mdroth/huggingface-course_section-5_zst huggingface dataset:
Case: The General Tire &amp; Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457
Outcome: cited
As patent specifications and claims must be construed in light of the common general knowledge of a person skilled in the art before the priority date, it is necessary to ask: who is the skilled addressee? Various descriptions have been given to the skilled addressee, including the 'notional skilled addressee', the 'uninventive skilled worker in the particular field', the 'non-inventive worker in the field', the 'person skilled in the art', the 'non-inventive hypothetical skilled addressee', and 'those likely to have a particular interest in the subject matter of the invention': Root Quality at 241 [70]-[71] per Finkelstein J. The person skilled in the art is a 'relative expression which does not identify any specific person' and may consist of a team of persons with combined skills: Root Quality at 242 [71]; see also The General Tire &amp; Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 ( 'General Tire' ) at 485. 69 There is, accordingly, an important distinction between common general knowledge and public knowledge. In General Tire at 482, the Court of Appeal illustrated the distinction by saying that each and every patent specification of the last 50 years would form part of relevant public knowledge if it is resting anywhere in the shelves of the patent office, whereas common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee the sort of person good at his or her job that could be found in real life. The Court then observed at 482 that: '... individual patent specifications and their contents do not normally form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge.' The Full Federal Court referred to this distinction, with approval, in W R Grace &amp; Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 at 492; see also Heerey J at first instance: Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace &amp; Co (1991) 22 IPR 491 at 523.
Case: NSI Dental Pty Ltd v University of Melbourne (2006) 69 IPR 542
Outcome: approved
In NSI Dental Pty Ltd v University of Melbourne (2006) 69 IPR 542 ( 'NSI Dental' ) Tamberlin J said at 570 [151]: 'At the outset, it is necessary to describe the attributes of the skilled addressee and the relevant patent area. The skilled addressee is a legal construct and is assumed to be a person, or team, who is "not 'particularly imaginative or inventive'": Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [288] per French and Lindgren JJ. This does not mean that the addressee is a technician or person with only practical and non-academic qualifications. In fields such as chemistry, the addressee can be a person or group with high level qualifications and a capacity for original research: Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411 at [30] .' 227 This test was approved by the Full Court in Pfizer at 80-83 [394]-[403] and by Crennan J in JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2005) 67 IPR 68 at 94 [134]-[136]. There is no requirement of a deliberate intent to deceive: Pfizer at 80 [394]. Insofar as the representation is based on belief, it is relevant to consider whether the belief is false or not reasonably held: see NSI Dental at 579 [207] per Tamberlin J.
Case: Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411
Outcome: cited
In NSI Dental Pty Ltd v University of Melbourne (2006) 69 IPR 542 ( 'NSI Dental' ) Tamberlin J said at 570 [151]: 'At the outset, it is necessary to describe the attributes of the skilled addressee and the relevant patent area. The skilled addressee is a legal construct and is assumed to be a person, or team, who is "not 'particularly imaginative or inventive'": Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [288] per French and Lindgren JJ. This does not mean that the addressee is a technician or person with only practical and non-academic qualifications. In fields such as chemistry, the addressee can be a person or group with high level qualifications and a capacity for original research: Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411 at [30] .' 67 Axiomatically, the identity of the person who is skilled in the art will vary with the nature of the invention and the field with which it is concerned. The level of skill which can properly be attributed to the skilled addressee will be an important determinant of his or her common general knowledge. The qualifications of the skilled addressee, the setting in which and the resources with which he or she operates, and the practices and techniques that he or she regards as commonplace and known will also be important considerations: see Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411 ( 'Alphapharm' ) at 465 [153] per Kirby J. 68 In Minnesota Mining &amp; Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 ; (1980) 144 CLR 253 ( 'Minnesota' ) at 292, Aickin J described 'common general knowledge' as: '... that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.' Aickin J went on to add that those working or studying in some fields of endeavour may make themselves familiar with all patent specifications as they become available for inspection, in one or in many countries, so that their contents become common general knowledge in that particular trade or field of manufacture in the country in question. But that is not so in all fields or in all countries. There must be evidence that the content of a patent specification has become part of the common general knowledge of those working in the relevant field before it can be regarded as part of the background knowledge and experience of the skilled addressee: at 294-295. The High Court confirmed this analysis in Alphapharm at 426-427 [31], 430-431 [44]-[45] and 434 [55].
