US supreme court’s final ruling on breast cancer gene patents should apply to all other gene patents, especially on deadly viruses such as the recent Middle Eastern Respiratory Syndrome virus.
Gene patents bad for science and bad for health
Genes in humans and other organisms should not be patentable (see [1] Why Biotech Patents Are Patently Absurd, ISIS scientific publication). In the first place, they are discoveries, not inventions. The DNA sequences that people are claiming as their own existed in nature long before molecular biology was thought of. It’s as though Friedrich Wöhler, the first person to isolate aluminium, had been entitled to been able to patent not just the process by which he did it but the element itself.
Patents are meant to be awarded only if there has been an inventive step that was not obvious to anyone ‘skilled in the art.’ This hardly applies to DNA sequencing, which has now become so routine that you can have your entire genome sequenced for $5000 [2].
Some claim that research will be hindered if laboratories cannot obtain patents on what they have found. On the contrary, it is patents and the pressure to obtain patents that can inhibit research. An important factor in the progress of science is that people and laboratories working in an area share their results and experience. That happens much less when there are patents and possibly large profits at stake. There is plenty of opportunity for patenting once the basic science has been done and the effort moves on to applications. To be sure, the boundary between pure and applied science is not always clear cut and there will be occasional border disputes, but we will have to cope with these, just as we cope with the many other grey areas of patent law.
Two recent cases illustrate clearly how patenting can get in the way of science and health. One – concerning the breast cancer genes BRCA1 and BRCA2 – has been resolved by the recent decision of the US Supreme Court that naturally occurring genes cannot be patented. The other, involving a recently discovered virus that appeared in the Middle East about a year ago, is still to be resolved.
BRCA1 and BRCA2
In 1990, a group at Berkley led by Mary-Claire King found that a gene associated with an increased risk of breast cancer was located on the long arm of chromosome 17. A number of laboratories set out to find the precise location of the gene and to sequence it; and to speed the work up they shared their results, as is usual in science – or used to be. In 1994, researchers at Myriad Genetics Inc. together with colleagues at the University of Utah, the US National Institutes of Health, and McGill University in Montreal, succeeded in determining the sequence of the gene. They immediately applied for and were awarded a patent.
What exactly had the team done to deserve this patent and the monopoly that went with it? They had indeed been the first to sequence the gene. They had not been the first to suggest that such a gene exists. They had not worked out its approximate location in the genome, they had relied on results from other laboratories that were being freely shared in the manner that was then usual. In effect, they had put the last piece of a jigsaw into place and claimed ownership of the results of the whole project.
The patents gave Myriad a monopoly and they took full advantage of it. Myriad offers diagnostic tests for BRCA1 and another similar gene BRCA2, and charges a high price for them. They also have not allowed other laboratories to produce tests for these genes. Not only has this almost certainly kept the price of the test high, it has also made it impossible to obtain a second opinion. In addition, it has had the perverse effect that where methods have been developed to test simultaneously for a range of possibly harmful mutations, the laboratories involved were forbidden to reveal the results for BRCA1 and BRCA2 to the woman who has undergone the test.
Myriad’s patents were challenged, and the case went all the way to the US Supreme Court. On 13 June 2013 it ruled unanimously against Myriad. In the words of Justice Thomas, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” He went on, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” Justice Breyer added that natural laws may not be patented either standing alone or in connection with processes that involve “well-understood, routine, conventional activity” [2].
The Supreme Court justices were unanimous, but it has taken a long time to get to this decision and some of the lower courts had taken a different view.
Myriad reacted by pointing out that they still had “strong intellectual property protection” for their tests, and while their share price fell, it was only by about 5%. This clearly shows that not being able to patent genes will inhibit neither the identification of genes nor the development of tests and treatments.
MERS
Since June 2012, there have been 60 cases of a newly identified disease, Middle Eastern Respiratory Syndrome (MERS). It is caused by a coronavirus, one of a family that includes the viruses that cause SARS and the common cold. So far it appears to be transmitted less readily than SARS, but the death rate is much higher. Of the 60 cases so far, 38 have been fatal.
