28 March 2011

‘Late’ Submissions to Senate Inquiry on ‘Gene Patent’ Ban

A few weeks back, we reported on the 100 submissions received by the Australian Senate inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which seeks to outlaw the patenting of human genes, and other biological materials that are ‘substantially identical to such materials as they exist in nature’.

At that time, the score-card was 67 opposed to the Bill, and 23 in favour, with the remaining ten being generally supportive of the intent of the Bill, but opposed to it in its current form.

We also noted the absence of any submission from Dr Luigi Palombi, who was mentioned in the Senate as a potentially interested party and who, so it was rumoured, was largely responsible for drafting of the Bill.

Since our previous summary, ten further submissions have been added to the list on the Inquiry’s web site.  Five of these are opposed to the Bill, three are supportive, and the remaining two are listed as ‘confidential’ (confidentiality can be considered on the request of the person making the submission, but is not guaranteed).

Notably, the ‘late’ publications include not one, but two, submissions from Dr Palombi, in the first of which he confirms his role as the primary drafter of the Bill.

COMMENTS ON FURTHER SUBMISSIONS

Generally speaking, the pattern of the first 100 submissions continues in the further ten, with the notable exception of the NSW department of Industry and Investment, which becomes the first state government representative to support the Bill.  Overall, the submissions remain overwhelmingly opposed to the Bill (72 clearly against, out of 110 submissions).

We cannot, however, avoid commenting on a couple of interesting aspects of the late submissions.

For one, Gene Ethics’ submission (no. 106) is dated 25 February 2011, but quotes and responds to the submissions of BIO (submission no. 86, dated 25 February), Agrifood Awareness (submission no. 51, dated 24 February), CSIRO (submission no. 78, dated only ‘February 2011’), and Hexima (submission no. 58, dated 25 February).   It is not clear how Gene Ethics was able to review and respond to these opposing submissions within such a short period of time, but far be it for us to suggest that their submission was not actually finalised and submitted on 25 February 2011, as the date suggests!

Dr Palombi’s submissions are also interesting.  The plural is not accidental – he has made two submissions, the first of which explains (with the assistance of colour drawings) exactly how the amendment proposed in the Bill is ‘intended’ to work.   The second submission is the more intriguing of the two. 

Although dated 24 February 2011, Dr Palombi’s second submission states that one of its purposes is to ‘address some of the issues raised in other submissions.’  In doing so, Dr Palombi has a second shot at the proposed amendment, making the following revised proposal:
Subsection 18(2)

Repeal the subsection, substitute:

(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.
After subsection 18(4), insert:

(5) In this section:
        biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids and their components.
        identical, in section 18, means a biological material which is structurally and functionally identical and where any structural change or difference is immaterial to its function.

This does not appear to us to be much of an improvement.  The AIPLA submission (no. 110) gives the example of insulin analogues, for use in the treatment of diabetes, and it does not appear certain that this proposed amendment  would avoid the exclusion of these important drugs.

Also intriguing is a redacted passage on pages 2 and 3 of Dr Palombi’s supplementary submission.  The sentences leading up to this passage suggest that the Australia Law Reform Commission (ALRC) exceeded its terms of reference when reporting on its enquiry into gene patents in 2004.  Dr Palombi goes on to state that the reason for this:

…is not to be found by reading the ALRC’s report. It is to be found by looking into the backgrounds of the people who oversaw the Inquiry, had a significant role in crafting its recommendations and authoring its report.

The subsequent paragraphs are redacted, and we can only assume that they contain comments on the background and character of one or more members of the relevant ALRC committee, which were considered to be inappropriate for publication.

We trust that Dr Palombi feels that he has had ample opportunity to have his say.  He drafted the Bill, and thus clearly has the attention of some fairly influential people in the Australian parliament.  He has then had the opportunity to comment in support of his own Bill, and (it seems) to respond to the criticisms in other submissions, including by proposing an alternative version of his Bill!

For a person who purports to ‘have no interest, direct or indirect, financial or otherwise, in the subject of this Inquiry or in its results’ (final paragraph of his main submission), Dr Palombi certainly has some strong views on the subject, and on those who hold differing opinions.  While he may have no direct financial interest in the final outcome, we are having difficulty believing that he is as disinterested as he proclaims.  We hope that his ‘Declaration of Interest’ is not intended to imply that other contributors’ views should be accorded less weight than his own, due to their financial interest in the outcome of the inquiry, because that would be offensive and unbecoming from an academic of Dr Palombi’s standing.

SUMMARY OF ‘LATE’ SUBMISSIONS

The table below briefly summarises the further ten submissions now received by the Senate Committee. 

No.
Contributor
Disposition
Interest
101
Janssen, Pharmaceutical Companies of Johnson and Johnson (Janssen-Cilag Pty Ltd)
Opposed to Bill. (13 pages)
Industry (Pharmaceuticals)
102
Meat and Livestock Australia Limited (MLA)
Supports the Bill. (3 pages)
Industry (producer-owned R&D company)
103
Dr Luigi Palombi
Supports the Bill. (14 pages, across two submissions)
Legal academic and  principal drafter of Bill.
104
MS Research Australia
Opposed to Bill. (2 pages)
Research organisation (multiple sclerosis)
105
Industry and Investment NSW 
Opposed to Bill. (3 pages)
State Government department.
106
Gene Ethics
Supports the Bill. (13 pages)
Non-profit public network (against GM technologies and products)
107
Confidential
Unknown
Unknown
108
Confidential
UnknownUnknown
109
The Burnet Institute
Opposed to Bill. (6 pages)
Independent, non-profit, public health organisation
110
American Intellectual Property Law Association
Opposed to Bill. (7 pages)Professional association (US IP lawyers)

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