Fertilitescentrum AB and Luminis Pty. Ltd - [2004] APO 19

OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Application : No. 44916/99 in the name of Luminis Pty Ltd and Fertilitescentrum AB

Title: Method and medium for in vitro culture of human embryos

Action: Proposed direction under s.107 to delete certain claims

Decision: Issued 13 July 2004
Abstract

The application included claims to a ‘method of growing pre-blastocyst human embryos’ in a particular medium. The examiner objected that these claims contravened s.18(2), and a direction under s.107 was proposed to delete those claims. Applicant argued that a human being was generated at fertilisation. And since the claimed method was applied at a later stage, it could not be a process for generating a human being.
· The correct interpretation of s.18(2) is ascertained by recognising a human being as being in the process of generation from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth. This arises either as a general belief that the status of human being does in fact arise over a period of time, or as a reflection of the divergent views in society about when a human being comes into existence (with no view being more right than others).
·    The prohibition of ‘human beings’ is a prohibition of patenting of any entity that might reasonably claim the status of a human being, including a fertilised ovum and all its subsequent manifestations.
·    The prohibition of ‘biological processes for (the generation of human beings)’ clearly covers all biological processes applied from fertilisation to birth – so long as the process is indeed one that directly relates to the generation of the human being.
·    The exclusion of biological processes includes the processes of generating the entity that can first claim a status of human being. For example, processes for fertilising an ovum; processes for cloning at the 4-cell stage by division; processes for cloning by replacing nuclear DNA.
·    Direction given to delete claims directed to a method of growing preblastocyst human embryos.
PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent Application 44916/99 in the name of Luminis Pty Ltd and Fertilitescentrum AB, and a proposed direction under s.107 to delete certain claims

BACKGROUND

Application 44916/99 was filed under the provisions of the Patent Co-operation Treaty. The basic concept of the invention is the discovery that a substance called ‘granulocyte-macrophage colony-stimulating factor’ (otherwise referred to as GM-CSF) ‘is effective at substantially increasing the proportion of early embryos that develop to blastocyst and increasing the proportion of those embryos that continue to expanded blastocyst and then hatched blastocyst stages of development’. This substance is apparently present in the natural environment of the fallopian tube. The present invention involves ensuring its present in an IVF environment.
As filed, the application included claims to a culture medium, to a method of growing preblastocyst human embryos, and an IVF program. During examination, the examiner objected to…

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: [2004] APO 19
Decision Date: 13 July 2004

CaseChat Overview and Summary

The decision concerns patent application 44916/99, which includes claims to a method of growing pre-blastocyst human embryos in a culture medium containing GM-CSF. The applicant sought to exclude the claims from a direction to delete, which had been proposed under section 107 of the Patents Act 1990 due to the claims contravening section 18(2). This section prohibits the patenting of human beings and the biological processes for their generation. The applicant argued that the process was not a process of generating a human being, but merely a treatment of a human being, as the process was applied after the creation of the human being. The court considered the interpretation of section 18(2), which prohibits patenting of any entity that might reasonably claim the status of a human being, and all biological processes applied from fertilisation to birth that directly relate to the generation of a human being. The court concluded that the process of growing pre-blastocyst human embryos was a biological process that directly related to the generation of a human being, and thus fell within the exclusion of section 18(2). Therefore, the proposed direction under section 107 was upheld, and the applicant was directed to delete claims 10 to 23. The time for filing such a statement was set to be the current final date for acceptance of the application, 12 August 2004.

Orders