Encompass is still too abstract to be patentable subject matter

A Full Bench[1] of the Federal Court’s appeal jusrisdiction has dismissed Encompass’ appeal against Perram J’s ruling that its computer-implemented method was not a patentable invention because it was not a manner of manufacture.

Encompass had two innovation patents covering its concept. It sued Infotrack for infringing them. Infotrack admitted its conduct would infringe, but contended the patents were invalid on the grounds that they did not claim a manner of manufacture and did not involve “an innovative step”.[2]

At first instance, amongst other things, Perram J found the claims did involve an innovative step, but were not patentable because they were not for a manner of manufacture.

Infotrack was joined in resisting the appeal by the Commissioner of Patents (appearing as of right pursuant to r 34.23. The Institute of Patent Attorneys also sought and obtained (on a limited basis) leave to intervene.[3]

The claimed invention

Encompass’ (innovation) patent claimed a computerised method and apparatus for displaying business intelligence about “entitites”. The idea seems to have been to facilitate searching of multiple third party electronic databases[4] to ascertain and present aggregated data about the “entity” of interest. Claim 1 provided:

A method of displaying information relating to one or more entities, the method including, in an electronic processing device:

a) generating a network representation by querying remote data sources, the representation including:

i) a number of nodes, each node being indicative of a corresponding entity; and,

ii) a number of connections between nodes, the connections being indicative of relationships between the entities; and,

b) causing the network representation to be displayed to a user;

c) in response to user input commands, determining at least one user selected node corresponding to a user selected entity;

d) determining at least one search to be performed in respective of the corresponding entity associated with the at least one user selected node by:

i) determining an entity type of the at least one user selected entity;

ii) displaying a list of available searches in accordance with the entity type; and,

iii) determining selection of at least one of the available searches in accordance with user input commands;

e) performing the at least one search to thereby determine additional information regarding the entity from at least one of a number of remote data sources by generating a search query, the search query being applied to one of the number of remote databases to thereby determine additional information regarding the entity; and,

f) causing any additional information to be presented to the user.

Crucially for the outcome of the appeal, the Court noted at [30] that neither claim 1 nor any of the other claims “characterised” the electronic process device which performed the method – “any suitable process system” may be used.

Encompass’ challenge

Basing itself on NRDC and CCOM, Encompass argued that the concept of manner of manufacture required the claim to give rise to an artificially created state of affairs which had economic significance. These requirements were satisfied, Encompass argued, because the claimed invention involved:

(a) the interrogation of remote data sources;

(b) the generation and display of the network representation;

(c) the interaction with the network node to initiate a further search;

(d) the determination that the results thereby produced relate to the same entity as the one produced from the first search (the contention that this is a step of the claimed method is an issue in this appeal); and

(e) the display of the results of that search.

Encompass argued that Perram J had erred by considering whether the claimed invention “improved the functionality of the machine”. This was said to be an erroneous incorporation of the “machine or transformation” test from US law.

The appeal

Despite what it described as the “oblique attacks” made by Encompass and IPTA on Research Affiliates and RPL Centrol, the Court considered at [77] the appeal did not raise any significant question of principle. Their Honours considered that, having regard to the submissions made by Encompass and IPTA, the correctness of the two earlier decisions was not seriously in doubt. Rather, the issue was whether Perram J had applied the principles from those cases correctly.

The Court started by noting that the High Court in Myriad had agreed with NRDC that the issue is whether the claimed invention is a proper subject for the grant of a patent.

At [80], therefore, the Court noted that to determine whether a claimed invention involves a manner of manufacture requires a characterisation of the claim.

At [81], the Court reiterated that this characterisation is to be undertaken as a matter of substance rather than merely as a matter of form.

At [83], the Court noted the Myriad majority had held the NRDC court had not been attempting an exhaustive definition of “manner of manufacture” when it referred to ‘an “artificially created state of affairs of economic significance”’. Further, the satisfaction of that formulation did not necessarily lead to a finding of “inherent patentability”.

