01 July 2011

Update on the Australian Senate Gene Patent Inquiry

As we have previously reported, the Australian Senate Legal and Constitutional Committee, which is currently conducting the inquiry on the Patent Amendment (Human Genes and Biological Materials) Bill 2010, was due to report by 16 June 2011.

As a reminder, the Bill (as originally introduced) seeks to outlaw the patenting of human genes, and other biological materials that are ‘substantially identical to such materials as they exist in nature’.

Anybody who has been waiting with bated breath for the results of the inquiry (and how the Committee manages to address the concerns expressed in over 100 submissions) will just have to be patient and wait a little longer.  On 15 June 2011, the Senate granted the Committee an extension of time for reporting, until 25 August 2011.

Nonetheless, this provides us with an opportunity to review what has been happening with the inquiry since we last reported (see ‘Late’ Submissions to Senate Inquiry on ‘Gene Patent’ Ban, and our more recent ‘opinion’ piece Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously).

In summary:
  1. four further late submissions have been received;
  2. public hearings were held on 28-29 April 2011; and
  3. Senator Heffernan introduced a further amended version of the Bill during the hearing sessions on 28 April 2011.

ADDITIONAL SUBMISSIONS

The table below summarises the further four submissions received by the Senate Committee.

No.
Contributor
Disposition
Interest
111
Dr Warwick Neville FM, Dr Luigi Palombi, Dr Buddhima Lokuge
Resubmission of comments made to the National Health and Medical Research
Council Review of Commonwealth legislation concerning cloning and research into stem cells. (6 pages)
Academia (legal, regulatory).
112
Victorian Government
Opposed to Bill. (5 pages)
State government.
113
Ms Katrina Howard
Argues that Bill may be unconstitutional. (3 pages, plus attachment)
Barrister (Senior Counsel).
114
Genzyme Australasia
Opposed to Bill. (1 page, plus 2 page attachment)
Industry (pharmaceuticals).

Copies of the submissions are available from the Committee’s web site.

PUBLIC HEARINGS

The transcripts of the public hearings make for interesting, if fairly lengthy, reading.

The Committee Hansard (PDF) for the two days of the hearing can be downloaded here:
  1.  Thursday, 28 April 2011; and
  2. Friday, 29 April 2011.
Many of the questions, and responses, reflect a high level of interest and engagement with the issues.  Most of the Senate Committee members come across as genuinely open to the perspectives of the various witnesses appearing before them, and concerned to understand the technical and legal complexities of the ‘gene patent’ debate, and the potential consequences of passage of the Bill for the various stakeholders.

However, it is fairly clear that the main proponents of the Bill on the Committee are Senators Heffernan and Xenophon, whose views seem unlikely to be swayed by anything  that anyone might say.  Of course, they are entitled to their opinions, and to represent the interests of their constituents.  But we cannot help but note that the few low-points in the hearings almost invariably involve Senator Heffernan, who on a number of occasions comes across as ignorant of the complexities of the patent law, unnecessarily aggressive in his questioning of those individuals appearing before the Committee who do not share his views and, at times, downright rude, arrogant and dismissive. 

Now, obviously words on the page do not always convey the real tone or full content of a face-to-face discussion, and we therefore accept that the Senator’s attitude may not be accurately represented in print.  However, it is difficult to misconstrue the disrespect in the Senator’s denigration of Dr Anna Lavelle’s (of AusBiotech) title (on page 17 of the Friday transcript: ‘So it is a doctor of dust, not medicine’).  Yet, we note, Senator Heffernan has no such trouble with Dr Palombi’s title.

Overall, we have the impression from the transcripts that the majority of the Committee members will be inclined to proceed with caution, recognising that many submissions have supported the general intent of the Bill, but that stakeholders across a broad spectrum have raised concerns about its specific form, and potential ‘unintended consequences’.

A number of questions were directed to the relationship between the ‘Human Genes and Biological Materials’ Bill and the ‘Raising the Bar’ Bill (see, most recently, Senate Patent Reform Bill – A Closer Look), and the extent to which the latter Bill may alleviate the concerns in relation to gene patents.  Generally speaking, however, ‘Raising the Bar’ addresses different issues, proposing no amendment to the fundamental threshold test for patentable subject matter, while seeking to raise standards of patentability across all technologies.

We were interested to note that while a number of witnesses testified that a higher standard of inventive step would help to prevent the grant of overly broad patents on genetic materials, there was very little discussion of the proposed enhancements to the utility requirements, which would also limit broad speculative claiming (see Patent Reform Exposed Part II – Usefulness).

QUESTIONS ON NOTICE

A number of witnesses took questions on notice, either because there was insufficient time to respond fully during the hearing, or because the nature of the questions required additional fact-checking and/or consideration.

Responses to the questions on notice by the following parties are available from the Committee’s web site:
  1. Royal College of Pathologists of Australasia;
  2. Professor Dianne Nicol and Mr Johnathon Liddicoat;
  3. Dr Luigi Palombi;
  4. CropLife Australia;
  5. Walter and Eliza Hall Institute of Medical Research;
  6. Medicines Australia; and
  7. Generic Medicines Industry Association.

AMENDED BILL

During the hearings on Day 1 (Thursday 28 April 2011), Senator Heffernan introduced the following amended version of the Bill for discussion:

1 Paragraph 18(1)(a)

Repeal the paragraph, substitute:

(a) is a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and

2 Paragraph 18(1A)(a)

Repeal the paragraph, substitute:

(a) is a manner of manufacture within the full meaning, including the proviso, of section 6 of the Statute of Monopolies; and

3 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.

4 After subsection 18(4)

Insert:

(5) In this section:
  1. biological materials , in section 18, includes DNA, RNA, proteins, cells and fluids and their components.
  2. identical, in section 18, means a biological material which is structurally and functionally identical.

This version of the Bill is the same alternative proposed by Dr Palombi in his submissions to the Committee (see ‘Late’ Submissions to Senate Inquiry on ‘Gene Patent’ Ban).

CONCLUSION

We now await the Committee’s report, by 25 August 2011 (assuming that no further extensions are granted). 

As noted above, we think it likely that the Committee will wish to proceed with caution, and we would therefore be surprised if its report recommends that the Bill be passed by the Senate in its current form.  The amended version was not received no more favourably that the original draft.

The Committee may endorse the ‘Raising the Bar’ Bill, which was the subject of positive comments from a number of witnesses.  It may also encourage the Government to accept at least some of the recommendations of the ACIP report into patentable subject matter, which was also discussed during the hearings (see ACIP Reports on ‘Patentable Subject Matter’).

Finally, we note that as of today (1 July 2011) the make-up of the Senate changes, as the new Senators elected in 2010 take up their terms.  This hands the Greens – not known for their support of biological patents – the balance of power, and is therefore a potential wildcard in the whole process.

We continue to live in interesting times, with patent law enjoying a rare focus of parliamentary attention!

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