Aristocrat’s electronic gaming machine is patentable

Burley J – one of the judges in the Full Court’s Rokt ruling – has upheld Aristocrat’s appeal and ruled that four of its innovation patents[1] for electronic gaming machines (EGMs) were manners of manufacture and not mere schemes or rules for a game.

[2]

The parties charaterised claim 1 of the 2016101967 patent as having 12 integers:

A gaming machine comprising:

(1.1) a display;

(1.2) a credit input mechanism operable to establish credits on the gaming machine, the credit input mechanism including at least one of a coin input chute, a bill collector, a card reader and a ticket reader;

(1.3) meters configured for monitoring credits established via the credit input mechanism and changes to the established credits due to play of the gaming machine, the meters including a credit meter to which credit input via the credit input mechanism is added and a win meter;

(1.4) a random number generator;

(1.5) a game play mechanism including a plurality of buttons configured for operation by a player to input a wager from the established credits and to initiate a play of a game; and

(1.6) a game controller comprising a processor and memory storing (i) game program code, and (ii) symbol data defining reels, and wherein the game controller is operable to assign prize values to configurable symbols as required during play of the game,

(1.7) the game controller executing the game program code stored in the memory and responsive to initiation of the play of the game with the game play mechanism to:

(1.8) select a plurality of symbols from a first set of reels defined by the symbol data using the random number generator;

(1.9) control the display to display the selected symbols in a plurality of columns of display positions during play of a base game;

(1.10) monitor play of the base game and trigger a feature game comprising free games in response to a trigger event occurring in play of the base game,

(1.11) conduct the free games on the display by, for each free game, (a) retaining configurable symbols on the display, (b) replacing non-configurable symbols by selecting, using the random number generator, symbols from a second set of reels defined by the symbol data for symbol positions not occupied by configurable symbols, and (c) controlling the display to display the symbols selected from the second set of reels, each of the second reels comprising a plurality of non-configurable symbols and a plurality of configurable symbols, and

(1.12) when the free games end, make an award of credits to the win meter or the credit meter based on a total of prize values assigned to collected configurable symbols.

No doubt oversimplifying, it seems the “clever” aspect of the patent was the use of a combination of configurable symbols and non-configurable symbols in which the display of a pre-determined number of configurable symbols on a base reel triggered free or bonus games. The configurable symbols were retained in the “free” game, while the non-configurable symbols were replaced with symbols from a second set of “reels”.

On the appeal, the Commissioner’s primary argument was that the claims were just claims to “a generic computer implementation”, leaving the hardware and software uncharacterised where the only features that distinguished the claimed invention from previous EGMs were the scheme or rules of the game. Thus, at [80] Burley J summarised the Commissioner’s submission:

integers 1.1 to 1.6 reflect the components of an EGM, including hardware (for example a display) and software (for example a random number generator) and some that are a combination of both (for example a game controller comprising a processor and memory). These were all standard components of EGMs.

Integers 1.7 to 1.12 deal with the conduct of the game and amount to a scheme or set of rules for doing so.

Amongst other things, the claim does not define any hardware features of the “game controller comprising a process or a memory” or any technical means by which the necessary processing functions are performed to implement the game. No software application or program code for carrying out the steps is defined by the claims. There is no suggestion of ingenuity in their implementation, which is left entirely to the skilled person reading the claim.

Consideration

In a point which bears emphasising (as it appears so often overlooked or misunderstood), Burley J began by reiterating that the ground of manner of manufacture is a separate and discrete requirement of validity, independent of other grounds like novelty, innovative step, utility and secret use. So, as his Honour pointed out at [84]:

whilst a claim for a ball point pen would fail for anticipation and inventive step, it would still be a claim for a manner of manufacture.

After referencing the “scheme” line of cases,[3] Burley J considered at [91] they mandated a two stage inquiry:

  1. The initial inquiry was whether or not the claim was for a mere scheme or business method of the type that was not the proper subject matter for a grant of a patent.
  2. If so, a second inquiry arose: whether or not the claim involved the creation of an artificial state of affairs where the computer was integral to the invention, rather than a mere tool in which it was performed. That is, was there invention in the computerisation of the claimed method?

Each step was to be undertaken as a matter of substance rather than mere form.

According to his Honour, it was at the second stage that it became necessary to identify whether or not the “contribution” was “technical in nature” or solved a “technical” problem or merely required a “generic” computer implementation.

The present case was different to the “mere scheme” line of cases because what was claimed was a mechanism of a particular construction where the integers interacted to produce a particular product. At [95], his Honour summarised:

the invention described and claimed, when understood as a matter of substance, is to a mere scheme or plan. It is to a mechanism of a particular construction, the operation of which involves a combination of physical parts and software to produce a particular outcome in the form of an EGM that functions in a particular way.[4]

Accordingly, it was unnecessary to embark on the second inquiry required for “mere scheme” cases.

As there was a physical product, therefore, it appears that the instant claims were conceptually different to those in Emcompass and Rokt. Burley J considered the instant claims were conceptually more like those upheld by Nicholas J in Konami and Dowsett J in LTH Consulting where, for example, Nicholas J had explained:

the inventions in suit claimed are not “mere ideas” but “new and useful gaming machines and new and useful methods of operation producing new and improved results”.

In opposing this claim, the Commissioner was labouring under the difficulty of the many, many patents already granted for EGMs and gaming machines generally. Moreover, the Commissioner necessarily conceded (consistently with his Honour’s ball point pen example) that the claim would have been a manner of manufacture if it had been implemented “the old-fashioned way, without using software but instead using cogs, physical reels and motors to create the gameplay”.

Thank goodness for that blow in favour of modernity and technological developement! One might question whether, when putting the elements into a box qualifies as a manner of manufacture, offering exactly the same functionality online accessible through a browser would also qualify as a manner of manufacture. Indeed, the specification refers to the invention being implemented alternatively by a “thick client” architecture or a “thin client” architecture.[5] And, if it did, how would one reconcile that with Rokt?

Aristocrat Technologies Australia Pty Limited v Commissioner of Patents [2020] FCA 778


  1. All four were divisionals from the same parent: AU 2015210489.  ?
  2. In this image from the decision, the vertical, numbered lines represent a portion of 5 “reels” (showing 3 symbols per reel) and the horizontal, lettered lines are rows.  ?
  3. Grant v Commissioner of Patents [2006] FCAFC 120; 154 FCR 62; Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150; 227 FCR 378; Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177; 238 FCR 27; Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2019] FCAFC 161; 372 ALR 646; Watson v The Commissioner of Patents [2020] FCAFC 56 and Commissioner of Patents v Rokt [2020] FCAFC 86.  ?
  4. At [96], Burley J expanded on the physical components claimed and how they interacted through the software to produce an outcome and, at [97], his Honour referred to the tight regulatory supervision imposed on EGMs.  ?
  5. P. 4: “For example, a ”thick client“ architecture may be used wherein part of the game is executed on a player operable gaming machine and part of the game is executed remotely, such as by a gaming server; or a ”thin client“ architecture may be used wherein most of the game is executed remotely such as by a gaming server and a player operable gaming machine is used only to display audible and/or visible gaming information to the player and receive gaming inputs from the player.”  ?

