FEDERAL COURT OF AUSTRALIA Medrad Inc v Alpine Medical Pty Ltd [2009] FCA 949 PATENTS – syringes for use with medical injector systems – alleged infringement of patent – application for interlocutory injunction – alleged invalidity of patent on ground of obviousness – construction of claims – whether serious question to be tried – balance of convenience – interlocutory relief granted PRACTICE AND PROCEDURE – application for leave to further amend statement of claim and application – leave granted Therapeutic Goods Act 1989 (Cth) Patents Act 1990 (Cth) Australian Broadcasting Corporation v O'Neill (2006) 227 CLR 57 referred to Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 discussed AB Hassle v Pharmacia (Australia) Pty Ltd (1995) 33 IPR 63 referred to Genrx Pty Ltd v Sanofi-Aventis (2007) 73 IPR 502 referred to Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261 referred to American-Cyanamid Co v Ethicon Ltd [1975] AC 396 cited Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2009] FCA 595 cited Wake Forest University Health Sciences v Smith & Nephew Pty Ltd [2009] FCA 630 referred to Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR 405 referred to Pharmacia Italia SpA v Interpharma Pty Ltd (2005) 67 IPR 397 referred to MEDRAD INC and IMAXEON PTY LTD v ALPINE MEDICAL PTY LTD VID 529 of 2009 KENNY J 25 AUGUST 2009 MELBOURNE IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY VID 529 of 2009 GENERAL DIVISION BETWEEN: MEDRAD INC First Applicant IMAXEON PTY LTD Second Applicant AND: ALPINE MEDICAL PTY LTD Respondent JUDGE: KENNY J DATE OF ORDER: 25 AUGUST 2009 WHERE MADE: MELBOURNE THE COURT ORDERS THAT: 1. A trial in the proceeding be fixed for 10.15 am on 22 February 2010, with an estimated duration of 4 days. 2. On or before 4 pm on 27 August 2009: (a) the applicants file and serve short minutes of orders in conformity with these reasons; and (b) the parties file and serve short submissions on costs. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. The text of entered orders can be located using eSearch on the Court's website. IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY VID 529 of 2009 GENERAL DIVISION BETWEEN: MEDRAD INC First Applicant IMAXEON PTY LTD Second Applicant AND: ALPINE MEDICAL PTY LTD Respondent JUDGE: KENNY J DATE: 25 AUGUST 2009 PLACE: MELBOURNE REASONS FOR JUDGMENT INTRODUCTION 1 The first applicant, Medrad Inc, is the registered owner of Australian Patent No 2005200597, entitled "Improvements relating to medical injector systems". This is the patent in suit. The earliest priority date claimed for the patent is 10 July 2000. The invention is concerned with aspects of a medical injector system for injecting fluid from a syringe into a patient. An aspect of the invention disclosed in the patent relates to the syringes, including associated hubs and seals, used in the injector system. 2 The second applicant, Imaxeon Pty Ltd, claims to be the exclusive licensee of the patent in suit. 3 The applicants seek an interlocutory injunction in order to prevent the respondent, Alpine Medical Pty Ltd, from selling or offering for sale syringes, including hubs and seals sold with them, allegedly having features falling within claims of the patent. In particular, the applicants seek an interlocutory injunction against the respondent in respect of the following syringes: (a) syringes entitled "High Pressure Syringe" with product numbers 100104, 100102 and 500102; (b) syringes the subject of ARTG entry no 158824 that: (1) include or incorporate any hub for syringes as claimed in claim 1 and/or claim 4 of the patent; or (2) include or incorporate any hub and seal combination systems for syringes as claimed in claim 9 and/or claim 12 of the patent; and/or (3) are for use with a medical injector system as claimed in claims 51 and 52 of the patent; (c) syringes manufactured by Shenzhen Ant Medical Devices Co Ltd, Shenzhen City, People's Republic of China that: (1) include or incorporate either any hubs for syringes as claimed in claim 1 and/or claim 4 of the patent; or (2) include or incorporate any hub and seal combination systems for syringes as claimed in claim 9 and/or claim 12 of the patent; and/or (3) are for use with a medical injector system as claimed in claims 51 and 52 of the patent. 4 In an amended statement of claim filed 30 July 2009, the applicants allege that each of these products contain an essential integer of claims 1, 9, 51 and 52 of the patent in suit and that, by selling these products or offering them for sale, the respondent has infringed claims 1, 9, 51 and 52 of the patent. 5 At the hearing of the application for interlocutory relief, the applicants applied to amend their statement of claim, in order to add the further or alternative allegation that the respondent's products contain an essential integer of claims 4 and 12 of the patent, and that, by selling these products or offering them for sale, the respondent has infringed claims 4 and 12 of the patent. The respondent opposed the amendment, but, for the reasons stated below, I would grant the applicants the leave they sought. This application is determined on this basis. 6 In support of their claim for relief, the applicants rely on two affidavits of Alwyn William Reynolds sworn on 30 July and 18 August 2009, two affidavits of Victor Chang Ting Tse sworn on 30 July and 18 August 2009, an affidavit of Timothy James Hands sworn on 18 August 2009, and an affidavit of Wayne McMaster also sworn on 18 August 2009. 7 The respondent filed its defence on 19 August 2009, which: (1) denied the alleged infringements in respect of syringes with product numbers 100102 and 100104 (i.e, the Stellant substitute syringes) upon the basis that they do not contain the integers of the claims as alleged; (2) accepted that syringes with product number 500102 (i.e, the Klikfit substitute syringe) have the alleged features; and (3) asserted that claims 1, 9, 51 and 52 of the patent are invalid "as those claims do not define a patentable invention for the reason that the invention, as claimed in claims 1, 9, 51 and 52 of the patent, is obvious having regard to common general knowledge at the earliest priority date for each of those claims". The respondent indicated in argument that, in so far as necessary, its challenge to invalidity on the ground of obviousness should be understood to extend to the invention as claimed in claims 4 and 12. 8 In opposition to the relief sought, the respondent relied on an affidavit of Susan Terry Evans sworn on 14 August 2009 and an affidavit of Frank Papamichalakis (known also as Frank Pappas) also sworn on 14 August 2009. BACKGROUND 9 In his 30 July 2009 affidavit, Mr Reynolds, the Managing Director of Imaxeon, deposed that Imaxeon is a wholly owned subsidiary of Medrad. Mr Reynolds described Medrad as "a worldwide, market-leading manufacturer and distributor of high technology medical devices". Mr Reynolds stated that "Medrad has a worldwide reputation for performance that helps physicians diagnose patients more accurately and, ultimately, deliver quality patient care". Mr Reynolds noted that Medrad is also the registered owner of two Australian trade marks in Australia, both of which are exclusively used in Australia by Imaxeon. These trade marks are "KLIKFIT" and "VISIMAX". 10 Turning to Imaxeon, Mr Reynolds said that "Imaxeon designs, manufactures, imports, exports, distributes and supplies contrast injection systems for computer tomography ("CT") and cardiovascular ("CV") applications, as well as all associated consumables". 