In a decision handed down on 10 May 2018, the Full Federal Court of Australia unanimously upheld the trial judge’s finding of validity of a patent to a sustained release pharmaceutical formulation containing the active ingredient paracetamol, and confirmed that the patent was not infringed. The Court dismissed both the appeal by the patent owner GlaxoSmithKline Consumer Healthcare Investments (GSK), and the cross-appeal by Apotex and Generic Partners (the respondents), in relation to (respectively) the infringement and validity of the patent. [1]
Background
The patent in question, Australian Patent No 2001260212 (the ‘212 patent), claims a bilayer tablet having an immediate release phase of paracetamol and a sustained release phase of paracetamol. Claim 1 further specifies that the paracetamol composition has a specified dissolution profile determined by the use of a USP (United States Pharmacopeia) type III apparatus, with a “reciprocating basket”.
It was established at first instance, that a ‘USP type I apparatus is generally referred to by pharmaceutical scientists as a “basket”, USP type II apparatus as a “paddle”, USP type III apparatus as a “reciprocating cylinder” ’. [2] Each apparatus was known to have a differing hydrodynamic profile, which resulted in a differing dissolution profile of an analysed formulation.
At first instance, the ‘212 patent was found to be valid, but not infringed by the respondents. In particular, the trial judge found that a mistake was made in claim 1 in identifying the relevant dissolution apparatus and that the term ‘basket’ should have read ‘cylinder’. The trial judge noted that the term ‘basket’ was used consistently throughout the specification and found that ‘basket’ had a clear and unambiguous meaning. As such, even though the use of the term ‘basket’ was alleged to be a mistake, the trial judge found that there was an obligation ‘to construe the claim as it ‘is’, rather than what it should have been.’ [3] GSK failed to prove infringement as it did not test the alleged infringing products using USP type III apparatus with a basket. Accordingly, at first instance it was found that there was no infringement of the ‘212 patent.
In relation to validity of the patent, the respondents argued that the claims lacked an inventive step, lacked fair basis, and, that the specification was insufficient, failed to define the invention and failed to describe the best method of performing the invention. However, the trial judge found that none of the arguments on invalidity were made good and the patent was found to be valid.
Appeal by GSK
In the appeal to a three judge bench of the Full Federal Court, it was alleged by GSK that the trial judge erred in his original finding, and that the respondents should have been found to infringe the ‘212 patent. In particular, GSK argued that the primary judge should have found that claim 1 referred to the USP type III apparatus with a reciprocating cylinder, claiming that the reference to a ‘basket’, in both the claims and body of the specification, would have been understood by a person skilled in the art (PSA) to be an error.
The Full Court upheld the primary decision, stating that ‘a “basket” means “basket” not a cylinder’. The claim language suggested that reference to “the USP type III apparatus” alone was not sufficient to describe the apparatus relevant to the claimed method, and that including the term ‘reciprocating basket’ was required to accurately describe the apparatus. In handing down its decision, the Court stated that ‘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.’ [4]
Cross-appeal by Apotex and Generic Partners
The cross-appeal pressed that the claims in question were not fairly based upon the matter described in the specification of the patent and that the patentee did not disclose a best method of performing the invention.
The respondents argued that the claims were too broad because the specification disclosed only two pharmaceutical formulations, which were essentially the same, with a specific dissolution profile. The Full Court dismissed this argument finding that the invention was a bi-layer tablet having two phases of paracetamol release, an immediate and a sustained release phase, with a defined dissolution profile. Furthermore, it found that the two formulations described were merely examples of the claimed invention and that the specification as a whole allowed for an invention that was not limited to the exemplified embodiments.
The Court also found that a specification is not required to identify the reasoning or theoretical basis which determines the selection of content referred to by the claims. While Australian patent law requires a specification to describe the invention fully, this does not extend to requiring the specification to ‘describe why the invention works’. By way of example, the Court said that ‘[an] 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.’[5]
The respondents pressed that the trial judge erred in his finding that the specification disclosed the best method of performing the invention, arguing that a PSA should not be required to undertake any experimentation to arrive at the best method of performing the invention.
The Full Court dismissed this argument finding that the best method to perform the invention was in fact disclosed, despite the specification not including information relevant to manufacturing and production, which was deemed to be not essential to the invention.
Conclusion
This decision, handed down by the Australian Full Federal Court, emphasises the nuances of claim construction and the importance of construing each and every feature of a claim. In particular, the decision highlights that the language used in claims cannot be interpreted beyond plain meaning, or simply ignored, for the sake of convenience. Furthermore, this decision reinforces that a specification need not explain the reasons why an invention works, but simply describe the invention fully, so as to be understood by a PSA.
It is not yet known whether there will be a further appeal against the Full Federal Court’s decision. However, an appeal to Australia’s highest court, the High Court, would require special leave of that Court to proceed.
This article was written by Dr Benjamin Cleary.
If you have any specific enquiries about this article, please contact Paul Jones or Debra Tulloch.
[1] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71
[2] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71 [48]
[3] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No. 2) Limited v Apotex Pty Ltd [2016] FCA 608 [14]
[4] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71 [136-138]
[5] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71 [170]