Rokt take 2

As noted last week, the Full Court has allowed the Commissioner’s appeal and ruled that Rokt’s patent application for a digital advertising method is in fact an unpatentable scheme. Disagreeing with the trial Judge, the Full Court considered the case was no different to Encompass and just involved a scheme using the well-known and understood functions of computer technology.

Perhaps, the point of general application arising from this decision (barring a successful application to the High Court for special leave) is the very limited role for evidence in assessing whether a claim is a claim to a manner of manufacture for the purposes of s 18(1)(a).

The claim

Claim 1 is involved and was characterised by the Court as involving 12 integers:

(1) A computer implemented method for linking a computer user to an advertising message by way of an intermediate engagement offer which is operable to drive a higher level of engagement with the advertising message than if the advertising message was presented without the offer, the method comprising:

(2) providing computer program code to be delivered with publisher content to a computing device operated by the computer user and which computing device comprises an interface arranged to display the publisher content, the computer program code operable to be implemented by a processor of the computing device to perform the additional steps of:

(3) gathering engagement data associated with the user, the engagement data derived from interactions made by the user with the interface and related to at least one of the following:

an attribute of the publisher content;

an interaction with the publisher content by the computer user; and

an attribute of the user;

(4) communicating the engagement data as it is gathered to a remote advertising system implementing an engagement engine, the engagement engine operable to:

(5) continuously evaluate the engagement data to determine whether a predefined engagement trigger has occurred, the predefined engagement trigger being representative of a user response or action that is contextually relevant for presentation of the engagement offer;

(6) responsive to determining that the predefined engagement trigger has occurred, selecting an engagement offer from a pool of different engagement offers stored by the remote advertising system that is relevant to the evaluated engagement data and wherein,

(7) where multiple engagement offers are deemed to be relevant, the engagement engine implements a ranking algorithm operable to dynamically rank the relevant engagement offers based on at least one of: > >(a) an engagement score determined from one or [more] performance metrics recorded from past user interactions with the corresponding engagement offers; > >(b) a revenue score determined from one or more revenue metrics recorded from past user interactions with the corresponding engagement offers, and

wherein the engagement engine selects which engagement offer to present based [on] the rankings;

(8) causing the interface to insert the selected engagement offer into the publisher content for displaying to the computer user;

(9) implementing the computer program code to determine an acceptance of the engagement offer by the computer user based on a user interaction with the engagement offer; and

(10) following the determined acceptance, presenting an advertising message comprising one or more advertisements selected from a pool of different advertisements on the interface and

(11) wherein user interactions with each of the presented advertisements are gathered by the widget script and communicated to the remote advertising system for use in selecting subsequent advertisements, and

(12) whereby the selection of [sic] engagement offer is additionally made such that there is no direct advertising benefit to the subsequent advertisers of the selected advertisements through presentation of the selected engagement offer to the computer user other than encouraging positive engagement by the user with the advertising system prior to presentation of the advertising message.

According to Rokt, one of the particularly clever, if not the clever, insight in this combination was the “engagement offer”. As the specification explained:

Through extensive testing, it has been found that initiating engagement with the advertisement system 10 by way of an engagement offer results in a more positive and deeper engagement with advertisements subsequently presented to the consumer (i.e. during the engagement journey) than if those advertisements were presented in the traditional search or display based manner, as described in the preamble. In turn, the consumer is more likely to continue to engage with the advertisement system 10, thus creating a sustainable advertising revenue module which is of benefit to each of the advertisement system 10, publishers 12 and advertisers 14.[1]

The Full Court explained that engagement offers could take any of numerous forms “including coupons, discounts, vouchers, scratch and win prizes, surveys and polls, competitions, video images, free games and the like.” Or, as their Honours summed up, “click bait”.

The trial judge

Based on the expert of evidence of Professor Verspoor, the trial judge had allowed Rokt’s appeal from the Commissioner’s rejection of the application on the basis that the claims were not directed to a “manner of manufacture”.

Given the Full Court’s ruling it is worth noting what Professor Verspoor had been asked to do. Professor Verspoor had given evidence directed to four questions:

(1) What is the “substance” of the invention? In other words, what specifically lies at the heart of the invention?

(2) Does the invention solve a technical problem?

(3) Is the use of a computer (or computers) integral to carrying out the invention, or could the invention be carried out in the absence of a computer (or computers)?

(4) Does the invention involves [sic] steps that are foreign to the normal use of computers (as at December 2012)?[2]

Based on Professor Verspoor’s evidence in answer to these questions, the trial judge had found that the introduction of the intermediate “engagement offer” to provide an alternative advertising technique was the key feature of the claimed invention.

The Commissioner argued that the method was merely an unpatentable scheme to solve a business problem. The trial judge held, however, that the claim solved both a business problem and a technical problem. At [205], his Honour said:

The invention solved not only a business problem but also a technical problem. As to the latter, it provided a single platform in which user engagement data could be coupled with transactional data and user context data to provide a personalised ranking of engagement offers to the user. This technical problem of providing this single platform was solved by introducing the tracking database and the objects database and designing the ranking engine and the engagement engine which accessed and manipulated the data in the two databases to rank and select engagement offers. The ranking engine optimised the personalised output for the consumer. Critically, the ranking engine implemented a ranking algorithm which ranked the retrieved object by a combination of an engagement score and revenue score. I also accept the evidence Professor Verspoor gave, which is summarised at [46]-[54], [104]-[107], [134]-[135] and [145] above.

and at [207]:

I find that there was a business problem of attracting the attention of the user and having the user choose to interact with the advertiser, but this problem was translated into the technical problem of how to utilise computer technology to address the business problem. The invention aimed to solve this technical problem through the introduction of the engagement offer and identifying what steps the software needed to execute in order to modify dynamically the website that the user was browsing while they were browsing it to, first, implement in the web browser or device the concept of the engagement offer, second, to implement in the computer system the necessary software for selecting engagement offers and advertisements for the given user based on the previous interactions with the system and the interactions of other similar users and, third, to have that system interact with the widget in the web browser in real time.

Accordingly, his Honour found at [208] that the use of the computers was integral, rather than incidental, to the invention and so qualified as patentable subject matter.

The Full Court

As already noted, the Full Court allowed the Commissioner’s appeal from the trial judge’s decision. Rokt’s invention is not a manner of manufacture and so not a patentable invention.

Before the trial judge, the parties had advanced a substantial body of expert evidence, leading the trial judge to characterise the problem before him “as one that lay in the realm of fact”.

According to the Full Court at [72], that was wrong.