11 Imaxeon has been Medrad's sole distributor in Australia since 2000. According to Mr Reynolds, the main focus of its business is CT contrast injection systems and the sale of consumables for injection systems. Imaxeon's customers are typically hospitals and radiology clinics. 12 This proceeding involves the sale by the respondent of syringes (including their hub and seal components) for use as part of CT contrast injector systems supplied by the applicants for use in CT imaging. Injector systems are used for injecting contrast dyes intravenously into patients. Mr Reynolds deposed that CT imaging frequently involves injecting intravenous contrast dye materials into patients, in order to enhance the images obtained from a CT scan by highlighting structures such as blood vessels and soft organs that would otherwise be difficult to delineate from their surroundings. 13 According to Mr Reynolds, an injector system consists of: (a) a programmable and processor-controlled injector unit that automatically regulates the rate at which the contrast dye materials are injected into the patient; (b) a specifically designed disposable contrast injector syringe that fits into the injector unit to deliver the contrast dye material and is automatically operated by the injector unit according to pre-set parameters; and (c) tubing that extends from the contrast injector syringe to the intravenous cannula connected to the patient. Once the injector unit has been programmed, it automatically controls the piston of the contrast injector, which pushes the hub and seal within the syringe barrel to deliver the contrast dye materials for the patient. 14 Mr Reynolds deposed that the software algorithms installed on the computer processor within the injector unit regulate the rate of injection of the contrast material into the patient. The algorithms are designed to take into account the technical features of the relevant contrast injector syringe that are specific to that injector system. Mr Reynolds stated that "the syringe is an integrated component of the entire system, the characteristics of which are important to the accurate and safe operation of the system". He also stated that "[i]t is for this reason that a contrast injector system uses only the syringes that are specifically designed for that particular injector system". 15 According to Mr Reynolds, the two main contrast injection systems supplied by Imaxeon were the Imaxeon™ VISIMAX® CT contrast injector system and the Medrad™ STELLANT™ CT contrast injector system. Imaxeon and Medrad only sell single use disposable syringes for their own systems. Imaxeon presently prices its STELLANT™ syringes on average at $9 per syringe and its KLIKFIT syringes, at $6 each. The VISIMAX® injector system is designed to use syringes sold by Imaxeon under the "KLIKFIT" trade mark. The STELLANT™ injector system is designed to use syringes sold by Imaxeon and Medrad under the STELLANT™ mark. Both types of syringe include a transparent cylinder with a hub and seal combination that fits inside the base of the cylinder. The syringe, including the hub and seal combination, fits onto a piston of the injector system. 16 Mr Reynolds stated that, typically, the injector system is supplied to the hospital or clinic and consumables, including syringes and tubings, are purchased as needed on the basis of an agreed unit price. He added that the hospitals and clinics also engage the suppliers to service and maintain the injector systems. Imaxeon considered the revenue obtained in the on-going sale of consumables, including syringes, in setting the price and terms of supply of the injector system. Mr Reynolds said that, as the syringes are disposable, the costs of the syringes over the life of the injector system will significantly exceed the initial cost of the injector system. Mr Reynolds observed that, since Imaxeon supplies consumables (such as syringes) to its customers on an on-going basis, Imaxeon is in regular contact with its customers, "keeping it in the customer's mind for its future injector system needs". 17 Mr Reynolds stated that Imaxeon has developed a strong reputation in the disposable contrast dye syringe market, which is based on the quality of its products and after-sale service. Imaxeon holds around 80% of the market for injector systems and related consumables, including the syringes, in the CT segment of the Australian disposable contrast dye syringe market. The respondent is not amongst its main competitors in this market. Imaxeon's competitors are typically other manufacturers of competing injector systems that require specific single use syringes manufactured specifically for their own systems. 18 Mr Reynolds stated that, on or about 18 May 2009, Timothy Hands advised him that he had become aware that the respondent was promoting syringes for use with the STELLANT™ injector system. Mr Reynolds later looked at the respondent's website, noting, amongst other things, that one of the products on the website was entitled "Visimax CT 150ml". The website included a statement about the compatibility of the respondent's syringes with Imaxeon's syringes, stating that "[t]hese are like for like replacement for popular syringe types". Mr Reynolds produced a computer print-out from the respondent's website apparently obtained on 27 May 2009 that evidenced these matters. 19 In its defence filed 19 August 2009, the respondent admitted that, since 30 March 2009, it had offered for sale and sold in Australia syringes with product numbers 100104 and 100102, which were manufactured by Shenzhen Ant Medical Devices Co Ltd for use with a medical injector system, and registered on the Australian Register of Therapeutic Goods, administered under the Therapeutic Goods Act 1989 (Cth), under ARTG 158824. These syringes are amongst the allegedly infringing syringes. 20 Mr Reynolds believed that the respondent's syringes were being sold at a price of about $7 – approximately 20% below the price of comparable syringes sold by Imaxeon in Australia. Mr Reynolds also noted that some of Imaxeon's promotional material indicated that its syringes were patented. The affidavit of Mr Hands, a territory manager for Northern New South Wales, supported the proposition that the syringes manufactured by Shenzhen Ant are to be sold at about $2.00 cheaper than the equivalent ones supplied by Imaxeon. 21 Mr Reynolds deposed that, if the respondent were able to continue to sell the allegedly infringing syringes, then Imaxeon would be forced to lower its supply price in order to be competitive in the market. Mr Reynolds considered that any such price reduction would be permanent, and gave his reasons for this opinion. He added that "[a] price decrease would … result [in] a significant overall loss of revenue both immediately and into the future …". He gave further reasons for this view in his affidavit of 18 August 2009. 22 Mr Reynolds observed that, since the sale of syringes allowed Imaxeon to have regular contact with its customers, Imaxeon was able to address any problems that customers might have with its injector systems. He added that "[r]egular contact with customers also allows Imaxeon to understand the changing needs of its customers and develop improvements and new features for its products to address these needs". Further, Mr Reynolds said that, if the respondent supplied syringes to its customers and Imaxeon lost the opportunity for regular contact, then it also lost the opportunity "to convince the customer to accept a replacement injector system from [it] and continuously develop and maintain its injector systems and associated products". Finally, Mr Reynolds said that he believed that "it is uncertain whether the Alpine Syringes will work correctly, or to the same standard as syringes supplied by Imaxeon, within the injector systems supplied by Imaxeon". 