B. Braun Melsungen AG v Multigate Medical Devices Pty Ltd
[2014] FCA 1110
•17 October 2014
FEDERAL COURT OF AUSTRALIA
B. Braun Melsungen AG v Multigate Medical Devices Pty Ltd [2014] FCA 1110
Citation: B. Braun Melsungen AG v Multigate Medical Devices Pty Ltd [2014] FCA 1110 Parties: B. BRAUN MELSUNGEN AG and B. BRAUN AUSTRALIA PTY LTD (ACN 002 945 155) v MULTIGATE MEDICAL DEVICES PTY LTD (ACN 132 290 058); MULTIGATE MEDICAL DEVICES PTY LTD (ACN 132 290 058); B. BRAUN MELSUNGEN AG and B. BRAUN AUSTRALIA PTY LTD (ACN 002 945 155) File number: VID 463 of 2013 Judge: PAGONE J Date of judgment: 17 October 2014 Catchwords: PATENTS – patents for safety IV catheters – infringement – “pith and marrow” principle – whether alleged infringing items disclose all essential features of claims in suit – construction of claims – validity of patents – whether invention novel – priority date of patents – whether claims fairly based on matter disclosed by ancestors – whether real and reasonably clear disclosure of claimed invention in body of specification – whether invention sufficiently described in specification. Legislation: Civil Disputes Resolution Act 2011 (Cth)
Evidence Act 1995 (Cth), s 79(1)
Patents Act 1990 (Cth), ss 7, 18(1), 40, 43, 79B, 119, 123, 128, 129, 138
Patents Regulations 1991 (Cth), reg 3.12
Cases cited: Arrow Pharmaceuticals Ltd (2006) 154 FCR 31
Australian Mud Company Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188
Azuko Pty Ltd v Old Digger Pty Ltd (2001) 52 IPR 75
Bitech Engineering v Garth Living Pty Ltd (2010) 86 IPR 468
Bristol Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524
C Van Der Lely NV v Bamfords Ltd (1961) 1A IPR 86
Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260
Clark v Adie (1877) 2 App Cas 315
Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160
Danisco A/S v Novozymes A/S (No 2) (2011) 91 IPR 209
F Hoffman-La Roche & Co Aktiengesellschaft v Commissioner of Patents (1971) 123 CLR 529
Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 224 ALR 168
GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited (2013) 305 ALR 363
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Hill v Evans (1862) 45 ER 1195
JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2005) 67 IPR 68
Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1
Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178
Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274
Martin v Scribal Pty Ltd (1954) 92 CLR 17
Mechanical Services (Trailer Engineers) Ltd v Avon Rubber Co Ltd [1977] RPC 66
Merck & Co Inc v Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228
Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253
Minnesota Mining & Manufacturing Co v Tyco Electrics Pty Ltd (2001) 53 IPR 32
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513
Olin Corp v Super Cartridge Co Pty Ltd (1977) 180 CLR 236
PAC Mining v Esco Corporation (2009) 80 IPR 1
Pfizer Overseas Pharmaceuticals v Eli Lilly & Co (2005) 225 ALR 416
Populin v HB Nominees Pty Ltd (1982) 41 ALR 471
Radiation Ltd v Galliers and Klaerr Pty Ltd (1938) 60 CLR 36
Re Imperial Chemical Industries Ltd (Clark’s) Application [1969] RPC 574
Re Mond Nickel Co Ltd’s Application [1956] RPC 189
Rehm Pty Ltd v Webster Security System (International) Pty Ltd (1988) 81 ALR 79
RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458
Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231
Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 221 ALR 373
Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132
Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5
Universal Oil Products Co v Monsanto Co (1972) 46 ALJR 658
Vehicle Monitoring Systems Pty Ltd v SARB Management Group Pty Ltd (2013) 101 IPR 496
Welch Perrin and Co Pty Ltd v Worrel (1961) 106 CLR 588
Date of hearing: 17, 18, 19 and 24, 25, 26, 27 and 28 March 2014 Date of last submissions: 28 March 2014 Place: Melbourne Division: GENERAL DIVISION Category: Catchwords Number of paragraphs: 125 Counsel for the Applicants: Mr D Shavin QC with Mr E Heerey Solicitor for the Applicants: Davies Collison Cave Counsel for the Respondent: Ms J Baird SC with Ms H Rofe and Ms C Cunliffe Solicitor for the Respondent: Chrysiliou Lawyers
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY
GENERAL DIVISION
VID 463 of 2013
BETWEEN: B. BRAUN MELSUNGEN AG
First ApplicantB. BRAUN AUSTRALIA PTY LTD (ACN 002 945 155)
Second ApplicantMULTIGATE MEDICAL DEVICES PTY LTD (ACN 132 290 058)
Cross-ClaimantAND: MULTIGATE MEDICAL DEVICES PTY LTD (ACN 132 290 058)
RespondentB. BRAUN MELSUNGEN AG
First Cross-RespondentB. BRAUN AUSTRALIA PTY LTD (ACN 002 945 155)
Second Cross-RespondentJUDGE:
PAGONE J
DATE:
17 October 2014
PLACE:
MELBOURNE
REASONS FOR JUDGMENT
B. Braun Melsungen AG (“Braun”) and B. Braun Australia Pty Ltd claim that Multigate Medical Devices Pty Ltd (“Multigate”) infringed two patents. The first is Australian Patent Number 2012258327 entitled “IV Catheter” (“the 327 Patent”) filed on 21 November 2012. The second is Australian Patent Number 2012260577 entitled “IV Catheter” (“the 577 Patent”) filed on 30 November 2012. Multigate admits having offered for sale, sold, supplied or kept for sale two catheters and that it intends to market and sell a third (referred to in these reasons, respectively, as catheters A, B and C), but denies infringement and has cross‑claimed seeking revocation of the two patents on the grounds of invalidity. Braun claims that Multigate’s catheters infringe claim 1 of the 327 Patent and claims 1 to 6 of the 577 Patent.
Both patents are for a safety needle protecting device for an intravenous catheter. Both claim the priority date of 12 June 1998 through the same chain of intermediate patents. The original ancestor was patent application 1998095323 entitled “Spring clip as needle tip protection for a safety IV catheter”. The intermediate patents in the chain from the original ancestor included Australian Patent Application 2009233612 filed 30 October 2009 (“the Parent”), Australian Patent Application 2005203491 filed 5 August 2005 (“the Grandparent”) and Australian Patent Application 200142070 filed 4 May 2001 (“the Great Grandparent”). The original ancestor was filed as an international application numbered PCT/EP98/05231 later published as WO99/08742. The original ancestor has an effective filing date of 18 August 1998 because of entry into the Australian National Phase through the Australian Patent Office, but claims the priority date from two US patents, the first being US Patent Application No. 08/915,148 filed on 20 August 1997 (referred to by the parties as PD1), and the second being US Patent Application No 09/097,170 filed on 12 June 1998 (referred to by the parties as PD2). Aspects of the original ancestor that could be relevant to the patents in suit were first disclosed in PD2 and, therefore, the earliest possible priority date is 12 June 1998.
The 327 Patent has only one claim, namely:
1.An IV catheter apparatus including a tubular catheter having a proximal end and a distal end, a needle having a needle shaft and a tip and wherein the needle is attached to a distal end of a needle hub, said needle being received within said tubular catheter when the needle is in a ready position, a catheter hub attached to the proximal end of said catheter, said catheter hub having a hollow interior and an inner wall, said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub, a needle guard positioned in the interior of said catheter hub in a spaced apart relationship from the distal end of the needle hub;
wherein the needle guard has a resilient portion engaged by said needle shaft when said needle is in its ready position, the needle guard resilient portion is movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said resilient portion of said needle guard;
wherein an outer contact surface on the needle guard is secured to a groove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwardly; and
wherein the needle guard further includes a needle guard proximal end, wherein the needle guard is secured to the needle tip when the needle is in the fully retracted position by a portion of the needle guard proximal end making contact with a needle crimp and the resilient portion blocking the needle tip.
The 577 Patent has seven claims of which claims 1 to 6 are in suit and claims 2 to 6 depend on claim 1. Those claims are:
1. A safety IV catheter comprising:
a) a needle having a needle shaft and a needle tip;
b) said needle shaft comprising a bulge;
c) a hollow tubular catheter having a proximal end;
d)said hollow tubular catheter is secured to the distal end of a catheter hub;
e)said catheter hub having a hub section, wherein a chamber is formed in said hub section, and having an inner wall;
f)a resilient spring clip needle guard located within said chamber being formed in said hub section of said catheter hub and having a distal end wall;
g)said needle being received within said hollow tubular catheter when in a ready position, wherein said needle extends through said chamber, a passageway and distally beyond said catheter hub and said hollow tubular catheter so that said needle tip extends beyond the tapered distal end of said hollow tubular catheter and said needle guard located within said hub chamber is adapted to automatically snap or pivot into a retracted position for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position;
h)said needle guard being adapted to be inserted into said catheter hub and to be urged by said needle shaft into contact with said inner wall of said catheter hub so that the needle guard is retained therein;
i)and a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position;
j)said needle shaft of needle being adapted to engage said distal end wall of said needle guard when said needle is in its said ready position; and
k)the said catheter hub being configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted causing said needle guard to pivot or snap to the retracted position in which said distal end wall blocks said needle tip;
l)and said needle guard further comprising a proximal wall having an opening adapted to let said shaft of needle freely pass through and axially move;
m)wherein said bulge has a diameter greater than that of said opening of said proximal wall.
2.The safety IV catheter of claim 1, wherein said needle guard is adapted to automatically snap into said retracted position as said needle is being retracted for blocking access to said needle tip and preventing further distal movement of said needle tip to prevent accidental contact with said needle tip.
3.The safety IV catheter of claim 1 or 2, wherein said distal end wall terminates in a lip adapted to be engaged by said needle shaft when said needle is in its said ready position.
4.The safety IV catheter of any one of claims 1 to 3, wherein the said catheter is configured such that a lower end or curved protrusion of said needle guard is urged by said needle shaft into retaining contact with said inner wall of said catheter hub when said needle is in its said ready position.
5.The safety IV catheter of any of claims 1 to 4, wherein said spring clip needle guard is configured such that a downward or radial force exerted by said needle shaft on said spring clip needle guard in said catheter hub is released when said needle is retracted to said retracted position, and said distal tip of said needle moves past a lip of said spring clip needle guard causing said spring clip needle guard to pivot or snap to said retracted position in which said distal end wall is adapted to block said needle tip.
6.The safety IV catheter of any one of claims 1 to 5, wherein said resilient spring clip needle guard has two arms.
7.The safety IV catheter of claim 6 wherein each of said arms has a distal end wall.
