Case: Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2005) 222 ALR 552
Outcome: discussed
VID 439 of 2003 ("the Pharmacia Proceeding") concerns the scope of the final injunction to be granted and, in particular, its duration, in a matter that was heard by Crennan J: Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2005) 222 ALR 552 ("the Pharmacia Infringement Proceeding"). Her Honour found that Mayne Pharma Pty Ltd and the Faulding Co respondents ("Mayne") had infringed Pharmacia Italia SpA's ("Pharmacia") patent, Australian patent no. 598197 ("the Patent"). The injunction that she granted on 8 September 2005 restrains Mayne from infringing certain claims of the Patent until 19 June 2006, the end of the original term of the Patent, or until "such later date as the Court may hereafter order". Mayne objects to any further order being made that would extend the term of that injunction, namely to cover the period of the Patent's extension from 19 June 2006 to 19 June 2011. 3 In the second proceeding before the Court, VID 1274 of 2005 ("the Interpharma Review Proceeding"), Interpharma Pty Ltd ("Interpharma") challenges the decisions of the Commissioner of Patents ("the Commissioner") to: (a) accept an application for an extension of the term of the Patent; (b) fail to refuse to accept an application for an extension of the term of the Patent; and (c) to grant an extension of the term of the Patent. 4 It does so pursuant to s 5 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) ("the ADJR Act ") and s 39B(1) of the Judiciary Act 1903 (Cth) ("the Judiciary Act "). Interpharma has also applied to the Court for rectification of the Register of Patents pursuant to s 192 of the Patents Act 1990 (Cth) ("the Patents Act "). The basis of that claim is that the Register erroneously records the Patent as having been extended to 19 June 2011. 14 According to Crennan J, at [4] of her reasons for judgment, the primary issue in relation to infringement was whether Mayne's product had "not been reconstituted from a lyophilizate", as that phrase appeared in claim 1 of the Patent. A secondary issue identified by her Honour was whether Mayne avoided infringement on the specific occasions on which they used sodium hydroxide, in addition to hydrochloric acid, to adjust the pH of the solution, given that claim 1 of the Patent refers to the pH being adjusted "solely with a physiologically acceptable acid". 15 On 5 August 2005, Crennan J delivered judgment. Aspects of the dispute between the parties that were dealt with by Crennan J provide relevant background to the proceedings currently before me. Her Honour found that the Patent had been infringed. However, she did not make final orders on that day. Rather, she ordered: "The parties to prepare short minutes of final orders on liability in accordance with these reasons and include any other orders or directions as appropriate for the further disposition of the matter." 16 Pursuant to her Honour's orders, each party prepared proposed minutes of final orders. On 8 September 2005, Crennan J made orders by consent, including the following order: "Until 19 June 2006 or such later date as the Court may hereafter order , the respondents and each of them, whether by themselves, their directors, officers, servants or agents or otherwise, be restrained in Australia from exploiting any anthracycline glycoside ready-to use solution as claimed in any of claims 1 to 30 (inclusive), 5 to 10 (inclusive), 13 to 15 (inclusive), 18, 19, 22, 25 and 26 of Australian patent no. 598197, save that the respondents may until further order exploit: i. doxorubicin hydrochloride injection; and ii. daunorubicin hydrochloride injection." (emphasis added) 17 The orders reflect the reasons given in her Honour's judgment. However, they gave rise to the further issue that is now the subject of the two proceedings presently before this Court. In the Pharmacia Proceeding, Mayne contends that the term of the injunction granted by Crennan J should not be extended to 19 June 2011 to cover the extension of patent granted by the Commissioner, but rather should end on 19 June 2006. In the Interpharma Review Proceeding, Interpharma challenges the validity of the extension itself. 18 Of relevance to both proceedings currently before the Court, Crennan J, at [5], summarised the three aspects of the invention to which the Patent relates: "(a) a pharmaceutical product, being a stable intravenously injectable ready-to-use solution of an antitumor anthracycline glycoside, for example, doxorubicin; (b) a process for preparing such a solution, [providing] the same in a sealed container; and (c) a method for treating tumours by the use of the ready-to-use solution." 19 These three aspects of the invention are reflected in the 26 claims of the Patent which define the invention. Using the language adopted by Crennan J in her judgment at [19], Pharmacia submits that there are 20 product ("solution") claims, four "process" claims and two "method" claims. Of course, whether that is in fact a wholly accurate characterisation of the claims is the very point in issue in the proceedings before me. 20 The parties do not contend that all the claims are in issue. Relevantly, claims 3 to 19, and claim 22 (described by Crennan J as the "solution" claims), are dependent on claim 1. If claim 1 is not properly to be characterised as a "solution" claim, but does, in fact, incorporate significant elements of "process", Pharmacia acknowledges that none of the remaining "solution" claims can lawfully be the subject of an extension. The parties are agreed that resolution of the construction of claim 1 will resolve the controversy between them. It is convenient therefore, to deal with each of the alleged "process" features in the context of claim 1. 