Whether a claim is directed to a manner of manufacture is a question of construction. Construction of a claim is a matter of law, to be determined by the Judge. The role of evidence is limited.

At [71], the Court stated:

it is fundamentally a matter for the Court to determine and characterise the invention having regard to the principles of construction that are now well settled.[3]

At [73], the Court explained:

The role of expert evidence in construing the patent specification and the claims is limited. It is to place the Court in the position of the person acquainted with the surrounding circumstances as to the state of the art and manufacture as at the priority date: Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [24]; Myriad Genetics at [12]. Typically, the Court will read the specification with the benefit of expert evidence as to the meaning of words that are terms of art, or with an explanation of technical concepts relevant to the understanding of the invention as described and claimed. The question of construction remains with the Court. However, in his reasons, the primary judge adopted the approach of preferring the expert opinion evidence of Professor Verspoor over that of Mr Ries, and then adopting Professor Verspoor’s view as to the identification of the invention as claimed and characterised in the specification. It is not apparent that his Honour separately gave consideration to these matters. In our respectful view, that is an error in approach.

There is, however, at least this anomaly. If one is engaging in an exercise in legal construction, how does one decide whether the claim is nothing more than the implementation of a scheme by the use of a computer for its “well-known and understood functions”?[4] This is, apparently, not a function of evidence or even common general knowledge. At [91], the Full Court explained:

It is apparent that where the cases refer to “generic software” or to the use of computers for their “well-known” purpose, it is not a finding as to common general knowledge. Rather, it is a reference to computer technology that is utilised for its basic, typical or well-known functions. The means of determining that this is so is primarily by a careful review of the specification in order to ascertain, by construing that document, whether the invention described and claimed is in substance any more than a scheme that utilises computers in such a way. This is a question of characterising the invention as set out in the specification.

What appears to have been decisive in this case, as in Encompass, was that the hardware and the software to be used in implementing the method was “uncharacterised”. All that was identified in the claim was a series of high level instructions, leaving it to the user to write their own program.

Rokt argued that the High Court’s decision in Data Access[5] had differentiated between the realms of copyright and patent by identifying that patents are concerned with function, while copyright is concerned with forms of expression. Rokt submitted therefore, that there was no requirement for a claim to incorporate specific programming code.

At [114], however, the Full Court explained at [114] that Encompass was unpatentable because it was “just” an instruction to use computer technology for its well-known and understood functions”:

In Encompass the Full Court found that where the claims in suit do not secure, as an essential feature of the invention, any particular software or programming that would carry out the method and the method is entirely left to those wishing to use the method to devise and implement a suitable program for that purpose and all the specification teaches is that the processing system may be “suitably programmed” then the method is really an idea for a computer program, it being left to the user to carry out the idea in a computer system …. By the claim and the specification leaving entirely to those wishing to use the method to devise and implement a suitable computer program for purpose, it was apparent that the invention did not rise above the level of being an instruction to use computer technology for its well-known and understood functions to implement the scheme.

So, in Rokt, at [115]:

In the present case, the claim amounts to an instruction to carry out the marketing scheme. The level of abstraction at which it is expressed demonstrates that it does no more than provide a list of steps to be implemented using computer technology for its well-known and understood functions. Nothing in the specification suggests otherwise. This may be seen from the instructions explained as steps S1a to S10a in the specification (see [26] above). They comprise a list of general instructions to write software. Even if the scheme is new and ingenious, it is not made patentable merely because it can or must be implemented using computer technology. Rather, the language of the specification and the broad statements of steps required to be taken in claim 1 do no more than locate the scheme in computer technology, using its well-known and understood functions. The position is not distinguishable from that in Encompass. In our respectful view, the learned primary judge erred in finding otherwise. (emphasis supplied)

Another point to worry at

In addition to rejecting the relevance of the kind of expert evidence led (on both sides) before the trial judge, the Full Court was also critical of what Professor Verspoor’s evidence did address.

For example, having set out [205] of the trial judge’s analysis, the Full Court considered that Professor Verspoor had not even addressed the relevant question of what was actually claimed in claim 1, but had instead based her opinions on what was disclosed in the body of the specification. Their Honours said at [95]:

It is apparent that his Honour was not at this point adverting to the method of the claim, which refers to an engagement engine but contains no integer requiring a ranking engine (only a ranking algorithm). Nor does the claim require that there be a tracking database or an objects database. Those features are present in the system architecture identified in figure 3 in the specification, but not in claim 1. Section 18(1)(a) of the Patents Act draws attention to whether the invention so far as claimed in any claim is a manner of manufacture. That is, while the claims must be read with reference to the body of the specification, the invention is defined by the claims. Professor Verspoor, and the primary judge, relied upon the technical problem and solution identified in the specification, and the primary judge did not address the important question of whether the technical solution was claimed.

This with respect appears potentially difficult. Claim 1 with its concatenation of integers is not exactly straightforward. On what basis, for example, do lawyers or other patent advisers conclude that the reference in the claim to a “ranking algorithm” means *and* is something different to a “ranking engine”. Integer 7 for example refers to the “engagement engine” implementing a ranking algorithm “*operable to dynamically rank the relevant offers based on*” various criteria. [Edit]

These may not be the same things. The point is, understanding the claim may well not be simply an exercise in grammar and syntax which a person skilled in the tools of the lawyer’s trade can carry out.

More generally, one might wonder if the stipulation of those features in the claim, or a dependent claim, would have introduced sufficient detail into the claim to elevate the claim from unpatentable scheme to patentable manner of manufacture.

Some concluding comments

The clarification of the correct approach to determining whether a claim is to a manner of invention should be welcome. On the approach to this issue taken since at least Grant, however, it does mean that there is great scope for the Tribunal’s discretion to decide whether something should be patentable or not. That is of course inherent in the ‘proper question’.[6] For that reason, it could be argued that the NRDC Court sought to confine the inquiry – somewhat ironically undermined by Myriad – to a very limited examination of whether the claim was directed to “a mode or manner of achieving an end result which is an artificially created state of affairs of utility in the field of economic endeavour.”[7]

It is difficult with respect to see why, if a claim consisting entirely of a combination of known integers in some new and inventive way can be valid subject matter,[8] the same should not apply equally to a new and ingenious combination of computer technologies. It has long been recognised that there can be invention in the idea or concept or principle even where the means of carrying it into effect are themselves not new or inventive. [9]

The difficult path we are travelling down is evident in the previously unheard of volume of cases we now have about manner of manufacture issues, no doubt exacerbated by the innovation patent. The problems are not confined to Australia. Indeed, matters have reached the state in the United States where a claim to a garage-door-opener, devices which have been patentable subject matter for 150 years (to quote Patently-O) has been held unpatentable as an abstract idea.