A description of the invention appeared in the body of the patents in suit and will need to be referred to later in these reasons.
The patents included a number of diagrammatic representations of the inventions. It may be helpful for the purpose of explanation in these reasons to reproduce the first two of those diagrams. Figure 1 (modified with the additional words as explained below) is a longitudinal section across an embodiment of an intravenous catheter device:
Distal to User
Proximal to User
Figure 2 shows the distal end of the needle with the needle protecting means protecting the needle point when the needle has been removed from the catheter:
The figures in the patents do not include the words “Distal to User” and “Proximal to User” which have been added to the reproductions of those figures in these reasons as those words were used and understood in the proceeding.
The parties prepared claim charts for the proceeding in which the text of the claims was divided into and set out as integers or features, and instructed their expert witnesses to refer to those integers in a joint report prepared for the purposes of the hearing. Counsel submitted copies of the claims charts for each of the two patents identifying, by yellow highlighting, the issues which were in dispute between the experts. The claims charts reproduce in all but one respect Multigate’s formal admissions made for the purposes of the proceeding. A copy of the admissions is annexure A to these reasons and the claims charts are, respectively, annexures B and C to these reasons.
There are many common features to the claims in the inventions in the 327 and 577 Patents but Multigate drew attention to what were contended to be important differences. The first was that the 327 claim provides that the needle has a crimp whereas the claims in the 577 Patents provide that the needle shaft comprises a bulge. Secondly, the 327 claim provides that the needle guard “has a resilient portion on which the needle shaft exerts a force which is engaged by the side of the needle shaft and biased radially outwardly by it, which is moveable within the interior of the catheter hub to a blocking position distal of the needle tip and which blocks the tip of the needle tip when the needle is retracted”, whereas the claims in the 577 Patents (a) specify that the needle guard is a resilient spring clip needle guard which is adapted automatically to snap or to pivot into a retracted position for blocking access to the distal needle tip, and (b) further specify that the needle guard has a distal end wall such that the needle shaft is adapted to engage the distal end wall when the needle is in its ready position, and the distal end wall blocks the needle tip when the needle guard is in its retracted position. Thirdly, the 327 claim provides that the needle guard is secured to a groove formed in the catheter hub interior, whereas the 577 claims provide that a curved protrusion of the needle guard is engaged by a groove or bump being formed in the inner wall of the catheter hub. Fourthly, that the 327 claim provides that the needle guard is secured to the needle tip when the needle is fully retracted, whereas the 577 claims provide that the needle guard blocks access to the needle tip and prevents further distal movement of the needle tip when the needle is in its retracted position. Fifthly, that the 327 claim provides that a portion of the needle guard proximal end makes contact with a needle crimp when the needle is in its fully retracted position, whereas the 577 claims provide that the needle guard has a proximal wall having an opening adapted to let the shaft of the needle freely pass through and axially move where the diameter of the opening is less than the diameter of the needle bulge. Sixthly, that the 327 claim does not require the feature in the 577 claims which provides that the catheter hub is configured such that a force exerted by the needle shaft on the needle guard is released when the needle is retracted causing the needle guard to pivot or snap to the retracted position. Seventh, that the 327 claim specifies that the needle is attached to a distal end of a needle hub, and that there is a “spaced apart relationship” between the needle guard and the distal end of the needle hub, whereas the 577 claims are silent about attachment of the needle to the needle hub and any requirement for a spaced apart relationship between the needle guard and the distal end of the needle hub. Eighthly, that in the 327 claim the needle has a ready position in which the needle is received within the tubular catheter, the needle tip is outside the catheter hub and the needle shaft engages a resilient portion of the needle guard, whereas in the 577 claims the needle has a ready position in which the needle is received within the tubular catheter, the needle tip extends beyond the tapered distal end of the tubular catheter and the needle shaft is adapted to engage a distal end wall of the needle guard.
CONSTRUCTION OF THE PATENTS
The determination of infringement depends upon whether the product in question embodies each and every essential integer of the particular claim of the patent in question: Populin v HB Nominees Pty Ltd (1982) 41 ALR 471 (‘Populin’), 475. Ultimately that will depend upon looking at the products said to infringe the patents and comparing them with the claims in the patent. The first step in that process, however, requires a construction of the patent without an eye to the alleged infringement: Bitech Engineering v Garth Living Pty Ltd (2010) 86 IPR 468 at [26]; Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 224 ALR 168, 184 at [95]; GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited (2013) 305 ALR 363, 379 at [60]. In that process the court “derives assistance from experts who are skilled addressees” and in doing so should be careful “to avoid assuming a technical expertise” which the court does not have: CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260, 284.
The parties disagreed about the principles to be applied in the construction of the words of the patents in relation to what was described in the proceedings as the “pith and marrow” principle expressed by Lord Cairns in Clark v Adie (1877) 2 App Cas 315 at 320. The disagreement concerned the extent to which a finding of infringement required an exact correspondence between the terms of the claim and the alleged infringing device. The principle was explained in C Van Der Lely NV v Bamfords Ltd (1961) 1A IPR 86, 96 and protects a patentee whose invention is taken without exact textual infringement: see also Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160, 167‑168; Olin Corp v Super Cartridge Co Pty Ltd (1977) 180 CLR 236, 246; Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253, 286; Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183, 242-3; Populin, 476-7; Azuko Pty Ltd v Old Digger Pty Ltd (2001) 52 IPR 75, [31(4)], [36]; Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 221 ALR 373, [51]-[56]; Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 224 ALR 168, [50]; Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126, 148. In Radiation Ltd v Galliers and Klaerr Pty Ltd (1938) 60 CLR 36, Dixon J said at 51 that:
…on a question of infringement, the issue is not whether the words of the claim can be applied with verbal accuracy or felicity to the article or device alleged to infringe. It is whether the substantial idea disclosed by the specification and made the subject of a definite claim has been taken and embodied in the infringing thing.
That passage was followed by the full court of the Federal Court in Populin at 475. Counsel for Multigate contended, however, that “the question of infringement is not of taking the ‘pith and marrow’, ‘substance’ or ‘idea’ of the invention”.
The relevant principles were considered by Bennett J in Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 221 ALR 373 (‘Sachtler’) at [43]-[67]. In particular, her Honour said at [50]-[53]:
50In Populin at 475, the Full Court reiterated the fundamental proposition that, to establish infringement of a combination patent, the patentee must show that the defendant has taken each and every one of the essential integers of the claim. If, on its true construction, the claim is for a particular combination of integers and the alleged infringer omits one of the essential integers, the infringer escapes liability (Populin at 475). A defendant will not escape liability if an inessential integer is omitted or replaced by an equivalent.
51In Populin at 475 the Full Court discussed the taking of the substantial idea disclosed by the specification and infringement of the claims:
… it is whether the substantial idea disclosed by the specification and made the subject of a definite claim has been taken and embodied in the infringing thing… [Emphasis added.]
This is the “pith and marrow” test which is based on a statement by James LJ in Clark v Adie (1875) LR 10 Ch App 667 that one should look to whether the allegedly infringing article is the same in substance and effect or is a substantially new or different combination. This principle applies to immaterial variations where an inessential part or step is omitted or substituted. A modification may be so small as to be insignificant and to have no material effect on the way the invention works: Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160 at 168; Rehm at ALR 92 per Gummow J.
52This is consistent with the principle in Catnic, as discussed in Kirin-Amgen at [50], that there is no infringement if a variant has a material effect on the way the invention works. Put another way, if the variant were of an inessential integer, it would not be a mechanical equivalent.
53This does not mean that there is infringement where there has been no taking of all the essential integers of the claim (Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 246 per Gibbs J) or where the wording of the claims make it clear that the relevant area has been deliberately left outside the claim: 3M at CLR 286. Catnic is clear authority for the proposition that it is the essential integers of the claim that constitute the “pith and marrow” of the claim: at 243.
Her Honour’s observations were endorsed by the Full Court in Australian Mud Company Pty Ltd v Coretell Pty Ltd (2011) 93 IPR 188, 198 [64] where the Full Court went on to caution against applying the “pith and marrow” principle as extending a patentee’s monopoly to products or processes that the patentee did not, by the claims, define as the invention. The Court said at [66]-[69]:
66In Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 Gummow J (when in this Court) observed (at 528-529) that, for an Australian court dealing with patent infringement, Catnic did not propound any novel principle or new category of “non-textual infringement”: see also Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 92; Fisher & Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 103 ALR 239 at 255.
67In Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 246 Gibbs J, when dealing with the so-called “pith and marrow” principle of infringement, cautioned that the application of that principle did [not] mean that there would be infringement where the patentee has, by the form of his claim, left open that which the alleged infringer has done.
68Indeed, in C Van der Lely NV v Bamfords Ltd (1962) 1A IPR 86, on which Gibbs J based his observation in Olin, Viscount Radcliffe (at 96) said:
When, therefore, one speaks of theft or piracy of another’s invention or says that it has been “taken” by an alleged infringer and this “pith and marrow” principle is invoked to support the accusation, I think that one must be very careful to see that the inventor has not by the actual form of his claim left open to the world the appropriation of just that property that he says has been filched from him by piracy or theft. After all, it is he who has committed himself to the unequivocal description of what he claims to have invented, and he must submit in the first place to be judged by his own action and words.
See also the discussion in Populin v HB Nominees Pty Ltd (1982) 41 ALR 471 at 476-477.
69To give a purposive construction to a patent specification, and in particular its claims, is not to engage in a process of reasoning that extends the patentee’s monopoly to the “ideas” disclosed in the specification. Nor does it extend the patentee’s monopoly to products or processes that the patentee did not, by the claims, define as the invention, even if those products or processes can be seen to perform the same function as the invention or to be based on the patentee’s “ideas”.
[The word “not” in [67] above has been added as agreed between the parties to have been omitted from the judgment by a typographical error].
Recourse to broad notions of the “pith and marrow”, the “substance” or “the idea” disclosed by a specification in the interpretation of a patent cannot, therefore, impermissibly enlarge a claim if not fairly made on a proper reading of the patent. The test of infringement is whether the infringing item embodies each and every essential integer of the claim and in that task regard must be had to the terms of the claim. The application of the “pith and marrow” test must, therefore, be based on the claim in the patent. The test does not permit recourse to the substantial idea disclosed by the specification but requires that it be found in the subject of a definite claim.
The parties were otherwise in agreement that the approach to the construction of a patent is similar to that of construing any other commercial instrument. In H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 Emmett J said at [53]-[54]:
53While the last proposition is correct, and evidence as to how the hypothetical addressee would have understood a specification at the relevant date may strictly be admissible, the underlying principle is that contained in the first proposition stated above, namely, that the construction of a specification, including the claims, is a question of law for the Court. However, the Court may be informed, for example, as to the way in which particular terms were, as a general rule, used by relevant addressee at the relevant time or what the use of a particular term or expression disclosed or conveyed to a relevant addressee at the relevant time, so long as it is shown that an understanding different from the ordinary usage of English was generally accepted by relevant addressees.
