mdroth/huggingface-course_section-5_zst huggingface dataset:
Case: Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc 348 F Supp 2d 713
Outcome: approved
construction, independently arrived at, accords with that of District Judge Keeley in Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc 348 F Supp 2d 713. Her Honour had to construe a claim of "An S( )-pyridobenzoxazine compound represented by [a certain formula]". Her Honour said (at 726): Thus, while it is certainly necessary to distinguish a new invention over the prior art, there is no indication that an inventor must use a plain-English purity limitation, as Mylan contends. Instead, an inventor may use anything that a person skilled in the relevant art would understand to limit the claim. In this case, the term "S( )" clearly and plainly limits the claim language to the levorotatory enantiomer. Those skilled in the art clearly understand the term "S( )" to affirmatively denote only the levorotatory enantiomer of a racemic compound, and not the racemic compound itself. Later (at 729-730) Keeley J said that those skilled in the art would have understood the claim to cover "levofloxacin with a purity that was highly, but less than 100%, optically pure". Her Honour's observations apply mutatis mutandis to the present case. While my construction would leave unanswered the question how much "impurity" would prevent a compound from meeting the formula in claim 1 (see below), it does establish that when the compound is present only as 50% of a racemate, it does not meet the description in claim 1. The construction outlined above is also supported by the body of the specification and a certain convention in the way in which chemists understand references to compounds, both discussed below, but does not depend on those two additional considerations. I rely on them as alternative bases for my construction if I am wrong in thinking that claim 1 is unambiguous. Rules of construction There is a series of decisions of the various courts of the United States in which it has been accepted that unexpected superiority in effectiveness is probative of non-obviousness: see, for example, Sterling Drug Inc v Watson 135 F Supp 173 (1955) at 175-176; In re Gershon , 372 F 2d 535 (1967) at 537; In re Skoner , 517 F 2d 947 (1975) at 950; Ex parte Sohda 2002 WL 519757 at 2-3; In re Chupp , 816 F 2d 643 (1987) at 646-647; Ortho-McNeil Pharmaceutical Inc v Mylan Laboratories Inc 348 F Supp 2d 713 at 755-756. In some of these cases it has been said that the evidence of unexpected superior clinical benefits has been admitted to counter prima facie obviousness arising from other evidence. I do not find other evidence in the present case raising a prima facie case of obviousness. In any event, this was not a basis of admissibility relied upon by Lundbeck.
Case: Pfizer Canada Inc v Apotex Inc (1998) 78 CPR (3d) 3
Outcome: referred to
the Canadian case Pfizer Canada Inc v Apotex Inc (1998) 78 CPR (3d) 3, the court stated that the doctrine of equivalents applies to compositions where there is equivalence between chemical ingredients. That approach was followed in the Canadian case Merck Frosst Canada Inc v Canada (Minister of National Health and Welfare) (2000) 8 CPR (4 th ) 48. In the later case, the court stated, quoting from the earlier one, that "basically, there is equivalence when the substituting ingredient or device 'performs substantially the same function in substantially the same way to obtain the same result'". Accordingly, the court accepted expert evidence that the chemical properties and activities of the substituted ingredient were similar to those of the ingredient that it replaced. That evidence showed that both compounds were electron withdrawing groups and would therefore allow a particular reaction to occur, resulting in the same products. Importantly, the court accepted expert evidence that "a person reasonably skilled in the art would have known of the inter-changeability of that ingredient not contained in the patent with the one that was". Accordingly, the court found infringement proved. The evidence
Case: Pfizer Overseas Pharmaceuticals v Ely Lilly &amp; Co [2005] FCAFC 224 ; (2005) 225 ALR 416
Outcome: cited