The issue becomes even more difficult of resolution where, accepting that Australia is a net importer of intellectual property generally and patent claiming technology, it becomes undesirable to grant patents in Australia for “things” which do not qualify for patent protection overseas, particularly in the patent applicant’s “home” jurisdiction. Given the lack of harmonisation internationally, however, there is no certainty that all, or even many, jurisdictions will reach the same result.

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86 (Rares, Nicholas and Burley JJ)


  1. The numerals are references to elements illustrated in Figure 1 (shown at paragraph 13 of the Reasons).  ?
  2. The Full Court extracted key parts of the evidence of Professor Verspoor’s and the Commissioner’s expert, Mr Ries, at [36] – [44].  ?
  3. See also [93]. At [71], the Court cited [Jupiters Ltd v Neurizon Pty Ltd][jup] (2005) 222 ALR 155 at [67] as summarising “many” of the principles.  ?
  4. Rokt Full Court at [84] citing Commissioner of Patents v RPL Central Pty Ltd (2015) 238 FCR 27 at [96] and Encompass at [95].  ?
  5. Data Access v Powerflex Services (1999) 202 CLR 1 at [20].  ?
  6. ‘whether the subject matter in issue is “a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies”’. Perhaps borne down under the weight of so-called “innovation patents”, however, one might feel some skepticismto the notion that it is to be answered “consistently with a “widening conception of the notion [which] has been a characteristic of the growth of patent law”.  ?
  7. NRDC]nrdc 102 CLR at 275–277; CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 295 and Welcome-Real Time v Catuity. Ironically, since undone by the High Court in Myriad.  ?
  8. For example, AB Hässle v Alphapharm Pty Ltd at [6].  ?
  9. For example, Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173 at [59] – [60].  ?

Rokt loses the Commissioner’s appeal

The Full Court (Rares, Nicholas and Burley JJ) has upheld the Commissioner’s appeal against the ruling that Rokt’s digital advertising system was patentable subject matter as a manner of manufacture. So, barring special leave), another computer implemented “invention” isn’t patentable.

More analysis later.

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86

A computer related invention is patentable

Robertson J has allowed Rokt’s appeal and held that its ‘computer implemented method for linking a computer to an advertising message by way of an intermediate engagement offer ….” was a manner of manufacture and so patentable subject matter.

The Commissioner had found (and here) that Rokt’s patent was not a manner of manufacture as required by s 18(1)(a) and so refused grant.

On the appeal, Robertson J found Rokt’s claims were patentable subject matter in application fo the principles from Research Affiliats and RPL Central on the facts.

Crucial to his Honour’s decision was evidence that computer systems at the priority date in December 2012 did not work in the way claimed, which was not just a routine use of the technology.

In response to the Commissioner’s argument that the method was just a business method, Robertson J said at [205]:

The invention solved not only a business problem but also a technical problem. As to the latter, it provided a single platform in which user engagement data could be coupled with transactional data and user context data to provide a personalised ranking of engagement offers to the user. This technical problem of providing this single platform was solved by introducing the tracking database and the objects database and designing the ranking engine and the engagement engine which accessed and manipulated the data in the two databases to rank and select engagement offers. The ranking engine optimised the personalised output for the consumer.  Critically, the ranking engine implemented a ranking algorithm which ranked the retrieved object by a combination of an engagement score and revenue score. I also accept the evidence Professor Verspoor gave, which is summarised at [46]-[54], [104]-[107], [134]-[135] and [145] above.

On the evidence, Robertson J found that known, exiting components were integrated into a new system in an innovative and previously unknown way. At [213], his Honour explained:

Taken in isolation, a database, a client-server architecture, the running of the Javascript program on a publisher’s website and the creation of a ranking engine to rank abstract data to achieve an ordered list were each known as at December 2012 but, in combination, the distinction between engagement offers and general advertising, coupled with the algorithms making use of background data for personalisation and ranking was a new combination of new and previously existing components and a new use of computer technology.

In this case, the evidence showed that the use of computers was integral to the invention, not just incidental. At [208] – [210], Robertson J said:

The use of computers was integral, rather than incidental, to the invention in the sense that there is an invention in the way in which the computer carries out the business scheme: see RPL Central at [107]. It was not feasible to store and manage large amounts of tracking data collected from real-time interactions with digital devices and manipulate large quantities of data for context-sensitive decision-making without the use of computers. The data bank that was the source of engagement objects and historical/tracking data was a critical component of the invention. I accept the applicant’s submission that the computer was not merely acting as an “intermediary” but that the substance of the invention involved the new functioning given to the computer. I accept Professor Verspoor’s evidence summarised at [55]-[57] above.
Storage and manipulation of data at the magnitude and speed that was required to implement the method could only be done on a computer or computers. The data analysis claimed in the patent could not be performed without a computer or computers, particularly having regard to the gathering, manipulation and subsequent use of the data by the engagement engine.
The user interactions took place on the user’s computer and it was integral to the invention that data be collected, and engagement offers presented, through that computer. The transmission and receipt of data over the internet to and from the advertising system could also only be done using computers.

Rokt Pte Ltd v Commissioner of Patents [2018] FCA 1988

Selected links,from last week

Here is a selection of links to IP-related matters I found interesting this week:

Patents

Trade marks

Copyright

Remedies

Not categorised

I hope you find some interesting. If you did or have a question, leave a comment or send me an email

Selected links from last (couple of) weeks

Here is a selection of links to IP-related matters I found interesting this past week (or two):

Patents

Trade marks

Copyright

Not categorised

I hope you find some interesting. If you did or have a question, leave a comment or send me an email

RPL Central also refused special leave

The High Court has also refused RPL Central special leave to appeal.

RPL Central had applied for the grant of an innovation patent entitled ‘Method and System for Automated Collection of Evidence of Skills and Knowledge’.

Middleton J had upheld RPL’s appeal from the Commissioner’s decision to reject the application on the grounds it was not a manner of manufacture. The Full Court allowed the Commissioner’s appeal. In rejecting special leave, the High Court baldly stated:

The Full Court was plainly correct and, accordingly, none of the applicant’s proposed grounds of appeal enjoys sufficient prospects of success to warrant the grant of special leave to appeal. Pursuant to r 41.11.1 of the High Court Rules 2004 (Cth), we direct the Registrar to draw up, sign and seal an order dismissing the application with costs.

So, so far as patenting business methods goes in Australia, it looks like Research Affiliates will be the last word … for a long time.

If you have a question or wish to make a comment, feel free to post it in the comments box or send me an email.

RPL Central Pty Ltd v Commissioner of Patents [2016] HCASL 84

Myriad’s BRCA1 claims – take 2

As previously noted, the High Court has unanimously ruled that Myriad’s 3 claims for isolated nucleic acids for the BRCA1 gene that codes for specific mutations and polymorphisms are invalid.[1]

Claim 1 was:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

Claims 2 and 3 were subsidiary claims for narrower formulations.