Encompass’ reliance on the reasoning in CCOM was misplaced. The Full Court in CCOM had explained why the computer program in that case was a manner of manufacture in the following terms:

The NRDC case at 275–277 requires 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. In the present case, a relevant field of economic endeavour is the use of word processing to assemble text in Chinese language characters. The end result achieved is the retrieval of graphic representations of desired characters, for assembly of text. The mode or manner of obtaining this, which provides particular utility in achieving the end result, is the storage of data as to Chinese characters analysed by stroke-type categories, for search including “flagging” (and “unflagging”) and selection by reference thereto.

First, however and as the High Court in Myriad had confirmed, this reaoning was a guide only and not a rigid formula.

Secondly, the Court rejected Encompass’ argument that the proposition in Grant that a manner of manufacture required a “physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation” was inconsistent with CCOM and Catuity. Rather, both CCOM and Catuity involved methods where a component was physically affected or a change in state or information in a machine.

The Court then confirmed that the presence of a physical effect in the broad sense envisaged in Grant was also not conclusive. (There being such a transformation in the electronic processing device’s state by performing Encompass’ method.) The question was whether the claimed invention as a matter of substance transcended an abstract idea or mere information.

Encompass’ claimed invention did not provide sufficient specificity to transcend the abstract idea. At [99], the Court explained:

99 the method claims in suit are, in truth, no more than an instruction to apply an abstract idea (the steps of the method) using generic computer technology. The appellants endeavoured to explain why the claimed method falls within the notion of an artificially created state of affairs by attributing computer functionality to the method: the computer (or, in the language of the claims, the electronic processing device) searches remote data sources; the computer generates a network representation; and the computer responds to a user’s selection to conduct a further search. The appellants also attributed computer functionality to the method by the computer determining additional information relating to the same entity. As we have previously noted, this involves the contentious question of “entity matching”—a step which the primary judge found was not a step in the claimed method. We discuss this below when dealing with the grounds relating to innovative step. But even if for present purposes “entity matching” is taken to be a step in the claimed method, neither it nor the other steps, individually or collectively, amount to anything more than a method in which an uncharacterised electronic processing device (for example, a computer) is employed as an intermediary to carry out the method steps—where the method itself is claimed in terms which amount to no more than an abstract idea or scheme. (emphasis supplied)

The Court accepted that Encompass’ method could not be implemented using “generic software”. This did not save the claims as they did not specify as an essential feature of the invention any particular software or programming. It was left to a user of the method to devise and implement their own suitable computer program. According to the Court, this was merely an idea for a computer program. As in Research Affiliates and RPL Central, at [101] the Court characterised Encompass’ claims as merely a “method … in an electronic processing device”, which itself is not characterised.”

Finally, the Court at [105] – [110] rejected Encompass’ criticism that Perram J had improperly required the claimed method to result in “an improvement in the computer” by reference to the Research Affiliates court’s discussion at [104] – [105] to Alice Corporation in the USA. The Court considered that Perram J’s reference to these matters, properly understood, was just “an inquiry into and search for possibly patentable subject matter by reference to a touchstone of such subject matter.”

So, there you have it; all cleared up!

Next up, the Commissioner’s appeal (NSD66 of 2019) against the finding that Rokt did claim a manner of manufacture.

IPTA’s intervention

The Court summarised IPTA’s intervention as seeking to contest the Commissioner’s approach to computer related inventions. The Court outlined how it understood IPTA’s proposed intervention:

72 IPTA’s submissions took issue with the Commissioner’s statement that, in considering the patentability of computer-implemented methods, a key consideration is determining where the alleged ingenuity lies. IPTA submitted that this statement is “misconceived” because it intrudes questions of novelty and inventive step into the question whether the invention is a manner of manufacture; it suggests that the way in which the method is implemented in the computer is decisive and directs attention away from the method as claimed; and it suggests that a method characterised as a business method or a scheme is unpatentable, whereas it is only methods or schemes that are no more than a method of doing business or an abstract idea (with no practical application or effect) that are not patentable.

