Further savings expected following Australian Crestor patent decision, says GMiA

In a decision brought down by the Australian Federal Court earlier this week, suppliers of generic medicines are a step closer to launching a generic version of rosuvastatin, the cholesterol lowering drug marketed by Anglo-Swedish drug major AstraZeneca (LSE: AZN) as Crestor, which will reduce the cost of the 6.7 million prescriptions dispensed under the Pharmaceutical Benefits Scheme (PBS) annually, notes the Australian Generic Medicines Industry Association (GMiA). Crestor was the second highest cost medicine to the PBS last financial year at a total cost of A$466 million.

Justice Jagot held on March 4, 2013, that all claims of the ‘045 (low dose) patent and the asserted claims of the ‘165 (HeFH) and ‘842 (cation salt) patents were invalid and liable to be revoked and therefore not infringed by the generic medicine sponsors - Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd (The Pharma Letter March 5). AstraZeneca is currently considering its legal options, including the option of filing for an appeal.

Pharmaceutical patents play an important role in encouraging the innovation of new pharmaceuticals and it is imperative that innovation is directed to the invention of products that improve health outcomes, said the GMiA, noting that patents already provide exclusivity for up to 25 years and most medicines are protected by multiple patents.