Mylan Health Pty Ltd v Cipla Australia Pty Ltd

1. The applicants' application for interim injunctive relief against the first respondent (the application) be dismissed.
2. The applicants pay the respondent's costs of the application.
3. The proceeding be listed for case management at 9.30 am on 6 May 2019. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

YATES J: 1 This is an application for interim injunctive relief against the respondent, Cipla Australia Pty Ltd (Cipla) for threatened infringement of certain claims of two patents. 2 The first patent is Patent No. 2006313711 (the 711 patent), the complete specification of which is entitled "Use of fenofibrate or a derivative thereof for preventing diabetic retinopathy". The second patent is Patent No. 2003301807 (the 807 patent), the complete specification of which is entitled "Nanoparticulate fibrate formulations". 3 The proceeding has been commenced against Cipla because of its intention to supply, in the foreseeable future, certain pharmaceutical products containing fenofibrate (the Cipla Products). 4 The present application is made in somewhat unusual circumstances. The applicants, Mylan Health Pty Ltd (Mylan Health) and BGP Products Operations GmbH (BGP), unsuccessfully sued Sun Pharma ANZ Pty Ltd (Sun Pharma) for threatened infringement of the two patents and another patent, Patent No. 731964: Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd) [2019] FCA 28 (the Sun Pharma proceeding). The primary judge found the relevant claims to be invalid. 5 Mylan Health and BGP are related entities. I will refer to them as a single entity (Mylan) unless it is necessary to distinguish between them. BGP is the patentee of the 711 patent and a co-owner of the 807 patent. Mylan Health is the exclusive licensee of the 711 patent and a licensee of the 807 patent. Mylan sued Sun Pharma because of its intended supply of certain pharmaceutical products containing fenofibrate (the Ranbaxy Products). 6 Mylan has filed an appeal from the primary judgment in the Sun Pharma proceeding (the Sun Pharma appeal). Mylan has also sought interim injunctive relief against Sun Pharma until the determination of the appeal. 7 I heard Mylan's application for interim injunctive relief against Cipla, and its application for interim injunctive relief against Sun Pharma, together. For the reasons published today in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2019] FCA 505 (the Sun Pharma reasons) I dismissed Mylan's application for interim injunctive relief against Sun Pharma. I will also dismiss Mylan's application for interim injunctive relief against Cipla in this proceeding. 8 My reasons for dismissing the application for interim injunctive relief against Cipla in this proceeding are essentially the same reasons for dismissing the claim for interim injunctive relief against Sun Pharma in the Sun Pharma appeal. Accordingly, the Sun Pharma reasons should be read with these reasons. There are, however, some additional comments I wish to make in respect of the claim against Cipla in this proceeding. 9 Before dealing with those matters, I should record that the application for interim injunctive relief against Sun Pharma and the application for interim injunctive relief against Cipla were heard together, on the basis that the balance of convenience should be considered having regard to the individual and collective positions of Sun Pharma and Cipla as intending suppliers of, respectively, the Ranbaxy Products and the Cipla Products. 10 Further, for the purpose of the application for interim injunctive relief in this proceeding, it was agreed by Mylan and Cipla that it can be assumed that the Cipla Products have the same stability, particle size, bioavailability and redispersibility characteristics as the Ranbaxy Products, and that the Cipla Products include at least one surface stabiliser. 11 In this proceeding, Cipla submitted that Mylan has a "very weak" prima facie case for the interim injunctive relief it seeks, essentially because, in the Sun Pharma proceeding, the primary judge found that the relevant claims of the 711 patent and the 807 patent were invalid. Further, in relation to the 807 patent, Cipla pointed to the fact that no findings of infringement were made against Sun Pharma in respect of the Ranbaxy Products and, in this proceeding, there is no evidence that would support the conclusion that findings of infringement are likely to be made against Cipla in respect of the Cipla Products. 12 In the Sun Pharma reasons, I concluded that Mylan has an arguable appeal in relation to the validity of the 711 patent and the 807 patent, although I pointed to some difficulties that will confront Mylan in succeeding in that appeal. In light of those findings, I do not approach the application for interim injunctive relief against Cipla merely on the basis that the claims in suit have been held to be invalid. Rather, the application against Cipla must be approached on the basis that there is an arguable appeal on foot which may affect the findings on validity which the primary judge has made in the Sun Pharma proceeding. 13 In the Sun Pharma reasons, I also concluded that Mylan had established a prima facie case of infringement of the 807 patent in respect of the Ranbaxy Products. In my view it must follow, contrary to Cipla's submission, that a prima facie case of infringement of the 807 patent is also established in respect of the Cipla Products, given the assumptions to be made with respect to the characteristics of those products. 14 For completeness, I note that, at least at this stage, Cipla does not appear to dispute that the findings made against Sun Pharma in the Sun Pharma proceeding concerning the application of s 117(2)(b) of the Patents Act 1990 (Cth) (the Patents Act) with respect to the use of the Ranbaxy Products are findings that similarly should be made against Cipla in this proceeding in respect of the use of the Cipla Products. 15 As explained in the Sun Pharma reasons at [129] - [145], the balance of convenience is against granting the interim injunctive relief that Mylan seeks. It is not necessary for me to repeat my reasons for that conclusion. There is, however, an additional matter to which I should refer. 16 Mylan submitted that, in its evidence, Cipla had not addressed its capacity to meet an award of damages should infringement be found against it at a final hearing. Further, on the eve of the hearing for interim injunctive relief, Mylan's solicitors sent a letter to Cipla's solicitors requesting that Cipla's parent company, Cipla Limited, provide an undertaking to the Court that it would pay any and all pecuniary relief ordered to be paid by Cipla for infringement if Cipla fails to comply with such an order, on the basis that Mylan's parent would provide a corresponding undertaking in respect of a claim by Cipla under an undertaking as to damages. Cipla Limited has not provided a response to Mylan's request. 17 I am not persuaded that this circumstance militates in favour of granting interim injunctive relief against Cipla. There is no evidence that Cipla would be unable to meet an award of damages in Mylan's favour. Mylan cannot manufacture a case that Cipla would be unable to meet a damages award simply by pointing to a belated and unrequited request for an undertaking from Cipla's parent company. 18 Orders will be made accordingly. Mylan should pay Cipla's costs. I certify that the preceding eighteen (18) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates.