2013/05: Should private companies be able to patent human genes?
What they said...
'Health economic studies conclude that Myriad's genetic tests are fairly priced'
Myriad Genetics Inc
'As a matter of principle, patents on naturally-occurring genes should not have been approved'
Editorial from Incite, the online magazine of the Cancer Institute of New South Wales
The issue at a glance
On February 15, 2013, an anti-cancer support group, Cancer Voices, lost a case before the Australian Federal Court.
Cancer Voices had brought a case against Myriad Genetics Inc, which owns patents on the genes BRCA1 and BRCA2, genes linked to breast and ovarian cancer.
Cancer Voices argued that Myriad Genetics Inc had claimed an unfair monopoly on naturally occurring genes and that the company's patents were likely to impede the use of these genes in cancer research.
Justice John Nicholas ruled in favour of Myriad Genetics Inc, upholding the company's patents.
On March 4, 2013, the law firm Maurice Blackburn lodged documents to appeal Justice Nicholas's decision.
Cancer Voices Australia has already launched a petition asking the government to change patenting laws.
(The following information has been abbreviated from the Wikipedia entry titled 'Biological patent'.
The full text of the entry can be accessed at http://en.wikipedia.org/wiki/Biological_patent#Myriad_Genetics_case)
A gene patent is a claim made by a company or individual to exclusive intellectual property rights in relation to a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims.
Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. In the United States, patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.
Myriad Genetics Inc and BRCA1 and BRCA2 patents
A patent application for the isolated BRCA1 gene and cancer-promoting mutations, as well as methods to diagnose the likelihood of getting breast cancer, was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics in 1994.
Over the next year, Myriad, in collaboration with investigators from Endo Recherche, Inc., HSC Research & Development Limited Partnership, and University of Pennsylvania, isolated and sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by Myriad and other institutions in 1995.
Myriad is the exclusive licensee of these patents and has enforced them in the United States against clinical diagnostic labs. This means that legally all testing must be done through Myriad's lab or by a lab which it had licensed. This business model led from Myriad being a start-up company in 1994 to being a publicly traded company with 1200 employees and about $500M in annual revenue in 2012. It also led to controversy and the Association for Molecular Pathology v. Myriad Genetics lawsuit. The patents expire, starting in 2014.
Controversy over gene patents
Controversy over biological patents occurs on many levels, driven by, for example, concern over the expense of patented medicines or diagnostics tests (against Myriad Genetics with respect to their breast cancer diagnostic test), concerns over genetically modified food which comes from patented genetically modified seeds as well as farmer's rights to harvest and plant seeds from the crops.
Each nation has its own patent law, and what is patentable in some countries is not allowed to be patented in others. Stem cells derived from humans are a good example of these differences. In the United States, isolated stem cells are patentable subject matter. However, a challenge against some United States stem cell patents is being litigated by two non-profit organizations: The Foundation for Taxpayer & Consumer Rights and Public Patent Foundation along with molecular biologist Jeanne Loring of the Burnham Institute. The European Patent Office has ruled that certain stem cell lines, derived from destruction of human embryos, were not to be granted a European patent.
In the United States, biological material derived from humans can be patented if it has been sufficiently transformed. In litigation that was famous at the time, a cancer patient, John Moore, sued the University of California. Cancer cells had been removed from Moore as part of his medical treatment; these cells were studied and manipulated by researchers. The resulting cells were 'immortalized' and were patented by the university as U.S. Patent 4,438,032 and have become widely used research tools. The subject of the litigation was the financial gain that the university and researchers achieved by additionally charging money to companies by licensing the cell line.
Michael Heller and Rebecca Eisenberg are academic law professors who believe that biological patents are creating a 'tragedy of the anticommons', 'in which people underuse scarce resources because too many owners can block each other'. Others claim that patents have not created this 'anticommons' effect on research, based on surveys of scientists.
Professional societies of pathologists have criticized patents on disease genes and exclusive licenses to perform DNA diagnostic tests. In the 2009 Myriad case, doctors and pathologists complained that the patents on BRCA1 and BRCA2 genes prevented patients from receiving second opinions on their test results. Pathologists complained that the patent prevented them from carrying out their medical practice of doing diagnostic tests on patient samples and interpreting the results.
