March 7, 2013

Apotex Wins Rosuvastatin Litigation

Dear Customer,

Apotex is pleased to announce the success of its litigation challenge on rosuvastatin as the lead litigant - another example of Apotex leading the way in the generic pharmaceutical industry in litigation.

The judgement delivered by Justice Jagot on 5 March 2013 found that Apotex's re-formulated rosuvastatin products do not infringe any of the three patents asserted by AstraZeneca. Further, all three patents in question were found to be invalid on several grounds and should be revoked. The interlocutory injunction against Apotex has been dissolved and there are no patent restraints on Apotex's rosuvastatin products.

Apotex took the lead by commencing the first of the Federal Court proceedings for rosuvastatin in May 2011, seeking to revoke AstraZeneca's patent for a rosuvastatin dosing regimen. The Apotex products were subsequently registered on the ARTG in November 2011 and launched for early 2012 delivery. AstraZeneca applied for an urgent injunction to stop the Apotex product launch and a temporary injunction was imposed in December 2011. Apotex has since vigorously defended AstraZeneca's patent infringement claims, including taking steps to amend the formulation to avoid infringement and challenging the validity of the patents.

It is possible that AstraZeneca will appeal the judgement. Any appeal may be heard later this year or early 2014. Given the breadth of the court's findings in Apotex's favour, Apotex is very confident that an appeal by AstraZeneca will not impact on Apotex's supply of rosuvastatin products.

The success of Apotex's efforts to challenge the patents on rosuvastatin demonstrates its persistence and commitment to deliver value and support to community and hospital pharmacy. Apotex will continue to assert its position as the leader in litigation in the generic pharmaceutical industry.

Best regards,