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!  ?

EIFY: terms of use

Following on from this week’s earlier post about the copyright issues in the EIFY case, McDougall J also held the “clickwrap” agreement was enforceable, but the breach did not result in any compensable loss.

You will remember that EIFY and 3D Safety provide competing web-based induction services for the construction industry. The principals of 3D Safety had accessed EIFY’s site in the course of developing its websites for Mirvac and Thiess.

Before a browser could access the web-based induction services provided by EIFY, he or she had to check a box acknowledging that he or she had read and agreed to the terms and conditions of use. McDougall J found this sufficient to form an agreement.

The registration details a user was required to input included an ABN and at least one of the 3DSafety principals had entered in his company name as well.

The terms and conditions, however, followed the modern form of drafting, referring to “you” and “your”. At [324] – [325], McDougall J found that this gave rise to a binding contract only with the particular user and not his or her company:

324 The strong impression conveyed by the terms of use overall is that they are directed to regulating the basis on which each person who has access to the website exercises that access. The terms of use appear to distinguish between those who access the website (“you”) and those with whom EIFY “enters into agreements” (“Clients”).

325 In the absence of any express acknowledgment, either in the registration webpages or in the terms of use themselves, that an individual who registers and thereafter accesses the site accepts the terms of use not only in his or her own right but also on behalf of his or her employer, I think that Mr Andronos’ submission on this point is correct. By clicking to acknowledge their acceptance of the terms of use, Messrs Conacher and Morrow indicated that they personally accepted those terms. That must mean that they agreed to accept those terms of use as regulating their personal access to the website. It does not follow, and I do not find, that by doing so they agreed to bind Services or Systems to those terms of use.

326 In short, Messrs Conacher and Morrow were bound by the terms of use. [3D Safety was] not.

The terms of use included clause 5:

  1. Access and Interference
    You agree that you will not use any robot, spider, other automatic device, or manual process to monitor or copy our web pages or the content contained herein without our prior written permission. You agree that you will not use any device, software or routine to interfere or attempt to interfere with the proper working of our Site. You agree that you will not take any action that imposes an unreasonable or disproportionately large load on our infrastructure. Much of the information on our Site is updated on a real time basis and is proprietary or is licensed to e-Induct® by our Clients or third parties. You agree that you will not copy, reproduce, alter, modify, create derivative works, or publicly display any content from our Site without the prior written permission of e-Induct or of the party authorised to grant such permission.

McDougall J was rather critical of the drafting of this clause. Nonetheless, he was able to find that Conacher and Morrow (the principals of 3D Safety)[1] had accessed EIFY’s site and breached the terms. However, this did not help EIFY.

This was because McDougall J found that the only breach of the terms had been accessing confidential information. The confidential information was confidential to EIFY’s clients, not to EIFY. As a result, his Honour considered EIFY would not be able to establish any loss to be compensated through damages.

EIFY Systems Pty Ltd v 3D Safety Services Pty Ltd [2017] NSWSC 1310 (McDougall J)

  • By the time of the trial, Morrow had in fact ceased being a director and only held some shares.  ?

Omnibus claims: substantially the same

In partly allowing Glaxo’s appeal, the Full Court (Allsop CJ, Yates and Robertson JJ) has ruled against an expansive interpretation of omnibus claims.

You may recall (here and here) that Reckitt Benckiser has a patent protecting its bottle / syringe combination for dispensing Panadol to children aged between 1 – 5 years old.[1]

Claim 1 claimed:

A liquid dispensing apparatus comprising a bottle, a bottle neck liner and a flat-nosed syringe having a plunger and a barrel, the barrel terminating at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal axis of the barrel, the bottle having a bottle neck in which is located the bottle neck liner having a cylindrical body sealingly engaged inside the bottle neck such that liquid cannot flow between the bottle neck liner and the bottle neck, the bottle neck liner comprising a sleeve comprising at its lower end an inward step located within the bottle neck, an aperture being defined inwardly of the inward step, wherein the cylindrical body and the sleeve are connected together with a web of material only at the upper end of the cylindrical body and of the sleeve, wherein the sleeve is formed with a flared portion at its upper end into which the distal end of the syringe barrel passes; wherein when the syringe barrel is inserted into the sleeve the inward step prevents the syringe barrel from protruding past the step and liquid cannot flow between the sleeve and the barrel, but can leave the bottle only via the aperture and thence the syringe. (emphasis supplied)

and claim 9 was an omnibus claim:

A liquid dispensing apparatus, substantially as described with reference to the drawings and/or examples.

