Case: Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444
Outcome: applied
The parties were not in dispute as to the principles that apply to the construction of the 981 Patent. I was referred to numerous authorities in which these principles have been clearly articulated, including Welch Perrin &amp; Co Pty Ltd v Worrel [1960] HCA 91 ; (1961) 106 CLR 588 ( 'Welch Perrin' ) at 610; Interlego AG v Toltoys Pty Ltd [1973] HCA 1 ; (1973) 130 CLR 461 ( 'Interlego' ) at 478 (see also Stephen J at first instance at 466); D&eacute;cor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 400; Fisher &amp; Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 22 IPR 1 at 18-19; Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 67 IPR 230 at 236 [39], 238 [52] and 245-246 [91]-[94]; Pfizer Overseas Pharmaceuticals v Ely Lilly &amp; Co (2005) 68 IPR 1 ( 'Pfizer' ) at 52-54 [247]-[250]; Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 ( 'Kirin-Amgen' ) at 452-457 [27]-[35]; PhotoCure ASA v Queen's University at Kingston (2005) 216 ALR 41 ( 'PhotoCure' ) at 85 [172] and 85-86 [168]-[174]; Sachtler GmbH &amp; Co KG v RE Miller Pty Ltd (2005) 221 ALR 373 ( 'Sachtler' ) at 380-382 [39]-[42]; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 ( 'Clorox' ) at 260-262 [13]-[22]. 64 For present purposes, however, it is helpful to refer specifically to several principles that have particular resonance with the circumstances of this case: (1) The underlying consideration in the construction of the patent is that it is a public instrument, conferring a public monopoly, that is meant to define the monopoly in such a way that it is not capable of being misunderstood: see eg Pfizer at 52 [247]. The patentee must define the invention with sufficient precision to permit the monopoly to be determined and to allow the general public to identify from the words of the claims the conduct that is prohibited: see eg Clorox at 261 [18]. (2) The claims define the invention which is the subject of the patent. They must be construed according to their terms by applying the ordinary rules of construction that apply to any written instrument: see eg D&eacute;cor at 400; Clorox at 260 [15]. (3) The claims must be construed in the context of the specification as a whole. The rest of the specification may explain the background to the claims, assist in ascertaining the meaning of technical terms, or aid in resolving ambiguities in the construction of the claims: Clorox at 260 [16]; Sachtler at 381 [42]. (4) Although the claims are to be construed in the context of the specification as a whole, 'the settled rule is that it is not permissible to vary or qualify the plain or unambiguous meaning of the claim by reference to the body of the specification': see Interlego per Barwick CJ and Mason J at 478. Further, 'it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification. Similarly, if a claim be clear it is not to be made obscure simply because obscurities can be found in particular sentences in other parts of the document': Welch Perrin at 610 per Dixon CJ, Kitto and Windeyer JJ; see also Clorox at 261 [17]. (5) A patent specification must be given a purposive rather than a purely literal construction. This involves construing the claims in a practical, commonsense manner, avoiding too technical or narrow a construction of the claims, and preferring a construction under which the invention will work to one where it may not work: Pfizer at 53-54, citing Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56. It also means construing the claims in light of what a reasonable person to whom the patent was addressed would have understood the language of the claim to mean: Kirin-Amgen at 453-454 [30], [32] and [34] per Lord Hoffman. (6) The hypothetical addressee of the patent specification is the non-inventive person skilled in the art before the priority date. The words used in the specification and the claim are to be given the meaning that the skilled addressee would attach to them, both in the light of his or her own general knowledge and what is disclosed in the body of the specification: Clorox at 261-262 [20]; D&eacute;cor at 391; PhotoCure at 85 [170]. (7) The proper construction of the specification is a matter of law for the Court to determine. However, evidence can be given by experts on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings given by such persons to words that might otherwise bear their ordinary meaning: see Clorox at 262 [21]; see also Root Quality Pty Ltd v Root Control (2000) 49 IPR 225 ( 'Root Quality' ) at 237 [49]. 146 Ranbaxy argued that the actions that Warner-Lambert had to take after 30 May 1986 to develop and market a single enantiomeric drug showed that the practical difficulties to which it pointed were very real. In particular, Ranbaxy referred to the fact that Warner-Lambert encountered difficulties with racemic atorvastatin lactone in mid 1987; at that point it decided to resolve the racemate into its individual enantiomers; and on 1 February 1989 Warner-Lambert filed a United States patent application directed to the process it had developed for the chiral synthesis of enantiomers of atorvastatin lactone. Assuming that it is appropriate on a question of construction to have regard to these subsequent events, these matters do not affect my conclusion as to the proper construction of the 981 Patent. On the evidence before me, there was a common expectation prior to 30 May 1986 that single enantiomeric drugs could be commercially produced whether by way of resolution or chiral synthesis. The fact that there were numerous single enantiomeric drugs on the market by that stage confirmed this expectation. The possibility that difficulties may be encountered in developing an enantomeric drug for commercial sale does not have the consequence, in my view, that the 981 Patent should be read down so that it only claims racemic mixtures. It must be borne in mind that the patent is concerned with the grant of a monopoly in respect of the claimed compounds for a period of 20 years. There is no reason to doubt that there was a general expectation that means could be found to develop methods of synthesising single enantomeric drugs for commercial sale over that time frame. To my mind, it is unreasonable to suppose that the patent was intended to be confined to racemates simply because difficulties might arise in the near term in producing a single enantiomeric drug on a commercial scale. In any event, I have grave doubts that subsequent conduct of the kind to which Ranbaxy refers in this argument (as distinct from the surrounding commercial circumstances at 30 May 1986) can properly be used as an extrinsic aid to the proper construction of the 981 Patent: cf FAI Traders Insurance Co Ltd v Savoy Plaza Pty Ltd [1993] 2 VLR 437; see also Kirin-Amgen at 452 [28].