Becton Dickinson Pty Ltd v B. Braun Melsungen AG - [2018] FCA 1692

FEDERAL COURT OF AUSTRALIA
Becton Dickinson Pty Ltd v B. Braun Melsungen AG [2018] FCA 1692

File number: NSD 1297 of 2014

Judge: NICHOLAS J

Date of judgment: 9 November 2018

Catchwords:
PATENTS – claims for catheter insertion device – claim construction – meaning of “needle protective device” – whether claims infringed

PATENTS – whether claims entitled to priority date based on prior application – whether claims fairly based on matter disclosed in prior application

PATENTS – whether claims invalid for non-compliance with s 40(3) on the ground that they are not fairly based on the matter described in the specification

PATENTS – inventive step – whether claims invalid for lack of inventive step

Legislation:
Patents Act 1990 (Cth) s 18(1)(b)(ii), 40(3), 79B(1), 128

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Patent Regulations 1991 (Cth) reg 3.12

Cases cited:
Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411

Allsop Inc v Bintang Ltd (1989) 15 IPR 686

AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324

AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356

Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160

Decor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 285

ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (1999) 45 IPR 577

Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155

Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited (2011) 92 IPR 21

Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444

Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274

Martin v Scribal Pty Ltd (1954) 92 CLR 17

Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Ltd (1980) 144 CLR 253

Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (2016) 117 IPR 1

Olin Mathieson Chemical Corp v Biorex Laboratories Ltd [1970] RPC 157

Pharmacia Italia SPA v Mayne Pharma Pty Ltd (2005) 222 ALR 552

Rehm Pty Ltd v Webster Security System (International) Pty Ltd (1988) 81 ALR 79

Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605

Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18

Vickers, Sons & Co Ltd v Siddell (1890) LR 15 App Cas 496

Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262

Welsh Perrin & Co Pty Ltd v Worrell (1961) 106 CLR 588

Date of hearing: 5, 6, 7, 8, 9, 14, 15 and 16 June 2017

Registry: New South Wales

Division: General Division

National Practice Area: Intellectual Property

Sub-area: Patents and associated Statutes

Category: Catchwords

Number of paragraphs: 346

Counsel for Becton Dickinson Pty Ltd: Mr CA Moore SC with Mr AR Lang

Solicitor for Becton Dickinson Pty Ltd: Herbert Smith Freehills

Counsel for B. Braun Melsungen AG: Mr D Shavin QC with Mr EJC Heerey QC

Solicitor for B. Braun Melsungen AG: Davies Collison Cave

Table of Corrections

5 December 2018 Para [259] first sentence “indication” be amended to read “insertion”

ORDERS

NSD 1297 of 2014

BETWEEN:
BECTON DICKINSON PTY LTD (ACN 005 914 796)

Applicant

AND:
B. BRAUN MELSUNGEN AG

Respondent

AND BETWEEN:
B. BRAUN MELSUNGEN AG

Cross-Claimant

AND:
BECTON DICKINSON PTY LTD (ACN 005 914 796)

Cross-Respondent

AND BETWEEN:
BECTON DICKINSON PTY LTD (ACN 005 914 796)

Cross-Claimant

AND:
B. BRAUN MELSUNGEN AG

Cross-Respondent

JUDGE:

NICHOLAS J

DATE OF ORDER:

9 November 2018

THE COURT ORDERS THAT:
1.The originating application be dismissed.
2.The amended notice of cross-claim be dismissed.
3.Claims numbered 14 and 26 in Australian Patent No 2012244163 be revoked.
4.Claim numbered 17 in Australian Patent No 2012244164 be revoked.
5.Claim numbered 10 in Australian Patent No 2013201814 be revoked.
6.The amended notice of further cross-claim be otherwise dismissed.
7.Within 14 days, the parties file and serve (by way of exchange) brief written submissions (limited to 3 pages in length) on questions of costs.
8.Within 21 days, the parties file and serve (by way of exchange) brief written submissions in reply (limited to 2 pages in length) on questions of costs.
9.Upon the respondent, by its counsel, undertaking to the Court during the period of the stay:
A.to prosecute any appeal expeditiously; and
B.forthwith to serve on the Commissioner of Patents copies of these orders pursuant to s 140 of the Patents Act 1990 (Cth) with a request that particulars of Orders 3, 4 and 5 (“the Revocation Orders”) be registered in accordance with section 187 of the Patents Act 1990 (Cth),

the Revocation Orders be stayed:
(a)initially for a period of 21 days from today; and
(b)if an appeal from any of the Revocation Orders is lodged within that period, until the final determination of that appeal or further order.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT
NICHOLAS J:
BACKGROUND
The proceeding

