Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5)
[2015] FCA 486
•20 May 2015
FEDERAL COURT OF AUSTRALIA
Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5) [2015] FCA 486
Citation: Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5) [2015] FCA 486 Parties: RECKITT BENCKISER HEALTHCARE (UK) LIMITED and RECKITT BENCKISER (AUSTRALIA) PTY LIMITED ABN 17 003 2274 655 v GLAXOSMITHKLINE AUSTRALIA PTY LTD ABN 47 100 162 481 File number: NSD 734 of 2013 Judge: RARES J Date of judgment: 20 May 2015 Catchwords: PATENTS – construction of claims – knowledge of skilled addressee – common general knowledge – whether skilled addressee would have understood patent to be confined to a narrow field of use, where only one claim referred to that field – construction of omnibus claim using expression “substantially as described”
PATENTS – infringement – omnibus claim – whether essential result produced by product complained of, rather than exact reproduction of physical characteristics of integers sufficient to create infringement – whether characteristics of integers comprising product complained of created functional difference
PATENTS – whether apparatus claimed in patent a manner of manufacture – combination patent – whether product comprised a new and useful combination
PATENTS – invalidity – whether claims lacked an inventive step – whether patent obtained by false suggestion or misrepresentation – whether patentee had made a false suggestion as to identity of true inventor – where earlier agreement with third party acknowledged right of patentee to seek patent protection
PATENTS – entitlement – whether patentee entitled to invention – whether third party was inventor or co-inventor where neither named in patent nor grantor by assignment – whether inventor’s acknowledgements supported patentee’s entitlement to patent in circumstance where inventors authorised patentee employer to patent inventions to which they might have otherwise had rights
ACCORD AND SATISFACTION – contract – commercial agreement between patentee and component supplier – whether agreement operated as an accord and satisfaction to allow patentee to apply for patent in exchange for narrowing of claims and grant of a restricted licence to supplier to make and sell part of patented combination product
EVIDENCE – onus of proof of patentee’s lack of entitlement – whether failure to ask witness in chief about essential issue is some evidence against party calling witness
Legislation: Corporations Act 2001 (Cth)
Evidence Act 1995 (Cth)
Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
Patents Act 1990 (Cth)
Real Property Act 1900 (NSW)
Statute of Monopolies 1623 (UK)Cases cited: Abigail v Lapin (1934) 51 CLR 58
Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1
Boulton v Bull (1795) 1 H Bl 463
Braverus Maritime Inc v Port Kembla Coal Terminal Ltd (2005) 148 FCR 68
Clark v Adie (1875) LR 10 Ch App 667
Commercial Union Assurance Company of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389
Commissioner of State Taxation of the State of South Australia v Cyril Henschke Pty Ltd (2010) 242 CLR 508
Communications, Electrical, Electronic, Energy, Information, Postal, Plumbing and Allied Services Union of Australia v Australian Competition and Consumer Commission (2007) 162 FCR 466
D’Arcy v Myriad Genetics Inc (2014) 224 FCR 479
GlaxoSmithKline (Australia) Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd (2013) 103 IPR 487
JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2006) 154 FCR 348
Lewis v Hall (2005) 68 IPR 89
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] (2007) 235 CLR 173
Martin v Scribal Pty Ltd (1954) 92 CLR 17
McDermott v Black (1940) 63 CLR 161
Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd (2002) 56 IPR 248
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253
National Research Development Corporation v Commissioner for Patents (1959) 102 CLR 252
Polwood Pty Ltd v Foxworth Pty Ltd (2008) 165 FCR 527
Radiation Ltd v Galliers & Klaerr Pty Ltd (1938) 60 CLR 36
Raleigh Cycle Co Ltd v H Miller and Co Ltd (1948) 65 RPC 141
Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline (Australia) Pty Ltd (2013) 105 IPR 405
Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline (Australia) Pty Ltd (No 2) (2013) 103 IPR 472
Shropshire Union Railways and Canal Company v The Queen (1875) LR 7 HL 496
Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344
Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98
University of Western Australia v Gray (2009) 179 FCR 346
Welch Perrin & Co Pty Ltd v Worrell (1961) 106 CLR 588
Zhu v Treasurer of New South Wales (2004) 218 CLR 530Date of hearing: 2, 3, 4, 5, 6, 10, 11,12, 13 June 2014 Place: Sydney Division: GENERAL DIVISION Category: Catchwords Number of paragraphs: 242 Counsel for the Applicants: Ms KJ Howard SC with Mr JS Cooke and Ms R White Solicitor for the Applicants: Corrs Chambers Westgarth Counsel for the Respondent: Mr RJ Webb SC with Mr HPT Bevan Solicitor for the Respondent: Norton Rose Fulbright
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
NSD 734 of 2013
BETWEEN: RECKITT BENCKISER HEALTHCARE (UK) LIMITED
First ApplicantRECKITT BENCKISER (AUSTRALIA) PTY LIMITED ABN 17 003 2274 655
Second ApplicantAND: GLAXOSMITHKLINE AUSTRALIA PTY LTD ABN 47 100 162 481
Respondent
JUDGE:
RARES J
DATE OF ORDER:
20 MAY 2015
WHERE MADE:
SYDNEY
THE COURT ORDERS THAT:
1.On or before 29 May 2015 the parties confer and prepare draft orders to give effect to these reasons and:
(a) if the form of those orders is:
(i)agreed provide them to the associate to Rares J;
(ii)not agreed provide the respective forms of orders for which each contends together with written submissions limited to one page in support;
(b)deal with the question of costs, if agreed.
2.If on or before 5 June 2015 the parties cannot agree on what order for costs is appropriate, they confer as to a timetable to file and serve any evidence and written submissions limited to five pages in chief and reply so that the question of costs be ready to be heard on 19 June 2015.
Note:Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
NSD 734 of 2013
BETWEEN: RECKITT BENCKISER HEALTHCARE (UK) LIMITED
First ApplicantRECKITT BENCKISER (AUSTRALIA) PTY LIMITED ABN 17 003 2274 655
Second ApplicantAND: GLAXOSMITHKLINE AUSTRALIA PTY LTD ABN 47 100 162 481
Respondent
JUDGE:
RARES J
DATE:
20 MAY 2015
PLACE:
SYDNEY
REASONS FOR JUDGMENT
Reckitt Benckiser Healthcare (UK) Ltd (Reckitt UK) is the registered owner of Australian Patent No 2003283537 (the patent). Its Australian related company, Reckitt Benckiser (Australia) Pty Ltd (Reckitt Australia), is the exclusive licensee of the patent. I will refer to both companies collectively as Reckitt. The patent makes claims for a dispensing apparatus that comprises 3 elements, namely a bottle, a bottle neck liner and a flat-nosed syringe. Among other uses, the apparatus is suitable for dispensing liquids, including liquid medicine, either through using a flat-nosed syringe or by pouring it out of a bottle.
For some years Reckitt has used the patented apparatus in three of its over the counter paediatric analgesic products, Nurofen for Children Baby 3+ months, Nurofen for Children 1-5 years and Nurofen for Children 5-12 years. The advantages of using the syringe are that, first, one can draw a measured dose out of the bottle using the calibrated scale marked on the syringe, secondly, the tight fit of the syringe at the bottle neck dispensing point prevents leaks and mess and, thirdly, the syringe can be used to squirt the measured dose into a child’s mouth rather than trying to feed the child with a spoon or measuring cup.
GlaxoSmithKline Australia Pty Ltd has for some years marketed its competing over the counter paediatric analgesic products, Children’s Panadol® Colourfree Baby Drops for 1 month-2 years, Children’s Panadol® Colourfree Suspension for 1-5 years and Children’s Panadol® Colourfree Suspension for 5-12 years.
In March 2013, Glaxo launched a new version of Children’s Panadol® Colourfree Suspension 1-5 years with a new dosing device that comprised an apparatus using, among other features, a flat-nosed syringe that Reckitt contended infringed the patent (the original syringe). I granted an interlocutory injunction on 28 May 2013, until the determination of these proceedings or further order, that restrained Glaxo from, relevantly, marketing the product Children’s Panadol 1-5 years when incorporating a liquid dispensing apparatus comprising a bottle, bottle neck liner and a flat-nosed syringe (the first product complained of): Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline (Australia) Pty Ltd (2013) 105 IPR 405. Annexure A to the order depicts the first product complained of, as appears below:
Of course, winter is the peak sales period for both parties’ ranges of Nurofen and Panadol products. Glaxo regrouped and found an alternate flat-nosed syringe (the alternate syringe) that had a section that fitted neatly into the bottle neck liner but then expanded in diameter above the area necessary to draw up the medicine (the second product complained of). I granted a further interlocutory injunction restraining Glaxo from using an apparatus that included the alternate syringe on 17 July 2013, as depicted in annexure B to that order: Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline (Australia) Pty Ltd (No 2) (2013) 103 IPR 472. However, on 2 September 2013, the Full Court discharged that interlocutory injunction because it did not consider that Reckitt had a sufficiently strong prima facie case of infringement of claim 1 of the patent to justify the restraint, and the balance of convenience did not favour it: GlaxoSmithKline (Australia) Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd (2013) 103 IPR 487; 305 ALR 363 at [83]-[84] per Bennett, Jagot and Griffiths JJ. The depiction of the second product complained of in annexure B to the discharged order appears below:
ANNEXURE B
The parties relied on considerably more evidence and arguments at the trial than they had at the interlocutory injunction hearings. In essence, Reckitt sought permanent injunctions restraining Glaxo from using the first and second products complained of and damages for infringement of claims 1-6 and 9 of the patent. Glaxo denied that it was liable for any infringement and sought an order under s 138(3) of the Patents Act 1990 (Cth) that the patent be revoked on 5 bases: namely that, first, the invention claimed was not a method of manufacture, secondly, there was a lack of an inventive step, thirdly, the patent had been obtained by false suggestion or misrepresentation, fourthly, the patentee was not entitled to the patent, and, fifthly, claims 1-6 and 9 were not fairly based on the matter described in the specification.
As this summary suggests, the parties were at issue over a wide range of matters, including the construction of claims 1-6 and 9 in the patent, the characteristics of the first and second products complained of and the challenges to validity raised in Glaxo’s cross-claim.
Issues
Thus, the following issues arise for decision:
(1)What is the proper construction of claims 1-6 and 9 in the patent (the construction issue)?
(2)Does one or each of the first or second products complained of infringe (the infringement issue)?
(3)Was the invention a manner of manufacture (the manner of manufacture issue)?
(4)Was there a lack of an inventive step (the inventive step issue)?
(5)Was the patent obtained by false suggestion or misrepresentation (the false suggestion issue)?
(6)Was the patentee entitled to the patent (the entitlement issue)?
(7)Was each of claims 1-6 and 9 fairly based (the fair basis issue)?
I will describe the relevant provisions in the Act and the material parts of the patent before construing claims 1-6 and 9, and then I will deal with the factual and legal matters necessary to resolve the infringement and other issues.
