Apotex Pty Ltd v AstraZeneca AB (No 2)  FCA 142 (28 February 2012)
Watson Pharma Pty Ltd v AstraZeneca AB  FCA 200 (9 March 2012)
Apotex Pty Ltd v AstraZeneca AB (No 3)  FCA 265 (23 March 2012)
AstraZenenca’s cholesterol drug CRESTOR will remain without generic competition in the Australian market for the foreseeable future, following a series of interlocutory decisions in which injunction were granted against three rival pharmaceutical manufacturers.
Back in March we wrote about a number of ongoing cases between original manufacturer AstraZeneca AB, and generic pharmaceutical companies Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd, over cholesterol drug rosuvastatin, marketed in Australian by AstraZeneca as CRESTOR. (See Preliminary Injunction for CRESTOR—Not All ‘Tablets’ are Equal and Generics Unsuccessful in CRESTOR Injunction Challenges.)
In a series of three interlocutory decisions reported in our earlier articles, Federal Court judges Rares, Emmett and Jagot determined that all of the relevant factors supported the grant of injunctions barring the sale of generic versions of rosuvastatin pending a full hearing on the validity and infringement of three AstraZeneca patents:
- the ‘051 patent’, or ‘dosage patent’ (no. 2000023051), which relates to the treatment of hypercholesterolemia using a daily oral dosage of 5-10 mg of rosuvastatin;
- the ‘842 patent’ or ‘composition patent’ (no. 2000051842), which relates to a formulation (e.g. a tablet) in which rosuvastatin is present in combination with a specified inorganic salt (which serves to stabilise the active ingredient); and
- the ‘165 patent’, or ‘generic patent’ (no. 2002214165), relating to the use of rosuvastatin for treatment of heterozygous familial hypercholesterolemia.
However, Apotex’s last-ditch effort has been dismissed, maintaining the status quo and excluding generic competition to CRESTOR pending a final determination on the issues of infringement and validity of the patents.