54In that regard, there should be no difference in the approach to the construction of a patent from the approach to the construction of any other commercial instrument. That is to say, neither a patent nor any other commercial instrument should be construed in a vacuum but must be construed in the context in which the patent or instrument is being considered. Thus, the claims and specification of a patent must be construed in the way in which they would be understood by the relevant addressee. In the same way, a commercial instrument would be construed in the light of facts that might reasonably be expected to be known to the parties to the commercial instrument.
[Bennett J agreeing at [148] and Middleton J agreeing at [250]].
In Kinabalu Investments Pty Ltd v Barron & Rawson Pty Ltd [2008] FCAFC 178 the Full Court said at [44]-[45]:
44The principles of construction applicable were not in dispute. When determining the nature and extent of the monopoly claimed, the specification must be read as a whole. But as a whole it is made up of several parts which have different functions. The claims mark out the legal limits of the monopoly granted. The specification describes how to carry out the process claimed and the best method known to the patentee of doing that. Although the claims are construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim, by adding to those words glosses drawn from other parts of the specification. If a claim is clear and unambiguous, it is not to be varied, qualified or made obscure by statements found in other parts of the document. It is legitimate, however, to refer to the rest of the specification to explain the background of the claims, to ascertain the meaning of technical terms and resolve ambiguities in the construction of the claims. See Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [73]-[75] (Hely J).
45Other more specific principles of construction collected in Flexible Steel at [81] are:
•a specification should be given a purposive construction rather than a purely literal one;
•the hypothetical addressee of the specification is the non-inventive person skilled in the art before the priority date;
•the words used in a specification are to be given the meaning the hypothetical addressee would attach to them, both in the light of the addressee’s own general knowledge and in the light of what is disclosed in the body of the specification;
•as a general rule, the terms of the specification should be accorded their ordinary English meaning;
•evidence can be given by experts on the meaning those skilled in the art would give to technical or scientific terms and phrases, and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning;
•however, the construction of the specification is for the court, not for the expert. In so far as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the court reads the patent in the same way.
Ordinarily, therefore, words are to be given their ordinary meaning unless a person skilled in the relevant art would, in the context of a claim, give a special meaning to them or unless the specification ascribes a special meaning to the words: Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385, 391, 400, 410-11. What is left unclaimed by the words of the claim properly construed is not within the patentee’s monopoly: GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited (2013) 305 ALR 363, [60]. The patent is not to be construed “in some way to be ‘fair to the patentee’… [there being] no presumption about the width of the claims” (Sachtler at [60]), although the claim is to be construed with “an eye benevolent to the inventor and with a view to making the invention work”: Martin v Scribal Pty Ltd (1954) 92 CLR 17, 97 (applied in Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126, 134). In Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 Sheppard J said at 400 (in a passage noted with approval in Pfizer Overseas Pharmaceuticals v Eli Lilly & Co (2005) 225 ALR 416, 467-9 and PAC Mining v Esco Corporation (2009) 80 IPR 1, [26]-[29]):
(1)The claims define the invention which is the subject of the patent. These must be construed according to their terms upon ordinary principles. Any purely verbal or grammatical question that can be answered according to ordinary rules for the construction of written documents is to be resolved accordingly.
(2)It is not legitimate to confine the scope of the claims by reference to limitations which may be found in the body of the specification but are not expressly or by proper inference reproduced in the claims themselves. To put it another way, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification.
(3)Nevertheless, in approaching the task of construction, one must read the specification as a whole.
(4)In some cases, the meaning of the words used in the claims may be qualified or defined by what is said in the body of the specification.
(5)If a claim be clear, it is not to be made obscure because obscurities can be found in particular sentences in other parts of the document. But if an expression is not clear or is ambiguous, it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claim.
(6)A patent specification should be given a purposive construction rather than a purely literal one.
(7)In construing the specification, the court is not construing a written instrument operating inter partes, but a public instrument which must define a monopoly in such a way that it is not reasonably capable of being misunderstood.
(8)The body, apart from the preamble, is there to instruct those skilled in the art concerned in the carrying out of the invention; provided it is comprehensible to, and does not mislead, a skilled reader; the language used is seldom of importance.
(9)Nevertheless, the claims, since they define the monopoly, will be scrutinised with as much care as is used in construing other documents defining a legal right.
(10)If it is impossible to ascertain what the invention is from a fair reading of the specification as a whole; it will be invalid. But the specification must be construed in the light of the common knowledge in the art before the priority date.
Multigate also submitted that in construing the patents it was relevant to take into account the circumstances in which the patents in suit were brought into being. The two patents in suit are the fifth generation of their family of patents in claims for a safety intravenous catheter apparatus. The two patents in suit were applied for, respectively, on 21 and 30 November 2012. The agreed statement of facts included an admission by the applicants that they had been aware of Multigate’s catheter B before 21 November 2012 when the second applicant obtained a sample of catheter B in its packaging from the intensive care unit of Epworth Eastern Hospital in early November 2012. Multigate had first imported samples of catheter A in May 2012 and had supplied them to customers between August and November. It had been provided for exhibition at the conference of the Australian College of Infection Prevention and Control in October 2012. Multigate submitted that in these circumstances the Court should proceed cautiously before adopting a broad construction of any of the terms in issue and should not accept that the similarity of the substantial idea of a feature of a claim, or similar functionality of a feature, sufficed to establish infringement. Multigate’s submission in this respect was, in essence, that the patents in suit were filed only after the Multigate catheters A and B were supplied in to the market and that the claims were framed with knowledge of the Multigate catheters. Multigate otherwise conceded, however, that there was no material difference between catheter A and catheter C other than what was referred to in the submissions as the tolerance gap.
The parties also relied upon expert evidence on the construction of the patents in suit as well as on questions of infringement and invalidity. Five expert witnesses were called to give evidence in the proceeding. They provided a joint report and gave oral evidence concurrently. Their evidence was directed to the meaning of the words in the claims although, ultimately, the construction of the claims is a matter for the Court: Minnesota Mining & Manufacturing Co v Tyco Electrics Pty Ltd (2001) 53 IPR 32, [92]; Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 224 ALR 168, [34]. In that task the claims are to be seen by the Court through the eyes of a non‑inventive skilled worker in the relevant field as the relevant person to whom the patent is addressed before the priority date: Welch Perrin and Co Pty Ltd v Worrel (1961) 106 CLR 588, 610. In Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 the High Court said at [24]:
It is well settled that the complete specification is not to be read in the abstract; here it is to be construed in the light of the common general knowledge and the art before 2 July 1984, the priority date; the court is to place itself "in the position of some person acquainted with the surrounding circumstances as to the state of [the] art and manufacture at the time".
[Footnotes omitted.]
In Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 177 ALR 231 Finkelstein J said at [71]:
Generally speaking the skilled addressee is the person who works in the art or science with which the invention is connected. In Plimpton v Malcolmson (1876) 3 Ch D 531 Jessel MR said (at 556):
What is meant is that if [the invention] is a manufacture connected with a particular trade, the people in the trade shall know something about it; if it is a thing connected with a chemical invention, people conversant with chemistry shall know something about it.
In Catnic Lord Diplock said (at 242) that skilled addressees are "those likely to have a practical interest in the subject matter of [the] invention". A variety of people may have that interest. There are those who might wish to make or construct the invention, those who may wish to compound the invention and those who may wish to use the invention. The skilled addressee seems to me to be a relative expression which does not identify any specific person. Because the patent is directed to a person interested in making, constructing, compounding or using the invention (see, for example, s 27(3)(b) of the Patent Act 1993 (Canada); International Standard Electric Corp v Ooms 157 F 2d 73 (1946)), this hypothetical person, the patent lawyer's "reasonable man", may be required to be skilled in more than one art. Such a person might be thought of as the composite being, mentioned by Buckley LJ in Tetra Molectric at 583. It may be preferable not to search for a composite addressee but a team whose combined skills are to be employed. In General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485; (1971) lA IPR 121 at 137-8, Sachs LJ said:
The construction of these documents is a function of the court, being a matter of law, but, since documents of this nature are almost certain to contain technical material, the court must, by evidence, be in the position of a person of the kind to whom the document is addressed, that is to say, a person skilled in the relevant art at the relevant date. If the art is one having a highly developed technology, the notional skilled reader to whom the document is addressed may not be a single person but a team, whose combined skills would normally be employed in that art in interpreting and carrying into effect instructions such as those which are contained in the document to be construed.
In this case the field of inventions of the patents in suit is the design and manufacture of safety intravenous catheters. Multigate submitted that the relevant notional person to whom the patents were addressed was a team of people comprising a designer or engineer skilled in medical device design and production, a clinical advisor and a toolmaker. Multigate relied upon the expert evidence of Mark Bennett, Vincent Leskowich and Timothy Spencer who, together, Multigate contended, constituted the notional team to which the patents were directed, namely: an expert user (Mr Spencer), a medical devices designer (Mr Leskowich) and a tool maker (Mr Bennett). The applicants relied upon the expert evidence of Dr Haindl and Dr Esnouf. Dr Haindl had spent much of his professional life working in the design, development and manufacturing of medical devices and intravenous catheters. Dr Esnouf had been a qualified medical doctor since 1979 and had worked in various hospitals in surgical roles and in private practice in which he had engaged in inserting intravenous catheters into patients on a regular daily basis. The use made of that evidence is best considered below in the context of the specific question of construction raised by the parties.
The approach adopted by the parties to the issues raised in this litigation was to have posed, and to have asked as questions for the experts, a number of questions in the three broad areas of dispute, namely, construction of the patents, infringement and invalidity. There was, in this approach, substantial overlap of the issues arising for considerations and of the positions taken and of the views expressed. Thus, for example, the first question posed to the experts for their joint report in relation to the construction of the 327 Patent was “where is the distal end of the needle hub?” and the first question in relation to infringement in respect of the 327 Patent was “where and what is the distal end of the needle hub?”. This approach, however, carries with it the need for caution to ensure that questions concerning the proper construction of the patent were not being answered “with an eye to infringement”. The experts had also been asked for their views about the presence of the integers in dispute in Multigate’s catheters A, B and C. The joint expert report set out their respective views on the presence in the Multigate catheters of the integers in the respective patents, and the experts were cross‑examined about some of those views in the concurrent evidence given by them orally. The first step in the ultimate determination of infringement requires a construction of the patent without an eye to the alleged infringement (Bitech Engineering v Garth (2010) 86 IPR 168 at [26]; Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 67 IPR 230, 246 at [95]; GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited (2013) 103 IPR 487, 503 at [60]) and care must therefore be taken to ensure that answers given to questions raised for construction are not given to secure an outcome when the corresponding question is raised in the context of infringement or validity. It is also important not to lose sight of the fact that the words in a patent are used in a context and their meaning must be discerned and should reflect their use in that context.
