Alphapharm Pty Ltd v Cypress Bioscience, Inc - [2016] APO 58

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Alphapharm Pty Ltd v Cypress Bioscience, Inc. [2016] APO 58

Patent Application: 2012203789

Title:Milnacipran for the long-term treatment of fibromyalgia syndrome

Patent Applicant:  Cypress Bioscience, Inc.
Opponent:  Alphapharm Pty Limited
Delegate:  Dr B. Akhurst
Decision Date:  5 September 2016
Hearing Date:  16 June 2016, in Sydney.

Catchwords: PATENTS – section 59 opposition to the grant of a patent – manner of manufacture – whether the claimed methods of treatment were obvious on the face of the specification – inventive step – whether the claimed methods are obvious in light of the common general knowledge or prior art documents – fair basis – real and reasonably clear disclosure – grounds of opposition not established.

Representation: Patent attorney for the applicant: Shelston IP.
Counsel for the opponent: Ben Fitzpatrick.
Patent attorneys for the opponent: Paul Whenman and Jess Gledhill of FB Rice.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012203789

Title:Milnacipran for the long-term treatment of fibromyalgia syndrome

Patent Applicant: Cypress Bioscience, Inc.
Date of Decision: 5 September 2016
DECISION
The opposition is unsuccessful. Costs are awarded according to Schedule 8 against Alphapharm Pty Limited.
REASONS FOR DECISION
Background

Cypress Bioscience, Inc. (Cypress) filed patent application 2012203789 on 27 June 2012 as a divisional of application 2006294645, claiming priority from application US 60/721,722 filed on 28 September 2005. Following examination, acceptance of the application was advertised on 11 December 2014.
Alphapharm Pty Limited (Alphapharm) filed a notice of opposition to the grant of a patent on 11 March 2015 and a statement of grounds and particulars (SGP) on 11 June 2015. Evidence in support, answer and reply was completed on 11 September 2015, 15 December 2015 and 16 February 2016, respectively.
Alphapharm appeared at the hearing, which took place on 16 June 2016 at FB Rice’s premises in Sydney. Cypress appeared by written submissions filed on 8 and 15 June 2016.
The Evidence
Evidence in support consisted of a declaration by:
- Peter Brooks dated 10 September 2015 (PB#1) with exhibits PB-1 to PB-22.
Evidence in answer consisted of declarations by:
- Geoffrey Littlejohn (GOL) dated 14 December 2015 with exhibits GOL-1 to GOL-8; and
- John Louis Quintner (JLQ) dated 14 December 2015 with exhibits JLQ-1 to JLQ-34.
Evidence in reply consisted of a declaration by:
- Peter Brooks dated 15 February (PB#2) with exhibits PB-23 to PB-30.
Grounds of opposition
The grounds of opposition pressed by the opponent at the hearing were manner of manufacture, inventive step and fair basis.
Onus of Proof
The request for examination in relation to the patent application was filed on 12 November 2012. As a consequence, the substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application. This includes the amendment to subsection 60(3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that…

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: [2016] APO 58
Decision Date: 5 September 2016

CaseChat Overview and Summary

In the proceedings before the Australian Patent Office, Alphapharm Pty Ltd opposed the grant of a patent to Cypress Bioscience, Inc. relating to the use of milnacipran for the long-term treatment of fibromyalgia syndrome. The opposition was based on the grounds of manner of manufacture, inventive step and fair basis. The opposition was unsuccessful. The opposition was heard on 16 June 2016 and this decision was issued on 5 September 2016. The invention related to the long-term treatment of fibromyalgia syndrome by administration of milnacipran, a dual norepinephrine serotonin reuptake inhibitor, according to a dose escalation schedule. The decision found that the claims were a manner of manufacture, had an inventive step and were fairly based on the specification. The claims related to a dose escalation schedule for the administration of milnacipran to a subject in need of treatment. The expert evidence did not establish that in seeking to develop new methods for the treatment of fibromyalgia syndrome using dual norepinephrine serotonin reuptake inhibitors, the person skilled in the art would try milnacipran in the particular dosing schedules in the opposed claims. The evidence did not establish that in seeking to solve the problem the person skilled in the art would be led as a matter of course or a matter of routine to try the precise combination of features in each of the opposed claims, with a reasonable expectation that it would result in a useful alternative treatment for fibromyalgia syndrome. The evidence established that the body of the specification provides a real and reasonably clear disclosure of the use of milnacipran for the treatment of fibromyalgia syndrome, the method comprising administering a composition comprising milnacipran to a subject in need thereof according to a dose escalation schedule as presently claimed.

Orders