parties' written submissions referred to numerous authorities on the construction of patents, and, in particular, on the construction of patent claims. I need not refer to more than the following: The construction of a specification is a question of law and belongs to the Court: Hill v Evans (1862) 1A IPR 1 ( Hill v Evans ) at 3; The Court must construe the specification as it would be understood by the notional skilled addressee as at the relevant date: Hill v Evans at 3-4; D&eacute;cor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 ( D&eacute;cor ) at 400; Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890 ; (2000) 49 IPR 331 ( Flexible Steel Lacing ) at [81]; Evidence from a skilled addressee in the field of the invention as to how he or she would have understood the specification at the relevant date is relevant evidence for the purposes of s 55(1) of the Evidence Act 1995 (Cth) (Evidence Act): EI Dupont De Nemours &amp; Co v Imperial Chemicals Industries plc [2002] FCA 230 ; (2002) 54 IPR 304 at 320-322; Flexible Steel Lacing at [81]; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 at [21]; Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 ; (2000) 177 ALR 231 at [49] ; The claims must be construed in the context of the specification as a whole, and the rest of the specification may explain the background to the claims, assist in ascertaining the meaning of technical terms, or aid in the resolving of ambiguities in the construction of the claims: Clorox at [16]; Sachtler GmbH &amp; Co KG v RE Miller Pty Ltd [2005] FCA 788 ; (2005) 65 IPR 605 ( Sachtler ) at [42]; A patent specification must be given a purposive rather than a purely literal construction, and must be construed in a practical commonsense manner avoiding a too technical or narrow construction in favour of a construction under which the invention will work, as against one according to which it may not work: Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56; Pfizer Overseas Pharmaceuticals v Ely Lilly &amp; Co [2005] FCAFC 224 ; (2005) 225 ALR 416 ( Pfizer v Eli Lilly ) at [249]-[250]; The hypothetical addressee of the patent is the non-inventive person skilled in the art before the priority date, and the words used in the specification and the claims are to be given the meanings that that skilled addressee would give them, both in the light of his or her own general knowledge and what is disclosed in the body of the specification: Clorox at [20]; D&eacute;cor at 391; PhotoCure ASA v Queen's University at Kingston [2005] FCA 344 ; (2005) 216 ALR 41 at [170] . Professors Banwell and Davies on the meaning that the Patent claims would convey to the hypothetical skilled chemist at the priority date
Case: Pharmacia Corporation v Merck &amp; Co Inc [2002] RPC 775
Outcome: cited
so holding, the High Court rejected a less demanding "worth a try" or "obvious to try" test. Astra therefore stands for the rejection of a line of United Kingdom authority to the effect that "all of the courses of action which present themselves without the exercise of invention are obvious": Pharmacia Corporation v Merck &amp; Co Inc [2002] RPC 775 at 818 (see Astra at [54] per Gleeson CJ, Gaudron, Gummow and Hayne JJ). Their Honours explained that "[t]he tracing of a course of action which was complex and detailed, as well as laborious, with a good deal of trial and error, with dead ends and the retracing of steps [a description taken from the judgment of the trial Judge] [was] not the taking of routine steps to which the hypothetical formulator [would be] taken as a matter of course" (at [58]; also per Callinan J at [185]).
Case: Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1
Outcome: discussed
refers to three authorities as being relevant to the construction of the expression "pharmaceutical substance per se ": Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 ; (2001) 112 FCR 595 ( Boehringer ); Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 ; (2003) 57 IPR 424 ( Prejay ); and Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1 ( Pharmacia ).
Case: PhotoCure ASA v Queen's University at Kingston [2005] FCA 344 ; (2005) 216 ALR 41
Outcome: cited
parties' written submissions referred to numerous authorities on the construction of patents, and, in particular, on the construction of patent claims. I need not refer to more than the following: The construction of a specification is a question of law and belongs to the Court: Hill v Evans (1862) 1A IPR 1 ( Hill v Evans ) at 3; The Court must construe the specification as it would be understood by the notional skilled addressee as at the relevant date: Hill v Evans at 3-4; D&eacute;cor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 ( D&eacute;cor ) at 400; Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890 ; (2000) 49 IPR 331 ( Flexible Steel Lacing ) at [81]; Evidence from a skilled addressee in the field of the invention as to how he or she would have understood the specification at the relevant date is relevant evidence for the purposes of s 55(1) of the Evidence Act 1995 (Cth) (Evidence Act): EI Dupont De Nemours &amp; Co v Imperial Chemicals Industries plc [2002] FCA 230 ; (2002) 54 IPR 304 at 320-322; Flexible Steel Lacing at [81]; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 at [21]; Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 ; (2000) 177 ALR 231 at [49] ; The claims must be construed in the