INJUNCTIVE RELIEF
2 Wyeth proposes the following form of order:
3. The Applicants/Cross-respondents, whether by themselves, their directors, officers, servants or agents, or otherwise, in the patent area (as that term is defined in Schedule 1 to the Patents Act), during the term of the 013 Patent, without the licence or authority of the Respondent/Cross-claimant, be permanently restrained from infringing claims 1 to 8 (inclusive), 10 to 13 (inclusive) and 16 to 17 (inclusive) of the 013 Patent, including by engaging in the following acts in the patent area, without the licence or authority of the Respondent/Cross-claimant:
(a) importing, making, selling, supplying or otherwise disposing of, or offering to import, make, sell, supply or otherwise dispose of, the 15-valent vaccine;
(b) using or keeping the 15-valent vaccine for the purpose of doing any of the acts described in sub-paragraph 3(a) above;
(c) authorising other people to engage in any of the acts described in sub-paragraphs 3(a) and (b) above.
3 MSD does not challenge the form of this proposed order, but contends that there is a substantive question to be determined, which is whether, for public interest reasons, any injunction should be ordered at all. It submits that, in any event, no order should be made now, and that the question should be deferred until after the determination of any appeal from the judgment, and will only subsequently arise if MSD's appeal fails. It offers undertakings to prosecute any appeal or cross-appeal expeditiously, and to give Wyeth notice of when it intends to import or sell its 15-valent vaccine (unless the appeal is determined in its favour or the injunctive relief issue is determined in its favour before that event occurs).
4 MSD's position can be briefly summarised. It submits that its 15-valent vaccine will provide health advantages over Wyeth's Prevnar 13. It wishes to adduce evidence going to this point, and for the Court to conduct a separate hearing on whether it is against the public interest to grant an injunction restraining infringement. The proposed additional evidence would address:
(1) the prevalence in the community of invasive pneumococcal disease caused by serotypes 22F and 33F;
(2) the ability of the MSD 15-valent vaccine to provide additional protection against those serotypes;
(3) recent changes in government policy concerning making pneumococcal conjugate vaccines more available in Australia; and
(4) evidence that Wyeth's Prevnar 13 vaccine does not provide effective protection against serotype 3.
5 MSD relies on the United Kingdom decision of Evalve Inc v Edwards Lifesciences Ltd [2020] EWHC 513 (Birss J) where the court noted at [87] that the relevant public interest sufficient to justify a refusal in part of a patent injunction is the need to protect the lives of patients for whom the defendant's product is the only suitable treatment, when that fact is established by objective evidence. It submits that the additional evidence it seeks to adduce will lead to that outcome.
6 Wyeth opposes any deferral of the making of injunctive orders. It submits that, where there is a threat of ongoing infringement, the patentee is, as a matter of course, awarded both a specific and a general injunction to restrain infringing conduct, citing Calidad Pty Ltd v Seiko Epson Corporation (No 2) [2019] FCAFC 168; 147 IPR 386 (Greenwood, Jagot, Yates JJ) at [25] and [44]. It was for MSD to displace the presumption that Wyeth is entitled to a final injunction at the trial of the proceedings and it did not do so. It submits that the procedure that MSD now seeks to adopt is unorthodox and liable to create irregularity and prejudice, not least because it would deprive Wyeth of the fruits of the outcome that it has achieved at trial. Furthermore, it submits that the decision in Evalve only provides a very narrow exception to the general approach of awarding a final injunction following a finding of patent infringement in circumstances where the defendant's product is needed to protect the lives of existing patients and is the only suitable treatment. That, it submits, is not established on the basis of any evidence in these proceedings.
7 In my view, for the following reasons it is appropriate to make the injunctive order for which Wyeth contends.
8 First, the status quo is that Wyeth has established that MSD threatens to launch a product that has been found to infringe the asserted 013 patent claims. It is prima facie entitled to an injunction as a consequence of that finding: Calidad at [30]. It is for MSD to establish on the basis of evidence that such an order should not be made.
9 Secondly, there is no current evidence as to the state of MSD's proposed 15-valent vaccine. MSD has not obtained regulatory approval in Australia for a launch of such a product. Ms Howard SC, who appeared with Mr Larish for MSD, informed the Court at the hearing that MSD intends to commence the process of seeking regulatory approval first in the United States towards the end of the year and subsequently in Australia. The question of whether there is any public health benefit arising from the launch of a 15-valent vaccine would fall to be determined at the time when that product becomes available and, presumably, this determination would depend on the form of that vaccine, about which there is also no evidence. Included within the relevant information for consideration at that point will no doubt be the question of whether any additional non-infringing products are available to the Australian public. In that respect Mr Bannon SC, who appeared with Ms Cochrane and Mr Clarke for Wyeth, informed the Court that Pfizer Inc (the parent company of Wyeth) proposes to launch a 20-valent vaccine that may be launched in advance of the MSD product. Neither of the statements from the bar table of Ms Howard SC or Mr Bannon SC amount to evidence. They do, however, serve to demonstrate that the timeline relevant to any public interest argument is inchoate. For that reason, the debate about whether or not there would be a public health benefit if an otherwise infringing product were permitted to be launched would appear at this point to be entirely hypothetical.
10 Thirdly, MSD commenced these proceedings in August 2017 by way of actions to revoke Wyeth's patents in order, as it said during the course of the preparation of the case, to "clear the way" for the launch of a 15-valent product. Wyeth then instigated a cross-claim in November 2017 seeking orders to restrain future infringement. MSD pleaded in its defence to Wyeth's statement of cross-claim that it did not infringe the claims and that they were invalid. In [23] of its defence (which has been in this form since 11 December 2017) MSD contended that any relief restraining the supply of a 15-valent vaccine "would be inequitable, unconscionable and contrary to the public interest". No particulars were appended to that paragraph. However, it is apparent from that pleading that MSD was conscious of the public interest issue well before the hearing. Wyeth joined issue with the point.
11 Once the question of the availability of a public interest defence to the grant of an injunction was in issue, it was open to MSD to take one of at least three courses. One was to adduce evidence at trial going to the basis upon which it alleged that it would be contrary to the public interest to restrain infringement. Another was to seek orders formally deferring consideration of the question of whether or not injunctive relief should be granted and, in so doing, explaining why that issue should not be heard at the time that liability was determined. Another was to do neither, which is what it chose to do.
12 Even if there was a present basis for declining to grant an injunction, in the absence of any evidence to explain why MSD did not either (1) lead such evidence it had available to it relevant to its public interest arguments at the trial; or (2) seek to raise the public interest point as a separate issue, I would be reluctant to permit it to, in effect, re-open its case after judgment in order to advance evidence and arguments that could have been raised then.
13 Finally, MSD complains that Wyeth has taken a "different position" in equivalent proceedings in the United Kingdom. In those proceedings, Wyeth is said to have informed the Court at trial that it did not seek an injunction to restrain the launch of a 15-valent vaccine because of public health considerations. However, the concession apparently made in the United Kingdom proceedings concerned alleged infringement of claims of an equivalent to those in the container patent, which require as an integer that the product be supplied in a "siliconized container" (see judgment at [659]). The circumstances of the making of that concession have not been explored and it is unclear, in any event, what MSD seeks to make of it in the present application.
14 Accordingly, I will make the injunctive order proposed by Wyeth.