Eli Lilly and Company v Apotex Pty Ltd

REASONS FOR JUDGMENT 1 The substantive proceeding involves a claim by the applicant for patent infringement. The patent in suit is the same patent that was referred to in Eli Lilly and Company v Generic Health Pty Ltd [2013] FCA 1254. Both proceedings are fixed for hearing commencing on 2 June 2014. 2 A key issue in the infringement case concerns the size of raloxifene particles in the respondent's tableted products. Considerable time and effort has been spent by the parties over many months attempting to agree upon an appropriate protocol that would form the basis for experimental evidence directed to that issue. The protocol that was finally agreed between the parties had been through numerous previous iterations. Experiments were conducted in England earlier this year pursuant to the agreed protocol and related orders made pursuant to rule 34.50 of the Federal Court Rules 2011 (Cth). 3 Now before me is an application brought by the applicants pursuant to rule 34.50(2) seeking leave to rely on evidence contained in sections F9 and G of the affidavit of Dr Shen Luk sworn on 10 March 2014. Also before me is an application by the respondent for an order pursuant to s 192A of the Evidence Act 1995 (Cth) ruling that parts of the applicants' affidavit evidence are inadmissible in so far as it relates to the following: evidence as to the use of "Image J" software, and all evidence based directly or indirectly on such evidence (category (a)); and evidence as to the "Aggregate Experiment" referred to in paragraph 143 of the affidavit of Shen Yung Luk sworn on 10 March 2014, and all evidence based directly or indirectly on such evidence (category (b)). 4 Prior to the interlocutory hearing, the dispute between the parties also extended to evidence as to the use of Raman microscopy/spectroscopy, and all evidence based directly or indirectly on such evidence. However, the applicants have indicated that they will not seek to rely at the trial upon the evidence in that category. Nothing more need be said concerning that evidence. 5 The category (a) evidence relates to Dr Luk's examination and analysis of digital images captured pursuant to the agreed protocol and is described in section F9 of Dr Luk's affidavit. The respondents say that the agreed protocol did not contemplate further analysis of those images which, according to the respondent, were merely intended to serve as a record of what was done pursuant to it. 6 I am satisfied that the applicants should be given leave pursuant to rule 34.50(2) to rely upon the category (a) evidence at the trial. Senior Counsel for Apotex accepts that his client will be able to meet that evidence in the time available between now and the trial and variations to the existing timetable which would enable his client to do so have already been agreed. 7 The category (b) evidence relates to what is essentially an extension of the analytical work undertaken pursuant to the agreed protocol to determine particle size. It is described in section G of Dr Luk's affidavit. This further analytical work apparently involved additional "sonication" beyond what was provided for in the agreed protocol. 8 The further analytical work was not provided for in the agreed protocol, and it took place over the objection of the respondent. It also occurred in circumstances where there is likely to be a significant debate between experts as to the effect upon particle size of sonication, particularly additional sonication beyond that already provided for in the agreed protocol. However, it is accepted by the respondent that this further work was conducted in the presence of, and observed by, the respondent's expert and the court appointed expert. 9 In the result, I think the respondent is sufficiently protected if I grant the applicants leave to rely upon the material in section F9 and section G of Dr Luk's affidavit while making it clear that such leave is granted in circumstances where the relevance and reliability of the additional analysis undertaken by Dr Luk remains an issue still to be explored in evidence. In granting leave to the applicants to rely upon such material, I am not to be taken as expressing a view as to the weight that should be given to it if it is admitted into evidence. 10 The costs of both interlocutory applications will be the respondent's costs in the proceedings. 11 Orders accordingly. I certify that the preceding eleven (11) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Nicholas.