The respondent (“Braun”) is the patentee of three Australian patents (“the Patents”) no AU2012244163 (“the 163 Patent”) filed 23 October 2012, no AU2012244164 (“the 164 Patent”) also filed 23 October 2012, and no AU2013201814 (“the 814 Patent”), filed 22 March 2013. Each of the Patents is entitled “Catheter insertion device” and relates to an intravenous (“IV”) catheter designed to reduce the risk of needle stick injuries and the outflow of a patient’s blood from the catheter. Mr Kevin Woehr is the sole inventor named in the Patents.
The applicant (“Becton”) commenced this proceeding against Braun alleging that Braun had made unjustified threats contrary to s 128 of the Patents Act 1990 (Cth) (“the Act”). Braun brought a cross-claim alleging that Becton had infringed various claims (“the relevant claims”) of the Patents by selling in Australia (inter alia) an intravenous catheter known as the “Insyte Autoguard BC” (“the BD device”). Becton has also filed a cross-claim seeking revocation of each of the relevant claims.
Braun alleges that Becton has infringed the following claims:
·the 163 Patent: claims 14 (in so far as it is dependent on claim 9) and 26;
·the 164 Patent: claims 10-12, 15-20, 24-25 and 28-30;
·the 814 Patent: claims 1-2, 4-6, 8-13, 17-18 and 21-23.
Becton denies that it has infringed any of the relevant claims. In total there are 15 integers in dispute in the infringement case.
Becton also contends that each of the relevant claims is invalid and should be revoked. The grounds of invalidity relied upon are lack of novelty, lack of fair basis and lack of inventive step.
Each of the Patents claims a priority date of 4 July 2002 through (inter alia) Australian Patent No 2009238275 (“the Parent”). Becton contends that, on the construction of the relevant claims propounded by Braun, none of them is entitled to the priority date claimed on the basis that there is no real and reasonably clear disclosure in the Parent of what is claimed. It is accepted by Braun that if the relevant claims are not entitled to the asserted 4 July 2002 priority date, and if the BD device is within any of the relevant claims, then any such claim will be invalid for lack of novelty based upon the sale of the BD device in the patent area commencing in September 2011.
There is also an issue in the proceeding as to whether the relevant claims are not fairly based on the matter described in the complete specification of the Patents in which the relevant claim appears contrary to s 40(3) of the Act as it stood prior to its amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).
Intravenous catheters
Intravenous catheters are mainly used for the puncture of superficial veins to provide access to a vein for more than just a single injection or blood withdrawal. These devices usually include a steel needle and a plastic catheter. After accessing the vein with the needle, the needle is removed and discarded and the plastic catheter stays in the patient. The catheter is commonly then hooked up to a drip line to give intravenous therapy to the patient.
The usual first step to using an intravenous catheter on the arm of a patient is to put a tourniquet around the upper arm and apply a pressure that makes the superficial veins visible. The patient is asked to close his or her fist two or three times which causes the veins to appear on the back of the hand and on the lower forearm. A vein is then punctured, and the blood runs through the hollow steel needle until blood appears at the rear end of the transparent needle hub. The appearance of blood in the needle hub (sometimes called “blood flashback”) indicates to the user that the vein has been successfully punctured. At this stage, the catheter (that is the catheter system with the needle) is not inserted with its full length completely in the vein, because pushing it forward risks further perforation of the vein with the steel needle. After the vein has been successfully punctured, the steel needle is then drawn back and the plastic catheter alone is pushed forward into the vein. Normally the user puts his or her finger on the tip of the catheter to avoid blood flowing out of the catheter and then takes out the steel needle and places it down or discards it. If infusion therapy is to be administered, the user then takes the drip line, connects it to the catheter, and fixes the drip line in place by applying an adhesive bandage or a film to the patient’s arm.
There is a particular risk with needle stick injuries from intravenous catheters. Because the needle becomes filled with the blood of the patient, and the needle is relatively large, the risk of infection from contact with a patient's blood is much higher than with normal hypodermic needles.
Safety intravenous catheters are devices which, in some manner, protect the needle tip of the used needle of the intravenous catheter.
THE WITNESSES
Dr Hans Haindl
Dr Haindl was called by Braun. He is a medical device consultant who is both a medical doctor and a mechanical engineer. He has worked in the medical devices field since the early 1980’s including for Braun, its affiliated companies and various competitors. Much of his practical work and advisory work involves solving problems relating to medical devices in collaboration with device manufacturers and medical personnel.
Dr Haindl holds a degree in mechanical engineering conferred in 1974 by the University of Hannover, Germany, and an MD (Doctor of Medicine) conferred in 1979 by the Hannover Medical School Germany. His thesis for his medical degree, published in 1972, is entitled “Central Venous Catheters Compared” and compares different venous catheters that were on the market in Europe at that time. He practiced as a medical doctor between 1980 and 1986 and designed or developed various medical devices during that period.
Between 1987 and 1990 Dr Haindl was employed by Braun as its head of research and development for “medical disposables”. During this period he worked on the development of various catheters and related devices including a new type of needle bevel to be used with port catheters for which he received royalty payments from Braun until about 2012.
Dr Haindl has worked on a large number of design projects for various companies since 1991 including Johnson & Johnson, Baxter, Braun and Fresenius. He first became involved with safety intravenous catheters while working for Johnson & Johnson in about 1991 or 1992 when Johnson & Johnson launched a product known as “Protect IV”. According to Dr Haindl, this product was an “active” safety catheter which the user was required to activate in order to obtain protection from needle stick injuries.
Although Dr Haindl was not familiar with any of the Patents in suit until he was retained to act as an expert witness for Braun in this proceeding, he was familiar with the detailed description of the invention (including the drawings) in the Patents which appears in various other Braun patents in relation to which he has given evidence in other proceedings.
Mr Mark Crawford
Mr Crawford was called by Becton and gave evidence on the issues of construction, infringement and inventive step.
Mr Crawford obtained his qualifications and experience in the USA. Mr Crawford has a Bachelor of Arts Degree in Biology from the University of Utah and began his career working as a cardiovascular technician. His role expanded into project management and product development when Becton Dickinson in the USA (“Becton USA”) purchased his employer Deseret Medical in 1986. Mr Crawford worked for Becton USA from 1987 until 2007.
In his role at Becton USA, Mr Crawford was responsible for project management and product development of products including IV catheters, arterial catheters, accessor devices, adapters, plugs, central venous catheters and peripherally inserted central catheters. He was also responsible for working with Becton’s patent attorneys in relation to IV catheters and related areas. In early 2002, Mr Crawford qualified as a US patent agent.
Mr Chris Cindrich
Mr Cindrich was called by Becton. He gave evidence on the issues of construction, infringement and common general knowledge.
Mr Cindrich obtained his qualifications and experience in the USA. Mr Cindrich obtained a Bachelor of Industrial Design in 1995. He worked for Becton USA from 1996 until 2007 as an industrial designer in research and development in the field of infusion therapy, where he was involved in the design of IV catheters as well as peripherally inserted central catheters and mid-line IV catheters.
Professor David Bihari
Professor Bihari was called by Becton, and gave evidence on issues of common general knowledge.
Professor Bihari is qualified medical doctor and specialist intensive care physician. He has worked as a doctor in the United Kingdom (from 1978 to 1987) and in Australia (since 1987).
As an intensive care specialist, Professor Bihari is highly skilled in the use of IV catheters within the specialised environment of a hospital’s intensive care unit.
Between 1989 and 2002, Professor Bihari was part of a clinical trial team focused on providing clinical feedback and assessment on arterial and central venous catheters being developed in Munich by a company called Pulsion Medical Systems.
Professor Bihari’s evidence addressed the types of catheters used in medical practice in Australia as at July 2002 and also the areas of concern for clinicians using IV catheters at that time.
Mr Craig Wilson
Mr Wilson was called by Becton, and gave evidence on issues of common general knowledge.
Mr Wilson has a Bachelor of Applied Science and a Bachelor of Industrial Design. He has worked as a medical device design consultant since 1989 including for two years in the United Kingdom. Since 1991 he has been based in Australia.
In 2002 Mr Wilson ran an industrial design consultancy firm based in Sydney and was involved in the design of a wide range of medical devices including “sharps” protection devices such as trays for passing “sharps” devices between medical personnel. His company designed the DonorCare needle guard for use in relation to blood collection needles on blood bags, and the Platypus needle guard for apheresis dialysis needle applications.
Dr Philip Esnouf
Dr Esnouf was called by Braun. He gave evidence on issues of construction and inventive step.
Dr Esnouf has been an Australian qualified medical doctor since 1979 and since that time has worked in various hospitals in Australia in surgical roles and also in private practice as a general practitioner. Throughout his time working in hospitals, a regular part of his daily duties involved inserting intravenous catheters into patients.
Dr Esnouf has invented and designed a number of products in the medical field, and between around 1994 and 2004 he invented or co-invented a range of medical devices. During his career Dr Esnouf developed a practical understanding of tooling for the manufacture of medical devices, including maintaining his own laboratory with equipment to make moulds and prototypes.
If Dr Esnouf had been approached in around July 2002 and asked to develop an IV catheter which mitigated the risk of needle stick injuries occurring as a result of use of the catheter, he would have considered himself qualified to take on this project based on his medical training, his background knowledge of engineering, his experience in developing medical devices, and his experience in using IV catheters and observing others who did so.
Mr Leones and Mr North
Mr Leones and Mr North are both patent attorneys employed by Freehills Patent Attorneys who gave evidence for Becton concerning patent searches conducted by them at Becton’s request that were relied upon by Becton on the issue of inventive step. Neither of them was cross-examined.
THE PATENTS
There is a large measure of uniformity in what appears in the complete specification of each of the Patents. It is common ground that the text and drawings in each of the Patents are almost exactly the same except that the claims and matching consistory statements are quite different.
Each of the Patents commences with a statement incorporating by reference the disclosure of the complete specification of Australian Patent Application No 2004238275 as originally filed. It is common ground that this is a reference to the Parent. Accordingly, the contents of the Parent form part of the disclosure in the body of each of the Patents.
The Parent
The Parent is entitled “Catheter Insertion Device”. The invention is said to relate to such a device. This is followed by the brief description of prior art and a problem associated with it. The Parent states at page 1 lines 5 to 10:
A device of this kind is known from EP 352 928, wherein in a hollow catheter hub a needle guard element is arranged. On withdrawal of the hollow needle from the catheter over an engaging means near the tip of the hollow needle, the needle guard element engages with the engaging means and covers the tip when the hollow needle is separated from the catheter. In this design, after withdrawal of the hollow needle from the catheter, through this catheter blood can issue with which the operating personnel can come into contact.
The Parent also states at lines 11 to 14:
An object of the invention is to provide a catheter insertion device of the type described above such that an outflow of blood from the catheter is prevented after removal of the hollow needle with the needle guard element.
I will return to the European Patent No 352 928 (“the 928 Patent”) later in these reasons. It is sufficient to note at this point that there is a dispute between the parties as to whether it is permissible to have regard to the 928 Patent for the purpose of interpreting the Patents.
The Parent includes the following consistory statement at page 1, lines 16 to 31:
Accordingly, this invention provides a catheter insertion device comprising
an approximately hollow-cylindrical catheter hub to whose distal end a catheter is attached,
a needle hub having a hollow needle attached thereon and extending in the ready position through the catheter hub and the catheter,
a check valve through which the hollow needle extends in the ready position and which automatically closes after the needle is removed, and
a needle guard element arranged displaceably on the needle and engaging with the needle near the needle tip when the hollow needle is removed from the catheter hub,
a valve actuating element displaceably guided in the catheter hub and arranged proximally of the check valve arranged in the catheter hub and having a hollow cylindrical space for receiving the needle,
wherein the needle guard element is arranged in the hollow cylindrical space of the valve actuating element and has an engaging section which engages with an engaging means provided on the inner circumference of the valve actuating element when the hollow needle is removed from the catheter hub.