CONSTRUCTION ISSUES IN THE 327 PATENT
Multigate conceded that its catheters A, B and C have each of the integers of claim 1 of the 327 Patent except for those integers in which the words and phrases were underlined and emboldened as appears in annexure A to these reasons. The claim under the 327 Patent, as in contention between the parties, was relevantly:
An IV catheter apparatus including a tubular catheter having a proximal end
and a distal end, a needle having a needle shaft and a tip and wherein the
needle is attached to a distal end of a needle hub, said needle being
received within said tubular catheter when the needle is in a ready position,
a catheter hub attached to the proximal end of said catheter, said catheter
hub having a hollow interior and an inner wall, said needle being movable
between said ready position in which said tip is outside of said catheter hub
and a retracted position in which said tip is within the interior of said
catheter hub, a needle guard positioned in the interior of said catheter hub
in a spaced apart relationship from the distal end of the needle hub;wherein the needle guard has a resilient portion engaged by said
needle shaft when said needle is in its ready position, the needle guard
resilient portion is movable within the interior of said catheter hub to a
blocking position distal of said needle tip when said needle is in its retracted position in which said needle shaft no longer exerts a force on said resilient
portion of said needle guard;wherein an outer contact surface on the needle guard is secured to a
groove formed in the catheter hub hollow interior when the resilient portion
is engaged by the side of the needle shaft and biased radially outwardly; andwherein the needle guard further includes a needle guard proximal
end, wherein the needle guard is secured to the needle tip when the needle
is in the fully retracted position by a portion of the needle guard proximal
end making contact with a needle crimp and the resilient portion blocking
the needle tip.The first area of disputed construction of the 327 Patent concerned the needle hub. The first question within this topic was about the meaning of the words “distal end” in relation to the needle hub, and illustrated the need for caution when construing the claims of a patent that the words of the claim should not be construed with an eye to infringement. The differences between the parties, and between their respective experts, concerning the meaning of the words “distal end” of the needle hub was essentially about whether the distal end was a specific point or region. Multigate contended that the distal end of the needle hub meant “the most distal perimeter or the outer face of the needle hub”. That was the view advanced in the joint report by two of Multigate’s experts, namely, Mr Leskowich and Mr Bennett. The construction advanced by Multigate had, of course, a favourable consequence for Multigate in relation to whether its catheters A, B or C had infringed the 327 Patent because, as Mr Bennett said in the joint report, in each case “the needle [was] not attached to the distal most face but in the central section of the needle hub”. The construction advanced by Braun, in contrast, was that the words “distal end” referred to a region rather than to an end point. That construction, in turn, had an unfavourable consequence for Multigate’s infringement case, and a corresponding favourable consequence for Braun’s infringement case, since it was possible to contend, on that construction, that the needle was attached to a distal end of the needle hub if the distal end was, as Dr Haindl said in the joint report, any region “distal from the midpoint of the length”.
The words “distal end” appear more than once in claim 1 of the 327 Patent. The words appear in the second and third lines preceded by the indefinite article and in the thirteenth line preceded by the definite article in the context of the positioning of the needle guard in a spaced apart relationship. In each case, however, the words are not used to refer to the furthest distal point of the needle hub but to a more general area which is distal to the user. The patent does not use such words as “distal point”, “distal end point” or “furthest distal point”, which would be more specific and narrower in meaning than “a distal end” or “the distal end”. The words “distal end” are more general and in their ordinary and natural meaning are apt to encompass the region ending with the furthest most distal point and including the area of the needle hub up to its centre. The patent relevantly refers to the attachment of the needle to the needle hub. The place of attachment is identified as “a distal end” and informs the reader of an aspect of the construction of the catheter; namely that the attachment occurs, as can be seen by figure 1, in a wider region than only at an end point. The needle hub is connected to the needle in the centre of the needle hub. The hub is a structure with a rotational symmetry and the needle is attached to the centre. The distal end, in that context, is that part of a wider region than just the end point at which the attachment occurs: the point of attachment is in the axial centre of the needle hub.
The second question for construction raised by the parties in respect of the needle hub concerned the meaning of the phrase “spaced apart relationship” in relation to the needle guard and the distal end. The words appear in the last line of the first paragraph of the claim in the 327 Patent concerning the positioning of the needle guard in the interior of the catheter hub. Multigate contended that the term should be given its ordinary English meaning to require that the needle guard and the distal end of the needle hub be separate from, or be some distance apart from, each other. Thus, to be in a “spaced apart relationship” from the needle hub, as submitted for Multigate, the needle guard must physically be outside the needle hub. In other words, that the needle guard and the distal end of the needle hub will only be spaced apart if there is an intended gap between the needle guard and the distal end of the needle hub. The construction of “spaced apart relationship” urged for Braun, in contrast, was that there was no need for a gap between the needle guard and the needle hub. The latter is seen in figure 1 marked with the number 12. The needle guard is located within the catheter hub (numbered 16) and for present purposes may be understood to include the mechanism within the catheter hub including the features identified with the numbers 122, 126, 128, 132 and 136a. For present purposes what is significant is the space appearing in figure 1 between the rear wall of the needle guard (identified with the number 126 and described in the patent as “rear wall of needle protecting means”) and the distal end of the needle hub. Braun contended that the words “spaced apart relationship” in the claim which described the relationship between the needle guard and the needle hub did not require there to be a gap between the two and that they could be in a “spaced apart relationship” even though they might be touching, provided that they were not constructed as connected. The construction of the words “spaced apart relationship” urged by Braun, which permitted the needle guard and the needle hub to be touching, was contended by Multigate to be “a nonsense”.
The construction advanced for Braun is to be preferred. Figure 1 does show a gap in the catheter in the ready position but the function of the requirement of a “spaced apart relationship” is to enable the needle to be withdrawn and be secured in the needle guard. The invention in the patent requires the needle hub to move independently of the needle guard so that the needle may be guarded when retracted. The relationship between the needle guard and needle hub is that they are to be placed separately within the device during the course of construction without there needing to be a gap: any space or gap between the two would serve no function; what does serve a function is that the two be separate for the operation of the device. The relationship of being spaced apart is not a relationship which prevents the two from having a connection or to be touching at all times. The need for a gap between the two only becomes a necessary feature in the operation of the catheter and is provided for by a construction of the catheter which ensures that the gap emerges in its operation. The description of the words refers to a relationship of two elements of the apparatus. The description in the claim is not that the needle guard is placed in the ready position with a gap between the needle guard and the distal end of the needle hub. Rather, the claim refers to a relationship between the needle guard and the needle hub. That relationship points to a positioning of the needle guard as a separate part of the apparatus permitting movement between the two. Mr Leskowich accepted that there was no need for a gap to be present for the proper functioning of the device.
The second topic raised for construction concerned the needle, including the various positions of the needle. Question 2(a) in the joint report dealt with the needle’s ready position. Braun contended that the use of the words “ready position” in the claim referred to any position where the needle tip protrudes from the distal end of the catheter hub. Mr Leskowich, in contrast, contended that the words “ready position” when used in the claim meant ready for insertion into the patient, as might be assumed to be depicted in figure 1. The construction advanced by Mr Leskowich has an intuitive appeal with the words “ready position” presupposing readiness for a purpose or use. However, the claim is not describing the use of the intravenous catheter in connection with a patient. Relevantly what is described is the position of the needle and its moveability from a ready position to a retracted position. The former describes the situation in which the needle is exposed and not secured by the needle guard. The latter is that point when the needle guard is positioned in the interior of the catheter hub and is not exposed. The ready position, therefore, within the meaning of the claim, is where the needle tip protrudes from the distal end of the catheter hub.
The second question concerning the needle raised for construction in the joint report concerned the position of the needle in the retracted position and the fully retracted position. The difference between the experts in relation to the retracted position of the needle was about whether the needle might be in the retracted position whilst the needle tip was still outside the needle guard. Mr Leskowich held the view that the needle tip might still be outside the needle guard in the retracted position because until fully retracted the needle could be returned to be ready for use if desired. Mr Spencer agreed with that view and agreed also with the view expressed by Mr Bennett that the retracted position referred to the points along the path of the needle retraction following withdrawal from the catheter. The view advanced for Braun was that the retracted position was where the needle tip had been withdrawn into the catheter hub including where the needle guard blocked the needle tip.
The terms of the claim clearly enough indicate that the retracted position of the needle was when the needle “tip [was] within the interior of [the] catheter hub”. It is distinguished in the claim itself from what is described in the last paragraph as the “fully retracted position”, namely, when the needle guard has done its work in securing the needle tip. The fully retracted position, as it seemed all of the experts agreed, is when the needle tip is within the needle guard and can no longer be returned to the ready position. It is not necessary, as Mr Spencer had opined, that the words “fully retracted position” be construed to require the needle guard to have been removed from the catheter hub; although, of course, it may be assumed that the needle will be in the fully retracted position when the catheter hub is removed. The words “retracted position” include the position when the needle is fully retracted but includes also where it is within the catheter hub but not yet fully secured in the needle guard.
The final question in relation to the needle raised by the parties and considered by the experts was the meaning of the words “needle crimp”. All agreed that the crimp was the deformation of the needle shaft. Dr Esnouf explained the process which caused a deformation of the needle shaft by applying external force to the wall of the shaft to change its shape. The process creates a flattened portion of the tube and corresponding bulge where the wall had been deformed radially by the crimping force. The purpose of the crimp, as revealed in the claim, can be seen when the needle is in the fully retracted position. In that position the needle crimp blocks the needle within the needle guard when the crimp of the needle reaches the proximal end of the guard.
The third broad topic for construction concerned the needle guard. Three questions were considered in the experts’ joint reports on this topic, namely: what is the “resilient portion” of the needle guard; what does it mean to say that the needle guard is “secured to” the needle tip when the needle is in the fully retracted position; and what is the “proximal end” of the needle guard. An issue of disagreement between the parties concerning the “resilient portion” of the needle guard was whether it included the arms identified in figure 1 by the numbers 122 and 124. The word “resilient” itself indicates something which resumes its original shape or position after movement. The needle guard in this invention blocks the needle tip when the needle is in the fully retracted position because parts of the guarding mechanism blocks the needle from moving forward. The claim refers to “the resilient portion blocking the needle tip” and the dispute concerning the construction of those words was whether that portion was limited to those parts of the guarding mechanism physically blocking the needle when fully retracted. Mr Bennett pointed to the use of the words “portion” as indicating that only part of the needle guard was referred to by the claim rather than the whole of the mechanism which effected the blockage when the needle was fully retracted. His view was that the resilient portion did not include the arms but was intended to refer more narrowly to the parts of the mechanism that blocked the needle in the fully retracted position. Mr Leskowich expressed a similar view in the joint report when saying that the resilient portion was the area in figure 2 between the lip identified by the number 132 and the elbow identified by the number 128.
