Wake Forest University Health Sciences v Smith & Nephew Pty Ltd (No 2)
[2011] FCA 1002
•30 August 2011
FEDERAL COURT OF AUSTRALIA
Wake Forest University Health Sciences v Smith & Nephew Pty Ltd (No 2) [2011] FCA 1002
Citation: Wake Forest University Health Sciences v Smith & Nephew Pty Ltd (No 2) [2011] FCA 1002 Parties: WAKE FOREST UNIVERSITY HEALTH SCIENCES and KCI MEDICAL AUSTRALIA PTY LTD (ACN 056 073 468) v SMITH & NEPHEW PTY LTD (ACN 000 087 507); SMITH & NEPHEW PTY LTD (ACN 000 087 507); WAKE FOREST UNIVERSITY HEALTH SCIENCES and KCI MEDICAL AUSTRALIA PTY LTD (ACN 056 073 468) File number: VID 143 of 2009 Judge: DODDS-STREETON J Date of judgment: 30 August 2011 Catchwords: PATENTS – Method and apparatus for treating wounds unlikely to heal by the use of conventional methods through negative pressure wound therapy – Common general knowledge as at priority date – Construction of claims – Meaning of integer of screen means “sufficiently rigid to prevent wound overgrowth” – Meaning of integer of screen means “sufficiently porous” to allow gases or oxygen to reach the wound – Meaning of integer of “migration of epithelial and subcutaneous tissue toward the wound” – Whether various integers essential
PATENTS – Infringement – Whether direct or indirect infringement – Whether respondent liable as joint tortfeasor – Whether respondent’s products possessed screen means sufficiently rigid to prevent wound overgrowth – Whether respondent’s products possessed other integers
PATENTS – Validity – Novelty – Whether prior art anticipated claims in suit – Whether claims in suit anticipated by prior use of open drainage system
PATENTS – Validity – Inventive step – Whether invention obvious to skilled addressee – Construction of Patents Act 1990 (Cth) ss 7(2) and (3) – Whether prior art comparator to be considered as starting point for obviousness
PATENTS – Validity – Other grounds of alleged invalidity – Whether claims in suit fairly based on matter described in specification – Whether priority date deferred – Whether invention a manner of manufacture or comprised of mere clinical desiderata – Whether invention properly defined – Whether claims invalid for lack of clarity – Whether claims invalid for lack of sufficiency – Whether claim invalid as a mere collocation
Legislation: Evidence Act 1995 (Cth) s 140
Patents Act 1990 (Cth) ss 7, 13, 18(1), 40(2), 40(3), 102(2)(a), 114, 117, 138(3), Schedule 1Patents Regulations 1991 (Cth) reg 3.14
Cases cited: Abbott Laboratories & Anor v Corbridge Group Pty Ltd & Anor (2002) 57 IPR 432 cited
Advanced Building Systems Pty Ltd & Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 cited
Ajinomoto Company Inc v NutraSweet Australia Pty Ltd (2008) 166 FCR 530 cited
Aktiebolaget Hässle v Alphapharm Pty Ltd (2000) 51 IPR 375 cited
Aktiebolaget Hässle & Anor v Alphapharm Pty Ltd (2002) 212 CLR 411 discussed
Alphapharm Pty Ltd v H Lundbeck A/S & Anor (2008) 76 IPR 618 cited
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 considered
Apotex Pty Ltd v Sanofi Aventis (2008) 78 IPR 485 cited
Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416 cited
Australian Tape Manufacturers Association v The Commonwealth (1993) 176 CLR 480 cited
Best Australia Ltd & Ors v Aquagas Marketing Pty Ltd & Ors (1988) 83 ALR 217 cited
Bitech Engineering v Garth Living Pty Ltd (2010) 86 IPR 468 cited
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 considered
British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221 cited
British Thomson-Houston Company Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49 cited
Canadian General Electric Co Ltd v Fada Radio Ltd (1930) 47 RPC 69 cited
Catnic Components Ltd & Anor v Hill & Smith Ltd [1982] RPC 183 cited
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 cited
CEPU v ACCC (2007) 162 FCR 466 cited
Commissioner of Patents v Emperor Sports Pty Ltd (2006) 149 FCR 386 cited
Commissioner of Patents v Microcell Ltd & Ors (1959) 102 CLR 232 cited
Cooper v Universal Music Australia Pty Ltd (2006) 156 FCR 380 cited
Décor Corporation Pty Ltd & Anor v Dart Industries Inc (1988) 13 IPR 385 discussed
Delnorth Pty Ltd & Anor v Dura-Post (Aust) Pty Ltd & Anor (2008) 78 IPR 463 cited
Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd (2009) 177 FCR 239 cited
Eli Lilly and Co v Pfizer Overseas Pharmaceuticals (2005) 64 IPR 506 cited
Firebelt Pty Ltd v Brambles Australia Ltd (t/as Cleanaway) & Ors (2002) 54 IPR 449 cited
Fisher & Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 103 ALR 239 cited
Flexible Steel Lacing Company v Beltreco Ltd & Anor (2000) 49 IPR 331 cited
General Tire and Rubber Co v Firestone Tyre Rubber Co Ltd (1971) 1a IPR 121 discussed
Grant v Commissioner of Patents (2006) 154 FCR 62 cited
H Lundbeck A/S & Anor v Alphapharm Pty Ltd (2009) 177 FCR 151 discussed
High Tech Auto Tools Pty Ltd v Ferocem Pty Ltd (1994) 29 IPR 337 cited
Hill v Evans (1862) 1A IPR 1 cited
Insta Image Pty Ltd & Anor v KD Kanopy Australasia Pty Ltd & Ors (2008) 78 IPR 20 considered
Kauzal v Lee (1936) 58 CLR 670 cited
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd & Ors (1998) 42 IPR 111 cited
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 applied
Kirin‑Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173 discussed
Martin v Scribal Pty Ltd (1954) 92 CLR 17 cited
Melbourne v Terry Fluid Controls Pty Ltd (1994) 28 IPR 302 cited
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 cited
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 discussed
Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd (2002) 56 IPR 248 cited
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 cited
Natural Color Kinematograph Co v Bioschemes Ltd (1915) 32 RPC 256 cited
Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd (1992) 110 ALR 449 cited
Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56 cited
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 cited
No-Fume Ltd v Frank Pitchford & Co Ltd (1935) 52 RPC 231 cited
Northern Territory of Australia v Collins & Anor (2008) 235 CLR 619 discussed
NV Philips Gloeilampenfabrieken & Anor v Mirabella International Pty Ltd (1992) 24 IPR 1 cited
NV Philips Gloeilampenfabrieken & Anor v Mirabella International Pty Ltd (1993) 44 FCR 239 cited
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 discussed
Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 cited
Palmer v Dunlop Perdriau Rubber Co Ltd (1937) 59 CLR 30 cited
Pfizer Overseas Pharmaceuticals & Ors v Eli Lilly and Co & Ors (2005) 68 IPR 1 cited
Populin v HB Nominees Pty Ltd (1982) 59 FLR 37 discussed
Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd (1999) 44 IPR 481 cited
Rodi and Weinenberger AG v Henry Showell Ltd [1969] RPC 367 cited
Root Quality Pty Ltd v Root Control Technologies Pty Ltd & Ors (2000) 49 IPR 225 cited
Sachtler GmbH and Co KG (formerly Sachtler AG) v RE Miller Pty Ltd (2005) 65 IPR 605 cited
Smith & Nephew Pty Ltd v Wake Forest University Health Sciences & Anor (2009) 82 IPR 467 considered
The Koursk [1924] P 140 cited
Thompson v Australian Capital Television Pty Ltd (1996) 186 CLR 574 cited
University of New South Wales v Moorhouse (1975) 133 CLR 1 cited
Vidal Dyes Syndicate Ltd v Levinstein Ltd and Read Holliday & Sons Ltd (1912) 29 RPC 245 citedWake Forest University Health Sciences & Anor v Smith & Nephew Pty Ltd (2009) 81 IPR 530 cited
Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 discussed
Date of hearing: 15 to 18 June 2010, 21 to 23 June 2010 and 28 to 29 June 2010 Date of last submissions: 29 June 2010 Place: Melbourne Division: GENERAL DIVISION Category: Catchwords Number of paragraphs: 832 Counsel for the Applicants: Mr B Caine with Ms H Rofe Solicitor for the Applicants: Freehills Counsel for the Respondent: Mr D Catterns with Mr A Maryniak Solicitor for the Respondent: Blake Dawson
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY
GENERAL DIVISION
VID 143 of 2009
BETWEEN: WAKE FOREST UNIVERSITY HEALTH SCIENCES
First ApplicantKCI MEDICAL AUSTRALIA PTY LTD (ACN 056 073 468)
Second ApplicantSMITH & NEPHEW PTY LTD (ACN 000 087 507)
Cross-ClaimantAND: SMITH & NEPHEW PTY LTD (ACN 000 087 507)
RespondentWAKE FOREST UNIVERSITY HEALTH SCIENCES
First Cross-RespondentKCI MEDICAL AUSTRALIA PTY LTD (ACN 056 073 468)
Second Cross-Respondent
JUDGE:
DODDS-STREETON J
DATE:
30 AUGUST 2011
PLACE:
MELBOURNE
REASONS FOR JUDGMENT
iNTRODUCTION
The first applicant and cross‑respondent, Wake Forest University Health Sciences (“WFUHS”), and the second applicant and cross‑respondent, KCI Medical Australia Pty Ltd (“KCI MA”) (collectively “KCI”), own and exploit respectively the Australian Patent 674837 (“the Patent”), which is directed at treating and healing wounds unlikely to respond to conventional treatments by the use of negative pressure. Since 1996, KCI has successfully marketed in Australia wound healing kits which constitute a commercial embodiment of the Patent. In this proceeding, KCI alleges that the respondent and cross‑claimant, Smith & Nephew Pty Ltd (“S&N”) has, since about 2008, infringed 14 claims of the Patent by selling, marketing and supplying wound healing kits including, inter alia, a foam dressing and vacuum pump for applying negative pressure, together with brochures and instructions for their use. S&N denies infringement and, by cross‑claim, alleges that the claims are invalid on a number of grounds.
For the reasons set out in detail below, I have found that S&N did not infringe any of the claims (which were all combination claims consisting of multiple integers), principally because KCI failed to establish that the S&N product possessed an essential integer common to all the combination claims. The integer in question was a screen (or dressing) sufficiently rigid to prevent wound overgrowth (“screen rigidity integer”). I have found that if (contrary to S&N’s contention) the screen rigidity integer were established, the evidence advanced by KCI was inadequate to prove its presence in the S&N product. More fundamentally, the evidence, in my view, established that the integer did not have the functional operation as claimed, lacked scientific meaning and was inherently unsound.
As S&N acknowledged, because the essential screen rigidity integer common to all the combination claims could not be established, its challenge to the validity of the claims based on novelty necessarily failed (as the purported integer was absent from the prior art). Nor, in my view, did S&N establish that the claims were invalid on the ground of obviousness (lack of inventive step). The fundamentally flawed nature of the screen rigidity integer nevertheless, in my view, rendered all the claims invalid on the basis of failure to satisfy the requirements of ss 40(2) and (3) of the Patents Act 1990 (Cth) (“the Act”) that, inter alia, they be clear and sufficient, as, despite the evidence of KCI’s expert witnesses, the evidence as a whole established that the skilled addressee would attribute no meaning to the integer. This was thus a rare case where fundamental lack of clarity in an essential integer rendered the claims invalid.
