Apotex Pty Ltd v Astrazeneca AB - [2012] APO 95

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Apotex Pty Ltd v Astrazeneca AB [2012] APO 95

Patent Application: 2005202392

Title:Pharmaceutical compositions

Patent Applicant:  AstraZeneca AB
Opponent:  Apotex Pty Ltd
Delegate:  Nicole Howard
Decision Date:  7 September 2012
Submissions Received:             16 April 2012 and 7 June 2012 from Apotex
  31 May 2012 from AstraZeneca
Catchwords:  PATENTS – Reg 5.10 – further evidence application– evidence highly significant to whether citation would be ascertained- explanation of delay unsatisfactory – application allowed – costs awarded against opponent

Representation: Patent applicant: Davies Collison Cave
Opponent:Freehills Patent and Trademark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005202392

Title:Pharmaceutical compositions

Patent Applicant: AstraZeneca AB
Date of Decision: 7 September 2012
DECISION
Application to serve further evidence allowed. Costs awarded against Apotex.
REASONS FOR DECISION
Background

1.Patent application 2005202392 in the name of AstraZeneca AB (hereafter AstraZeneca) was filed on 2 June 2005 claiming divisional status from Australian Patent 781269. The application was advertised accepted on 20 November 2008. The application relates to pharmaceutical compositions comprising (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R, 5S)-3, 5-dihydroxyhept-6-enoic acid or a pharmaceutical salt thereof as the active ingredient, the composition having a ferric oxide light protective coating. The active ingredient is commonly known as rosuvastatin.

2.Apotex Pty Ltd (hereafter Apotex) filed a notice of opposition under Section 59 of the Patents Act 1990 on 20 February 2009. The opposition was heard in Melbourne on 4 and 5 April 2012. During the hearing Apotex indicated that they wished to file further evidence pertaining to whether the person skilled in the relevant art could reasonably be expected to have ascertained the UK Patent citation primarily relied upon. Apotex requested one week in which to make their application to serve further evidence and were directed to do so by 16 April 2012.

3.Apotex applied to serve further evidence on 16 April 2012. AstraZeneca objected to the service of further evidence, and the matter was heard on the basis of written submissions.

4.Submissions were received from Apotex on 16 April 2012 and from AstraZeneca on 31 May 2012. Submissions in response were received from Apotex on 7 June 2012.
The law
5.Further evidence is governed by regulation 5.10(4).

(4) The Commissioner may:

(a)on the application of a party; and
(b)on such reasonable terms (if any) as the Commissioner specifies;

permit the party to serve further evidence on the other party.

This provision must be read in conjunction with regulation 5.10(5):

(5)The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:
(a)if he or she proposes to grant an application by a party - is reasonably satisfied that the other party has been notified of the application; and
(b)if he or she proposes to act on his own motion - ensures that the parties are notified of the proposed action; and
(c)in either case:

(i)gives the parties a reasonable opportunity to make representations concerning the application or proposed action; and
(ii)is reasonably satisfied that a direction, and extension of time…

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 [2012] APO 95
Case: [2012] APO 95
Decision Date: 7 September 2012

CaseChat Overview and Summary

The case of Apotex Pty Ltd v AstraZeneca AB [2012] APO 95 involves a patent application for pharmaceutical compositions, specifically relating to rosuvastatin, filed by AstraZeneca AB. Apotex Pty Ltd opposed the patent application, and during the hearing, Apotex requested permission to present additional evidence concerning whether the cited UK patent would have been found by a person skilled in the art. AstraZeneca objected to this request, leading to a decision by the Delegate, Nicole Howard, on whether to permit the service of further evidence.

The legal issue at hand was whether the Commissioner should allow the service of additional evidence under Regulation 5.10(4) of the Patents Regulations 1991. The key considerations involved the discretionary nature of the Commissioner's power, the explanation for the delay in presenting the evidence, and the interests of both parties and the public. The decision must also consider the significance of the proposed evidence and its potential impact on the opposition proceedings.

The Delegate, Nicole Howard, allowed the application for further evidence despite finding the explanation for the delay unsatisfactory. The decision was based on a balance of factors, including the highly significant nature of the evidence related to the inventive step and the potential impact on the outcome of the opposition. Although the timing of the request was late, the Delegate found that the public interest in determining the opposition on its merits favoured allowing the further evidence. The Commissioner also awarded costs against Apotex for their unsatisfactory explanation and for delaying the correction of evidential flaws until after the hearing.

The final orders included permission for Apotex to serve further evidence, with AstraZeneca granted one month to respond. Costs were awarded against Apotex due to the unsatisfactory explanation for the delay and the impact on the orderly conduct of the proceedings.

Orders