Case: Minnesota Mining &amp; Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 ; (1980) 144 CLR 253
Outcome: approved
In Minnesota Mining &amp; Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 ; (1980) 144 CLR 253 ( 'Minnesota' ) at 292, Aickin J described 'common general knowledge' as: '... that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.' Aickin J went on to add that those working or studying in some fields of endeavour may make themselves familiar with all patent specifications as they become available for inspection, in one or in many countries, so that their contents become common general knowledge in that particular trade or field of manufacture in the country in question. But that is not so in all fields or in all countries. There must be evidence that the content of a patent specification has become part of the common general knowledge of those working in the relevant field before it can be regarded as part of the background knowledge and experience of the skilled addressee: at 294-295. The High Court confirmed this analysis in Alphapharm at 426-427 [31], 430-431 [44]-[45] and 434 [55].
Case: W R Grace &amp; Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481
Outcome: approved
There is, accordingly, an important distinction between common general knowledge and public knowledge. In General Tire at 482, the Court of Appeal illustrated the distinction by saying that each and every patent specification of the last 50 years would form part of relevant public knowledge if it is resting anywhere in the shelves of the patent office, whereas common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee the sort of person good at his or her job that could be found in real life. The Court then observed at 482 that: '... individual patent specifications and their contents do not normally form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge.' The Full Federal Court referred to this distinction, with approval, in W R Grace &amp; Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 at 492; see also Heerey J at first instance: Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace &amp; Co (1991) 22 IPR 491 at 523.
Case: Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace &amp; Co (1991) 22 IPR 491
Outcome: cited
There is, accordingly, an important distinction between common general knowledge and public knowledge. In General Tire at 482, the Court of Appeal illustrated the distinction by saying that each and every patent specification of the last 50 years would form part of relevant public knowledge if it is resting anywhere in the shelves of the patent office, whereas common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee the sort of person good at his or her job that could be found in real life. The Court then observed at 482 that: '... individual patent specifications and their contents do not normally form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge.' The Full Federal Court referred to this distinction, with approval, in W R Grace &amp; Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 at 492; see also Heerey J at first instance: Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace &amp; Co (1991) 22 IPR 491 at 523.
Case: NutraSweet Australia Pty Ltd v Ajinomoto Co Inc (2005) 67 IPR 381
Outcome: cited
In an international field such as drug discovery and development, the Court may have regard to evidence given by experts from outside Australia in assessing the state of common general knowledge of a skilled addressee or a skilled team working in Australia at the priority date: Pfizer at 63 [293]-[295]. Evidence from such witnesses may support the inference of a global pool of common general knowledge on issues relevant to the invention which would have been known to the skilled addressee in Australia: at 63 [294]; see also NutraSweet Australia Pty Ltd v Ajinomoto Co Inc (2005) 67 IPR 381 at 387-388 [29]-[32] per Finkelstein J. 73 Both Warner-Lambert and Ranbaxy called evidence from expert witnesses as to the identity of the skilled addressee in the relevant field, and as to the matters that would fall within the common general knowledge of the skilled addressee immediately before the priority dates of the 981 Patent (30 May 1986) and the Enantiomer Patent (21 July 1989). Neither party, nor any witness, suggested that the nature of the relevant field, or the identity of the skilled addressee, differed between May 1986 and July 1989. 74 Professor Christopher Easton gave evidence on behalf of Warner-Lambert. He is a professor at the Research School of Chemistry, Institute of Advanced Studies, Australian National University. He was awarded the Degree of Doctor of Philosophy by the University of Adelaide in 1981. His PhD involved research in the area of organic chemistry. In 1982, he was a Research Fellow in the Research School of Chemistry at the Australian National University, working on projects relating to organic and biological chemistry including reactions involving the biosynthesis of penicillin. From 1983 to 1986, he was a Lecturer and Senior Lecturer in the Department of Chemistry at the University of Canterbury, New Zealand. From 1986 to 1988 he was a Lecturer in the Department of Organic Chemistry at the University of Adelaide and on 1 January 1992 he was appointed a Reader in the Department of Organic Chemistry. Since 1995, he has held the positions of a Senior Fellow, Professor and Distinguished Professor at the Research School of Chemistry. From 1988, he has also been involved in numerous research projects in the field of medicinal chemistry and drug research.