23 Mr Tse, a patent attorney, stated that, based on his observations of the pertinent features of the allegedly infringing products, it was his opinion that the Stellant substitute syringe "embodies each and every feature of claims 1, 9, 51 and 52 of the patent [in suit]". 24 Mr McMaster's affidavit was to the effect that searches had failed to disclose that the respondent had assets sufficient to meet a compensation claim and had failed satisfactorily to answer the applicants' inquiries in this regard. 25 Mr Pappas, also a patent attorney, gave his opinion that the syringes manufactured by Shenzhen Ant under product numbers 100102 and 100104 are identical and that neither 100102 nor 100104 possesses all the features of claims 1, 9, 51 and 52 of the patent. In his opinion, "[t]he hub of Shenzhen 100102 has an 'annular engaging portion', but that engaging portion does not have or comprise a groove". Mr Pappas continued that "feature 108 identified by Mr Tse in photo 7-8 is a 'ridge' (or 'projecting lip') and not a groove". 26 This reasoning prompted the applicants to seek the leave mentioned above, to amend their application and statement of claim a second time, so as to include references to claims 4 and 12 of the patent in suit, since both of these claims referred to a ridge instead of a groove. I return to this application for leave below. 27 Mr Pappas also stated that it was his opinion that "the inner surface of the Shenzhen 100102" could not be described as "complementary in shape" to that of the plunger as the claims required. The basis of this opinion is discussed below. 28 If Mr Pappas' opinion were accepted, there would be no infringement of claims 1, 9, 51 or 52 by the Stellant substitute syringes (products numbered 100102 and 100104). 29 Mr Pappas also deposed to a number of documented and anecdotal illustrations of the use of an "annular engaging portion" and reinforcement by the use of complementary shapes outside the medical device or injector fields. Both of these features were said to pre-date the earliest priority date of the patent in suit. 30 Ms Evans, a director and secretary of the respondent, stated that the respondent had received three shipments of syringes (bearing product numbers 100102, 100104 and 500102) from Shenzhen Ant on 11 March, 7 and 20 April 2009. Ms Evans deposed that a syringe under product number 500102 is compatible with Medrad's Visimax injector system and a syringe under product numbers 100102 and 100104 is compatible with the Stellant injector system. Ms Evans also accepted that the respondent made the first sale of the imported syringes on 30 March 2009. Ms Evans noted that she recalled representatives of Shenzhen Ant saying that there were no patents that would cause any issue for the respondent in selling syringes in Australia. 31 As noted below, Ms Evans disagreed with the proposition that Imaxeon would be forced to lower the prices of its syringes if the respondent sold its products in competition with it. THE PATENT IN SUIT 32 The field of the invention, as described in the specification, "relates to medical injector systems for injecting medical fluids into a patient's vascular system". Under the heading "background of the invention", the patent noted that "[m]edical injectors and syringes for injecting contrast media into a patient for imaging biological structures are known in the art". The patent illustrated and amplified this proposition. Amongst other things, the patent noted the need "for a simpler front-loading medical injector". In the course of presenting a "summary of the invention", the patentee stated: According to a further aspect of the invention, there is provided a hub for a syringe for use with a medical injector system, comprising an outer surface adapted to slidingly engage with a barrel of the syringe, and an inner surface having a substantially annular engaging portion adapted to be releasably engaged by a plunger to permit the hub to be selectively withdrawn along the barrel by the plunger. By providing a hub with these features, a number of benefits can be obtained which relate to the efficiency of use and safety of the patient to be injected … The engaging portion may be of any convenient conformation for example, it may be a cavity, a groove or a ridge. Where the engaging portion is a groove, the groove may define a semi-circular cross-section or the groove may extend at least partially along the circumference of the inner surface of the hub. … … According to one preferred embodiment, the inner surface of the hub is complementary in shape to an outer surface of the plunger. Preferably the inner surface of the hub comprises an interior hollow that contacts the plunger. Such an arrangement allows for a form fit which has the advantage of providing a reinforcing effect to the hub. … Preferably the plunger has a tapered front end, which is inherently "self centering" as it engages the hub. … … The hub may also be adapted to engage a seal associated with at least a portion of an outer surface of the hub, or alternatively, the hub may perform the function of a seal. … As is customary, the patent provided a detailed and illustrated description of preferred embodiments, to some of which I was taken in argument. 33 The claims upon which the applicants rely read as follows: 1 A hub for a syringe for use with a medical injector system, comprising an outer surface adapted to slidingly engage with a barrel of the syringe, and an inner surface having an annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub to be selectively withdrawn along the barrel by the plunger wherein the inner surface of the hub is complementary in shape to an outer surface of the plunger. … 4 A hub according to claim 1 wherein the engaging portion is a ridge. … 9 A hub and seal combination for a syringe for use with a medical injector system, the seal comprising an outer surface adapted to slidingly engage with a barrel of the syringe and an inner surface adapted to engage the hub, and the hub comprising an outer surface adapted to engage the seal and an inner surface having a substantially annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub and seal combination to be selectively withdrawn along the barrel by the plunger wherein the inner surface of the hub is complementary in shape to an outer surface of the plunger. … 12 A hub and seal combination according to claim 9 wherein the engaging portion is a ridge. … 51 A syringe for use with a medical injector system comprising a hub, the hub comprising an outer surface adapted to slidingly engage with a barrel of the syringe, and an inner surface having an annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub to be selectively withdrawn along the barrel by the plunger wherein the inner surface of the hub is complementary in shape to an outer surface of the plunger. 52 A syringe for use with a medical injector system comprising a hub and seal combination, the seal comprising an outer surface adapted to slidingly engage with a barrel of the syringe and an inner surface adapted to engage the hub, and the hub comprising an outer surface adapted to engage the seal and an inner surface having a substantially annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub and seal combination to be selectively withdrawn along the barrel by the plunger wherein the inner surface of the hub is complementary in shape to an outer surface of the plunger. 