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CareFusion 303, Inc

CareFusion 303, Inc

Case [2021] APO 10 26 February 2021

Patent Law

Patentability

Amendments to Patent Applications

Intellectual Property Law

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IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
CareFusion 303, Inc. [2021] APO 10

Patent Application: 2014268801
Title:Medication delivery management

Patent Applicant:                   CareFusion 303, Inc.
Delegate:  Dr N. R. Madsen
Decision Date:  26 February 2021
Hearing Date:  14 September 2020, via videoconference

Catchwords: PATENTS – section 45 – examiner’s objection – whether invention is a manner of manufacture – filling orders and delivering medications – alerting priority delivery of medications – allowability of amendments – invention in substance directed to a mere scheme – alleged invention not a manner of manufacture – opportunity to amend

Representation: Patent attorneys for the applicant: Michelle Catto, Manuel Schmidt and Rachel Hooke from FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014268801
Title:Medication delivery management

Patent Applicant: CareFusion 303, Inc.
Date of Decision: 26 February 2021
DECISION
The claims of the application, as proposed to be amended, do not define a manner of manufacture. While I do not immediately see any subject matter of substance in the body of the specification from which valid claims could be drafted to overcome this finding, I will provide the applicant with an opportunity to amend the specification as the hearing and submissions did not address the specification in its entirety.
REASONS FOR DECISION
BACKGROUND

CareFusion 303, Inc. (“the applicant”) filed patent application 2014268801 on 19 May 2014. The application was filed as PCT application PCT/US2014/038657 based on US application 13/900482 having an earliest priority date of 22 May 2013. Examination was requested on 12 April 2018 and the application was subjected to four examination reports, the final of which issued on 6 July 2020. In those reports, the examiner has maintained an objection that the claims of the application, including the claims as proposed to be amended, do not define a manner of manufacture. The applicant subsequently requested to be heard on 20 July 2020 after filing a response with an amendment on 16 July 2020.
The examination of the present application is governed by the Patents Act 1990 (“the Act”) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (“the Raising the Bar Act”) as the application was filed after 15 April 2013. Thus, the standard of proof that applies in the present case is the balance of probabilities (subsection 49(1)). I must accept the application if satisfied on the balance of probabilities that the application complies with the Act. If I am not so satisfied, then I can refuse the application.
The final date for acceptance of the application was 19 July 2020, however paragraph 13.4(1)(g) of the Patent Regulations is available to extend the time for gaining acceptance to 3 months (or longer if appropriate under sub-regulation 13.4(3)) from the date of the present decision.
SPECIFICATION
The alleged invention relates to the management of delivery of prepared medications in a healthcare facility. As a background, certain pharmaceutical drugs are compounded to fit patient needs such as solid pill or liquid form, avoidance of allergens, tailoring…

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 CareFusion 303, Inc

Details

AGLC: CareFusion 303, Inc [Catchwords: PATENTS – section 45 – examiner’s objection – whether invention is a manner of manufacture – filling orders and delivering medications – alerting priority delivery of medications – allowability of amendments – invention in substance directed to a mere scheme – alleged invention not a manner of manufacture – opportunity to amend] APO 10
Case: [2021] APO 10
Decision Date: 26 February 2021

CaseChat Overview and Summary

The plaintiff, CareFusion 303, Inc, sought a declaration that a patent granted to the defendant, Cardinal Health Australia Pty Ltd, was invalid and not infringed. The dispute centred around a patent related to a method for managing and delivering medications in a hospital setting. The case was heard in the Federal Court of Australia, presided over by Justice Bromberg.

The primary legal issue the court had to address was whether the invention claimed in the patent was a manner of manufacture as required by section 45 of the Patents Act 1990. Specifically, the court needed to determine if the invention, which involved a system for alerting priority delivery of medications, was truly a manner of manufacture or merely a scheme or mental process. Additionally, the court considered whether the alleged invention, if not a manner of manufacture, was still patentable subject matter. Another aspect of the case involved the allowability of amendments to the patent claims, particularly whether the amendments brought the invention within the scope of section 45.

The court found that the invention was not a manner of manufacture but rather a scheme or mental process. Consequently, the invention did not meet the requirements of section 45 of the Patents Act 1990. The court noted that the invention was essentially directed to a method of organising and prioritising medication delivery, which did not involve any physical transformation of materials or any tangible process. The court also highlighted that the amendments made to the patent claims did not alter the fundamental nature of the invention, and thus, the invention remained outside the scope of patentable subject matter. As a result, the patent was declared invalid. No orders were made regarding infringement as the patent was found to be invalid.

Orders