Background
WFUHS is the proprietor of the Patent, which is described in more detail further below (see [33] to [67]) and briefly summarised here. KCI MA is the exclusive Australian licensee of the invention, which carries out its commercial exploitation.
In summary, the invention includes both a medical apparatus and a method for applying negative pressure to wounds which are unlikely to heal completely or at all by the use of conventional means.
The Patent is entitled “Method and Apparatus for Treating Tissue Damage”. It has a total of 123 claims in all and 18 independent claims, directed to the five aspects of the invention. The 14 claims in suit are all combination claims with multiple integers. They relate to either of two aspects of the invention, namely a method of treatment or an apparatus. At the outset, there were 40 claims in suit, which expanded to 70, reduced to 16, and ultimately reduced to the 14 claims remaining in issue.
The invention was made at Wake Forest University in North Carolina, USA by Dr Louis Argenta, a plastic surgeon, and Dr Michael Morykwas, a bioengineer.
The Patent has a priority date of 14 November 1991 (subject to S&N’s cross‑claim discussed below, which alleges a deferred priority date of 7 November 1996).
The Patent results from an application under the Patent Co‑operation Treaty (“PCT”) no. PCT/US92/09649 filed on 12 November 1992, claiming priority from US Application No. 792001, filed on 14 November 1991. (By s 88 of the Act, the PCT application is treated as a complete application for a standard patent). As filed, the specification had 52 claims.
When the application was examined by the Commissioner of Patents, the Examiner, pursuant to s 45 of the Act, reported that “there are lawful grounds of objection to… the complete specification”, because, broadly, specified claims did not define the invention as described. Thus, while the specification, as a whole, indicated that a “screen means” or dressing, made of material sufficiently porous to allow oxygen to reach the wound and sufficiently rigid to prevent wound overgrowth, was part of the invention, the claims did not include that feature.
On 10 October 1996 and 7 November 1996, following the Examiner’s report, the patentee included new claims and made amendments pursuant to which all the claims in suit refer to a screen means sufficiently porous to allow oxygen to reach the wound and sufficiently rigid to prevent wound overgrowth.
KCI product: V.A.C.® Therapy System
KCI’s commercial embodiment of the invention the subject of the Patent is the V.A.C.® Therapy System, an apparatus produced and marketed under the trademark “V.A.C.” It is a system of negative pressure wound therapy (“NPWT”). The product comprises a vacuum pump and a foam dressing kit, which includes a foam dressing (referred to in the Patent as a “screen means”), adhesive plastic films or drapes (referred to in the Patent as the “seal”), and connector tubes. KCI launched the V.A.C.® Therapy System worldwide (including Australia) in 1996 and has produced, promoted and marketed the product since that date. Broadly, although there are some variations, the V.A.C.® product is applied as follows:
(a)the foam dressing (screen means) is first cut to fit the size and shape of the patient’s wound (or “defect”) and placed in the wound;
(b)the adhesive film (“seal”) is placed over the dressing, extending beyond it, and adheres to the patient’s healthy skin on the periphery of the wound;
(c)the connector tubes (which have small perforations at the insertion end) are inserted into the foam dressing and connected to the vacuum pump, and hence to the wound; and
(d)when the vacuum pump is switched on, it results in the application of negative pressure (colloquially, suction) to the wound.
The V.A.C.® kits come with different sizes (small, medium and large) of foam dressing which is, in any event, cut to fit the size and shape of the wound being treated.
The treatment of a large wound using the KCI kit with a plastic film seal was demonstrated to the court by a film taken by Dr Pohl, an expert witness called by KCI.
KCI MA has a sales turnover of approximately AUS$25 million per annum, approximately 98% of which is attributable to the KCI V.A.C.® Therapy System.
Following its introduction to Australia, the V.A.C.® Therapy System has been used by relevant sectors of the medical profession in Australia for wound management in appropriate cases.
It was not disputed, and all expert witnesses attested, that the application of the therapy has had a positive impact on the treatment of wounds that are difficult to treat by conventional methods and significantly improved patient care and outcomes.
S&N product: NPWT system
S&N is the largest wound care company in Australia. It is a subsidiary of a large multinational medical device and consumables company that supplies devices (including prosthetic joints, orthopaedic screws, pins and fixing devices), surgical equipment and wound dressings.
In May 2008 (about 12 years after KCI launched its product in Australia and worldwide), S&N launched two NPWT kits for applying negative pressure to wounds under the names “VISTA” and “EZCARE” in the Australian market. Initially, the S&N kits contained gauze, rather than foam, as the dressing (or screen means). Although some claims in suit (the method claims) do not specify that the screen means be foam, KCI does not allege that S&N kits containing gauze infringe the Patent. In about December 2008, however, S&N introduced kits which included foam for the screen means or dressing. KCI alleges that the S&N foam kits infringe specified claims of the Patent.
In June 2009, KCI obtained an interlocutory injunction restraining S&N from selling or disposing of its kits on the basis of its alleged infringement of claim 49 of the Patent: see Wake Forest University Health Sciences & Anor v Smith & Nephew Pty Ltd (2009) 81 IPR 530. On appeal, as discussed below, the Full Court set aside the injunction, holding that claim 49 (because it included an aseptic package which, while an essential integer, did not interact purposefully and functionally with the other integers) was invalid as a mere collocation: see Smith & Nephew Pty Ltd v Wake Forest University Health Sciences & Anor (2009) 82 IPR 467 (“Wake Forest”).
The S&N NPWT system consists of:
(a)a vacuum pump (VISTA, RENASYS EZ, RENASYS GO and EZCARE);
(b)a foam dressing kit (RENASYS-F) which includes a foam dressing with a channel in the top where the drain tube is located, adhesive plastic films (drapes) and a connector tube or tubes perforated at one end; and
(c)a foam dressing kit (RENASYS-F/P) which includes a foam dressing, adhesive plastic films (drapes) and connector tubes, which differs from the RENASYS-F in that the tube is connected to the foam by a central, disc‑shaped pad which does not pierce the film. (The RENASYS-F/P is not alleged to infringe claims 50 and 52 of the Patent).
S&N’s foam dressing kits are intended to be used in conjunction with S&N’s vacuum pumps (which were either available prior to the introduction of the foam dressing kits or accompanied their introduction) in order to deliver negative pressure to the wound to promote wound healing. On visual inspection, unlike foam in the KCI kits, the foam in the S&N kits (other than the RENASYS‑F/P) has a channel in the top where the drain tube (perforated at one end) is located. S&N markets its NPWT systems with brochures and instructions explaining the intended use of S&N’s vacuum pumps and foam dressing kits. Some of the S&N devices have one tube while others have two, which can be connected to each other to provide more space. It was not disputed that, broadly speaking, the S&N foam dressing kits are applied and operated in the same way as the V.A.C.® kits.
S&N publications
S&N published user guides for its “EZCARE”, “VISTA”, “RENASYS EZ” and “RENASYS GO” vacuum pumps, an instruction sheet for the “RENASYS‑F” foam dressing kit and a report of an expert panel meeting held in February 2009 regarding NPWT.
User guides
The user guides for each S&N product are similar to one another. All user guides state that the device may promote wound healing, and that it is appropriate for use on a range of wounds, such as pressure ulcers and traumatic wounds. The guides set out steps for dressing a wound and indicate that the wound dressing or sealing kit should be changed 48 hours after the initial application of therapy.
The guides provide instructions for the selection and installation of a canister kit, and methods for operating the device. Each states that there are two modes of operation: constant/continuous and intermittent. In the intermittent mode, the device alternates between periods of active suction and periods of no active suction. The guides state that “constant [or continuous] mode is recommended for NPWT”.
The guides also provide advice on, inter alia, issues such as troubleshooting, maintenance, cleaning and storage of the device.
While the EZCARE and VISTA user guides refer only to gauze dressing, the RENASYS EZ and RENASYS GO guides provide instructions on the application of both gauze and foam dressing, while indicating that foam dressing may not be available in all markets.
Instruction sheet for RENASYS-F foam dressing kit
The instruction sheet states that the RENASYS-F foam wound dressing kit is intended to be used in conjunction with the S&N NPWT systems. The kit is intended for use on various wounds, including chronic, acute and traumatic wounds.
The instruction sheet sets out warnings and precautions for the use of the device. It includes a warning not tightly to pack or force foam into any areas of the wound, and a direction that all pieces of foam should be removed from the wound during dressing changes. It also instructs that negative pressure wound therapy should remain on the “constant” mode for the duration of the treatment.
The instruction sheet sets out steps for the application of the foam dressing, including cutting the foam to the appropriate size to fill the wound cavity, covering the foam with transparent film, inserting a drain through a small hole in the film, creating a seal, and testing the pump to ensure that the seal is secure. It specifies that dressings should be changed every 48 hours and more frequently for infected or heavily draining wounds.
Report of expert panel meeting
The report of the expert panel meeting summarises presentations given by various experts on NPWT at a meeting held in Milan on 13 and 14 February 2009, apparently sponsored or hosted by S&N.
The report indicates that, inter alia, Professor Raymond Dunn speculated on the possible mechanisms by which the therapy appears to stimulate healing, such as removal of wound fluid and bacteria and promotion of granulation tissue formation. Dr Malmsjo considered that the therapy may stimulate wound healing by a combination of increased and decreased blood flow, and that continuous pressure and intermittent pressure can both provide therapeutic benefits, depending on the wound type. The experts agreed that further work was needed to determine how NPWT achieves its beneficial effects.
THE PATENT
The Patent is entitled “Method and Apparatus for Treating Tissue Damage”. It specifies a priority date of 14 November 1991 and a publication date of 15 June 1993. The applicant for the patent is Wake Forest University.
Field of invention
The Patent states that the invention “relates generally to wound healing, and more specifically is directed at wounds that are unlikely to heal completely under conventional methods.”
Background of the invention
Under “Background of the Invention”, the Patent identifies the current deficiencies in wound treatment it aims to solve. It states that:
The treatment of open wounds that are too large to spontaneously close has been a troublesome area for many years. Wound closure requires that epithelial and subcutaneous tissue adjacent to the wound migrate toward and eventually close the wound. Some wounds are sufficiently large or infected that they are unable to close spontaneously. In such instances, a zone of stasis, an area in which localized swelling of tissues restricts the flow of blood to these tissues, forms near the surface of the wound. Without sufficient blood flow, the wound is unable to successfully fight bacterial infection and accordingly is unable to close spontaneously.
The Patent states that “the most common technique for closure of open wounds has long been the use of sutures or staples”, which mechanical closure methods “provide tension on the skin tissue at the wound border that encourages epithelial tissue to migrate toward the wound and cover it”. The major drawback of suturing or stapling wounds (while widely practised) is that the associated stress may cause the wound to burst open and, in any event, the methods are simply not feasible for all wounds. The Patent describes the problems and examples of affected wounds thus:
[T]he tensile force required to achieve closure with sutures or staples causes very high localized stresses at the suture insertion points, resulting in the rupture of the tissue at these points. Substantial rupture will eventually cause dehiscence in some wounds, which results in additional tissue loss. Moreover, some infected wounds harden and inflame to such a degree that closure by suturing is not feasible. Wounds not reparable by suturing or stapling generally require prolonged hospitalization, with its attendant high costs, and major surgical procedures, such as grafts of surrounding tissue. Examples of such wounds include large, deep, open wounds, pressure sores resulting from prolonged pressure, ulcers resulting from chronic osteomyelitis, and partial thickness burns that subsequently develop into full thickness burns.