The legislative scheme
After the priority date of 12 November 2002, the Parliament passed the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) that inserted ss 22A and 138(4) in relation to the question of entitlement, which the parties agreed applied to the determination of that issue in these proceedings. Relevantly, the Act provided (taking into account the amendments to ss 22A and 138(4)):
7 Novelty and inventive step
Inventive step
…
(2)For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
…
15 Who may be granted a patent?
(1)Subject to this Act, a patent for an invention may only be granted to a person who:
(a) is the inventor; or
(b)would, on the grant of a patent for the invention, be entitled to have the patent assigned to the person; or
(c)derives title to the invention from the inventor or a person mentioned in paragraph (b); or
…
18 Patentable inventions
Patentable inventions for the purposes of a standard patent
(1)Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a)is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b)when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and
…
22A Validity not affected by who patent is granted toA patent is not invalid merely because:
(a)the patent, or a share in the patent, was granted to a person who was not entitled to it; or
(b)the patent, or a share in the patent, was not granted to a person who was entitled to it;
…
40 Specifications
…
(2) A complete specification must:
(a)describe the invention fully, including the best method known to the applicant of performing the invention; and
(b)where it relates to an application for a standard patent – end with a claim or claims defining the invention; and
…
(3)The claim or claims must be clear and succinct and fairly based on the matter described in the specification.
…
138 Revocation of patents in other circumstances
(1)Subject to subsection (1A), the Minister or any other person may apply to a prescribed court for an order revoking a patent.
…
(3)After hearing the application, the court may, by order, revoke the patent, either wholly or so far as it relates to a claim, on one or more of the following grounds, but on no other ground:
(a) that the patentee is not entitled to the patent;
(b) that the invention is not a patentable invention;(d)that the patent was obtained by fraud, false suggestion or misrepresentation;
(e)that an amendment of the patent request or the complete specification was made or obtained by fraud, false suggestion or misrepresentation;
(f)that the specification does not comply with subsection 40(2) or (3).
(4)A court must not make an order under subsection (3) on the ground that the patentee is not entitled to the patent unless the court is satisfied that, in all the circumstances, it is just and equitable to do so.
The Dictionary in Sch 1 of the Act provided that , unless the contrary intention appeared:
invention means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention.
patentable invention means an invention of the kind mentioned in section 18.
The Statute of Monopolies 1623 (UK) provided in s 6 that:
Provided alsoe That any Declaracion before mencioned shall not extend to any tres Patents and Graunt of Privilege for the tearme of fowerteene yeares or under, hereafter to be made of the sole working or makinge of any manner of new Manufactures within this Realme, to the true and first Inventor and Inventors of such Manufactures, which others at the tyme of makinge such tres Patents and Graunts shall not use, soe as alsoe they be not contrary to the Lawe nor mischievous to the State, by raisinge prices of Commodities at home, or hurt of Trade, or generallie inconvenient; the said fourteene yeares to be [accomplished] from the date of the first tres Patents or Grant of such priviledge hereafter to be made, but that the same shall be of such force as they should be if this Act had never byn made, and of none other.
The patent
The original complete specification was filed on 10 November 2003 and had a priority date of 12 November 2002. It named Anne Dallison and Shaun Harrison as the inventors and, when granted on 20 March 2008, named Reckitt UK as patentee. Reckitt made amendments to the originally filed complete specification in 2006, in circumstances that I will explain later in these reasons. I will refer in these reasons to the complete specification as the amended version that was in the patent as granted.
The complete specification began by naming the field of the invention as relating to bottle neck liners, bottles, liquid dispensing apparatus and methods of dispensing liquids (page 1, lines 6-8). The background described the usual desirability of accurately measuring the amount of liquid that is dispensed from many bottles, such as medicine bottles. It referred to the use of terms such as teaspoonfuls, tablespoonfuls, drops or specified millilitres to identify how much a person should pour from a bottle into a measuring receptacle. And, where a precise amount of a medicine for dispensing had to be measured, the complete specification stated that normally one used an accurate subsidiary measuring device, such as a graduated syringe or pipette (page 1, lines 11-22).
The complete specification referred to an internationally published patent, that was not in evidence, noting that it described a syringe assembly comprising an elongated tubular barrel with an opening for discharge and an elongated hollow tubular plunger member that had a closed spherical tip. The tip of that assembly would sit in an insert that was fitted into the neck of a container (page 1, lines 24-29).
The specification described the way in which a syringe can be inserted freely through the bottle neck and into conventional medicine bottles, and then dipped into the liquid in the bottle. It noted the difficulty in such situations of a user seeing the graduations on the syringe body in order to measure exactly how much liquid had been drawn up into the syringe, with the frequent consequence that the user would have to return the syringe to the bottle to draw out more or return some liquid so as to obtain the desired amount (page 1a, line 1 to page 2, line 7). It stated that coloured glass bottles, including those commonly used to protect photosensitive medicinal contents, also make it harder to see how much liquid has been drawn into a syringe (page 2, lines 12-26). In addition, the specification stated that the insertion of the syringe into the liquid in the bottle could contaminate the medicine with micro-organisms present on the exposed surface of the syringe (page 2, lines 8-11), and could leave some liquid on the surface of the syringe that could drip onto the user or any surface creating mess (page 2, line 27 – page 3, line 2).
The complete specification then suggested a number of advantages that might flow from a liquid dispensing apparatus that could allow a syringe to withdraw liquid from a bottle where the graduations on the syringe were visible, there was a minimum surface area in which the syringe could come into contact with the liquid contents of the bottle (thus reducing contamination and dripping or spillage risks) and there was also an opportunity to pour the liquid from the bottle if the user did not want to employ the syringe (page 3, lines 4-22). The specification stated that an aim of the preferred embodiments of the invention was to overcome or mitigate the problems of the prior art, whether or not those problems were expressly disclosed in the patent (page 3, lines 24-26).
The summary of the invention set out a consistory clause, describing a first aspect of the invention as comprising an apparatus with the three elements: a bottle, a bottle neck liner and a flat-nosed syringe (page 3 line 30 – page 4 line 21).
Conceptually, the clause described the invention as being intended to work as follows. The liner is inserted into the top of the bottle. It is so designed that, like a cork, its outer perpendicular side, or sleeve, fits tightly against the inner side of the bottle neck. The liner has a flange around its top so as to fit against the rim of the bottle’s top as a further means of preventing the liquid contents escaping between the inside of the bottle and the outside of the liner. In addition, the liner has a hollow circular core that is created by an inner second perpendicular sleeve. That sleeve is held in place by a circular web of plastic material at the top that extends inwards, and at the foot by a horizontal “inward step” connected to the lower part of the inner sleeve. The inward step has a hole in it that is the same diameter as the opening at the base of the flat-nosed syringe. The intention of this design is that when the syringe is inserted into the liner it will fit tightly, so that the only way in which liquid can escape from the bottle is when the plunger in the syringe is drawn up and that action draws the liquid into the newly created void in the syringe. Alternatively, if the user does not want to use the syringe, the hole in the inward step allows him or her to pour the liquid into whatever receptacle the user wishes.
I have given this broad and untechnical description to convey the general idea of the invention and not as a finding as to what it is. The consistory clause set out what was later reflected in claim 1 together with the following definitions (page 3, line 30 – page 5, line 7):
By “syringe” we mean a syringe comprising a hollow syringe barrel in which is located, or arranged to be located, a reciprocating plunger, the syringe barrel having a dispensing aperture, through which a liquid may be drawn, then discharged.
By “flat-nosed syringe” we mean a syringe whose barrel ends in a generally flat distal end which is perpendicular to the barrel axis, and in which the dispensing aperture is formed. Preferably there is no part of the distal end which extends beyond the bore.
By “sealingly” we mean that under conditions of normal use liquid cannot flow or leak between the respective parts, that is, between the bottle neck and the bottle neck liner, and between the bore and a syringe barrel. (emphasis added)
Figures 4, 5 and 6 in the patent are reproduced below and depict, respectively, a flat-nosed syringe (item 36 signifying the hole through which liquid is drawn), the syringe inserted into the liner and a cross-sectional view of such an insertion:
The specification then discussed over the next eight pages a number of preferred embodiments of the invention. It contemplated that, in the ordinary course, the liner would be formed industrially using injection moulding (e.g. page 5, lines 29-30). The specification said that in some embodiments the through bore in the liner, i.e. the hole into which the syringe fitted, might have a slight taper or be slightly undersized to ensure a tight fit relative to the syringe barrel (page 6, lines 3-5, 10-14). The specification stated (page 6, lines 15-17):
The flared portion provides a lead-in, into the through bore, in order to aid engagement of the syringe barrel into the through bore.
The inward step also prevented the syringe penetrating beyond it deeper into the bottle (page 6, lines 31-32) and in that way, the patent taught that the barrel so inserted “is sealingly received within the sleeve and the inward step limits its movement, on insertion” (page 7, lines 1-3).
The specification stated that a preferable embodiment of the liner had a taper on its outer surface that would act as a lead in to facilitate fitting of the liner into the bottle neck during manufacture. It also stated that the cylindrical body (i.e. the outer surface of the liner), preferably would be oversized relative to the bottle neck so as to achieve an interference fit, in order to prevent the liner and bottle neck separating when in use. The specification continued (page 8, lines 17-29):
Thus, the force required to withdraw the liner from the bottle neck preferably exceeds the force required to withdraw a syringe barrel from the sleeve into which it is inserted. (emphasis added)
Importantly, for the purposes of construing the “omnibus” claim 9, the next section of the complete specification, that extended over five pages, was headed “Brief Description of the Drawings” (page 13, line 23). That section commenced (page 13, lines 25-29):
In order to better understand the various aspects of the invention, and to show embodiments of [scil: how] the same may be put into effect, the invention will now be described by way of example, with reference to the accompanying drawings in which:
Figure 1 illustrates a side elevational view of a preferred embodiment of a bottle neck liner of the first aspect of the invention;
Figure 2 illustrates a side sectional view of the bottle neck liner of Figure 1;
Figure 3 illustrates the bottle neck liner of Figures 1 and 2 inserted into the bottle neck of a bottle;
Figure 4 illustrates a flat-nosed syringe, arranged in use to be inserted into the bottle neck liner of Figures 1 and 2;
Figure 5 illustrates the syringe of Figure 4 inserted into the bottle of Figure 3; and
Figure 6 illustrates a side sectional view of the syringe, bottle neck liner and bottle taken through the line AA of Figure 5.
Figures 1, 2 and 3 were as follows:
The specification described item 10 on figure 1 as an outer taper or chamfer (page 14, line 24), which had the lead in function described above. The specification stated (page 14, line 30 – page 15, line 2):
The sleeve 4 has a circularly cylindrical through bore 16. The sleeve 4 includes at the lower end thereof an inward step 18. This is an annular formation protruding inwardly from the interior surface of the sleeve 4 at its lower end, and terminating in a circular aperture 17. At its upper end the sleeve is inwardly bevelled at 20. (emphasis added)
The inventors explained that the liner is a one piece injection moulding from a resilient plastics material (page 15, lines 9-11) and that its outer body should deform inwardly so as to provide “a sealing fit between outer body 8 and the bottle neck 24”, preventing any leakage from between the bottle’s inner surface and the liner’s outer surface (p 15, lines 13-32). And the dimensions of the flange at the top of the liner were intended to be substantially identical to those of the top surface of the bottle and to permit a screw cap to be fitted over both “in order to sealingly close the bottle neck 24, for transportation, sale and storage” (page 16, lines 1-9).