34 Counsel for the applicants argued that, if Stellant substitute syringes (products numbered 100102 and 100104) were found to feature a ridge, instead of a groove, then the respondent would be found to infringe claims 4 and 12 and properly be enjoined from selling the barrel of the syringe alone. Whether this would have any practical significance is uncertain. THE PARTIES' SUBMISSIONS ON INJUNCTIVE RELIEF 35 Briefly, the applicants argued that there was a serious question to be tried as to whether the Stellant substitute syringes infringed the patent in suit. (As already noted, the respondent conceded that its Klikfit substitute syringes had the essential integers of the applicants' KLIKFIT syringes.) The applicants argued that the respondent's challenge to patent validity needed "to be tempered by the proposition that registration of a patent constitutes prima facie evidence of validity". Thus, said the applicants, unless the case of invalidity was sufficiently strong, the Court should move to consider the adequacy of damages, the balance of convenience, and other discretionary factors. The respondent's approach to evidence on invalidity focused, so the applicants said, on identification of isolated features of the claims from the prior art: (i) with full knowledge of the patent and its contents (and therefore hindsight); (ii) without proper identification of the common general knowledge; and (iii) significantly, without proof of relevance to the inquiry under Section 7(3) of the Patents Act. Such an approach does not provide a basis for qualifying the serious question on infringement. The applicants submitted that damages would be an inadequate remedy and that the balance of convenience favoured preservation of the status quo pending trial. The applicants cited loss of sales; loss of regular contact with customers; temporary and permanent reduction in the price of their Australian products; and potential loss of reputation. The applicants noted that they had an established trade, and that that there was no evidence that the respondent would be forced out of business or otherwise unable to conduct its business normally until the trial if an interlocutory injunction were granted. The applicants noted that the respondent had not provided any financial or asset information, notwithstanding requests to do so. The respondent had entered the market, so the applicants said, with "its eyes wide open" and there was insufficient evidence to suggest that it would suffer reputational harm in the event of an interlocutory injunction. 36 The respondent argued that there was no serious question to be tried because the Stellant substitute syringes (products numbered 100102 and 100104) did not have two essential integers. This argument is explained below. It followed, so the respondent said, that none of claims 1, 9, 51 and 52 were infringed. Moreover, according to the respondent, each of the claims merely defined syringes or parts of syringes by reference to broad features that were well known and in use in syringes in Australia before the earliest possible priority date. The only ways in which the defined syringes or parts could differ from the prior art are, so the respondent said, with respect to mere specific, constructional features which, in themselves, were, at that time no more than obvious mechanical equivalents or design variants for locking components or for providing means of reinforcement, commonly known in Australia by designers and engineers alike. Thus, said the respondent, there was nothing in the claims, either alone or in combination, which provides an inventive step to support a patentable invention in the terms used in the claims. 37 The respondent argued that it had not been shown that the balance of convenience favoured an interlocutory injunction. Further, the respondent argued that its was a growing business and the grant of interlocutory injunctive relief may well signal to the market that it is an unreliable supplier. CONSIDERATION (a) Approach to the grant of interlocutory relief 38 The principles governing the grant of interlocutory relief are settled. On application for an interlocutory injunction, the applicants must show that: (a) there is a serious question to be tried in respect of the actual or threatened infringement of the patent in suit; and (b) the balance of convenience favours the grant of an interlocutory injunction, including that an award of damages would not be an adequate remedy for the irreparable harm the applicants would suffer if an interlocutory injunction were not granted. In order to demonstrate that there is a serious question to be tried, the applicants must make out a prima facie case in the sense that, if the evidence remains the same, then there is a probability that at trial they will be found entitled to relief. As Gummow and Hayne JJ explained in Australian Broadcasting Corporation v O'Neill (2006) 227 CLR 57 at 81-82 [65]-[70], "it is sufficient that the plaintiff show a sufficient likelihood of success to justify in the circumstances the preservation of the status quo pending the trial". Their Honours added at 84 [71], "the governing consideration [is] that the requisite strength of the probability of ultimate success depends upon the nature of the rights asserted and the practical consequences likely to flow from the interlocutory order sought". 39 The respondent's submission – that, in a patent infringement case such as this, where the validity of the patent is challenged, the practice of the court is to refuse an interlocutory injunction – depended on Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 at 623-624. In Beecham, Kitto, Taylor, Menzies and Owen JJ referred (at 623) to "the special considerations which generally arise in a patent action where there is a substantial issue to be tried as to the validity of the patent". Their Honours (at 623-624) said: [T]he plaintiff's prima facie case must be a strong one so far as the question of validity is concerned, for he asserts a monopoly and must give more proof of the right he claims than is afforded by the mere granting of the patent … The general practice in that kind of case has long been to refuse an interlocutory injunction unless either the patent has already been judicially held to be valid or it has stood unchallenged for a long period … 40 The practice to which their Honours referred is no longer the practice of the courts. This much appears from the authorities to which counsel for the applicants referred me, including AB Hassle v Pharmacia (Australia) Pty Ltd (1995) 33 IPR 63, Genrx Pty Ltd v Sanofi-Aventis (2007) 73 IPR 502, and Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261. The reason for the change in practice is that the legislative requirements for grant of a patent are more exacting than they once were and include provision for opposition proceedings before the grant. 41 In AB Hassle (33 IPR at 69-70) Ashley J specifically rejected a submission similar to that made by the respondent in this case and held that, where the defendant challenged the validity of the patent, it was for the defendant to establish a triable question in respect of validity. If a strong case for invalidity was provisionally made out, then, as his Honour said, this factor would be relevant to the exercise of discretion. 