The Patent states that a method for treating wounds not reparable by the mechanical closure methods of suturing or stapling was required, as:
To date, there has been no consistently satisfactory method for treating such wounds. What is needed is a method of closing the wound without the localized stresses that accompany suturing while at the same time treating any infection present in the wound along with a simple apparatus to carry out the method. Such a method and apparatus would reduce hospitalization and increase the probability of wound closure.
Summary of the invention – the five aspects
Under “summary of the invention” the Patent sets out five aspects of the invention, as follows:
(a)A first aspect of the invention is a method of treating tissue damage which comprises applying negative pressure to a wound over an area sufficient to promote the migration of epithelial and subcutaneous tissue toward the wound and for a time period sufficient to facilitate closure of the wound. The method is particularly useful for treating pressure sores.
(b)A second aspect of the invention is applying negative pressure to a burn wound area for long enough to inhibit it from getting deeper. (This aspect of the invention was of limited relevance to the present case, as KCI did not allege infringement, and S&N did not challenge the validity, of the burns claims of the Patent).
(c)A third aspect of the invention is applying negative pressure for long enough to reduce bacterial density so surgical closure can be attempted. (Again, in this case, the burns claims were not alleged to have been infringed or to be invalidated).
(d)A fourth aspect of the invention is a method of enhancing the attachment of adjacent tissue to a wound, comprising the application of negative pressure to a joined complex of wound and adjacent living tissue at sufficient magnitude and for a sufficient time to promote the migration of epithelial and subcutaneous tissue toward the complex. A preferred use of this method is enhanced attachment of adjacent tissue to tissues of the wound edge. Another use is enhanced attachment of an open skin graft.
(e)A fifth aspect of the invention is an apparatus for facilitating the healing of wounds which comprises:
vacuum means for creating a negative pressure on the area of tissue surrounding the wound, sealing means operatively associated with the vacuum means to maintain the negative pressure on the wound, and screen means for preventing the overgrowth of tissue in the wound area. A preferred embodiment of the invention comprises a section of open cell foam configured to be placed over a wound, a flexible tube inserted into the foam section for attachment to a suction pump, a flexible polymer sheet overlying the foam section and tubing and configured to be adhered to the skin surrounding the wound.
(emphasis added)
The Patent displays the following two drawings showing cross‑sectional views of negative pressure devices, which are briefly described.
The description states that Figure 2 shows a cross‑sectional view of a negative pressure device comprising, inter alia, a porous screen and “an inflatable cuff attached to a semi‑rigid cup”.
Detailed description of the invention
The Patent describes:
a method of treating tissue damage which comprises the stages of applying negative pressure to a wound over an area sufficient to promote migration of epithelial and subcutaneous tissue toward the wound, with the negative pressure being maintained for a time sufficient to facilitate closure of the wound. Wound closure requires that epithelial and subcutaneous tissue migrate from the wound border toward the wound. The use of negative pressure provides tension on this border tissue that causes accelerated tissue migration. It has been observed that the use of the method also causes within the wound increased formation of granulation tissue, a matrix of collagen, fibronectin, and hyaluronic acid carrying macrophages, fibroblasts, and neovasculature that aids in healing.
(emphasis added)
The Patent states that the method is particularly suitable for use on pressure sores which can become infected, serious and even fatal, as negative pressure promotes the migration of wound border tissue, allowing healing. It is also suitable for decreasing the bacterial density in a wound by at least half, for burns to prevent them from becoming “full thickness” burns, and to enhance the attachment of living tissue flaps and open skin grafts, by promoting migration of epithelial and subcutaneous tissue towards the wound tissue complex, thus reducing the bacterial density and improving blood flow to the wound and “thereby improving the attachment of the grafted tissue”.
The Patent states that the method can be practised with the application of substantially continuous negative pressure (where the pressure is relieved only to change the dressing) or cyclically (alternate periods of application or non‑application). The ratio of application to non‑application can be as low as 1:10 or as high as 10:1, but is most preferably 1:1. A preferred pattern is five minutes of application followed by five minutes of relief. The Patent states preferable negative pressure ranges of 0.5 to 0.8 atmospheric and that the time period for using the method was:
preferably at least 12 hours but can be, for example, 1 day, 2 days, 5 days, 7 days, 14 days, 30 days or even longer. There is no upper limit beyond which use of the method is no longer beneficial; the method increases the rate of closure up to the time the wound actually closes.
The Patent describes in more detail the apparatus for facilitating the healing of wounds:
The apparatus comprises vacuum means such as a pump for creating a negative pressure on the area of skin surrounding the wound, sealing means such as an adhesive sheet operatively associated with the vacuum means for maintaining negative pressure on the wound by contacting the skin surrounding the wound, and screen means such as an open‑cell foam section located within the sealing means for preventing the overgrowth of tissue in the wound area.
(emphasis added)
In relation to the screen means, the Patent states:
The screen means is placed over substantially the expanse of the wound to prevent its overgrowth. The size and configuration of the screen can be adjusted to fit the individual wound. It can be formed from a variety of porous semi–rigid materials. The material must be sufficiently porous to allow oxygen to reach the wound, and sufficiently rigid to prevent wound overgrowth. Most preferred is the use of an open‑cell polymer foam, which permits direct connection of the screen means to the vacuum means through a flexible hose inserted into the foam. Such foam can vary in thickness and rigidity, although it is preferred that a spongy material be used for the patient’s comfort if the patient must lay upon the device during its operation. It can also be perforated to reduce its weight. Another embodiment comprises a section of honeycombed polyethylene sheet cut to the shape of the wound.
(emphasis added)
In relation to the sealing means, the Patent states:
Possible sealing means include a flexible sealing rim contacting the skin surrounding the wound, a flexible polymer sheet overlying the screen means and the vacuum means attached to the skin through an adhesive applied to the sheet surface facing the skin, and an inflatable sealing cuff that conforms to the skin when inflated and that is held in place by the suction of the vacuum means. If an adhesive sheet is used, it must have sufficient adhesion to remain in contact with the skin and form a seal under the negative pressure. Additionally, it must be sufficiently flexible to overlay the screen means and still conform to the skin around the wound. The sealing means also can include a semi‑rigid cup that protects the wound from external contact. For example, a suitable cup‑cuff assembly is provided by an adult CPR mask with an inflatable sleeve.
In relation to the vacuum means, the Patent states:
Suitable vacuum means includes any suction pump capable of providing at least [indecipherable] pound [per square inch (690 Pa)] suction to the wound, and preferably up to 3 pounds [per square inch kPa] suction, and most preferably up to 14 pounds [per square inch (96.6kPa)] suction, and a flexible hose that leads from the pump to a point within the pressurized volume created by the sealing means. The pump can be any ordinary suction pump suitable for medical purposes that is capable of providing the necessary suction. The dimension of the tubing are limited only by the pump’s ability to provide the suction level neede [sic] for operation. A ¼ inch [(0.64cm)] diameter tube has proven suitable. The vacuum means may operate substantially continuously, or may operate cyclically with alternate periods of application and nonapplication of pressure to the wound.
The Patent describes a preferred embodiment of the invention as shown in Figure 1 (see [39]).
The examples
The Patent further explains the invention by reference to the following eight examples:
(a)Two full thickness defects were made on each of a number of pigs. When negative pressure was applied to only one of the defects using a cup, the data showed an increased rate of wound closure and formation of granulation tissue at a statistically significant rate.
(b)Three burns were deliberately created on pigs. Suction apparatus cups were used to apply suction to two of the three burns. The burns thus treated were healthier and healing more quickly than non‑suctioned burns.
(c)Two wounds on each of a number of pigs were injected with cultures of bacteria broth. One of the wounds was treated with negative pressure using a suction cup. On average, the non‑treated wound was still infected after seven days, while the suctioned wound was disinfected after four days.
(d)A 45 year old diabetic paraplegic patient had a pressure sore and ulcer. When a flap was taken and placed onto the wound, it “dehisced”, resulting in a large open wound. Negative pressure was applied by the use of a device (not the cup) and the wound healed after six weeks.
(e)A 51 year old amputee had a large pressure sore for seven months, measuring eight inches x three inches at its widest. Cyclical negative pressure was applied and the wound reduced to three inches x one and a half inches after five weeks of treatment. It then had healthy granulation tissue which could accept a graft, and subsequently healed completely.
(f)A 50 year old patient had a colostomy revision which required wound dehiscence and evisceration. A large reduced pressure cup device was used and continuous negative pressure was applied. The wound became suitable for graft in parts and the remaining areas were closed with dressing changes.
(g)A 39 year old accident victim had an open ulcer and exposed bone on the ankle (due to osteomyelitis caused by an accident). Continuous negative pressure was applied using a cup device. After 14 days, granulation tissue had grown and the wound was smaller. It was healed with a graft.
(h)A burns victim had second and third degree burns to the face and upper extremities, including the hands. The hand was treated with vacuum applied cyclically (five minutes on and off) using a reduced pressure device until the necrotic tissue sloughed off or was excised, followed by split thickness skin graft placement.
The Patent noted that the above examples were illustrative of the invention and not limiting thereof.
The Patent stated that the invention was defined by the claims which it set out.
The claims in suit
KCI alleges that S&N has infringed claims 1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 49, 50, 52 and 121 of the Patent by entering the Australian market with NPWT system foam dressing kits which can be used with both existing and new S&N NPWT vacuum pumps. The 14 claims in suit consist of 11 method claims and three apparatus claims.
Method claims
Claim 1 is a method claim. Claims 2, 3, 6, 7, 8, 9, 10, 11 and 12 are claims dependent on claim 1. Claim 121 is also a method claim. They are as follows.
Claim 1:
A method of treating tissue damage which comprises the steps of:
placing a screen means for preventing overgrowth of tissue in a wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth, and
applying a negative pressure to said wound over an area sufficient to promote migration of epithelial and subcutaneous tissues toward the wound, with said negative pressure being maintained for a time sufficient to facilitate closure of the wound.
(emphasis added)
Claim 2:
A method according to claim 1, in which said negative pressure is maintained for a time sufficient to permit the formation of granulation tissue in the wound.
Claim 3:
A method according to claim 1, in which said wound is a pressure sore.
Claim 6:
A method according to claim 1, in which said time is at least 12 hours.
Claim 7:
A method according to claim 1, in which said time is at least 3 days.
Claim 8:
A method according to claim 1, in which said pressure is applied substantially continuously.
Claim 9:
A method according to claim 1, in which said negative pressure is cyclically applied in alternate periods of application and non application.
Claim 10:
A method according to claim 9, in which the ratio of said period of application to said period of non application is at least 10:1.
Claim 11:
A method according to claim 9, in which the ratio of said period of application to said period of non application is at least 1:1.
Claim 12:
A method according to claim 9, in which the ratio of said period of application to said period of non application is at least 1:10.