Myriad Genetics case in the United States
Association for Molecular Pathology v. Myriad Genetics is a case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences.
The case was originally heard in the United States District Court for the Southern District of New York, which ruled against Myriad Genetics Inc and found that all the challenged claims were not patentable subject matter.
Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature can be patented and that the drug screening claims were valid. The Circuit court also confirmed in part, finding that the diagnostic claims were unpatentable.
The plaintiffs appealed to the Supreme Court, which remanded the case back to the Federal Circuit. The Federal Circuit did not change its opinion, so on September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision. As of December 2012 isolated genes remain patentable in the United States.
On February 21, 2013, Radio National's Life Matters broadcast a segment treating in detail the February 15 Australian Federal Court decision to uphold Myriad Genetics Ltd's gene patents. The program presents detailed interviews with stakeholders on both sides of the issue.
It can be downloaded and listened to at http://www.abc.net.au/radionational/programs/lifematters/gene-patents/4530608
On February 20, 2013, the ABC online's opinion segment, The Drum included a comment by Luigi Palombi titled 'Patent law must recognise human genes are no invention'.
Dr Palombi is the Director of the Genetic Sequence Right Project at Australian National University. He presents a range of arguments attempting to demonstrate that it is inappropriate to patent human genes.
The full text of this comment can be found at http://www.abc.net.au/unleashed/4528914.html
On February 16, 2013, The Conversation published a background piece by
Bill Madden, Adjunct Fellow at the University of Western Sydney. Madden gives a brief explanation of the Australian Federal Court's recent ruling in favour of Myriad Genetics Inc's gene patent rights.
The full text can be found at http://theconversation.edu.au/gene-patenting-australian-court-rules-brca1-patent-is-legal-12240
On February 15, 2013, Radio National's PM program conducted interviews with a number of the stakeholder's affected by the Australian Federal Court decision to uphold Myriad Genetics Inc's gene patents.
A full transcript of this program can be found at http://www.abc.net.au/pm/content/2013/s3691488.htm
On February 15, 2013, New Scientist ran a detailed background piece titled 'Victory for gene patent firm in Australian court'.
The article gives a clear explanation of the basis of the court's ruling and discusses its implications for medical research in Australia.
The full text of the article can be accessed at http://www.newscientist.com/article/dn23180-victory-for-gene-patent-firm-in-australian-court.html
On February 15, 2013, Wired.Co.UK ran a supposed background piece titled 'Firm wins right to breast cancer gene patent in Australia, ahead of US case'. Though the article gives detailed information on the legal situation regarding gene patents in the United States, the United Kingdom and Australia, the piece clearly emphasises the negative aspects of gene patents.
The full text of this comment can be accessed at http://www.wired.co.uk/news/archive/2013-02/15/australia-breast-cancer-gene-patent
On February 15, 2013, the Australian Federal Court ruled in favour of Myriad Genetics Inc and Genetics Technologies Limited in a challenge to their patents brought by Cancer Voices Australia and Yvonne D'Arcy.
The full text of the ruling can be found at http://www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2013/2013fca0065
On June 20, 2012, Clinical Pharmacology & Therapeutics published a comment and analysis by Steven Salzberg titled 'The Perils of Gene Patents'.
Steven Salzberg is a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine.
Salzberg argues in detail that the effect of gene patents is to hinder research. His full comment can be accessed at http://genomics.jhu.edu/papers/Perils-of-gene-patents-reprint-CPT2012.pdf
On February 27, 2012, The Conversation published a comment by Dianne Nicol, Professor of Law at University of Tasmania. The piece is titled 'Genetic land-grab or reward for ingenuity? Australian court to rule on gene patents'
Professor Nicol gives background to gene patents in other countries and gives particular detail regarding intellectual patent law in Australia.
The full text of this article can be found at http://theconversation.edu.au/genetic-land-grab-or-reward-for-ingenuity-australian-court-to-rule-on-gene-patents-5244
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. The article is titled 'Do patents promote innovation?'
