Patenting of the human genome: “discovery” not “invention”

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Should companies own the human genome?
Should companies own the human genome?

Should companies own the human genome?

Should companies own the human genome?
Should companies own the human genome?

A 30-year-old law has allowed research companies that worked with the human genome to claim that they could own the rights to any discovered gene sequences found through the Human Genome Project. Australia, the US, and several other countries have allowed research companies to do this with the belief that if discoveries could produce monetary gains for these private firms, then they would be more motivated to produce new and innovative results or treatments. This however has not been largely the case. Private labs worked hard to discover distinct parts of the human genome and then paten them for commercial advantage, shutting out non-profit and government researchers.

At issue, specifically, was a move made by Genetic Technologies Limited in 2006 to make use of the patent laws in Australia so that they were granted specific rights to human genome components BRCA 1 and BRCA 2 under four separate applications that were granted by IP Australia.  The importance of these specific genome series is that they have been linked to breast cancer and its related research.  Many regarded this as an attempt to corner the market on breast cancer research conducted within Australia. The result was that GTL was able to say that no research on these specific series of genes, government or private, could be conducted without using their labs. It was estimated that because of the patents, research in this area had gone up by three-times what should have been expected.

Under the current laws ”isolated genetic material” can be declared an invention. Noting this, Liberal senator Bill Heffernan, backed by Nick Xenophon and the Green party moved that the legislation should be changed so that it would be declared a “discovery” rather than an “invention”.

“The bedrock principle of patent law, and one that has stood for nearly 400 years, is that an inventor receives a patent monopoly for disclosing an invention and how to make it. This principle, however, has been for the past 30 years the subject of a legal trick played by clever patent attorneys. As a result isolated biological materials, that is, naturally occurring biological materials that have been removed from their natural environment, such as the human body, are no longer regarded as products of nature, but as inventions, the product of humankind. This legal hocus-pocus has apparently satisfied IP Australia, the sole regulator of intellectual property in this country,” said senator Heffernan in a speech while tabling his recommendations on November 24th 2010.

According to Heffernan, “inventions are new, contain an inventive step and have a practical application. The word ‘invention’ … is undefined but that does not mean that anything can be the subject of a patent.” At issue was the basic definition of what constitutes an invention. He went on to further clarify his meaning by saying that “biological materials which are identical or substantially identical to what exists in nature are not inventions. They are discoveries and therefore incapable of being inventions.”

By the 26th, the committee charged with debating the report found that “it would not recommend at this stage that the Patents Act 1990 be amended to include an express prohibition on human genes and genetic products.” Although they recommended in their 190 page report that these are major concerns they also stated that the move to “clarify the definition of ‘invention’ could act to prevent the patenting of human genes and genetic materials” would not be considered in its present form.

The report claimed that economic interests often provided institutions the motivation to develop research, and that interfering in this state of affairs could be difficult. They attempted to tone down what many where calling the outright banning of  commercial patents placed on genome research saying that a “comprehensive set of reforms to the patent system in this area could substantially address many of the concerns raised about the impacts of gene patents on healthcare and medical research”.

As of now, the current issue at hand will be examined, and hopefully clarified in the near future. The fact that this was tabled in the Senate has many seeing a small victory, and are increasing the call to re-examine a 3 decade old law.