Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132 (28 October 2011)
Validity – ‘external’ fair basis – whether claims entitled to priority date of original US application – whether claims are novel
Generic pharmaceutical manufacturers Sigma Pharmaceuticals (Australia) Pty Ltd, Alphapharm Pty Ltd and Generic Health Pty Ltd will be free to sell in Australia their own versions of an "extended release" formulation of antidepressant drug venlafaxine hydrochloride (marketed by Wyeth as EFFEXOR-XR), after a Full Bench of the Federal Court of Australia upheld their appeal against a decision issued a year ago by Justice Jagot.
Each of the three generic pharmaceutical companies had previously obtained registration of extended release formulations of venlafaxine hydrochloride on the Australian Register of Therapeutic Goods (ARTG). According to these registrations, Sigma's product is known as Evelexa XR, Alphapharm's as Enlafax-XR and Generic Health's as "generichealth XR".
In the original case before the Federal Court, the generic manufacturers sought revocation of Wyeth’s Australian Patent No. 2003259586 ("the XR patent"), so that they would be free to market their generic products in Australia. In response, Wyeth argued that the proposed manufacture and sale of generic drugs would infringe claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the XR patent. Justice Jagot dismissed the generic manufacturers' invalidity claims, and granted an injunction barring them from selling generic extended release venlafaxine hydrochloride in Australia.
On appeal, Justice Bennett, Justice Nicholas and Justice Yates have found that the relevant claims of the XR patent are invalid, and that the primary judge erred in finding that they were entitled to the benefit the priority date of United States Patent Application No 60/14006, filed on 25 March 1996. In fact, the Full Court has found, the claims are based on amendments filed on 20 December 2006, and are not entitled to any earlier date. As a result, they are anticipated by the sale of EFFEXOR-XR in Australia since 1999.
Justice Bennett has written the leading opinion of the Full Court, with Justices Nicholas and Yates concurring, and providing their own additional reasons in relation to selected aspects of the case.
Appeal from: Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth Australia Pty Ltd [2010] FCA 1211
See also: Australian Federal Court Blocks Generic EFFEXOR-XRValidity – ‘external’ fair basis – whether claims entitled to priority date of original US application – whether claims are novel
Generic pharmaceutical manufacturers Sigma Pharmaceuticals (Australia) Pty Ltd, Alphapharm Pty Ltd and Generic Health Pty Ltd will be free to sell in Australia their own versions of an "extended release" formulation of antidepressant drug venlafaxine hydrochloride (marketed by Wyeth as EFFEXOR-XR), after a Full Bench of the Federal Court of Australia upheld their appeal against a decision issued a year ago by Justice Jagot.Each of the three generic pharmaceutical companies had previously obtained registration of extended release formulations of venlafaxine hydrochloride on the Australian Register of Therapeutic Goods (ARTG). According to these registrations, Sigma's product is known as Evelexa XR, Alphapharm's as Enlafax-XR and Generic Health's as "generichealth XR".
In the original case before the Federal Court, the generic manufacturers sought revocation of Wyeth’s Australian Patent No. 2003259586 ("the XR patent"), so that they would be free to market their generic products in Australia. In response, Wyeth argued that the proposed manufacture and sale of generic drugs would infringe claims 1, 4, 5, 8, 9, 10, 15, 16 and 27 of the XR patent. Justice Jagot dismissed the generic manufacturers' invalidity claims, and granted an injunction barring them from selling generic extended release venlafaxine hydrochloride in Australia.
On appeal, Justice Bennett, Justice Nicholas and Justice Yates have found that the relevant claims of the XR patent are invalid, and that the primary judge erred in finding that they were entitled to the benefit the priority date of United States Patent Application No 60/14006, filed on 25 March 1996. In fact, the Full Court has found, the claims are based on amendments filed on 20 December 2006, and are not entitled to any earlier date. As a result, they are anticipated by the sale of EFFEXOR-XR in Australia since 1999.
Justice Bennett has written the leading opinion of the Full Court, with Justices Nicholas and Yates concurring, and providing their own additional reasons in relation to selected aspects of the case.