Nicol and Liddicoat look at the arguments for and against patents as a means of promoting innovation and suggest a number of reforms that would make them more effective as a means of encouraging innovation.
The full text of this article can be accessed at https://theconversation.edu.au/do-patents-promote-innovation-5443
Myriad Genetics home page can be accessed at http://www.myriad.com/
Under 'Investor Relations' and then 'Press Releases' is a November 30, 2012 entry titled 'Supreme Court of the United States to Hear Isolated DNA Patent Case'. This can be found in a list located at http://investor.myriad.com/releases.cfm
The media release gives a detailed statement of Myriad Genetics justification of its gene patents. The release is a pdf.
On May 31, 2011, The Conversation published an opinion piece by Luigi Palombi titled 'Who owns the rights to the human body? It's patently obvious.'
Dr Palombi is the Director of the Genetic Sequence Right Project at Australian National University. He argues that while the processes used to extract genes may be patented and the diagnostic procedures within which they are employed may also be patented, it should not be possible to patent the genes themselves.
The full text of this opinion can be accessed at http://theconversation.edu.au/who-owns-the-rights-to-the-human-body-its-patently-obvious-835
On March 2, 2011, On Line Opinion published a comment by Dr Anna Lavelle.
Dr Lavelle is the CEO of AusBiotech, Australia's biotechnology industry organisation that represents more than 3,000 members. She has previously worked as an executive with the Australian Red Cross Blood Service, as the CEO of a public health organisation, as an industry lobbyist and academic. She holds a PhD in genetics from the University of Melbourne.
Dr Lavelle's comment is titled 'Without gene patents people will die'. Dr Lavelle looks at a number of the claims made against gene patents and disputes them.
The full text of this comment can be found at http://www.onlineopinion.com.au/view.asp?article=11692
On September 13, 2010, On Line Opinion published a comment titled 'Who owns you?' arguing against the patenting of human genes. The article stresses the distinction between an invention, which it believes should be patented, and a discovery, which it argues should not.
The full text of this article can be found at http://www.onlineopinion.com.au/view.asp?article=10963&page=0
On September 6, 2010, the ABC's Four Corners telecast a program supplying detailed argument and analysis regarding gene patents, especially as they are applied within the United States.
A full transcript of this program can be accessed at http://www.abc.net.au/4corners/content/2010/s3004027.htm
On May 10, 2010, On Line Opinion published a comment by Leslie Cannold titled 'Patently absurd'. Dr Leslie Cannold is a writer, columnist, ethicist and academic researcher.
Dr Cannold is critical of gene patents. The full text of her opinion can be found at http://www.onlineopinion.com.au/view.asp?article=10397
On December 7, 2006, Patent Docs, Biotech & Pharma Patent Law & News Blog published a comment by Dr Kevin Noonan titled 'In Support of Gene Patents'. Kevin Noonan is a biotechnology patent lawyer. He argues in favour of biotech companies being able to patent genes.
The full text of this argument can be accessed at http://patentdocs.typepad.com/patent_docs/2006/12/by_kevin_noonan.html
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.'
Arguments against private companies being able to patent human genes
1. The monopoly on diagnostic tests held by gene-patent holding companies can restrict access to medical treatment
Myriad Genetics Inc currently charges US$3,340 for its genetic test for breast cancer.
In this test Myriad sequences the two patented genes, known as BRCA1 and BRCA2, checking for mutations that raise the risk of a woman getting breast and ovarian cancer. It is Myriad's patent on the two genes which allows it control of the testing process. The sequencing process itself can and is employed by other institutions.
The breast cancer test accounted for $353 million, or 88 percent, of Myriad's $402 million in revenue in the fiscal year that ended in June 2011. It has been claimed that Myriad Genetics is hampering treatment and research because of the increased costs its charges create and because the gene sequencing process it uses has now been superseded.
In an article published in The New York Times, Andrew Pollack claimed, 'Newer DNA-sequencing techniques are far faster and only a fraction of the cost of the 1990s technology that Myriad uses. Indeed, it will soon be possible to sequence a person's entire genome, all 22,000 or so genes, for less than Myriad charges for just two genes.'