This is followed by two further passages at page 2, lines 1-6 and lines 7-9 that state:
It will be apparent that in accordance with the invention after withdrawal of the hollow needle from the catheter the latter can be reliably closed such that an outflow of blood is prevented, while simultaneously the tip of the hollow needle is securely covered by the needle guard element so that the operating personnel cannot injure themselves on the needle tip.
Exemplary embodiments of the invention are explained in more detail below with reference to the drawing …
The opening words of the corresponding passage in the Patents makes express reference to preferred embodiments. They state “[i]t will be apparent that in accordance with preferred embodiments of the invention [etc] …”.
There was a debate as to whether the statement at page 2, lines 1-6 constitutes a statement of the invention or a statement of an advantage or advantages of the invention. This is a significant question that I will return to later in these reasons.
The statement at page 2 lines 1 to 6 is followed by a reference to “exemplary embodiments of the invention” explained in more detail by reference to 10 drawings. I shall refer to this more detailed explanation as the detailed description. It is important to recognise, of course, that what is described in the detailed description are preferred (or “exemplary”) embodiments of the invention which may take other forms.
The Parent identifies drawings at page 2, lines 11 to 21 as follows:
Fig. 1 shows a longitudinal section through a catheter insertion device in the ready position,
Fig. 2 shows the catheter insertion device with the hollow needle removed,
Fig. 3 shows the device with an attached syringe,
Fig. 4 shows a sectional view along the line A-A in Fig. 1,
Fig. 5 shows a longitudinal section through another embodiment,
Fig. 6 shows a view of the valve disc,
Fig. 7 shows different views of a valve actuating element,
Fig. 8 shows a longitudinal section through a further embodiment,
Fig. 9 shows front views of the valve actuating element of Fig. 8, and
Fig. 10 shows a longitudinal section through a further embodiment.
Copies of the drawings (Fig 1-Fig 10) are also reproduced in Annexure A to these reasons.
After the detailed description of the preferred embodiments, the following statements appear at page 7, lines 19 to 28:
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.
THE DETAILED DESCRIPTION
Except where otherwise stated, the page and line numbers cited in these reasons are to the page and line numbers for the Parent.
The complete specification for each of the Patents and the Parent are virtually identical except for the consistory statements and the claims.
The detailed description in the body of the specification describes four embodiments of the invention. The first (“Embodiment 1”) is described at page 2 line 23 to page 5 line 9, the second (“Embodiment 2”) at page 5 line 11 to page 6 line 4, the third (“Embodiment 3”) page 6 lines 6 to 14 and the fourth (“Embodiment 4”) at page 6 line 16 to page 7 line 17.
With reference to Fig 1 and Fig 2, the catheter insertion device (1) of Embodiment 1 includes a catheter hub (2) of two parts consisting of a distal hub element (3) and a proximal hub element (5). The catheter (4) is fitted into a holding section (3a) of the distal hub element. The proximal end of this element (3) has an enlarged diameter which is overlapped by the distal end of the proximal hub element (5). At the proximal end of this element (5) is an attachment means known as a Luer thread (6).
Between the distal and proximal hub elements (3, 5) is a check valve in the form of a valve disc (7) fixed in place by these two hub elements. Figure 6 shows a valve disc with three slits (7a) that form elastic flaps (7b) which can be expanded by the hollow needle.
In the ready position, the hollow needle (9) extends through the proximal hub element, the check valve, the distal hub element, and the catheter, with the needle tip (9a) located at the distal end of the device. At its proximal end, the needle is fixed to a needle hub (8) inserted into the proximal end of the proximal hub element (5).
Within the proximal hub element, between the needle hub and the valve disc, there is a displacably arranged valve actuating element (10) with a truncated cone shaped locating section (10a) which opens the valve disk (as shown in Fig 3) and a plunger section (10b) that has a hollow space which receives the needle guard element (13). The plunger section (10b) is in the form of two spaced plungers into which a spring clip is inserted as shown in the cross-sectional view in Fig 4.
The needle guard element is in the form of the spring clip (13) with two spring arms (13a, 13b) as shown in Fig 1 when in the ready position. Upon engagement of the spring clip following withdrawal of the needle, the two spring arms cover the needle tip as shown in Fig 2.
After insertion of the catheter into the vein, the needle is withdrawn through the catheter and the catheter hub as the user pulls the needle hub in the proximal direction. An engaging means (9b) shown in Fig 2 located near the needle tip (which may consist of a lightly crimped radical projection on the needle) engages with the outer circumference of a bore in the rear wall (13c) of the spring clip. This allows the spring clip to be removed from the catheter hub with the needle, and with the needle tip completely covered and protected by the two spring arms of the spring clip. In this way the catheter insertion device provides protection against needle stick injury.
Once the needle tip has been withdrawn through the valve disc in the catheter hub, the elasticity of the valve disc causes it to close. This prevents blood flowing through the valve disc and into the proximal hub element in the direction of the user. In this way the catheter insertion device provides blood control protection by reducing the risk of contamination from infected blood that would otherwise spill out of the proximal end of the catheter hub.
Once the needle is fully withdrawn and the needle tip is protected and covered by the spring clip, it may be disposed of. A syringe or tube with a suitable fitting may then be connected to the catheter hub by means of the Luer thread.
Figure 3 shows a syringe that has been inserted into the proximal end of the catheter hub. The neck of the syringe (14) pushes against the valve actuating element (10) and presses it against the disc valve which displaces the flaps (7b) so as to open the valve. The contents of the syringe can then pass through the valve disc, into the distal hub element via the catheter and into the vein of the patient. When the syringe is withdrawn the valve disc will once again close.
With reference to Figs 5-7e, Embodiment 2 includes a modified catheter hub consisting of two modified hub elements (3, 5) and a modified valve actuating element (10). The valve actuating element is in a U-shaped form with a spring clip (13) inserted in it. The valve actuating element includes two plunger sections (10b) that extend into a locating section 10(a) at its distal end. As shown in the sectional view in Fig 7d, the needle (9) passes between the plunger elements, the spring clip, and into the locating section. It then passes through the valve disk (7) and into the catheter (3). In this embodiment, the hub element (5) includes a projection (5f) which, as shown in figure 5, projects inwards at diametrically opposite positions on the bore (5c) of the hub element and fixes the spring clip in the hub element until the spring arms spring over the needle tip when the needle is removed from the catheter hub.
Embodiment 3, as shown in Figs 8-9b, has a modified valve actuating element (10) in which the spring clip (13) is positioned. The valve actuating element (10), in this embodiment, incorporates inwardly projecting ribs (10e) which protrude radially into the bore (5c) of the hub element (5) as shown in Figs 8 and 9a.
Embodiment 4 includes a modified check valve (17) in the form of a “duck-bill” valve which includes two opposite flaps (17c) that are elastically deformable and which close when the needle is withdrawn. In this embodiment, there is no actuating element for opening the valve. The valve is instead opened by the pressure of fluid from the syringe (14). As illustrated in figure 10, the proximal hub element (5) in this embodiment includes a projection (5f) which extend radially inwards and hold the spring clip (13) until the spring arms spring back radially inwards to cover the needle tip.
There are a number of observations worth recording at this point in relation to the described preferred embodiments.
First, all of the described devices are of the “over the needle” variety in which the hollow needle extends through the interior of a catheter and a catheter hub assembly. This arrangement allows for the needle to be pulled along its longitudinal axis in the catheter and the catheter hub assembly, and for the needle tip to be withdrawn through the catheter and the catheter hub assembly.
Secondly, all of the described devices provide a form of needle stick protection that is achieved automatically by the withdrawal of the needle (ie. without any additional action by the operator) through the catheter and catheter hub assembly where the needle tip is covered by a needle guard element. They are all what I shall refer to as “passive” devices in which the needle stick protection is achieved by the operator drawing the needle through the catheter and catheter hub assembly. There were numerous other well-known devices available before the priority date that required the user to take some additional step to activate the needle stick protection mechanism. I shall refer to these devices as “active” devices.
Thirdly, in all of the described devices the needle tip protection is achieved by the withdrawal of the needle through the catheter hub assembly where the needle tip is protected by a needle guard element before the needle is fully withdrawn from the catheter hub assembly.
Fourthly, the embodiments described are all similar in arrangement and operation to the catheter insertion device described at page 1, lines 5 to 10 and said to be known from the 928 Patent but without providing any blood control protection. In particular, they all utilise a form of needle tip protection that involves covering a needle tip with a guard.
I should note that Mr Shavin QC (who appeared with Mr Heerey QC for Braun) made the point that the terms “passive” and “active” are not used in any of the Patents. That is true. However, the distinction between passive and active devices is one that was made by the expert witnesses when explaining how various prior art devices operate.
THE CLAIMS
The 163 Patent
The 163 Patent includes a number of consistory statements that mirror the language of various claims including 9, 14 and 26 for:
9. A catheter insertion device comprising:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve for regulating fluid flow positioned inside the interior cavity of the catheter hub for regulating fluid flow into the interior cavity; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub and said valve being in contact with a valve actuating element when in an open position for fluid flow; and
a needle protective device for preventing unintended needle sticks, said needle protective device positioned in-line with the catheter hub and the needle hub and having at least a portion extending distally of the proximal end of the catheter hub.
…
14.The catheter insertion device of any one of claims 9 to 13, wherein the needle protective device comprises a resilient portion made from a metal material for moving the needle protective device from a ready position to a protected position.
…
26.A catheter insertion device comprising a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end; a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip; a valve for regulating fluid flow positioned inside the interior cavity of the catheter hub for regulating fluid flow into the interior cavity; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub; a needle protective device for preventing unintended needle sticks, said needle protective device positioned in-line with the catheter hub and the needle hub and having at least a portion extending distally of the proximal end of the catheter hub; and wherein the needle protective device comprises a resilient portion for moving the needle protective device from a ready position to a protected position.
The 164 Patent
The 164 Patent also includes a number of consistory statements that mirror the language of various claims. These claims include 10-12, 15-20, 24-25 and 28-30 for:
10.      A catheter insertion device comprising:
a catheter hub comprising an interior cavity, a perimeter defining an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the catheter hub;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve configured to obstruct fluid flow comprising a slit positioned inside the interior cavity of the catheter hub and having a distal surface pushed against a shoulder in the interior cavity; said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub configured to actuate the valve, the valve actuating element comprising a nose section having a tapered end with an opening configured to push the valve to open the slit and at least two plunger elements extending proximally of the nose section and having a gap therebetween; wherein the at least two plunger elements with the gap therebetween are disposed distally of the proximal end of the catheter hub and are slidable distally when a male implement projects into the opening of the catheter hub to transfer a distally 10 directed force to the nose section to push the valve to open the slit;
a needle protective device positioned proximal of the valve and at least in part around the needle and distal of the proximal end of the needle hub in a ready position and configured to prevent unintended needle sticks in a protective position.
11.The catheter insertion device of claim 10, wherein the valve has a radial outer perimeter abutting the interior cavity of the catheter hub.
12.The catheter insertion device of claim 10 or claim 11, wherein the valve comprises three slits that converge at a single point.
…
15.The catheter insertion device of any one of claims 10 to 14, wherein the valve actuating element further comprises a projection located proximally of the tapered nose section and projects radially outwardly of the nose section and engaging a shoulder of the catheter hub.
16.The catheter insertion device of claim 15, wherein the projection is distal of the two plunger elements.
17.The catheter insertion device of any one of claims 10 to 16, wherein the needle protective device comprises an arm that is located, at least in part, in the catheter hub.
18.      A catheter insertion device comprising:
a catheter hub comprising an interior cavity comprising a shoulder, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve configured to obstruct fluid flow positioned inside the interior cavity of the catheter hub; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub for actuating the valve, the valve actuating element comprising a nose section having a tapered end configured to open the valve, a projection on the valve actuating element located proximally of the tapered nose section engaging the shoulder of the catheter hub, and a plunger end extending proximally of the nose section having one or more gaps to permit fluid flow to flow therebetween and to transfer a distally directed force to the nose section to open the valve;
a needle protective device positioned, at least in part, around the needle between the valve and the proximal end of the needle hub in a ready position and configured to prevent unintended needle sticks in a protective position.
19.The catheter insertion device of claim 18, wherein the plunger end comprises at least two plunger elements defining the at least one or more gaps.
20.The catheter insertion device of claim 18 or claim 19, wherein the valve comprises three slits that converge at a single point.
…
24.The catheter insertion device of claim 19 or any one of claims 20 to 23 when dependent on claim 19, wherein the projection is distal of the at least two plunger elements.
25.      A catheter insertion device comprising:
a catheter hub comprising an interior cavity comprising a shoulder, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve comprising one or more slits configured to obstruct fluid flow positioned inside the interior cavity of the catheter hub; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub for opening the one or more slits and actuating the valve, the valve actuating element comprising a nose section having a tapered end configured to open the valve and a plunger end extending proximally of the nose section having at least one gap to permit fluid flow to flow thereacross and to transfer a distally directed force to the nose section to open the valve;
a needle protective device positioned, at least in part, around the needle between the valve and the proximal end of the needle hub in a ready position and configured to prevent unintended needle sticks in a protective position.
…
28.The catheter insertion device of any one of claims 25 to 27, further comprising a fluid path between a distal most end of the valve actuating element and a proximal most end of the valve actuating element.
29.The catheter insertion device of any one of claims 25 to 28, further comprising a second gap in the plunger end.
30.The catheter insertion device of any one of claims 25 to 29, further comprising a projection that extends radially outwardly of the valve actuating element for engaging a shoulder in the catheter hub.
The 814 Patent

