Case: Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261
Outcome: followed
(a) and (c) are related in this sense, that whether there is a serious question or a prima facie case should not be considered in isolation from the balance of convenience. The apparent strength of the parties' substantive cases will often be an important consideration to be weighed in the balance: Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR 405 at [416]; Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261 ( Interpharma ) at [16]. Special considerations apply where, as here, the party seeking interlocutory relief alleges infringement and the other party alleges invalidity. As to this, in Interpharma 79 IPR 261 at [17] Jessup J said: In such a situation, it will not be enough to ask whether the applicant has shown a serious question, or a probability of success, on his or her own case. While the answer to that question may be in the affirmative, it will then be necessary to consider whether that answer should be qualified by the apparent strength of the defence. In a patent case, the fact of registration constitutes prima facie evidence of validity: AB Hassle v Pharmacia (Aust) Pty Ltd (1995) 33 IPR 63 at 69-70 ( AB Hassle ); GenRx Pty Ltd v Sanofi-Aventis [2007] FCA 1485 ; (2007) 73 IPR 502 ... at [2]-[6] ... It has been said that it is for the respondent to show that want of validity is a triable question: AB Hassle at 69. This seems clear enough, but, in my opinion, the analysis needs to be taken a step further. Is it sufficient that the respondent does show a triable question on validity? In my view, if that is as far as the respondent goes, then, assuming always that the applicant has shown a triable issue on infringement, absent questions of validity, the conclusion would remain that the latter had a triable question. That is to say, as a matter of analysis, unless the case for invalidity is sufficiently strong (at the provisional level) to qualify the conclusion that, overall, the applicant has a serious question, or a probability of success, the court should move to consider the adequacy of damages, the balance of convenience and other discretionary matters. It is the applicant's title to interlocutory relief which is under consideration, and the bottom-line question, as it were, is whether the applicant has a serious question, or a probability of success, not whether the respondent does in relation to some point of defence raised or foreshadowed. The purpose of an interlocutory injunction is to preserve the status quo pending trial. What was said by Gyles J in GenRx Pty Ltd v Sanofi-Aventis [2007] FCA 1485 ; (2007) 73 IPR 502 at [15] is applicable here. A new entrant into the market would have an effect which may be both unpredictable and irreversible. Once Sigma is in the market, it is likely that other generic manufacturers will also come in. I doubt whether, if Sigma is not restrained and Wyeth succeeds at trial, Wyeth will ever be able to resume the position it now occupies. Cf Interpharma 79 IPR 261 at [71]. In my view it is likely that Wyeth will suffer irreparable harm for which damages will not adequately compensate it, unless an injunction is granted. A similar situation existed in Interpharma 79 IPR 261 where the alleged infringer had proceeded with its preparations to enter the market "with its eyes wide open". Jessup J said at [77] that this significantly compromised that party's attempt to resist an injunction which went no further than to maintain the status quo. See also Pharmacia Italia 67 IPR 397 at [38] and Merck &amp; Co Inc v GenRx Pty Ltd (2006) 70 IPR 286 at [19].