42 In Genrx (73 IPR at 503-504 [2]-[6]), Gyles J again considered the ongoing significance of Beecham for the grant of interlocutory injunctions in cases of alleged patent infringement. As his Honour observed, after American-Cyanamid Co v Ethicon Ltd [1975] AC 396, there was a good deal of discussion about the importance of apparent differences between American-Cyanamid and Beecham. His Honour continued (at 503 [4]): The most influential consideration of the issue in relation to patents was that by Gummow J in Martin Engineering Co v Trison Holdings Pty Ltd (1988) 81 ALR 543; 11 IPR 611. In the course of that judgment his Honour pointed out that the authorities referred to by the High Court in Beecham Group for not attributing great significance to the grant of a patent were old cases from England based upon a different system for grant than that which had developed in Australia by that time. The system of examination of patents prior to grant in Australia was more stringent than had been the case in England the century before. The practical effect of this decision was to give greater weight to the grant of a patent thereafter than might have been deduced from Beecham Group. 43 Gyles J rejected a submission to the effect that the decision of the High Court in Australian Broadcasting Corporation v O'Neill (2006) 227 CLR 57 had restored the authority of Beecham in this regard. His Honour noted, correctly in my view, that the reaffirmation of Beecham by the High Court in O'Neill concerned the elucidation of what is required for a prima facie case (or serious question to be tried). 44 In Interpharma, Jessup J stated (79 IPR at 267 [17]) that "[i]n a patent case, the fact of registration constitutes prima facie evidence of validity", noting that it is for the respondent to show that want of validity is a triable question. His Honour continued that, in his view, if the respondent went no further than showing a triable case on validity, "then, assuming always that the applicant has shown a triable issue on infringement, absent questions of validity, the conclusion would remain that the latter had a triable question". 45 This approach is consistent with that of Sundberg J in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2009] FCA 595, where his Honour granted an interlocutory injunction in an alleged case of patent infringement, notwithstanding that he was satisfied that there was a prima facie case that the invention would have been obvious to a person skilled in the relevant art in light of the common general knowledge as it existed in Australia before the priority date. See also Wake Forest University Health Sciences v Smith & Nephew Pty Ltd [2009] FCA 630 at [36] and [55], where Ryan J held that there was a serious question to be tried on the issue of novelty, but granted an interlocutory injunction on the basis that the applicants had established a serious question to be tried on infringement. (b) Serious question to be tried on infringement 46 Each of claims 1, 9, 51 and 52 of the patent in suit requires each of the following essential integers, namely a hub having: (a) an inner surface having an annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub to be selectively withdrawn along the barrel by the plunger; and (b) an inner surface complementary in shape to an outer surface of the plunger. 47 As previously noted, the respondent has admitted that the Klikfit substitute syringes have the essential integers of these claims, as the applicants alleged. If the respondent fails on its invalidity defence, then the applicants' case on infringement is made out in respect of the Klikfit substitutes. 48 The respondent submits, however, that the Stellant substitute syringes do not contain the integers of the claims as alleged. First, according to the respondent, these syringes have no groove adapted to be releasably engaged by a plunger. 49 On this issue, the applicants relied on the evidence of patent attorney Tse, who expressed the opinion that the Stellant substitute syringes had an inner surface having an annular engaging portion comprising a groove adapted to be releasably engaged by a plunger to permit the hub to be selectively withdrawn along the barrel by the plunger. In tables within his affidavit, Mr Tse observed that: The inner surface (which includes the area shown by item 110) of the hub (100) comprises an annular engaging portion (106) comprising a groove (112). The groove (112) is adapted in shape to define a ridge (108) that is releasably engagable by a plunger of the injector system to enable the plunger to selectively withdraw the hub (100) along the barrel (104). 50 References to the item numbers in brackets correspond to the features shown by the numbered arrows in the photographs that constituted VCT-1 to Mr Tse's affidavit. Photos 5, 6, 7 and 8 are reproduced in Appendix A. 51 Mr Tse added "[t]he plunger has engaging protrusions (116) for engaging a part of the groove (112) of a syringe" and that without this feature the Stellant substitutes would not be compatible with a STELLANT™ medical injector system. 52 In argument, the applicants submitted that (108) was a ridge and that, when one drops down the side of that ridge, from (108) to the flat portion (112), one is dropping into a groove in the sense of a depression or recess. The pins on the plunger drop into the groove so understood. Alternatively, the applicants submitted that, having regard to Mr Pappas' affidavit, the engaging portion comprised a ridge, within claim 4 and claim 12. 53 Referring to a definition of the word "comprising" in the specification, the respondent argued that the Stellant substitute syringes have an engaging portion comprising a ridge, rather than a groove. The respondent relied on patent attorney Pappas for the contrary opinion to Mr Tse. 54 Mr Pappas expressed his opinion in this way: Plainly feature 108 identified by Mr Tse in photos 7-8 is a "ridge" (or "projecting lip") and not a groove. It is this ridge that is engaged by the plunger by means of pins projecting from the outer surface of the plunger. When the pins on the plunger (which are retractable within the body of the plunger) pass through the smallest diameter of the hub (being the diameter of the ridge), they extend or can be actuated to extend and, in their extended state, sit against the ridge. When the plunger is withdrawn the pins sitting against the ridge apply a force to the ridge to move the hub in the direction of the force of the withdrawing plunger. Whilst the ridge is annular, it is not a cut or indentation, furrow, track or channel in a surface or any other shape that is a groove. Nor is feature (108) a component of a groove. Moreover, feature 112 identified by Mr Tse in photos 7-8 is an inner cylindrical surface. Whilst 112 is cylindrical, there is no cut or indentation, track or channel in that surface that in anyway resembles a groove. Nor is feature (112) a component of [a] groove. 55 As explained hereafter, because of claim 4, the issue, whether the engaging portion of the Stellant substitute syringes is a groove or a ridge, appears to be of limited practical importance. 56 For this reason, I deal with the submissions on this issue comparatively briefly. In its ordinary natural meaning, the word "groove" may signify a generally narrow channel, hollow, furrow, or rut: see Oxford English Dictionary and Macquarie Dictionary. The specification for the patent in suit uses the words "groove or recess" apparently as indicative of the same feature. As presently advised, it is reasonably arguable that the engaging portion is a groove. I accept the applicants' submission that, if the engaging portion is the hollow or recess created by and under the ridge, then the engaging portion may well be said to comprise a groove within the meaning of claims 1, 9, 51 and 52. 57 If, however, the engaging portion is, as the respondent said, better described as a ridge, then the engaging portion will apparently comprise a ridge within the meaning of claims 4 and 12. 