reasonably limit its request for production having insufficient information concerning the trial report and its contents. However, it appears to me also that Apotex is pursuing a theoretical line of inquiry in the hope of identifying a case rather than supporting a case for which it has some factual basis. In my view it does not even suggest a specific and realistic basis on which the clinical trial report might support a ground of secret prior use, nor how it could assist in supporting a ground of lack of novelty or of inventive step.
11.In addition to this I am concerned that Apotex was required by the regulations to serve its evidence in support on 18 December 2009. It has subsequently obtained multiple extensions of time but the inordinate delay in completing the service of evidence in this case in my mind weighs heavily against a requirement for production without a more concrete line of inquiry than currently proposed. The Commissioner will of course be concerned that an invalid patent is not granted however this must be balanced against the requirements for efficient conduct of opposition proceedings and the interests of the applicant. It is also the case that Apotex, if unsuccessful in its opposition, will have the opportunity on appeal or in revocation proceeding to make use of the processes of discovery and production available in the court.
12.On this basis I am disinclined to add further significant delay to the resolution of the opposition without greater confidence that the documents sought will have a significant impact on the outcome of the opposition. At the hearing I invited Lilly to provide a table of contents for the trial report which it subsequently filed. With the documents that it has agreed to produce under categories 1, 3 and 4 and in the circumstances indicated above I consider this sufficient answer to the notice for production. Lilly has lawful excuse in relation to the documents covered by categories 2 and 5. If Apotex, on the basis of this material, can demonstrate a substantial forensic purpose for production of relevant parts of the trial report, I will consider further whether that material should be produced but not otherwise.
Confidentiality
13.I am prepared on the same basis as in Eli Lilly & Company v Novo Norodisk, supra, to order under regulation 4.3(2)(b) that all documents produced in relation to the notice are not to be open to public inspection. I will for the purpose of section 56 also direct that Apotex may inspect the documents produced subject to undertakings of confidentiality agreed between the parties. If agreement cannot be reached I will determine the terms subject to the submissions of the parties.
Conclusion
14.The applicant has a lawful excuse in relation to categories 2 and 5 of the notice issued on 17 May 2012. I order under regulation 4.3(2)(b) that the documents to be produced in categories 1, 3 and 4 and the table of contents of the clinical trial report already produced not be open to public inspection and be available for inspection subject to undertakings of confidentiality agreed between the parties.
15.Following inspection, if Apotex can demonstrate a substantial forensic purpose for production of relevant documents in category 5, I will consider further whether that material should be produced but not otherwise.
Costs
16.In effect both parties have been successful in this matter. Lilly advised the Commissioner of its decision to agree to production of certain categories of documents on the day before the hearing, and had that been known earlier, it is possible that a hearing could have been avoided. On the other hand given the way the case was pursued by Apotex this is perhaps unlikely. Taking all the circumstances into account I make no award of costs.
Philip Spann
Deputy Commissioner of Patents
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