The patent itself refers to the arms moving “resiliently” into the position shown in figure 2 when the needle point passes the lips and arms:
When the needle point passes the lips 132 the arms 122, 124 resiliently move into the position shown in Fig. 2 in which the front walls 129, 130 cover the needle point. […] The annular projection 136a retains the needle protecting means 120 in the catheter hub 26 when the needle 16 is removed from the catheter hub 26 until the arms 122, 124 of the needle protecting means 120 are no longer supported by the needle 16 and resiliently move towards the inside.
[Emphasis added.]
No doubt what causes the movement in the guard is the pressure in the points on the arms which is released when the needle tip passes the lips of the distal end of the guarding mechanism. The arms (numbered 122 and 124) in the mechanism shown in figure 2 spring together once the needle tip moves past the distal end of mechanism in the proximal direction. The force or pressure in the mechanism (including the arms) which had been applied to the needle is released when the needle passes the lips. It is the whole of the mechanism (including the arms by the release of the pressure but excluding the proximal end wall) which blocks the needle tip when it resiliently effects the blockage of the needle.
The debate concerning the construction of the needle guard being “secured to” the needle tip was about whether the words required that there be some form of attachment, locking or fixing of the needle tip to the needle guard. Mr Leskowich construed the terms of the patent as indicating that the crimp on the needle performed the function of securing the needle guard to the needle tip to prevent movement of the guard in the distal direction. In that context “secured” was said to mean that the guard over the needle’s tip could not be pulled off or removed. The relevant description in the patent of the operation by reference to figure 2 was:
When the needle 16 is removed from the catheter 24 the needle protecting means 120 is retained in the catheter hub 26 such that the needle 16 slides through the catheter hub. When the needle point passes the lips 132 the arms 122, 124 resiliently move into the position shown in Fig. 2 in which the front walls 129, 130 cover the needle point. In this condition the engagement element 127 abuts the irregularly configured portion 138 such that the needle protecting means 120 is prevented from sliding beyond the distal end of the needle 16.
The “securing to” of the needle guard to the needle tip in the patent explains that the needle guard in the position shown in figure 2 cannot move in such a way that would expose the needle tip or which would permit the needle tip to leave the guard. No part of the invention affixes the needle tip to the needle guard in any way that might be regarded as an attachment or affixing of one onto the other. The needle guard, however, in the position shown in figure 2, is secured such that it cannot permit the needle to move distally.
The experts also disagreed about whether the securing contemplated by these words meant that the needle guard was secured in one or two directions. Dr Haindl was of the view that the securing had a two directional function whilst Mr Leskowich considered that the securing of the needle guard had only a one directional function because, in his view, the needle in a fully retracted position engaged the crimp which, according to Mr Leskowich, performed “the function of securing the needle guard to the needle tip to prevent movement of the guard in the distal direction (towards the needle tip)”. However, the crimp is not locked into the proximal wall of the needle guard and it is the blocking arms which perform the function of preventing needle exposure from distal movement of the needle tip. Accordingly the view of Dr Haindl is preferred.
Debate about the meaning of the words “the proximal end of the needle guard” was about whether what was to be understood by those words was the proximal face of the wall marked as number 126 on figure 1 or the whole of the wall and not just its outer (proximal) face. Dr Haindl urged the construction that the proximal end of the needle guard was the whole wall whilst Mr Bennett urged the view that the words referred to the most proximal perimeter or face of the needle guard. Mr Leskowich in this respect appeared to support Dr Haindl rather than Mr Bennett. The view of Dr Haindl is the more natural meaning of the words in the claim. The last paragraph in the claim refers to a needle guard proximal end as part of the mechanism of securing the guard to the needle tip. What is described in that function is performed by the whole of the proximal wall labelled 126 in figure 2 and not just one of its faces. The example used in argument of the difference between the paint on a wall and the wall itself may not be a perfect analogy but usefully points to the competing views. The function in the patent is relevantly performed by the wall and not just by its surface: indeed, without the wall the surface would neither exist nor be capable of performing the function Mr Bennett ascribed to it.
The next topic for construction of the claim concerned the catheter hub. In that context the experts were asked four questions for their joint report, namely: what does “attached to the proximal end” mean in relation to the catheter hub and catheter; what does “positioned in the interior of said catheter hub” mean in relation to the needle guard; what is a groove; and what does “secured to a groove in the catheter hub hollow interior” mean.
The claim describes the catheter hub being attached to the catheter at the proximal end of the catheter. Figure 1 shows the catheter hub numbered 26 being attached to the catheter numbered 24. The attachment of the catheter hub is at the proximal end of the catheter; that is, the distal end of the catheter hub is attached at the proximal end of the catheter. Mr Bennett, an expert called by Multigate, said that the words “attached to” in this context referred to a direct attachment of the kind shown in figure 1, but “does not include indirect attachment”. Mr Leskowich agreed with Mr Bennett to the extent that figure 1 showed “a direct connection between the two” but otherwise said that the words from a design engineer’s perspective meant that there had to be a connection between the catheter hub and the catheter that would meet the ISO requirements for tensile strength to ensure that the catheter did not break or dislodge when pulled during use. Dr Haindl agreed with Mr Leskowich’s comments in respect of the ISO requirements but expressed the view that it did not matter “if the connection happen[ed] directly or indirectly”. In Dr Haindl’s view the words meant that the proximal end of the catheter was “received in a distal hole of the catheter hub and [was] firmly connected with the hub”. The words of the claim require that the catheter hub be attached to the catheter but they do not exclude indirect attachment. It may be inferred that the attachment must be one that would meet the ISO requirements for tensile strength but there is otherwise no reason to construe the words to imply a limitation that the attachment be only a direct attachment.
The meaning to be given to the words “positioned in the interior of the said catheter hub” gave rise to sharp disagreement between the parties and their experts. The dispute focused upon the extent, if any, to which the needle guard was to be positioned in the interior of the catheter hub. Dr Haindl’s view was that the needle hub would be positioned in the interior of the catheter hub if it was either wholly or largely positioned in the interior. The view expressed by Mr Bennett in the joint report overlapped with that of Dr Haindl but Mr Bennett expressed himself as construing the words to be satisfied if the needle guard was positioned only partly in the interior of the catheter hub. Mr Leskowich, in contrast, expressed the view that the words required that the whole of the needle guard be entirely positioned in the interior of the catheter hub.
The needle guard shown in figure 1 is wholly positioned in the interior of the catheter hub but the claim is not limited in that way and should not be interpreted as if it were limited. Nor is there reason to reject Mr Bennett’s view that the words might be satisfied by less than the majority of the needle guard being positioned within the interior of the catheter hub. The extent of positioning within the interior of the catheter hub may be so slight that it could not be regarded as being positioned in the interior of the catheter hub in any meaningful sense but the words need not be restricted to a 50% or more interior placement of the needle guard within the catheter hub.
The question concerning the meaning of the word “groove” arose in the context of the role played by what was described in the legend to figure 1 as an “annular projection” and marked as numbered 136a. The claim refers to the needle guard being “secured to a groove” formed in the catheter hub hollow interior. The description in the claim can be seen from figure 1 with the resilient portion of the needle guard being engaged by the sides of the needle shaft in the ready position. The figure shows the distal end of the needle guard being pushed outwards as the needle passed through with the annular projections on the wall of the catheter hub securing the needle guard from moving in the proximal direction. The meanings given by each of the experts to the word “groove”, in this context, did not differ materially. In each case the word was said to mean an increase in the projected internal diameter of the interior hollow portion of the catheter hub in some part of its surface.
The differences between the experts about the meaning of the phrase “secured to a groove in the catheter hub hollow interior” was about whether the securing needed to be fixed or locked. Mr Bennett considered the words “secured to a groove” to mean “firmly attached, fixed to or locked together, as may be illustrated by a dovetail joint”. All other experts took a more general view. Mr Leskowich, for example, considered the words to mean that there be a “frictional fit present”. The views expressed by the experts, apart from Mr Bennett, best express the words in the claim, that is, that the words of the claim do not require that the securing of the needle guard be fixed or locked, provided that what occurs secures the needle guard to a groove when the resilient portion is engaged.
CONSTRUCTION ISSUES IN THE 577 PATENT
Multigate also conceded that its catheters A, B and C have each of the integers to claims 1 to 6 of the 577 Patent except for those integers in which the words and phrases were underlined and emboldened as appeared in annexure A to these reasons. The claims under the 577 Patent, as in contention between the parties, were relevantly:
In claim 1 of the 577 patent:
A safety IV catheter comprising:
(a)a needle having a needle shaft and a needle tip;
(b)said needle shaft comprising a bulge;
(c)a hollow tubular catheter having a proximal end;
(d)said hollow tubular catheter is secured to the distal end of a catheter hub;
(e)said catheter hub having a hub section, wherein a chamber is formed in said hub section, and having an inner wall;
(f)a resilient spring clip needle guard located within said chamber being formed in said hub section of said catheter hub and having a distal end wall;
(g)said needle being received within said hollow tubular catheter when in a ready position, wherein said needle extends through said chamber, a passageway and distally beyond said catheter hub and said hollow tubular catheter so that said needle tip extends beyond the tapered distal end of said hollow tubular catheter and said needle guard located within said hub chamber is adapted to automatically snap or pivot into a retracted position for blocking access to said distal needle tip and preventing further movement of said needle tip when said needle is in its retracted position;
(h)said needle guard being adapted to be inserted into said catheter hub and to be urged by said needle shaft into contact with said inner wall of said catheter hub so that the needle guard is retained therein;
(i)and a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position;
(j)said needle shaft of needle being adapted to engage said distal end wall of said needle guard when said needle is in its said ready position; and
(k)the said catheter hub being configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted causing said needle guard to pivot or snap to the retracted position in which said distal end wall blocks said needle tip;
(l)and said needle guard further comprising a proximal wall having an opening adapted to let said shaft of needle freely pass through and axially move; [denied for Catheters A and C, admitted for Catheter B]
(m)wherein said bulge has a diameter greater than that of said opening of said proximal wall. [denied for Catheters A and C, admitted for Catheter B]
In claim 2 of the 577 Patent:
"wherein said needle guard is adapted to automatically snap into said retracted position as said needle is being retracted for blocking access to said needle tip and preventing further distal movement of said needle tip to prevent accidental contact with said needle tip."