73 IPTA submitted that the Commissioner’s “misconceptions” had become established practice when examining patent applications. IPTA said that this was of “central concern to IPTA and its members’ clients seeking patent protection for their inventions”. IPTA said, further, that these “misconceptions” are reflected in the Australian Patent Office Manual of Practice and Procedure (the Manual) on which the Commissioner’s delegates rely for authoritative guidance in the examination of patent applications. IPTA argued that this has “led … to a confused state of affairs in the examination of computer-implemented inventions, and will cause examination of many such applications to miscarry”.

The Court, however, refused to buy into this fight on the grounds that the correctness or otherwise of the Commissioner’s earlier decisions was not a controversy before the court. The Court also refused to engage with what it described as “IPTA’s editorial comments” on the Manual of Practice and Procedure.

Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2019] FCAFC 161 (Allsop CJ, Kenny, Besanko, Nicholas and Yates JJ)


  1. A sitting of the Full Court constituted by 5 judges, rather than the more usual 3 judges. A bench of 5 judges appears to be appointed where there appear to be inconsistent rulings of differently constutited (3 Judge) full courts or there may be some compelling reason to doubt the correctness of an earlier decision.  ?
  2. Patents Act 1990 s 18(1A).  ?
  3. IPTA’s intervention sought to challenge the Commissioner’s approach to computer related inventions  ?
  4. For example, land registries, ASIC company records, police records “or the like”.  ?

Repeal of s 51(3)

The bill repealing (amongst other things) s 51(3) of the Competition and Consumer Act did get passed and has received royal assent.

The repeal takes effect on 13 September 2019.

So, if you thought you were relying on s 51(3)’s protection, you have a bit less than 6 months to get your house in order.

Your licences and assignments of IP rights probably will not get you into trouble for the most part unless you have market power. But that is not exactly a hard and fast rule so you should discuss your arrangements with your lawyers ASAP.

As discussed in this post, one area of potentially significant concern is where the IP holder has its own retail outlets and also licenses other retail outlets – e.g. not uncommon for franchisors who have their own outlets and franchisees. There is a concern that may give rise to criminal cartel conduct.

If you want to know about the prohibitions on cartel conduct, Ian Wylie has published a paper “Cartel conduct or Permissible Joint Venture?

On Tuesday, the ACCC also announced it hopes to publish draft guidelines by “mid-2019” and finalise them before 13 September. Amongst other things, these proposed guidelines will outline:

how the ACCC proposes to investigate and enforce Part IV in relation to conduct involving intellectual property rights. They will also provide hypothetical examples to illustrate conduct that the ACCC considers is likely or unlikely to contravene Part IV.

Invalidity cross-claim blocks interlocutory injunction

The Full Court has upheld Burley J’s refusal to grant Sanofi-Aventis an interlocutory injunction over Alphapharm’s SEMGLEE insulin solution for an injector pen. The significance here is that this is an unusual case where the (alleged) infringer’s cross-claim has negatived the patentee’s prima facie case of infringement. The Full Court also affirmed his Honour’s approach to balance of convenience issues.

Burley J found a clear case that Alphapharm’s product fell within claim 1 of Sanofi-Aventis’ patent. His Honour found, however, that Alphapharm’s cross-claim that the patent was invalid for lack of novelty was sufficiently strong that “it was doubtful” Sanofi-Aventis had made out a prima facie case of infringement.

Since the Interpharma case, cross-claims by alleged infringers that the patent is invalid have not enjoyed much success as the Court has approached matters on the basis that it is the patentee’s “title” to interlocutory relief which is in issue.