Mary-Claire King, a professor of genome sciences and medicine at the University of Washington, has stated, 'Science has moved beyond what these folks do. It's not good for the science and it's not good for the patients and their clinicians if they cannot have the most complete, up-to-date, cost-efficient information.'
In 2006, Professor King of the University of Washington published a paper showing that Myriad's test, known as the Comprehensive BRAC Analysis, failed to detect a significant number of genetic alterations in the two genes.
Myriad then developed a test for these alterations. But instead of incorporating it into its main product, it offered it as a supplemental test at a price of $700. Many insurers do not pay for it, and therefore many women do not get this test.
2. Gene patents can discourage further research on the patented genes
It has been claimed that gene patents can discourage further research using the patented genes.
Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine has noted that by 2005, 4,382 human genes had either been patented or had related intellectual property claims files on them by more than 1,100 different claimants.
Professor Salzberg has claimed, 'This presents a bewildering "patent thicket" to any investigator wishing to pursue a new medical application of a gene. Working on a patented gene can involve endless hours talking with lawyers, negotiating licenses, and paying for those licenses. No scientist wants to spend time on such extraneous activities, and, when given a choice, most will simply avoid patented genes entirely, preferring instead to work on other genes.'
It has further been noted that legal disputes over access to patented genes are a further source of lost scientific effort. Professor Salzberg has stated, 'Patent lawyers have no business in the laboratory. But scientists have invited them in, and now we are finding that they are hard to chase out. Once a gene is patented, court cases drag on for years, taking up countless hours of scientists' time.'
3. Patents should be granted on processes and inventions, not discoveries
It is claimed that under Australian law a patent can be applied to an invention but not to a discovery. Patents, it is argued, are a means of protecting intellectual property, that is, the holder of the patent must have made or developed the product or process he or she has patented. It is claimed, therefore, that naturally occurring substances cannot be patented.
On September 13, 2010, On Line Opinion published a comment titled 'Who owns you?' arguing against the patenting of human genes. The piece includes the following comment 'No one is seeking to stop [companies] patenting and protecting their research product - in other words any "tests" or products derived from their work around the genes or other biological material.
If they've invented a treatment or an identification test, or whatever, then they deserve the benefits from that; and they also deserve the commercial protection a patent provides so they can maintain a good portion of the market before others who haven't done the early leg work can cash in, riding on their coat tails.'
The comment goes on to argue 'But patenting a gene is wrong. Patenting biological material that already exists in a particular form in nature is wrong. Patents recognise invention - not discovery of something which already exists.
A genuine invention should get all the protections it can, and if a large corporation happens to be that inventor then good on it and may it protect its interests with all its might...
But a patent should not apply to a discovery. Imagine the world if all the past discoveries in the natural world were owned by a company rather than just being part of the human knowledge bank.'
On May 10, 2010, On Line Opinion published a comment by Leslie Cannold titled 'Patently absurd'. The comment included the observation, 'Genes are part of our bodies. The understandings derived from them - knowledge critical to understanding and curing disease - is the birthright of all humanity, not the private property of a corporation. If we want knowledge about human nature and human health to flourish, we must ensure it is available to and for us all.'
In an editorial published in Incite, in September, 2010, it was stated, 'Patents are designed to protect the commercial interests arising from an invention, not a discovery. Discoveries are part of the natural world and are there for all to explore and utilise. In claiming a patent over a gene, the patent holder is making a claim over something that he did not synthesise or create... As a matter of principle, patents on naturally-occurring genes should not have been approved.'
Incite is the online magazine of the Cancer Institute of New South Wales.
4. The processes involved in isolating and sequencing genes are not sufficiently complex or costly to warrant patenting the resulting product
Those who argue that genes should be able to be patented, stress the complexity of the process which results in the isolation of genes. They argue that this constitutes a form of manufacture and that the resulting product should be able to be patented. Critics claim that the complexity of these processes has been exaggerated and do not warrant the granting of patents for genes that are discovered using these techniques.
In June 2012, The Journal of Clinical Pharmacology & Therapeutics published an article by Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine.