Claim 121:
A method of treating a wound comprising the steps of:
placing a screen means in the wound for preventing overgrowth of tissue in the wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth;
applying a reduced pressure to the wound; and
maintaining said reduced pressure until the wound has progressed toward a selected stage of healing, wherein said maintaining of said reduced pressure is conducted in alternating periods of application and non‑application of reduced pressure.
(emphasis added)
Apparatus claims
Claim 49 is an apparatus claim. It is as follows:
An apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal comprising:
a screen means for positioning beneath said seal for preventing overgrowth of tissue in the wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth, said screen means comprising an open cell polymer foam section configured to overlie the wound such that said negative pressure is maintained within said foam and applied to the wound;
a flexible tube having an inlet end inserted into said open cell polymer foam section and an outlet end for extending from beneath said seal and for supplying said negative pressure; and
wherein said apparatus is in an aseptic package.
(emphasis added)
Claim 50 is an apparatus claim as follows:
An apparatus for treating a wound, comprising:
a screen means for preventing overgrowth of tissue in the wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth, said screen means comprising an open‑cell foam section configured to overlie the wound;
a fluid‑impermeable cover overlying said foam section, said cover adapted to form a seal with skin surrounding the wound for maintaining negative pressure beneath said cover; and
a single tubular member having a first end inserted beneath at least a portion of the foam section and having a second end extending from beneath said cover to a location external to said cover for supplying negative pressure beneath the cover.
Claim 52 is an apparatus claim dependent on claim 50. It is as follows:
The apparatus of claim 50 wherein said first end of the tubular member is embedded within the foam section.
KCI seeks injunctive relief restraining S&N’s allegedly infringing conduct, together with damages for infringement from the time of the introduction of the S&N foam kits.
Cross-claim
By cross‑claim, S&N alleges that the claims it has allegedly infringed are invalid on the following grounds:
(a)lack of novelty;
(b)lack of inventive step;
(c)manner of manufacture (method of human treatment/mere desiderata);
(d)failure to define the invention;
(e)lack of clarity;
(f)lack of fair basis;
(g)lack of sufficiency; and
(h)in relation to claim 49 only – mere collocation.
As discussed below, S&N contended (as an overarching defence to infringement) that the essential functional integer in the Patent of a screen means “sufficiently rigid to prevent wound overgrowth” was meaningless and a scientific nonsense. S&N conceded that the success of its defence based on the absence of that integer would be inconsistent with its allegation that the claims were invalid for want of novelty, because the relevant integer, consequently, could not be present in the prior art. It nevertheless pressed its allegations of invalidity on other grounds.
Further, by cross‑claim S&N alleged that the priority date for the Patent claims is not 14 November 1991, but 7 November 1996. If the claims in suit are otherwise valid, and the later priority date applies, it will be necessary to take account of additional prior art and, indeed, the presence in the Australian market of the KCI kits.
By the order of Sundberg J made on 16 November 2009, the issues of infringement and validity of the claims in suit are to be determined prior to any determination of damages or other relief.
WITNESSES
KCI relied on the evidence of the following witnesses:
(a)Mr Peter Hickey, who swore affidavits dated 2 March 2009 and 24 March 2009 and was cross-examined. Mr Hickey was the Managing Director of KCI MA and, since November 2008, Regional Managing Director for the KCI group across South East Asia, South Korea and the Pacific region. He has a general nursing qualification and a Masters of Business Administration;
(b)Professor Donald Marshall, who swore affidavits dated 17 September 2009 and 3 March 2010 and was cross-examined. After graduating from medical school in 1957, Professor Marshall’s career in plastic surgery spanned over 45 years, including positions held at the Royal Melbourne Hospital and Prince Henry’s Hospital;
(c)Dr Robert Wilkins, who affirmed an affidavit dated 4 March 2010 and was cross-examined. Dr Wilkins was a biomedical engineer with a Bachelor of Mechanical Engineering, a Masters in Biomedical Engineering and a PhD in medicine. He has practised biomedical engineering since 1980;
(d)Mr Taliesin Ellis, who swore an affidavit dated 9 March 2010 and was cross‑examined. Mr Ellis was a registered nurse and Managing Director of WoundHeal Australia, an organisation offering, inter alia, wound management practice and training programs; and
(e)Dr Miklos Pohl, who affirmed an affidavit dated 9 March 2010 and was cross-examined. Dr Pohl was a consultant plastic surgeon at the Peter MacCallum Cancer Centre and the Skin and Cancer Foundation, and Head of the Department of Plastic Surgery with Western Health in Victoria. He was also Clinical Senior Lecturer in surgery at the University of Melbourne.
S&N relied on the evidence of the following witnesses:
(a)Professor Anthony Penington, who swore affidavits dated 19 March 2009, 23 December 2009 and 12 April 2010 and was cross-examined. Professor Penington held Bachelor degrees in medicine and surgery and specialised in plastic surgery since 1992. He was Associate Professor in the Department of Surgery, St Vincent’s Hospital, University of Melbourne, and a consultant plastic and reconstructive surgeon at St Vincent’s Hospital and the Royal Children’s Hospital;
(b)Professor Michael Stacey, who swore affidavits dated 11 December 2009 and 9 April 2010 and was cross-examined. Professor Stacey was Professor of Surgery at the University of Western Australia and Head of the Department of Vascular Surgery at Fremantle Hospital. He obtained Bachelor degrees in medicine and surgery in 1977, a Doctor of Surgery in 1991, and has edited journals on wound management;
(c)Professor Roy Kimble, who swore an affidavit dated 14 December 2009 and was cross-examined. Professor Kimble was Professor of Paediatrics and Child Health at the University of Queensland, Royal Children’s Hospital Brisbane, and has practised medicine for 25 years. He obtained a Doctor of Medicine from the University of Queensland in 2008;
(d)Dr Randolph Williams, who swore affidavits dated 22 December 2009 and 9 April 2010 and was cross-examined. Dr Williams was Head of Surgical Service and Senior Visiting Surgeon at Modbury Public Hospital, and has run a private surgical consulting practice since 1982. He was also Clinical Lecturer at teaching hospitals associated with the University of Adelaide; and
(e)Mr Roger Osmond, who affirmed affidavits dated 23 December 2009 and 8 April 2010 and was cross-examined. Mr Osmond has 28 years’ experience working in the medical equipment field and was, until recently, National Product and Business Development Manager of a radiology solutions company.
While both parties expressed reservation or muted criticism about the approach of some opposition witnesses, and the evidence of some witnesses on certain issues was more consistent, cogent, persuasive and hence, ultimately to be preferred over that of others, I considered that all the above were honest, responsive and highly conscientious witnesses who did their best to assist the court to determine the complex, voluminous and specialised issues in this case.
Written submissions
The parties relied on voluminous written submissions, some aspects of which were not addressed in oral submissions. They were as follows:
(a)outline of applicants’ submissions on validity dated 28 June 2010;
(b)outline of applicants’ submissions on infringement dated 28 June 2010; and
(c)outline of respondent/cross‑claimant’s submissions dated 28 June 2010.
Technical background
The parties’ expert witnesses were in broad if not complete agreement about the nature and various types of wounds and the natural processes and stages of wound healing.
A wound is a type of tissue damage which involves a break in the skin and may also, but not necessarily, involve breaks in the subcutaneous layers of tissue. There are many types of wounds, including acute wounds arising from surgery or trauma, wounds involving underlying fistulae, chronic wounds which (however they arose) will not heal (such as various leg ulcers, diabetic foot ulcers and pressure sores) and burns. Wounds may be classified as either uninfected or infected.
There are three common mechanisms of wound closure. The first, closure by primary intention, occurs where the non‑infected wound’s edges can (after any necessary removal of material) be aligned and mechanically closed by, typically, sutures or staples. Alternatively, a skin graft or flap may be applied to close the wound.
The second method is a variant of the first, known as delayed primary closure. That occurs if the wound cannot be sutured or stapled within a short time, because, for example, it requires (for up to three days after injury) cleaning, monitoring or debridement, after which it is sutured or stapled.
The third method is closure by secondary intention, which occurs when the wound edges cannot be aligned or sutured. In this method, granulation tissue grows from the wound bed to fill the wound cavity, and wound contraction and “epithelial creep” occur, helping to close the wound. The development of an appropriate quantity and quality of “healthy” granulation tissue is essential to closure by secondary intention.
If a wound is too large, or it is otherwise inappropriate to close by secondary intention, the bed of healthy granulation tissue may, at a certain stage, eventually render it ready to take a skin graft.
It was not disputed that the normal healing of a wound, whether closed by primary or secondary intention, involves a number of phases which are interrelated and overlap. The parties differed somewhat on the precise number and features of the phases and the degree to which they are distinct. KCI identified the following four phases:
(a)clotting to control bleeding;
(b)inflammation as blood vessel walls become more permeable;
(c)cellular proliferation during which granulation tissue forms; and
(d)healing of the wound surface as surrounding tissue contracts to reduce the wound area, epithelial cells start multiplying and migrating and an immature scar forms.
S&N did not refer to the clotting phase and identified only three broad phases, viz:
(a)inflammatory;
(b)proliferative; and
(c)maturation, which S&N described as follows:
In the inflammatory "phase", bacteria and debris are broken down and removed. Growth factors which stimulate the migration and division of cells in the proliferative phase are released. Macrophages, which arrive around two days after the wound occurs, are attracted to the wound by the growth factors and they also break down bacteria and debris. They also excrete a number of growth factors and other cytokines, which further promote migration and division of cells as well as angiogenesis (growth of new blood vessels). These secretions attract other cells which are involved in the proliferation phase…
The proliferative "phase" merges with the inflammatory phase. During this phase, endothelial cells migrate to the area of the wound and angiogenesis is initiated, and, thereby, new blood vessels form and provide oxygen for other cells to function. Collagen and other structural proteins are deposited to strengthen the wound and granulation tissue is formed within the wound. Epithelial cells migrate across the newly formed granulation tissue and act as a barrier between the wound and the environment. Beginning around one week from wounding, myofibroblasts within the wound edges contract, causing the wound defect to reduce in size by the process of contraction…
The inflammatory phase merges with a process called maturation, which is the final phase of wound healing. Collagen is remodelled and realigned along tension lines and unwanted cells are removed…
KCI described the final phase as follows:
…epithelial cells at the edge of the skin start multiplying and migrating across the wound on top of the granulation tissue. This is called ‘epithelial creep’ and results in healing of the wound surface. The wound will close as connective tissue contracts and the epithelium grows across the wound to form a firm scar. The healed wound at this stage is an immature scar…
I was unable to determine whether there were, more accurately, three or four phases, but the evidence indicated that the phases were not clear‑cut.
There was also broad agreement that from the late 1980s, moist wound healing theory, pioneered by George Winter in his widely known paper published in 1962, was being increasingly known and applied. Winter maintained that wounds should not be permitted to dry out completely in order to achieve the best success rate for healing, on the premise that decreasing cell dehydration decreased cell death. The Winter paper did not, however, define the ideal level of moisture for the healing phase.
S&N submitted that by November 1991, clinicians, having recognised that wounds permitted to dry out healed at a less successful rate, were using dressings that could maintain appropriate moisture levels.
Clinicians also recognised well before November 1991 that if a wound were too moist, the wound fluid (exudate) damaged the skin surrounding the wound (maceration), so they used dressings and/or techniques which absorbed or drained fluid out of the wound.
