Discovery by Merck on issue of utility
15 Alphapharm presses discovery of the class of documents described as "All documents relating to the utility of the processes claimed in the Patent". Alphapharm intends to capture in this class of documents all documents reporting results of experiments which prove or disprove the allegations made in the particulars. As an example of documents that would be directly relevant, Alphapharm pointed to documents which demonstrated the conduct of experiments within claim 1 at different temperatures, and submitted that documents relating to experiments conducted at temperatures at which the claimed reaction did not occur would tend to directly support Alphapharm's case. It submitted that similar arguments would apply in relation to documents proving or disproving the allegations made in the other particulars.
16 Merck seeks orders limiting discovery in two ways. First, Merck resists the discovery of documents relating to experimental work, testing or evaluation conducted after the date of grant. Merck has agreed to discover documents up to the date of the grant. The issue is whether documents relating to work conducted post-grant are discoverable. Merck submitted that although s 18(1)(c) of the Act does not identify or suggest the date at which utility is to be determined, the relevant date is the date of the grant (or possibly earlier). It was said that if Merck's position was accepted, what Merck did after the grant was not relevant, so documents relating to experiments after that date should be excluded from discovery.
17 In support of the proposition that the date of grant was the relevant date, Merck referred to Lane Fox v Kensington and Knightsbridge Electric Lighting Company [1892] 3 Ch 424 at 431:
"To judge of utility the directions in the amended specification must be followed, and, if the result is that the object sought to be attained can be attained by the patentee, and is practically useful at the time when the patent is granted, the test of utility is satisfied." (emphasis added)
Merck also relied on Re Alsop's Patent (1907) 24 RPC 733 at 752-753 and American Cynamid Co v Ethicon [1978] RPC 667 at 677.
18 Merck also referred to the recent decision of Finkelstein J in Conor Medsystems, Inc v University of British Columbia (No 2) (2006) 68 IPR 217. His Honour considered the meaning of the words "is not entitled to the patent" which appear in the ground of revocation under s 138(3)(a) of the Act. His Honour said at [19]:
"The respondents also contend that, having regard to the use of the present tense in s 138(3)(a), a condition precedent to a revocation order is a finding that the patentees were not entitled to the patent at the time of the application for revocation (or perhaps at the time of the hearing). I am far from persuaded that this construction is correct and it seems to be contrary to the views of Cooper J in Stack v Brisbane City Council (1999) 47 IPR 525, 536 and Crennan J in JMBV Enterprises Pty Ltd v Camoflag Pty Ltd [2005] FCA 1474, [130]-[131]. But even if this construction were correct, the way in which I would read the section is that if a person were not entitled to the patent at the time of grant then, at least in most cases, that non-entitlement would be (as here) a continuing state of affairs. So there is really nothing in the point."
19 It also relied, by way of analogy, on the decision of the Full Court in Pfizer Overseas Pharmaceuticals v Eli Lilly and Co (2005)225 ALR 416 at [347] (per French and Lindgren JJ), which identified the date of grant as the relevant date for assessing whether specification was sufficient under s 40(2)(a) of the Act.
20 Merck also submitted that there was some authority supporting the proposition that utility should be determined at a date earlier than the grant, being the date of filing or the date of the invention, citing Edison & Swan United Electric Light Company v Holland (1889) 41 Ch D 28 and Patent Gesellschaft AG v Saudi Livestock Transport & Trading Co (1996) 33 IPR 426.
21 Alphapharm contended that documents within the class sought should be discovered, regardless of when the experiments were conducted. It submitted that the question of whether an invention was useful, and whether usefulness was to be assessed at a particular point in time, was a matter of fact to be determined on the basis of the particular promises made by the patentee. In the present case, the promise was not confined by time to the date of the grant. The question of whether or not the promise was fulfilled depended upon objective scientific facts (for example, whether a reaction was to be conducted at certain temperatures), such that the date at which such facts are proved or disproved was irrelevant. It likened the promise in this case to that in Norton and Gregory Ltd v Jacobs (1937) 54 RPC 271, which held that the date on which certain reducing agents would not achieve the promised result was irrelevant. A distinction was drawn between the present case and cases where a particular date is relevant because of the nature of the promise, as in Lane Fox v Kensington & Knightsbridge Electric Lighting Co [1892] 3 Ch 424. In that case, the promise was the invention would result in "improvements", which, in Alphapharm's submission, was a promise inherently confined to a particular point in time.
22 Alphapharm also submitted that it was at least arguable that s 18(1)(c) of the Act did contain an indication as to the date for determining utility. The argument was that since the paragraph requires that the invention claimed "is" useful, then where the patentee promised that a fact was true, then that fact must be correct at all times during the life of a patent.
23 In addition to the time-based exclusion, Merck argued that it should not be required to discover documents relating to the adaptation of processes for manufacturing purposes. It claimed that the issue of utility was directed at whether the invention claimed did not attain the result promised by the patentee and not whether following the directions in a patent was commercially viable (citing Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 111 ALR 205and Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171). It submitted that although documents showing that commercial manufacturing was possible might be relevant, documents relating to commercial production (such as manufacturing documents, including scale up documents) were not relevant.
24 Alphapharm claimed that manufacturing documents were relevant to utility in this case because of the particular promises of the invention which include a specific reference to commercial manufacturing capabilities. It submitted that the cases relied upon by Merck to support the irrelevance of commercial practicality were not on point because in those cases, the patentee did not promise commercial practicality. It also submitted that on Merck's evidence (being the affidavit of John Simpson sworn 2 June 2006), commercial manufacture of the process claimed in the patent did not commence until 1993. It referred to the fact that the Merck's proposed exclusion on manufacturing documents, as expressed in order 4 of its notice of motion, expressly referred to "documents relating to the adaptation of the processes claimed". Those factors, it was said, made it clear that the process the subject of the promises required adaptation in order to make them work commercially. Such documents were therefore clearly within the scope of discoverable documents.
25 As an additional or alternative basis for limiting discovery in the way proposed, Merck submitted that the Court should exercise its discretion not to order discovery beyond what Merck offered to discover, on three main bases. First, it submitted that Alphapharm's case based on inutility, as particularised, was unarguable or unlikely to succeed. Secondly, the requested discovery would be oppressive for Merck, as it would have to trawl through 17 years of documents. In support of oppressiveness, Merck relied on the affidavit of John Simpson sworn 2 June 2006. His evidence was that the documents relating to manufacture of the drug comprised over 100,000 pages, held at the plant in the Republic of Ireland. The costs to Merck of discovering those documents, including the costs of solicitors travelling to Ireland to review the documents, was estimated as being in the order of $55,000. That amount excluded any allowance for time spent by the respondent's employees in assisting with the task. Thirdly, the interests of justice would not be served by requiring further discovery because Alphapharm's case was weak and the discovery sought was a fishing expedition.
26 Alphapharm resisted the proposition that the Court's discretion should be exercised as proposed by Merck. It submitted that as a matter of policy, Merck should not be able to rely on an arbitrary date limitation on discovery to avoid having to discover documents which are directly relevant and probative.