What was different here was that the invalidity cross-claim was not “merely” a triable issue. It was of such strength that Burley J considered (provisionally) the patent was invalid. The Full Court explained the correct approach at [14]:

…. A case for invalidity which is merely arguable, of itself, does not undermine the existence of a prima facie case of infringement which has otherwise been found to exist. However, a sufficiently strong case of invalidity may well qualify the conclusion that there is a prima facie case of infringement at all. Far from reasoning contrary to the approach in Interpharma and Janssen, the primary judge was applying the same reasoning, albeit with an outcome not to Sanofi’s liking because his Honour was satisfied that Alphapharm’s case on invalidity was sufficiently strong to qualify (indeed, virtually to negate altogether) Sanofi’s prima facie case of infringement. Further, it is Sanofi’s submissions which have conflated the relevance of the competing cases on invalidity. What is relevant is the strength of the case that the claim or claims said to be infringed are invalid. The primary judge at [118] found that “the lack of novelty case advanced by Alphapharm is sufficiently strong (at the provisional level) to qualify (in the sense contemplated in Interpharma at [17]) the conclusion that Sanofi has a probability of success”. ….

Sanofi-Aventis argued that the weight of the balance of convenience in its favour was a factor in considering its prima facie case of infringement. This argument failed both at the level of principle and on the facts.

First, the Full Court accepted that the strength of a plaintiff’s prima facie case is relevant to consideration of the balance of convenience. Balance of convenience, however, did not affect the assessment of the strength of the prima facie case of infringement. At [8], the Full Court explained:

…. The strength of the prima facie case is relevant to the balance of convenience, but the weighing process involved in evaluating where the balance of convenience lies does not affect the assessment of the existence or strength of the prima facie case. As was said in Samsung at [59] “[t]he critical integer in the test …is the need for the Court to assess the strength of the probability of ultimate success on the part of the plaintiff. The strength of that probability will depend upon the nature of the rights asserted and the practical consequences likely to flow from the grant of the injunction which is sought”. ….

Secondly, Burley J had apparently considered the respective losses relatively finely balanced on the question of balance of convenience, but had ultimately considered the difficulties of calculating Alphapharm’s losses outweighed the difficulties in calculating Sanofi-Aventis’.

In particular, the Full Court considered that Burley J had not inappropriately undervalued Sanofi-Aventis’ position as a long standing incumbent. For example at [51], their Honours explained:[1]

… Sanofi had not demonstrated a sufficient likelihood of success in all of the circumstances to justify the preserving of the status quo. Each case turns on its own facts so it is not the point that in GenRx and Warner Lambert the preservation of the status quo was given considerable weight. In neither case was the strength of the prima facie case undermined in the same way as in the present case. In neither case was there a suggestion of market circumstances similar to the present case given the primary judge’s reference in [174] to the real possibility of Alphapharm’s prospective market disappearing as a “significant aspect” of this matter. Faced with the primary judge’s reasons, Sanofi’s submission that his Honour failed to take into account the disruption of the status quo as a material consideration is untenable. His Honour weighed all those matters but the balance favoured Alphapharm not Sanofi.

Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28 (Jagot, Yates and Moshinsky JJ)


  1. One can only speculate how the 1336 paragraphs Jagot J had to write to work out the quantum on an undertaking as to damages in Sigma v Wyeth concentrated her Honour’s appreciation of this issue!  ↩

Cartel conduct and IP licences and assignments

Will your assignments and licences of intellectual property, such as in a typical franchise agreement, expose your client to liability for cartel conduct or will you be ready to apply for an authorisation?

One of the bills pending before Parliament contains the long pursued (by the ACCC) repeal of s 51(3) of the Competition and Consumer Act 2010.

Section 51(3) exempts from most of the prohibitions in Pt IV of the Competition and Consumer Act terms and conditions in assignments and licences of intellectual property which most of us take for granted.

The rationale for repeal is that most transactions involving IP do not have anti-competitive effects or purposes and, if they do, they should not be exempt from the competition laws.

Rodney De Boos, a consultant at DCC with many years’ experience in licensing and commercialisation of IP, however, points out that this explanation was developed before the provisions banning cartel conduct were introduced into the Act. And, he contends, typical arrangements in IP agreements which allocate, for example, territories or customers will constitute cartel conduct and so need authorisation if the parties are not to be in breach of the cartel provisions.

As Rodney explains, a cartel provision are certain types of specified provisions between competitors.

