Aspen settles patent case over generic Lexapro
Intellectual Property June 13, 2018 2:01 pm By Christine Caulfield | Melbourne

Generic pharmaceutical company Aspen Pharma has resolved a patent infringement case brought by the maker of the anti-depressant Lexapro, according to a Federal Court order Tuesday.

The settlement comes a month after Aspen faced off at trial with two other generic makers accused by global drug giant Lundbeck of infringing its Lexapro patent with their cheap versions of the blockbuster medicine.

Details of the settlement are not known, but the proceedings wrapped up on Tuesday with an order by Federal Court Justice Jayne Jagot finalising the case. Lundbeck’s cases against generic makers Apotex and Sandoz remain open.

Lundbeck and Aspen did not immediately respond to requests for comment Wednesday.

The settlement ends a battle that has raged for 15 years between Lundbeck and the generic makers over the rights to sell escitalopram, the chemical name for Lexapro.

At trial, which began in April and adjourned mid May, Aspen and Apotex barrister David Catterns, QC, told the court that if his client’s drugs contained different levels of “chiral purity” than Lexapro, their drugs escaped the infringement claim.

Lundbeck barrister Tony Bannon SC, blasted the generic makers’ claim that their generics did not infringe Lundbeck’s patent because of chemical differences in chiral purity.

Bannon questioned why such weight had been placed on chiral purity in their defence when the companies had failed to mention the characteristic in their product information sheets, consumer medicine information sheets or product packaging for their Lexapro copies.

“In the marketplace, it doesn’t bear mention. When they come to court, they say this is a matter of significance,” he said.

Since minute levels of impurity are inevitable in any mixture, a difference in purity was not fatal to Lundbeck’s case, at any rate, he said.

“You can’t make these things without chiral impurity,” Bannon said.

Lundbeck’s case, filed in June 26, 2014, also accuses Apotex, Aspen and Sandoz of launching their generic products despite being made aware that Lundbeck had won approval to apply to IP Australia for an extension on the life of the patent at issue. The 20-year patent expired in 2003.

Bannon said emails between the companies made clear that they were aware of the risks of launching their generics.

“If they launched, each of them took a commercial risk,” he said.

The battle over generic versions of Lexapro began in December 2003, when Lundbeck first made its application with IP Australia for a patent term extension and a group of generic drug makers opposed the move.

Lundbeck won a significant ruling from the High Court of Australia over the right to apply for the extension in November 2014. The court found that the Commissioner of Patents could extend the time for making an application under the Patents Act for an extension of term of a pharmaceutical patent.

A fourth generic drug maker, Alphapharm, which also launched a generic version of escitalopram when Lundbeck’s patent expired, had appealed to the High Court after losing a battle over the extension at the Federal Court. A series of misleading conduct claims were also brought against Alphapharm by CNS Pharma, a subsidiary of Lundbeck.

All disputes with Alphapharm, which included patent infringement and misleading conduct allegations, were settled in April.

Lundbeck is represented by Corrs Chambers Westgarth. Aspen is represented by King & Wood Mallesons.

The case is H Lundbeck A/S & Anor V Aspen Pharma Pty Ltd.

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Christine Caulfield

Christine Caulfield has been a journalist for 18 years. She was most recently the Co-Managing Editor at US legal news publication Law360. Prior to that she worked as the County Court reporter for The Herald Sun. She is Co-Founder and Editor of Lawyerly.