Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697639652255.pdf (Australia)
CHAPTER 3 OVERVIEW OF THE BILL Key provisions of the Bill The key provisions of the Bill amend the Patents Act.1 In particular, the Bill 3.1 amends section 18 which sets out the substantive requirements of a valid patentable invention for the purposes of a standard patent and innovation patent.

Items 1 and 2 amend the 'manner of manufacture' test of patentability.

Item 3 adds a new specific exclusion to patentability for 'biological materials', and Item 4 adds a new definition related to that exclusion.
3.2 The EM states that the Bill '(a) reinforces the applicability of the proviso in section 6 of the Statute of Monopolies within the meaning of section 18(1)(a) and section 18(1A)(a), (b) reinforces the applicability of the distinction between discovery and invention and (c) applies that distinction by expressly excluding from patentability, biological materials which are identical or substantially identical to such materials as they exist in nature, however made'.2 3.3 Item 1 of Schedule 1 of the Bill repeals existing paragraph 18(1)(a) of the Patents Act and substitutes '(a) is a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and'.
In effect, this inserts the phrase 'within the full meaning, including the proviso' into the requirements of a patentable invention for the purposes of a standard patent.

3.4 Item 2 of Schedule 1 repeats this amendment of the requirements of a patentable invention for the purposes of an innovation patent.

It repeals existing paragraph 18(1A)(a) and again substitutes 'a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and'.
3.5 Item 3 of Schedule 1 repeals subsection 18(2) and substitutes: (2) The following are not patentable inventions: (a) human beings, and the biological processes for their generation; and (b) biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.

1 Possible amendments to the Bill were also proposed during the inquiry.

These are addressed in chapter 4.


2 EM, p. 2.

Page 16 3.6 In effect, this adds new paragraph (b) to existing subsection 18(2) which currently provides that human beings, and the biological processes for their generation, are not patentable inventions.

3.7 Finally Item 4 of Schedule 1 inserts new subsection 18(5).

It provides 'biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids' [bold in original].
The abbreviation DNA presumably refers to deoxyribonucleic acid and is currently used elsewhere in the Patents Act without further definition.

The abbreviation RNA presumably refers to ribonucleic acid and is not currently used or defined in the Patents Act.

Amended section 18 3.8 For convenience, the following extract indicates the proposed additions and deletions of the Bill's amendments to section 18 of the Patents Act.
Underlined words are those added by the amendments in the Bill, while those words crossed out would be deleted.
Section 18 Patentable inventions Patentable inventions for the purposes of a standard patent (1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: (a) is a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and (b) when compared with the prior art base as it existed before the priority date of that claim: (i) is novel; and (ii) involves an inventive step; and (c) is useful; and (d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee's or nominated person's predecessor in title to the invention.
Patentable inventions for the purposes of an innovation patent (1A) Subject to subsections (2) and (3), an invention is a patentable invention for the purposes of an innovation patent if the invention, so far as claimed in any claim: (a) is a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and (b) when compared with the prior art base as it existed before the priority date of that claim: Page 17 (i) is novel; and (ii) involves an innovative step; and (c) is useful; and (d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee's or nominated person's predecessor in title to the invention.
(2) The following are not patentable inventions: (a) Hhuman beings, and the biological processes for their generation; and, are not patentable inventions.

(b) biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.
Certain inventions not patentable inventions for the purposes of an innovation patent (3) For the purposes of an innovation patent, plants and animals, and the biological processes for the generation of plants and animals, are not patentable inventions.

(4) Subsection (3) does not apply if the invention is a microbiological process or a product of such a process.

(5) In this section: biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids.