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Patent

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on 21 October 2013

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Transcript of Patent

Patent
Intellectual Property Laws Amendment Bill 2013
Cancer Voices Australia V
Myriad Genetics Inc (2013)
A
Balancing
Act
‘Patents are an attempt to balance the rights of innovators with the rights of the community to the fruits of innovation’

This balance can be particularly difficult to achieve in the area of medical technology

This presentation shall seek to answer whether or not the needs of either innovators or the community are being underrepresented by considering:
Intellectual Property Laws Amendments Bill (2013)
Cancer Voices Australia v Myriad Genetics Inc(2013)
Clarify the scope of Crown use and its operation, particularly in the context of healthcare


Allow any Australian, state or territory government to authorise private service providers to use an invention

Concern as to whether genetic testing material could be transferred across state lines

Enable pharmaceutical firms to apply for a compulsory licence to export a patented product to address health crises

Government commitment to WTO’s TRIPS Protocol
The scope of 'Crown use' is unclear, in particular the extent to which the Commonwealth can include non-government bodies
Insufficient transparency and accountability in the process for using the Crown use provisions.
Cancer Voices Australia v Myriad Genetics Inc. (2013)

Myriad’s Australian licensee Genetic Technologies Ltd (GTI) attempted to enforce its rights over testing in 2002, 2003 & 2008
How did it start?
Central Question
Whether the ‘isolated’ nucleic acid (DNA and RNA) is patentable
The applicant:

Questioned the validity
of claims 1, 2 & 3
The respondent

held a patent of 30 different claims
What is it all about?
Cancer Voices Australia’s (CVA) arguments
Claims 1, 2 & 3 of the patent were invalid because none constituted a ‘manner of manufacture.’ Provision of s 18 (1) (a) of the Patents Act (1990).

Claims 1,2 & 3 cannot satisfy s 18 (1) (a) of the Act because each claim comprises ‘isolated’ DNA that is not materially different to DNA that occurs in nature. Provision of s 18 (2) of the Patents Act (1990).

Myriad claimed its ‘product exists in an artificial state of affairs, which provides a new and useful effect that is of economic significance.’ [National Research Development Corporation v Commissioner of Patents (1959)].

Our Perspective
Cancer Voice Australia
Myriad Genetics Inc.
Claimed that DNA found in a human cell differs chemically, structurally and functionally from the isolated DNA of the disputed claims.

Myriad Genetics Inc (Respondent)
Nicholas J found
‘Isolated DNA & RNA is not ‘naturally occurring’ as it has been removed from the body and ‘purged of biological materials with which it is associated’

‘Each of the claims is too a ‘manner of manufacture’ as the term is not meant to be understood in a literal sense but given a ‘wider conception’ - Maeder v. Busch (1938)

CVC has appealed to the High Court.
Was this the right decision?
It's a matter of perspective ....
‘Myriad Genetics needs to find some heart, which can be found behind the breasts’
((Mary Clair King - Discovered BRCA 1 )

Does this influence your perspective?
BRCA and Cancer

12 % of women will develop breast before the age of 70

1.9 % will develop ovarian cancer before the age of 70.

65% of women who inherit a harmful BRCA 1 mutation will develop breast cancer

45 % of women who inherit a harmful BRCA 2 mutation will develop breast cancer

39 % of women who inherit a harmful BRCA 1 mutation will develop ovarian cancer

17% of women who inherit a harmful BRCA 2 mutation will develop ovarian cancer

(Nation Cancer Institute – 2013)

Currently the needs of the community are underrepresented but things are changing…

Community needs



Current situation of BRCA 1 & 2 testing
Access to medical innovations or inventions
Access at a fair and reasonable cost
Continued and unhindered medical research
Only 10 laboratories in Australia are accredited
Current testing cost range from AUD$2000 - $3000
Scope for research limited due to legislative restrictions around commercialisation
BRCA genetic testing is not covered by Medicare

Why has patent law favoured medical innovators and inventors ?
Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)
Case concerned Myriad Genetics BRCA 1 & 2 Patent, specifically claims 1 &2
Intellectual Property Laws Act Amendment Bill 2012 (The Raising the Bar Bill)
Intellectual Property Laws Amendment Bill 2013
The amendments clear any ambiguity over the use of commonwealth and state
So what's changing?
Intellectual Property Laws Amendment Bill 2013

Intellectual Property Laws Act Amendment Bill 2012 (The Raising the Bar Bill)

Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)
Statute
Uncertainty over scope of Patents Act (1990) provisions

Political unwillingness to enact government provisions

Concern over reducing incentives for innovation (Patent Amendment Bill 2010)

Common Law
National Research Development Corporation v Commissioner of Patents (1959) HCA 67

Kirin-Amgen Inc v Board of Regents of University of Washington (1995) APO 61

Public opinion
Compulsory licensing provisions (s 133-140 of the Patents Act 1990)

Government use and acquisition provisions (s 163-171 of the Patents Act 1990).

Effective 13th April 2013
Key Amendments:
Raising the quality of patents granted
Patent infringement exemption for the purposes of gaining regulatory approval (non pharmaceuticals) s 119 B
Patent infringement exemption for experimental purposes s 119 C
J Nicholas (CVA v Myriad): ‘the imminent changes should address at least some of the problems identified by opponents of the APO’s practices (123)’
‘Genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material’

‘The processes used by Myriad to isolate DNA were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene’

‘A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’
Public
Opinion
The US Supreme court in its ruling in June 2013 found that
Myriad's Arguments
Full transcript