In claim 3 of the 577 Patent:
"wherein said distal end wall terminates in a lip [denied for Catheter B, admitted for Catheters A and C] adapted to be engaged by said needle shaft when said needle is in its said ready position."
In claim 4 of the 577 Patent:
"wherein the said catheter is configured such that a lower end or curved protrusion of said needle guard is urged by said needle shaft into retaining contact with said inner wall of said catheter hub when said needle is in its said ready position."
In claim 5 of the 577 Patent:
"wherein said spring clip needle guard is configured such that a downward or radial force exerted by said needle shaft on said spring clip needle guard in said catheter hub is released when said needle is retracted to said retracted position, and said distal tip of said needle moves past a lip of said spring clip needle guard causing said spring clip needle guard to pivot or snap to said retracted position in which said distal end wall is adapted to block said needle tip ."
In claim 6 of the 577 Patent:
"wherein said resilient spring clip needle guard has two arms."
The first topic for construction presented by the parties concerned the needle and gave rise to five questions. The experts agreed on the construction of the first two questions which they had been asked on this topic. The first was “what is the bulge in the needle shaft”. The experts agreed that the bulge is a section of the needle where the diameter is greater in a localised region. Mr Leskowich, with whom the others agreed, said that the word bulge meant the flattened section of a needle diameter that decreased the diameter in one direction and increased the diameter in another direction creating an irregularly configured portion of the needle shaft resulting in two outward protrusions. That construction of the word can readily be accepted and may be seen in figures 1 and 2. The second question was “what is a ready position in relation to the needle”. On this question of construction all agreed with the views expressed by Dr Haindl and Mr Leskowich. The former said that the patent defined “ready position” as when the needle tip extends beyond the tapered distal end of the hollow tubular catheter. Mr Leskowich said that it meant when the needle tip protrudes from the catheter as shown in figure 1. Those views of the meaning of the words may also be accepted.
The third question for construction presented by the parties in relation to the needle, and put to the experts, was “what is a retracted position, in relation to the needle”. The views of the experts appeared not to differ materially and were to the effect that the needle was in a retracted position when its tip was blocked within the needle guard. The words appear in several places in claim 1 including subparagraph (g). There, and in the other paragraphs in the claim where the words appear, it refers to the position of the needle when locked by the needle guard.
The fourth question presented by the parties and considered by the experts was “what does adapted mean in the phrase ‘adapted to engage the distal end wall of the needle guard when the needle is in its ready position’”. The word “adapted” in claim 1(j) is used in the sense of made or constructed to suit a purpose. That may occur by the modification of something from a standard model, as indicated by Mr Bennett, but something need not be a modification from a standard for it to be “adapted”. It is sufficient, as Dr Haindl and Mr Leskowich said, for the needle to be designed and constructed to perform a specific function. In other words, something may relevantly be “adapted” where it is constructed to suit a need irrespective of any difference it may or may not have from some standard or norm.
The last question in this group was “what does preventing further movement of said needle tip mean”. This phrase is similar to the word “secured” previously considered in the context of patent 327. The experts were largely in agreement, and their view is accepted, that the phrase conveyed the meaning of preventing the movement of the needle in the distal direction (beyond, perhaps, manufacturing tolerances) but not necessarily preventing rotational or other movement.
The next group of terms presented by the parties for construction concerned the resilient spring clip needle guard in the 577 Patent. The first question posed for the experts was the meaning of the words “resilient spring clip needle guard”. Claim 1(f) of the 577 Patent describes the catheter as comprising a resilient spring clip needle guard located within the chamber being formed in the hub section of the catheter and having a distal end wall. The experts differed sharply on the meaning of the words “resilient spring clip needle guard” and their disagreement included whether such a clip could be produced by any material other than metal. Dr Esnouf, with whom Dr Haindl agreed, said that the words “resilient spring clip needle guard” were to be understood as referring to a needle guard which had the characteristics of a spring (that is, which had the capacity to store energy), and was resilient such that following deformation the spring could return to its pre‑deformation state. Dr Esnouf believed that it was possible to fabricate a spring clip needle guard from non‑metallic material. He was cross‑examined about this and confirmed his belief that it would be possible to fabricate a spring clip needle guard of the appropriate size to fit inside an intravenous catheter other than from metallic material. His evidence was of personal experience with folding material of sheet plastics reinforced with non‑metallic materials in the context of a very small resilient ring used in a laryngeal mask and that evidence is accepted. Mr Bennett and Mr Leskowich, in contrast, maintained that the words meant a spring metal material such as stainless steel or spring steel. The terms in the patent, without an eye to infringement, do not require the words in question to be construed as limited to a spring clip made from a metallic substance. The words are to be understood as referring to a clip having a resilient feature in the sense of moving back into a position after its static state was altered.
The second question posed by the parties, and dealt with by the experts in this topic was what does “located within” mean in terms of the relationship between the needle guard and the chamber? The views of the experts on this question were the same as those they had expressed in relation to the same words in the context of the 327 Patent. There is no reason to adopt a different construction of the words in the 577 Patent from that in the 327 Patent. Mr Leskowich stated in the joint report that the text of the patent did not clearly define the position of the clip needle guard within the interior of the catheter hub but that a review of figure 1 revealed that the guard was shown to be fully and entirely contained within the catheter hub. Mr Leskowich supported that conclusion by his review of the prior art in which he saw in every figure a needle guard to be fully and entirely contained within the catheter hub. Similarly, the abutment of the needle hub (identified with the number 12 in figure 1) to the catheter hub (identified with the number 26 in figure 1) would, Mr Leskowich said, make it impossible for the needle guard to be anything other than fully and entirely contained within the hub. However, the terms of the patent are not so proscribed. The patent does not limit the needle guard to be located wholly within the catheter hub.
The third question asked about the meaning of the words “distal end wall” of the needle guard. The words are used in claim 1(f) by reference to an attribute of the spring clip needle guard and, therefore, relevantly refer to the whole of that feature of the needle guard. For that reason the view of Mr Leskowich (with whom Mr Bennett agreed) cannot be accepted to the extent that the distal end wall was seen as limited to what he considered to be the resilient portion of the needle guard, namely the points labelled 129 and 130 in figure 2. What is referred to as the “distal end wall” in the patent is a part of a structure having a thickness as well as a regional position and function.
The fourth question concerned the meaning of the words “retracted position” in relation to the needle guard in respect of which the parties and their experts found more agreement. Those words, as in relation to the 327 Patent, referred to the position of the needle guard when fully retracted for blocking access of the needle tip in the distal direction. Mr Leskowich considered there to be some ambiguity in the words because the words “further movement of the needle tip” were not clearly defined in the patent. Mr Bennett and Mr Spencer agreed with Mr Leskowich, but the absence of specific definition does not create ambiguity if the words are capable of sufficient understanding and meaning. The meaning of those words, in the context of an intravenous catheter designed to prevent injury from needle prick, is that in the retracted position the needle tip cannot move in the distal direction whatever its movement might otherwise be within the enclosing chamber.
The Kuracina patent also does not disclose integer (g) in claim 1 of the 327 Patent because the claim requires the tip of the needle to be blocked within the catheter hub in its retracted position and the moveable arm in figure 63 of Kuracina is not within the catheter hub in its retracted position. Dr Haindl accepted that the needle tip was within the catheter hub when the needle had moved past moveable arm 42 in figure 62 but not that it was within the catheter hub in the retracted position.
Mr Leskowich offered an additional comment in support of Multigate’s contention that feature (f) of the 577 Patent could be seen to be located within the catheter hub from figures 114, 118 and 123. The relevant features are best seen figure 118 of the Kuracina patent:
Multigate submitted, based upon Mr Leskowich’s observation, that it was apparent from figure 118 that lip 42 was located within the catheter hub. Mr Bennett was asked about figure 118 in light of the description of the needle guard in Kuracina as being adjacent to the catheter hub rather than being located within the interior. His evidence was that, despite the patentee’s wording, the needle trap 41 was actually inside the catheter hub as shown in figure 118. That was because, according to Mr Bennett, the lip part numbered 42 in figure 118 is part of the needle trap numbered 41 and the lip part numbered 42 is located within the chamber of the catheter hub. It is true that figure 118 shows that part of the feature including both items numbered 41 and 42 are within the catheter hub but to regard that part numbered 41 as being within the catheter hub because a small portion of it (namely that numbered 42) is within the catheter hub would not be an accurate statement as a matter of language or as a matter of function of the invention. An element of the needle trap shown in figure 118 is within the interior of the catheter hub but it is not wholly “located within” or “within the interior” of the catheter hub nor is it substantially or significantly located within or within the interior of the catheter hub such as to be an anticipation of the patents in suit.
INTERNAL FAIR BASIS
Multigate also contended that the claims in the patents in suit are not fairly based on matter disclosed in the body of the specifications. Section 40(3) of the Patents Act 1990 (Cth) requires that the claims in patents be “fairly based on the matter described in the specification”. In assessing Multigate’s claim it is necessary to split the patent into the claims and the body of the specification to determine whether the former are fairly based on the matter described in the latter: Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274, [49] (‘Lockwood’). The question as posed by Barwick CJ in Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 was “whether the claim to the product being new, useful, and inventive, that is to say, the claim as expressed, travels beyond the matter disclosed in the specification”: see also Lockwood, [57]. There must be a real and reasonably clear disclosure in the body of the specification of what is claimed so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification (Lockwood, [69]), but the words “a real and reasonably clear disclosure” do not limit the relevant disclosure to the preferred embodiments: Vehicle Monitoring Systems Pty Ltd v SARB Management Group Pty Ltd (2013) 101 IPR 496, 517 [121]-[123]; Lockwood, [68]-[69]; Rehm Pty Ltd v Webster Security System (International) Pty Ltd (1988) 81 ALR 79, 95.
Multigate contended that claim 1 of the 327 Patent was not fairly based on the specification when requiring that an outer contact surface on the needle guard be secured to a groove formed in the catheter hub hollow interior. It also claimed that there was no real and reasonably clear disclosure in the 577 Patent specification that a groove can be used to engage the needle protecting means in the catheter hub and no explanation or identification of anything as integer (k) of claim 1 of the 577 Patent to give it a fair basis.
Claim 1 of the 327 Patent requires that an outer contact surface on the needle guard is secured to a groove formed in the catheter hub hollow interior. The relevant description of the integer in the claim in the 327 Patent is:
wherein an outer contact surface on the needle guard is secured to a groove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwardly…
Multigate contended that the specification of the patent does not provide a real and reasonably clear disclosure of this groove feature.