The 814 Patent also includes various consistory statements the language of which mirror various claims including 1-2, 4-6, 8-13, 17-18 and 21-23 for:
1.        A catheter insertion device including:
a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve sized and shaped to obstruct fluid flow through the catheter hub comprising a wall surface comprising a slit positioned inside the interior cavity of the catheter hub and abutting a shoulder in the interior cavity of the catheter hub; said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub to actuate the valve and having a longitudinal passage therethrough for the needle shaft, the valve actuating element comprising a nose section having a tapered end for pushing the valve to open the slit of the valve and at least two plunger elements extending proximally of the nose section, the plunger elements having a gap therebetween to permit fluid flow to flow therethrough; the two plunger elements structured to transfer a distally directed force to the nose section to push the valve to open the slit;
a needle protective device spaced from the needle tip in a ready position and movable relative to the needle tip to a protective position, at least in part, distally of the needle tip to prevent unintended needle sticks.
2.The catheter insertion device of claim 1, wherein the valve is generally round.
…
4.The catheter insertion device of claim 1, wherein the valve actuating element further includes a projection located proximally of the tapered nose section and projects radially outwardly of the nose section and abuts a shoulder of the catheter hub.
5.        A catheter insertion device including:
a first hub comprising an interior cavity, a perimeter defining an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub:
a needle having a needle shaft defining a needle axis projecting distally of an end of a second hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve sized and shaped to obstruct fluid flow comprising a slit positioned inside the interior cavity of the first hub and having a distal surface pushed against a shoulder in the interior cavity; said valve remaining inside the interior cavity when the needle is removed from the catheter tube and the first hub;
a valve actuating element slidingly disposed in the first hub to actuate the valve and having a longitudinal passage therethrough for the needle shaft, the valve actuating element comprising a projection, a nose section having a tapered end with an opening structured to push the valve to open the slit, and at least two plunger elements extending proximally of the nose section, the plunger elements having a gap therebetween; wherein the at least two plunger elements with the gap therebetween are disposed distally of the proximal end of the first hub and are slidable distally when a male implement projects into the opening of the first hub to transfer a distally directed force to the nose section to push the valve to open the slit;
a needle protective device positioned proximal of the valve and at least in part around the needle and distal of the proximal end of the second hub in a ready position, the needle protective device is moveable to prevent unintended needle sticks in a protective position.
6.The catheter insertion device of claim 5, wherein the valve has a radial outer perimeter abutting the interior cavity of the catheter hub.
…
8.The catheter insertion device of claim 5, wherein the projection is located proximally of the tapered nose section and projects radially outwardly of the nose section and abuts a shoulder of the catheter hub.
9.The catheter insertion device of claim 4 or claim 8, wherein the projection is distal of the two plunger elements.
10.The catheter insertion device of claim 1 or claim 5, wherein the needle protective device has an arm that is located, at least in part, in the catheter hub.
11.      A catheter insertion device comprising:
a catheter hub comprising an interior cavity comprising a shoulder, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve comprising a slit and sized and shaped to obstruct fluid flow through the catheter positioned inside the interior cavity of the catheter hub; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub for actuating the valve and having a longitudinal passage therethrough for the needle shaft, the valve actuating element comprising a nose section having a tapered end being sufficiently rigid to open the valve, a projection on the valve actuating element located proximally of the tapered nose section abutting the shoulder of the catheter hub, and a plunger end extending proximally of the nose section, the plunger end having one or more gaps therein to permit fluid flow to flow therethrough and to transfer a distally directed force to the nose section to open the valve;
a needle protective device positioned, at least in part, around the needle between the valve and the proximal end of the needle hub in a ready position, the needle protective device being moveable to prevent unintended needle sticks in a protective position.
12.The catheter insertion device of claim 11, wherein the plunger end has at least two plunger elements defining the at least one or more gaps.
13.The catheter insertion device of any one of claims 1, 5 or 11, wherein the valve has three slits that converge at a single point.
…
17.The catheter insertion device of claim 11, wherein the projection is distal of the two plunger elements.
18.      A catheter insertion device comprising:
a catheter hub comprising an interior cavity comprising a shoulder, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end;
a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip;
a valve comprising one or more slits movable to obstruct fluid flow positioned inside the interior cavity of the catheter hub; said valve remaining inside the interior cavity of the catheter hub when the needle is removed from the catheter tube and the catheter hub;
a valve actuating element slidingly disposed in the catheter hub for opening the one or more slits and actuating the valve, the valve actuating element having a longitudinal passage therethrough for the needle shaft and comprising a nose section having a tapered end made of a sufficiently rigid material to open the valve, a projection extending in a radial direction relative to a longitudinal length of the valve actuating element, and a plunger end extending proximally of the nose section, the plunger end having at least one gap therein to permit fluid flow to flow therethrough and to transfer a distally directed force to the nose section to open the valve; a needle protective device positioned, at least in part, around the needle between the valve and the proximal end of the needle hub in a ready position, the needle protective device being moveable to prevent unintended needle sticks in a protective position.
…
21.The catheter insertion device of claim 18, further comprising a fluid path between a distal most end of the valve actuating element and a proximal most end of the valve actuating element.
22.The catheter insertion device of claim 21, further comprising a second gap at the proximal plunger section.
23.The catheter insertion device of claim 22, wherein the projection abuts a shoulder in the catheter hub.
THE CONSTRUCTION ISSUES
The relevant principles
There was no dispute between the parties as to the relevant principles of construction. These were summarised by the Full Court (Hill, Finn and Gyles JJ) in Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 at [67]:
…
(i)the proper construction of a specification is a matter of law: Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 400;
(ii)a patent specification should be given a purposive, not a purely literal, construction: Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890 at [81] (Flexible Steel Lacing); and it is not to be read in the abstract but is to be construed in the light of the common general knowledge and the art before the priority date: Kimberley-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1; 177 ALR 460; 50 IPR 513; [2001] HCA 8 at [24];
(iii)the words used in a specification are to be given the meaning which the normal person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification: Décor Corporation Pty Ltd at 391;
(iv)while the claims are to be 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, although terms in the claim which are unclear may be defined by reference to the body of the specification: Kimberley-Clark v Arico at [15]; Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610; Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 478; the body of a specification cannot be used to change a clear claim for one subject matter into a claim for another and different subject matter: Electric & Musical Industries Ltd v Lissen Ltd [1938] 4 All ER 221 at 224–5; (1938) 56 RPC 23 at 39;
(v)experts can give evidence on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings to be given by skilled addressees to words which might otherwise bear their ordinary meaning: Sartas No 1 Pty Ltd v Koukourou & Partners Pty Ltd (1994) 30 IPR 479 at 485–6 (Sartas No 1 Pty Ltd); 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 (Kimberley-Clark v Arico at [24]); and
(vi)it is for the court, not for any witness however expert, to construe the specification; Sartas No 1 Pty Ltd at 485–6.
Plain language must be given its plain meaning, and clear words in a claim must not be given an unnatural meaning by imposing glosses drawn from the body of the specification. However, the context in which the relevant language is used is of crucial significance to the ascertainment of its meaning. When construing a patent specification the Court seeks to give the document a purposive construction by reading the document as it would be understood by a person skilled in the art and without engaging in overly meticulous verbal analysis. It is worth repeating what Lord Hoffman said on the topic of purposive construction in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 at [34]:
“Purposive construction” does not mean that one is extending or going beyond the definition of the technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. And for this purpose, the language he has chosen is usually of critical importance. The conventions of word meaning and syntax enable us to express our meanings with great accuracy and subtlety and the skilled man will ordinarily assume that the patentee has chosen his language accordingly. As a number of judges have pointed out, the specification is a unilateral document in words of the patentee’s own choosing. Furthermore, the words will usually have been chosen upon skilled advice. The specification is not a document inter rusticos for which broad allowances must be made. On the other hand, it must be recognised that the patentee is trying to describe something which, at any rate in his opinion, is new; which has not existed before and of which there may be no generally accepted definition. There will be occasions upon which it will be obvious to the skilled man that the patentee must in some respect have departed from conventional use of language or included in his description of the invention some element which he did not mean to be essential. But one would not expect that to happen very often.
There is a danger that in seeking to give a claim a purposive construction, or in seeking to read it in context, an impermissible gloss might be imposed upon the language used based on material found in the body of the specification: see Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605 at [42], Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18 (“Tramanco”) at [175]. However, as was noted in Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited (2011) 92 IPR 21 at [47]:
The part of a patent specification which is put forward by the patentee as a general description or summary of the invention may have a significant role to play in the construction of a claim which is open to different interpretations. This is because the general description or summary of the invention will often describe the invention by reference to features that the skilled addressee would understand to be common to all possible embodiments of the invention.
There are three further principles to which I should also refer.
First, in a combination patent, the invention resides not merely in the collocation of particular integers, but also in the manner in which those integers interact. In Welsh Perrin & Co Pty Ltd v Worrell (1961) 106 CLR 588 Dixon CJ, Kitto and Windeyer JJ said at 612 that in a patent for a combination:
.. the most important function of the body of the specification is to show what are the mechanical means which, operating together, produce the result claimed; and how they so operate.
Each of the Patents is for a combination in the sense explained by Aickin J in Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253 (“3M”) at 266 because it:
… combines a number of elements which interact with each other to produce a new result or product. Such a combination may be one constituted by integers each of which is old, or by integers some of which are new, the interaction being the essential requirement.
Secondly, a construction according to which the invention will work is to be preferred to one according to which it will not work: Martin v Scribal Pty Ltd (1954) 92 CLR 17 at 97.
Thirdly, in construing a claim, the Court should disregard the alleged infringing article and not construe a patent claim with an eye to the alleged infringement.
Both parties relied on Crennan J’s statement of the relevant principles in Pharmacia Italia SPA v Mayne Pharma Pty Ltd (2005) 222 ALR 552. The question in that case was what did “reconstituted from a lyophilizate” mean. After referring to the judgment of Sheppard J in Decor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 285, her Honour said at [56]-[59]:
[56]Particularly relevant are the principles that the specification as a whole must be read and the context of a specification may qualify the prima facie meaning of a word or expression in a claim. If a word used in a claim is not a term of art, by reference to the technical knowledge possessed by persons skilled in the art, and is used in a plain, clear and unambiguous way in a claim, there should be no resort to the body of the specification to aid in the construction of the claim: Welch Perrin and Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610; Electric & Musical Industries Ltd v Lissen Ltd (1936) 54 RPC 23 at 41. That principle is subject to the proviso that any lack of clarity or ambiguity in a claim can be resolved by resort to the body of the specification: Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 457–8 (per Barwick CJ and Mason J); Décor at 391; Marconi v Mullard (1923) 40 RPC 159 at 175.
[57]There is no inconsistency in the principles governing construction of patent specifications as explained by Hely J in Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890 at [73]–[76] and especially [78]. It is as true of patent specifications, as of statutes (or any documents), as noted by Viscount Simonds in Attorney-General v Prince Ernest Augustus of Hanover [1957] AC 436; [1957] 1 All ER 49:
... words, and particularly general words, cannot be read in isolation: their colour and context are derived from context [at AC 461; All ER 53] ... the elementary rule must be observed that no one should profess to understand any part of a statute or of any other document before he has read the whole of it. Until he has done so he is not entitled to say that it or any part of it is clear and unambiguous [at AC 463; All ER 55].
[58]Similarly, the meaning of a word in a particular context may involve some limitation on its application in a patent claim, but such a meaning can only be derived from the context in which the word is used: see some examples, Henriksen v Tallon [1965] RPC 434 at 445 (per Reid LJ); Minnesota Mining at CLR 261ff; ALR 32; IPR 233–4, esp CLR 272; ALR 41–2; IPR 241–2 (per Aickin J) and Décor at 410–11 (per Sheppard J).
[59]The word “reconstituted” as it appears in the relevant expression in claim 1 is not a term of art used to refer to the dissolution of a lyophilized product so as to produce a solution suitable for intravenous injection shortly thereafter. It is clear however that both the word “reconstituted” and the expression of which it forms a part in claim 1 are used in a special sense in the specification. Alternatively, because the word is capable of more than one meaning it lacks clarity. It is permissible to have resort to the body of the specification both to see whether a word or expression has a special meaning or whether it requires clarification because the ordinary, or usual, meaning is not sufficiently precise. To find a word or expression is used in a special sense it is only necessary that an intention to so use the word or expression is plainly indicated in the specification: Minerals Separation North American Corporation v Noranda Mines (1952) 69 RPC 81 at 96.
The 928 Patent
In its submissions on construction, Becton made extensive reference to a copy of the 928 Patent that was admitted into evidence in the absence of any objection by Braun. However, it is important to point out that the 928 Patent is neither incorporated by reference nor shown to be common general knowledge as at the claimed priority date.
Becton was unable to refer me to any authority which supports its reliance on the 928 Patent for the purpose of construction. Braun submitted that it is not permissible to refer to the 928 Patent for that purpose. I agree. In the circumstances, I will ignore the 928 Patent except insofar as its contents are disclosed at page 1, lines 5-10 as that passage would be understood by the notional skilled addressee armed only with the Patents, the Parent (which is incorporated by reference) and the common general knowledge.
The fifteen construction issues