Many laboratories are working to devise tests and treatments for MERS. Unfortunately, a dispute over intellectual property rights seems to be detracting from the research effort.
The physician who reported the first case, Dr Ali Mohammed Zaki, was working at a hospital in Jeddah, Saudi Arabia. He sent a sample of the virus to the Viroscience Department at Erasmus University Medical Centre in Rotterdam. They sequenced the virus and then applied for patents on the sequences, effectively on the virus [3].
The Saudi Deputy Health Minister told the World Health Assembly in Geneva that the Dutch scientists had signed contracts with companies that produce treatments. This, he claimed, had delayed the work. The head of the Virosciences Department, Ab Osterhuis, has said that no contracts had been signed with any companies, but while we have no reason to doubt his word on this, it still does not mean there have not been delays due to issues of intellectual property rights and the potential for their exploitation. On the Al Jazeera programme Inside Story, Osterhuis acknowledged that while his laboratory itself is non-profit, there are companies spun off from the laboratory that do make profits from their work [4]. Presumably negotiations with these would be less formal than those with outsiders.
The Saudi Ministry of Health insists that as the virus was first discovered in Saudi Arabia, that country has sovereignty under the Convention on Biological Diversity. Osterhuis responds that viruses know no boundaries and that consequently Saudi Arabia has no better claim than Jordan or any of the other countries in which MERS has occurred.
There are claims and counter claims flying around, and it is impossible at this stage to determine what really happened and whether the search for antivirals and vaccines has been significantly affected by all this. The ongoing arguments about intellectual property rights and sovereignty of genetic material are certainly creating a distraction from the task at hand.
What happens now?
The US Supreme Court has ruled that naturally occurring genes are not patentable. Welcome though this decision is, it is not the end of the matter because the Court also held that manipulating genes to create something not found in nature is an invention that is eligible for patent protection [3]. Courts in the US and other countries are going to have to decide how much change in a gene is necessary before it counts as different from the natural form. They are also going to have to decide whether the change involves an inventive step or is merely the carrying out of a routine procedure in the way that anyone ‘skilled in the art’ would have done.
Patenting is not a basic human right but a legal device most societies have chosen to encourage innovation by giving innovators temporary monopolies on their inventions. What is patentable varies from country to country and changes in time in response to the needs of society and lobbying by corporations, and there are bound to be disagreements about where the border lies between what is eligible for a patent and what is not (see [6] End of Drug Monopolies and Mega-profits? SiS 58). In ruling on such issues, courts should ask whether to allow a patent on this and similar innovations would be in the best interests of society, for that is what patenting is meant to promote.
The cases of Myriad Inc and MERS clearly demonstrate that to allow patenting of genes would hinder rather than encourage both scientific research and the development of innovations such as new tests and vaccines, and worse, obstruct prompt diagnoses that could save lives.
Editor’s addition — PBS Newshour Video:
//www.youtube.com/embed/yNx-BhgE5oo
Jeffrey Brown gets details from National Law Journal’s Marcia Coyle, plus
viewpoints from Ellen Matloff of Yale Cancer Center, a plaintiff in the case,
and Kevin Noonan, an intellectual property attorney.
References:
- Ho MW. Why biotech patents are patently absurd. Journal of Intellectual Property Rights 2002, 7, 151-165.
- “What happened when I had my genome sequenced.” Carole Cadwalladr. The Observer, 9 June 2013. https://www.guardian.co.uk/science/2013/jun/08/genome-sequenced?INTCMP=SRCH
- “Justices, 9-0, bar patenting human genes.” Adam Liptak, New York Times, 13 June 2013. https://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html?_r=0
- “As outbreak continues, confusion reigns over virus patents.” Kai Kupferschmidt. Science Insider, 28 May 2013, https://news.sciencemag.org/scienceinsider/2013/05/as-outbreak-continues-confusion-.html 24/06/13
- “Who owns medical research?” David Foster, Inside Story (Al Jazeera). Broadcast 20 June, 2013. https://www.aljazeera.com/programmes/insidestory/2013/06/2013621103641903601.html 24/06/13
- Saunders PT. End of drug monopolies and mega-profits? Science in Society 58 2013 2-4.
Gene patents are only good for profiteers.