21 Claim 1, in its current form, is in the following terms: "1. A sterile, pyrogen-free, anthracycline glycoside solution which comprises a physiologically acceptable salt of an anthracycline glycoside dissolved in a physiologically acceptable aqueous solvent therefor at an anthracycline glycoside concentration of from 0.1 to 50 mg/ml, which has not been reconstituted from a lyophilizate and the pH of which has been adjusted [to] from 2.5 to 5.0 solely with a physiologically acceptable acid." 22 As will be seen, in broad terms Mayne focuses upon the terms "dissolved", "not being reconstituted from a lyophilizate" and "adjusted" as the basis for its submission that claim 1 contains elements of process that prevent it from being the subject of a lawful extension. I should interpolate that it was common ground between the parties that the word "to", which appears in square brackets in claim 1, as set out above, but does not appear in the claim as it actually stands, should be read into it. It does not matter, for present purposes, whether that is because the word was excluded inadvertently, or whether it is necessary to insert it in order to give sensible meaning to the claim. 36 Mr Macaw QC, on behalf of Mayne, submitted that the various claims of the Patent that Crennan J found had been infringed (namely, claims 1 to 3, 5 to 10, 13 to 15, 18, 19, 22, 25 and 26) were not claims to a "pharmaceutical substance per se " within the meaning of s 78(1)(b)(i) , and therefore do not warrant any protection by injunctive relief beyond the expiry date of the original term of the Patent, 19 June 2006. 37 Mr Macaw submitted that claim 1 (and therefore the dependent claims as well) was a "product by process" claim, because of the various process elements that were included in the claim, as formulated. He contended that the introduction of "process elements" as part of the description of the product prevented claim 1 from being a claim to a "pharmaceutical substance per se ". 38 According to Mr Macaw, it followed that any infringing activity on Mayne's part was, and is, by way of exploitation of a form of the invention other than a "pharmaceutical substance per se ". As a result, by reason of section 78(1)(b)(i) , the final injunction to be granted should not continue for the extended period of the Patent but, rather, should end at the expiry of the original patent period, on 19 June 2006. 44 Mr Macaw noted that in addition to manufacturing epirubicin hydrochloride solution, Mayne manufactured anthracycline glycoside solutions such as doxorubicin hydrochloride and daunorubicin hydrochloride, neither of which was alleged, nor found by Crennan J, to infringe the Patent in the Pharmacia Infringement Proceeding. Mr Macaw contended that the scope of the injunction should therefore be limited, on a permanent basis, to include only the epirubicin hydrochloride solution that was found to infringe, and not the other anthracycline glycoside solutions, such as doxorubicin hydrochloride and daunorubicin hydrochloride, that Mayne produces. 45 It seems that the position regarding these other anthracycline glycoside solutions remains somewhat uncertain. Order 1 of the orders made by Crennan J on 8 September 2005 reflected an agreement between the parties, on an interim basis, that doxorubicin hydrochloride and daunorubicin hydrochloride should be excluded from the scope of the injunction. There was also an agreement that they be excluded from any order for damages, or an account of profits, again on an interim basis only, pending Pharmacia having further time to consider its position in relation to them. Mr Macaw submitted that given that Pharmacia had now had that opportunity, but was unprepared to commit itself to a stance, the interim position should be made permanent. 46 In the course of oral submissions Mr Macaw referred to Mayne's licence to produce doxorubicin hydrochloride and daunorubicin hydrochloride and the question of "the appropriate formulation of the injunction". He stated: "[T]he parties have attempted a commercial resolution of that matter and my instructions are that it's close and we would seek merely have that aspect of the matter adjourned to a date to be fixed" . 47 Mr Caine SC, on behalf of Pharmacia, did not have anything to say regarding this matter. It may be, therefore, that the form of the injunction granted by Crennan J will have to be varied irrespective of the outcome of this proceeding, in order to make it clear that Mayne's entitlement to manufacture its non-infringing products is not in any way impaired by that injunction. 48 Finally, Mr Macaw referred to order 2 of Crennan J's orders of 8 September 2005. That order is in the following terms: "Save for the samples referred to at paragraph 27 to 29 of the affidavit of Joanna Elizabeth Johnson sworn on 7 September 2005, the respondents, within 21 days of the date of this Order, destroy all epirubicin hydrochloride ready-to-use solutions in their possession, custody, power or control, the sale, supply or use of which by the respondents, their servants or agents or by any person to whom such epirubicin hydrochloride solution were to be supplied would be in breach of the foregoing injunction." 49 Mr Macaw contended that it was implicit that the injunction should not prevent use of the retained samples, referred to in order 2, for the particular purposes identified in the affidavit of Joanna Elizabeth Johnson sworn on 7 September 2005. In relation to this matter, Mr Macaw stated: "...I don't think I need to trouble your Honour with [the samples point] , because I understand that it's not contentious. We'll hand your Honour a form of the order which incorporates those which accommodates those matters... in due course, but we apprehend to say that that's not an issue. HIS HONOUR: So, on any view the injunction would be limited if the injunction extends beyond June of this year in the weigh [sic] group. MR MACAW: Would in any event be limited, yes. HIS HONOUR: Yes, I follow." 