The groove in question is that portion visible in figure 1 of the 327 Patent above, being the space between the annular projection marked as 136a and the inner distal wall at the distal end of the catheter hub. It was marked by Dr Esnouf as a groove in the figure considered above at paragraph 90. The experts were asked for their opinions about this and gave conflicting answers. Mr Spencer, called for Multigate, considered that the annular projection was not a groove and he could not identify any disclosure in the 327 Patent specification of a groove which secured the needle guard. He could find only three references to a “groove”, namely, in the specification in the consistory clause (which he believed did not disclose how the feature would work), in prior art, and in the context of a snap ring inserted into the groove where the ring and not the groove secured the needle guard. Dr Haindl, in contrast, identified the “groove” in figure 1 extending from the distal end of the bump marked 136a to the inner distal wall of the catheter hub. His evidence included the following statements:
I disagree with Mr Spencer’s view […] regarding a groove which secures the needle guard into the catheter hub. In figure 1 of both the ‘327 Patent and the ‘577 Patent there is a groove extending from the distal edge of bump 136a to the inner distal wall of the catheter hub. I have marked the groove on the figure 1 below [not reproduced in these reasons but substantially the same as annotated by Mr Esnouf above]. In the sense that the distal edge of bump 136a defines one edge of the groove, there is a relationship between the bump and the groove […]
Figure 1 alone enables me to understand how the groove will work, that is:
(a) the groove is for securing an outer contact surface on the needle guard in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwards, as required by feature (k) of claim 1 of the ‘327 Patent. The outer contact surfaces of the needle guard are “form locked” in the groove, so they are secured in the groove in this manner; and
(b) the groove is for engaging a curved protrusion of the needle guard for retaining the needle guard in the catheter hub in the ready position, which is an aspect of feature (i) of claim 1 of the ‘577 Patent. The curved protrusions of the needle guard are “form locked” in the groove, so the groove retains the needle guard in the catheter hub in this manner.
The groove was referred to in the consistory clause on page 2 at lines 24 to 27 which stated:
wherein an outer contact surface on the needle guard is secured to a grove formed in the catheter hub hollow interior when the resilient portion is engaged by the side of the needle shaft and biased radially outwardly.
The conclusion of Dr Haindl is consistent with other views expressed by the experts. Mr Bennett stated in the joint report that a “groove” means an increase in the projected internal diameter of the interior hollow portion of the catheter hub in a localised region. Dr Esnouf expressed a similar understanding of a “groove”, namely, that a groove was a depression, sulcus or undercut whereby the floor of the feature is lower than the adjacent structure. Mr Spencer had stated in the joint report that a “groove” is defined as a cut or a trench in a given surface.
Whether there has been disclosure of the feature depends upon an inquiry “into what the body of the specification read as a whole discloses as the invention” including the consistory clause: Lockwood, [92], [99]. In CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 280 it was said that it was “well established that a claim may be fairly based on matter in the specification which is not verbal description [found in the] but accompanying drawings”. The specifications are to be read by “the skilled addressee” (Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5, 11; CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260, 280), and in the context of claim 1 of the 327 Patent the integer in the claim was fairly based on the disclosure in the specification from the drawing in figure 1 and the consistory clause. It is clear from the drawing, as explained by Dr Haindl, how the groove would work.
In relation to the 577 Patent, Multigate contended that there was no real and reasonably clear disclosure that a groove could be used to engage the needle protecting means in the catheter hub and that there was no explanation or identification of anything which might be construed as integer (k) of claim 1. Claim 1 of the 577 Patent requires that the intravenous catheter has a “groove or bump” formed in the inner wall for engaging a curved protrusion of a needle guard. The words in the claim in 1(i) are:
and a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position…
Multigate claimed that there was no real or reasonably clear disclosure in the 577 Patent specification that a groove can be used to engage the needle protecting means in the catheter hub and, therefore, that the claim lacked fair basis. This issue in the context of the 577 Patent is essentially the same as that considered above in relation to the 327 Patent and, for the reasons given in that context, the submissions of Multigate are not accepted. The groove can be seen in figure 1 of the 577 Patent which is the same figure as in the 327 Patent, and the consistory clause in the 577 Patent referred to “a groove or bump being formed in said inner wall of said catheter hub for engaging a curved protrusion of said needle guard for retaining said needle guard in said catheter hub in the ready position”. Accordingly, this feature of the claim was fairly based on matter disclosed in the 577 Patent specification.
The second challenge by Multigate to the claim in the 577 Patent concerned the configuration of the catheter hub in integer (k) of claim 1 in that patent. That feature was expressed in the claim as follows:
the said catheter hub being configured such that a force exerted by said needle shaft on said needle guard in said catheter hub is released when said needle is retracted causing said needle guard to pivot or snap to the retracted position in which said distal end wall blocks said needle tip…
Multigate contended that the specification of the 577 Patent “does not mention feature (k), other than in the first consistory statement” and that there was no explanation or identification of anything which might be construed as integer (k) or which gave it fair basis.
The experts had also been asked about this feature, including the meaning of the word “configured” as appearing in the specification. The experts disagreed about the meaning of the word “configured” in the patent. Multigate’s witnesses all agreed with the view expressed by Mr Leskowich that the word “configured” was “the same as ‘designed’”. Dr Haindl, in contrast, considered the word to mean in relation to a catheter hub that the catheter hub contains structures to ensure that the biasing force of the needle shaft must be released before the needle guard can leave the catheter hub. Dr Esnouf expressed the same idea more simply, namely, that “configured” meant that the catheter hub was “arranged” in a fashion that allows the needle guard to operate as intended. The experts were also asked further questions in oral testimony in which they essentially confirmed their views.
Integer (k) of claim 1 of the 577 Patent is separate from integer (i). The latter is concerned with retaining the needle guard in the hub in preparation for operation when the needle is fully engaged and the bend of the distal end of the arms abut the annular projection. Integer (k), on the other hand, is concerned with the release of a force when the needle is retracted. It is concerned with the means by which the distal end walls of the needle guard block the needle tip when the needle is retracted. Figure 1 discloses that and is described in the specification in the following lines:
The needle protecting means 120 is retained in the catheter hub 26. For this purpose an annular projection 136a extending about the inner wall of the catheter hub 26 is provided. While the lips 132 press against the outer walls of the needle 16 from opposite sides (Fig. 1), the bends 128 grip behind the projection 136a. When the needle 16 is removed from the catheter 24 the needle protecting means 120 is retained in the catheter hub 26 such that the needle 16 slides through the catheter hub. When the needle point passes the lips 132 the arms 122, 124 resiliently move into the position shown in Fig. 2 in which the front walls 129, 130 cover the needle point. In this condition the engagement element 127 abuts the irregularly configured portion 138 such that the needle protecting means 120 is prevented from sliding beyond the distal end of the needle 16. In the embodiment shown in fig 1 the projection 136a is a completely round or continuous configuration. The annular projection 136a retains the needle protecting means 120 in the catheter hub 26 when the needle 16 is removed from the catheter hub 26 until the arms 122, 124 of the needle protecting means 120 are no longer supported by the needle 16 and resiliently move towards the inside. Here, the projection 136 is integrally molded to the catheter hub 26, e.g. by injection molding.
What is thus disclosed is a configuration, in the sense of an arrangement or structure, operating in the way identified in integer (k) of claim 1 of the 577 Patent. The feature may also be seen by the further embodiments shown in figures 4 and 5:
The embodiment in figure 4 is disclosed in the specification as follows:
In the embodiment shown in Fig. 4 the projection 136b oriented towards the inside is of generally C-shaped configuration. Said C-shaped projection 136b can be made from a metal snap ring partially seated in an annular groove on the inside of the catheter hub. In this way it is possible to produce the projection 136b by inserting the snap ring into the catheter hub 26 until it lockingly engages the corresponding groove.
Figure 5 is disclosed in the specification as follows:
Fig. 5 shows another alternative where the projection 136c is divided into two segments with intermediate interruptions 137. Each segment has a larger circumferential extension than the immediate interruptions 137. Further, the circumferential extension is considerably larger than the width of the distal front walls 129, 130 of the needle protecting means. Preferably, the generally annular projection projecting towards the inside does not have any interruptions 137 whose width is larger than the width of the distal front walls 129, 130, respectively, of the needle protecting means. The interruptions 137 being dimensioned such that they are smaller than the width of the front walls prevents the needle protecting means 120 from unintentionally passing the interruptions 137 thus sliding out of the catheter hub without covering the needle point. According to the present invention any number of separate segments forming a generally annular projection may be provided as long as the needle protecting means 120 is securely retained in the catheter hub when the needle 16 is removed from the catheter 24.
In each case what is disclosed is the configuration claimed as integer (k) permitting the release of the force exerted when the needle guard pivots or snaps to the retracted position in the catheter hub by the needle being retracted.
SUFFICIENCY
Multigate challenged the sufficiency of the 327 and 577 Patents substantially on the same basis as its challenges to internal fair basis. That is, that the disclosure in the 327 Patent specification would not enable a skilled addressee to produce a catheter in which an outer contact surface of the needle guard was secured to a groove in the catheter hub, and that the disclosure in the 577 Patent specification would not enable a skilled address to produce a catheter which included integer (k).
Section 40(2)(a) of the Patents Act 1990 (Cth) requires that a complete specification describe the invention “fully”. In Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 the High Court said at [16] in a joint judgment:
Other considerations arise from the statutory text where the issue concerns par (a) of s 40(2). The question then is whether the invention has been fully described in the complete specification. The text speaks here of the complete specification, not any one part thereof. From the distinction drawn in s 40(2) between describing the invention in the complete specification and defining the invention in any claims with
which the complete specification ends, it does not follow that the description is to be gleaned solely from one part (the body) and that it is forbidden to obtain any assistance by regard to the remainder (the claims) of the complete specification. Rather, the text indicates that the specification must be read as a whole and that reference to the claims may dispel ambiguity or uncertainty from the body of the specification concerning the description of the invention.In Lockwood the High Court said in another joint judgment at [49] that in assessing whether a patent complies with the requirement of s 40(2)(a) it is “necessary to take into account the whole of the complete specification – both the body of the specification and the claims”.
