Glaxo

Omnibus claims: substantially the same

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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

[lewis]:

  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].  ?

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Of flat nosed syringes or if at first you don’t succeed

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Having had the interlocutory injunction he granted overturned on appeal, Rares J has now determined at the substantive trial that both of Glaxo’s syringe variants infringed Reckitt Benkiser’s “flat-nosed syringe” patent.

You will recall that Reckitt has patented a bottle and syringe combination to simplify “feeding” medicines to babies and toddlers in particular. Claim 1 in part provides:

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 claim goes on at some length to elaborate in further detail the features of the various elements.

Glaxo had two variants of its competing product:

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

For present purposes, I found two points of interest: the finding that the second variant infringed and the failure of Glaxo’s entitlement attack.

Infringement

After dealing with construction issues at some length, Rares J found the first version infringed claim 1, but Glaxo’s second version did not. This was because, at [126], the indented “tip” at the distal (bottom) end of the syringe meant the end was not substantially the same diameter as the barrel itself.

Notwithstanding this, Rares J found the second version did infringe claim 9, the omnibus claim:

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

Rares J considered that the second variant functioned the same as the preferred embodiment described in the specification and drawing. While the indented tip was a difference, claim 9 required only substantial compliance and there was no difference in substance between the second variant and the patent description. At [149], his Honour explained:

…. 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 ….

Earlier, his Honour had pointed out that the bottle liner of Glaxo’s second variant was shaped to complement the configuration of the indented tip of the syringe to sealingly engage as required by the patent. Although liquid was drawn into the indented tip from the bottle, it was essentially “dead space” as the tip of the syringe’s plunger had a correspondingly indented end so that the barrel measured volumes in the same as as the patented description. Accordingly at [150]:

The alternate syringe takes the substance of the flat-nosed syringe described in the patent and drawings as stated in claim 9.

Entitlement

In coming up with the claimed apparatus, Reckitt[1] had engaged a contractor. Glaxo argued that it was the contractor’s operative, a Mr Pearce, who was actually the inventor. Even though Reckitt’s posited inventors did not give evidence, Rares J rejected this attack without needing to resort to s 22A or s 138(4).

Glaxo’s challenge essentially ran into two problems. First, when the contractor discovered the early version of the patent application leading to the patent, it did challenge Reckitt about it. It’s concern, however, was to ensure its continued ability to use the “liner” element, only one integer of the claimed invention as a whole. Arising from this, Reckitt did make some modifications to its application and the contractor reached agreement with Reckitt preserving the contractor’s ability to use features of the liner for other projects freely.

Secondly, although Mr Pearce did give evidence, it was limited to claiming inventive contribution only to the liner element and it was not suggested to him that he, rather than Reckitt’s employees, came up with the idea for the features of the other elements comprising the invention.

Glaxo’s claim based on false suggestion similarly failed:

the documentary evidence suggests that the idea that conceived of a combination of a flat-nosed syringe co-operating with a bottle neck liner and a bottle in the form of the apparatus had nothing to do with Mr Pearce or HDB and was Ms Dallison’s inspiration. She also had envisaged the features of that combination, being the way in which the flat-nosed syringe would co-operate with the liner, and, with Mr Harrison, the need for the liner to be adapted suitably to pour, without mess, the liquid contents from the bottle ….

Reckitt Benckiser Healthcare (UK) Ltd v Glaxosmithkline Australia Pty Ltd (No 5) [2015] FCA 486

  1. The named inventors were actually employees of Boots, the pharmacy chain, and Reckitt’s predecessor in title.  ?

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Dosing up children, overturning interlocutory injunctions and the balance of convenience

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An IPwars first: my colleague, Susan Gatford, provies an update in which a Full Court overturned an interlocutory injunction against an alleged patent infringement. Do you agree with Sue that a trend seems to be developing?

Remember way back at the start of the Apple v Samsung litigation the Full Court dissolved the interlocutory injunction granted to Apple? Well, they did it again earlier this month in GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited.