Now, it may well be that an assignor and assignee, or a licensor and licensee, will not be competitors. There are many types of arrangements, however, where the Competition and Consumer Act will deem them to be competitors. An obvious example is the case of a franchisor who has retail outlets (either itself or through a related body corporate) as well as retail franchisees. Other arrangements involving IP could also be similarly problematical.

You can read Rodney’s concerns in more detail here.

The bill repealing s 51(3) has already passed the House of Representatives and is due to be debated by the Senate in the sittings coming up.

Section 105(1A) passes its test

While some of us have been sweltering on the beach or disporting in the northern snows, Beach J has granted Branhaven’s application to amend its patent application for compositions and methods of inferring bovine traits following Meat & Livestock Australia’s opposition.

You will recall that Beach J had earlier rejected MLA’s attack based on manner of manufacture, novelty and inventive step. However, his Honour upheld the challenges based on lack of clarity and, to an extent, utility.

Branhaven applied to amend under s 105(1A) of the Patents Act 1990.

MLA opposed; in broad terms arguing that Branhaven was too late, there was no power to amend at this stage; the amendments were not permissible in any event and, as a matter of discretion, should not be allowed even if the Court did have power.

Prior to the Raising the Bar Amendments, the Court had power under s 60(4) to hear an appeal from the Commissioner’s decision in an opposition. The Court was restricted, however, to dealing with the application in the form the subject of the opposition before the Commissioner. If the opposition was successful but on grounds that could be cured, any application to amend had to be remitted to the Commissioner.[1] Two of the amendments introduced by Raising the Bar were s 105(1A) and s 112A. Section 105(1A) provides:

If an appeal is made to the Federal Court against a decision or direction of the Commissioner in relation to a patent application, the Federal Court may, on the application of the applicant for the patent, by order direct the amendment of the patent request or the complete specification in the manner specified in the order.

MLA argued that, after such a hotly contested ‘appeal’ and detailed reasons, Beach J was in effect functus officio. Amongst other things, MLA’s application was not made during the appeal and the Court therefore had no power to deal with the amendment application.

Beach J has rejected all these attacks. In the course of doing so, his Honour recognised it would not be appropriate to remit the matter to the Commissioner (even if there were power). His Honour also found that s 105(1A), like s 105(1) but unlike the Commissioner’s powers under s 60, was discretionary. His Honour’s reasons also explored the types of considerations that might affect the exercise of that discretion in the context of an application instead of a granted patent.

At this stage, it is not known if MLA will seek to appeal.

Meat & Livestock Australia Limited v Cargill, Inc (No 2) [2019] FCA 33

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

Productivity Commission implementation part 2

IP Australia has released draft legislation for the proposed Intellectual Property Laws Amendment Bill (Productivity Commission Response Part 2 and Other Measures) Bill 2018.

Schedule 1 of the proposed bill includes measures to:

  • amend inventive step requirements for Australian patents (to bring them into line with the imagined approach of the EPO;
  • introduce an objects clause into the Patents Act 1990
  • phase out the abomination innovation patent system.

Well, 1 out of 3 is not so bad.

Schedules 2 – 4 propose the mooted amendments to the Crown use provisions (both patents and designs) and the compulsory licensing provisions.

There are also streamlining measures and “technical improvements” in schedules 5 to 7.

Download the draft bill, the draft EM and consultation questions from here.

Written submissions are due by 31 August 2018.

GSK’s extended release paracetamol patent 2

In addition to dismissing GSK’s appeal against the construction of “basket” (noted here), the Full Court also dismissed Apotex’ cross-appeals on fair basis and best method.

Fair basis

Apotex and Generic Partners also lost their appeals against the trial judge’s ruling that GSK’s patent was fairly based and there had been no failure to disclose the best method.

On fair basis, the claims were consistent with the consistory clauses, but Apotex argued the body of the specification showed that the invention was narrower than the broad consistory clauses. This appears to have been an attempt to read the claims down to two specific formulations discussed in the specification, Formulations C and D.

