Wyeth says generic Effexor registration ‘not legitimate’
Intellectual Property June 5, 2018 10:14 pm By Miklos Bolza | Sydney

Three generic drug manufacturers cannot claim damages for an injunction barring the release of cheaper versions of Effexor-XR, even if the injunction was later overturned, pharmaceutical giant Wyeth told a judge on day two of a six-week trial over its blockbuster antidepressant.

Wyeth’s method patent covering the extended-release Effexor was invalidated two years after the company secured an interlocutory order from the Federal Court blocking Sigma Pharmaceuticals, Alphapharm and Generic Health from marketing generic copies of the medication.

The generic drug makers now want damages for years of lost sales, but Wyeth said Tuesday during its opening submission in the trial that the companies were owed nothing because their actions in registering copies of the drug with the Australian Register of Therapeutic Goods were illegitimate.

“The generics come to this court and say, ‘We should be compensated implicitly for what would have been legitimate activity.’ It’s plain that their activity was not legitimate,” Bannon told Justice Jayne Jagot.

A business should only be compensated for damages to its legitimate business, he said.

Wyeth barrister Tony Bannon, SC, also accused Sigma, Alphapharm and Generic Health of infringing Wyeth’s compound patent for the drug, contravening the Therapeutic Goods Act, and infringing copyrights on Wyeth’s product information and consumer medicine information sheets for Effexor XR.

In detailing the new pleadings, filed by Wyeth on Friday and described as an 11th-hour “ambush” by Sigma barrister David Shavin, QC, on Monday, Bannon said the allegations were nothing new. The generics, he said, were merely “ambushed by their own evidence”.

“This is just a farce,” Shavin was heard remarking in the midst of Bannon’s statement.

Later, before the judge, Shavin said the case alleging illicit conduct by the generics had emerged for the first time in Friday’s new pleadings by Wyeth.

“We’re terribly old fashioned. We took the [original] points of pleading as meaning what they said,” he told the court, describing the case the generics have spent four years preparing for. “There must be a recognition that the whole of our friend’s case has changed.”

Judge Jagot said she would allow most of Wyeth’s new claims, but expressed concern about the fresh allegation of infringement of Wyeth’s compound patent. The dispute, which began with a claim of invalidity by the generics in 2009, has for the past decade involved Wyeth’s method patent for Effexor- XR.

Bringing the compound patent in now would “blow out” the proceedings and create a “trial within a trial,” Judge Jagot said.

The three generic pharma companies are joined by a fourth, Pharmathen Industrial, which is claiming damages for lost sales through its customers, Generic Health and Alphapharm. The Commonwealth of Australia is seeking damages for losses, too, claiming it subsidised extra for the brand name Effexor when, but for the injunctions, it would have had the option of subsidising cheaper versions.

The trial continues Wednesday.

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.

Bannon is from Tenth Floor Chambers and Shavin is from Owen Dixon Chambers West.

Richard Lancaster, SC, represents Alphapharm and is from Fifth Floor, St James Hall. Robert Dick, SC, represents Generic Health and is from Banco Chambers.

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.