Professor Salzberg argued, 'Today we can sequence an individual human genome in just a few days, for less than $5,000. Once we have a person's genome, we can easily and rapidly discover all known mutations in that genome, and with ever-increasing accuracy we can link these mutations to risk factors for disease.'
Professor Salzberg has gone on to argue that the granting of gene patents has exaggerated the complexity and thus the intellectual property rights of those many companies which have now been granted gene patents. The Professor has stated, 'In 1982, DNA-sequencing technology was a very new idea and the patent examiners probably had little, if any, idea of where the technology was heading. Once they allowed the first patent, the floodgates opened and patent applications poured in. As genome-sequencing technology improved, scientists using highly automated procedures discovered thousands and later millions of genes, and the flood of gene patents became unmanageable.'
5. Myriad Genetics Inc is monopolising information in a way which damages research and treatment options
It has been claimed that Myriad Genetics Inc is monopolising information in a way which undermines effective research and treatment.
In the United States, Myriad Genetics Inc requires all BRCA testing to be done in its own laboratories. The biotech company has been particularly vigilant in enforcing its patent rights in America.
When Myriad Genetics Inc carries out its BRCA Analysis (on behalf of a research or testing facility which it has charged for the process) it can sequence the test material and retain information on the different variants in its database.
Myriad Genetics Inc used to share such information with a public database maintained by the National Institutes of Health, and it also cooperated with academic scientists trying to analyse the mutations. However, Myriad Genetics Inc is currently stockpiling huge amounts of data on the gene, which it has not shared with an international community of cancer researchers since 2004.
Daniel B. Vorhaus, a New York lawyer and editor of the Genomics Law Report, has claimed there are ethical questions about whether Myriad should be withholding the mutation information, important for public health, to extend its monopoly beyond the life of the patents.
Commenting on the impact of gene patents, Steven Salzberg, a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins School of Medicine, has stated, 'Much of the scientific progress during the past two centuries has occurred because we share our scientific discoveries. The faster our work is disseminated, the more rapidly we move forward. The entire system of scientific journals was created to serve this purpose. Science that remains secret cannot contribute to scientific progress and is for all intents worthless.'
The right of companies such as Myriad Genetics Inc to control access to genes which they have patented remains a subject of contention.
The recent Australian Federal Court decision supporting Myriad Genetics Inc's ownership of patents on the genes BRCA1 and BRCA2 will not remain uncontested.
On March 4, 2013, the law firm Maurice Blackburn lodged documents to appeal Justice Nicholas's decision. Cancer Voices Australia has already launched a petition asking the government to change patenting laws. Thus Myriad Genetics patents operating in Australia are still under challenge.
Within the United States the situation is similar. On May 12, 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that Myriad Genetics' patents on two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2) are unconstitutional and invalid. The suit charges that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care. In November 2012, the Supreme Court granted the plaintiffs' cert petition and agreed to hear argument during the current session on the patentability of human genes. As of February, 2013, the issue remains unresolved.
Within the next two years, Myriad Genetics patents on genes BRCA1 and BRCA2 will expire and thus the impediments these patents are said to impose to further research and medical treatment will be largely removed. Within Australia the issue is even less acute. For Australian genetic researchers, the patent's effect will be mitigated because in 2012 the country's parliament introduced an 'experimental use defence', whereby researchers investigating a patent's subject matter, or related areas, cannot be found to infringe the patent.
Despite these factors which would seem to reduce the influence of the Myriad Genetics patents, Myriad Genetics has retained control of the data generated by its control of diagnostic tests. Critics have complained that even when the company's patents expire, its control of this database will continue to act as a brake on research.
The larger issue is not Myriad Genetics gene patents but those of the other biotech companies with gene patents. Thus the fate of the Myriad Genetics cases before the courts in both Australia and the United States is the precedents they will set.
Newspaper items used in the compilation of this issue outline
The Australian: February 16, 2013, page 2, news item by Rick Morton, `Ruling flags price hike for cancer tests'.
The Age: February 16, 2013, page 3, news item by Amy Corderoy, `Victory for private control of genes'.