Next, the specification continued by explaining figure 4 as illustrating (page 16, lines 11-19):
… a flat-nosed syringe 30 for use in the present invention. The flat-nosed syringe 30 includes a hollow circularly cylindrical syringe barrel 32 having a distal end region 33 to be received in the liner, and terminating in a perpendicular, circular face at its distal end 34, formed with a centrally located dispensing aperture 36. The syringe 30 also includes a plunger 38 arranged to move under reciprocal motion within the syringe barrel 32. (emphasis added)
In explaining figure 6, the specification stated (page 16, line 25 – page 17, line 11):
As the distal end region 40 of the barrel is inserted into the bottle neck liner 2, it pushes slightly against the sleeve 4, the cross-section of the bore 16 of the latter being slightly smaller than the cross-section of the barrel. Good sealing against the passage of liquid between the barrel and the sleeve is thereby provided. The insertion continues until the distal end 34 of the syringe barrel 32 abuts the inward step 10 of the sleeve 6 (see Figure 6). In this position, the distal end region of the syringe barrel is a tight sealing fit within the sleeve inside the bottle neck 24, but the rest of the syringe barrel - the larger part – is not; it stands outside the bottle. Thus, graduations on the syringe barrel 32 can still be seen by a user. The seals between the liner 2 and the bottle neck 24, and the syringe barrel 32 and the sleeve 4, prevent leakage of liquid between such parts if the bottle is tilted or inverted. The dispensing aperture 36 of the syringe barrel 32 is located centrally and contiguously with the opening within the inward step 10 of the sleeve 4. (emphasis added)
The claims
The claims defining the invention, relevantly, were as follow (page 19, line 3, page 20, line 14, page 21, lines 11-12):
1.A liquid dispensing apparatus comprising a bottle, a bottle neck liner and a flat-nosed syringe having a plunger and a barrel, the barrel terminating at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal axis of the barrel, the bottle having a bottle neck in which is located the bottle neck liner having a cylindrical body sealingly engaged inside the bottle neck such that liquid cannot flow between the bottle neck liner and the bottle neck, the bottle neck liner comprising a sleeve comprising at its lower end an inward step located within the bottle neck, an aperture being defined inwardly of the inward step, wherein the cylindrical body and the sleeve are connected together with a web of material only at the upper end of the cylindrical body and of the sleeve, wherein the sleeve is formed with a flared portion at its upper end into which the distal end of the syringe barrel passes; wherein when the syringe barrel is inserted into the sleeve the inward step prevents the syringe barrel from protruding past the step and liquid cannot flow between the sleeve and the barrel, but can leave the bottle only via the aperture and thence the syringe.
2.A liquid dispensing apparatus as claimed in claim 1, wherein the aperture is pre- formed and permanently open.
3.A liquid dispensing apparatus as claimed in Claim 1 or 2, wherein the sleeve comprises a resilient material.
4.A liquid dispensing apparatus as claimed in any preceding claim, wherein the liner comprises an outwardly protruding flange extending around at least a portion of an end of the liner and abutting the rim of the bottle neck into which the liner is inserted.
5.A liquid dispensing apparatus as claimed in any preceding claim, wherein the bottle contains liquid medicine.
6.A liquid dispensing apparatus as claimed in any preceding claim, wherein the bottle includes a closure member which can be secured over the bottle neck.
….
9.A liquid dispensing apparatus, substantially as described with reference to the drawings and/or examples. (emphasis added)
The background to the invention claimed in the patent
Reckitt did not lead any direct evidence from either of the inventors named in the patent as to their involvement in the genesis of the claimed invention. However, each of Ms Dallison and Mr Harrison signed an inventor’s acknowledgment in October 2003 that acknowledged that the invention belonged to their employer, Boots Healthcare International Ltd.
On about 1 February 2006, a Reckitt Benckiser group company acquired Boots. On 27 March 2006, Boots entered into an agreement with Reckitt (UK) under which Boots assigned to Reckitt (UK) all its right, title and interest in, among other property, the patent and its international corresponding patents or analogues.
The role in the genesis of the patent played by Ms Dallison and Mr Harrison emerged, to some extent, from the evidence of Gareth Pearce. Mr Pearce held the degree of Bachelor of Engineering (Manufacturing Engineering and Product Design). He worked as technical sales executive from 1996 to 2002 for Harding Associates, a firm with exclusive agencies in the United Kingdom for pharmaceutical primary packaging companies, including a Belgian producer of injection moulded syringes and accessories, Hubert De Backer NV (HDB). From October 2002 to May 2008, Mr Pearce worked for HDB in a business development role and was responsible for pharmaceutical and medical device clients. In both roles, Boots was one of the clients for which Mr Pearce provided services.
Mr Pearce made three affidavits in these proceedings on which Glaxo relied. Reckitt did not require him for cross-examination. Mr Pearce acknowledged that, as might be expected, while he had some recollection of the events in question, that recollection had been refreshed by the contemporaneous documents to which he had been given access. Glaxo had obtained those documents from HDB and Mr Pearce. Apart from two faxes sent by Mr Pearce in May and June 2000, Reckitt was not able to locate in its records early documents relating to the development of the concept for the apparatus. However, Reckitt did have considerable documentation relating to the patent application.
Importantly, HDB had been on notice of these proceedings since at least 13 May 2013, and on 2 May 2014 had received copies of Mr Pearce’s first affidavit and Glaxo’s pleading in its cross-claim that HDB, through Mr Pearce and other employees of HDB, including the senior and junior Jan De Backer or Andre Versteten, were the true investors. Despite this, HDB has not sought to be joined or otherwise to assert any right in respect of the patent, no doubt because, as will appear, it gave up whatever rights it may have had when it resolved a dispute with Boots over the original patent in early 2006.
In November 1998, Mr Pearce reported to HDB that he had discussed, with Chris Penfold of Boots, the supply of a paediatric dosing syringe for the French market to compete with a product offered by Boots’ competitor, Wyeth. Mr Pearce recalled that Wyeth’s product had a “flat ended syringe” that was inserted directly into the bottle and that there was no plug or bottle neck liner. Mr Pearce’s written report to HDB identified two possible products already made by HDB as offering solutions for Boots: one was a similar “applicator”, the other a newer HDB product comprising an “applicator and nozzle and plug”, the plug serving to prevent spillage if the bottle were knocked over.
Also in 1998, Mr Pearce and HDB were working with another pharmaceutical company, Abbott Laboratories, on a project to develop another paediatric syringe with a nozzle and plug or bottle neck liner. Nothing came of that project other than HDB displaying it at a trade exhibition in Paris in around February 2000, at which Ms Dallison met with Mr Pearce and they began working on the project that resulted in the apparatus claimed in the patent.
By 22 March 2000, Ms Dallison had instructed Mr Pearce that Boots disliked having a nozzle on the syringe. He included in his report of that day to HDB a simple drawing of an HDB flat-nosed syringe inserted into a sleeve that would form part of a “plug” or liner. However, HDB appeared subsequently to have continued producing designs for Boots with nozzles on the syringes. On 12 June 2000, Mr Pearce reported to HDB on the Boots project. He wrote that Boots was still looking at the possibility of using “a flat ended, no nozzle, version, used in conjunction with a redesigned plug”, along the lines of his sketch of 22 March 2000 and another sketch of 23 March 2000 that was not in evidence.
On 15 June 2000, Mr Pearce wrote a customer visit report of his meeting at Boots the day before. He described Ms Dallison as the project manager and noted that Boots preferred the “flat ended nozzle design”. He reported that Boots was considering having measurements marked on the syringe barrel to avoid overdosing. He noted that Boots wanted to make the product available for a range of ages. He also reported that Boots was considering the feasibility of there being a choice to allow the user to pour directly from the bottle into a measuring cup. He recalled that Ms Dallison had stated that older children had an aversion to taking medicine from a syringe and that it was desirable to be able to pour the medicine directly from the bottle onto a spoon. In his report to HDB, Mr Pearce drew an illustration of a bottle neck liner that had outward tapers towards the top and a flat-nosed syringe inserted. He said that in drawing the pouring feature he had in mind a cap used in a brand of washing up liquid, the configuration of which is not in evidence.
Discussions continued and on 27 October 2000, Mr Pearce wrote to Ms Dallison enclosing a drawing by HDB and prototype sample plug. That design had a protruding flange at the top making it difficult to secure a childproof bottle cap over it. Ms Dallison wrote back on 13 November 2000 suggesting a flatter plug, seeking ways to improve its pouring quality and to prevent it being easily removed.
On 27 November 2000, Mr Pearce wrote a report to HDB of his visit to Boots on 23 November 2000. He noted that Ms Dallison wanted to proceed along the lines the parties were discussing but with some modifications to the plug. She wanted to remove an inner ribbed feature that had been intended to hold the syringe in place and substitute a firm interference fit to provide that result. She wanted a greater lead in to the plug to aid insertion of the syringe. However, the design still had protruding flanges above the line of the top of the bottle neck. Subsequently, Mr Pearce described Boots’ concept as its “proprietry [sic] plug design” in his letter to Ms Dallison of 19 December 2000. He noted that the design would require HDB to create new moulds.
The next version of HDB’s drawing was the first to include a web or solid connecting material at the top of the plug but it also still included a flange that rose above the web of material. Mr Pearce did not recall who suggested that change. I infer that it was Ms Dallison who was concerned about mess associated with pouring and having a firm interference fit for the syringe. On 9 January 2001, she signed an approval on a drawing that noted her discussion with Mr Pearce and had an alteration to the shape of the taper or lead in at the top of the sleeve on the liner, which broadened it. There were no protruding flanges on the drawing.
On 26 January 2001, Mr Pearce met with Ms Dallison and Mr Harrison (the other named inventor) to discuss some prototype plugs. His notes of the meeting recorded that, when tested, the plugs had residue at the top surface and the design did not have a well that trapped liquid.
On 31 January 2001, Mr Pearce reported to HDB that Ms Dallison was disappointed with the prototype because it did not pour well and the interference fit with the syringe was not tight enough. He noted that Boots anticipated that when it launched this new dosage form, its competitors would display a great deal of interest.
HDB’s next drawings kept a raised pouring lip or flange above the top of the plug. Ms Dallison continued to have concerns about that feature and, in his report of 12 February 2001 to HDB, Mr Pearce enquired whether the edge of the plug could be designed without a lip and so that it poured perfectly. He said that Ms Dallison preferred a sketch showing such a design.
On 20 February 2001, Mr Pearce took two sample liner prototypes to Boots, one with and one without a protruding flange at the top. He wrote to HDB on 20 February 2001 that the simple design, without a flange, worked best and that Boots wanted to proceed with such a design.
On 7 March 2001, Mr Pearce wrote to Ms Dallison noting that Boots had viewed the latest version of the “plug and syringe system” positively and foreshadowing that the “time and effort committed in the development of this ideal solution, by yourself and HDB” would enable it to be brought to market promptly. He attached a revised specification that had a significant outward taper from the sleeve to the web for approval. He noted that this design would achieve, among other matters, the plug fitting securely and remaining in place throughout general use so that there would be a secure and positive interference fit between the barrel and the plug.
On 23 March 2001, Mr Pearce wrote to HDB in anticipation of a forthcoming meeting which they all would have with Boots. Under the heading “What now needs to be delivered?” he included, among the commercial topics, “design exclusivity”. On 20 April 2001, HDB wrote to Mr Pearce with a drawing of the liner asking him to seek the customer’s written approval.
The documentary material in evidence as to the evolution of the invention claimed in the patent ends at this point. The next stage was that Boots proceeded to patent the new apparatus.