Multigate’s contention that what was disclosed would not enable a skilled addressee to produce a catheter with the relevant features in the claim relied primarily upon the evidence of Mr Spencer. Braun objected to that evidence of Mr Spencer relating to this issue on the grounds that his opinion was not based on any specialised knowledge from his training, study or experience and, therefore, was said not to be admissible under s 79(1) of the Evidence Act 1995 (Cth). Mr Spencer has had long experience as an end user of intravenous catheters but did not claim any experience in the design or manufacture of them or of any other medical device. His evidence did not identify specialised knowledge based on training, study or experience in the design or manufacture of intravenous catheters and, in oral testimony, confirmed that he had never been involved in either the design or the manufacture of IV catheters. He had, however, in 1998 been part of a focus group that had looked at the workings of catheters but not in the sense of actually designing catheters. In the end, it is not necessary to rule upon the admissibility of his evidence but to receive it subject to the qualification of taking into account the grounds upon which it had been challenged in considering the weight it should be given. That is because the question for determination is one of fact, and Mr Spencer’s opinion, although not as an expert in design of intravenous catheters, may assist in evaluating the evidence. Whether a specification discloses a method is best determined by receiving evidence from persons skilled in the art (Universal Oil Products Co v Monsanto Co (1972) 46 ALJR 658, 661) and the finding to be made in this case may benefit from the view of an end user able to inform the Court about how the end user understood the disclosure. However, in this case, it follows from the conclusions in relation to internal fair basis, and the acceptance of the evidence of Dr Haindl in particular, that what is disclosed is sufficient to “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”: see Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1, 17 [25]. In other words, the disclosure in the 327 Patent specification would enable a skilled addressee to produce a catheter in which an outer contact surface of the needle guard was secured to a groove in the catheter hub and the disclosure in the 577 Patent specification would enable a skilled addressee to produce a catheter which included integer (k) in the sense of having the configuration of the catheter hub in that part of the claim.
UNJUSTIFIED THREATS
In light of the findings made above, it is not necessary to consider Multigate’s claim under ss 128 and 129 of the Patents Act 1990 (Cth). Those sections provide:
128 Application for relief from unjustified threats
(1)Where a person, by means of circulars, advertisements or otherwise, threatens a person with infringement proceedings, or other similar proceedings, a person aggrieved may apply to a prescribed court, or to another court having jurisdiction to hear and determine the application, for:
(a) a declaration that the threats are unjustifiable; and
(b) an injunction against the continuance of the threats; and
(c)the recovery of any damages sustained by the applicant as a result of the threats.
(2)Subsection (1) applies whether or not the person who made the threats is entitled to, or interested in, the patent or a patent application.
129 Court's power to grant relief if threats related to a standard patent or standard patent application
If an application under section 128 for relief relates to threats made in respect of a standard patent or an application for a standard patent, the court may grant the applicant the relief applied for unless the respondent satisfies the court that the acts about which the threats were made infringed, or would infringe:
(a)a claim that is not shown by the applicant to be invalid; or
(b)rights under section 57 in respect of a claim that is not shown by the applicant to be a claim that would be invalid if the patent had been granted.
The effect of these provisions is to prohibit the making of unjustified threats and to impose an onus of justification upon the party making the threat. On 11 May 2013 Braun’s solicitors wrote to Multigate stating, in part:
We act for B. Braun Melsungen AG and its Australian exclusive licensee, B. Braun Australia Pty Ltd.
B. Braun Melsungen AG is the proprietor of Australian Standard Patent Numbers 2012258327 and 2012260577 (collectively, “the Patents”), and B. Braun Australia Pty Ltd is the Australian exclusive licensee for the Patents. Copies of these Patents are *enclosed for your information. Each of the Patents was granted by the Australian Commissioner of Patents on 2 May 2013, and is registered with an effective term of monopoly from 18 August 1998 to 18 August 2018.
Pursuant to section 13(1) of the Patents Act 1990 (Cth) our clients have the exclusive right in Australia to exploit the inventions the subject of the Patents that is, to make, sell or otherwise dispose of the safety IV catheter claimed in the Patents, and to offer to make, sell, hire or otherwise dispose of the safety IV catheter, or use or import it, or keep it for the purpose of doing any of those things.
Our clients have become aware that, without our clients' consent, your company has been importing, offering for sale, selling, using or otherwise exploiting in Australia, the PolyMed safety IV cannula ("the infringing product").
Our clients consider that the infringing product infringes claim 1 of Patent Number 2012258327 and at least claims 1 to 6 inclusive of Patent Number 2012260577.
In addition, our clients are aware that:
(a)your company exhibited the infringing product at the recent Australia & New Zealand College of Anaesthetists meeting held in Melbourne from 4 to 8 May 2013;
(b)your company has recently given the Infringing product to several Victorian hospitals, presumably for trial purposes;
(c)Health Purchasing Victoria (HPV) recently invited bids for tender for a 3-year purchasing contract for products including safety IV catheters, intended to commence on 3 October 2013. Submissions for tender close on 21 May 2013; and
(d)your company has previously submitted tenders relating to the infringing product for health purchasing contracts in other Australian states and territories, including its successful tender in the Northern Territory in late 2012.
Given that it is a condition of the HPV tendering process that products offered for tender must be trialled in Victorian or other hospitals, and in light of your company's recent promotional activities and previous bids to win other health purchasing contracts in relation to the infringing product, it can reasonably be inferred from the circumstances that your company intends to submit a tender for the HPV contract on or before 21 May 2013. Our clients view this as a clear and imminent threat to infringe their patent rights.
It is our clients' policy to rigorously enforce their intellectual property rights and they are prepared to institute legal proceedings where necessary to enforce those rights. However, before embarking on that course in respect of the infringing product we have been instructed to write to you to see whether the matter can be resolved without resort to Court proceedings. You should note however that this should not be taken as any indication of a lack of resolve on our clients' part; it simply reflects our clients' desire to comply with their obligations under the Civil Dispute Resolutions Act 2011 (Cth) and their desire not to incur unnecessary legal costs.
With that in mind, our clients are prepared to refrain from commencing court proceedings but only if a properly authorised officer of your company provides the following undertakings on behalf of the company and each of its directors, servants and agents.
1.THAT your company, whether acting by itself, its directors, officers, servants or agents or otherwise howsoever will immediately cease and until 18 August 2018 desist from making, selling or otherwise disposing of the infringing product, offering to make, sell or otherwise dispose of the infringing product, or using or importing, or offering to import the infringing product, or keeping the infringing product for the purpose of doing any of those things.
2.THAT, without limiting the generality of paragraph 1, your company, whether acting by itself, its directors, officers, servants or agents or otherwise howsoever, will immediately:
(a) cease and refrain until 18 August 2018 from submitting any tender to Health Purchasing Victoria (HPV) (or to any other Australian health or other purchasing entity) which refers to, promotes or offers to sell the infringing product; and
(b) to the extent that such a tender has already been submitted to HPV or any other Australian health or other purchasing entity, immediately withdraw your company's tender.
3.THAT your company, whether acting by itself, its directors, officers, servants or agents or otherwise howsoever, will immediately recall from all of its outlets, agents and distributors all infringing product in its power, possession or control, or otherwise in the power, possession or control of its servants or agents and deliver them to our clients care of Davies Collison Cave Law, Level 15, 1 Nicholson Street, Melbourne, Victoria, or at our clients' direction.
4.THAT an authorised representative of your company will provide, within seven days of giving these undertakings a Statutory Declaration specifying full particulars of:-
(i) The manufacturers and suppliers of the infringing product;
(ii) The quantity of infringing product supplied to it;
(iii) Those to whom the infringing product have been sold;
(iv) The number of infringing product that have been sold;
(v) How much each infringing product costs to produce or acquire;
(vi) The sale price of each infringing product; and
(vii)Your company's agents, distributors and/or re-sellers of the infringing product.
5.THAT your company will deliver up to our clients, care of Davies Collison Cave Law, Level 15, 1 Nicholson Street, Melbourne, Victoria, all copies in its possession, power or control, or in the possession, power or control of its servants or agents, of advertisements, brochures, catalogues or other documents that advertise, promote, display or offer for sale the infringing product.
6.THAT your company will pay our clients damages, or at our clients' option, an account of profits in respect of your company's infringing conduct.
Accordingly, to avoid our clients instituting patent Infringement proceedings, our clients require your company to give, and comply with, the undertakings set out in paragraphs 1 to 6 above, by no later than 2.00pm on Tuesday 14 May 2013.
The undertakings may be given by an authorised representative of your company signing the endorsement below and sending it to us by the date and time specified.
Please note that if our clients do not receive the undertakings by the date and time specified, our clients intend to immediately institute, without further notice to you, patent infringement proceedings against your company in the Federal Court of Australia. These proceedings will include an application for the grant of an interlocutory injunction restraining your company from any dealings with the infringing product pending the outcome at trial.
It was contended that the letter constituted a threat and that it was unjustified. In Mechanical Services (Trailer Engineers) Ltd v Avon Rubber Co Ltd [1977] RPC 66 Graham J said at 75:
A patentee’s first and proper remedy when he considers the defendant is infringing is to bring an action for infringement, without making any threats at all. This is however in the life of the market place no doubt a counsel of perfection and, patentees and travellers being human as they are, no doubt threats against potential defendants will continue to be made. That does not meant to say that the law approves of such action, which, as already stated, can obviously cause serious damage which it is often difficult or impossible to recover …
The [UK equivalent to s 128 of the Act] gives a right to the plaintiff [in the threat suit] but not to the defendant. The latter is only given a shield or defence when he is able successfully to prove justification. He is not given any right to make a threat even if in fact it ultimately turns out to be justified. As patentee he can perfectly well bring his action for infringement without making a threat. […] If however a defendant does make a threat and it is held that he was unjustified, there is every reason why, if in all the circumstances including the generality of the threat it appears just and convenient, he should be restrained in general terms from making such threats in the future in respect of the plaintiffs’ goods or methods of manufacture. Such an injunction causes him no hardship for the reasons given above. The person threatened, on the other hand, will by such an injunction expressed in general terms be properly protected in the future against having to go through the very expensive business of bring an action to invalidate another of his rivals’ patents in order to show that such threats were unjustified. Only thus can the damage liable to be caused by threats unaccompanied by a patent action be positively prevented.
The conclusions in these reasons in favour of Braun also establish justification and it is, therefore, unnecessary to consider whether the threat ought not to have been made by Braun or whether the observations by Graham J fairly represent the law in Australia since the enactment of the Civil Disputes Resolution Act 2011 (Cth) which require that “genuine steps” be taken to resolve a dispute prior to instituting legal proceedings, or whether, in the circumstances any discretion should be exercised in favour of Braun: see JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2005) 67 IPR 68, 108 [212]. For present purposes it is sufficient to note that claims brought under ss 128 and 129 of the Patents Act 1990 (Cth) may need to take into account the impact, if any, of the provisions in the Civil Disputes Resolutions Act 2011 (Cth). On the findings in these reasons there is no occasion to make the orders sought under those sections.
ORDERS
Accordingly there will be judgment for the applicants and Multigate’s cross‑claim will be dismissed. The parties will be heard on the form of the orders and on any question about the costs of the proceeding.
I certify that the preceding one hundred and twenty-five (125) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Pagone. Associate:
Dated: 17 October 2014
ANNEXURE A
ANNEXURE B
ANNEXURE C
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