Should Genes be Patentable?

The Debate

There has been heated discussion in the media lately about the validity of gene patents, much of which was provoked by the recent decision by the United States District Court for the Southern District of New York in Association for Molecular Pathology v. US Patent & Trademark Office No. 09-Civ-4515 (Myriad). 

The case, filed by a coalition of plaintiffs led by the American Civil Liberties Union, assessed the validity of Myriad Genetics Inc.’s patent claims covering the BRCA1 and BRCA2 gene sequences and their use in diagnostic tests. The issue is very emotive due to the involvement of these sequences in human breast cancer and the decision by Myriad to tightly control the licensing of the patented diagnostic screening technology based on the sequences. 

Recent US Ruling

The US Court held that 15 claims in 7 Myriad patents to DNA sequences and their use in methods for analysing these DNA sequences were invalid, overturning the long held understanding in all of the major patent jurisdictions, including the United States, Europe and Australia, that isolated or purified genetic sequences with a particular usefulness, are patentable subject matter because they are a product of man and not of nature (i.e. the intervention by a human was sufficient to provide patentability).  The Myriad case questioned this stance, putting forth the proposition that isolated or purified genetic sequences are merely purified products of nature that do not possess the requisite ‘markedly different characteristics’ to satisfy the threshold requirement for patentability.  The Myriad ruling emphasised the role of DNA as an information carrier rather than the chemical and structural differences between isolated and natural genetic sequences in coming to its decision that isolated or purified genetic sequences, even with a specified use, are products of nature and therefore not patentable subject matter. 

What Next?

The Myriad case is the first to really challenge the validity of gene patenting, and many believe that it will be the first of many such cases around the world.  The Myriad ruling currently only has effect in the Southern District of New York, but has been appealed by Myriad to the Court of Appeals for the Federal Circuit, where it is anticipated by many that the decision will be overruled.  However, no matter what the outcome of that appeal, this case is likely to be appealed all the way to the Supreme Court before a final determination is made, a process that is likely to take several years.  Other countries will be watching what happens in the United States with interest.  More importantly, interest groups in other jurisdictions might be more committed to begin challenges in their own countries. 

Where Does Australia Stand on the Issue?

The controversy surrounding the patenting of genes has been investigated already in Australia.  In 2004 the Australian Law Reform Commission published its report “Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99, 2004)”.  The key recommendations of this report were:

Publicly funded research should result in appropriate public benefits. 
Patent Examiners should receive additional training in examining genetic technology patents.  
Revise the ‘usefulness’ assessment so that a specific, substantial and credible use must be included in the specification to discourage speculative applications (in line with the European test for utility).       
Create an infringement exemption for experimental use of patented technology.       
Establish mechanisms to monitor the implications of gene patents for research and healthcare and clarify the Crown use and compulsory licensing provisions.
While there was no formal Government response to this report, there is now an Australian Senate enquiry into the validity of gene patenting which seeks to amend the Patents Act in Australia to expressly prohibit the granting of patents for genes, proteins and their derivatives, even in isolated form(http://www.aph.gov.au/Senate/committee/clac_ctte/gene_patents/).  If you have an opinion on this issue, we suggest you make a submission to the enquiry or write to your local MP so that your opinion can be taken into consideration. 

In Conclusion

It may be that the time for gene patents, especially human gene patents, is almost at an end. However, especially since the complete sequence of the diploid human genome was published in September 2007, researchers have already begun moving more towards other aspects of genetic technology rather than patenting gene sequences per se. Consequently, by the time this long running and emotionally charged gene patenting debate has run its course, there might be few, if any, real gene patents still in force. 

By Dr Belinda McKenzie, Patent Professional.

Please contact Amanda Stark, Principal at amanda.stark@griffithhack.com.au if you would like to discuss further.

Disclaimer – This information is a general outline; it is not legal advice. You should take legal advice before acting on its contents. 

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