There is a total of fifteen construction issues to be resolved each of which are gathered around five topics:
(a)the meaning of “needle protective device”;
(b)the location of the needle protective device;
(c)the movement of the needle protective device;
(d)the valve;
(e)the valve actuating elements.
Needle protective device
Construction Issue 1
The first construction issue concerns the meaning of the words “needle protective device” as used in claim 26 of the 163 Patent.
The same issue arises in relation to:
·claim 14 (as dependent on claim 9) of the 163 Patent;
·claims 10 (and claims 11-12 and 15-17 as dependent on claim 10), 18 (and claims 19-20 and 24 as dependent on claim 18) and 25 (and claims 28-30 as dependent on claim 25) of the 164 Patent;
·claims 1 (and claims 2, 4, 9, 10 and 13 as dependent on claim 1), 5 (and claims 6, 8-10 and 13 as dependent on claim 5), 11 (and claims 12-13 and 17 as dependent on claim 11) and 18 (and claims 21-23 as dependent on claim 18) of the 814 Patent.
The term “needle protective device” is not used anywhere in the Parent. It uses the term “needle guard element”. The Patents use both terms, however, the term “needle protective device” appears only in the consistory statements and the claims including claims 14 and 26 of the 163 Patent, claims 10, 18 and 25 of the 164 Patent and claims 1, 5, 11 and 18 of the 814 Patent. The consistory statements also use the term needle protective element.
Braun submitted that a “needle protective device” is a device which operates to cover or otherwise preclude accidental access to the needle tip to prevent a healthcare worker from pricking him or herself on the needle tip (needle stick injuries) after the needle is withdrawn from the patient and the catheter hub. It submitted that needle guard element and needle protective device were interchangeable terms that have the same meaning.
It was submitted by Braun that the word “element” did not qualify the words “needle guard” except to say that the needle guard is an element of the catheter insertion device claimed. It submitted that the term needle guard element describes a needle guard that is an element of the catheter insertion devices described. I accept that submission.
Becton submitted that the term needle guard element has a special meaning that derives from the introductory passages at page 1 of the 163 Patent. In particular, it relied on the use of the term needle guard element:
·in the 275 Patent that is said in the first paragraph of the 163 Patent to be incorporated by reference;
·the discussion of the 928 Patent in the third paragraph of the 163 Patent and the reference to needle guard element in that paragraph;
·the statement of the object of the invention appearing in the fourth paragraph on page 1 of the 163 Patent and its reference to the needle guard element.
Becton also relied on the passage at page 3 lines 11-15 of the 163 Patent, which is the same as what appears at page 3 lines 1-6 of the Parent quoted above.
Becton submitted that these passages suggested that the term needle guard element was used to describe a particular type of needle guard that covers the needle tip after the needle is withdrawn from the catheter.
However, the question for present purposes is what do the words needle protective device as used in the relevant claims mean. These words are different from those used to describe the needle guard element referred to in the Parent. While there is no reason to think that these differences in language do not reflect deliberate choices on the part of those who drafted the Patents, it does not necessarily follow that two different terms should not be given the same meaning.
I accept Braun’s submission that the term needle guard element describes a needle guard that is an element of a catheter insertion device. But I do not consider that has any significance for the purpose of ascertaining the meaning of the term needle protective device. Needle protective device is not a term of art nor is it a term that has any special meaning to the notional skilled addressee beyond the meaning conveyed when read in the context of a description of a catheter insertion device.
I do not think it is permissible to read down the words needle protective device by reference to the words needle guard element and the use made of the latter term in the Patents.
So far as the question of construction is concerned I am satisfied that the term needle protective device as used in the relevant claims refers to a device that provides protection from needle sticks. This reflects the plain and ordinary meaning of the language used.
Location
Construction Issue 2
The second construction issue concerns the meaning of the following words as used in claim 17 (as dependent on 10) of the 164 Patent:
… the needle protective device comprises an arm that is located, at least in part, in the catheter hub …
The same issue arises in relation to claim 10 (as dependent on 5) of the 814 Patent although in that claim the word “has” appears instead of the word “comprises”.
Each of the relevant claims require that the needle protective device comprise an arm that is located, at least in part in the catheter hub.
Ultimately there was little difference between the parties as to what the word “arm” means in the context of the relevant claims. Braun submitted that the word arm should be given its ordinary meaning which, in the present context, refers to something that resembles an arm in form or function. Becton relied on the Shorter Oxford English Dictionary which defines an arm, relevantly, as “a part of an apparatus which resembles an arm in shape, disposition, or function”. I am satisfied that the word “arm” is used in the relevant claims in accordance with that definition.
Construction Issue 3
The third construction issue relates to the meaning of the following words as used in claims 14 (as dependent on 9) and 26 of the 163 Patent:
… a needle protective device … having at least a portion extending distally of the proximal end of the catheter hub …
The issue is whether in the context of the relevant claims, the term “proximal end” means the proximal end plane or face of the catheter hub, or the proximal end region of the catheter hub.
Braun submitted that the relevant claims also refer to the “proximal end” of “an opening” and that, in context, the “proximal end” of such an opening is the most proximal plane or face of the opening. Braun relied on oral evidence of Dr Haindl who considers the point at which there is such an opening is a “definitive frontier”. At that point, as Dr Haindl explained, the “opening” divides the space at the “proximal end” into two alternatives, being either outside the opening, or inside it. Dr Esnouf similarly considers that in the context of the relevant claims, it makes more sense for the proximal end to be a point or face, otherwise the starting point for determining when a part of the needle protective device is said to extend distally at the proximal end would be “indeterminate”.
Claim 26 of the 163 Patent uses the term “proximal end” twice, once to refer to an opening at a proximal end of an interior cavity, and once to refer to the proximal end of the catheter hub. The expert evidence relied on Braun focused on the first of these references, it being suggested that the proximal end of an opening was the most proximal plane or face of the opening. It was submitted that the second reference to proximal end should likewise be understood as referring to the most proximal plane or face of the catheter hub.
Becton submitted that the “proximal end” of the catheter hub refers to a region rather than a specific plane or face. This is how Mr Crawford and Mr Cindrich understand “proximal end of the catheter hub”. Becton submitted that the patent specification provides some assistance as what these words mean. At page 4 lines 3-6 of the 163 Patent it is stated:
The proximal end of the hub element 3 has an enlarged diameter with regard to the distal end and forms a connecting section with a hub element 5 whose distal end overlaps the proximal end of the hub element 3 and which is provided at its proximal end with a Luer thread 6.
(emphasis added)
Becton submitted that the patent specification, by contemplating that the “ends” of elements could overlap, is using the word “end” to mean an “end region”.
In his oral evidence Dr Haindl said in relation to the passage at page 4 lines 3-6 of the patent specification:
There is no general rule what a formulation like a proximal end means. The meaning must be defined from the context. To give an example, 163 says on page 4, line 5 to 6, which is provided at is proximal end with a Luer thread 6. That means the hub is provided at its proximal end with a thread. This thread has a certain length. So the proximal end cannot be understood as a definite point. It must be understood as a region.
However, Dr Haindl went on to say that the reference to the “opening” in the relevant claims “at a proximal end” was referring to a specific plane or face of the opening. Dr Esnouf made the same point.
One difficulty with Braun’s submission is that the relevant claims do not refer to a proximal end of an opening. Rather, they refer to an opening at a proximal end of the catheter hub. It is not the position of the opening (or the face or place of the opening) that defines the location of the proximal end.
The relevant claims also refer to the “distal end” and, in particular, a catheter tube attached to the catheter hub “and extending from a distal end”. I note that the catheter tube in the preferred embodiment depicted in the drawings (Fig 2(4)) does not extend from the most distal point of the device which is located where at the tip of the needle (9a). This also suggests that when the claim refers to the “proximal end” or the “distal end” that it is referring to a region rather than a precisely defined end-point.
In my view Becton’s construction of the relevant claims is to be preferred. The relevant claims should be understood as referring to an opening in the region of the “proximal end” of the interior cavity. Similarly, the “proximal end” of the catheter hub should be understood as referring to that same region rather than a definite point defined by the face of the opening. In my view the passage in the specification at page 4 lines 3-6 supports this construction.
Construction Issue 4
The fourth construction issue concerns the meaning of the following words as used in claim 10 (and 11-12 and 15-17 as dependent on 10) of the 164 Patent:
… a needle protective device positioned proximal of the valve and at least in part around the needle and distal of the proximal end of the needle hub …
The same issue arises in relation to claim 5 (and 6, 8-9 and 10, 13 as dependent on 5) of the 814 Patent except that it uses the words “second hub” rather than “needle hub”.
The words are readily understandable when applied to the preferred embodiments. The needle protective device, which in the detailed description of the preferred embodiment is in the form of a spring clip (referred to as the needle guard element) is positioned around the circumference of the needle between the valve and the proximal end of the needle hub when the catheter insertion device is in the ready position. The words “at least in part” make it clear that the needle protective device need not wholly surround the circumference of the needle. This is consistent with the arrangement depicted in the drawings.
Braun submitted that the qualifying words “at least in part” qualify not only the words “around the needle” but also the words “and distal of the proximal end of the needle hub”. In other words, Braun submitted that the relevant integer should be read as requiring that only part of the needle protective device had to be positioned distal of the proximal end of the needle hub.
Braun submitted that the relevant claims require the needle protective device to be both at least in part around the needle and at least in part distal of the proximal end of the needle hub in a ready position. Braun submitted that claim 18 of the 164 Patent supports this construction of the relevant claims. For the reasons stated below in relation to the meaning of that claim I do not think this submission should be accepted.
In my view the words “at least in part” as they appear in the relevant claims qualify the words “around the needle” but not “distal of the proximal end”. This reflects what I consider to be the preferable construction of those words as used in the relevant claims.
Construction Issue 5
The fifth construction issue concerns the meaning of the following words as used in claims 18 (and 19-20 and 24 as dependent on 18) and 25 (and 28-30 as dependent on 25) of the 164 Patent:
… a needle protective device positioned, at least in part, around the needle between the valve and the proximal end of the needle hub in a ready position …
The same issue arises in relation to claim 11 (and 12-13 and 17 as dependent on 11) and claim 18 (and 21-23 as dependent on 18) of the 814 Patent.
Braun submitted that as a matter of grammar, the preferable construction of this integer is that the words “at least in part” qualify the words that follow this phrase. It submitted that the commas before and after the words “at least in part” demonstrate that what is qualified by these words is the position of the needle protective device in relation to the needle, the valve and the proximal end of the needle hub when the device is in a ready position.
Becton submitted that the words “at least in part” qualify the words “around the needle” but not the other words. It submitted that this construction of claim 18 was consistent with the proper construction of claim 10 of the 164 Patent. It also sought to support its construction of claim 18 by reference to the configuration and functionality of the needle protective device disclosed in the body of the specification.
In my view claim 18 is ambiguous in so far as it defines the position of the needle protective device relative to the needle, the valve and the proximal end of the needle hub. In particular, it is not clear from the language of claim 18 whether the whole of the needle protective device, or merely some part of it, must be positioned between the valve and the proximal end of the needle hub.
There are two reasons why I think claim 18 should be understood as requiring that the whole of the needle protective device be positioned between the valve and proximal end of the needle hub.
First, this construction of the relevant integer is consistent with the proper meaning of the corresponding integer in claim 10 (similarly, claims 5 and 11 in the 814 Patent). When I say that, I do not mean to suggest that the language and punctuation used to describe the relevant integer is the same in both claims, merely that both integers seek to define the location of the needle protective device when the catheter insertion device is in the ready position. There is no obvious reason for attributing to the draftsperson an intention to describe that location in claim 18 differently from what is described in claim 10.
Secondly, the skilled addressee seeking to understand claim 18 would look to the description of the preferred embodiments and notice that the needle guard element (13) is quite clearly positioned partly around the needle (9) but wholly between valve (7) and the proximal end of the needle hub (8). In the type of needle protective device described generally at page 5 lines 5 to 14, and more specifically in the description of preferred embodiments, it is apparent that the whole of the needle protective device is between the valve and the proximal end of the needle hub when the device is in the ready position.
Action
Construction Issue 6
The sixth construction issue concerns the meaning of the following words as appearing in claim 5 (and 6, 8-10 and 13 as dependent on 5) of the 814 Patent:
… the needle protective device is movable to prevent unintended needle sticks in a protective position.
The same issues arises in relation to claims 11 (and 12-13 and 17 as dependent on 11) and 18 (and 21-23 as dependent on 18) of the 814 Patent although those claims use the word “being” rather than “is”.
Becton submitted that claim 5 requires that the needle protective device is moveable to prevent unintended needle sticks in a protective position. It submitted that this requires the needle protective device being capable of moving into a “protective” position so that it protects the needle tip, and thereby prevents unintended needle sticks. On this construction of the claim, it is necessary to identify a part of the needle protective device which moves into a position in which it protects the needle.
Braun submitted that there is no requirement for the whole of the needle protective device to change position in a physical sense and that it is sufficient if only a part of the device moves so that the device changes from being in a ready position to being in a protective position. Braun also submitted that when the relevant words are considered in the context of the specification as a whole, what is required is that some part of the needle protective device move with the consequence that the device changes from the ready position to the protective position.
I accept that the relevant words do not require that the whole of the needle protective device move when the device changes from the ready position to the protective position and that it will be sufficient if some part of the needle protective device moves. However, in my opinion the relevant words require that the needle protective device, or at least that part of it, be capable of moving relative to the needle tip into a protective position in which it protects against unintended needle sticks.
Construction Issue 7
The seventh construction issue concerns the meaning of the following words as used in claim 1 (and 2, 4, 9-10 and 13 as dependent on 1) of the 814 Patent:
… a needle protective device … movable relative to the needle tip to a protective position, at least in part, distally of the needle tip to prevent unintended needle sticks.
Braun submitted that this integer is concerned with relative movement as between the needle protective device and the needle tip. It submitted that although these things must be moveable in relation to each other, it was not necessary for the needle protective device to move, and that the relative movement could be achieved by movement of the needle tip. This interpretation of the requirements of the integer is supported by Dr Haindl and Dr Esnouf’s interpretation of the relevant claims.
Mr Cindrich and Mr Crawford consider that the needle protective device must be moveable. But I think it is fair to say that their view of the claim is heavily influenced by their understanding of the invention and the description of the preferred embodiments. They look at the embodiments of the invention described in the body of the specification and see a needle protective device that moves into a protective position when the spring arms of the needle guard element move to block the needle tip as the needle is withdrawn through the plunger elements. In that situation the spring arms move relative to the needle tip to put the device into the protective position.
Relative movement between two objects may imply that either or both objects move in relation to the other. This is the sense in which Mr Haindl and Dr Esnouf understand the relative movement referred to in the claim. However, there is another interpretation of the claim that is open, which is that it requires that there be physical movement by the needle protective device relative to the needle tip. On this view of the claim there would be no relative movement by the needle protective device in relation to the needle tip if the needle tip also moved physically in a corresponding direction and over a corresponding distance.

