Can you patent a disease? <http://www.cbc.ca/> Description: CBCCBC 9 hours ago
The outbreak of a novel coronavirus in the Middle East is not only raising
worldwide health concerns but triggering questions about the ability of
organizations to patent the genetic sequences of diseases for profit.
The World Health Organization reports that there have been 53 lab-confirmed
cases of infection with a new coronavirus called the Middle East Respiratory
Syndrome (MERS-CoV). Thirty-one of the people infected with the disease have
died.
WHO team, including Canadian, investigates how MERS spreads
B.C. health officials on lookout for deadly new virus
Saudi Arabia has seen the most cases, but the infection has also been found
in countries such as Tunisia, Jordan and Qatar, as well as in Germany and
Italy.
The virus was identified in September 2012, three months after the Erasmus
Medical Center in Rotterdam, Netherlands, acquired a sample of it. The
centre has taken out a patent on the viruss genetic sequence.
While Saudi officials and the WHO have said the patent will impede the
process of containing MERS-CoV and developing treatments, Erasmus has
defended the move.
Albert Osterhaus, a virologist at Erasmus, told Bloomberg News that
patenting the virus was a normal thing to do.
Indeed, the patenting of genetically modified or isolated viruses is nothing
new, says David Schwartz, a patent lawyer and partner at the Canadian
intellectual property firm Smart & Biggar.
You cant patent a disease condition per se, such as cancer or influenza,
says Schwartz. But if youre talking about patenting a lifeform like a
bacteria or virus, if altered by man, the answer there is yes.
A patent is a form of intellectual property that allows the patent holder to
control the use of a product or method of doing something. That control
includes the ability to charge royalties for its use.
Schwartz says that obtaining a patent on a simple mechanical invention, such
as a Christmas tree stand, in a single country might cost about $10,000. But
getting a patent on a more complex technology - such as one involving
chemical synthesis - that also covers multiple countries can run $200,000 or
more.
While patent law differs somewhat from country to country, in the area of
microorganisms most nations agree on general principles, says Schwartz.
You cant patent something that is naturally occurring, he says, but if an
organism is modified in some way, it is patentable.
One of the most famous cases of biological patenting is the so-called
Harvard mouse, a type of laboratory mouse genetically modified by
scientists at Harvard University to carry an oncogene, which makes the
animal susceptible to cancer. It was patented in the United States, though
not in Canada.
Ninety-nine point nine per cent of the mouse is Gods creation, but in its
totality, as you would claim it as the subject for a patent, its a
non-naturally occurring, man-made thing, says Schwartz.
In the case of a gene, modifying its information or removing it from its
chromosome typically would be enough to warrant a patent, says Schwartz,
because the snippet of chromosome would not appear in nature by itself.
This is a key point in the case of the novel coronavirus. To pinpoint it,
Erasmus likely used what is called deep sequencing, says Earl Brown,
executive director of the Emerging Pathogens Research Centre at the
University of Ottawa.
In this process, the infected sample would be run against databases of known
genes and viruses to determine its genetic composition. Brown says the
researchers would then typically remove the sequence from its chromosome and
copy it in order to conduct further tests.
The rationale for patenting a genetic sequence such as the novel coronavirus
is to be able to develop products, such as diagnostic tests or a vaccine,
that could be marketed and sold, says Bernard Dickens, professor emeritus of
Health Law and Policy at the University of Toronto.
Profit is what underlies the whole patent system, he says.
But as the science of biotechnology advances, people are taking a second
look at some of the original patent decisions that helped set precedent.
The boom in biological patenting began with the identification of the gene
for breast cancer, says Dickens.
In 1994, the University of Utah, National Institute of Environmental Health
Sciences (NIEHS) and Myriad Genetics filed a U.S. patent on BRCA1, a gene
that indicates a womans susceptibility to breast and ovarian cancer. The
patent was granted in 1997. (In 1995, the same consortium filed a patent on
the BRCA2 gene, which was granted in 2000.)
BRCA1 was recently in the news after Hollywood actor Angelina Jolie
announced that she had undergone a double mastectomy after learning that she
had a faulty BRCA1 gene that greatly increased her risk of breast cancer.
The problem with the breast cancer patent, Dickens says, is that Myriad
Genetics was charging exorbitant rates for the use of its diagnostic tests.
They were prohibiting hospitals, including in Canada, from undertaking the
test using their technique. They were imposing charges that were really at a
prohibitive level, says Dickens.
The dispute over the BRCA1 and BRCA2 patents has sparked a legal challenge
that is currently before the Supreme Court in the U.S.
Question over human gene ownership before U.S. Supreme Court
Depending on the court's decision, the case could either strengthen or
undermine what can and can't be patented.
Meanwhile, at the World Health Organizations annual conference in Geneva in
May, WHO Director General Margaret Chan stressed that countries need to
share information on the novel coronavirus.
"Making deals between scientists because they want to take [intellectual
property], because they want to be the world's first to publish in
scientific journals, these are issues we need to address," she said.
Albert Osterhaus, the virologist at Erasmus, has said that his organization
is sharing this coronavirus with everyone who wants to do public health
research.
The aim of patenting, says Dickens, is to encourage organizations to pour
investment into solving a specific problem.
The balance, and it still hasnt been satisfactorily resolved in every
case, is giving investigators an incentive to invest in research to produce
products, which they can then license and receive results on, says Dickens.
Some universities patent particular inventions for the purpose of preventing
commercial exploitation, Dickens says. They get the patent and then publish
it widely, so its available to all researchers.
Thats part of the mission of universities, of course: to make investments
for the public good, says Dickens. So it doesnt follow that [a patent] is
necessarily going to be exploited for profit.
Schwartz says that while some may see biological patents like a hindrance to
gaining a handle on potentially lethal organisms such as a coronavirus, they
are ultimately intended as an incentive for researchers to find solutions.
Perhaps there are also other ways of advancing industry and science, but
this is the globally accepted system, he says.
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