AstraZeneca goes down

The High Court has unanimously dismissed AstaZeneca’s appeal from the finding that its low dose patent for rosuvastatin was invalid as obvious. The main issue was whether the Courts below had impermissibly allowed one or other prior publication to be “added” to common general knowledge under the then narrow version of section 7(3). This was unanimously rejected.

AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30.

Rosuvastatin goes to the High Court

The High Court has allowed special leave to appeal from the Full Federal Court’s decision in AstraZeneca v Apotex (“Rosuvastatin”).

From the special leave transcript, it looks like the main issue will be the operation of s 7(3) and the basis on which a reference ascertained for the purposes of s 7(3) may be combined with common general knowledge under s 7(2).

In Rosuvastatin, a Full Bench of 5 justices held that the “starting point” identified in the patent could be used as the “starting point” for testing whether the solution in the patent was obvious only when shown to be part of the prior art base. The Full Court nonetheless held the patent was invalid as a s 7(3) reference, the Watanabe paper, was added to the common general knowledge.

From the special leave transcript, it appears that all parties were in agreement that the person skilled in the art would undertake a literature search. The resulting search would have thrown up a number of documents. AstraZeneca argues that the Full Court erred in allowing the Watanabe paper to be used as a s 7(3) reference. Its main argument appears to be that the search would have thrown up at least 2 papers, Watanabe and Aoki. AstraZeneca argues that, before the Watanabe paper can be combined with common general knowledge under s 7(2), it needs to be shown that the person skilled in the art would have chosen the Watanabe paper over Aoki. According to AstraZeneca, however, the evidence did not establish that. Again according to Astrazeneca, there was evidence that the skilled person could choose either paper and, if Aoki was chosen, would fail:

If you had gone down the NK-104 path you fail – a relative fail. If you had gone down the other one, you win. The evidence of Professor O’Brien was – others can reasonably make one choice or another. Dr Reece did not even venture on the issue as to which one he would go down.

A second point that AstraZeneca argues is that to choose Watanabe the skilled person would have needed to refer first to Aoki. That is, it argues that it was necessary to engage in impermissible masoning.

If AstraZeneca succeeds, there will also be a dispute about entitlement issues and the operation of new s 22A and 138(4).

No doubt more will become clearer when the appeal documents are posted on the High Court’s website.

Astrazeneca AB & Anor v Apotex Pty Ltd; Astrazeneca AB & Anor v Watson Pharma Pty Ltd; Astrazeneca AB & Anor v Ascent Pharma Pty Ltd [2015] HCATrans 58

 

The rosuvastatin patents are still invalid

If you have been waiting for the outcome of the appeals from Jagot J’s decision to revoke 3 of AstraZeneca’s patents relating to rosuvastatin and the treatment of hypercholesterolemia

  • one of the extremely rare 5 member Full Benches of the Federal Court –

the decision is out and the patents are still invalid.

Jessup J agreed with Besanko, Foster, Yates and Nicholas JJ, but delivered separate reasons on the question of obviousness.

At 180 pages, further comment will have to wait.

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99