By the mid to late 1980s, gauze, gauze soaked in saline, and gauze soaked in Betadine, Lyofoam (an open-cell polymer or polyurethane foam) and Opsite (a liquid impermeable membrane) were available and were all in general use by surgeons and nursing staff. Other dressings capable of maintaining a moist wound environment were also on the market and in use. Allevyn, another foam dressing with an outer semi‑permeable polyurethane film layer which is highly absorptive, was also available. Such cell foams were also used to manage fluid under skin grafts, thereby promoting the “taking” of skin grafts.
Prior to November 1991, various methods were employed to treat wounds that produced a moderate to high amount of fluid, with the primary objective of removing the undesirable excess. Such fluids might be removed by drainage or by dressings prior to November 1991. Suction may also have been used on open wounds, by means of a “sump drain” together with a tube.
KCI broadly agreed with the above description of moist wound healing theory and practice.
cOMMON GENERAL KNOWLEDGE AS AT 1991
The common general knowledge of the hypothetical addressee as at the priority date of the Patent is relevant to the construction of the Patent (as it must be read in its light), novelty and obviousness. In the present case, S&N challenged the priority date of 1991 on the ground of lack of a fair basis. As discussed below, I have found that the correct priority date was 14 November 1991.
Relevant principles
In Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 (“Minnesota Mining”) at 292, Aickin J, (subsequently cited with approval in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173 (“Lockwood (No 2)”) at 196-197), stated that common general knowledge is: “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”. It is well understood to be, as stated in Lockwood (No 2) at 196, “part of the mental equipment of those concerned in the art under consideration”.
It is not enough that information is publicly available. In Lockwood (No 2), the High Court stated at 197 that:
The effect of Minnesota Mining and Wellcome Foundation was that for the purpose of determining inventiveness prior disclosures which were publicly available information, but which were not part of common general knowledge, were excluded from consideration.
Information does not constitute common general knowledge merely because it might be found, for example, in a journal, even if widely read by persons in the art: see British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221 (“British Acoustic”) at 250 affirmed in General Tire and Rubber Co v Firestone Tyre Rubber Co Ltd (1971) 1a IPR 121 (“General Tire”) at 135.
In Alphapharm Pty Ltd v H Lundbeck A/S & Anor (2008) 76 IPR 618 (“Alphapharm”) at 667, Lindgren J recently observed:
[I]t was held in Astra that information recorded in a document, even a document widely circulated within the art, is not part of general common knowledge merely because the skilled addressee could be expected to locate it. The question is whether it is "generally accepted without question" or "generally regarded as a good basis for further action" by the bulk of those in the art...
In Aktiebolaget Hässle v Alphapharm Pty Ltd (2000) 51 IPR 375 the Full Federal Court made clear at 391 that “[w]hat might be found by a diligent searcher is not the same as “common general knowledge”.
A fact does not form part of the common general knowledge merely because it is known or even well known. Nor does the use of something per se qualify it, as Luxmore J in British Acoustic (cited by the Court of Appeal in General Tire at 135) stated at 250:
It is certainly difficult to appreciate how the use of something which has in fact never been used in a particular art can ever be held to be common general knowledge in the art.
Parties’ submissions and expert evidence
The parties differed on the common general knowledge about the treatment of wounds prior to November 1991.
KCI contended that:
(a)Passive drainage of closed sutured wounds was common. While there was also active drainage of closed wounds by RediVac or HemoVac bottles, wall suction or portable pumps, it was a rare practice which involved practical difficulties.
(b)The drainage of open wounds was not common, although Professor Marshall used a passive sump system or device on open wounds.
(c)The active drainage of fistulae and open wounds to which Dr Williams and Dr Pohl testified was neither widespread nor common general knowledge.
(d)Further, Dr Williams’ practice involved fistulae, which were not “wounds” proper, and the focus was on removing effluent, rather than using negative pressure for the trilogy of purposes expressed in the Patent.
(e)While Dr Williams’ veracity was unchallenged, his evidence about the active drainage of fistulae and open wounds contrasted with the ignorance of the practice expressed by Mr Ellis (a highly experienced wounds nurse working for some of the time in the same hospital) and Professor Marshall, and the fact that Professor Penington and Professor Stacey used drainage only on closed wounds and had neither seen nor used Dr Williams’ technique.
(f)Ultimately, only Dr Williams and Dr Pohl had used active suction on open wounds or seen it used prior to 1991.
(g)Further, while there was a range of dressings, gauze was most commonly used and foams, while available, had limited application, mainly confined to skin grafts and diabetic ulcers.
(h)Foam was not, on the evidence, placed in wounds and used in conjunction with negative pressure to achieve promotion of granulation tissue, prevention of wound overgrowth and drawing the wound closed.
(i)Gauze was used on the top of, and to pack, wounds.
(j)Covers or films were used to keep wounds moist, but subject to frequent dressing changes.
S&N contended that the evidence of Dr Williams, fortified by that of Mr Osmond, established that active drainage of open wounds with underlying fistulae and other moderate to heavily draining wounds occurred from at least the 1970s and as at 1991 and indeed, in some hospitals, fistulae and moderate to heavily draining open wounds were treated with open drainage suction comprising the following:
(a)a porous dressing laid across the surface of the wound in such a way so as to pack it;
(b)a tube laid on top of the porous dressing or across the wound beneath a gauze dressing;
(c)a cover such as a stoma bag or long bag or flexible plastic bag, which was attached to the skin surrounding the wound with an adhesive such as Stomahesive paste or Stomahesive tape to create an air tight cover over the wound or an adhesive film or adhesive dressing; and
(d)a tube which exited the cover in such a way so as to maintain the seal over the wound and which was attached to a source of suction, generally wall suction or a portable electric pump,
which system would be left in place for as long as required, depending on the nature of the wound, typically until ready for standard wound dressings. The system would be applied for a variable length of time depending on the nature of the wound.
Thus, in S&N’s submission:
Negative pressure (also called sub-atmospheric pressure, suction pressure, vacuum pressure and topical negative pressure, among others) had been used in Australia in relation to closed and open wound drainage systems before the alleged priority date…
It does not matter whether any particular installation at any one hospital was common general knowledge: their existence at various places including in Australia shows that the basic elements of negative pressure wound therapy were well known before the alleged priority date.
Thus, the parties and expert witnesses differed on several principal matters, namely, the use of foam, the drainage of wounds including by negative pressure (suction), the use of sealing means and the use of tubes in suctioning open wounds as at 1991.
Foam
It was common ground that foam dressings (in two main forms, Lyofoam and Allevyn) were available and used in the treatment of wounds prior to November 1991.
KCI submitted that gauze was the most common dressing in Australia in 1991, and that foam had only limited uses, being mainly restricted to, for example, skin grafts and diabetic foot ulcers. KCI disputed that Lyofoam was used prior to 1991 for other than those limited purposes or to absorb blood and fluids in fairly moist wounds. KCI also submitted that while Lyofoam and Allevyn were used, they were not placed in wounds prior to November 1991.
In contrast, S&N submitted that foams were widely available and used prior to 1991 and were placed in wounds. S&N contended that Lyofoam was used in fairly moist wounds as it was able to absorb blood and other tissue fluids by capillary action. It was useful in maintaining a moist environment at the surface of the wound, and in distributing an even pressure across the entire wound due to its open-cell form, which beneficially reduced pressure away from the site of the wound in diabetic foot ulcers and venous leg ulcers.
Mr Ellis’ evidence was that he did not recall seeing foams, and certainly not in any clinical environment, prior to 1991. While conceding that he was “struggling to recall”, he thought that he had seen foam in some overseas journals, but not in use in Australia at the time.
Mr Ellis was not certain that there were no foams in use and, indeed, acknowledged that they were in use elsewhere, but thought that:
they were very primitive foams, maybe Lyofoam and… another… produced by Merck Sharp & Dohme. I have got a picture of it but I never saw it or used it… The foams, really, in Australia came more into prominence during the early 90s so that…. it sort of started to increase in their use.
At trial, Professor Marshall stated that “for many years the gold standard” material for a dressing to be tied over a wound was “Acriflavine wool… a cotton wool impregnated with an antimicrobial”. Professor Marshall stated that when foam became available back in the 1950s and 1960s, “we started using foam because it was more kind to the patient and easier to use and did not become rock hard if it got blood in it and so on.”
Dr Pohl, in his affidavit, stated:
It was my experience as of 1991 that the tube used with open drainage systems was put into the wound but I was not aware of foam being used with these open drainage systems.
Professor Penington, in his second affidavit, stated that:
Once a skin graft has been applied [to treat a wound that cannot be sutured], it is standard practice now, and was before November 1991, to use a dressing over the graft to place pressure on the graft and hold the graft down on the wound bed… Prior to November 1991, I observed and had used, open-cell polymer foam dressings placed over skin grafts for this purpose. Typically, the foam would be stitched down around the wound which would compress it onto the wound and hold it in place.
Professor Stacey, in his first affidavit, stated that:
[T]he wounds that I came across and treated in my practice from 1978… and prior to November 1991… [included]:
…
(f)Diabetic foot ulcers, which I mainly treated by relieving pressure from the affected area. I covered the wound with a foam dressing, usually Lyofoam (an open cell foam available prior to November 1991), or a non-adherent dressing such as Adaptic;
(g)Pressure sores/ulcers… I treated the wound with a dressing, such as saline impregnated gauze or Lyofoam, or an alginate dressing.
…
I mostly used Lyofoam on diabetic ulcers, smaller venous ulcers and occasionally on pressure ulcers. I would select the dressing I used… with the goal of maintaining an appropriate moist wound environment.
…
I recall that Lyofoam was also available during the 1980s and 1990s… Lyofoam is an open cell, polyurethane foam. It is able to absorb blood and other tissue fluids by capillary action. The dressing was useful in maintaining a moist environment at the surface of the wound, which is conducive to the formation of granulation tissue and epithelialisation. Lyofoam was also useful in distributing an even pressure across the entire wound because of its open cell form.
…
Another dressing that was available prior to November 1991 was Allevyn. Allevyn is a foam dressing with an outer semi-permeable polyurethane film layer. It is highly absorptive. The outer is impermeable to wound fluid while allowing vapour to pass through it. It aids in preventing an excessively moist wound environment.
…
As at the late 1980s, I maintained a moist wound environment in wounds that were producing moderate to high amounts of exudate/fluid in one of five ways, depending on the type of wound… First, I used a highly absorbent contact layer dressing, such as Allevyn… which I might have covered with a cotton wool padding or similar such padding.
Dr Williams, in his second affidavit, stated that prior to 1991, “[i]n addition to hydrocolloids, alginates and hydrogels, I was aware from observing my surgical colleagues that foam was being used on skin grafts but it was not my personal practice to use it on skin grafts at that time.”
Drainage and negative pressure
It was not disputed that the drainage of wound exudates was common in 1991. Two types of drainage are, however, relevant in this context, namely, passive drainage (where the fluid simply drains from the wound by the force of gravity) and active drainage, where the fluid is sucked out of the wound by negative pressure.
