11 June 2010

More on Australian Gene Patent Challenge

Patentology reported earlier this week on the challenge to the validity of Myriad's Australian patent relating to the BRCA1 and BRCA2 genes, which can be used to diagnose genetic predispostion to breast and ovarian cancer.

This is not at all our area of expertise, so we are grateful to one of our colleagues for providing us with additional background.

BACKGROUND

The Australian patent in question (no. 686004) is jointly owned by Myriad Genetics, Inc (US), Centre de Recherche du Chul (CA) and The Cancer Institute (JP).  Details of the patent can be found in the IP Australia database, while the patent specification itself can be viewed or downloaded from the EPO esp@cenet system.

Genetic Technologies Limited (GT) is an Australian Stock Exchange and NASDAQ listed company (ASX: GTG; NASDAQ: GENE), which has held an exclusive license to the patent in Australia and New Zealand since 2002.  It seems that the patent, and the cancer screening test, have had a controversial history.

GT initially sought to assert its newly-acquired rights, but subsequently retreated from this position.  Between 2002 and 2008 GT did not seek to enforce its exclusive rights in relation to the patent.  My understanding is that, as a result, various institutions (mainly research centres and hospitals that already had the necessary laboratories and tools) continued to offer screening services falling within the scope of the patent.

On 11 July 2008 GT announced that it was going to start enforcing its rights.  It seems that this was a controversial decision, and presumably a PR nightmare, because on 24 July 2008 and 31 October 2008 GT issued "clarifications" on its new policy of enforcement.  On 24 November 2008 GT informed the market that it was reviewing its decision, and on 2 December 2008 announced that it was reverting to its original policy.

However, in some respects the damage was already done, because GT's letters to various laboratories had come to the attention of Australian Senator Bill Heffernan (about whom Patentology expresses no opinion), the end result of which has been a Senate inquiry into gene patents and their effects on the Australian people.  The Committee is due to report on 17 June 2010.

MORE ON THE 'TEST CASE'

There is also a little more that we can report on the Federal Court challenge to the patent.

According to this press release from Maurice Blackburn lawyers:
...the test case is supported by patent law expert Dr Luigi Palombi from Australian National University and Sydney University and will be run on a pro bono basis by Maurice Blackburn partner Rebecca Gilsenan and barristers David Catterns QC and Peter Cashman.
As we noted previously, Patentology is unaware that Maurice Blackburn has any significant experience running intellectual property cases, however Mr David Catterns QC is a very well-known and highly respected practitioner in this area.  You can read more about Dr Luigi Palombi on this Australian National University web page.  A link to an opinion piece by Dr Palombi on this subject can be found in the further sources listed below.

The Maurice Blackburn press release incorrectly asserts that the patent is "held" by parties including GT.  As an exclusive licensee, GT is a respondent (along with the three patent owners) in the litigation, but it is not actually itself an owner of the patent.  This misinformation has been reporduced in most of the reports appearing in the media. 

This letter to The Australian newspaper (Australia's News Corp owned national daily broadsheet) from GT CEO Paul MacLeman, in response to this article the previous day, is interesting in view of the history of the patent.

We will continue to keep an eye on the case, as well as the Senate Committee Report, due out next week.

FURTHER SOURCES

GT Announcement, 11 July 2008
GT Announcement, 24 July 2008
GT Announcement, 31 October 2008
GT Announcement, 2 December 2008
Luigi Palombi, "A gene inventor? Patent nonsense," Sydney Morning Herald opinion piece, 16 July 2009

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