Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

Claims 1-3 were claims to a manner of manufacture. Although naturally occurring DNA and RNA as they exist inside human cells cannot be the subject of a valid patent, the disputed claims extended only to DNA and RNA extracted from cells and purged of other biological materials. That extraction and purification involved human intervention and produced an artificial state of affairs. Because non-compliance with s 18(1)(a) was the sole ground of invalidity relied on, the application to revoke the claims failed.

Jurisdiction
Australia
Judgment Date
15 February 2013
Procedural Posture
Application Challenging Validity of Patent Claims and Seeking Declarations and Orders Revoking Claims 1 3 of Australian Standard Patent Number 686004 / First Instance Judgment in the Federal Court of Australia
Outcome
Amended application dismissed with costs; costs order stayed for 21 days and, if a notice of appeal is filed within that time, until determination of the appeal.
Legal Topics
['manner of Manufacture' 'patentable Subject Matter' 'isolated DNA and Rna' 'gene Patenting' 'revocation of Patent Claims' 'patents Act 1990 (cth) S 18(1)(a)']
['patents' 'intellectual Property'] ['manner of Manufacture' 'patentable Subject Matter' 'isolated DNA and Rna' 'gene Patenting' 'revocation of Patent Claims' 'patents Act 1990 (cth) S 18(1)(a)']

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Procedural Posture

Application Challenging Validity of Patent Claims and Seeking Declarations and Orders Revoking Claims 1 3 of Australian Standard Patent Number 686004 / First Instance Judgment in the Federal Court of Australia

Legal Issues

  1. 1 ['Whether claims 1-3 to isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptides are for a manner of manufacture within the meaning of s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth).' 'Whether naturally occurring DNA or RNA that has been isolated from the cellular environment is a mere discovery or product of nature and therefore not patentable.' 'Whether isolation of naturally occurring DNA and RNA produces an artificial state of affairs with a discernible effect.']

Ratio Decidendi

Claims 1-3 were claims to a manner of manufacture. Although naturally occurring DNA and RNA as they exist inside human cells cannot be the subject of a valid patent, the disputed claims extended only to DNA and RNA extracted from cells and purged of other biological materials. That extraction and purification involved human intervention and produced an artificial state of affairs. Because non-compliance with s 18(1)(a) was the sole ground of invalidity relied on, the application to revoke the claims failed.

Court Disposition

Amended application dismissed with costs; costs order stayed for 21 days and, if a notice of appeal is filed within that time, until determination of the appeal.

Orders

  • ['The amended application be dismissed.' "The applicants pay the respondents' costs." 'Subject to any further order, order 2 is stayed for 21 days and, if a notice of appeal is filed within that time, until the determination of the appeal.']