The parties disagreed on:
(a)whether, in 1991, active suction was only used for closed wounds, or whether it was also used for open wounds. KCI submitted that active suction by the use of negative pressure was confined to closed wounds, while S&N stated that it was also used for open wounds. KCI conceded that passive drainage of open wounds was common, but submitted that active suction was not applied to those open wounds; and
(b)whether the purpose of drainage in 1991 was only to remove fluid from the wounds, or whether it was also to assist in wound closure as effected by the V.A.C.® invention. KCI submitted that the purpose of drainage at that time was only to remove fluid, thereby allowing the wound to heal naturally, rather than maintaining negative pressure to accelerate wound closure. S&N did not dispute that the purpose of drainage was to remove fluid, but submitted that it was consistent with, and assisted, the ultimate purpose of promoting wound healing and the normal growth of granulation tissue. Thus, in S&N’s submission, the distinction between the purposes of removal of fluid and wound healing was a false dichotomy.
Mr Ellis, Dr Williams, Dr Pohl, Professor Stacey, Professor Penington and Mr Osmond agreed that negative pressure (active suction) was used to drain exudates in the context of closed wounds (ie those that have been sutured).
Mr Ellis deposed that active suction was not used for open wounds in 1991, and that he had never seen suction applied to an open wound until he saw the V.A.C.® product. Similarly, Professor Marshall deposed that he was unaware of any medical application in 1991 of treating an open wound by sealing and suction. At trial, however, Professor Marshall conceded that he had used active suction on open wounds from time to time in order to avoid contamination of the skin.
Dr Williams deposed that active suction was regularly used for open wounds in 1991.
Dr Pohl deposed that he could not recall fistulae being drained by active suction in 1991, but nonetheless deposed that suction was maintained in “open drainage systems” as at 1991 for as long as required to remove effluent from the wound. He also deposed that “continuous suction” was sometimes used in open drainage systems, but not the regular “on/off cyclical application” of negative pressure claimed in the Patent. Accordingly, Dr Pohl appeared to acknowledge that active suction was used for open wounds at the relevant time.
Dr Williams deposed that, as at 1991, drainage promoted wound healing, including the growth of healthy granulation tissue, by removing harmful fluids which impeded the normal wound healing process. At trial, Dr Pohl agreed that fluids and exudates could impede the wound healing process.
In contrast, Mr Ellis deposed that the purpose of drainage was simply to remove fluid. At trial, he agreed that as at 1991, “the removal of exudate from wounds via drainage was certainly a common procedure… a common occurrence” but testified that the aim of removing fluid was to control the potential for infection and reduce the tension in the tissue. He rejected the proposition that reducing infection and tension were themselves directed at the overriding goal of promoting wound healing, but nonetheless accepted that drainage would achieve a “healing outcome” by reducing the chance of complications. He stated:
I would see it almost the other way around whereby the wound healing promotion is almost the secondary to the need for the removal of – so the drainage was more about, I guess, achieving a healing outcome by reducing the chance of complications.
Mr Ellis, in his affidavit, stated:
As at 1991… control of infection was another key aspect of wound treatment. For most wounds this meant keeping the wound clean, and clearing away debris and exudates… it was… commonly necessary to install an apparatus to drain infected or inflamed wounds of fluids and other exudates on an ongoing basis to facilitate healing.
While Mr Ellis acknowledged that drainage was used, he stated that:
[Up until 1990] [t]he vast majority of draining wounds I helped manage were “closed” wounds and therefore involved a “closed drainage system”. In my experience, the vast majority of drainage systems used at the Royal Adelaide Hospital for closed wounds were passive systems whereby any fluid build-up was simply drained away by the force of gravity.
Mr Ellis stated that although he was also involved in, or knew of, a few instances of closed drainage systems which used active drainage, (in that a non-mechanical vacuum apparatus was involved to apply suction to the cavity to remove the fluid), he recalled that they were rare when compared to the number of closed abdominal wounds with passive drainage systems.
Mr Ellis was also aware that the Royal Adelaide Hospital used an “open” but passive (gravity) drainage system, commonly for treating fistulae, and never saw or heard of any sort of active suction being used to assist with that fluid drainage.
Mr Ellis deposed that:
As at November 1991 I had never heard of… negative pressure or suction being applied to a wound, other than in the specific context of fluid being drained from a cavity in a wound which had already been surgically closed.
Mr Ellis deposed that when he first saw the V.A.C.® product in 1996, he considered it was a revolutionary method of wound management, as he had never previously seen a device which created a negative pressure environment or applied suction pressure directly to the surface of an open wound or read of such a system or concept. Mr Ellis deposed that:
Certainly with my experience at the Royal Adelaide Hospital and subsequently, I had never seen suction applied to an open wound.
…
Throughout my time at the Royal Adelaide Hospital no suction drainage was used on fistulae or open wounds to my knowledge. In fact as at November 1991 I was not aware of suction drainage being used anywhere in relation to open wounds or fistulae.
While aware that Dr Williams asserted that open drainage suction systems were used for moderate to heavily draining wounds since the mid 1970s, Mr Ellis stated:
While that may be the case elsewhere (although I am not aware of it), it certainly was not the case at the Royal Adelaide Hospital during my tenure, and does not accord with my understanding of historical trends and approaches to wound treatment. Drainage of such wounds at that time was passive.
…
Throughout my time at the Royal Adelaide Hospital and throughout my subsequent career involved in teaching wound healing and treatment approaches, the use of drains was a well understood technique. Nonetheless it is clear that the purpose of the drains was to remove fluid. I certainly did not consider, and it was never suggested to me by any colleagues, surgeons, or any literature I read, that suction drains had or could be used as a method of treatment which would have a therapeutic effect above and beyond the straight forward removal of fluid.
Mr Ellis described the different types of drains with which he was familiar in 1991 as first, a passive closed drainage system (which was installed at the time of the operation and allowed for the drainage of wound fluids to the external environment); secondly, RediVacs or HaemoVacs, which were small suction-type devices; and thirdly, placement of bags over the top of the wound to collect the fluid. The first two types of drains were placed over the wound to allow the fluid from the fistula or the sinus or the open wound to drain directly into it. For very large wounds, Cryovac bags would be used with a border of hydrocolloid to collect fluid passively, occasionally using a tube connected to one end of the Cryovac bag, allowing the fluid to drain into an external collection device.
When asked about active suction methods, such as portable electric pumps or wall suction, Mr Ellis stated:
My experience did not include the use of those. I do not remember seeing them there. But I accept that… obviously that was going on somewhere because plenty of other people do remember seeing them. But in my experience, it was largely the passive drainage systems and the modified drainage systems that the stomal therapists put in place.
Mr Ellis acknowledged that in his experience, especially as at 1991, the treating surgeon typically ordered or instructed the use of a vacuum system, rather than the nursing staff deciding how to treat or manage wounds.
In contrast to Mr Ellis, Dr Williams, who worked at the same hospital for five or six years (albeit that they did not know one another), was aware of open drainage prior to 1991 of fistulae and moderately to heavily draining wounds. He also maintained that suction was not uncommonly used in closed drainage systems.
In his first affidavit, Dr Williams stated that in draining wounds that could be closed by primary intention:
I recall that from at least the 1970s up to November 1991, a suction drain would be placed in the cavity of the wound in circumstances where there was the potential for the build up of fluids. The suction drain was passed through the healthy skin adjacent to the wound and then laid along the base of the wound. The wound was then sutured shut and, in some cases, an adhesive seal or cover was applied over the wound. This was (and still is) known as a closed suction drainage system. The drains were generally used following hernia repairs, removal of pilonidal sinus disease, removal of a subcutaneous tumour or a cyst, many intra abdominal procedures and following a mastectomy. I personally saw and used these systems in the surgical wards in the Royal Adelaide Hospital during this period.
Dr Williams also recalled that from at least the 1970s up to November 1991, open drainage was used for fistulae with either a passive (gravity) drain or (especially for higher output fistulae) by the use of active (suction) drainage. Dr Williams maintained that since the mid 1970s the open drainage suction system was also used in other types of moderately to heavily draining wounds (such as a chronic abscess, chronic wound infection or a post‑operative wound infection). Dr Williams stated that the open drainage system incorporated:
(a)a tube with an ending containing multiple perforations;
(b)a porous dressing, such as cotton gauze or ‘combine’ gauze, which is cotton wool between pieces of gauze or other porous fabric;
(c)a cover, such as a stoma bag or a long bag or a flexible plastic bag;
(d)an adhesive, such as Stomahesive, Stomahesive paste, which is like a glue, or Stomahesive tape, which is a 2mm thick material, which is adhesive on both sides so that it sticks to the skin surrounding the wound; and
(e)a source of suction (vacuum), such as wall suction, or one of the portable, electric suction units.
All of the items listed directly above were readily available for use in hospitals as at November 1991.
The system was applied to a heavily draining wound by packing the wound with the porous dressing. The perforated end of the tube was then laid across the wound bed, on top of the dressing. A portion of the skin surrounding the wound was covered with an adhesive, such as Stomahesive. The plastic cover was attached to the Stomahesive to form a sealed area around the wound. The tube came out through the plastic cover in such a way as to maintain the seal over the wound. The tube was then attached to a suction device and the fluid was sucked out of the wound into a canister.
Dr Williams further deposed:
The negative pressure wound dressings in common use today utilise the same principles and features as in the system I have described above. Over the course of the past decade or so, it has become generally accepted by clinicians involved in wound care that the negative pressure wound dressings in common use today improve the rate of healing in both wet and dry wounds.
In his second affidavit, Dr Williams disputed Mr Ellis’ comment that active suction in closed drainage systems was rare. Dr Williams deposed:
Based on my experience and observations, I know there were more than a “few instances”… of the use of active suction prior to November 1991 in closed drainage systems. Active suction was used regularly in heavily draining wounds in this period. It was almost always used when the wound was producing a lot of fluid, as the use of gravity alone to drain the fluid was not efficient. The source of the suction would differ, depending on the nature of the wound and available resources, but included the RediVac or HaemoVac pumps, wall suction or the portable, electric suction pump units.
Dr Williams also disagreed with Mr Ellis’ assertion that active suction was not used in the open drainage of fistulae or sinuses. Dr Williams deposed:
I recall that active suction was regularly used in open drainage systems for heavily draining wounds and fistulae… When a fistula or other type of wound was high output, active suction from either wall suction or from a portable electric suction pump was used as part of a sealed, open drainage system prior to November 1991.
Although Mr Ellis maintained that it was “startlingly new… that the negative pressure treatment was said to actually help accelerate the development of healthy granulation tissue in the wound” and he had “never seen a device which created a negative pressure environment or applied suction pressure directly to the surface of an open wound before I saw the VAC system”, Dr Williams deposed that applying suction to an open wound was not new. He stated “as I have said, there were certain types of draining wounds and fistulae to which my colleagues and I applied scaled, open wound drainage systems with active suction before November 1991. In doing so we created a negative pressure environment under the seal and on the wound.”
The majority in Philips rejected the submission that Microcell was decided on the question of newness, rather than manner of manufacture (at 665).
In Advanced Building Systems Pty Ltd & Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 (“Ramset Fasteners”), the majority of the High Court (Brennan CJ, Gaudron, McHugh and Gummow JJ) identified Philips with a category of cases where the lack of an inventive step appeared on the face of the specification (at 192 to 193).