Case: Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA 876
Outcome: considered
Claim 5 of the 981 Patent uses the (+/-) sign so as clearly to indicate that claim 5 was confined to racemic mixtures. That descriptor is not applied to claim 1 or other claims. Arguably, this provides a slight indication that claim 1 was not intended to be limited to racemic mixtures. It also shows that the patentee was aware of particular means by which claims could be limited to a claim to a racemic mixture. This factor is not irrelevant because it is consistent with other indicators that the patent does not exclude the individual enantiomers. However, I am not disposed to attach significant weight to it: see Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA 876 ( 'Ranbaxy UK' ) at [30] per Jacob LJ; see also the warnings given about the incautious use of the expressio unius maxim of construction in Houssein v Under Secretary, Department of Industrial Relations and Technology (NSW) [1982] HCA 2 ; (1982) 148 CLR 88 at 94 and Wentworth v NSW Bar Association [1992] HCA 24 ; (1992) 176 CLR 239 at 250.
Case: Houssein v Under Secretary, Department of Industrial Relations and Technology (NSW) [1982] HCA 2 ; (1982) 148 CLR 88
Outcome: cited
Claim 5 of the 981 Patent uses the (+/-) sign so as clearly to indicate that claim 5 was confined to racemic mixtures. That descriptor is not applied to claim 1 or other claims. Arguably, this provides a slight indication that claim 1 was not intended to be limited to racemic mixtures. It also shows that the patentee was aware of particular means by which claims could be limited to a claim to a racemic mixture. This factor is not irrelevant because it is consistent with other indicators that the patent does not exclude the individual enantiomers. However, I am not disposed to attach significant weight to it: see Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA 876 ( 'Ranbaxy UK' ) at [30] per Jacob LJ; see also the warnings given about the incautious use of the expressio unius maxim of construction in Houssein v Under Secretary, Department of Industrial Relations and Technology (NSW) [1982] HCA 2 ; (1982) 148 CLR 88 at 94 and Wentworth v NSW Bar Association [1992] HCA 24 ; (1992) 176 CLR 239 at 250.
Case: Wentworth v NSW Bar Association [1992] HCA 24 ; (1992) 176 CLR 239
Outcome: cited
Claim 5 of the 981 Patent uses the (+/-) sign so as clearly to indicate that claim 5 was confined to racemic mixtures. That descriptor is not applied to claim 1 or other claims. Arguably, this provides a slight indication that claim 1 was not intended to be limited to racemic mixtures. It also shows that the patentee was aware of particular means by which claims could be limited to a claim to a racemic mixture. This factor is not irrelevant because it is consistent with other indicators that the patent does not exclude the individual enantiomers. However, I am not disposed to attach significant weight to it: see Ranbaxy (UK) Ltd v Warner-Lambert Company [2006] EWCA 876 ( 'Ranbaxy UK' ) at [30] per Jacob LJ; see also the warnings given about the incautious use of the expressio unius maxim of construction in Houssein v Under Secretary, Department of Industrial Relations and Technology (NSW) [1982] HCA 2 ; (1982) 148 CLR 88 at 94 and Wentworth v NSW Bar Association [1992] HCA 24 ; (1992) 176 CLR 239 at 250.
Case: FAI Traders Insurance Co Ltd v Savoy Plaza Pty Ltd [1993] 2 VLR 437
Outcome: cited
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].