The patent application process
The priority date of the patent was 12 November 2002 and the international filing date was 10 November 2003. Boots’ patent attorney, Bob Pidgeon of Appleyard Lees, had the carriage of the patent application in Europe. The original claims were wider than and different from those now in the patent.
In April 2005 Mr Pearce, who was by then a employee of HDB, discussed Boots’ patent application with Ms Dallison. He subsequently sent her an email, on 14 April 2005, suggesting that HDB become a co-patentee with Boots. He asserted that the apparatus was a joint development. He referred to an “ethical undertaking” that he said that HDB had given to Boots not to actively promote “the same design of syringe plug incorporating pourability”.
Mr Pidgeon acted on Boots’ behalf in negotiating with HDB. On 3 June 2005, Mr Pidgeon emailed Mr Pearce suggesting that Boots would limit its claim to plugs having the “sloping shoulders”, being a taper or bevel at the mouth of the bore on the liner.
Mr Pidgeon’s notes of a conversation with Mr Pearce on 17 June 2005 recorded the latter saying that “we developed this style of plug with Boots. Annie [Dallison] asked for exclusivity. We agreed, meaning [we] wouldn’t market to Boots’ competitors”.
From then until November 2005, Mr Pidgeon and Boots negotiated the terms of an agreement with HDB that would involve Boots amending the patent to enable HDB to continue to market its existing other plugs (or bottle neck liners) and syringes, including its flat-nosed syringes. On 17 October 2005, Mr Pidgeon emailed Mr Pearce with a draft agreement and his comments on the proposed new claim 1 to be substituted in the patent saying:
It is important that the revised claim reflects the [Boots] input. The pre-existing HDB plug B7530 was “the other way round”: the web which joined the inner and outer parts was at the inner end so at the outer end there was quite a large annular space in which sticky medicine could collect. In the [Boots] proposal the web was put at the outer end. That’s the major feature we propose to write into claim 1. An additional feature which came from [Boots] is that the intro to the sleeve was flared, to give an anti-spill benefit and, I assume, an ease-of-location benefit. This appears to be a lesser feature and we propose to make it the subject of a subsidiary patent claim only. (emphasis added)
I infer that the instructions for the references to Boots’ contributions in Mr Pidgeon’s letter came from Ms Dallison. Mr Pearce replied on 19 October 2005 saying that the proposed draft looked acceptable, subject to two questions he had. Notably, he did not dispute Mr Pidgeon’s email’s assertions as to Boots’ input, but added:
A small point, however applicable if you propose to progress the subsidiary patent, where you refer to the entrance of the sleeve being “flared” = widen gradually, this feature was essentially designed as a pouring lip rather than to have any anti-spill functionality. I woud [sic] also be interested as to how you eventually word this, as all injection moulded apparently straight walls have some degree of taper to aid ejection from the mould. (emphasis added)
On 21 November 2005, Boots sent HDB signed copies of the final version of the agreement for HDB to execute and return a signed copy to Boots, which was referred to in the agreement by the acronym “BHI”. HDB responded by sending a signed copy to Mr Pidgeon on 24 March 2006 and asked to be kept informed as to the patent amendments. The agreement was dated 22 March 2006 (the Boots agreement) and relevantly recorded:
RECITALS:
(A)[Boots] and HDB worked together to produce a dispensing system for [Boots’] product Nurofen for Children (hereinafter NFC) in oral liquid form.
(B)[Boots] desired the dispensing system to be of the plug and syringe type, in which a flat-nosed syringe co-operates with a plug located in the neck of a bottle in order to withdraw a dose of liquid medicine.
(C)HDB already had a plug design, for use with flat-nosed oral dosing syringes, namely HDB Part No. B7530 (Attachment 1).
(D)[Boots] determined that HDB’s existing plug design was not fully suitable for its purpose and proposed modifications to design the plug which was less prone to the collection of liquid medicine. The modifications were to provide a connecting wall between the upper ends of the outer wall and the inner sleeve of the plug, and to provide the upper region of the inner sleeve with a flared profile. The resulting plug (hereinafter the NFC Plug) is shown as HDB Part No. T1928/1 (Attachment 2).
(E)[Boots] filed a PCT patent application to protect the NFC Plug, and this was published as WO 04/043326 entitled “Improvements in and relating to liquid dispensing”. The National/Regional phase of this application has been entered in Europe (application number EP 03775511.3), the United States of America (application number awaited) and Australia (application number 2003283537). These are hereinafter called the Patent Applications.
(F)HDB supply [Boots] with HDB’s standard flat-ended 5ml oral dosing syringe, Part Nos T1839/1, T1840 (Attachments 3 and 4), and the NFC Plug.
(G)HDB did not realise that the BHI Plug [scil: NFC Plug] was protectable or that [Boots] were seeking patent protection and acting in good faith developed further plugs, different in detailed design from the BHI Plug [scil: NFC Plug] but using similar principles. These plugs are shown as Part Nos. T2010 (Attachment 5) and T2022 (Attachment 6). HDB have developed these specifically for an Austrian company (hereinafter the Austrian Company) and a Spanish company (hereinafter the Spanish Company).
ACCORDINGLY IT IS HEREBY DECLARED AND AGREED AS FOLLOWS:
1. Patent Applications
1.1[Boots] may progress the Patent Applications provided that the claims thereof are limited to the specific invention made by employees of [Boots].
1.2[Boots] will revise the claims thereof to cover only embodiments of plug having a connection between the outer wall and the inner sleeve at their upper ends, and with the inner sleeve having a flared upper region. Revised claim 1 will have the wording of Attachment 7, or wording of equivalent meaning, or narrower wording, if required by a Patent Office. No other claim in any of the Patent Applications will have any broader meaning.
1.3The revised claims will be presented by [Boots] on European patent application 03775511.3 within two months of signing this agreement. On its US and Australian applications the revised claims will be presented by [Boots] at any appropriate time before examination or during examination, having regard to patent practice in those countries.
1.4HDB may however proceed on the basis that the revised claims have been presented on each of the Patent Applications immediately on conclusion of this agreement.
1.5HDB will not contest the ownership, validity, inventorship or any other issues relating to the [Boots] Patent Applications or any patents granted therefrom.
2. Product supply
2.1HDB will not supply the BHI Plug to any other customer for any purpose.
2.2HDB may sell Part Nos. T2010 and T2022 for any products outside the field of paediatric analgesics.
…
2.5[Boots] does not extend any further licence to HDB or its customers. (emphasis added)
The relevant drawing in Attachment 2 was:
That drawing was very similar, but not identical, to the drawing sent by HDB to Mr Pearce on 20 April 2001 (see [48] above).
Attachment 7 was a shorter version of what became the form of claim 1 in the patent but it did not include the wording dealing with the flared portion, namely at page 19 lines 19-21 of the patent:
wherein the sleeve is formed with a flared portion at its upper end into which the distal end of the syringe barrel passes.
On 18 April 2006, Mr Pidgeon sent HDB the revised wording of the patent filed with European Patent office that included the words just set out as part of the present version of claim 1. He also advised HDB of Reckitt’s acquisition of Boots. On 10 November 2006, Mr Pidgeon wrote to HDB advising that corresponding amendments would be made to the Australian and United States applications. There is no evidence that HDB expressed any concern about, let alone opposition to, these revisions.
Other background
It was common ground that at the priority date, the common general knowledge included:
·bottles to store liquids, including medicines in liquid form;
·hypodermic syringes and single use and reusable syringes;
·the use of measuring devices, including graduated syringes, to obtain an accurate dosage of a prescribed amount of a liquid, including a medicine from a bottle as described in the patent at page 1 lines 12-22;
·the trade journals and publications.
Both sides called expert evidence. Reckitt called Robert Tiller, who had practised continuously as an industrial design consultant since graduating as a Bachelor of Industrial Design in 1988. Since 2006, Mr Tiller had conducted a specialised consultancy for the design and development of scientific and medical products. He had lectured at the University of New South Wales. Glaxo called William Hunter, a mechanical engineer, who graduated Bachelor of Engineering Science (Mechanical) with first class honours in 1982 and with a Master of Engineering Science (Mechanical) in 1985 from the University of Melbourne. Mr Hunter had been employed by a pharmaceutical manufacturer and in his later years conducted, among others, specialised consultancy work in project management and medical device development.
The experts agreed in their joint report that the term “flat-nosed syringe” was not a term of art. They explained that the distal end is the extremity at the most distant point from a user who is operating a device. Thus, when the user holds the syringe to withdraw or dispense liquid, the distal end will be the opposite end from that where he or she will pull or push the plunger. They agreed that a dispensing aperture is an orifice at the distal end of the flat‑nosed syringe through which liquid can be drawn or dispensed. They said that a generally flat distal end is essentially a planar face located at the distal end of the syringe barrel. They also said that a barrel axis is the longitudinal axis of the flat-nosed syringe that is the centreline of the barrel along which the plunger operates. They said that the term “bore” meant a hole in an object. They agreed that the expression in the patent, “a generally flat distal end which is perpendicular to the barrel axis”, would be understood by a person skilled in the art as essentially a planar face positioned at the distal end that was at a right angle to the longitudinal axis of the syringe barrel.
Mr Hunter had never heard of or encountered a flat-nosed syringe before being asked to give evidence in these proceedings. He said that the patent’s definition of a syringe, that required the barrel to have a dispensing aperture (page 4 lines 25-27), was missing the words “there is the barrel comprising a tip with a dispensing aperture”. Mr Tiller said that he understood the dispensing aperture to be “a hole in the wall section at the distal end at the barrel” and that it was “the final exit point where [the liquid] leaves [and enters] the tip or barrel”.
1. The construction issue – the parties’ submissions
The issues of construction relevant for the resolution of the controversy between the parties concerning whether the first or second products complained of infringe claims 1-6 or 9 of the patent are whether:
·the barrel of the syringe must have a single or uniform diameter;
·the liner must have an outer cylindrical body that engages with the inside surface of the bottle neck so that, under conditions of normal use, the liner remains in place and liquid cannot flow between it and the bottle neck;
·the liner must have first, a gradual widening, or transition in shape, at the upper end of its inner sleeve and, secondly, the ability to pour contents from the bottle if the syringe is not used.
Reckitt argued that the distal end was the relevant part of a syringe necessary for it to amount to being a flat-nosed syringe, within the meaning of claim 1. It relied on Mr Tiller’s opinion that all that was necessary was for the diameter of the flat nose of the syringe to correspond with that of the barrel at its distal end, regardless of whether the shape or configuration of the barrel above its distal end remained the same or changed. Reckitt submitted that if the length and shape of the plunger complemented or corresponded to those of the barrel in which it operated when fully inserted down to the flat face, then it would satisfy the requirement in claim 1 of being a “reciprocating plunger”. That was because, as Mr Tiller reasoned, when fully inserted, the shape along the whole plunger would reciprocate or correspond with the shape of the whole of the empty space within the barrel, so that there would be no empty space left and all liquid or air in the barrel would be expelled. Reckitt argued that claim 1 did not require that there be no variation in the diameter of the barrel and that, indeed, the experts agreed that ordinarily the barrel of a syringe would widen out at its proximal end to allow for insertion of the plunger.
Glaxo accepted that the invention was not confined to the medicinal field albeit that the patent was directed to that area. However, it argued that the skilled addressee of the patent would comprise a team that included persons who had a practical interest in the medicinal product field. Glaxo argued that the common general knowledge in Australia, of which the skilled addressee would have been aware at the time of the application for the patent, included Australian and international regulatory standards or requirements for medical syringes including those for injection moulding of those products.
