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Win For Generic Pharmaceutical Companies In Australia

Issued: August 20 2014

In a unanimous five-judge Full Federal Court decision handed down on August 12, 2014, AstraZeneca once again failed to prevent generic companies from selling competing generic versions of its Crestor (rosuvastatin) cholesterol drug.

 

Rosuvastatin is now reportedly Australia's leading "genericised" drug.

 

According to Pharmaceutical Benefits Scheme (PBS) figures, the Australian government spent A$298.6 million (US$278.3 million) on rosuvastatin in the 2013-14 financial year. 

 

In 2011/2012, AstraZeneca, the holder of three Crestor-related patents, commenced infringement proceedings against generic pharmaceutical companies Watson and Ascent, both now part of the Actavis Group, and Apotex.  AstraZeneca was relying on patents concerning dosage ranges, methods of treatment and pharmaceutical compositions, respectively.

 

In 2013, the Federal Court held that the generic companies' products would not infringe AstraZeneca's patents and, in any event, all three patents were partially or wholly invalid on numerous grounds. 

 

The Full Federal Court has now upheld that earlier decision, finding that two of the patents were invalid (the trial judge's findings on the third patent were not appealed), dismissing AstraZeneca's appeal and ordering it to pay 80% of the generic companies' costs of the appeal.

 

Wayne McMaster, a partner at Minter Ellison in Melbourne successfully led senior associate Jonathan Kelp and associate Amy Surkis to win this case for Watson and Ascent.

 

“The Full Court's decision ensures the generic market for rosuvastatin (and therefore the current cost to the Australian government through the PBS) is maintained,” McMaster says. “It that Australian courts will not permit an unwarranted extension of an innovator's monopolydemonstrates  beyond the compound itself unless the patent appropriately covers patentable subject matter."

 

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