In dismissing the appeal brought by the patentee in that case (AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356), the High Court focused on both the role of s 7(3) and that of the PSA.
French J said at [18]:
[18]The text of s 7(2) required, in unambiguous language, that “the onus to establish the absence of an inventive step rests upon the party challenging validity”. It was, as Jessup J correctly observed in the Full Court, a deeming provision. Section 7(2) would defeat a claim for want of inventive step unless one of the alternative conditions set out in s 7(2), read with s 7(3), was satisfied. Those conditions involved the following elements:
1.An hypothetical person skilled in the relevant art.
2.The person being, therefore, notionally possessed of the common general knowledge as it existed in the relevant area before the priority date of the impugned claim.
3.The invention being obvious to that person in the light of the common general knowledge.
4.Alternatively, that person being provided with prior art information made publicly available in a single document or through doing a single act, or made publicly available in two or more related documents or through doing two or more related acts if the relationship between them satisfied the requirement of s 7(3)(b).
5.That prior art information, as defined by s 7(3), being information that the person could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant to work in the relevant art in the patent area (the relevance requirement). “Ascertained”, in this context, means “discovered or found out”. “Understood” means that, having discovered the information, the person would have “comprehended it” or “appreciated its meaning or import”.
6.The invention being obvious to the person in the light of the common general knowledge considered together with either of the classes of prior art information defined in s 7(3).
The judicial determination whether want of inventive step is established pursuant to s 7 is mediated through the legal construct of the hypothetical person skilled in the relevant art. The construct is of a kind well-known to the law and used for setting parameters for evaluative judgments. It is a tool of analysis and is given statutory recognition, for that limited purpose, in s 7.
(footnotes omitted)
Kiefel J (as her Honour then was) said at [68]:
[68]Before a document containing prior art information can be used along with the common general knowledge for the purposes of the s 7(2) inquiry, it is necessary that it meet the requirements of s 7(3). In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] it was explained that prior art information which is publicly available in a single document is “ascertained” if it is discovered or found out, and “understood” means that, having discovered the information, the skilled person would have comprehended it or appreciated its meaning or import. The Court also explained that the phrase “relevant to work in the relevant art” is directed to publicly available information, not part of the common general knowledge, which the skilled person could be expected to have regarded as relevant to solving a particular problem, or meeting a long-felt want or need, as the patentee claims to have done.
[69]Lockwood [No 2] also explains that, in answering the question of obviousness, the information referred to in s 7(3), like that part of the prior art base which is the common general knowledge, is considered for a particular purpose. That purpose is to look forward from the prior art base to see what the skilled person is likely to have done when faced with a problem similar to that which the patentee claims to have solved with the claimed invention. It is this aspect of the s 7(2) inquiry which assumes particular importance on these appeals.
[70]In addressing s 7(2), it is to be borne in mind that the skilled person is an artificial construct, intended as an aid to the courts in addressing the hypothetical question of whether a person, with the same knowledge in the field and aware of the problem to which the patent was directed, would be led directly to the claimed invention. The statute’s creation of the skilled person construct for this purpose is not to be taken as an invitation to deal with the question posed by s 7(2) entirely in the abstract. Whilst the question remains one for the courts to determine, the courts do so by reference to the available evidence including that of persons who might be representative of the skilled person.
(footnotes omitted)
Section 7(2) of the Act uses the word “obvious” in describing what must be established before an invention can be held not to involve an inventive step. Something may be “obvious” in light of the common general knowledge, or the common general knowledge coupled with relevant s 7(3) information, if it is “plain or open to the eye or mind, something which is perfectly evident to the person thinking on the subject” (Olin Mathieson Chemical Corp v Biorex Laboratories Ltd [1970] RPC 157 at 188) or something which “would at once occur to anyone acquainted with the subject and desirous of accomplishing the end” (Vickers, Sons & Co Ltd v Siddell (1890) LR 15 App Cas 496). An invention may also be obvious in light of the common general knowledge if the PSA faced with the same problem as the inventor would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not (Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 (“Wellcome”) at 286 per Aickin J) if the PSA would be directly led as a matter of course to take such steps in the expectation that doing so might well produce a useful or better alternative to the prior art (Alphapharm at [50]-[53]).
Becton’s Inventive Step Analysis
Becton’s inventive step case is founded on the following propositions:
·Proposition 1: It would be obvious to the hypothetical team to attempt to design an IV catheter incorporating needle-stick protection and blood control.
·Proposition 2: The hypothetical team engaged in the design of such a device, would have ascertained the B Braun Introcan Safety IV catheter (“the Braun Introcan”) and considered it a good option for an IV catheter incorporating needle-stick protection, in particular because it was a passive design rather than an active design. It was a commercially successful product in the United States that had been approved and sold there in large numbers.
·Proposition 3: The hypothetical team would then have considered incorporating a blood control mechanism based on US Patent No. 4,387,879 (“Tauschinski”) and/or a product made by the Fresenius Group of companies (“Fresenius”) embodying the teachings of Tauschinski. This blood control mechanism had a cylindrical sliding valve actuator which was activated by the Luer, and which actuated a pre-slit elastomeric disc valve. This was an obvious choice because it was embodied in a product used as a Luer access device or connector for an IV catheter and known globally in the field (and was off-patent by July 2002).
·Proposition 4: It would have been necessary to modify the mechanism to accommodate the Braun Introcan spring clip. In particular, it would have been necessary to bifurcate the cylindrical valve actuator so as to produce two elongated members between which the spring clip was accommodated. These modifications would have been straightforward.
·Proposition 5: The resulting design would embody the claims in suit, which are repetitive combinations of a limited set of distinctive integers, and which are inevitably embodied in a design which combines the Braun Introcan with a bifurcated Fresenius blood control mechanism.
Becton contended that at the claimed priority date the Fresenius blood control mechanism was common general knowledge and that Tauschinski was relevant as s 7(3) information. It was also contended that the Braun Introcan was “readily ascertainable” implying, as I understood Becton’s submission, that it too was relevant as s 7(3) information. I will say more about these contentions shortly.
Becton also contended that US Patent No. 5,954,698 (“Pike”), US Patent No. 5,053,014 (“Van Heugten”) and US Patent No. US 4,842,591 (“Luther”) were relevant to inventive step as “secondary indicia”.
I can say at once that I do not think Pike, Van Heugten or Luther is relevant to inventive step on that or any other basis. They are not said by Becton to form part of the common general knowledge or to constitute s 7(3) information. They could perhaps be relevant as evidence of “secondary indicia” of a lack of inventiveness if they tended to show that there were persons working in the relevant field in the patent area at the claimed priority date that knew of a need for a catheter insertion device that combined needle stick and blood outflow protection.
Blood control protection
Proposition 1 is supported by the evidence of Professor Bihari and Mr Wilson, who I considered to be impressive witnesses.
Professor Bihari, whose evidence on this point I accept, said:
… there’s always a risk of blood spillage during IV cannulation in 2002, and this technique described by my colleague of occluding the vein, having placed the cannula with your non-dominant hand, releasing the tourniquet, occluding the vein and then withdrawing the needle requires a certain amount of practice. And we used to see many medical students or interns or residents and nurses in training who found this difficult to do and would contaminate the area of the bed space. You can walk into an emergency department and see IV cannulation going on and see blood dropping onto the floor, you know, from where the cannula has disconnected from the device for a period of time and contamination of the environment.
Professor Bihari said that in 2002 the avoidance of blood spillage was a major priority in Australia and that “… it was clear that if there was a device that would cut down contamination, then that would be a device that we would want to see brought into clinical practice.”
Mr Wilson, whose evidence on this point I also accept, said that if he had been asked to design an IV catheter in 2002, he would have assumed that it would need to provide needle stick and blood spillage protection.
I agree with Becton that as at the claimed priority date it would have been obvious to the hypothetical team seeking to design an IV catheter to attempt to design one incorporating needle stick protection and blood control.
Mr Crawford’s hypothetical design task
Becton’s inventive step analysis was largely based on the evidence of Mr Crawford who gave evidence of a hypothetical design task that he was said by Becton in its opening submissions to have undertaken before reviewing the Patents and without prior knowledge of the Braun Introcan with blood control, the latter referring to a commercial embodiment of the invention described in the Parent.
Mr Crawford’s affidavit evidence with respect to the hypothetical design task he performed was, in summary, as follows:
·He said that the problems of needle stick injury and blood control formed part of the background knowledge, and that it was desirable to design a safety IV catheter addressing both of these problems as at the claimed priority date. In fact, he said he had undertaken design work within Becton on a device addressing both problems at an earlier point of time.
·He said that he would take as his point of departure (or what could be described as his starting point) the Braun Introcan, which was a catheter insertion device with a spring clip form of needle protection with which he was familiar. He said that the needle-stick protection of that device was small and passive, which he considered to be an advantage.
·He said that he would also feel confident that the Braun Introcan, having been launched onto the market several years before by Braun, would be sufficiently effective and reliable. He said that using pre-existing device that had already been commercialised by a large company as his point of departure would provide a degree of comfort with respect to the design safety, manufacturability and ease of use.
·He said he would have sought to incorporate a blood control valve in the Braun Introcan. He said he would have considered a range of different valves, but would have had a preference for a valve with a slit disc septum because it would be simple, effective, bi-directional and easy to manufacture.
·He said he was well aware of valves with a slit disc septum, including those shown in Luther and Tauschinski.
·He said that to combine needle and blood control protection in a catheter insertion device he would have incorporated the spring clip of the Braun Introcan inside the sliding element of the valve actuator.
Braun Introcan
Becton submitted that the PSA seeking to develop a new catheter insertion device providing needle stick and blood outflow protection would have ascertained the Braun Introcan, and chosen it as a starting point over other IV catheters that had needle-stick protection. This is because it was a passive device, which required no change in technique by the user. It was also compact, and a commercially successful product.
The Braun Introcan was launched in the USA in July 1999. By July 2002 it had sold over 30 million units. Braun admitted that the Braun Introcan formed part of the background knowledge in the field in the United States as at July 2002 as follows:
B Braun accepts that, for the purposes of this proceeding, as at 4 July 2002, the B Braun Introcan Safety IV Catheter … including its features and manner of operation, formed part of the background knowledge and experience of persons in the United States of America in the trade of making new, or making improvements in old, IV catheter devices within the understanding of Australian Patent Law.
Mr Cindrich, Mr Crawford and Dr Haindl knew of the Braun Introcan prior to July 2002. However, neither Dr Esnouf nor Mr Wilson (the Australian designers) knew of the Braun Introcan as at that date.
Becton submitted that the evidence of Dr Esnouf and Mr Wilson showed that, when given a design task, they would research products on the market, including, in particular, the United States market, and the products of the major manufacturers. This would include attending, or otherwise obtaining materials from, trade shows, obtaining sample products, and reviewing manufacturers’ websites. Dr Esnouf in particular had a practice of obtaining samples which he said he found “very helpful”.
Becton submitted that the Braun Introcan was readily ascertainable by these means, and that it would have been ascertained, understood and regarded as relevant by the hypothetical team engaged in the design and development of a catheter insertion device that provided needle stick and blood outflow protection. I accept that submission. I think it is borne out by Braun’s admission coupled with the evidence of Dr Esnouf and Mr Wilson. Accordingly, I am satisfied that the Braun Introcan qualifies as s 7(3) information.
Tauschinski Patent
Becton submitted that Tauschinski constituted s 7(3) information because it would have been ascertained by a patent search undertaken by or at the request of the hypothetical team.
The expert evidence in relation to patent searches was not totally consistent. Some of the witnesses would invariably conduct patent searches as part of the design process to generate ideas (Dr Haindl and Mr Crawford). However, others would do so not to generate ideas but for the purpose of identifying areas where they would be free to invent (Dr Esnouf and Mr Cindrich). It was accepted by these witnesses that searches conducted for that purpose would extend to both existing and expired patents.
The evidence showed that one way of conducting patent searches was to include the name of a particular medical device company in the field of interest. Dr Haindl, Dr Cindrich and Dr Crawford agreed that searching by company name was a strategy they used. Mr Wilson also said that this was a strategy he used. The evidence of Mr Leones and Mr North was relied upon by Becton to show that Tauschinski would have been found in a search for the word “Fresenius”.
But none of this evidence assists Becton’s inventive step analysis. Tauschinski cannot be relevant as s 7(3) information in combination with the Braun Introcan unless the Braun Introcan was common general knowledge in Australia, which it was not. Tauschinski and the Braun Introcan must be considered separately. If Becton wishes to rely on the Braun Introcan as s 7(3) information then it cannot also, as part of the same inventive step analysis, rely on Tauschinski as s 7(3) information.
In circumstances where Becton’s inventive step analysis takes the Braun Introcan as its starting point, there is no scope for it to rely on the information in Tauschinski except in so far as it is proven to be common general knowledge. Becton sought to prove this through the evidence of Dr Esnouf and Mr Wilson concerning the blood control mechanism said to embody the teaching of Tauschinski.
Fresenius blood control mechanism
Dr Haindl’s and Mr Crawford’s evidence establishes that the Fresenius blood control mechanism uses a sliding actuator that activates a pre-slit elastomeric disc valve. It was used in Luer access devices made by Fresenius that were designed to be connected to an IV catheter.
Becton submitted that the evidence demonstrated that the blood control mechanism of the kind found in Tauschinski was common general knowledge at the priority date. In support of this submission it relied on evidence given by Dr Esnouf (who had not seen Tauschinski until it was provided to him by Braun’s solicitors) who said:
I was aware of the Tauschinski device (or a very similar device) prior to 2002. This device (or a similar device) features in many of the luer-activated devices that I have seen.
He was not asked to expand on this statement in his oral evidence. It is therefore not possible to identify any of the devices that he was referring to or to what extent they were known or used in Australia.
Mr Wilson appears to have known of Fresenius but his evidence did not disclose whether he was familiar with the Fresenius blood control mechanism or any similar device as at the priority date.
In my view the evidence does not establish that the Fresenius blood control mechanism formed part of the common general knowledge in Australia as at the priority date. It follows that Becton’s challenge to the validity of the relevant claims for lack of inventive step fails.
Criticism of Mr Crawford’s evidence
Braun submitted that Mr Crawford’s evidence in relation to his hypothetical design task should be given little weight. It submitted that he had prior knowledge of the invention described in the Patents, and that his description of the hypothetical design task that he says he would have performed was the product of a large measure of hindsight.
Mr Crawford worked on a special project at Becton in the late 1980s or early 1990s to develop what he referred to as the “Combined Device” which was an IV catheter device providing needle protection and a valve for blood outflow control. In the course of working on various features which were included in Becton’s prototype product, Mr Crawford and his colleagues at Becton developed at least three patented inventions. They also developed functional prototypes of the Combined Device.
Although the product was the subject of a clinical trial, it was not published or released for sale. Mr Crawford said that the decision by Becton’s management not to commercialise the product was, for him, disappointing but understandable. He said that there were issues with the way the product worked.