58 The respondent argued that, even if the engaging portion were a ridge, it would not follow that the Stellant substitute syringes infringed the patent in suit by falling within claim 4. The respondent contended that to so conclude involved a misconstruction of claim 4. The respondent submitted that claim 4 required a hub according to claim 1, such that the engaging portion is a ridge and that did not obviate the necessity for a groove. On the respondent's construction, "an inner surface having an annular engaging portion comprising a groove" was to be read as "an inner surface having an annular ridge comprising a groove". 59 At this stage, I would be inclined to reject the respondent's construction. As the applicants submitted, I would construe claim 4 so as relevantly to read, "an inner surface having an annular engaging portion comprising a ridge". Hence, I am inclined to the view that little may in practice turn on whether the engaging portion is said to be a groove or a ridge. 60 Secondly, the respondent submitted that the inner surface of the hub of the Stellant substitute syringes is not complementary in shape to an outer surface of the plunger. The respondent relied on an asserted lack of conformity with this integer. The respondent noted that the plunger was cylindrical with a thruster conical tip whilst the inner hub of the Stellant substitute syringe was complex in shape (because of its interior ribs) and flaring outwards. The respondent argued that the applicants' case disregarded the conical tip at the end of the syringe and the complexity brought about by the ribs and the flaring. 61 In this respect too, the applicants relied on the opinion of Mr Tse. In his first affidavit, Mr Tse gave the opinion that "[t]he inner surface (which includes the area shown by item 110) of the hub (100) is complementary in shape to an outer surface (118) of the plunger of a STELLANT™ medical injector system, which has a substantially round cross-section". Mr Tse added that the Stellant substitute syringes and each of the applicants' Stellant syringes "have this feature and work in the same way". That is, the hub was designed to fit over the plunger by adopting a shape conformable to the plunger. 62 In his affidavit, Mr Pappas expressed the contrary view. Mr Pappas' reasoning is as follows: In the specification at page 10 of the Patent … lines 19-24, an embodiment is described that explains what is meant by "complementary in shape" when the plunger engages the hub. An advantage of this feature is a form fit which provides a reinforcing effect to a thin walled hub. The presence of a thin walled hub is said to contribute to economies of manufacture: see lines 15-18 on the same page. This arrangement is also described between page 35 line 29 to page 36 line 4 of the Patent (pages 65 to 66) of the Tse affidavit). The plunger of the STELLANT medical injector system is illustrated in exhibit VCT-5 at pages 141 to 143 of the Tse affidavit. It can be seen that that part of the plunger which engages the hub of the syringe comprises a shaft that is of substantially uniform cylindrical shape (I leave aside the engaging pins indicated by the numeral 116), with a frusto-conical tip or dome on which there is a projecting pin. By way of contrast, the inner surface of the Shenzhen 100102 (a) has no area or portion that corresponds to the frusto-conical tip and projecting pin of the STELLANT plunger (the rubber seal itself forms a "dome" and simply sits on the hub where it is directly engaged by the tip of the plunger that passes through the hub); and (b) is of a complex shape that is generally flared (because of differing diameters) with numerous reinforcing ribs. When the plunger of a STELLANT medical injector system is engaged with the hub of the Shenzhen 100102, in no way can the inner surface of the hub be "complementary in shape" to that of the plunger or any part of the plunger. With respect to the differing diameters, the smallest (narrowest) diameter of the hub of the Shenzhen 100102 is at the annular engaging ridge. The plunger must pass through that portion of the hub so that the pins on the plunger can engage with the ridge. The inner cylindrical surface of the hub of the Shenzhen 100102, being the feature identified by numeral 112 as indicated in photos 7-8 of exhibit VCT-1 on page 18 of the Tse affidavit, has a diameter grater than the diameter where the plunger passes through the annular engaging ridge. This arrangement is in fact the opposite to that shown in Fig 6 of the Patent … in the sense that, in Fig 6, the diameter of the inner surface of the hub is substantially constant until it narrows in the region of the frusto-conical tip. On the other hand, in the Shenzhen 100102, the diameter of the inner surface of the hub in fact widens in the region beyond the engaging portion provided by the ridge. If in fact the plunger was complementary in shape to the inner surface of the Shenzhen 100102, that part of the plunger that was complementary in shape to that region of the hub beyond the ridge (towards the tip of the seal) would not be able to pass through the diameter of the annular engaging ridge. It would be impossible for it to do so. Similarly, in the region of the Shenzhen 100102 before the annular engaging ridge, the diameter of the inner surface of the hub is in fact wider than the diameter of the annular engaging ridge. Because the inner surface of the Shenzhen 100102 hub is not complementary in shape to an outer surface of the plunger in the STELLANT medical injector, there is no form fit between the plunger and the hub so as to provide a reinforcing effect on the hub. … 63 In Mr Pappas' opinion, Mr Tse was wrong to regard the inner surface of the hub as "complementary in shape" to an outer surface of the plunger simply because the plunger has a "substantially round cross-section". Mr Pappas argued that: The claim, by definition, expressly requires "the inner surface of the hub" to be complementary in shape with an outer surface of the plunger. This means that the whole inner surface of the hub must be "complementary in shape" to an outer surface of the plunger, except for where the groove/annular engaging portion is. 64 The applicants argued that Mr Pappas' reasoning was erroneous because Mr Pappas sought to construe claim 1 by reference to a preferred embodiment, which gave a form fit. The applicants noted that the notion of "form fit" was not part of claim 1 but was part of claim 5. There is some substance to this objection. 65 The whole of the specification, including the preferred embodiments, may assist in the construction of the claims. The preferred embodiment of the invention is, in this instance, a statement of the preferable method of construction of the article (or, in other instances, best method of performing the invention), but it is the claim that actually defines the invention the subject of the patent. As presently advised, the respondent's argument on form fit apparently seeks to limit the monopoly as fixed by the words of claim 1 by adding a gloss drawn from the statement of a preferred embodiment in the specification. There would appear to be no good reason to do this, especially having regard to claim 5. 66 The word "complementary" is not apparently a technical term. The word "complement" can signify "[s]omething which, when added, completes or makes up a whole; each of two parts which mutually complete each other, or supply each other's deficiencies": see Oxford English Dictionary. If understood as broadly as this, it may well be that "complementary in shape" includes a feature wherein the inner shape of one component follows the general shape of an outer surface of another component that is in close proximity, such as the Stellant substitute hub and plunger. As presently advised, I do not consider that "complementary in shape" requires that the inner surface of the hub must entirely conform to the whole outer surface of the plunger. 