Apotex Pty Ltd v Otsuka Pharmaceutical Co., Ltd - [2014] APO 28

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Apotex Pty Ltd v Otsuka Pharmaceutical Co., Ltd [2014] APO 28

Patent Application: 2009233591
Title:Substituted carbostyril derivatives as 5-HT_1A receptor subtype agonists

Patent Applicant: Otsuka Pharmaceutical Co., Ltd

Opponent: Apotex Pty Ltd

Delegate: Karen Ayers

Decision Date: 19 May 2014

Hearing Date: 28 February 2014, in Melbourne

Catchwords: PATENTS – preferred construction of independent claim defined a broad population group of patients with treatment resistant schizophrenia –– claims inventive and a define a manner of manufacture –– knowledge of mechanism of drug increased possibility of success for certain patients–– this improved clinical outcomes for treatment-resistant schizophrenia as a whole even if success for an individual patient could not be predicted–– knowledge of drug mechanism therefore had practical implications and was not a mere discovery

Representation: Patent applicant: Cynthia L. Cochrane of counsel assisted by Dr Paula de Bruyn and Richard Jarvis of Davies Collison Cave, Melbourne
Opponent:Mr Neil Murray of counsel assisted by Dr Tom Gumley and Milena Dryza of Freehills Patent Attorneys, Melbourne

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2009233591

Title:Substituted carbostyril derivatives as 5-HT_1A receptor subtype agonists

Patent Applicant: Otsuka Pharmaceutical Co., Ltd

Date of Decision: 19 May 2014

DECISION

The opposition is unsuccessful.

All the claims are inventive in light of the citations raised by the opponent. There are also no objections under manner of manufacture or section 40.

Absent an appeal being filed within 60 days of this decision, I direct the application proceed to grant.

REASONS FOR DECISION

Background

Patent application 2009233591 was filed on 29 October 2009 in the name of Otsuka Pharmaceutical Co., Ltd as part of a long chain of divisional applications. Its parent application (2007201701) is a divisional application of 2005201772 (grandparent) which in turn is a divisional application of 2002226752 (great grandparent). The great grandparent was filed on 29 January 2002 as a PCT application (PCT/JP02/00626) claiming priority from a US basic application (09/770210) filed on 29 January 2001.
Revocation-infringement proceedings are currently before the Federal Court in relation to the grandparent (‘772) and great-grandparent (‘752). The Full Court issued a decision on 6 March 2013 granting interlocutory injunctive relief on the supply of a particular pharmaceutical (see Generic Health Pty Ltd v Otsuka Pharmaceutical Co., Ltd [2013] FCAFC 17). The substantive hearing is expected to occur sometime this year. The parent application (‘701) was opposed but the opposition was withdrawn and the application proceeded to grant in March 2013.
The current application (‘591) was advertised accepted on 25 October 2011 and Apotex Pty Ltd filed a notice of opposition on 20 January 2012. The evidence stages were completed on 21 November 2013 and the matter was set for hearing in Melbourne on 28 February 2014.

Evidence

The following evidence was filed in this matter:

(a)Evidence in support
Statutory declarations by:
Jayashri Kulkarni dated 15 April 2013 (Kulkarni#1)
Jayashri Kulkarni dated 03 May 2013 (Kulkarni#2)
Sarah Catherine Hennebry dated 10 May 2013
Jayashri Kulkarni dated 17 May 2013 (Kulkarni#3)
(b)Evidence in…

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.

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Details

Case: [2014] APO 28
Decision Date: 19 May 2014

CaseChat Overview and Summary

Apotex Pty Ltd filed an opposition against the grant of a patent to Otsuka Pharmaceutical Co., Ltd for substituted carbostyril derivatives as 5-HT1A receptor subtype agonists. The opponent argued that the patent claims lacked an inventive step, did not define a manner of manufacture and contravened section 40 of the Patents Act. The primary issues for determination were whether the patent claims involved an inventive step and defined a manner of manufacture and whether there were objections under section 40. The Commissioner found that the claims were inventive in light of the cited prior art. The claims defined a broad population of patients with treatment resistant schizophrenia that failed to respond to certain anti-psychotic drugs. The prior art disclosed the results of a study in which patients were treated with a fixed dose of aripiprazole. The drug was effective in treating the positive, negative and cognitive symptoms of schizophrenia. The skilled worker would have been directed to use aripiprazole as a treatment option for schizophrenia with the expectation that it would work. The Commissioner found that there was an inventive step in recognising that aripiprazole had 5-HT1A agonist activity because of its potential to improve clinical outcomes in the population of treatment-resistant schizophrenics. The Commissioner found that there were no objections under manner of manufacture or section 40. All the claims were inventive and defined a manner of manufacture. The Commissioner awarded costs to Otsuka Pharmaceutical Co., Ltd and directed the application to proceed to sealing.

Orders