Case: Pfizer Inc v Ranbaxy Laboratories Limited 457 F3d 1284 (2006)
Outcome: considered
The United States Court of Appeals for the Federal Circuit adopted a similar construction of the US equivalent of the 981 Patent in Pfizer Inc v Ranbaxy Laboratories Limited 457 F3d 1284 (2006). Like the Court of Appeal in England, the Court of Appeals read the passage in the specification which specifically referred to the four possible isomers as meaning that the invention would otherwise encompass all four isomers of the compounds of structural formula I but for the patentee's express disclaimer of the R-cis and S-cis isomers: at 1289. 158 The 1990 Act governs the issue of the infringement of the 981 Patent and the grant of relief. 159 Ranbaxy has acknowledged that the question of infringement of the 981 Patent will be resolved by a determination of the proper scope of claim 1 of the patent. Specifically, Ranbaxy has admitted that the Ranbaxy Product has the active ingredient atorvastatin calcium. Ranbaxy has also conceded that if claim 1 of the 981 Patent encompasses the R-trans enantiomer of the compounds of structural formula I, its proposed importation and sale of the Ranbaxy Product would infringe claims 1 to 4 and 8 to 9 of the 981 Patent. 162 Ranbaxy has admitted that its product, with its active ingredient atorvastatin calcium, falls within the scope of claim 6 of the Enantiomer Patent. Therefore, the only matters in dispute between the parties in relation to the Enantiomer Patent are as to its validity. The validity of patents that are equivalent to the Enantiomer Patent has been litigated in England, the United States and Canada. However, the decisions in these jurisdictions do not shed any light on the invalidity issues that were contested before me: see Ranbaxy UK at [32] and [40]-[41] per Jacob LJ; Ranbaxy UK Limited v Warner-Lambert Company [2005] EWHC 2142, at [62] per Pumfrey J; Pfizer Inc v Ranbaxy Laboratories Limited , supra; Pfizer Inc v Ranbaxy Laboratories Ltd 405 FSupp2d 495 (D Del 2005) at 512-513 [22]-[27], 518 [32], 519 [35] and 520-525 [36]-[43]; see also Pfizer Canada Inc v The Minister of Health [2006] FC 1471.
Case: Pfizer Inc v Ranbaxy Laboratories Ltd 405 FSupp2d 495 (D Del 2005)
Outcome: cited
Ranbaxy has admitted that its product, with its active ingredient atorvastatin calcium, falls within the scope of claim 6 of the Enantiomer Patent. Therefore, the only matters in dispute between the parties in relation to the Enantiomer Patent are as to its validity. The validity of patents that are equivalent to the Enantiomer Patent has been litigated in England, the United States and Canada. However, the decisions in these jurisdictions do not shed any light on the invalidity issues that were contested before me: see Ranbaxy UK at [32] and [40]-[41] per Jacob LJ; Ranbaxy UK Limited v Warner-Lambert Company [2005] EWHC 2142, at [62] per Pumfrey J; Pfizer Inc v Ranbaxy Laboratories Limited , supra; Pfizer Inc v Ranbaxy Laboratories Ltd 405 FSupp2d 495 (D Del 2005) at 512-513 [22]-[27], 518 [32], 519 [35] and 520-525 [36]-[43]; see also Pfizer Canada Inc v The Minister of Health [2006] FC 1471.
Case: Pfizer Canada Inc v The Minister of Health [2006] FC 1471
Outcome: cited
Ranbaxy has admitted that its product, with its active ingredient atorvastatin calcium, falls within the scope of claim 6 of the Enantiomer Patent. Therefore, the only matters in dispute between the parties in relation to the Enantiomer Patent are as to its validity. The validity of patents that are equivalent to the Enantiomer Patent has been litigated in England, the United States and Canada. However, the decisions in these jurisdictions do not shed any light on the invalidity issues that were contested before me: see Ranbaxy UK at [32] and [40]-[41] per Jacob LJ; Ranbaxy UK Limited v Warner-Lambert Company [2005] EWHC 2142, at [62] per Pumfrey J; Pfizer Inc v Ranbaxy Laboratories Limited , supra; Pfizer Inc v Ranbaxy Laboratories Ltd 405 FSupp2d 495 (D Del 2005) at 512-513 [22]-[27], 518 [32], 519 [35] and 520-525 [36]-[43]; see also Pfizer Canada Inc v The Minister of Health [2006] FC 1471.
Case: NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655
Outcome: applied
In advancing this argument, Ranbaxy did not go beyond matters which were apparent on the face of the complete specification for the Enantiomer Patent. The specification specifically refers to and incorporates the US Patent. It also refers to the 981 Patent as relevant prior art. In this sense, Ranbaxy based its argument squarely on the ground of invalidity that was recognised in Commissioner of Patents v Microcell Ltd [1958] HCA 58 ; (1959) 102 CLR 232 ( 'Microcell' ) and NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655 ( 'Philips' ).