context of the specification as a whole, and the rest of the specification may explain the background to the claims, assist in ascertaining the meaning of technical terms, or aid in the resolving of ambiguities in the construction of the claims: Clorox at [16]; Sachtler GmbH &amp; Co KG v RE Miller Pty Ltd [2005] FCA 788 ; (2005) 65 IPR 605 ( Sachtler ) at [42]; A patent specification must be given a purposive rather than a purely literal construction, and must be construed in a practical commonsense manner avoiding a too technical or narrow construction in favour of a construction under which the invention will work, as against one according to which it may not work: Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56; Pfizer Overseas Pharmaceuticals v Ely Lilly &amp; Co [2005] FCAFC 224 ; (2005) 225 ALR 416 ( Pfizer v Eli Lilly ) at [249]-[250]; The hypothetical addressee of the patent is the non-inventive person skilled in the art before the priority date, and the words used in the specification and the claims are to be given the meanings that that skilled addressee would give them, both in the light of his or her own general knowledge and what is disclosed in the body of the specification: Clorox at [20]; D&eacute;cor at 391; PhotoCure ASA v Queen's University at Kingston [2005] FCA 344 ; (2005) 216 ALR 41 at [170] . Professors Banwell and Davies on the meaning that the Patent claims would convey to the hypothetical skilled chemist at the priority date
Case: Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 ; (2003) 57 IPR 424
Outcome: discussed
refers to three authorities as being relevant to the construction of the expression "pharmaceutical substance per se ": Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 ; (2001) 112 FCR 595 ( Boehringer ); Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 ; (2003) 57 IPR 424 ( Prejay ); and Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1 ( Pharmacia ). In Prejay a Full Court of this Court followed Boehringer . All of the claims were method claims, not product claims. The Commissioner's delegate refused an application for an extension. The Full Court agreed with the delegate that a substance that is mentioned in the context of a method claim does not meet the requirement of s 70(2)(a) that the substance per se fall within the scope of a claim (at [23] [24] per Wilcox and Cooper JJ, [28] per Allsop J).
Case: Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC (No 2) [2006] FCA 1787 ; (2006) 71 IPR 46
Outcome: referred to
is perhaps the most critical aspect of the Revocation Proceeding (and the Arrow Proceeding). This appears to be the first time an Australian patent relating to a single enantiomer has been challenged on the ground of obviousness (the obviousness ground was abandoned in Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC (No 2) [2006] FCA 1787 ; (2006) 71 IPR 46 ( Ranbaxy ) as noted by Young J at [15]).
Case: Re Application of Eli Lilly &amp; Co [1982] 1 NSWLR 526
Outcome: referred to
Re Application of Eli Lilly &amp; Co [1982] 1 NSWLR 526, it was argued by the Commissioner in an application under s 90 of the Patents Act 1952 (Cth) for an extension of term, that the patentee had not properly exploited the invention. The patent was in respect of a pharmaceutical invention called monensic acid and a new process for producing that product. The patentee had exploited and used commercially only monensin sodium, a salt of monensic acid. The Commissioner argued that the salt was a product chemically distinct from the acid.
Case: Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289
Outcome: cited
is required is that there be a real and reasonably clear disclosure in the body of the specification, taken as a whole, of the invention that is claimed in the claims so that those who may wish to exploit the invention as claimed after the patent has expired will be enabled to do so: see, for example, Soci&eacute;t&eacute; Des Usines Chimiques Rh&ocirc;ne-Poulenc v Commissioner of Patents [1958] HCA 27 ; (1958) 100 CLR 5 at 11 per Fullagar J; F Hoffman-La Roche &amp; Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 at 539; CCOM v Jiejing at 281-282; Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 at 304; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274 ( Lockwood v Doric ) at [69].
Case: Richardson-Vicks Inc's Patent [1995] RPC 568
Outcome: cited
arriving at the conclusion expressed in the last paragraph, I have read what Kitchin J has said on the present issue in Generics v Lundbeck at [231] [237] and the passages from the authorities to which his Lordship refers, namely, Richardson-Vicks Inc's Patent [1995] RPC 568 at 581 and Glaxo Group Ltd's Patent [2004] EWHC 477 ; [2004] RPC 43 at [113] . I note that my conclusion is generally in line with those three authorities.