67 Having said this, however, I would not discount Mr Pappas' observations entirely. It may be that more is required to make the inner surface of the hub complementary in shape to an outer surface of the plunger than merely having a common round cross-section that enables the hub of the Stellant substitute syringe to fit over the plunger as it presently does. Whilst the construction of a claim is essentially a matter for the court, expert evidence is admissible on the meaning of technical terms and generally to put the court in the same position as a skilled addressee. Doubtless the parties will present evidence of the latter kind at the trial, which may assist on this aspect of the case. 68 As things presently, however, there is a serious question as to whether the respondent's Stellant substitute syringes infringe the applicants' Stellant syringes because the requirement for complementary surfaces in claims 1, 9, 51 and 52 is a feature of the Stellant substitute syringe. That is, this requirement may very well be found to involve no more than a round cross-section that enables the hub of the syringe to encircle the body of the plunger as it does in the Stellant substitute. 69 I have reached this conclusion that there is indeed a serious question to be tried as to whether there has been an infringement of the kind alleged by the applicants and not admitted by the respondent, especially having regard to the photos in Appendix A and to exhibits A1 and R1. The respondent accepts that, but for the issue of validity, the Klikfit substitute syringe would infringe the patent in suit. (c) Triable case on invalidity 70 The respondent has challenged the validity of the patent in suit on the ground of obviousness. Mr Pappas stated that he had seen "many publications and patent documents in the medical connector field and fluid connection fields … which predate the earliest possible priority date for the Patent … and which utilise movable engaging members, releasably or permanently engaging with annular grooves and recesses in other members both 'complementary' and 'non-complementary' in shape" and sought to illustrate his point by reference to numerous patents. He augmented this evidence by reference to arrangements in other fields, especially engineering. Mr Pappas also gave evidence directed to showing that reinforcement by the use of complementary shapes, especially in relation to the design and manufacture of plastic items, was well-known. 71 The respondent argued that Mr Pappas' evidence showed that to use an annular engaging portion as a means of locking or connecting two complementary members was to specify a well-known and obvious design technique. The respondent also observed that Mr Pappas referred to the fact that using complementary shapes as reinforcement was a well-known technique. The respondent relied on the fact that Mr Pappas was an engineer, and, so it said, therefore a person skilled in the art. In this context too, the respondent relied on the evidence of Ms Evans as a practising radiographer. 72 As Mr Tse noted, the documents to which Mr Pappas referred did not relate to medical injector systems, and did not appear to describe "any mechanism that enables two different parts to releasably engage with each other so that one part can selectively withdraw the other part from a container (such as a syringe)". 73 In argument, the applicants submitted that there was no evidence that any of the inventions disclosed in the documents to which Mr Pappas referred was part of the common general knowledge of a person skilled in the art at the relevant date. Thus, so the applicants submitted, there was no evidentiary basis for s 7(2) of the Patents Act 1990 (Cth). The respondent disclaimed any reliance on s 7(3) of that Act. 74 As things presently stand, I do not consider that the respondent has made out a prima facie case that the invention would have been obvious to a person skilled in the relevant art in light of the common general knowledge as it existed in Australia before the priority date. This is because there is insufficient evidence that the invention disclosed in the patent in suit would have been obvious to a person skilled in the art in the light of common general knowledge as it existed in the patent area before the priority date. Mr Pappas' evidence amounted to no more than general assertions about common arrangements in different fields of endeavour with different problems to confront. It is by no means clear that he should be regarded as a person skilled in the art simply because he has engineering qualifications. The respondent has not produced any document identifying a similar use of technology in the prior art to that found in the patent in suit. Ms Evans' evidence was not that of a person skilled in the art and was of a generalised kind. For these reasons, her evidence was of very limited utility. (d) Adequacy of damages, balance of convenience and other discretionary factors 75 Further, I am persuaded that the inadequacy of damages and the balance of convenience favour the grant of an interlocutory injunction. 76 First, the respondent has not been engaged in selling the impugned syringes for very long and the quantities involved are comparatively slight. Against this, the applicants have been in the business of selling syringes and medical injector systems for many years. They have a considerable business interest at stake. 77 It may be as Ms Evans deposed, that, if the respondent were enjoined as the applicants seek, then this would adversely reflect on the respondent's reputation for reliability as a supplier. It seems probable, however, that the respondent's representatives will be able to offer suitable explanations to its relatively new customers. The respondent has not said that it would suffer any other kind of harm to its business. 78 Secondly, damages would not be an adequate remedy for the harm that the applicants are likely to suffer. 79 There is no evidence that the respondent has assets available to satisfy an award of damages in the applicants' favour. The respondent, which was incorporated about two years ago, has paid-up capital of $2 and searches have revealed no significant assets. The respondent has stated that it is prepared to deposit into a separate bank account the gross profits it has received, and receives, from the sales of products numbered 100102, 100104 and 500102, pending the final determination of the proceeding, but this does not provide the needed assurance that the respondent could meet a significant award of damages. As previously noted, the respondent is a relatively new entrant into the market and is apparently still in the process of building its business. There is no dispute about the applicants' capacity to pay damages pursuant to the usual undertaking to do so. 80 Further, Mr Reynolds' evidence is that, if the respondent is permitted to sell the syringes in issue, there will be what Gyles J called "interference with … trade patterns": see Genrx at 506 [15] and Interpharma at 280 [71]. That is: 1. If the respondent is permitted to continue supplying its syringes at a price that is approximately 20% less than Imaxeon's price, then Imaxeon would probably be compelled to lower the price for its equivalent syringes or lose its customer base. 2. There is a real risk that if it held to its higher price, this would damage its reputation and have ramifications when a customer came to purchase or upgrade their injector system. 