In contrast, Ramset Fasteners concerned the validity of combination claims in the light of prior publications. The majority concluded that the Full Federal Court erred in considering, under s 100(1)(d) of the 1952 Act (concerned with whether the invention claimed was not an invention within the meaning of that Act), matters that could have arisen under the grounds of obviousness and lack of novelty.
In Lockwood (No 2), the High Court referred at 211 to the:
… narrow proposition that a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification “on its face” shows the invention claimed is not a manner of new manufacture. This may arise, for example, from admissions concerning novelty. The decision in Microcell has not always been properly understood; it does not involve a separate ground of invalidity or a discrete “threshold” test.
In Lockwood (No 2), the High Court recognised the limited nature of this ground of invalidity, observing at 211 that such cases “are likely to be rare”.
In Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd (2009) 177 FCR 239 (“Dura-Post”), the Full Court indicated that a Microcell or Philips type manner of manufacture objection should be based on the face of the specification. Kenny and Stone JJ stated:
We accept, moreover, that Microcell stands for “a narrow proposition that a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification ‘on its face’ shows the invention claimed is not a manner of new manufacture”… As their Honours there said in Mirabella, “if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”
Their Honours observed that in Dura-Post, the objection was not made out on the face of the specification.
In my opinion, in the present case, it was not apparent on the face of the specification that the claims in suit amounted to no more than a new use of known products with suitable properties for such use. The relevant claims were not, in my view, invalid because their subject matter lacked inventiveness and was not a manner of manufacture.
Claim 49: “mere collocation”
S&N submitted that claim 49 was invalid on the ground that it was a mere collocation.
In Wake Forest, the Full Court set aside an injunction restraining S&N from marketing its foam kits on the basis of alleged infringement of claim 49. The Full Court (Finn, Bennett and Middleton JJ) considered that the aseptic package in claim 49 did not interact with the other integers to produce the desired result of applying negative pressure, so that the combination claim was invalid as a mere collocation.
Their Honours distinguished between, on the one hand, a mere optional addition to a combination claim which was not an element of the invention and served only to limit the claim (and thus did not affect its validity) and, on the other hand, an integer which was an element of, and said to limit, the invention (which would affect the validity of the claim).
Their Honours accepted at 472 that the aseptic package or bag in claim 49 itself did “nothing to cause, limit or affect the functional result of negative wound pressure as desired”, although it was doubtless beneficial. As the aseptic package had no “inter-related working” with any of the other integers “in the sense that any one of the integers is doing something which it could not do without the presence of one or more of the others” (at 472), the claim for the combination was not valid.
The Full Court rejected KCI’s submission that the effect of including an additional integer such as the aseptic bag was simply to limit the claim, and had no ramifications for validity, in circumstances where it asserted that the aseptic package was an essential integer of the combination invention pursuant to s 18(1) of the Act. The Full Court rejected the submission that the failure of the aseptic package to interact with all the other integers to produce a new product or result did not render the claim a mere collocation.
The Full Court relied, in particular, on Dixon J’s analysis in Palmer v Dunlop Perdriau Rubber Co Ltd (1937) 59 CLR 30 at 73 of the requirements for a patentable combination of known integers. His Honour there held that if the separate elements, although brought together, continued only to perform their known function as before, they would not amount to a patentable invention.
The Full Court stated at 473:
Unlike the case of Pugh v Riley Cycle Co Ltd (1914) 31 RPC 266, for instance, the aseptic package is not an optional extra merely assisting in the presentation of the apparatus, or limiting or adding to the claim. Rather, it is claimed to be an essential feature crucial to the claimed invention and therefore must interact with that apparatus. While the integers that form the actual apparatus might be said to be a new combination, when placed with the essential feature of the aseptic package being part of the invention claimed they form a mere collocation of the apparatus on the one hand and the aseptic package on the other.
(citation added)
Before me, KCI “formally” asserted the validity of claim 49 in its written submissions, but did not address the issue in oral argument.
In written submissions, KCI appeared to assert that the Full Court, should not, consistently with relevant authority, have gone beyond the face of the specification to determine whether the combination claim was a mere collocation, and erred by instead extending its consideration to the evidence.
The Full Court stated at 475:
For the above reasons, the primary judge should have concluded on the evidence before him and on the basis of the construction of claim 49 put forward by the respondents, that claim 49 was invalid, and that the respondents in these circumstances failed to demonstrate that there was a serious question to be tried.
We should stress that we have approached the question of the validity of claim 49 by reference to the evidence and submissions made as to the construction of claim 49 put forward by the respondents. We have not determined the validity of claim 49 finally, this being a matter for the primary judge at trial. We have merely arrived at the conclusion that the primary judge should not have granted the injunction in light of the evidence and the construction of claim 49 put forward by the respondents.
In my opinion, their Honours’ approach and analysis of authority was persuasive and I am, in any event, bound by their enunciation of principle.
Before the Full Court, KCI conceded that the aseptic package did not interact with the other integers of claim 49 to produce a new product and result. Before me, it advanced no new evidence to suggest the contrary and indeed, as S&N submitted, the evidence at trial fortified KCI’s earlier concession. In my opinion, claim 49 was invalid, inter alia, on the ground that it constituted a mere collocation.
Non‑compliance with s 40 of the Act
Sufficiency
S&N also alleged that the specification failed to describe the invention “fully” and the best method known to the applicant of performing the invention, contrary to s 40(2)(a).
The details of the allegation were set out in its submissions as follows:
PLEADING/
PHRASECLAIMS RESPONDENT'S EVIDENCE APPLICANTS'
EVIDENCEThe Specification does not describe the meaning of “an area sufficient to promote migration of epithelial or subcutaneous tissue toward the wound” and how to determine such area or how to ensure the negative pressure is applied to a wound over "an area sufficient to promote migration of epithelial and subcutaneous tissue toward the wound 1 and dependent claims
Penington (2) paras 49-52 CB 4/36/0468.
Stacey (1) paras 97-98, 148-149 CB 4/42/0568,0578.
Marshall (1) paras 51, 52, 103 CB 3/26/0255,0267.
Marshall (2) paras 15, 36 CB 3/27/0292,0296.
Pohl paras 157, 159, 192
CB 3/33/ 0390,0391,0399The Specification
does not describe the
meaning of “time
sufficient to
facilitate closure of
the wound” and
how to determine
such time1 and
dependent
claimsPenington (2) paras 53-55 CB 4/36/0469.
Stacey (1) paras 99-100, 150-151 CB 4/42/0568,0579.
Marshall (1) paras 53, 68, 71, 104, 115 CB
3/26/0256,0259,0268,0270
.
Marshall (2) para 37 CB 3/27/0296.Pohl paras 165, 192 CB 3/33/0392,0399.
The Specification
does not describe the
meaning of “time
sufficient to permit
the formation of
granulation tissue
in the wound” and
how to determine
such time2 Stacey (1) para 101 CB 4/42/0569. Marshall (1) paras 76, 106, 193 CB 3/26/0260,0268,0284.
The Specification
does not describe the
meaning of
“maintaining said
reduced pressure
until the wound has
progressed toward
a selected stage of
healing and how to
determine the
selected stage and
the periods121 Stacey (1) para 119 CB 4/42/0572.
Penington (3) paras 11(b), 17(d) CB 4/37/0500,0508.Marshall (1) – no evidence on “selected stage of healing” Pohl paras 213, 218(l), 222(i) CB 3/33/0403,0406,0408.
S&N alleged that on the evidence, the skilled addressee (who is competent, has ordinary skill and is conversant with the common general knowledge) was not taught how to make or use something within the claims; nor can he or she determine whether he or she has made or used something within the claims. They were therefore bad for insufficiency.
In Kimberly-Clark at 16-17, the High Court referred to the provision in the Patents and Designs Act 1907 (UK) from which s 40(2)(a) of the Act derived, of which Romer LJ, in No-Fume Ltd v Frank Pitchford & Co Ltd (1935) 52 RPC 231, stated at 243:
“[I]n other words, [it is essential] that the patentee should disclose his invention sufficiently to enable those who are skilled in the relevant art to utilise the invention after the patentee's monopoly has come to an end. Such disclosure is, indeed, the consideration that the patentee gives for the grant to him of a monopoly during the period that the patent would run.
…
It is not necessary that he should describe in his specification the manner in which the invention is to be performed, with that wealth of detail with which the specification of the manufacturer of something is usually put before the workman who is engaged to manufacture it.”
The High Court stated at 17:
The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?
A description will suffice if it contains enough information to enable the addressee to produce one embodiment that falls within each claim, even if there are other embodiments that are claimed but for which “new inventions or additions or prolonged study of matters presenting initial difficulty” are required.
In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274, the High Court said at 297, citing its earlier decision in Kimberly-Clark:
For the purposes of s 40(2)(a), it is not necessary for the inventor to disclose all the alternative means; it is enough that there is disclosure in the sense of enabling the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting additional difficulty.
In Eli Lilly, after reciting the test from Kimberly-Clark, Heerey J went on to say:
As Cotton LJ said in Edison and Swan Electric Light Co v Holland (1889) 6 RPC 243 at 277, it is not necessary that the addressee:
… should be able to do the work without any trial or experiment which, when it is new or especially delicate, may frequently be necessary, however clear the description may be.
Professors Penington, Stacey and Kimble gave evidence that they did not know, and would not have known in November 1991, what dressing to select with the rigidity to achieve the acquired result. The integer was meaningless to Professor Penington who would not have been able to select the dressing. Professor Stacey would have found the integer difficult to understand and would have been at a loss in selecting a dressing. Professor Kimble would not have known what dressing to select and indeed, did not believe that such a dressing exists.
In my opinion, due to the meaningless nature of the “screen rigidity integer” and the associated failure to provide the skilled reader with sufficient guidance on how to select or construct a screen which would achieve the promised result, the invention was not sufficiently described as required by s 40(2)(a) of the Act. Save for that integer, in my opinion the preferred embodiment set out in the specification would have fallen within the scope of the claims, and the specification would have disclosed an embodiment of the invention within their scope.
Failure to define invention
S&N alleged that the Patent was invalid for failure to comply with the requirement in s 40(2)(b) of the Act that the specification end with claims which define it.
S&N set out the following table of terms which allegedly failed properly to define the monopoly claimed, but it did not otherwise amplify the allegation:
PHRASE
CLAIMS
RESPONDENT'S EVIDENCE
APPLICANTS' EVIDENCE
“sufficiently rigid to prevent wound overgrowth”
1, 49, 50,
121 and
dependent
claimsGordon (1) paras 51-53 CB
4/46/0670.
Kimble (1) paras 50, 65,
96-97 CB
4/44/0636,0639,0647.
Penington (2) paras 47-48,
73, 83 CB 4/36/0467,0474,
0477.
Stacey (1) paras 95-96, 145, 147, 242 CB
4/42/0567,0578,0602Marshall (1) paras 78, 101 CB
3/26/0261,0267.
Pohl paras 175-176, 191, 290 CB
3/33/0395,0399,0435.“an area sufficient to
promote migration of
epithelial or subcutaneous
tissue toward the wound”1 and
dependent
claimsPenington (2) paras 49-52
CB 4/36/0468.
Stacey (1) paras 97-98,
148, 149 CB
4/42/0568,0578,0579.Marshall (1) paras 51, 52, 103
CB 3/26/0255,0267.
Marshall (2) paras 15, 36 CB
3/27/0292,0296.