Case: Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 ; (2000) 177 ALR 231
Outcome: cited
parties' written submissions referred to numerous authorities on the construction of patents, and, in particular, on the construction of patent claims. I need not refer to more than the following: The construction of a specification is a question of law and belongs to the Court: Hill v Evans (1862) 1A IPR 1 ( Hill v Evans ) at 3; The Court must construe the specification as it would be understood by the notional skilled addressee as at the relevant date: Hill v Evans at 3-4; D&eacute;cor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 ( D&eacute;cor ) at 400; Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890 ; (2000) 49 IPR 331 ( Flexible Steel Lacing ) at [81]; Evidence from a skilled addressee in the field of the invention as to how he or she would have understood the specification at the relevant date is relevant evidence for the purposes of s 55(1) of the Evidence Act 1995 (Cth) (Evidence Act): EI Dupont De Nemours &amp; Co v Imperial Chemicals Industries plc [2002] FCA 230 ; (2002) 54 IPR 304 at 320-322; Flexible Steel Lacing at [81]; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 at [21]; Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 ; (2000) 177 ALR 231 at [49] ; The claims must be construed in the context of the specification as a whole, and the rest of the specification may explain the background to the claims, assist in ascertaining the meaning of technical terms, or aid in the resolving of ambiguities in the construction of the claims: Clorox at [16]; Sachtler GmbH &amp; Co KG v RE Miller Pty Ltd [2005] FCA 788 ; (2005) 65 IPR 605 ( Sachtler ) at [42]; A patent specification must be given a purposive rather than a purely literal construction, and must be construed in a practical commonsense manner avoiding a too technical or narrow construction in favour of a construction under which the invention will work, as against one according to which it may not work: Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56; Pfizer Overseas Pharmaceuticals v Ely Lilly &amp; Co [2005] FCAFC 224 ; (2005) 225 ALR 416 ( Pfizer v Eli Lilly ) at [249]-[250]; The hypothetical addressee of the patent is the non-inventive person skilled in the art before the priority date, and the words used in the specification and the claims are to be given the meanings that that skilled addressee would give them, both in the light of his or her own general knowledge and what is disclosed in the body of the specification: Clorox at [20]; D&eacute;cor at 391; PhotoCure ASA v Queen's University at Kingston [2005] FCA 344 ; (2005) 216 ALR 41 at [170] . Professors Banwell and Davies on the meaning that the Patent claims would convey to the hypothetical skilled chemist at the priority date
Case: Saccharin Corporation Ltd v Anglo-Continental Chemical Works Ltd (1900) 17 RPC 307
Outcome: referred to
is little case law in Australia in relation to "mechanical equivalents" and "non-essential integers" in the context of chemical formulae. In Saccharin Corporation Ltd v Anglo-Continental Chemical Works Ltd (1900) 17 RPC 307 at 319, Buckley J held that a method claim was infringed notwithstanding that changes had been made, because the same result was achieved.
Case: Seyfang v G D Searle &amp; Co [1973] QB 148
Outcome: cited
seems to me to reflect the only practicable way in which opinion evidence of the kind given by Professor Montgomery can be dealt with. In this respect, I note the statement made by Cooke J in Seyfang v G D Searle &amp; Co [1973] QB 148 at 151: It does appear to me with the greatest respect that a system which does not permit experts to refer in their expert evidence to the publications of other experts in the same field is a system which puts peculiar difficulties in the way of proof of matters which depend on expert opinion.
Case: Soci&eacute;t&eacute; Des Usines Chimiques Rh&ocirc;ne-Poulenc v Commissioner of Patents [1958] HCA 27 ; (1958) 100 CLR 5
Outcome: cited
is required is that there be a real and reasonably clear disclosure in the body of the specification, taken as a whole, of the invention that is claimed in the claims so that those who may wish to exploit the invention as claimed after the patent has expired will be enabled to do so: see, for example, Soci&eacute;t&eacute; Des Usines Chimiques Rh&ocirc;ne-Poulenc v Commissioner of Patents [1958] HCA 27 ; (1958) 100 CLR 5 at 11 per Fullagar J; F Hoffman-La Roche &amp; Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 at 539; CCOM v Jiejing at 281-282; Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 at 304; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274 ( Lockwood v Doric ) at [69].
