Wyeth faces trial over generic Effexor delay
Intellectual Property June 1, 2018 11:21 pm By Miklos Bolza | Sydney

A decade-long courtroom battle over a patent for Effexor-XR that delayed the release of cheap versions of the anti-depressant is at the centre of a trial starting Monday in Sydney pitting four generic drug makers against pharmaceutical giant Wyeth.

Three generics companies, Generic Health, Sigma Pharmaceuticals and Alphapharm, have all claimed loss of sales after an interlocutory injunction nine years ago halted their plans to market a generic version of Wyeth’s extended release Effexor during the protracted legal battle over the drug.

A fourth firm, Pharmathen Industrial, is claiming damages for lost sales through its customers, Generic Health and Alphapharm.

The Commonwealth of Australia is also seeking compensation for losses as a result of the injunctions. It alleges it had to subsidise a greater amount for Wyeth’s Effexor-XR on the Pharmaceutical Benefits Scheme because the drug had a higher price than a generic version would have had.

The case stretches back to 2009, when Generic Health, Sigma Pharmaceuticals and Alphapharm filed three separate cases against Wyeth. They claimed Wyeth’s patent for Effexor-XR was invalid and sought to get their own version of the drug — which contained a modified release formula of venlafaxine hydrochloride — onto the market.

After Wyeth filed a cross-claim accusing the three generics of patent infringement, Justice Jayne Jagot ordered interlocutory injunctions, barring the generics companies from marketing, selling or supplying cheap copies of Effexor-XR.

In November 2010, Judge Jagot ruled in favour of Wyeth, upholding nine claims of the Effexor-XR patent, restraining the generics from further infringement, and awarding final injunctive relief to Wyeth.

The generics appealed Judge Jagot’s decision, taking the case to the Full Court before Justices Annabelle Bennett, John Nicholas and David Yates. In December 2011, the Full Court ruled in favour of the generics’, revoking all claims of Wyeth’s patent and releasing the generics from Judge Jagot’s initial interlocutory injunctions.

An application by Wyeth to the High Court to appeal the Full Court’s decision was rejected.

In August 2013, the Commonwealth of Australia joined the case against Wyeth. In December 2015, a Full Court decision by Justices John Dowsett, Susan Kenny and John Nicholas ruled the Federal Government could seek damages, and ordered that Wyeth pay 50 percent of the Commonwealth’s costs on a party-party basis.

Wyeth is represented by DLA Piper Australia, Generic Health by Bird & Bird, Pharmathen and the Commonwealth by Corrs Chambers Westgarth, and Sigma Pharmaceuticals and Alphapharm by King & Wood Mallesons.

The cases are Generic Health Pty Ltd ACN 110 617 859 v WyethSigma Pharmaceuticals (Australia) Pty Ltd v Wyeth, and Alphapharm Pty Ltd ACN 002 359 739 v Wyeth.

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Miklos Bolza

Miklos Bolza has been a journalist for three years. He has written for a variety of publications, including NZ Lawyer, HRD Australia, and Australian Broker. He is currently the Sydney court reporter for Lawyerly.