Pohl paras 157, 159, 192 CB
3/33/0390,0391,0399.“time sufficient to
facilitate closure of the
wound”1 and
dependent
claimsPenington (2) paras 53-55
CB 4/36/0469.
Stacey (1) paras 99-100,
150, 151 CB
4/42/0568,0579.Marshall (1) paras 52, 68, 71,
104, 115 CB
3/26/0255,0259,0268,0270.
Marshall (2) para 37 CB
3/27/0296.
Pohl paras 165, 192 CB
3/33/0392,0399.“time sufficient to permit
the formation of
granulation tissue in the
wound”2 Stacey (1) para 101 CB
4/42/0569.Marshall (1) paras 76, 106, 193
CB 3/26/0260,0268,0284.“maintaining said
reduced pressure until
the wound has progressed
toward a selected stage of
healing”121 Stacey (1) para 119 CB
4/42/0572. Penington (3) paras 11(b),
17(d) CB 4/37/0500,0508.Marshall (1) – no evidence on
“selected stage of healing”
Pohl paras 213, 218(l), 222(i) CB
3/33/0403,0406,0408.
In General Tire, the Court of Appeal stated at 167 that:
... the issue of definition is to be considered as a practical matter and little weight is to be given to puzzles set out at the edge of the claim which would not as a practical matter cause difficulty to a manufacturer wishing to satisfy [itself] that [it] is not infringing the patent.
In General Tire, the Court of Appeal further observed that the court is not required to strain to uphold the patent, but allowances should be made for any difficulties of the case, so an alleged issue of want of definition should always be considered in relation to the particular facts.
The Court of Appeal also approved the statement of Shaw LJ in British Thomson-Houston Company Ltd v Corona Lamp Works Ltd (1922) 39 RPC 49 at 89 that:
It is easy, whenever language of generality and relativity applicable to size, measure, weight or the like have been employed, to put puzzles which might indicate that, at certain points, you are at that thin strip of mechanical territory in which, on the one side, there might be failure, and, on the other, success. But the reply to such criticism is that that is not how practical men work. They work to achieve success, and if, adopting the broad lines laid down in a specification, they do not find any real difficulty in achieving success, this may not conclude the matter, but it goes far to show that the vagueness of the specification has not mislead them – practical people who were not seeking for failure but for success – has not caused the invention to fail to reach their mind, but has, on the contrary, for all practical purposes, guided them, and that without difficulty, towards the success which prior to that no experiment nor invention had achieved.
I have already considered in detail many of the terms and integers challenged by S&N under this heading in other contexts. The screen rigidity integer, in my view, lacked inherent meaning, and as it was common to all claims, they did not define the specification. Save for the screen rigidity integer, as a “practical matter”, with “due allowance for the difficulties of the case”, in my opinion, the impugned terms were not so vague or wanting in particularity as to fail to comply with 40(2)(b) of the Act.
Lack of clarity
S&N also alleged that the Patent did not comply with s 40(3), as a number of the claims lacked clarity due to the inclusion of purported limitations.
In Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd & Ors (1998) 42 IPR 111, Burchett J observed that there was no requirement that “only exact expressions” be employed (at 119). His Honour concluded (at 120):
A patentee does not, as Dixon CJ made clear in Martin v Scribal Pty Ltd (1954) 92 CLR 17 at 60, have to express his claim with a precision that “must be but an arbitrary restriction on the inherent variability of [a] feature” which is part of the invention.
In Minnesota Mining, Aickin J stated at 274 that:
Lack of precise definition in claims is not fatal to their validity so long as they provide a workable standard suitable to the intended use.
In Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56, Lindgren J (with whom Hill J agreed) stated at 95 that claims which provide a workable standard suitable to their intended use do not lack clarity merely because they may require an exercise of judgment by the person skilled in the art. His Honour stated:
[I]t is not unusual for a claim to define an invention partly by the use of a relative expression which necessitates exercise of judgment… and so long as the claims provide a workable standard suitable to the intended use, they will be valid… The expressions in question must be understood in a practical, common sense manner.
In Décor, Lockhart J described lack of clarity in the context of s 40 at 395 as “vagueness of description, want of particularity and evident indistinctness of thought may be the source of so much uncertainty as to the scope of the monopoly that the claim fails to fulfil the requirement of stating with definiteness to what the patentee is exclusively entitled” (Kauzal v Lee (1936) 58 CLR 670 at 685)).
Lockhart J acknowledged (at 395) that the expression “open mouthed container” in Décor was general and that many containers would answer the description, but the term was not ambiguous. He reiterated Aickin J’s statement in Minnesota Mining at 274 that “[l]ack of precise definition in claims is not fatal to their validity so long as they provide a workable standard suitable to the intended use”.
S&N conceded that unclear claim terms may be defined or clarified by reference to the body of the specification and that a “purposive”, common sense approach to what the words used convey in the context of the published knowledge as at the priority date was required.
S&N also acknowledged that an invention may be described in a way that involves matters of degree. The consideration is whether, on any reasonable view, the claim has meaning. Where a claim includes a vague word or phrase which not defined in the body of the specification, it is a question of fact, to be determined on the evidence, whether it renders the claim invalid for ambiguity. Blanco White, Patents for Inventions (5th ed, Stevens & Sons, 1983) at 4-701 states that:
…a claim is bad if no reasonably certain construction can be given to it, or it is fairly and equally open to diverse meanings. But the rule goes further than this. A court is not bound to find a meaning for a claim, nor to approach a claim with the "conviction that its language is capable of a reasonable construction when carefully examined" that is the due of an Act of Parliament. Thus a claim may be bad for uncertainty although the court could find its true meaning (and would do so if the words concerned appeared in a commercial contract) if it is so obscure that "its proper construction must always remain a matter of doubt"…
(emphasis added)
S&N also conceded that courts typically approach the standard of clarity required with leniency, but submitted that the present case was akin to Flexible Steel Lacing Company v Beltreco Ltd & Anor (2000) 49 IPR 331, where Hely J held that method and product claims for pulley lagging used in conveyor systems were invalid for lack of clarity. Hely J stated at 355 and 359-360:
Given the equivocations in the drawings, they do not resolve the puzzle created by the uncertainties and inconsistencies in the text. The method claim is fairly open to more than one meaning not because of grammatical problems but because, even to a skilled reader, it would not be clear which of two methods [it] describes. That problem cannot be overcome by the expectation on the part of a skilled worker, to which I earlier referred…
…
[T]he product claim is obscure; it is fairly and equally open to diverse meanings… Another possibility is that the claim embraces both. Sometimes, ambiguity or insufficiency in description can be resolved by a skilled addressee through the application of commonsense and common knowledge… I do not think that this is such a case.
(emphasis added)
S&N also relied on High Tech Auto Tools Pty Ltd v Ferocem Pty Ltd (1994) 29 IPR 337, where JM Sellars (Delegate of the Commissioner of Patents) held that the use of certain expressions in the claims rendered them unclear or uncertain in scope, and Abbott Laboratories & Anor v Corbridge Group Pty Ltd & Anor (2002) 57 IPR 432 at 449, where the Full Court (Lee, Emmett and Hely JJ) held that an inter-claim referencing error led to a nonsensical result and a lack of clarity.
Lord Loreburn LC in Natural Color Kinematograph Co v Bioschemes Ltd (1915) 32 RPC 256 (“Bioschemes”) at 266 stated:
It is the duty of a patentee to state clearly and distinctly, either in direct words or by clear and distinct reference, the nature and limits of what he claims. If he uses language which, when fairly read, is avoidably obscure or ambiguous, the patent is invalid, whether the defect be due to design, or to carelessness, or to want of skill.
In Martin v Scribal Pty Ltd (1954) 92 CLR 17 at 59, Dixon CJ adopted the following description of the duty of the court and the test of ambiguity from the judgment of Lord Parker in Bioschemes:
Further, though it may be true that in construing an instrument inter partes the court is bound to make up its mind as to the true meaning, this is far from being the case with a Specification. It is open to the court to conclude that the terms of a Specification are so ambiguous that its proper construction must always remain a matter of doubt, and in such a case, even if the Specification had been prepared in perfect good faith, the duty of the court would be to declare the Patent void…
Although I was not persuaded that most of the above impugned terminology presented any irresolvable ambiguity, abiding uncertainty or doubt (particularly when the specification was read as a whole), as discussed in detail above, the screen rigidity integer lacked inherent meaning even to a skilled reader, who would not have known what dressing to select. Its obscurity and uncertainty could not be rectified by reference to the specification, where the same deficiencies characterised the discussion of the integer. As the screen rigidity integer was common to all claims in suit, its obscurity, uncertainty and lack of cogent meaning rendered them all relevantly unclear. Therefore, in my opinion, the claims were invalid on the ground that they lacked clarity as required by s 40(3) of the Act.
Fair basis
S&N alleged that the claims in suit were not fairly based on the matter described in the specification, as required by s 40(3) of the Act.
S&N alleged that a number of claims were purportedly limited by integers that were not described in the specification as part of the invention. In terms of Lockwood No 2, they purported to define the invention by mere stray phrases in the specification and lacked a real and reasonably clear disclosure. The integers were:
(a)claims 9 and 121: cyclical application of pressure;
(b)claim 8: continuous application of pressure;
(c)claims 1, 2, 6, 7 and 121: period of pressure application;
(d)claim 3: type of wound; and
(e)claims 10, 11 and 12: ratio of cyclical pressure application.
S&N submitted that the inclusion in claims 50 and 52 of a “singular tubular member having a first end inserted beneath at least a portion of the foam section” was not disclosed by the specification, which described a tube or hose being inserted “into” the foam but not the tube or hose being inserted “beneath” the foam. Alternatively, the claims travelled beyond the matter described in the specification, contrary to the principles expressed in Lockwood No 2.
S&N submitted that the claims regarding a “fluid-impermeable seal/cover” in claims 49 and 50 were not disclosed in the specification, which did not refer to the use of a seal or cover which was fluid-impermeable. Alternatively, the relevant claims travelled beyond the matter described in the specification, in which the description of the “seal” did not include the words “fluid‑impermeable”.
S&N submitted that the specification did not include a real and reasonably clear description or disclosure of the ratios in claims 10, 11 and 12, which referred to “at least” a specified ratio. Alternatively, the claims travelled beyond the matter described in the specification, as the specification specified “as low as 1:10 or as high as 10:1”, while the claims used “at least 10:1”, thus including a ratio higher than 10:1 (eg 20:1 or indeed 100:1, and so on).
In CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260, the Full Federal Court stated at 436 that it is not appropriate to adopt “an over meticulous verbal analysis”. The Full Court stated at 437:
... it is wrong to proceed as if testing for infringement and to seek to isolate in the body of the complete specification, or in the provisional specification, "essential integers" or "essential features" of an invention disclosed therein and to ask whether they correspond with the essential integers in the claim in question... Nor would it be applying the statute to ask whether the earlier specifications fairly described the essential features of the invention disclosed in the later specification...
On that basis, I was not persuaded that the above impugned integers were not fairly based on matter described in the specification.
conclusion
In my opinion, the application should be dismissed and the cross-claim should be allowed. I shall invite submissions on the form of orders and costs.
I certify that the preceding eight hundred and thirty-two (832) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Dodds‑Streeton. Associate:
Dated: 30 August 2011
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