Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth Australia Pty Ltd [2010] FCA 1211 (8 November 2010)
Validity – whether claims entitled to priority date of original US application – whether description is sufficient – whether claims are clear and fairly based on description – whether claims are novel – whether claims are inventive – whether patent obtained by false suggestion or misrepresentation –
entitlement – whether patentee gained title to the invention from all inventors – effect of omission of co-inventors' names from application –
infringement – whether generic pharmaceuticals would infringe patent
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EFEXOR-XR: C17H27NO2 |
An Australian Federal Court judge has upheld a patent covering the "extended release" formulation of Wyeth's antidepressant drug EFFEXOR (venlafaxine hydrochloride), marketed as EFFEXOR-XR, barring generic manufacturers Sigma Pharmaceuticals (Australia) Pty Ltd, Alphapharm Pty Ltd and Generic Health Pty Ltd from "importing, marketing, taking orders for, selling, supplying, and offering to supply" their own versions of the drug in Australia.
Each of the three generic pharmaceutical companies has obtained registration of extended release formulations of venlafaxine hydrochloride on the Australian Register of Therapeutic Goods. Sigma's product is known as Evelexa XR, Alphapharm's as Enlafax-XR and Generic Health's as "generichealth XR".
The extended release formulation of venlafaxine hydrochloride is the subject of Australian Patent No. 2003259586 ("the XR patent"), which was granted on 11 May 2007. The basic compound, venlafaxine hydrochloride, was the subject of Australian Patent No. 567524, which expired on 6 December 2008.