Right: Humanity's future? Advances in gene research promise enormous medical and other benefits, including longer, healthier lives for human beings.
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Arguments in favour of private companies being able to patent human genes
1. Patents are available for human genes
Traditionally patents have only been available for inventions, that is, products that have been devised and developed by a particular company or individual. However, as Luigi Palombi notes in an opinion piece published in The Conversation on May 31, 2011, 'About 30 years ago, a new patent office practice was established by the United States Patent and Trademark Office, the European Patent Office and the Japan Patent Office.
The change essentially meant that naturally occurring biological materials, such as DNA and amino acids or proteins, which have been isolated (removed from their natural environment), could be considered to be inventions.'
Palombi goes on to explain, 'This practice was subsequently adopted in Australia and its implementation resulted in the granting of thousands of patents over isolated biological materials from a variety of sources, including viruses, bacteria, human genome and plant genomes.'
When finding in favour of Myriad Genetics Inc's patents on the genes BRCA1 and BRCA2, Australian Federal Court judge, Justice John Nicholas, found 'in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and "isolated" nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell.' From this point of view, Justice Nicholas finding argues that 'isolated' genes are not a naturally occurring substance and so are able to be patented.
Justice Nicholas found that the process via which the gene was extracted from the human body constituted a form of manufacture and that this gave intellectual property rights to the group or individual that extracted the gene.
Justice Nicholas explained that a previous High Court decision had given a very broad definition of what 'new manufacture' meant, and that there was no legal basis to demand the product be substantially different from something that occurred in nature.
Judge Nicholas' judgement is similar to that given in a case brought against Myriad Genetics Inc at the Federal Circuit Court of Appeals in the United States in 2012. United States Circuit Judge Alan Lourie concluded, 'Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.'
2. Patents encourage research and innovation
It has been argued that patents help to ensure that researchers and innovators receive financial recompense for their efforts. By supplying this assurance, patents encourage researchers and innovators to invest the time and to take the financial risks associated with making innovations. It is claimed that biotech companies need a guarantee that they will be financially rewarded; without this they would not be prepared to undertake many forms of research.
On February 21, 2012, The Conversation published a comment by Dianne Nicol, Professor of Law at University of Tasmania, and John Liddicoat, a researcher at the University of Tasmania. Nicol and Liddicoat claim, 'Recent work by economists at the Intellectual Property Research Institute of Australia (IPRIA), based at the University of Melbourne, suggests patents provide some incentive to commercially develop an invention. The researchers found that, if a patent application is not granted for whatever reason, the chance of the invention making it to market decreases by 13%.'
Explaining the financial incentives that patents can provide, Nicol and Liddicoat have noted, 'A separate paper analysing the same dataset focused on the commercial returns from patents. Controlling for the value of the invention itself, it was found that having a patent increased the financial returns by between 40% and 50%.'
In a comment from Dr Anna Lavelle, published by On Line Opinion on March 2, 2011, it was claimed, 'Patents are important parts of the package that Australian innovators use to attract critical funding to progress early research through to the proof-of-concept stage. Similarly, granted patents in key markets will inform a commercial decision to invest significant amounts of money in a technology development plan.'
Dr Lavelle went on to argue that patents ensured profits and were necessary as the Government was not able to fund all research. The doctor explained, 'Since the Australian Government is not in the business of spending the hundreds of millions of dollars needed to translate inventions from 'bench to bedside' we rely here on corporations ... to invest and take the risks to develop and commercialise novel medicines and diagnostic technologies.'
3. Patents on genetic material have not impeded research
Supporters of gene patents argue there is nothing to indicate that such patents block the progress of medical research.
In a comment from Dr Anna Lavelle, published by On Line Opinion on March 2, 2011, it was claimed, 'There is little evidence to support claims that gene patents stifle research or that there is currently anything other than free and unfettered access to biological materials among the Australian research community. A recent study concluded that of 381 scientists surveyed, none had had their work stopped by the existence of third-party patents, only about 1% had a delay or were required to modify their work, and those that had been required to pay a fee to access patented technologies reported a modest charge in the range of US$1-100.'
Dr Lavelle went on to consider Myriad Research Inc patents, claiming, 'In the specific case of the Myriad gene patents (and the exercise of said patent rights to which much of the controversy around this issue can be traced back), there have been over 5,500 BRCA1 primary sequence publications in the 12 or so years since the patent was granted in Australia. With no fewer than 49 Australian research organisations having contributed to this total, it is disingenuous for claims to be made that the existence of the patents has stifled national or international research in this field of endeavour.'
4. Patents on genes expire
It has been claimed that patents represent no permanent impediment to research. This is said to be the case because all patents expire.
Kevin Noonan is a biotechnology patent lawyer. In 2006, Dr Noonan claimed, 'The patent right is finite - it expires. That's one of the beauties of the patent system, since it is a limited right, and one of those limitations is time. Presently, a U.S. patent expires 20 years from its earliest filing date.
For many of the earliest gene patents, that day is or soon will be here. For the vast majority of gene patents, expiration will occur by 2020.'
Myriad Genetics gene patents begin to expire in 2014. The Myriad Genetics patents for BRCA1 and BRCA2 are set to expire in 2015. For this reason, it has been argued that there is no need to continue the debate since only a few years remain.
Supporters of gene patents argue that biotech companies are not seeking an unfair advantage or a permanent monopoly. It is claimed that all they are seeking is a fair recompense on their investment over the limited time for which the patent operates - normally no more than two decades. Given that many major research developments and discoveries involve at least twenty years of preliminary research, supporters of patents claim that their imposition is only equitable.
5. Myriad Genetics tests and gives access to patented genetic material at fair prices
Myriad Genetics claims it does not charge excessively or prohibitively for access to its tests and patented genetic material.
On its web page, Myriad Genetics states, 'Myriad supports research studies on BRCA1, BRCA2 and other genes. More than 18,000 scientists have studied the BRCA genes and published more than 9,000 research papers, making these genes among the most widely researched genes in history.
In addition, Myriad has facilitated research through a partnership with the National Institutes of Health and provided at-cost testing for nearly 6,000 researchers receiving NIH grants.'
Myriad Genetics also claims, 'Health economic studies conclude that Myriad's genetic tests are fairly priced. Excerpts supporting this conclusion include the following:
A study published in Genetics In Medicine noted, "Prices for BRCA1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights..."
An Advisory Committee report to the Secretary of Health and Human Services stated, "...the per-unit price of the full-sequenced BRCA test, which often is cited as being priced very high, was actually quite comparable to the price of full-sequenced tests done on colon cancer, for which associated patents are nonexclusively licensed."
Myriad Genetics further claims, 'Additionally, Myriad has also established a Financial Assistance Program, which provides coverage at no charge to low-income patients who lack insurance. Over the past three years alone, more than 5,000 people have received free BRAC Analysis testing from Myriad.
Approximately 95% of all patients in the United States have access to BRAC Analysis either through private insurance, Medicare or Medicaid. The average out-of-pocket cost to a patient is less than $100.'