The proceeding concerns an invention for accurately serving up doses of liquid medicines for children. Apparently children don’t like taking medicine from syringes with nozzles because they remind them of bad things (injections). But syringes are the most accurate way to measure doses of medicine accurately. Solution: design a syringe that doesn’t quite look like one. The syringe in the patent looked like this

Patented embodiment
Patented embodiment

It was designed by Reckitt and called a flat nosed syringe (i.e. one without a nozzle). It fits into a plastic attachment inserted into the neck of a medicine bottle. The syringe fits tightly into the neck attachment and allows accurate dosages to be measured and then administered. Reckitt has patented its bottle-syringe-bottle neck arrangement. It uses it to sell nurofen for children. This has apparently given their nurofen product a substantial competitive advantage over Glaxo’s panadol (the medicines are largely interchangeable and parents chose the one that is easiest to use in terms of dose measurement and child acceptance).

Interestingly, despite being aware of and seeking to emulate the Reckitt product, Glaxo didn’t do any patent searches. It seems that this was because it was told by the third party manufacturers of the syringe and of the bottle and neck attachment that they as manufacturers held all of the relevant patents.[1] (They were wrong.)

Two injunctions were granted. On 28 May 2013 a Glaxo product that substantially replicated the Reckitt product was injuncted.[2] According to the Court’s reasons Reckitt’s only complaint was the similarity of the bottle neck liner.[3] This wasn’t, however, only what the patent claimed as its invention (remember, the aim was to design a syringe that didn’t look like one).

Version 1
Version 1

Glaxo then re-designed the shape of the syringe and advised Reckitt that it intended to sell their panadol with the offending bottle neck liner but with a different syringe. The re-designed syringe looked like this

Version 2
Version 2

Reckitt went back to Court to argue that this fell within claim 1 of the patent, which relevantly read:

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 and being perpendicular to the longitudinal access of the barrel….

The trial judge held that there was a sufficiently strong argument that the words

“having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal access of the barrel”

would be understood by an addressee skilled in the art at the time of the patent to apply to the distal end of the barrel.[4] Accordingly, his Honour held that Reckitt had a sufficiently strong prima facie case that warranted the grant of an injunction. His Honour rejected Glaxo’s application to lead further evidence as to the balance of convenience and made orders restraining the sale of the re-designed product. Glaxo appealed.

It argued that the trial judge’s interpretation required the additional words “at its distal end” to be added to the above extract, and that this was impermissible. The Full Court agreed. Put simply, its view of the strength of Reckitt’s infringement case on the design-around syringe was substantially lower than that of the trial judge. It also said that the trial judge erred procedurally by forcing Glaxo to rely only on its balance of convenience evidence from the May hearing, and by rejecting the further balance of convenience evidence on which it sought to rely in July. At the May hearing the trial judge had rejected Glaxo’s evidence as to balance of convenience in strong terms and made findings in accordance with of evidence filed by Reckitt in reply to it. The Full Court said

It was, of course, a matter for the primary judge to make findings of fact based on the evidence before him. But having made strong findings of fact, which were directly contrary to Ms Tomkins’ first affidavit, in the context of assessing the balance of convenience at the first hearing, it is difficult to understand why GSK should be prevented at the second hearing from relying upon additional evidence from Ms Tomkins in the form of her second affidavit which expanded upon the reasons why the primary judge’s suggested option was impracticable and posed public health and safety risks (see further below). All the more so in circumstances where the second hearing took place more than six weeks after the first hearing and related to an allegation of patent infringement in respect of a different apparatus. These considerations are not displaced or diminished by s 37M of the FCA Act.

The case is a timely reminder that:-
1. leave to appeal against interlocutory orders in patent and like cases is a serious option;
2. applications relating to “design around” products need to be considered both substantively and procedurally as the separate applications that they are in fact; and
3. it is worth paying very careful attention to balance of convenience evidence, which is often a moving feast, and doing your best to make sure that the Court does too. Referring the Court to this case might just help in that endeavour.

GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited [2013] FCAFC 102

Susan Gatford is barrister on Gordon & Jackson’s list at the Victorian Bar. She practices out of Owen Dixon Chambers in Melbourne and is also a registered trade mark attorney.

  1. Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline Australia Pty Ltd [2013] FCA 583 (Reckitt (No.1)) at [36].  ?
  2. Reckitt (No.1).  ?
  3. Reckitt (No.1) at [37].  ?
  4. Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline Australia Pty Ltd (No 2) [2013] FCA 736 at [20].  ?

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