CRESTOR Catch-Up

Apotex Pty Ltd v AstraZeneca AB [2011] FCA 1520 (14 December 2011)
Apotex Pty Ltd v AstraZeneca AB (No 2) [2012] FCA 142 (28 February 2012)
Watson Pharma Pty Ltd v AstraZeneca AB [2012] FCA 200 (9 March 2012)
Apotex Pty Ltd v AstraZeneca AB (No 3) [2012] 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:

1. 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;
2. 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
3. the ‘165 patent’, or ‘generic patent’ (no. 2002214165), relating to the use of rosuvastatin for treatment of heterozygous familial hypercholesterolemia.

Apotex’s efforts to circumvent the injunction against it were not yet over.  At a further hearing held on 16-17 March 2012, Justice Jagot was asked to determine whether changes in the coating of its generic rosuvastatin product were be sufficient to avoid the reach of AstraZeneca’s patents.

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.

BACKGROUND IN BRIEF

In May 2011 Apotex commenced proceedings in the Federal Court seeking revocation of the dosage patent.  AstraZeneca attempted, without success, to determine from Apotex whether this was a preliminary move to the launch of a generic product in Australia.

In November 2011 Apotex launched a marketing campaign for its own generic rosuvastatin product, and informed AstraZeneca.  In response, AstraZeneca filed a cross-claim in the ongoing revocation case, alleging threatened infringement of its three patents.

Following a hearing in December 2011, Justice Rares determined that it was appropriate to grant an interlocutory injunction pending trial.

Apotex returned to court, this time before Justice Emmett, on 2 February 2012 seeking a variation to Justice Rares’ orders.  Emmett J was not persuaded that there was any new evidence sufficient to upset the original decision, but nonetheless adjourned the matter pending a decision on similar injunctions being sought by AstraZeneca against Watson and Ascent.  The judge was concerned, in the event that an injunction were not issued against the other manufacturers, that it would be unfair to maintain an injunction barring Apotex from competing in the market for generic rosuvastatin.

But on 9 March 2012, Justice Jagot made orders restraining Watson and Ascent from marketing generic rosuvastatin, leaving Apotex with little hope of a different outcome in its case.

This did not stop Apotex from returning to court, before Justice Jagot, to argue its case once again, this time on the basis that it proposed a change to the formulation of its products said to avoid the AstraZeneca patents.

FOILED AGAIN

Based on the proposed change in formulation, AstraZeneca no longer asserted infringement of the ‘842 composition patent at the hearing before Justice Jagot on 16-17 March 2012.  However, this left the ‘051 and ‘165 patents still in-play.

It appears that Justice Jagot was unimpressed with Apotex’s conduct, particularly with regard to the timing of its change in formulation, and an apparent lack of candour regarding the circumstances of this change and failure to provide any explanation as to why it could not have been made, or at least foreshadowed, at the original hearing before Justice Rares.

As Her Honour stated (at [14]):

Considered in the context of the well-known principle that a party should not be permitted to relitigate “at will” the terms of an interlocutory injunction … Apotex’s conduct does not readily support an exercise of discretion in its favour.

Nonetheless, Her Honour accepted that the ‘842 patent was no longer being asserted, and that ‘[i]f the injunction is too broad in consequence then it would be unjust to maintain it and it should be varied irrespective of the concerns about Apotex’s conduct which remain given the state of the evidence’ (at [15]).  However, she concluded that the existing injunction should be maintained having regard to the other patents on which it was founded, summarising the various ‘balance of convenience’ considerations as follows (at [25]):

In short: –

(i) Apotex has no established position in the market,
(ii) Astra has a substantial existing market in Crestor,
(iii) Apotex has sought to enter the market knowing of Astra’s patents and the rights it asserts,
(iv) the patents on which Astra relies – in this case the 051 or low dose patent and the 165 or HeFH patent – are long-standing and were the subject of unsuccessful re-examination proceedings by Apotex, and
(v) Apotex’s entry into the market with its proposed 20mg and 40mg dosage forms will cause significant and most likely irreparable upheaval in the existing market, including by way of price pressure on Astra across its entire range and substantial erosion of Astra’s market share.

By contrast, maintaining the injunction made by Rares J will leave Apotex in the same position as it currently is in – and, moreover and not unimportantly, the same position as the other generic companies that wish to enter to rosuvastatin market. In these circumstances, Apotex will not be exposed to irreparable harm and will be adequately protected by Astra’s continued undertaking as to damages.

CONCLUSION

We understand that CRESTOR is one of AstraZeneca’s most important products, particularly bearing in mind the impending ‘patent cliff’ threatening various major drug originators.  The three rosuvastatin patents each have a number of years to run, expiring between February 2020 and November 2021.

The injunctions against Apotex, Watson and Ascent mean that AstraZeneca will continue to enjoy a monopoly in CRESTOR in Australia for the foreseeable future, bearing in mind the time required for such patent cases to come to trial, and the likelihood – indeed inevitability – of appeals, no matter what the outcome at first instance.

Tags: Australia, Interlocutory injunction, Pharmaceuticals