The sole issue in the case was whether claims 1 to 3 of Myriad’s patent were a “manner of manufacture” within the meaning of s 18(1)(a) of the Patents Act – what the American’s refer to as subject matter or patentable subject matter. There was no challenge to the novelty or inventive step of the claim – the basis on which the corresponding patent was rejected in Europe.

There was also no challenge to claims 4 – 30, which Gordon J at [191] and [257] characterised as applications of the isolated gene sequences to various purposes such as a probe (claim 4), vectors (claims 5 – 7), methods of producing mutant or polymorphic BRCA1 polypeptides (claims 8 – 9), preparations and uses of polypeptides (claims 10 – 16) and methods of diagnosis (claims 17 – 30).

Previously, this question fell to be determined according to the principles declared in the “watershed” NRDC case. All 3 sets of reasons acknowledged the continued relevance of that decision, but appear to have qualified its teaching in potentially far-reaching ways.

French CJ, Kiefel, Bell and Keane JJ

The majority judgment was delivered by French CJ, Kiefel, Bell and Keane JJ.

A narrow approach

At one level (one might hope the right level), their Honours’ judgment can be seen as focusing very specifically on the singular nature of Myriad’s claim. Thus, at [6], their Honours said:

Despite the formulation of the claimed invention as a class of product, its substance is information embodied in arrangements of nucleotides. The information is not “made” by human action. It is discerned. That feature of the claims raises a question about how they fit within the concept of a “manner of manufacture”. As appears from s 6 of the Statute of Monopolies, an invention is something which involves “making”. It must reside in something. It may be a product. It may be a process. It may be an outcome which can be characterised, in the language of NRDC, as an “artificially created state of affairs”. Whatever it is, it must be something brought about by human action. ….

In their Honours’ conception, that was not the case here. The judgment continues at [6]:

The requirement, in each claim, that the sequence in the isolate bear specified mutations or polymorphisms raises the same problem in a particular way. Satisfaction of that integer depends upon a characteristic of the human being from whom the nucleic acid is isolated, a characteristic which is not shared by all human beings. It has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence.

That is, nothing was “made”. Rather, the gene sequence with the relevant mutation(s) and/or polymorphism(s) was made in the individual from whom the genetic material had been extracted. “All” that Myriad did was whittle that genetic material down to identify whether or not the relevant mutation or polymorphism was present.[2]

Further, at [8]:

…. The size of the class of the products as defined is large. No upper limit was suggested in argument. The boundaries of the class are not defined by a limiting range of chemical formulae. There is a real risk that the chilling effect of the claims, on the use of any isolation process in relation to the BRCA1 gene, would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids containing the sequences coding for the BRCA1 protein. The infringement of the formal monopoly would not be ascertainable until the mutations and polymorphisms were detected. Such a result would be at odds with the purposes of the patent system.[3]

One might wonder how one works out whether or not the “monopoly” that would arise would be “exorbitant and unwarranted”. The size of the class claimed seems problematic, the “chilling effect” also might be thought something that flows from the grant of any patent. Why for example would that be any more of a problem than for the patents granted originally over compounds such as omeprazole or rosuvastating or any number of other drugs?

Moreover, the problem of infringement loomed very large. No-one could know in advance whether or not what they were doing would infringe. It would depend on whether a relevant mutation or polymorphism was present in the individual from whom the genetic material was extracted. One might say, of course, that one would not be at risk of infringing unless one was looking for the BRCA1 sequence. One might also say, at least up until today, that there was no bar to patenting omeprazole or rosuvastatin or any other chemical substance just because one had found a specific use for it such as treating disease A when, after the compound had been discovered, someone else might be precluded from investigating its use, surprisingly, to treat disease B.[4]

The problem seems particularly to come back to the nature of the claim as being tosomething generated in an individual naturally and independently of any action by the patentee.

Wider ramifications

French CJ, Kiefel, Bell and Keane JJ did not just declare that claims 1 to 3 were not patentable subject matter. Their Honours went on to explain the principles that should be applied in future.

First, their Honours accepted at [18] that the NRDC test was still the appropriate question:

“Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?”

As I tell my patents class students, that provides us with an awful lot of guidance! Their Honours continued:

That question is to be answered according to a common law methodology under the rubric of “manner of manufacture” as developed through the cases, but consistently with “a widening conception of the notion [which] has been a characteristic of the growth of patent law.” That widening conception is a necessary feature of the development of patent law in the 20th and 21st centuries as scientific discoveries inspire new technologies which may fall on or outside the boundaries of patentability set by the case law which predated their emergence.

So far, still so good; particularly the recognition of the need for the concept to continue developing.

The “common law methodology” is further explained in [5] – [7] and troubled French CJ in Apotex v Sanofi. The first point appears to be, if the claim falls within an existing recognised class of patentable subject matter, it is a manner of manufacture. If it is a new class, however, “policy factors informed by the purpose of the Act and considerations of coherence in the law” need to be considered. Moreover, there are limits in judicial law-making “inherent in common law methodology”:

Where an affirmative application of the concept is likely to result in the creation of important rights as against the world, to involve far-reaching questions of public policy and to affect the balance of important conflicting interests, the question must be asked whether that application is best left for legislative determination. The patentability of nucleotide sequences derived from human DNA is in that category. The inherent patentability of the invention as claimed would powerfully imply patentability of any claim for an isolated nucleic acid coding for a specified polypeptide.

Notwithstanding 50+ years of the Courts successfully applying the NRDC formula, this High Court is plainly very uncomfortable with that role.

For those 50+ years since NRDC, we had been thinking there were 2 (or 3) requirements for patentable subject matter:

  1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action; and
  2. Whether the invention as claimed has economic utility.[5]

French CJ, Kiefel, Bell and Keane JJ confirmed that requirements 1 and 2 are still necessary. As foreshadowed in paragraph [6], however, their Honours said that requirements 1 and 2, while necessary, are not in themselves sufficient.[6] Other factors must be taken into account. At [28], their Honours laid out four further considerations:

  1. Whether patentability would be consistent with the purposes of the Act and, in particular:
    1. whether the invention as claimed, if patentable under s 18(1)(a), could give rise to a large new field of monopoly protection with potentially negative effects on innovation;
    2. whether the invention as claimed, if patentable under s 18(1)(a), could, because of the content of the claims, have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee;
    3. whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes.
  2. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.
  3. Relevantly to Australia’s place in the international community of nations:
    1. Australia’s obligations under international law;
    2. the patent laws of other countries.
  4. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.

The new, additional factors 1, 2 and 4 above were described as the most important in the balancing process the inquiry envisaged by their Honours.[7]

Having regard to these considerations, French CJ, Kiefel, Bell and Keane JJ declared at [94]:

Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination. Further, to include this class of claim within that concept would not contribute to coherence in the law as was the case in Apotex. Nor do Australia’s international obligations and the differently framed patent laws of other jurisdictions, which were referred to earlier in these reasons, support the conclusion that this class of claim should fall within the concept.