50 Mr Caine did not have anything to say about this matter. Accordingly, it may be necessary, once again, to vary the terms of the injunction to reflect any agreement that is reached between the parties regarding this issue. 51 Mr Caine did not contend that the "process" or "method" claims defining the invention (by which he meant claims 2, 20, 21 and 23-26) could provide a basis for the extension of the term of the Patent. He agreed that the claims in issue were limited to claim 1, and claims 3 to 19. Claim 22, though not regarded as a "process" or "method" claim, was expressly abandoned by Mr Caine during the course of the hearing. 52 Mr Caine submitted that the solution that was the subject of the Patent was plainly a "pharmaceutical substance" within the meaning of Schedule 1 of the Patents Act . He further submitted that claim 1 involved a claim in relation to a pharmaceutical substance per se. In simple terms, he argued that the injectable ready-to-use solution was a mixture of substances which had particular characteristics. Those characteristics were what I referred to in argument as "descriptors", enabling the substance to be readily defined, and differentiated from other pharmaceutical substances that were not within the protection of the Patent. 59 Finally, Mr Caine referred to the judgment of Crennan J in the Pharmacia Infringement Proceeding. He noted that her Honour had found Mayne liable for infringing Pharmacia's patent rights, and submitted that it was at least implicit in her Honour's reasoning that Mayne had been seeking to exploit a form of the invention that was a pharmaceutical substance per se . It was equally implicit in that reasoning that the product was in substance disclosed in the complete specification of the Patent and that its product fell within the scope of the relevant claims of that specification, as Boehringer required. Accordingly, he submitted, Mayne would not be able to avoid infringement by reason of s 78(1)(b)(i). It followed that the term of the injunction granted by Crennan J should extend to 19 June 2011. 60 Interpharma seeks an order of review under s 5 of the ADJR Act of the following decisions of the Commissioner: (a) the decision of 24 October 2001 to accept Pharmacia's application for an extension of the term of the Patent filed on 14 March 2001; (b) the failure on or about the 24 October 2001 to refuse Pharmacia's application for an extension of the term of the Patent; (c) the decision to grant an extension of the term of the Patent by certificate dated 6 April 2002 for five years to 19 June 2011. 61 Ms Strong SC, who appeared on behalf of Interpharma, submitted that each of these decisions was of an administrative character, and that Interpharma was, and is, a "person aggrieved" within the meaning of s 5 of the ADJR Act . Pharmacia did not take issue with these contentions. 74 Ms Strong argued that it was not until Interpharma was in a position to market doxorubicin EBEWE, in about August 2005, after the judgment of Crennan J in the Pharmacia Infringement Proceeding had been delivered, that it was reasonable to expect Interpharma to challenge the extension of the Patent. Interpharma had filed its application for review of the Commissioner's decisions on 11 October 2005, not long after her Honour's judgment had become available. According to Ms Strong, "[f]rom August 2005, Interpharma moved with great expedition". 75 It should be remembered that Interpharma also relied upon s 39B of the Judiciary Act in challenging the validity of the Commissioner's decision to grant the extension of the Patent. Ms Strong noted that there was no specific time limit, under the Federal Court Rules , for the grant of certiorari, which was the principal remedy sought. It was only necessary, as a matter of discretion, to persuade the Court that relief should not be withheld by reason of excessive delay. She submitted that in context, the delay was adequately explained. 76 Finally, Ms Strong sought to invoke s 192 of the Patents Act , as a separate basis upon which relief should be granted. That section allows for rectification of the Register. She submitted that the need to ensure that the Register was properly maintained justified the relief sought, no matter how long, or how unjustified, the delay might be. 102 It follows that, in my view, the injunction granted by Crennan J, with some minor modifications, should continue over the life of the extension of the Patent, until 19 June 2011. I will order that the parties file proposed minutes of orders giving effect to these reasons for decision. The proposed minutes of orders should also deal with any other matters the parties consider appropriate, such as the resolution of the issues discussed above at [43]-[50]. 103 That takes me to the Interpharma Review Proceeding. The first issue to be determined in that proceeding is whether claim 1 relevantly describes a "pharmaceutical substance", putting to one side any additional requirements imposed by the words " per se ". 104 In that regard, I reject the evidence given by Dr Elliott. I accept that she is a highly qualified expert, and that she genuinely holds the opinions that she expressed in her report. However, she was cross-examined to very good effect by Mr Caine who demonstrated, to my satisfaction, that Dr Elliott's view of s 70(2)(a), and the meaning of the expression "pharmaceutical substance" in the context of that section, did not accord with the law as authoritatively determined in Boehringer .