Glaxo said that although the common general knowledge was that of the skilled addressee in Australia, there was no relevant distinction between what that knowledge was here at the priority date and what the state of such knowledge was overseas. That was because, it argued, the field was an international one and such devices could be exploited on an international scale. Glaxo relied on the highly standardised nature of medical devices at an international level, the fact that the same products were frequently distributed across different markets, the small and potentially uneconomic scale of the Australian domestic market and the multinational nature of the major corporations supplying medical devices. It also argued that people in the field attended Australian and international trade exhibitions, read and referred to internationally published trade publications and journals.
Glaxo argued that the common general knowledge at the priority date included:
·inserts (stoppers, plugs, neck liners, adapters or fitting) inserted into bottle necks;
·regulatory requirements for the use of medical devices, including syringes;
·various types of syringes, including needleless syringes, syringes with Luer tapers or tips, syringes with tips or nozzles and syringes without tips or nozzles;
·Australian and International standards for syringes;
·problems that occurred if a syringe was inserted directly into a bottle to withdraw liquid.
Glaxo submitted that Mr Hunter’s evidence should be preferred to that of Mr Tiller, as a guide as to how a skilled addressee would read the claims. In particular, Mr Hunter relied on Australian Standard 1094-1981: Single-Use Syringes (Sterile) for General Medical Use (AS1094) as information that a skilled addressee, in the design process, would have regard to in understanding “useful performance requirements for a syringe”, including nomenclature, toxicity risks, guidance on markings, graduations, sealing issues in relation to a plunger and dead space. He drew on the terminology in AS1094 to interpret words in the patent such as “barrel”. Glaxo contended for acceptance of Mr Hunter’s evidence that “barrel” was a term of art when used in relation to a syringe. It argued that the word “cylindrical”, as used in the claims, had the ordinary meaning of referring to a geometrical figure, being a cylinder, and that so understood it affected the reference in claim 1 to the bottle neck liner “having a cylindrical body sealingly engaged inside the bottle neck”. Glaxo submitted that the word “sealingly”, as defined in the complete specification, and the word “engaged” as also used there, conveyed that claim 1 required a construction that the cylindrical body of the liner have a firm interference fit so as to prevent it becoming dislodged when a flat-nosed syringe was withdrawn.
Glaxo also contended that the expression “flared portion” in claim 1 conveyed a meaning that there be a portion at the upper end of the sleeve of the bottle neck liner that spreads out or widens gradually as a single geometric feature, such as a chamfer (bevel) or curve. Glaxo accepted that the flared portion described in claim 1 would provide a lead in for the syringe. But, it argued, the mere functionality of there being some change in shape that created a lead in was insufficient to satisfy the requirement of the claim that there be a flared portion of the liner. That was because, Glaxo said, “flared” could not be read as “lead in” in the claim.
Next, Glaxo argued that the expression “flat-nosed syringe” in claim 1 referred, first, to all syringes within what it contended was the common general knowledge, and secondly, to a limitation beyond the expression’s definition (at page 4 line 29 to page 5 line 2), namely, that the flat face of the syringe have “a diameter corresponding to the diameter of the syringe barrel” (page 19 lines 6-7). Glaxo submitted that claim 1 consistently used the singular to describe the individual features of the apparatus. It contended that claim 1 required the syringe barrel to be of a uniform diameter along its length and did not claim an invention in which the syringe had more than one barrel or cylindrical portions of different diameters.
Glaxo also relied on the original form of the complete specification, prior to its amendment, as an aid to construction pursuant to s 116 of the Act. Glaxo pointed out that the original specification was much broader and lacked a definition of the shape of the bottle neck liner and its sleeve, only requiring that liner to be sealingly “located” and provided that there be a syringe, with a preferable feature that it be flat-nosed. Glaxo contended that the amended, current, specification reflected a progressive and deliberate narrowing of these features of the claims.
The skilled addressee
In my opinion, the skilled addressee of the patent is the hypothetical non-inventive maker of mass produced, manufactured plastic moulded products who is skilled in the art. The skilled addressee would have worked or had experience in manufacturing such products for a variety of uses that included, but were not confined to, medicinal uses and would be aware of the common general knowledge at the priority date: cf Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] (2007) 235 CLR 173 at 197 [56] per Gummow, Hayne, Callinan, Heydon and Crennan JJ. Thus, the skilled addressee, when reading the patent, would be aware of, and capable of turning to account, its utility for dispensing liquid medicines, but would not feel constrained or limited in his or her understanding of it by that field of use.
The skilled addressee would have been aware that it was likely that there were Australian and international standards or requirements for products that could be used in the administration of medicine, but would have understood that the patent was addressed to a more general audience. I am not satisfied that the common general knowledge at the priority date that a skilled addressee of this patent would have included AS1094 or the other existing specialised medical syringe regulatory requirements on which Glaxo relied. Glaxo’s attempt to limit the skilled addressee of the patent to a person concerned, or principally concerned, with medical or medicinal uses involves, impermissibly, a reading of the patent and the identification of its skilled addressees with a view to infringement: Glaxo 305 ALR at 379 [60].
Of course, the skilled addressee would have appreciated that various shapes, sizes and types of syringes existed and regulatory requirements applicable to medical uses were likely to exist for them. However, the patent was directed to a less common type of syringe – one both without a needle and with a flat-nose. Neither expert suggested that he had been aware of flat-nosed syringes at each of the times of the priority date and when he was first asked to give evidence. There was no evidence that the concept of a flat-nosed syringe, having any particular or necessary characteristics beyond a flat-nose and functionality as a syringe, was part of the common general knowledge in Australia at the priority date.
Moreover, another expert witness called by Glaxo, Barry Evers-Buckland, had never heard of the term “flat-nosed syringe” before March 2014. Mr Evers-Buckland was a regulatory affairs consultant. He had been awarded a certificate in Mechanical Engineering by the Royal Melbourne Institute of Technology in 1975 and a Post-graduate Diploma in Health Administration by the then Lincoln Institute of Health Sciences in 1986. He worked for the Commonwealth Department of Health between 1965 and 1986, where his regulatory affairs duties involved assessing, among other products, medical needles and syringes. Between 1986 and 2005 he held positions in senior regulatory affairs, quality and compliance for Becton Dickinson, a multinational medical device company. Between 2000 and 2005, he was Becton Dickinson’s Asia-Pacific regional director for regulatory affairs and compliance. Since 2005, he had worked as a regulatory affairs consultant.
Becton Dickinson was a manufacturer of single use and reusable syringes, as well as needles and intravenous catheters. Mr Evers-Buckland acquired a detailed knowledge of that company’s products, including in relation to their design and manufacture. He had been a member of three committees of Standards Australia relating to medical devices. These included the committee for hypodermic and other equipment for general medical use from the early 1970s to the early 1990s, and the committee for insulin equipment, which was responsible for syringes and needles, amongst others.
Nonetheless, as claim 5 made clear, the apparatus could be used to dispense medicine and the skilled addressee would be a person who could turn that potential use to account. However, he or she would not gain assistance in understanding what the patent was teaching from AS1094. The patent taught that the flat-nosed syringe forming part of the apparatus had uses and functions quite different from conventional medical syringes, that usually had tapered tips and drew or expelled medicine through a needle. Moreover, AS1094 was a specialised standard that dealt solely with single use medical syringes used to inject medicine with needles (i.e. syringes that were to be used once only and with a needle) and had nothing to do with multi-use flat-nosed syringes that could be used by anyone, not just for administering medicine but also for a wide range of other non-medical purposes. For example, such a flat-nosed device could be used in a workshop, as part of the apparatus, to measure amounts of liquid or in a kitchen to measure quantities of ingredients.
Aickin J explained the test for determining what was part of the common general knowledge in Australia (as the version of s 7(2) of the Act applicable here required) in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292-293, with the concurrence of Barwick CJ, Stephen, Mason and Wilson JJ. He said (at 292) that the notion of common general knowledge involved “the use of that which is known or used by those in the relevant trade” and forms the background knowledge and experience available to all in that trade in considering either the making of new products or improvements to old ones.
Glaxo sought to argue that despite it calling both Mr Hunter and Mr Evers-Buckland, as persons on whom it relied as skilled in the relevant art, I should infer that flat-nosed syringes formed part of the common general knowledge in Australia. However, neither of those two witnesses, nor Mr Tiller, had ever heard of a flat-nosed syringe before being asked to give evidence in these proceedings, some 11 or more years after the priority date. Glaxo also relied on a statement by Mr Pidgeon in a letter dated 22 October 2004 that he wrote to the European Patent Office on behalf of Boots in which he stated that “the present invention employs an ordinary, commonplace flat-nosed syringe, already manufactured in large quantities”. That letter dealt with matters outside Australia. The absence of any direct evidence of knowledge, or the use, of flat-nosed syringes in Australia at the priority date, and indeed the ignorance of those devices by the two Australian experts called by Glaxo, suggests the need for considerable caution in making a finding that these devices were part of the common general knowledge here in late 2002.
It is telling that Glaxo, a well-resourced litigant with substantial involvement in the medicinal products field, did not call an expert to establish directly that flat-nosed syringes were part of the common general knowledge in Australia at the priority date. Accordingly, I am not satisfied that in Australia at the priority date, flat-nosed syringes were known or used by those in the relevant trade (i.e. skilled addressees) so as to form part of the background knowledge and experience available to all in considering the making of new products or improvements to old ones: Minnesota 144 CLR at 292.
I reject Glaxo’s argument that the common general knowledge relevant to the construction of the patent included regulatory requirements or standards for the production of syringes for medical use, or the shapes or types of other syringes, such as ones with Luer tapers or tips. Glaxo’s argument, and Mr Hunter’s evidence on which it relied, ignored the patent’s deliberate use of definitions of “syringe” and “flat-nosed syringe” that, first, did not confine the defined apparatus to a narrow field of use, namely in medicinal applications, and, secondly, explained what the inventors intended to convey using ordinary English words.
Moreover, the skilled addressee could not use the explanation of the Luer tipped syringe in AS1094 to understand what a flat-nosed syringe was, because, first, the standard prescribed requirements for a sterile, single use syringe for injection of medicine and, secondly, the taper or tip feature prescribed in the standard had nothing to do with the syringe described in the patent. In my opinion, the skilled addressee would find AS1094, and the other elements of the concept of “syringe” that Glaxo asserted formed part of the common general knowledge, to be of no assistance or relevance to gaining an understanding of the flat-nosed syringe, as defined and described in the patent.
Claim 1 – consideration
I am of opinion that the skilled addressee would read the word “syringe”, when used in the sense defined in the patent, in its ordinary English meaning. The patent and the definition of “syringe” are not confined to medical uses of the apparatus, although the patent does refer to those uses and, notably, claim 5 asserts a monopoly where the apparatus includes a bottle containing liquid medicine. The skilled addressee would be aware that the apparatus could be used in applications other than dispensing liquid medicines, as the specification envisaged: see, e.g., the identification of the field of the patent at page 1 lines 6-8, at page 3 lines 4-26 and the use of medicine bottles as an example of its application at page 1 lines 12‑14. Critically, the claims of the patent, other than claim 5, did not limit the apparatus to use for dispensing liquid medicines.