Glaxo marketed two different versions of its competing product:

Glaxo Version 1
Glaxo Version 1
Glaxo Version 2
Glaxo Version 2

The trial Judge held that Version 1 infringed claim 1 but, because it had a narrower nozzle section at the spout[2] and so the barrel was not uniform along its length, Version 2 did not. The barrel of Version 2 did not terminate “at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe barrel”. The trial Judge, however, then went on to find that Version 2 infringed the omnibus claim because it functioned substantially in the same way as described in the patent:

The alternate syringe has exactly the same function as that described in the patent and the drawings. The alternate syringe is a flat-nosed syringe that has a distal end that fits into the liner and achieves a good seal with it so that it can draw up liquid without leaking from the bottle or the syringe. The mere fact that there is a corresponding tip on both the barrel and the reciprocating plunger used in the alternate syringe in the second product complained of should not be allowed to disguise that that product has taken the substantial configuration resulting from the patentee’s invention and its character for the dispensing of liquids from bottles without mess using an apparatus with a flat-nosed syringe: Radiation 60 CLR at 52; Raleigh 65 RPC at 160. The alternate syringe, as incorporated into the second product complained of, is not a substantially new or different combination

The Full Court dismissed the appeal from the trial Judge’s finding that Version 1 did infringe claim 1 and Version 2 did not. Importantly for present purposes, it allowed Glaxo’s appeal from the finding that Version 2 nonetheless infringed claim 9, the omnibus claim:

[79] … contrary to the conclusion of the primary judge, the use of the word “substantially” in claim 9 in the expression “substantially as described with reference to the drawings and/or examples” does not extend the definition of the invention to “the substantial idea” disclosed by the specification and shown in the drawings.

[80] The word “substantially” provides no warrant for departing from what the specification itself mandates to be the essential features of the invention. A flat-nosed syringe dimensioned as described in the consistory statement is one of the essential features of the invention. Thus, whatever work the word “substantially” is to perform in claim 9, it cannot transform a feature made essential by the description of the invention into one that is now inessential. Put another way, an embodiment that does not possess the essential features of the invention as described, cannot be one that is “substantially as described”. Thus, the word “substantially” in claim 9 does not do the work which the primary judge held that it did.

The Full Court pointed out that the description and drawings were a particular form of the first embodiment in the patent. It was plain from the consistory clause describing the embodiment and claim 1 that a barrel of uniform diameter throughout its length was an essential feature of the invention. All claims apart from the omnibus claim were dependent from claim 1. Claim 1 was the widest form of the claimed invention. Accordingly, the omnibus claim, which is a more narrowly defined claim, could not be wider than claim 1.[3]

Perhaps continuing the swing of the interpretation pendulum back towards the ‘literal meaning’ approach, their Honours also warned against too ready an assumption that some wording in a claim was just “a slip of the pen” rather than a carefully chosen limitation.

ps As Dr Patentology points out, s 40(3A) bans (or tries to ban) the use of omnibus claims in patents the subject of the new rules under the Raising the Bar regime; i.e., in broad terms, patents the subject of an application filed on or after 13 April 2013 or, if filed earlier, which had not been the subject of a request for examination before 13 April 2013.[4]

If you have a comment or a question, please feel free to post it in the comments section or, if you would prefer, email me.

GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Ltd [2016] FCAFC 90


  1. Australian Patent No. 2003283537 (the patent) entitled “Improvements in and relating to liquid dispensing”.  ?
  2. In expert witness legalese, “the indented section at the distal end”.  ?
  3. As the High Court explained in [Radiation]: “But it is said that the words in the claim. “ substantially as described,” tie the claim to the particidar form of construction illustrated in the drawings. The effect of the words depends upon the construc­ tion of the claim as a whole, but “ in general the words exercise a limiting effect by tying ” the claim “ more closely to the preceding description ” (See Fletcher Moulton on Patents (1913), p. 128). They do not, however, limit the claim to the precise construction shown in the drawings but rather to the kind of apparatus mentioned and the method described in the specifications and illustrated in the drawings.”.  ?
  4. Someone made a more detailed attempt to explain the transition provisions in Lahore, Patents, Trade Marks & Related Rights at [12,000].  ?