Mr Crawford worked with the inventor, Mr Woehr, for several years prior to 1989 in Becton’s research and development department before Mr Woehr left Becton to work for Braun. I think it is likely that Mr Crawford showed continuing interest in Mr Woehr’s research and development work while Mr Woehr was working for Braun.
While working for Becton, Mr Crawford made a practice of reviewing patent applications for the purpose of monitoring the research and development activities of Becton’s competitors. These patent applications included Braun’s application for the US equivalent of the Parent which was published on 13 July 2006 at a time when Mr Crawford was still working for Becton and after Mr Woehr had left Becton to work for Braun. In his oral evidence Mr Crawford agreed that it was more likely than not that he reviewed the US application. I am satisfied that he read the US application soon after it was published. I am also satisfied that he would have studied it very closely.
Mr Crawford said it was “a remarkable coincidence” that his design was so close to Mr Woehr’s design. When asked if this coincidence might be explained on the basis that the two designs were an obvious way to do something, Mr Crawford said:
… it’s just engineering. There are just obvious solutions to a problem of co-locating a valve actuating element inside of a catheter adapter with a tip shield … I don’t know how else you would do it. It seems obvious to me that that is the engineering solution.
Mr Crawford gave similar evidence in re-examination as to why he and Mr Woehr arrived at what was essentially the same design. He said, in effect, that the prior art provided good solutions for the design problem involving straightforward modifications to known elements.
The principal difficulty with this evidence is that it assumes that the hypothetical team would make the Braun Introcan the starting point. Other expert witnesses accepted that the Braun Introcan was an option but certainly not the only option. Dr Esnouf, for example, said:
… I would have initially looked for a solution that would address the issues of needle stick injury and blood control, and potentially other issues, in an integrated fashion. So, while Mr Crawford appears to have jumped directly to a very specific design task solution, I think I would have engaged in more research and postulated a number of concepts before arriving at what I thought was the best solution.
… Mr Crawford seems to immediately select a mechanism that protects only the needle tip. I would have been inclined to seek a solution that also provided greater needle coverage. This is because my personal experience with needles being removed from catheters is that they can flick blood that has coated the needle or is inside the needle when the needle is removed from the hub.
…
… Unlike Mr Crawford, I would have not automatically assumed the needle stick protection mechanism or the valve had to be located within the catheter hub.
Because of the small size of the catheter hub, I would have considered solutions that did not require trying to accommodate both components within a very small space.
Dr Haindl said:
… Mr Crawford also proposes that the needle guard to be located within the catheter hub. On the other hand, the competitors of B. Braun mostly had, to my knowledge, the needle protective devices out of the catheter hub. So from the German perspective, I have some doubts if I would have come to the same conclusion as Mr Crawford at that time …
Dr Haindl, referring to the Braun Introcan, also said:
… As I said already, I do think I would have considered it as an option, but on the other hand, the idea of full needle protection to avoid blood splashing from the needle that is drawn out of the catheter would also been an aspect.
Becton relied on business records produced by Braun which suggested that the inventor, Mr Woehr, took the Bruan Introcan as his starting point when developing the invention and modified it so that it would accommodate a Fresenius blood control mechanism (or a device very similar to it) in the catheter hub assembly. The evidence does not show why Mr Woehr selected the Braun Introcan for this purpose ahead of the other devices that would have been known to him but I would infer that the fact he worked for Braun had a significant part to play in his selection of that particular device. For that reason I do not consider that the route taken by Mr Woehr in arriving at his invention is helpful evidence of lack of inventive step: see Wellcome at 286.
Given Mr Crawford’s particular circumstances, including his work for Becton, his prior knowledge of the US application, and his relationship with Mr Woehr, I think there is a substantial risk that his evidence relating to this hypothetical design task was heavily influenced by hindsight. For that reason, I do not give it any significant weight.
Even if the Fresenius blood control mechanism formed part of the common general knowledge at the claimed priority date, I am not persuaded that the idea of taking the Braun Introcan and incorporating such a mechanism into it would have been an obvious way of achieving needle stick and blood outflow prevention in a catheter insertion device. In particular, I am not persuaded that the hypothetical team tasked with formulating a device having those attributes would have been directly led, as a matter of course, to combine the features of the Braun Introcan and the Fresenius blood control mechanism.
UNJUSTIFIED THREATS
Becton commenced this proceeding by an originating application seeking relief in respect of an unjustified threat. The threat was said to have been conveyed by a letter from Braun’s solicitors to Becton dated 27 November 2014. There is no evidence to suggest that Becton modified its conduct in any way as a result of the alleged threat nor that it caused Becton any loss or damage.
In its originating application Becton sought injunctive relief under s 128(1)(b) of the Act. Becton did not advance any written or oral argument in support of its claim for injunctive or any other relief under s 128 of the Act. Presumably the letter of 27 November 2014 (which is not in evidence) was nothing more than a letter before action of the customary kind. In the circumstances I would not be inclined to grant injunctive relief even if Becton were to have pressed for it in final submissions. I propose to dismiss the originating application.
DISPOSITION
None of the claims of the 163, the 164 and 814 Patents on which Braun sued Becton is infringed by the BD Device. Accordingly, Braun’s amended notice of cross-claim will be dismissed. Further, with respect to Becton’s amended notice of further cross-claim, claims 14 and 26 of the 163 Patent, claim 17 of the 164 Patent, and claim 10 of the 814 Patent are invalid and will be revoked. Becton’s amended notice of cross-claim will be otherwise dismissed. As I have said, Becton’s originating application will also be dismissed. The parties will be given an opportunity to file written submissions in relation to the question of costs.
There will be orders accordingly.