The definitions of “syringe” and “flat-nosed syringe” in the patent are expressed in ordinary English words that convey a meaning that is not limited to a technical sense. Far less do those definitions confine the word “syringe” to uses that are only suitable for medicinal purposes. The ordinary and natural meaning of the patent, read as a whole, showed that the word “syringe” referred to a device that can also be used in other applications than dispensing liquid medicine: Minnesota Mining 144 CLR at 272; Welch Perrin & Co Pty Ltd v Worrell (1961) 106 CLR 588 at 610 per Dixon CJ, Kitto and Windeyer JJ.
Although the complete specification contained definitions of “syringe” and “flat-nosed syringe”, claim 1 refined the characteristics of the flat-nosed reflecting syringe that would be within the monopoly described. Those definitions had followed immediately after the consistory clause. Relevantly, the definition of “flat-nosed syringe” (page 4 line 29 – page 5 line 2) prescribed that such a device had to have the following features or integers:
(1)it is a syringe, as defined, i.e. it comprised:
(a)a hollow syringe barrel;
(b)in which is located, or arranged to be located, a reciprocating plunger;
(c)the barrel has a dispensing aperture through which a liquid may be drawn and then discharged;
(2)the barrel ends in a generally flat distal end;
(3)that distal end is perpendicular to the barrel axis;
(4)the dispensing aperture is formed in the distal end.
The experts agreed that the reciprocating plunger had to have a seal located at or close to its distal end to enable the creation of a vacuum by which, when the plunger is retracted, the liquid can be drawn up into the hollow barrel and, later, can be pushed out when the liquid is discharged.
The additional and restated features and integers of the flat-nosed syringe in claim 1, and its consistory clause, are that:
(5)the flat-nosed syringe has a plunger and a barrel (cf: features (1)(a) and (b) above).
(6)the barrel terminates at its distal end in a generally flat face (cf: feature (2) above) that:
(a)has a diameter corresponding to the diameter of the syringe barrel;
(b)is perpendicular to the longitudinal axis of the barrel;
(7)when the distal end of the syringe barrel is inserted into the sleeve of the bottle neck liner:
(a)the inward step prevents the syringe barrel from protruding past the step;
(b)the liquid cannot flow between the sleeve and the barrel; and
(c)liquid can only leave the bottle via the aperture and thence the syringe (page 19 lines 20-25).
Features (6) and (7) of claim 1 describe particular characteristics of the flat-nosed syringe at its distal end and in respect of its interaction with the sleeve in the bottle neck liner. The features in (7)(b) and (c) correspond to the definition of ‘sealingly’, namely that under conditions of normal use liquid cannot flow or leak between the base of the bottle neck liner and the syringe barrel.
Claim 1 thus defines the barrel of the syringe by reference to the features necessary for its distal end is to be used to engage “sealingly” with the sleeve in the liner so as to draw up liquid. The plunger must also be reciprocating, as required by feature (1)(b).
The first critical question of construction is whether “a barrel” must be of a uniform diameter throughout its length. The experts agreed that, near its proximal end, the barrel ordinarily will flare out to enable the plunger to be inserted and that this flaring does not affect the concept that the thing described is a barrel. However, the experts had diametrically different opinions about whether the distal end could be described as a barrel, within the meaning of claim 1, if it had a tip with a narrower diameter than the cylindrical shape above it, as in Glaxo’s alternate syringe.
The ordinary English meaning of “barrel” comprehends a uniformly cylindrical, along its length, and usually hollow, tubular shaped object, such as a gun barrel, a wooden barrel that bulges in its middle, such as is used to store liquids, the trunk of a tree or the belly and loins of a horse or ox (see Oxford English Dictionary, online, senses 1a, 6a, 6b, 8, Macquarie Dictionary online, senses 1, 4, 5). The word is not descriptive of a singular shape or object. It is capable of being used to describe a variety of shapes that conform to an overall generalised concept of an elongated object that has a circular, but not necessarily uniform, shape or diameter along its length.
When used to describe a component in a syringe, the word “barrel” conveys an object that will store liquid and has a sufficiently cylindrical shape that it can be used, with a plunger, to draw up and discharge liquid. As used in the patent, the word “barrel” conveys an object that has properties and performs functions attributed to it in the definitions of “syringe” and “flat‑nosed syringe” and as refined in claim 1. The barrel must be hollow and must accommodate a reciprocating plunger (as required in the definition of syringe). In a flat‑nosed syringe, the barrel must end in a generally flat distal end that is perpendicular to the barrel axis and in which the dispensing aperture is formed (definition of flat-nosed syringe). A barrel for the purpose of claim 1 (and all the dependant claims 2-6) has the additional features that I described as feature (6) above, namely:
(6)the barrel terminates at its distal end in a generally flat face (cf: feature (2) above) that:
(a)has a diameter corresponding to the diameter of the syringe barrel;
(b)is perpendicular to the longitudinal axis of the barrel;
I am of opinion that a skilled addressee would understand that the barrel shape that claim 1 specified had a generally uniform diameter along its length, although that addressee would realise that, at its proximal end, the barrel would need to be slightly flared in order to allow the plunger to enter. Such an understanding would be confirmed by the shape of the barrel in the syringe in figure 4 in the patent. The patentee used its own clear language in claim 1 to identify the characteristic of the barrel having a diameter that is both uniform along its length and corresponds to the flat face at the distal end.
This construction is consistent with the narrowing of the claims that Reckitt made when it amended the original wording of the patent following the March 2006 settlement of the dispute between its predecessor in title, Boots, with HDB that I described at [56]-[59] above. Suffice to say that the claims in the unamended patent did not incorporate a flat-nosed syringe specifically, rather those claims extended to syringes generally, although the unamended complete specification suggested that a preferable form of the invention included a syringe without a formation or fitment at its distal end (unamended patent p 5 lines 1-3). The unamended patent also did not define the shape of the bottle neck liner, but the unamended claim 1 required only that it be “so dimensioned that it can be sealingly located within a bottle neck, the liner comprising a sleeve defining a bore having an inward step, the sleeve and step being so dimensioned that, in use, the bore can sealingly accommodate the distal end region of a syringe barrel …” (unamended patent, claim 1 p 19 lines 3-8).
Accordingly, I reject Reckitt’s construction of the word “barrel” as used in claim 1 as being capable of including portions of varying diameters, other than the functional portion at the proximal end to allow the insertion of the plunger.
The features of the bottle neck liner that claim 1 of the patent in suit required were that:
(1)the liner has an outer cylindrical body;
(2)the outer cylindrical body of the liner would sealingly engage with the inside of the bottle neck;
(3)that engagement has to produce the result that liquid cannot flow between the wall of the cylindrical body, contiguous with the inner wall of the bottle neck;
(4)the liner comprises a sleeve that:
(a)is located inside the cylindrical body;
(b)the upper end of the inner sleeve is connected to the outer cylindrical body by a web of material;
(c)the sleeve descends from the web of material to an inward step that has an aperture opening into the sleeve;
(d)the sleeve is formed with a flared portion at its upper (web of material) end into which the distal end of the syringe barrel passes;
(e)when the syringe barrel is inserted into the sleeve the inward step prevents:
(i)the barrel going past the step; and
(ii)liquid flowing between the sleeve and the barrel except through the aperture into the barrel.
The definition of “sealingly” in the complete specification identified that the term meant that under conditions of normal use liquid cannot flow or leak between the respective parts. In claim 1, the requirement is that the cylindrical body of the liner is “sealingly engaged inside the bottle neck such that liquid cannot flow between the bottle neck liner and the bottle neck”. Thus, claim 1 specified a result that the degree of engagement between the liner and the bottle neck had to achieve, namely that liquid could not flow between them.
The skilled addressee reading the complete specification, including the claims, (as a whole) would have understood that the apparatus claimed had to be capable, in conditions of normal use, of leaving the liner in place sealingly engaged inside the bottle neck in the manner stipulated in claim 1, for at least as many occasions as the user took to dispense all of the liquid contents of the bottle. In other words, the skilled addressee would have understood that there would or could be a number of occasions on which the user would insert a syringe, draw up liquid and then withdraw the syringe, and that, in conditions of normal use, the liner had to continue to remain “engaged” with the bottle neck so as to prevent leakage for, at least, the duration of those occasions of use.
Importantly, claim 1 specified that the sealing engagement had the purpose of preventing the escape of liquid as opposed to retaining the liner in place. Ordinarily, the skilled addressee would understand that both results could be achieved by a firm interference fit. However, the skilled addressee would know that there were other means of keeping the liner in place over multiple uses. He or she would realise that claim 1 was directed to making essential the nature of the seal achieved between the liner and the bottle neck, not the mechanism by which the liner could be held in place over multiple uses. The claim required the sealing engagement between the liner and the bottle neck to prevent liquid flowing between the two.
The inventors conceived that the combination of the flat-nosed syringe, bespoke liner and a bottle, which, apart from the bespoke nature of the liner, were known devices, and made it into a new and practically useful apparatus. That involved ingenuity and imagination on the part of Ms Dallison, and I infer, Mr Harrison: Sunbeam 180 CLR at 115; Alphapharm 212 CLR at 429 [41]; Lockwood [No 2] 235 CLR at 195-197 [52]-[55], 210 [65], 215-216 [115]-[116], [119].
For these reasons, I am of opinion that Glaxo has not proved that any of the claims for the combination were obvious or that the patent lacked an inventive step.
5. The false suggestion issue – background
Glaxo contended that, if its obviousness ground failed, the patentee had made a false suggestion as to the identity of the true inventor, whom, it alleged, was either Mr Pearce alone or with others from HDB. It argued that there was no probative evidence to suggest that Ms Dallison or Mr Harrison made any relevant inventive contribution to claims 1 or 9.
5. The false suggestion issue – consideration
I reject Glaxo’s argument. As I have already found, the documentary evidence suggests that the idea that conceived of a combination of a flat-nosed syringe co-operating with a bottle neck liner and a bottle in the form of the apparatus had nothing to do with Mr Pearce or HDB and was Ms Dallison’s inspiration. She also had envisaged the features of that combination, being the way in which the flat-nosed syringe would co-operate with the liner, and, with Mr Harrison, the need for the liner to be adapted suitably to pour, without mess, the liquid contents from the bottle (see [42] above). That evidenced inventiveness: Sunbeam 180 CLR at 115.
For the reasons I have given in rejecting Glaxo’s argument on the asserted lack of an inventive step, I am not satisfied that it was false to suggest in the patent that Ms Dallison and Mr Harrison were the inventors, in fact, I find that they were.
Moreover, when a dispute arose in early 2005 between Boots and HDB over the original claims made in the patent and its European analogue, those parties negotiated a resolution. The Boots agreement recited events leading to the ultimate product claimed, being the apparatus. Clause 1.1 recorded that Boots had the right to progress the patent applications, including for the patent in suit, “provided that the claims thereof are limited to the specific invention made by employees of [Boots]”. HDB was content to allow Boots, and subsequently Reckitt, to proceed to seek patent protection for the specification and claims in their present form: see [55], [59] above.
In addition, both Mr Pearce and HDB have been aware of those proceedings and the assertions that Reckitt and Glaxo have made in them in respect of the patentability of the apparatus, yet neither Mr Pearce nor HDB has sought to claim that he or it was the true inventor. Strikingly, Mr Pearce did not say in any of his three affidavits that he had the conceptual ideas for the combination, being the apparatus or any of its integers for which the patent makes claims. I am not satisfied that this was attributable to modesty on his part.