A key point was whether the trial judge had impermissibly taken into account information in an FDA report to ascertain if the claims travelled beyond the disclosure in the specification. Apotex argued this was excluded by the High Court’s decision in the first Lockwood decision, where it had said at [48]:

If all that is essential in assessing a fair basing objection is recourse to the contents of the specification, there is no call, for example, for an examination (except on construction questions) of common general knowledge (which is essential when considering an objection based on want of an inventive step), or of prior art (which is essential when considering novelty (s 7(1))) …

The Full Court, however, rejected this attack; concluding that the information in the FDA Report (which was common general knowledge) informed how the skilled addressee would understand the claims. At [166], the Full Court said:

What is critical to the pharmacokinetic behaviour of the many formulations within the claims is the dissolution profile (or release rate) of the formulation. The primary judge accepted that the FDA Report recognised that a variation of ±10% percentage points in the release rate was acceptable to the FDA even where no IVIVC had been established. This provides evidentiary support for the finding that the skilled addressee would know that various formulations within the claims apart from Formulations C and D were likely to have similar pharmacokinetic properties. This also provides a complete answer to Apotex’s argument that the skilled addressee (equipped with the common general knowledge) would approach the Patent with an understanding that there would be no reason to think that other formulations within the claims would have a similar pharmacokinetic profile to Formulations C and D in the absence of any established IVIVC.

The Full Court also rejected Apotex’ argument that a claim could not be fairly based unless the specification explained why the claims worked. Making it clear that they were dealing only with the position before the Raising the Bar Act reforms, the Full Court said at [170]:

Of course, it is important to note that s 40(2)(a) requires that the complete specification “describe the invention fully”. A complete specification may still “describe the invention fully” without explaining why the invention works. After all, the inventor, who presumably believes that the invention described works, may not understand why it works. But this does not prevent him or her from obtaining patent protection for the invention.

Best method

For best method, the argument built on the Servier ruling to argue there had been a failure to disclose the best method because the specification did not disclose the particular grade or viscosity of the high viscosity HPMC or the granulation end points used to make Formulations C and D.

At [192], the Full Court accepted that there could be a failure of best method if information was withheld even though it could be ascertained by routine experiment. The Full Court rejected the best method attack, however, finding that the information omitted was inessential manufacturing and production information. According to the Full Court at [201]:

It does not follow merely because the patent applicant uses a particular manufacturing process or a particular excipient in formulating its commercial embodiment that it will form part of the best method. The patent applicant may have adopted a particular process, or used a particular excipient, for reasons that are associated with its own particular circumstances rather than because it believes that they reflect the best method. The best method known to the patent applicant may be one that allows for the optimisation of a formulation by the skilled addressee rather than one that adheres to one specific formulation that the patent applicant seeks to commercialise.

Those preparing specifications might want, first, to note the reservation that the Full Court was not dealing with the “new” post-Raising the Bar regime. Secondly, [192] appears to carry with it the warning that, if one leaves something out, one does so at one’s own peril.

 

 

A Basket Is Still Not A Cylinder

Glaxo has lost its appeal against Beach J’s ruling that Apotex and Generic Partners did not infringe its sustained release paracetamol patent. In a battle between what the skilled addressee would understand and the plain, literal wording of the claim, the lawyers won out.

Interpreting the claim

Claim 1 of the patent is for a pharmaceutical composition with a bilayer tablet having both an immediate release phase of paracetamol and a sustained release phase wherein:

said composition has an in vitro paracetamol dissolution profile (as determined by the USP type III apparatus, reciprocating basket, with 250ml of 0.1M HCl at 37C set at a cycle speed of 15 strokes/min) with the following constraints:

(a) 30 – 48% released after 15 minutes,

(b) 56 to 75% after 60 minutes and

(c) more than 85% after 180 minutes.

The problem was in that reference to a “reciprocating basket”, as a USP type III apparatus had a reciprocating cylinder, not a basket.