I certify that the preceding three hundred and forty-six (346) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Nicholas.
Associate:
Dated: 9 November 2018
Annexure A

File number:	NSD 1297 of 2014
Judge:	NICHOLAS J
Date of judgment:	9 November 2018
Catchwords:	PATENTS – claims for catheter insertion device – claim construction – meaning of “needle protective device” – whether claims infringed PATENTS – whether claims entitled to priority date based on prior application – whether claims fairly based on matter disclosed in prior application PATENTS – whether claims invalid for non-compliance with s 40(3) on the ground that they are not fairly based on the matter described in the specification PATENTS – inventive step – whether claims invalid for lack of inventive step
Legislation:	Patents Act 1990 (Cth) s 18(1)(b)(ii), 40(3), 79B(1), 128 Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Patent Regulations 1991 (Cth) reg 3.12
Cases cited:	Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411 Allsop Inc v Bintang Ltd (1989) 15 IPR 686 AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324 AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356 Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160 Decor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 285 ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (1999) 45 IPR 577 Jupiters Ltd v Neurizon Pty Ltd (2005) 222 ALR 155 Kimberly-Clark Australia Pty Limited v Multigate Medical Products Pty Limited (2011) 92 IPR 21 Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 Martin v Scribal Pty Ltd (1954) 92 CLR 17 Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (2016) 117 IPR 1 Olin Mathieson Chemical Corp v Biorex Laboratories Ltd [1970] RPC 157 Pharmacia Italia SPA v Mayne Pharma Pty Ltd (2005) 222 ALR 552 Rehm Pty Ltd v Webster Security System (International) Pty Ltd (1988) 81 ALR 79 Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605 Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18 Vickers, Sons & Co Ltd v Siddell (1890) LR 15 App Cas 496 Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 Welsh Perrin & Co Pty Ltd v Worrell (1961) 106 CLR 588
Date of hearing:	5, 6, 7, 8, 9, 14, 15 and 16 June 2017
Registry:	New South Wales
Division:	General Division
National Practice Area:	Intellectual Property
Sub-area:	Patents and associated Statutes
Category:	Catchwords
Number of paragraphs:	346
Counsel for Becton Dickinson Pty Ltd:	Mr CA Moore SC with Mr AR Lang
Solicitor for Becton Dickinson Pty Ltd:	Herbert Smith Freehills
Counsel for B. Braun Melsungen AG:	Mr D Shavin QC with Mr EJC Heerey QC
Solicitor for B. Braun Melsungen AG:	Davies Collison Cave

Table of Corrections
5 December 2018	Para [259] first sentence “indication” be amended to read “insertion”

NSD 1297 of 2014
BETWEEN:	BECTON DICKINSON PTY LTD (ACN 005 914 796) Applicant
AND:	B. BRAUN MELSUNGEN AG Respondent
AND BETWEEN:	B. BRAUN MELSUNGEN AG Cross-Claimant
AND:	BECTON DICKINSON PTY LTD (ACN 005 914 796) Cross-Respondent
AND BETWEEN:	BECTON DICKINSON PTY LTD (ACN 005 914 796) Cross-Claimant
AND:	B. BRAUN MELSUNGEN AG Cross-Respondent

JUDGE:	NICHOLAS J
DATE OF ORDER:	9 November 2018