AstraZeneca (AZ) has lost a lawsuit in Australia seeking to defend its patents for cholesterol drug Crestor, exposing around $350m-worth of sales to generic competition.
The Federal Court of Australia ruled that three patents protecting Crestor (rosuvastatin) were invalid, overturning a prior ruling delivered in May 2012 which upheld the validity of AZ’s intellectual property.
AZ’s three patents are a formulation patent expiring in 2020, a use patent related to the treatment of heterozygous familial hypercholesterolemia expiring in 2021, and another use patent in hypercholesterolaemia which extends to 2020.
The patents were challenged by Canadian generic drugmaker Apotex, which was blocked from entering the Australian market with its own generic in the first round of the legal dispute in 2011, as well as Watson Pharma and Ascent Pharma.
Apotex tried to get round the block early last year by pledging only to sell two rosuvastatin dosage forms (5mg and 10mg) that were not covered by the formulation patent but was denied in the courts once again.
The generic firm then changed the formulation of its products to try to remove the basis of infringement of a fourth (composition) patent, was once again blocked, but in the latest round convinced the federal court that AZ’s IP was invalid.
AZ said it was disappointed with the ruling but downplayed its significance, noting that “the Federal Court decision is limited to Australia and has no impact on the validity of patents related to Crestor in other countries”.
The company added that it is considering its options and may choose to lodge an appeal in order to maintain the current injunction on generic Crestor sales in Australia.
The ruling in Australia follows a victory for AZ in the defense of Crestor’s IP in the US. In December, the company won a key legal round after an appeals court upheld an earlier district court ruling that Crestor has protection until 2016.
Analyst Savvas Neophytou at Panmure Gordon said the Australian decision was worrying as “Australia is likely to join Canada and Brazil in allowing generic copies of Crestor on the market”, with Israel likely to be the next battleground for AZ.
Australian Crestor sales represent around 6 per cent of total turnover for the brand, which is itself expected to account for 23 per cent of total 2013 revenues and 30 per cent of profits for AZ, said Neophytou.
“Given Crestor’s importance to the group … we believe this increases pressure on management to undertake some sort of M&A,” said Neophytou.