Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132

FEDERAL COURT OF AUSTRALIA

Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132 Citation: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132

Appeal from: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2010] FCA 1211

Parties: SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LIMITED ACN 004 118 594 v WYETH AND WYETH AUSTRALIA PTY LIMITED ACN 000 296 211 ALPHAPHARM PTY LIMITED ACN 002 359 739 v WYETH AND WYETH AUSTRALIA PTY LIMITED ACN 000 296 211 GENERIC HEALTH PTY LTD ACN 110 617 859 v WYETH AND WYETH AUSTRALIA PTY LIMITED ACN 000 296 211

File numbers: NSD 1533 of 2010 NSD 1603 of 2010 NSD 1644 of 2010

Judges: BENNETT, NICHOLAS AND YATES JJ

Date of judgment: 28 October 2011

Catchwords: PATENTS – characterisation of invention in priority document – whether method disclosed in priority document is confined to particular encapsulated formulation – relevance of claims of priority document to characterisation of invention PATENTS – characterisation of invention in patent – whether invention involves discovery of new method with any formulation PATENTS – validity – external fair basis – priority date – whether amended claim is "in substance disclosed" in priority document PATENTS – validity – internal fair basis – relevance of consistory clause mirroring claim of patent – whether claims encompassing a formulation using hydrogel technology lack fair basis where specification states that attempts to produce a formulation using hydrogel technology were fruitless and such a formulation is impossible to achieve – whether claims unconfined to treatment of depression lack fair basis where specification refers only to depression PATENTS – validity – sufficiency – relevance of statements made in specification that attempts to produce formulation using hydrogel technology were fruitless and such a formulation is impossible to achieve – relevance of failure to provide description to enable performance of claimed methods using hydrogel tablet technology PATENTS – validity – false suggestion – relevance of expert evidence concerning statement made in specification that production of formulation using hydrogel technology is impossible to achieve – whether statement was a false suggestion material to grant of patent – whether statement that attempts to produce formulation using hydrogel technology were fruitless was a false suggestion material to grant of patent – relevance of absence of evidence from Commissioner PATENTS – validity – false suggestion– relevance of failure to nominate all inventors correctly PATENTS – validity – clarity – definition of therapeutic blood plasma concentration – where further steps required to ascertain whether a particular formulation infringes patent PATENTS – validity – obviousness – expert evidence – whether knowledge of existence of patent and of successful formulation taints experts' conclusions with hindsight PATENTS – validity – entitlement – relevance of failure to nominate all inventors correctly – evidentiary onus PATENTS – infringement – whether claims of patent should be construed to exclude hydrogel technology