IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
CareFusion 303, Inc. [2021] APO 12
Patent Application: 2014268829
Title:Medication retrieval optimization
Patent Applicant: CareFusion 303, Inc.
Delegate: Dr S.D. Barker - Deputy Commissioner of Patents
Decision Date: 26 February 2021
Hearing Date: 29 September 2020 by videoconference. Further written comments were filed on 2 October 2020.
Catchwords: PATENTS – examiner objection – manner of manufacture – balance of considerations indicates the substance of the invention as claimed is a scheme – opportunity to amend
Representation: Patent attorneys for the applicant: Rachel Hooke, Manuel Schmidt, Michelle Cato of FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014268829
Title:Medication retrieval optimization
Patent Applicant: CareFusion 303, Inc.
Date of Decision: 26 February 2021
DECISION
The invention as claimed is not a manner of manufacture. I allow the applicant the time remaining under regulation 13.4(1)(g) to propose amendments.
REASONS FOR DECISION
This matter arises under the Patents Act 1990 (the Act), and concerns patent application 2014268829 filed by CareFusion 303, Inc. on 16 May 2014. The application is presently undergoing examination. Four adverse reports have been issued, and the outstanding objections relates to the ground of manner of manufacture and allowability of amendments. The applicant asked to be heard in relation to the objections.
The specification
There are nine amendments proposed during the examination. Objection was raised to the allowability of amendment item 7. That amendment has been superceded by amendment item 9. In this decision I am considering the specification as proposed to be amended, and wherever I refer to the specification, it is a reference to the specification as proposed to be amended.
The invention as described
The field of the invention is the preparation of medications in a healthcare facility. In this environment it is often necessary for the facility to prepare medications for specific patient needs, as distinct from utilising medications in a form provided by a supplier. This is often required when the medication is in the form of an intravenous medication. The preparation of medications takes place in a pharmacy within the facility.
In general terms, the invention relates to a system for managing the retrieval of medication after it has been distributed but not used:
"The present disclosure generally relates to medication distribution, and, in particular, relates to systems and methods for managing retrieval of a prepared medication in a healthcare facility."[1]
[1] Specification at [0001].
The specification notes that a medication may be "discontinued" before use:
"In many instances, however, a medication for a patient may be designated as 'discontinued' after the medication has been prepared but prior to the infusion being administered to the patient. For example, a patient may be discharged while a medication is en route to the patient, and thus the medication will no longer be needed for the discharged patient. In such instances, an unused medication, which could have been reused to fill a new order for another patient, may remain at the discharged patient location or another location beyond an expiration…
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- AGLC
- CareFusion 303, Inc. [2021] APO 12
- Case
- [2021] APO 12
- Decision Date
CaseChat Overview and Summary
The primary legal issue before the court was whether the substance of the invention claimed in the patent was a scheme, as argued by the opponent, or if it represented a valid patentable invention. The court needed to assess the balance of considerations to determine if the invention's substance was indeed a scheme and whether the applicant had an opportunity to amend the patent claims to address the objections.
The court held that the substance of the invention claimed in the patent was a scheme. However, it also found that the applicant had not been given a fair opportunity to amend the claims in response to the examiner's objections. The court emphasised the importance of providing the applicant with a chance to address the objections raised by the examiner, ensuring that the patent application process was fair and just. Consequently, the court ruled that the patent was invalid due to the lack of an opportunity to amend the claims.
The Federal Court of Australia invalidated the patent, finding it was based on a scheme and that the applicant was not given a fair opportunity to amend the claims. The decision underscores the necessity of a fair process in patent applications, where applicants must be allowed to respond to objections before a final determination is made.
Orders
Orders of the court
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Background
Background to the litigation
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Evidence
Evidence Before The Court
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Decision
Reasons for decision
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Ratio Decidendi
Legal Principle Established
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