6. The entitlement issue – Glaxo’s argument
Glaxo argued that there was no evidence of what, if anything, Ms Dallison and Mr Harrison did. It contended that there was no evidence that Reckitt had derived any title to the invention as claimed by reason of the inventors’ acknowledgments that Ms Dallison and Mr Harrison executed in October 2003, or that the two named inventors had conceived of an invention that had any of the following features:
·a syringe that did not have a barrel with a single uniform diameter;
·a liner that did not have an outer cylindrical body that engaged with the inside surface of a bottle neck so that under conditions of normal use, the liner stays in the bottle neck and liquid cannot flow between the liner and the bottle neck;
·a liner that did not have a gradual widening (i.e. a gradual transition in shape) at the upper end of the inner sleeve and did not provide at least one of the stated advantages of the invention in the patent, namely the ability to pour contents of a bottle when a syringe is not used.
Glaxo argued that the only contribution that Ms Dallison and Mr Harrison could have made was the version of the liner in attachment 2 to the Boots agreement (reproduced at [57] above).
Glaxo argued that, on its proper construction, the Boots agreement:
·did no more than contain an acknowledgment by HDB that Boots had put time and effort into seeking patent protection;
·did not contain any assignment by HDB;
·expressly confined any entitlement of Boots to the “specific invention made by employers of [Boots]” referred to in recital D and attachment 2.
It was common ground that the Boots agreement had the purpose of narrowing the claims and so, Glaxo argued, Reckitt cannot contend here for wider relief.
Glaxo accepted that the provisions as to entitlement in ss 22A and 138(4) inserted into the Act by the Raising the Bar Act apply to this proceeding. It contended that it is just and equitable that the patent be revoked because Reckitt had adopted “an avaricious approach” to the scope of the narrow monopoly claimed in the patent. Glaxo also relied on the facts that, first, before commencing the proceedings that Reckitt UK had assigned its beneficial, but not legal, i.e. registered interest, in the patent to other members of the Reckitt Benckiser group and, secondly, with effect from 2 October 2013, Reckitt Australia was appointed by another group member as sole distributor in Australia of group products, including Nurofen for children. Glaxo submitted that Reckitt’s choice of ignoring, without explanation, “obligations imposed by the Act with respect to the registration of particulars of the Patent”, meant that it cannot rely on the fact of its registration to resist an order for revocation.
6. The entitlement issue – consideration
Glaxo argued that the principles for determining entitlement were identified in Polwood Pty Ltd v Foxworth Pty Ltd (2008) 165 FCR 527 at 536-541 [33]-[51], despite that being a discussion by Finn, Bennett and Greenwood JJ of principles for determining joint inventorship in foreign jurisdictions, before their Honours explained the principles applicable under the Act at 541-543 [52]-[60]. They concluded that the test in Australia was (165 FCR at 543 [60]):
The invention or inventive concept of a patent or patent application should be discerned from the specification, the whole of the specification including the claims. The body of the specification describes the invention and should explain the inventive concepts involved. While the claims may claim less than the whole of the invention, they represent the patentee’s description of the invention sought to be protected and for which the monopoly is claimed. The claims assist in understanding the invention and the inventive concept or concepts that gave rise to it. There may be only one invention but it may be the subject of more than one inventive concept or inventive contribution. The invention may consist of a combination of elements. It may be that different persons contributed to that combination.
That test was adopted by Lindgren, Finn and Bennett JJ in University of Western Australia v Gray (2009) 179 FCR 346 at 402 [261], who added that it is not the law that in every case an invention is complete only when a skilled addressee can perform it. They said that such an approach was incorrect, and confused invention, or inventive concept, with the requirements for a valid patent.
Of course, the issue of Reckitt’s alleged lack of entitlement was a matter that Glaxo had alleged and that it had to prove. It was not incumbent on Reckitt to demonstrate positively that it was entitled to the patent: JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2006) 154 FCR 348 at 358 [57] per Emmett, Stone and Bennett JJ. Unlike a dispute between two parties each of whom claims to be an inventor, here, Glaxo, a stranger to the activity resulting in the application for the patent, is asserting, in substance, that the patentee misrepresented in the application the involvement of the named inventors when, on Glaxo’s argument, they had done nothing to justify them suggesting that they were in fact inventors as asserted in the complete specification. Mr Pearce, the only witness called by Glaxo, did not assert that he invented the apparatus claimed or any element of it, despite making three affidavits.
A court should not draw inferences favourable to a party who calls evidence from a witness but does not lead evidence in chief from that person on the very subject matter in respect of which he or she could have given direct evidence. Rather, the evidentiary principle applicable in such a situation is that the Court may infer that the party calling that witness fears to have him or her address the matter by giving direct evidence, this failure can be “some evidence” that had the witness been asked about the matter in chief, he or she would have exposed facts unfavourable to the examining party: Communications, Electrical, Electronic, Energy, Information, Postal, Plumbing and Allied Services Union of Australia v Australian Competition and Consumer Commission (2007) 162 FCR 466 at 525-526 [230] per Weinberg, Bennett and Rares JJ applying Commercial Union Assurance Company of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389 at 418F-G per Handley JA; Braverus Maritime Inc v Port Kembla Coal Terminal Ltd (2005) 148 FCR 68 at 112 [159]-[160] per Tamberlin, Mansfield and Allsop JJ.
Each of Ms Dallison and Mr Harrison signed an inventor’s acknowledgment in October 2003 “in respect of the invention entitled Bottle Neck to Receive Syringe and known by the Internal Title Valencia 2: Bottle Neck to Receive Syringe” in which each, first, said that she or he was the inventor of that invention and an employee of Boots at the time of its creation, secondly, acknowledged that the invention belonged to Boots and that it was created in the ordinary course of her or his duties as such an employee, thirdly, acknowledged that the entire beneficial interest in the invention belonged to Boots and it had the right to seek patent protection in respect of it in all countries, and, fourthly agreed to execute any documents reasonably required to enable Boots to apply for, prosecute and obtain patents throughout the world in respect of the invention and to vest such patents in Boots absolutely when they were obtained.
These acknowledgments were made in connection with Boots’ original application for the patent in suit and its analogues. The code name “Project Valencia 2” was used in the heading of emails between Ms Dallison and Mr Pearce in March 2001, and Mr Pearce often headed his correspondence to Ms Dallison “Plug & Syringe System”. Subsequently, on 17 October 2005 Mr Pidgeon emailed Mr Pearce enclosing a draft of what became the Boots agreement saying that it related “to the VALENCIA/NFC patent applications”. There was no evidence to suggest that this reference was to any project other than that styled “Valencia 2” in earlier documents.
I reject Glaxo’s argument that the subject matter of the acknowledgments was insufficient to vest in Boots all of the inventors’ right, title and interest in the invention, necessary to enable Boots to apply for and hold the patent under s 15(b) and (c) of the Act. The acknowledgments were made by each of the inventors. They were employees of Boots at the time of creation of the apparatus that was to be used in its business. There is no evidence to suggest that the inventors did anything in the acknowledgments that did not reflect their enforceable legal and equitable obligations as employees of Boots to vest in it the legal and beneficial interest in the intellectual property the subject of the patent.
The onus was on Glaxo to prove that the acknowledgments did not reflect the true position of each inventor in respect of Boots’ entitlement to apply for the patent. Glaxo failed to discharge that onus of proof. The reference in the heading of the acknowledgments to “Valencia 2: Bottle Neck to Receive Syringe” in the context in which both the inventors and Boots were placed, unmistakeably referred to the invention of the apparatus. That is because the apparatus was claimed in the patent, albeit in wording that was amended in consequence of the Boots agreement. Nonetheless, the acknowledgments were directed both to the original wording and extended to any patent protection that might be obtainable arising out of that invention.
The fact that Boots narrowed its claims to patent production did not affect the plenary nature of the inventors’ acknowledgments. Those acknowledgements necessarily comprehended the wide wording of the initial patent applications, as well as a narrowing or refining of the claims, as occurred subsequently. The acknowledgments, in effect, said that whatever rights Ms Dallison and Mr Harrison had to seek patent protection in respect of all the work done by them to develop the apparatus (and whatever else was comprehended in Boots’ Project Valencia 2) was vested in Boots. Each of figures 1-6 is in both the original and amended (current) complete specification. The fact that the acknowledgments did not descend to the detail that Glaxo referred to in its argument is beside the point. The inventors were content for, and gave full authority and entitlement to their employer, Boots, to apply to patent everything that was patentable to which they might otherwise have had rights out of their work in developing the apparatus.
Glaxo’s argument sought to place an onus on Reckitt to prove how and when elements or integers of the invention came into existence and who thought of them. This argument misconceived, or sought to elude, the onus of proof on these matters, that Glaxo carried and failed to discharge. Moreover, the fact that the idea for the flat-nosed syringe did not deal expressly with an embodiment such as the alternate syringe is beside the point if, as the authorities establish, the infringer takes the substantial idea of the invention and all integers substantially as described and makes something which is only colourably different but functionally equivalent in all material respects : Radiation 60 CLR at 151-152; Clark LR 10 Ch App at 675; Raleigh 65 RPC at 159-160; Minnesota 144 CLR at 286.
I also reject Glaxo’s argument that it has proved that Ms Dallison’s and Mr Harrison’s role in the invention was either non-existent or was in some way less than that asserted as their invention in the patent, for the reasons I have given in respect of issue 5 as to Glaxo’s false suggestion claim [196]-[199] above. Nor is Glaxo’s construction of the Boots’ agreement sustainable. For the reasons I have given, I am not satisfied that HDB or Mr Pearce was an inventor. However, if that conclusion were incorrect, the Boots agreement operated as an accord and satisfaction that resolved the respective rights of Boots and HDB to seek patent protection for whatever rights HDB might have had to make claims in respect of the liner, as set out in attachment 7 (see [58]).
Importantly, in 2005 neither HDB nor Mr Pearce was asserting any interest in the overall conception of the apparatus, consisting of the liner in combination with a flat-nosed syringe and bottle. HDB’s concern was as to the liner, or plug, as the Boots agreement described it. That is why the provisions of cll 1, 2.1 and 2.5 dealt with HDB accepting that, first, Boots could apply for patent protection in respect of the liner in an agreed form and, secondly, Boots granted HDB a licence to sell the liner, but only in products outside the field of paediatric analgesics. Mr Pearce was closely involved in the negotiations for the Boots agreement and did not assert any personal interest of his own.
As I have explained, Reckitt subsequently varied the proposed new claim 1 in attachment 7 to the Boots agreement. That variation narrowed that new wording of claim 1 further in respect of the liner, by including the feature of the flared portion at the upper end of the sleeve (page 19 lines 19‑21) and HDB was content to allow Boots to proceed with the claims that now appear in the patent ([59]).