3. If Imaxeon is compelled to lower the price for its syringes, the price reduction would probably be permanent (even if Imaxeon succeeded at trial) and result in a significant overall loss of revenue which would be very difficult to quantify. 4. Any price increase would compromise Imaxeon's reputation and goodwill and the chances of securing new customers in a market where prices are either stable or declining. 5. By regularly supplying their customers with replacement syringes, Imaxeon retains regular contact with the applicants' customers. This confers various advantages, including that Imaxeon is foremost in the customer's mind when the time arrives to replace an injector system. 6. Imaxeon would likely suffer a loss of reputation if there were defects in the respondent's syringes because the defects would affect the operation of the injector system. (I note that, in argument, the applicants did not invite the court to give this consideration a great deal of weight since there was no evidence of defects in the respondent's syringes.) 81 The respondent noted that the applicants had presented little detailed evidence on pricing and the effects of competition. The respondent noted that Mr Reynolds' affidavit established that, in any event, the major suppliers of injector systems compete against one another on the cost of the injector systems and consumables and that the prices for the applicants' syringes broadly reflect the pricing for other CT contrast injector systems. It followed, so the respondent said, that price competition was a feature of the market and that the applicants were already competing with the respondent, which was supplying syringes to competing systems. The respondent noted that the applicants had not yet lowered their prices as a result of the respondent's entry into the market. Further, the respondent challenged Mr Reynolds' evidence that any price reduction would be permanent and, in this regard, referred to Ms Evans' evidence that this had not been her experience in the business of Jacobs Medical Australia Pty Ltd. The respondent observed that, in elaborating on the harm likely to befall their business, the applicants had engaged in a degree of speculation. 82 I accept that evidence about the nature of the competition in the medical injector systems and associated consumables market and the effect of new entrants might well be complex. Obtaining complete evidence of this kind would be expensive and probably unjustified for this application. It is undisputed that the applicants occupy a large proportion of the present market, and derive a large proportion of their revenue from the sales of consumables for the contrast injector systems, particularly KLIKFIT syringes and STELLANT™ syringes for the VISIMAX® CT and the STELLANT™ CT contrast injector systems respectively. 83 Although the respondent disputed the propositions advanced by Mr Reynolds, ultimately, the respondent fails to take its case beyond the level of mere disagreement. The evidence of Ms Evans was very limited in that it concerned her experience in a different and not necessarily comparable business. None of the respondent's evidence seriously undermined the assessment made by Mr Reynolds as Imaxeon's managing director and a person with apparently considerable experience in the relevant market. As things presently stand, the respondent has not demonstrated that Mr Reynolds' assessment of the effect of the respondent's sales of the impugned syringes is significantly wrong in any material respect. 84 The effect on Imaxeon strongly argues in favour of preservation of the status quo until the issues in dispute can be determined at trial, the date for which is already fixed. The effect on the respondent provides no strongly countervailing consideration. Further, it is apparent that at least some of the harm that would be done to Imaxeon if an interlocutory injunction were not granted would not readily be met, if met at all, by an award of damages. 85 The applicants submitted that the respondent got itself into this situation with its eyes wide open. As noted above, Ms Evans' evidence was that representatives of Shenzhen Ant had said that there were no patents that would cause any issue for the respondent in selling syringes in Australia. The applicants argued that the respondent ought to have checked the position for itself. That is, the respondent has offered for sale or sold the syringes in the knowledge that they were the subject of a patent, or in circumstances where the respondent should have known of the patent. A consideration of this kind has been weighed in the balance of convenience from time to time: see Beecham 118 CLR at 626; Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR 405 at 415; Pharmacia Italia SpA v Interpharma Pty Ltd (2005) 67 IPR 397 at 408 [52]; Interpharma 79 IPR at 282 [77]; and Sigma Pharmaceuticals [2009] FCA 595 at [61]-[62]. There would indeed appear to be some force in the applicants' criticism of the respondent's conduct in this regard. The evidence on this point is slight, however, and I would not therefore be inclined to give this factor much weight in determining the outcome of the applicants' interlocutory injunction application. (e) Leave to amend the statement of claim and application 86 The final question raised on this application for interlocutory relief is whether the application should be determined by reference to the amendments that the applicants stated they wished to make to their previously amended statement of claim and amended application. In view of the way the respondent sought to answer the applicants, it would be contrived and artificial not to consider the present application for an interlocutory injunction on the basis of the applicants' further proposed amendments. 87 The respondent submitted that, had it known that the applicants would rely on claims 4 and 12, it would have presented evidence: (1) on the infringement question to the effect that the ridge on the hub of the Stellant substitute syringe does not contain a groove; and (2) on the validity question, that the use of a ridge as an engaging portion was common general knowledge. 88 For the reasons already given, I doubt that evidence on either of these matters would affect the conclusion that I have reached. First, as I have said, I am disinclined at this stage at least to accept the construction of claim 4 that the respondent urges. Secondly, had Mr Pappas and Ms Evans given further evidence as to the use of a ridge as an engaging portion, their evidence would still have suffered from the deficiencies to which I have already referred. (f) Disposition 89 For the reasons stated, I would grant the interlocutory injunction sought by the applicants. I would fix the trial of the matter for 10.15 am on 22 February 2010, with an estimate of 4 days. I would direct that, on or before 4 pm on 27 August 2009: (a) the applicants file and serve minutes of order in conformity with these reasons; and (b) the parties file and serve short submissions on costs. I certify that the preceding eighty-nine (89) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Kenny. Associate: Dated: 25 August 2009 Counsel for the Applicants: Mr A J Ryan SC with Mr I P Horak Solicitor for the Applicants: Mallesons Stephen Jaques Counsel for the Respondent: Mr D M Yates SC Solicitor for the Respondent: Hazan Hollander Date of Hearing: 20 August 2009 Date of Judgment: 25 August 2009