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Apotex Pty Ltd v AstraZeneca AB

Apotex Pty Ltd v AstraZeneca AB

Case [2013] APO 62 27 November 2013

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IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v AstraZeneca AB [2013] APO 62
Patent Application: 2005202392

Title:Pharmaceutical compositions

Patent Applicant:  AstraZeneca AB
Opponent:  Apotex Pty Ltd
Delegate:  Nicole Howard
Decision Date:  27 November 2013
Hearing Date:  Initial hearing took place on 4 – 5 April 2012 in Melbourne. Further evidence was allowed on 7 September 2012, and evidence in response was completed on 4 October 2012. Further submissions from the parties were sought on 10 April 2013, and submissions were provided on 24 April 2013.

Catchwords: PATENTS – opposition to the grant of a patent – lack of inventive step in the light of the common general knowledge – lack of inventive step in the light of UK patent application 2262229 – opportunity to amend

Representation: Patent applicant: Tony Bannon SC and Christian Dimitriadis of counsel, instructed by Michael Caine and Andrew Scott of Davies Collison Cave and Ian Pascarl of Davies Collison Cave Law
Opponent:Katrina Howard SC and Craig Smith of counsel, instructed by Nicole Watling of Freehills

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005202392

Title:Pharmaceutical compositions

Patent Applicant: AstraZeneca AB
Date of Decision: 27 November 2013
DECISION
Claims 1-27 lack an inventive step. AstraZeneca AB is allowed two months from the date of this decision to propose amendments. Costs according to Schedule 8 awarded against AstraZeneca AB.
REASONS FOR DECISION
Background

The present application was filed by AstraZeneca AB (AstraZeneca) on 2 June 2005 as a divisional application of 781269 (the parent patent). The divisional application was examined and advertised accepted on 20 November 2008. A notice of opposition was subsequently filed by Apotex Pty Ltd (Apotex) on 20 February 2009. A hearing was held on 4 April 2012 and 5 April 2012 in Melbourne. AstraZeneca was represented by Tony Bannon SC and Christian Dimitriadis of counsel, instructed by Michael Caine and Andrew Scott (patent attorneys of Davies Collison Cave) and Ian Pascarl of Davies Collison Cave Law. Apotex was represented by Katrina Howard SC and Craig Smith of counsel, instructed by Nicole Watling (patent attorney of Freehills). Following the hearing, there was a request to serve further evidence, which was ultimately allowed (see my decision in Apotex Pty Ltd v AstraZeneca AB [2012] APO 95). On 10 April 2013 I sought further submissions from the parties, which were supplied on 24 April 2013.
The parent patent was the subject of infringement proceedings brought by AstraZeneca and AstraZeneca Pty Ltd against Apotex, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd. Subsequent to the hearing, the Federal Court issued its decision wherein Justice Jagot found the parent patent was invalid, as the claims were not novel and lacked an inventive step (Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162; 100 IPR 285). The decision was appealed to the Full Bench of the Federal Court and heard on 31 July – 2 August 2013.
Grounds of opposition
The statement of grounds and particulars specified…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

Continue reading Apotex Pty Ltd v AstraZeneca AB

Details

AGLC: Apotex Pty Ltd v AstraZeneca AB [2013] APO 62
Case: [2013] APO 62
Decision Date: 27 November 2013

CaseChat Overview and Summary

Apotex Pty Ltd opposed the grant of a patent to AstraZeneca AB for pharmaceutical compositions comprising rosuvastatin and ferric oxide coatings. The opposition was heard over two days in April 2012 and further evidence was provided in September 2012 and October 2012. Further submissions were provided in April 2013. The primary ground of opposition was that the claimed compositions lacked an inventive step in light of the common general knowledge and prior art. The decision was handed down on 27 November 2013, finding that claims 1-27 lacked an inventive step in light of the common general knowledge and UK patent application 2262229. The opposition on the other grounds was dismissed. The decision allowed AstraZeneca two months to propose amendments and awarded costs to Apotex.

The key legal issues considered by the court were whether the claimed pharmaceutical compositions lacked an inventive step in light of the common general knowledge and prior art. The court found that it would have been routine for the skilled addressee to apply a ferric oxide coating to a pharmaceutical composition of rosuvastatin in the expectation that it would improve stability and reduce degradation of the active ingredient. The use of ferric oxides in coatings and the inclusion of inorganic salts in pharmaceutical compositions were common practice at the priority date. The features of the claimed compositions were thus part of the common general knowledge and prior art, leading to the conclusion that the claims lacked an inventive step.

The reasoning of the court focused on the problem to be solved, which was the instability and degradation of rosuvastatin in pharmaceutical compositions. The court found that the skilled addressee would have taken routine steps of applying a ferric oxide coating and including an inorganic salt in the composition in light of the common general knowledge and prior art. The use of ferric oxides in coatings and inorganic salts in pharmaceutical compositions was well known at the priority date. The additional features of the dependent claims were also part of the common general knowledge, leading to the conclusion that the claims lacked an inventive step. The opposition on the other grounds was dismissed as it had not been made out.

Orders