Patenting human genes – the ongoing debate

The Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth) (Bill) has added another dimension to the ongoing debate as to the way in which the patent system applies to biological and genetic material.  The effect of the Bill, should it pass into law, will be that biological materials, their components and derivatives, will not be patentable inventions.

The Bill is currently before the Senate Legal and Constitutional Affairs Committee, which at the time of writing has received over 110 submissions regarding the proposed amendments.  While the submissions are numerous and detailed, they clearly reflect the fact that there are several arguments fundamental to the cases of both the proponents and detractors of the Bill in its current form.

The provisions of the Bill

The Bill primarily amends section 18 of the Patents Act 1990 (Cth) (Act).  This key provision sets out the circumstances in which an invention is patentable, and expressly prohibits ‘human beings, and the biological processes for their generation’ from patentability.

This provision is currently applied by IP Australia, the government entity responsible for the granting of patents, to allow the granting of patents over biological materials that have been created, or modified in some way, by a human being.  Relevantly, the Bill will amend this principle by:

• expressly prohibiting ‘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’ from being patentable inventions; and
  
  
• defining ‘biological materials’ to include ‘DNA, RNA, proteins, cells and fluids’.  This list is non-exhaustive and does not appear to be limited merely to human genetic material.  The scope of this definition, and therefore the prohibition outlined above, is therefore largely undefined and uncertain of scope.

The effect of these amendments appears to be that biological materials of any sort, be they human, plant or animal, and regardless of whether they are natural or synthetic, cannot be patented if they are identical or substantially identical to those that exist in nature.

The proponents’ arguments

The proponents’ primary argument in favour of the Bill is that it will increase public access to advanced healthcare.  This argument is based on two grounds, firstly that developers of genetic diagnostic tests and treatment will not be able to exploit their patent monopoly in an anti-competitive manner and secondly, that it will increase medical research and thereby increase the chances of further medical advances.

A common example cited by many of the proponents in support of both of these grounds is the patent granted to Myriad Genetics Inc over the BRCA1 and BRCA2 genes.  Initial detection of these genes has been found to significantly increase the chances of an early diagnosis of breast and ovarian cancer, therefore reducing the risk of the patient succumbing to her illness.  Genetics Technologies Ltd is the exclusive Australian licensee of Myriad Genetics’ patent.

In October 2008 Genetics Technologies Ltd exercised its rights under the Act by requiring that all diagnostic testing for the BRCA1 and BRCA2 genes in Australia be exclusively conducted in its own laboratories in Melbourne.  While they have since reversed this decision, its initial effect was that public and private healthcare providers could not conduct this testing themselves, increasing the costs of and decreasing public access to this potentially life-saving process.

Further the patent awarded over these genes has been shown to have stifled research in this area.  Genetics Technologies’ unwillingness to consent to other laboratories using the BRCA1 and 2 genes for research purposes resulted in these projects being subjected to significant delays and costs blowouts.¹  These problems have delayed further research from reaching the market in a timely fashion, further reducing public access to advances in healthcare.

Essentially, the proponents of the Bill argue that if biological materials cannot be patented, then exploitative measures, such as those taken by Genetics Technologies referred to above, will no longer inhibit public access to healthcare.

The detractors’ arguments

In contrast, the Bill’s detractors present a number of arguments why these amendments should not be implemented.  Principally, and in direct contradiction to the proponents’ argument outlined above, they assert that the amendments would actually have the effect of stifling medical research and public access to advanced healthcare.  This contention is grounded on the basis that patent protection is a major incentive for biotechnology researchers to engage in and fund time-consuming and expensive scientific study.  They argue that, if this incentive is removed, biotechnology companies will be less inclined to conduct research in Australia, and there will be more delays in overseas medical advances being made available here.

The detractors also point out that there are better alternative methods by which any adverse impacts of gene patents on public access to healthcare may be ameliorated, suggesting various other amendments to the Act.  In this respect they generally endorse the recommendations found in the Senate Community Affairs Reference Committee report on its inquiry into gene patents.²  In their various submissions, the detractors have recommended that:

• the threshold of patentability be raised and applied more stringently to ensure that patents are only granted to products which are particularly novel, inventive and useful;
  
  
• the provisions relating to Crown use be strengthened by a statutory clarification of the circumstances in which they can be exercised and the development of governmental policies as to the circumstances in which they will be used;
  
  
• the compulsory licence provisions be clarified and a new test inserted so as to allow for their grant when the patentee engages in anti-competitive conduct;
  
  
• the enactment of a statutory exemption from infringement in circumstances where the patented invention is used for the exclusive purposes of research; and
  
  
• the creation of an external body be created for the purposes of overseeing the system of the granting of patents by IP Australia and their subsequent exploitation by the patentee.

The detractors also point out that the scope of the Bill is unnecessarily broad and uncertain.  The definition of ‘biological materials’ proposed to be inserted in section 18(5) of the Act is brief, non-specific and non-exhaustive.  It has been suggested that this will encompass at least 25 materials in addition to those listed in that section, including vaccines.³   The status of patents already issued over biological materials, which would not be considered patentable under these amendments, is also uncertain.  The detractors argue that this uncertainty will discourage commercial investment and lead to a sharp increase in litigation.

Lavan Legal comment

While the Bill only makes only minor textual changes it would, if implemented in its current form, bring about substantial changes to Australian patent law, changes which would put us out of step with important jurisdictions such as the United Kingdom and United States of America.  Regardless of whether you are inclined to believe the proponents’ or detractors’ arguments as to the commercial consequences of these proposed amendments, it seems likely that they will bring about a period of real uncertainty as to what biotechnology is or is not patentable.

For more information please contact partner Wayne Zappia on (08) 9288 6931 / wayne.zappia@lavanlegal.com.au.