Recently, Vaughan Barlow details the ramifications of the Patent Amendment (Human Genes and Biological Materials) Bill (2010), currently being debated before the Australian parliament.

The Bill seeks to ban the patenting of all biological material that is “identical or substantially identical to such materials as they exist in nature”. If passed, this legislation may significantly jeopardize the biotechnology, pharmaceutical, medical and agricultural industries in Australia.

Among other proposed changes, the Bill seeks to amend section 18 of the Patents Act (1990) as follows:

(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 meaning 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;


(2)        Human beings, and the biological processes for their generation, are not patentable inventions.

(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.


(5)        In this section:

biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids.

The proposed ban on patenting of biological materials under section 18(2) is therefore far broader than the current ban, which is limited to “human beings and the biological processes for their generation”.  Proposed section 18(2)(b) bans from patentability all biological materials that are “identical or substantially identical” to those existing in nature.

According to Barlow:

In addition to Australia’s potential contravention of its obligations under TRIPS, the commercial reality of banning from patentability all biological material that exists in nature could result in the biotechnology, pharmaceutical, medical and agricultural industries withdrawing investment in Australia. As a consequence, there is the potential for future difficulty in accessing medicines and associated problems in the provision of healthcare. This possible lack of investment could arise not only because of diminished returns on investments through a lack of patent rights, but also because of the remaining significant costs in obtaining regulatory approval.

Patent applicants seeking to claim biological materials in Australia should watch the progress of the Patent Amendment (Human Genes and Biological Materials) Bill (2010).

See:  Mumbo jumbo: The patentability of biological materials in Australia

Vaughan Barlow is a patent and trademark attorney with Pizzeys Patent and Trade Mark Attorneys in Australia.

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  1. Not sure how broad is 18(2)’s “identical or substantially identical”? Materials existing in nature are also excluded from palatability under the U.S. patent law, but there is the purification exception. The “substantial identical” in the proposed bio-material ban of Australian law does sound problematic.

    Regarding TRIP’s contravention, wonder Aus could argue under TRIPS 27(2)-public morality for the ban. Seems a little far fetched though.

  2. I Agree with the above comment. Sounds problematic from a US to AUS perspective.

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  3. […] Anti-gene-patents bill introduced in Lower House (Patentology) (IP Whiteboard) (Patent Baristas) […]

  4. For more than 20 years, the patentability of genes and genetic material has been a controversial issue, which is now coming to a head in a case before the Federal Court and with the introduction of a Private Member’s Bill which seeks to exclude the patenting of human genes and biological materials existing in nature.

  5. That was very informative and well written. I look forward for further posts from you. Recently I happened to read an article on Patent searching in India using IPAIRS system, which I felt quite interesting and informative. I would like to bring your kind attention to that post. Below mentioned is an excerpt of the mentioned article.

    Performing a search on IPAIRS using keywords is an important step in performing exhaustive patent searches in India. However, the extent of search which can be done by using keywords is limited to title and abstract fields only. One style of performing keyword searches includes the identification of keywords and arranging them in a hierarchy (moving from specific aspects to broader aspects) which is based on the technology that is being searched. e.g. if one is performing a search for a skin care composition which involves a skin lightening agent (niacinamide), then the keywords could be identified in the following hierarchical fashion.
    identify all the different keywords for niacinamide… To read more go this way