The “substance of the invention” and the considerations flowing

In the decision of the Full Federal Court under appeal, it had been pointed out that isolated DNA was in fact man made – it didn’t occur in nature. French CJ, Kiefel, Bell and Keane JJ, however, considered that was to elevate form over substance. So at [90], their Honours accepted a submission from the appellant:

“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”

That characterisation, so far as it emphasises the focus of the claims on genetic information, is applicable to the claims in this case and, contrary to the view of the Full Court, should be accepted.

At [93], their Honours then emphasised:

When proper regard is paid to their emphasis on genetic information, the subject matter of the claims lies at the boundaries of the concept of “manner of manufacture”. That it does lie at the boundaries is further evidenced by the odd consequence that if the claims are properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact. That consequence coupled with the very large, indeed unquantified size of the relevant class of isolated nucleic acids, all of which bear the requisite information, raises the risk of a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly and risks creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors.

The characterisation of the claims as “information”[8] has some affinity for Gordon J’s approach, discussed briefly below, ruling that the claims were to a mere discovery rather than invention. As discussed above under A narrow approach, this seems to flow from the singular nature of the claims in suit with the consequent uncertainties, particularly for infringement.

An extension of the concept

How do you tell that Myriad’s claim involved an extension of the concept of manufacture?

It is true that no court in Australia had ruled on the patentability of isolated gene sequences until the Myriad litigation. However, the Patent Office has been granting patents for ‘man made’ microbes since 1976 and for isolated genetic material since 1995. The legislative history showed that Parliament rejected an attempt to exclude genetic material from patentable subject matter when passing the 1990 Act. A further attempt to exclude human genetic material was rejected in the Senate in 2011. Two inquiries by Government agencies in the 2000s had also endorsed the status quo and recommended against exclusion. Indeed, the Government of the day had publicly announced its acceptance of the ALRC’s recommendation not to exclude isolated genetic materials from patentability. French CJ, Kiefel, Bell and Keane JJ said at [37]:[9]

This Court is not concerned in this appeal with “gene patenting” generally, but with whether the invention as claimed in Claims 1 to 3 falls within established applications of the concept of manner of manufacture. If it does not, then the question is one of inclusion not exclusion. The legislative history cannot be read as impliedly mandating the patentability of claims for inventions relating to isolated nucleic acids coding for particular polypeptides. The legislative history does not assist the Court in answering the question posed in this appeal.

Contribute to coherence

[Apotex][apotex] had (more or less) upheld the status of methods of medical treatment as patentable subject matter. That contributed to coherence because there was no rational basis to distinguish between patenting medical products and patenting methods of treatment.

Here, arguable, the nature of the claim as already discussed means it is impossible to assess the risks of infringement in advance. That presumably does not promote coherence. Their Honours also focused on the broad range of what was claimed and the potential impacts on future researchers. As already discussed, it may be difficult to distinguish those aspects from claims to other chemical compounds.

Gageler and Nettle JJ

Given the length of this post already, I shall only comment briefly on the remaining judgments.

Like French CJ, Kiefel, Bell and Keane JJ, Gageler and Nettle JJ considered at [125] that “an artificial state of affairs” and “economic utility” were necessary requirements for patentable subject matter, but not sufficient.

Also like French CJ, Kiefel, Bell and Keane JJ, Gageler and Nettle JJ stated at [144] that the question of patentable subject matter must be looked at as a matter of substance rather than form.

Invoking Microcell and Philips v Mirabella, their Honours considered at [133] that patentable subject matter involved a threshold inquiry of “inventiveness”.

Products of nature therefore did not qualify as at [136] they lacked the necessary quality of inventiveness. Gageler and Nettle JJ considered that Myriad’s claims were properly characterised as merely claims to products of nature.

Earlier at [128], Gageler and Nettle JJ had said:

Regardless, however, of the amount of labour involved or the differences between the product and the raw natural material from which it is derived, it is necessary that the inventive concept be seen to make a contribution to the essential difference between the product and nature.

Then, at [134], their Honours said:

Here, the essence of claim 1 is the correlation between the incidence of cancer and the presence of the specified mutations and polymorphisms in the mutated BRCA1 gene. Such ingenuity as that entails consists in the idea of examining an isolated fragment of a patient’s naturally occurring DNA constituted of the BRCA1 gene for the presence or absence of the specified mutations and polymorphisms. The subject matter of the claim does not make any contribution to the inclusion of the specified mutations and polymorphisms in the mutated BRCA1 gene. Their presence or absence in or from it is the result of the isolated BRCA1 gene being part of the naturally occurring DNA from which the sequence is isolated. To adopt and adapt the reasoning in NV Philips’ Gloeilampenfabrieken Application, it is “the inevitable result of that which is inherent in the [DNA]”.[10]

Like the reasons of French CJ, Kiefel, Bell and Keane JJ, this passage emphasises that Myriad did not itself make, or cause to be made, the relevant material. Rather, it was generated in the human body independently of any action by Myriad.

Thus, Gageler and Nettle JJ said at [139]:

…. the BRCA1 gene is not patentable as such because it is a naturally occurring phenomenon which lacks the quality of inventiveness necessary to qualify as a manner of new manufacture.

Gordon J

Gordon J at [222] – [225] specifically rejected D’Arcy’s argument that “naturally occurring things, or products or phenomena or principles of nature are excluded as a proper subject matter of a patent.” These were too vague, malleable and imprecise to be useful tools.

Instead, her Honour focused on the role isolation of the nucleic acid played: it simply allowed identification of the presence, or absence, of naturally occurring mutations or polymorphisms. Gordon J then advanced five reasons why the claims did not qualify as patentable subject matter:

  1. The claim is to multiple products, not a single product: [231]-[239];
  2. Although Myriad claims a class of chemical compounds as a product, it cannot delineate the bounds of its claim by reference to chemical composition: [240]-[243];
  3. Myriad did not create, make or alter the characteristic, the code: [244]-[249];
  4. There is no idea, concept or principle embodied in a manner of new manufacture: [250]-[258]; and
  5. The claim is too broad: [259]-[264].

Points 1, 2 and 5 focus on the sheer number and variety of compounds or sequences which were embraced. So at [241] and [242], her Honour recorded that Myriad could not identify the boundaries of the claims:

…. it is not possible for Myriad to record all of the various chemical compounds (or products) that might be produced by isolating an individual’s nucleic acid. For example, as Myriad accepted during argument, the claim is to an “extremely wide number” of chemical compounds where the compound formulae would vary according to the number of sequences extracted but the compound would nevertheless contain one or more of the specific mutations or polymorphisms.

As has been seen, changes in chemical composition are not limited to variation in the number of nucleotides. So, although the claimed product is a chemical compound, Myriad did not and cannot delineate the bounds of the class of compounds by reference to the chemical composition of the class of the claimed product. Instead, Myriad sought to delineate the boundaries of the claim by reference to what it described as the “characteristics identified within the claim” – the specific mutations and polymorphisms, represented by the code.

I am not sure why delineation by class of compound would be any more precise than the method chosen by Myriad – if you know, please leave a comment.

Under point 5, her Honour also pointed out the concern that no-one could know in advance whether they infringed or not and, if the role of the claim, is to identify the boundaries of the monopoly, that does rather cause a problem.

Under point 4, Gordon J referred to the nature of invention as discussed in the Hickton Patent Syndicate case:

In my opinion, invention may lie in the idea, and it may lie in the way in which it is carried out, and it may lie in the combination of the two; but if there is invention in the idea plus the way of carrying it out, then it is good subject-matter for Letters Patent. (Gordon J’s emphasis)

Her Honour considered that claims 1 to 3 failed to qualify because they did not carry out Myriad’s discovery that certain mutations or polymorphisms indicated increased risk of breast cancer. Gordon J said:

[254] Here, having located the BRCA1 gene and identified its nucleic acid sequence, Myriad’s idea, concept or principle is that specific mutations or polymorphisms in that sequence suggest a predisposition to breast cancer and ovarian cancer.

[255] How then is that idea carried out in claim 1? It is not. It is not and could not be carried out – as claim 1 suggests – by creating a product comprising isolated nucleic acid from a patient which contains the identified characteristic in any one of its many forms. As has been seen, Myriad does not claim the methods by which it isolates the nucleic acid or the methods by which it identifies the sequence of the patient’s nucleic acid. Myriad does not claim the characteristic. Claim 1 is not a claim to the idea, concept or principle.

Gordon J contrasted these claims to claim 4 which used the discovery to create a probe to test for the presence or absence of mutations. That was an invention. So analysed, claims 1 to 3 might be seen to be ‘mere’ discoveries’ rather than an application or now to offend against the enablement and sufficiency requirements.

Some other scary thoughts

First, it is not entirely clear from the decision whether cDNA is patentable subject matter as the US Supreme Court accepted. French CJ, Kiefel, Bell and Keane JJ said at [73]:

Nor, as previously noted, are the claims subject to any process?based limitation involving the breaking up and physical stitching together of the sequences comprising the isolated nucleic acids which are the products the subject of the claims. The “conceptual” stitching together, which may be regarded as the ordered compilation of information defining the relevant sequence, falls outside the claims entirely. The claims encompass molecules comprising isolated nucleic acids containing coding nucleotides arranged in the same sequence as appears in the DNA from which they were derived, whether or not introns and other non-coding sections have been removed from the relevant stretch of that DNA.

That might leave room for debate that cDNA could qualify. Also, the exclusion of introns or other “non-conding regions” might ameliorate the “chilling effects”. Gageler and Nettle JJ, however, at [116] characterised the claims as claiming “the uninterrupted sequence of nucleotides without introns”, i.e., cDNA. According to Gordon J at [283], the parties agreed that, if the claims were not patentable subject matter, they would not be saved where they extended to cDNA.

Philips v Mirabella!

Dr Patentology has called Philips the second worst ever patent judgment by the High Court. No argument from me. Turns out, we’re both wrong. At least 6 judges of the current High Court consider it good law[11] and appear to use it as their touchstone of patent principles.

I would say we need legislative reform but, as the Angel of Lake said, “Before you choose your wish son You better think first ….”

D’Arcy v Myriad Genetics Inc [2015] HCA 35


  1. According to Gordon J at [205] a “mutation” is a variation in a gene sequence “private to an individual or that indiviual’s immediate family.” In contrast, at [207] a “polymorphism is a genetic variant which has arisen in a distant common ancestor and is therefore not unique to an individual or that individual’s immediate family. Forty per cent of women in the general female population have one or more polymorphisms in the BRCA1 gene that are not found in the remaining 60 per cent of the population.”  ?
  2. Gageler and Nettle JJ also focused on this point at e.g. [162]. See also Gordon J at [248].  ?
  3. Citing Cornish, Llewellyn and Aplin for the final conclusion.  ?
  4. Of course, these days, s 119C would probably provide one with a defence to infringement, at least for the research into the possible use.  ?
  5. In fact, the Full Federal Court in Grant has told us there is a the third requirement: a physical transformation of something. Arguably, that was not in issue in Myriad as the isolated gene sequence was physically different to the unisolated genetic material in the human body to an extent.  ?
  6. Insofar as the claim falls within existing concepts of “manner of maufacture” as it has been developed through the cases, their Honours said at [28] requirements 1 and 2 “will also ordinarily be sufficient.” (emphasis supplied)  ?
  7. The survey of foreign laws didn’t really help as it was only the USA following the US Supreme Court’s Myriad decision that appears to have ruled out patent protection for isolated genetic material.  ?
  8. Optimistically hoping it was the claim to “information” rather than just genetic information which was important.  ?
  9. Gageler and Nettle JJ took a similar position at [171]. Nicholas J reviewed the legislative history at [113] – [123] in Cancer Voices.  ?
  10. A different Philips case, which their Honours read as endorsed by NRDC: (1954) 71 RPC 192 at 194, quoted in NRDC (1959) 102 CLR 252 at 279.  ?
  11. In addition to Gageler and Nettle JJ, see French CJ, Kiefel, Bell and Keane JJ at [12].  ?

Apotex v Sanofi: manner of manufacture

As briefly noted last week, the High Court handed down its ruling in Apotex’ appeal. Although the case will be mainly remembered because Apotex lost its challenge to the patentability of Sanofi’s method of medical treatment, Apotex actually won on the patent infringement point. (As there was no appeal on that point, however, it was still liable for infringing the copyright in Sanofi’s product information.)

Claim 1 of Sanofi’s relevant patent is for:

[a] method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide].

The patent for leflunomide itself has expired.

Apotex had received marketing approval from the TGA for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

By a majority of 4 – 1,[1] the High Court held that:

  1. a a method of medical treatment is indeed patentable subject matter – a manner of manufacture[2] – under Australian law;
  2. a second or subsequent use of a known substance could also be patentable subject matter; but
  3. Apotex did not infringe by selling or supplying its generic leflunomide according to its product information.

manner of manufacture

All 5 judges accepted the orthodoxy of the NRDC decision as defining the approach to whether a claim was to a manner of manufacture. And all 5 judges accepted it was a broad and widening concept.