At the relevant time, there were four types of apparatus for testing dissolution – a USP type I apparatus, a USP type II apparatus, a USP type III apparatus and a USP type IV apparatus. The four types of machines provided different hydrodynamics which, in turn, meant the user would obtain different dissolution results. If one used a different apparatus, therefore, one might get a different dissolution profile.[1]

As already noted, the USP type III apparatus did not have a reciprocating basket. “Pharmaceutical scientists” generally referred to the USP type 1 apparatus as a “basket”, the type II apparatus as a “paddle”, the type III apparatus as a “reciprocating cylinder” and the type IV apparatus as a “flow through cell”.

This reflected the different construction and working of the machines. To test dissolution using a type I apparatus, the composition was placed in a cylindrical mesh basket which was then placed inside a cylindrical vessel containg the dissolution medium. The basket then rotated around inside the cylindrical vessel.

In a type III apparatus, the composition is placed inside a glass reciprocating cylinder which is then moved up and down in a glass vessel containing the dissolution medium.

Apparently, it would be possible to modify a type III apparatus to use a “basket”, but there was no evidence anyone had ever done so.

Against this background, the evidence established that the skilled addressee would recognise that the reference to “basket” in the claim was a mistake.

The question is then how is the claim to be interpreted. GSK argued that the skilled addressee would simply read the reference to a “reciprocating basket” as a reference to the reciprocating cylinder that type III apparatus used. The Full Court considered that this went beyond a purposive construction and would involve impermissibly rewriting the claim.

After referring to Catnic[2] and Kirin-Amgen, the Full Court said at [109]:

It is important to note that Lord Hoffman [in Kirin-Amgen at [34]] was referring here to the meaning conveyed to the skilled addressee by the language used and was not directing himself to a situation in which the skilled addressee deduced that the language of the claim, although conveying to him or her a particular meaning, could never have been intended to mean what it conveyed.

Here, the skilled addressee knew what the term “basket” meant, but “deduced” it couldn’t be intended to mean that.

The Full Court then emphasised a point made in many cases: a patent is a document prepared by the patentee “in words of the patentee’s own choosing” and “the words will usually have been chosen upon skilled advice.”

First, if a mistake had been made, there was a procedure for amendment – which GSK had not invoked in this case. The availability of that procedure had the further significance that [s 115][s115] provided alleged infringers with some protection from damages before the amendments were allowed.

Secondly, in describing the device used for dissolution testing, GSK (at least on its case) was not trying to identify something new. So, the difficulties of describing something which had not existed before would not arise.[3]

Thirdly, the words had to have been put there to mean something. At [138]:

GSK’s infringement case can only succeed if the words “reciprocating basket” are either interpreted to mean “reciprocating cylinder” or simply ignored. Either approach involves an impermissible re-writing of the relevant claims.

And, really, that is the Full Court’s point. Athough one is supposed to interpet the claim through the eyes of the skilled addressee, reading claim 1 the way the skilled addressee apparently would have done did not make proper allowance for the function of the claims. At [139]:

This is a case in which the skilled addressee’s understanding of the claims, as found by the primary judge, does not make proper allowance for the function of the claims in defining the invention. Ultimately, it is for the court to decide the meaning of the claims. This is a case in which we think the language of the claim must be understood to mean what it actually says.

So, although the patent specification is addressed to, and to be understood through the eyes of the person skilled in the art, the Full Court qualified that approach in light of other policies gleaned fron the Act.

Fair basis

Apotex and Generic Partners also lost their appeals against the trial judge’s ruling that GSK’s patent was fairly based and there had been no failure to disclose the best method.

On fair basis, the claims were consistent with the consistory clauses, but Apotex argued the body of the specification showed that the invention was narrower than the broad consistory clauses. This appears to have been an attempt to read the claims down to two specific formulations discussed in the specification, Formulations C and D.