Case: Sydneywide Distributors Pty Ltd v Red Bull Australia Pty Ltd [2002] FCAFC 157 ; (2002) 55 IPR 354
Outcome: cited
submits that it has not been accepted in this Court that an expert's opinion is inadmissible if it is based on assumed or accepted facts that are not identified and proved, citing: Sydneywide Distributors Pty Ltd v Red Bull Australia Pty Ltd [2002] FCAFC 157 ; (2002) 55 IPR 354 ( Sydneywide ) at [16] per Branson J and [87] per Weinberg and Dowsett JJ); Neowarra v Western Australia (No 1) [2003] FCA 1399 ; (2003) 134 FCR 208 at [16] , [21] [27] per Sundberg J; Jango v Northern Territory (No 4 ) (2004) 214 ALR 608 at [19] per Sackville J; NutraSweet Australia Pty Ltd v Ajinomoto Co Inc [2005] FCA 1524 ; (2005) 67 IPR 381 at [33] per Finkelstein J; Cadbury Schweppes Pty Ltd v Darrell Lee Chocolate Shops Pty Ltd [2006] FCA 363 ; (2006) 228 ALR 719 at [7] per Heerey J.
Case: Wm Wrigley Jr Company v Cadbury Schweppes Pty Ltd (2006) 66 IPR 298
Outcome: followed
is a principle that all that is within the scope of a claim must be useful if the claim is not to fail for inutility, or, to express the matter differently, a claim is bad if it covers means that will not produce the desired result even if a skilful person would know which means to avoid: Wm Wrigley Jr Company v Cadbury Schweppes Pty Ltd (2006) 66 IPR 298 at [138] and authorities there cited. Alphapharm relies on the testimony of Professor Montgomery who was asked what the highest therapeutically useful unit dose of escitalopram was. He said that it was 20 mg of escitalopram, but that in treating obsessive compulsive disorder (OCD) clinicians normally use above that level, and that unit dosages of 30 mg and 40 mg are often used in the treatment of resistant OCD. Professor Montgomery was also asked what would be the minimum useful dose. He said that 5 mg was found to be effective in the treatment of social anxiety disorder in a very large study, but that that amount was found to be ineffective in the treatment of generalised anxiety disorder. He said that there is a general notion that one should use lower doses in the case of the elderly, and that the 5 mg dose is used for the treatment of them.
Case: Bagshaw v Scott [2005] FCA 104
Outcome: cited
my judgment, the proceedings were commenced without reasonable cause and were, from first to last, untenable: Bagshaw v Scott [2005] FCA 104 at [46] and [102]. From the outset, the proceedings had no substantial or any prospects of success, and it is clear, in my judgment, that the proceedings were commenced, maintained, and conducted vexatiously. Notwithstanding all of the above, for the reasons which follow, I think it right, in all the circumstances of this case, simply to order that, except where specific costs orders have been made with the opposite effect, the applicant pay the costs of the respondent of and incidental to the proceedings. I note that the dates that had been first set down for the hearing of the trial had to be vacated because of the inadequacy of the respondent's preparation for trial. In respect of that matter, I ordered the respondent to pay the costs of the applicant thrown away by the need to adjourn the trial of the proceedings. On 31 May 2007, I dismissed the application and set a timeframe in respect of the making of submissions as to costs.
Case: Australian Competition and Consumer Commission v Visy Paper Pty Ltd (No 2) (2004) 212 ALR 564
Outcome: cited
The context in which I need to consider this matter is somewhat unusual. In September 2004 the ACCC accepted an undertaking of indefinite duration from Harbin under s 87B of the Act which amongst other things obliged Harbin to establish, maintain and have independently audited annually a compliance program which was to have specific regard to conduct that might breach Part V of the TP Act. The undertaking is, in several respects, more expansive in its terms than would be acceptable to a Court making orders under s 86C of the Act: see Australian Competition and Consumer Commission v Visy Paper Pty Ltd (No 2) (2004) 212 ALR 564 at [55]-[56]. It has not been alleged that this undertaking has been breached. Nonetheless, a further probation order is being sought under s 86C. 3 My own view of the relief that is appropriate to be ordered is less burdensome than what is now sought by the ACCC (the amended application filed at the hearing responded to objections raised in Harbin's written submissions), but is more demanding than Harbin would concede. 4 I begin with an abbreviated version of the parties' Statement of Agreed Facts.