Crennan and Kiefel JJ identified NRDC as essentially requiring 2 conditions to be satisfied. For example, at [235], their Honours quoted the Wellcome case:

This principle [in the NRDC Case] extends to a process which does not produce a new substance but results in ‘a new and useful effect’. If the new result is ‘an artificially created state of affairs’ providing economic utility, it may be considered a ‘manner of new manufacture’ within s 6 of the Statute of Monopolies. (Crennan and Kiefel JJ’s emphasis)

At [278] – [285], their Honours identified 7 reasons why a method of medical treatment could be patentable. Gaegler J agreed with these 7 reasons and proposed an eighth.[3] Given the broad scope of the concept, Crennan, Kiefel and Gaegler JJ considered the crucial consideration was that there was no economic or ethical basis for distinguishing between the patentability of a pharmaceutical (or other medical) product and a method.[4] French CJ’s reasoning was similar to this point; considering the historical exclusion from patentability to be an anomaly for which no clear and consistent foundation had been established.[5]

In contrast, Hayne J in dissent considered at [143] – [150] that it could well be possible to distinguish between patenting medical products and methods of treatment. Instead, his Honour considered that a process would only be patentable if the product (in the sense of the result, outcome or effect) of the process, and not just the process itself, had economic utility. Hayne J considered that a method of medical treatment did not satisfy that criterion because (at [163]):

The effect of using the process is personal to the individual. It is not an effect which the person who owns the right to use the process, or any person other than the individual who has been treated, can turn to economic account in any way, whether directly or indirectly. If the individual who has been treated can turn the effect to economic account, he or she can do so only indirectly: by taking advantage of better health to make a more valuable contribution to national production. The individual is not a subject of commerce. The product of the process in the individual (having better health than might otherwise have been the case) cannot be sold. ….

Perhaps reflecting Hayne J’s approach to some extent, Crennan and Kiefel JJ at [287] did consider that there was a distinction to be drawn between uses of therapeutic substances and the activities and procedures of doctors when treating patients on the basis that the latter are “non-economic”:

There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, “essentially non?economic” and, in the language of the EPC and the Patents Act 1977 (UK), they are not “susceptible” or “capable” of industrial application. To the extent that such activities or procedures involve “a method or a process”, they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a “manner of manufacture”.[6]

French CJ, however, at [1] and [44] expressly included surgical procedures in his Honour’s finding in favour of patentability.

second use of a known substance

As Crrennan and Kiefel JJ pointed out, NRDC itself involved a second or subsequent use of a known substance, the hitherto unsuspected properties of which squarely satisfied the requirements for inventiveness. Apotex’ reliance on this basis, therefore, failed at [291] in succinct terms.

the infringement question

… will have to wait for another day.

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50


  1. French CJ, Crennan, Kiefel and Gaegler JJ; Hayne J dissenting.  ?
  2. Patents Act 1990 s 18(1)(a). The claim would, of course, also have to satisfy the other requirements including novelty, inventive step, utility etc.  ?
  3. Gaegler J appears to be alone in attributing weight to the potential disruption to business investments if the endorsement by Bristol-Myers v Squibb of the patentability of methods of medical treatment was overturned after 13 years.  ?
  4. See [282] for Crennan and Kiefel JJ; [314] for Gaegler J.  ?
  5. At [50]. See also [44] – [49].  ?
  6. Earlier, at [266] – [271], their Honours had noticed that Congress amended the US Patents Act to include §287(c)  ?

    “the effect of which is to permit the patenting of surgical methods to continue but to bar actions for patent infringement against medical practitioners (and ”related health care entit[ies]“) for ”the performance of a medical or surgical procedure on a body“.”

Patentable subject matter reform

IP Australia has issued an Issues Paper on the proposed amendments to the Patents Act:

(1) to insert an “objects” clause; and

(2) to exclude from patentable subject matter inventions which it would be “offensive” to commercially exploit.

These plans arise out of a recommendations made by ACIP which the Government announced it accepted. The consultation now is on the wording to implement those policies.

An objects clause

The consultation paper proposes 2 alternative “objects” clauses:

Option 1

…. the purpose of the legislation as being to provide an environment that promotes Australia’s national interest and enhances the well-being of Australians by balancing the competing interests of patent rights holders, the users of technology, and Australian society as a whole.

Option 2

the purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.

Now, one could very well wonder what possible help either of these statements might give a court if they were enacted. The consultation paper even notes that the Parliamentary Draftsman is rather ambivalent about the value of objects clauses in general:

Some objects provisions give a general understanding of the purpose of the legislation…Other objects provisions set out the general aim or principles that help the reader to interpret the detailed provisions of the legislation.

The first option is what ACIP proposed. ACIP considered its proposal a simplified version of the Objects identified in art. 7 of TRIPS:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

The consultation paper thought that Option 1 does not sufficiently recognise the economic and social welfare concerns of patent law and did not sufficiently recognise the interests of patent applicants as well as patent owners (formerly known in Olde English as patentees). As the consultation paper explains:

The economic goals of the patent system are to promote economic growth, trade and investment by encouraging innovation and the dissemination of knowledge and technology.

The patent system encourages innovation by giving patentees a period of market exclusivity in which to recoup their development costs through commercialisation of their inventions. In exchange, patentees are required to disclose the details of their inventions to the public. The patent system contributes to social welfare by providing Australians with access to new technologies and developments that otherwise would not have occurred and that improve our quality of life (for example new pharmaceuticals and medical technologies and improvements to safety and waste management technologies).

However, the patent system will only meet its economic goals if the positive effects of the patent system in stimulating investment in innovation and providing society with access to new technology are balanced against the potential negative effects of patents restricting access to follow-on innovation and increasing costs, and so restricting supply of new patented technologies.

This is better, at least the first 2 paragraphs (if one bears in mind that economists – to the extent they accept the role of patents – think of the market exclusivity as providing an incentive rather than a “reward”). The third paragraph is rather more ambivalent.The danger the third paragraph raises is that it could be used as a basis for excluding something from patentability because someone might use the patent to raise prices or the other evils identified. But, while there are some provisions in the Patents Act that address, or attempt to deal with, these issues, in many respects they seem more properly the territory of (take a deep breath) competition law.

Offensive commercial exploitation

What the consultation proposes is a new exclusion to be added to s 18:

…  for an invention the commercial exploitation which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public.

Wholly offensive?

Apparently, the test of the ordinary reasonable and fully informed member of the Australian public is intended to ensure that the exclusion is “applied in a consistent, predictable and neutral manner”. However, it is also proposed to assist the Commissioner by explicitly empowering the Commissioner  in his or her discretion to seek “non-binding” advice on ethical matters.

What seems to trigger the exclusion commercial exploitation in an wholly offensive way rather than at the specific subject matter itself. At what point is the appropriateness of the commercial exploitation determined? Will it be enough that the invention could be exploited in an wholly offensive way? The BRCA controversy erupted when Myriad announced it was going to start charging licence fees for its products. Would the ordinary, reasonable and fully informed Australian have considered its patent wholly offensive before that announcement? This rather suggests that the problem falls within the second type issue identified by ACIP: about how the patent is used, are better dealt with through Crown Use and other compulsory licence arrangements.

 

If you have views you want to inflict, they should be submitted by 27 September 2013.

Find the issues paper here.