Academic journal article Houston Journal of International Law

A "Myriad" of Controversy over the Question of Human Gene Patent Eligibility: A Comparison of the Differing Approaches in the United States and Australia

Academic journal article Houston Journal of International Law

A "Myriad" of Controversy over the Question of Human Gene Patent Eligibility: A Comparison of the Differing Approaches in the United States and Australia

Article excerpt

  I. INTRODUCTION  II. BACKGROUND      A. United States      B. Australia III. REASONING OF THE COURTS      A. Supreme Court of the United States      B. The Federal Court of Australia  IV. IMPLICATIONS OF PATENT ELIGIBILITY OR         INELIGIBILITY OF HUMAN GENE SEQUENCES      A. Proponents to Gene Sequence Patenting      B. Opponents to Gene Sequence Patenting   V. HUMAN GENE PATENT ELIGIBILITY DEBATE AS         APPROACHED FROM OTHER COUNTRIES      A. The European Union      B. Canada      C. Harmonization  VI. CONCLUSION 


   Next came the patent laws. These began in England in    1624, and in this country with the adoption of our    Constitution. Before then any man [might] instantly use    what another man had invented, so that the inventor had    no special advantage from his own invention. The patent    system changed this, secured to the inventor for a limited    time exclusive use of his inventions, and thereby added    the fuel of interest to the fire of genius in the discovery    and production of new and useful things. (1) 

Lincoln's metaphor of patent law's exclusive rights "add[ing] the fuel of interest to the fire of genius," can be applied to the area of patents in another way besides to the "discovery and production of new and useful things." The incentive of exclusive rights has also fueled a wealth of debate over the proper subject matter for patent protection.

The debate over whether human genes are eligible for patent protection has been prevalent for many years (2) and has come to the forefront once again. Currently, this issue is focused in the united states and Australia. in both countries, recent major decisions have shaken modern patent law.

In the United States, the U. S. Patent and Trademark Office (USPTO) has granted patent claims relating to newly identified human genes that are linked to the predisposition for diseases. (3) Although the area of human genetics research is relatively new and evolving, patents on human gene sequences (4) have been issued in Australia without much judicial intervention. (5)

The validity of gene patents held by the company Myriad Genetics has recently been challenged in both the United States and Australia. (6) The Supreme Court of the United States' decision to invalidate human gene sequence patents and the Federal Court of Australia's decision confirming their validity have ignited continued debate on the issue. (7)

These decisions have far-reaching effects on medical research, patients seeking genetic therapies or testing, and the international character of patents as a whole. The impact of these decisions has sparked much debate from critics and proponents in the scientific, legal, public interest communities. (8) The major scientific and public interest arguments focus on incentivizing research and patient access. (9) Specifically, arguments critical of gene patents center around restraining genetic research and making genetic testing excessively expensive for the public. (10)

This Comment examines the reasoning and policy implications of the two decisions, and suggests which decision yields the most favorable result. It then seeks to compare the approaches of the U.S. and Australian courts with other countries. It concludes by suggesting which approach produces the best outcome and proposes how and why gene patents should be regulated with international consistency.


In order to explain the arguments for and against the eligibility of human gene sequences for patenting, it is necessary to provide some background of the pertinent patent laws in the United States and Australia and the cases applying those laws in both jurisdictions. This section introduces a basic background of select United States and Australian patent law and the two major cases in the current controversy. Section A presents the law in controversy in the United States and a description of the case Association of Molecular Pathology v. …

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