Beach J has ruled that there is no warrant for interpreting “basket” in GSK’s patent to mean “cylinder”, with the consequence that the patent was neither infringed, nor invalid.

GSK’s patent is “for a sustained release paracetamol bilayer tablet with a specified in vitro dissolution profile”. Claim 1 is as follows:

A pharmaceutical composition comprising:

a bilayer tablet having an immediate release phase of paracetamol and a sustained release phase of paracetamol,

the immediate release phase being in one layer and comprising from about 10 to 45% by weight of the total paracetamol; and

the sustained release phase being in the other layer and comprising from about 55% to 90% by weight of the total paracetamol in admixture with a matrix forming polymer or a mixture thereof;

said composition comprising from 600 to 700mg of paracetamol per unit dose and a pharmaceutically acceptable carrier,

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:

Ÿ 30 to 48% released after 15 minutes

Ÿ 56 to 75% released after 60 minutes

Ÿ >85% released after 180 minutes.

I have emphasised the word “basket” above because it is a mistake. It should read “cylinder”. It was also a mistake repeated in the body of the specification. Beach J rejected Apotex’ argument that “basket” was a reasonable option for use in a USP type III apparatus at the priority date. However, none of the expert witnesses had heard of such a thing and Beach J held that the skilled addressee[1] would have recognised it was a mistake and should have read “cylinder”.

Now, the High Court has told us that a patent specification is a document directed to the public, but it is to be read through the eyes of the skilled addressee. So, for example, Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ said in Kimberly-Clark at [24]:

It is well settled that the complete specification is not to be read in the abstract; here it is to be construed in the light of the common general knowledge and the art before 2 July 1984, the priority date; the court is to place itself “in the position of some person acquainted with the surrounding circumstances as to the state of [the] art and manufacture at the time”.[2]

The courts have developed lengthy lists of propositions to implement that directive.[3] One of the propositions that repeatedly gets cited is the rule that you cannot expand or narrow the meaning of a claim by reference to the body of the specification. So, for example, the High Court in Kimberly-Clark itself helpfully said at [15]:

Where the question concerns infringement of a claim or the sufficiency of a claim to “define” the invention, it has been held in this Court under the 1952 Act that the plain and unambiguous meaning of a claim cannot be varied or qualified by reference to the body of the specification. However, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.[4]

How to reconcile the two?

Well, Beach J held that, notwithstanding the mistake, the words of the claim were clear and unambiguous and there was no warrant to substitute “cylinder” for “basket”. Warned by Apotex’ counsel, Ms Goddard, that the patent was a public instrument the amendment of which was addressed in the Act by a different mechanism,[5] his Honour summarised his conclusion at [14]:

No case expressly binds me to accept the result contended for by GSK. The hypothetical construct of the skilled addressee cannot be taken so far as to re-write or amend a claim of the specification. That conceptual tool has its limits. After all, the boundary constraint is that I am obliged to construe the claim as it is, rather than what it should have been. I accept Apotex’s contention. Accordingly, GSK must fail on infringement as claim 1 is the only independent claim. But Apotex and Generic Partners fail on invalidity.

His Honour elaborated on these conclusions at much greater length at [368] – [401].

Beach J’s rejection of the attacks on invalidity did not turn on whether “basket” meant “basket” or “cylinder”. Having found that “basket” did mean “basket”, the attacks on fair basis, sufficiency and lack of clarity necessarily failed. However, his Honour would also have rejected them even if “he had found ”some polytropic fairy dust“ could transform ”basket“ into ”cylinder”.

 

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 Consumer Healthcare Investments (Ireland) (No. 2) Limited v Apotex Pty Ltd [2016] FCA 608


  1. or “person skilled in the art” to use the language of the Act in s 7. Section 40 wants the person to be skilled in the relevant art, but that shouldn’t be much, if at all, different.  ?
  2. The citations have been omitted, but they included Samuel Taylor Pty Ltd v SA Brush Co Ltd (1950) 83 CLR 617 at 624?625; Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610; Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 at 102; Populin v HB Nominees Pty Ltd (1982) 41 ALR 471 at 476.  ?
  3. Sheppard J referred to 10 in Decor v Dart. Hely J identified a raft in Beltreco starting at [70]. The Full Court was rather more succinct at [67] in Jupiters.  ?
  4. The citations I have omitted again include reference to Welch Perrin at 610. This rule is Sheppard J’s second proposition, referred to by Hely J at [74] and elaborated at [76] to [78]and the 4th proposition in Jupiter’s.  ?
  5. Presumably, s 104 and, in the court proceeding context, s 105.  ?