Pharmaceutical giant Wyeth’s has launched an “ambush” at the beginning of a trial after a nine-year long battle against several generic drug makers, alleging infringement of a second patent for its blockbuster Effexor-XR, a judge heard Monday.
Barrister David Shavin, QC, for Sigma Pharmaceuticals, told Federal Court Justice Jayne Jagot on the first day of a six-week trial that Wyeth’s submissions on Friday, alleging for the first time that Sigma and fellow generics makers Alphapharm and Generic Health had infringed Wyeth’s compound patent covering the antidepressant, should be dismissed.
“It’s an ambush, Your Honour, because we have been given no opportunity … to test the underlying proposition as to whether or not there has been an infringement,” Shavin told the court. “Put to one side whether such conduct could even constitute infringement … the compound patent has never been in issue,” he said.
The new pleadings were revealed during Shavin’s opening statement at the trial, which seeks damages for the generic makers loss of sales, profit and market share of Effexor, estimated to be worth $100 million a year.
The companies were barred from launching cheaper versions of Wyeth’s extended-release Effexor after a judge issued injunctions in 2009 and 2010 as part of infringement proceedings. The final injunction was only lifted after a successful appeal by the companies in December 2011, when the patent at issue was revoked.
An application by Wyeth to the High Court to appeal the Full Court’s decision was rejected and the generics sought damages.
Calling on Judge Jagot to dismiss the new claims, Shavin said Wyeth’s 11th-hour allegations were of an “extraordinary character”. The dispute had up to now involved only the patent for the drug’s delivery method, not the compound patent.
Wyeth claims in the new pleadings that the generic companies’ bid for damages should be denied on the strength of the alleged infringement of the compound patent.
“It cannot be that in a closing outline the Friday night before a six-week trial commences on Monday morning that we have to deal with a whole new infringement case,” Shavin told the court.
Alphapharm’s barrister, Richard Lancaster, SC, and Generic Health’s lawyer, Robert Dick, SC, also gave their opening submissions on Monday.
Lancaster slammed Wyeth’s argument that the interlocutory injunction in 2009 was not wrongly issued because the company prevailed at trial. He called it a “futile search for an easy, complete answer to the applicant’s claims”.
A fourth generic company, Pharmathen Industrial is also claiming damages for lost sales through its customers, Generic Health and Alphapharm. The Commonwealth of Australia is seeking damages for losses, too, claiming it paid extra for the brand name Effexor when, but for the injunctions, it would have purchased the cheaper versions.
Opening submissions by Pharmathen, the Commonwealth of Australia and Wyeth are expected to be heard Tuesday.
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.
Shavin is from Owen Dixon Chambers West, Lancaster is from Fifth Floor, St James Hall, and Dick is from Banco Chambers.
The cases are Generic Health Pty Ltd ACN 110 617 859 v Wyeth, Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth, and Alphapharm Pty Ltd ACN 002 359 739 v Wyeth.
Miklos Bolza
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