A key point was whether the trial judge had impermissibly taken into account information in an FDA report to ascertain if the claims travelled beyond the disclosure in the specification. Apotex argued this was excluded by the High Court’s decision in the first Lockwood decision, where it had said at [48]:

If all that is essential in assessing a fair basing objection is recourse to the contents of the specification, there is no call, for example, for an examination (except on construction questions) of common general knowledge (which is essential when considering an objection based on want of an inventive step), or of prior art (which is essential when considering novelty (s 7(1))) …

The Full Court, however, rejected this attack; concluding that the information in the FDA Report (which was common general knowledge) informed how the skilled addressee would understand the claims. At [166], the Full Court said:

What is critical to the pharmacokinetic behaviour of the many formulations within the claims is the dissolution profile (or release rate) of the formulation. The primary judge accepted that the FDA Report recognised that a variation of ±10% percentage points in the release rate was acceptable to the FDA even where no IVIVC had been established. This provides evidentiary support for the finding that the skilled addressee would know that various formulations within the claims apart from Formulations C and D were likely to have similar pharmacokinetic properties. This also provides a complete answer to Apotex’s argument that the skilled addressee (equipped with the common general knowledge) would approach the Patent with an understanding that there would be no reason to think that other formulations within the claims would have a similar pharmacokinetic profile to Formulations C and D in the absence of any established IVIVC.

The Full Court also rejected Apotex’ argument that a claim could not be fairly based unless the specification explained why the claims worked. Making it clear that they were dealing only with the position before the Raising the Bar Act reforms, the Full Court said at [170]:

Of course, it is important to note that s 40(2)(a) requires that the complete specification “describe the invention fully”. A complete specification may still “describe the invention fully” without explaining why the invention works. After all, the inventor, who presumably believes that the invention described works, may not understand why it works. But this does not prevent him or her from obtaining patent protection for the invention.

Best method

For best method, the argument built on the Servier ruling to argue there had been a failute to disclose the best method because the specification did not disclose the particular grade or viscosity of the high viscosity HPMC or the granulation end points used to make Formulations C and D.

At [192], the Full Court accepted that there could be a failure of best method if information was withheld even though it could be ascertained by routine experiment. The Full Court rejected the best method attack, however, finding that the informatin omitted was inessential manufacturing and production information. According to the Full Court at [201]:

It does not follow merely because the patent applicant uses a particular manufacturing process or a particular excipient in formulating its commercial embodiment that it will form part of the best method. The patent applicant may have adopted a particular process, or used a particular excipient, for reasons that are associated with its own particular circumstances rather than because it believes that they reflect the best method. The best method known to the patent applicant may be one that allows for the optimisation of a formulation by the skilled addressee rather than one that adheres to one specific formulation that the patent applicant seeks to commercialise.

Those preparing specifications might want, first, to note the reservation that the Full Court was not dealing with the “new” post-Raising the Bar regime. Secondly, [192] appears to carry with it the warning that, if one leaves something out, one does so at one’s own peril.

GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v
Generic Partners Pty Limited
[2018] FCAFC 71 (Middleton, Nicholas and Burley JJ)


  1. At [50], the Full Court explained, “There is no established correlation between dissolution results measured using the different USP apparatus. Sometimes small differences are measured, other times the measured differences are large. Differences in measured dissolution profiles as between each of USP type I, II and III apparatus may not be predictable.”  ?
  2. Catnic Components Limited & Anor v Hill & Smith Limited [1982] RPC 183 (HL).  ?
  3. Referring to another aspect of the construction problem adverted to by Lord Hoffmann at [34] in Kirin-Amgen. Leading of course to the irony that GSK did in fact describe something new!  ?

Patent cases in the Federal Court

Kelvin Tran from Litimetrics has published some fascinating statistics about patent litigation in the Federal Court of Australia.

For example, since 2010, 472 cases have been commenced in the Federal Court involving patent issues. Mr Tran points out that number “compares” to 160,000 granted standard patents and 1,400 certified patents.

The publication also includes a breakdown of numbers by registry, length of proceedings, time to resolution and the average number of typical events such as directions hearings, interlocutory applications and the like. They may be useful if you have to prepare a budget or a costs disclosure statement. To view Mr Tran’s statistics, you should go here.