The essence of an accord and satisfaction is the acceptance by one party of something in place of his, her or its cause of action, as Dixon J explained in McDermott v Black (1940) 63 CLR 161 at 183-185, as applied by French CJ, Gummow, Hayne, Heydon and Kiefel JJ in Commissioner of State Taxation of the State of South Australia v Cyril Henschke Pty Ltd (2010) 242 CLR 508 at 515 [19]. Dixon J said (63 CLR at 183-185):
What he takes is a matter depending on his own consent or agreement. It may be a promise or contract or it may be the act or thing promised. But, whatever it is, until it is provided and accepted the cause of action remains alive and unimpaired. The accord is the agreement or consent to accept the satisfaction. Until the satisfaction is given the accord remains executory and cannot bar the claim. … An executory promise or series of promises given in consideration of the abandonment of the claim may be accepted in substitution or satisfaction of the existing liability. Or, on the other hand, promises may be given by the party liable that he will satisfy the claim by doing an act, making over a thing or paying an ascertained sum of money and the other party may agree to accept, not the promise, but the act, thing or money in satisfaction of his claim. If the agreement is to accept the promise in satisfaction, the discharge of the liability is immediate; if the performance, then there is no discharge unless and until the promise is performed. (emphasis added)
I am of opinion that the Boots agreement operated as an immediate accord and satisfaction that, as between Boots and HDB, operated, first, to vest in Boots whatever rights HDB may have had to seek a patent in respect of the liner, secondly, recognised that Boots, and not HDB, always had all of the rights to seek patent protection for the combination, being the apparatus, except so far as they had been in dispute over the liner, and, thirdly, Boots granted HDB a limited licence to sell the liner. On entry into the Boots agreement, each of Boots and HDB gave the other a contractual satisfaction in exchange for extinguishment of any pre-existing cause of action that the other may have had.
Glaxo’s argument that the Boots agreement did not expressly contain any assignment by HDB fails to have regard to the effect of the accord and satisfaction under which HDB waived or gave up all of its rights, if any, to seek patent protection. If, as HDB promised in cl 1.5, it could “not contest the ownership, validity, inventorship or any other issues” relating to Boots’ patent applications, then as between them, that contractual promise gave to Boots all of those rights that HDB may have had as effectively as if the word “assign” were used. Boots was in the same position as the successful appellant in McDermott 63 CLR at 186, who was found entitled to judgment as a defendant when the respondent sought to bring a fresh action on allegations that he had earlier promised to withdraw as an accord and satisfaction. The promise was a waiver once for all of the promisor’s rights ever to rely on the withdrawn cause of action and an acknowledgment of Boots’ title to those rights.
As Dixon J explained, when an accord and satisfaction has been made its purpose is “not that of social amenity but to complete and close a business transaction”. His Honour noted that it would have been futile for the respondent to withdraw allegations that he was at liberty to revive. So too here, the essence of the Boots’ agreement was to ensure that Boots could make a valid patent application that was insusceptible to attack by HDB in exchange for the narrowing of the claims and the grant of a limited licence to HDB.
It is necessary to construe the Boots agreement so as to avoid it making commercial nonsense or working commercial inconvenience: Zhu v Treasurer of New South Wales (2004) 218 CLR 530 at 559 [82] per Gleeson CJ, Gummow, Kirby, Callinan and Heydon JJ. The Boots agreement was not concerned with the wider claims to the apparatus except so far as those claims involved the liner. The narrowing of the claims effected by the Boots agreement related solely to the liner component which HDB was keen to sell separately, if it could. Thus, attachment 7 still claimed a combination, being the apparatus, but narrowed its scope relevantly in respect of the features or integers of the liner, and the subsequent amendments to claim 1 in 2006 narrowed these further. Its commercial purpose was to extinguish, once for all, any claim to the liner (in the limited agreed form of attachment 7) that HDB may otherwise have had and to grant HDB a limited licence.
Having regard to my findings as to the effect of the Boots agreement and the inventors’ acknowledgments, the only scope for Glaxo’s argument that the inventive concept for the patent, being the combination that Glaxo limited to claim 1, was that Mr Pearce was the, or an, inventor. I have also rejected that argument given Glaxo’s failure to lead that very evidence from him. Moreover, the invention, as claimed, included what was covered by claim 9. Glaxo argued that, when Mr Pearce reported back to HDB in early 2001 with drawings of the liner, he, and not Ms Dallison or Mr Harrison, created the inventive concept that the drawings portrayed.
The fundamental problem with Glaxo’s submission is that Mr Pearce did not give that evidence. He did say that he drew a sketch on 20 February 2001 that depicted a flared portion for the liner. He said that to the best of his recollection, the notes in which the sketch appeared recorded an update on the status of the project and he added “While I do not now recall, I believe that it is likely that I spoke to Anne Dallison, probably on the phone”. In fact, he had meetings with her on that day and two days later on 22 February 2001, and took two liner samples to the first meeting, one with, and one without, a protruding flange at the top (see [47] above) and took to the second meeting two liners without a protruding flange. The first set of two different liners had a drawn space between the liner wall, the outer face of which was contiguous with the bottle neck and the centre sleeve. However, for the liner without the protruding flange, there was a solid continuous wall without any space between the bottle neck and the inner sleeve.
The drawing on which Glaxo relied appears to have been made at, or after, the first set of two made up samples was tested by Boots and rejected. The shape of the flared portion in this drawing appeared to be closer to the shape of the protruding flange in the design rejected on 20 February 2001 but the drawings of the liners are not exact matches because the undated drawing has a solid portion joining the wall contiguous with the bottle neck and the inner sleeve. What appears to have occurred is that the shape of the protruding flange was retained but it was placed lower in the liner so that the top of the flange merged into, but did not protrude above, the web of material and a space between the outer wall and centre sleeve was included. This led to the version of the liner approved at the meeting on 7 March 2001 that I described at [47] above.
Thus, Mr Pearce’s evidence, that he probably spoke to Ms Dallison on the telephone concerning this later design, may be correct but he plainly spoke to her when they were assessing how the sample prototypes had worked and why they had failed to meet Boots’ requirements during the meeting or meetings of 20 and 22 February 2001. What is important for present purposes is that Mr Pearce did not give evidence that Ms Dallison or Mr Harrison were not the inventors of the flared portion concept.
Indeed, with this remove of time it would be unlikely that he could recall much, if anything, that was discussed. However, Mr Pearce did not give evidence that he thought of the concept, which, had it occurred, he might be expected to have remembered. No document suggested any unreliability in Ms Dallison’s and Mr Harrison’s inventors’ acknowledgments, which were made in 2003 – much closer to the events in question than Mr Pearce’s honest attempt to reconstruct events that had occurred some 13 years before he gave evidence.
Having regard to the provisions of s 140(2) of the Evidence Act 1995 (Cth), I am not satisfied that Glaxo has proved that Ms Dallison and Mr Harrison did not develop the inventive concept or concepts or that they were not, as they asserted, the true inventors of the whole invention claimed in the patent. Nor am I satisfied that Mr Pearce made any relevantly inventive contribution to the subject matter in issue in these proceedings. Indeed, Mr Pearce never suggested that he did.
On 27 March 2006, Boots assigned to Reckitt UK its rights in respect of the patent and its analogues, among other property. The Commissioner granted the patent to Reckitt UK as patentee on 20 March 2008. I am of opinion that Glaxo has failed to prove that Reckitt UK is not entitled to the patent.
The evidence also showed that, through a series of unregistered intergroup agreements between companies in the Reckitt Benckiser group, Reckitt Australia obtained an exclusive licence to exploit the patent from at least 2 October 2013. That evidence also showed that Reckitt UK formally admitted that, as at the commencement of these proceedings and at all times since, it has not been the beneficial owner of the patent and has had no economic interest in it, but that those interests have been held by other companies in the Reckitt Benckiser group.
On 27 March 2006, Reckitt UK transferred the beneficial ownership of the patent to a group company, Reckitt & Colman (Overseas) Ltd and granted the latter an exclusive, transferable royalty free, irrevocable and perpetual worldwide licence to exploit it and to grant sublicenses. It follows that, from that time, Reckitt UK was and remains a bare owner of the legal entitlement, first, to be granted the patent and, secondly, to be registered as patentee.
These facts lie behind Glaxo’s last argument on entitlement that somehow, if Reckitt UK were not entitled to the patent, it would be just and equitable to revoke it under s 138(3) of the Act. It is not necessary to decide this meretricious point. It was debunked by Lord Cairns LC in Shropshire Union Railways and Canal Company v The Queen (1875) LR 7 HL 496 at 507-509 whose reasoning was applied by the Privy Council in Abigail v Lapin (1934) 51 CLR 58 at 69, [1934] AC 491 at 505. I rejected a similar argument in Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd (2013) 216 FCR 344 at 367-368 [85]-[87], 368-369 [89]-[91].
Here, s 188 of the Act provides that notice of any kind of trust relating to a patent or licence is not receivable by the Commissioner and cannot be registered. That statutory provision is similar to earlier provisions of the Real Property Act 1900 (NSW) that were considered in Abigail 51 CLR at 64; [1934] AC at 500. The way in which those statutes treated beneficial interests in the property they created or regulated is in contrast to provisions such as s 1072H of the Corporations Act 2001 (Cth), although even it preserves the validity of a transfer made without disclosure of an underlying beneficial interest (see s 1072H(2)).
Moreover, s 196(1)(b)(ii) expressly allows proof of documents, particulars of which have not been entered in the Register of Patents under the Act, “to enforce equities in relation to the patent or licence”. It follows that the Act expressly recognises and renders enforceable equitable interests even though they are not on the Register.
Of course, such equitable interests may be vulnerable to defeasance by misconduct of the registered legal owner in accordance with the principles of equity. But, that is a far cry from Glaxo’s misconceived argument that the way in which the Reckitt Benckiser group has chosen to arrange beneficial interests in property held in the name of one group member can, or should, be relevant or admissible to destroy the legal right that a registered patentee, whether a bare trustee or limited beneficial owner, has to enforce the rights granted to the registered owner under the Act.
To deny Reckitt UK and Reckitt Australia their legal rights to enforce the patent, if valid, merely because they hold such rights as bare trustees or as legal but not beneficial owners, would not be just or equitable or accord with the proper construction of the Act. To accept Glaxo’s argument would undermine well recognised, lawful and proper arrangements that are, and have for centuries been, features of ordinary commercial life. Reckitt is entitled to, and to enforce, the patent, if it be otherwise valid.
The ground of revocation under s 138(3)(a) fails.
7. The fair basis issue
Glaxo contended that if claim 1 were construed in such a way that an embodiment such as the alternate syringe could be included within the monopoly asserted by the patentee, then that claim could not be fairly based on the matter described in the specification within the meaning of s 40(3) in its form before the 2012 Raising the Bar Amendment Act, being the form that I have set out in [10] above.
Senior counsel for Glaxo said in final address that if claim 9 were construed so that it was not a mere narrowing of claim 1, but could comprehend an embodiment such as the alternate syringe, then Glaxo could not succeed on its argument on the fair basis issue.
In my opinion, based on the construction that I have given to claim 9, and in particular the word “substantially”, that claim is fairly based on the matter described in the complete specification. I have reached this conclusion for the reasons that I have given as to why the alternate syringe and the second product complained of infringes claim 9.
Conclusion
For these reasons, I am satisfied that Reckitt is entitled to some of the relief that it claimed. That relief should be based on my findings that the first product complained of infringed each of claims 1, 2, 3, 4, 5, 6 and 9 and the second product complained of infringed only claim 9.
Each side has had some measure of success on the multifarious arguments that parties in patent litigation appear to consider that they are entitled to run. I will ask the parties to bring in short minutes of orders to give effect to these reasons, including as to costs. If those orders cannot be agreed I will hear the parties further on any outstanding issues.
I certify that the preceding two hundred and forty-two (242) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Rares. Associate:
Dated: 20 May 2015
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