[LST] Can genes be patented?

http://www.business-standard.com/article/printer-friendly-version?article_id=113053000933_1



Devangshu Datta | New Delhi May 30, 2013 Last Updated at 21:48 IST
Can genes be patented?Angelina Jolie has inadvertently highlighted a
key question about patenting

Angelina Jolies recent double mastectomy was obviously a very radical
decision. It is unusual for a healthy person to opt for pre-emptive
surgery to avert the probability, however high it may be, of getting
cancer. The tests Jolie relied on are also at the heart of a legal
battle, which could affect US biotech patenting norms. Since the US is
the global R&D leader, and other nations tend to fall in line with US
practice, the outcome will have a far-reaching impact on research into
stem cells, vaccines, antibiotics, insulin, enzymes and so on.

Jolie carries a mutation in the BRCA1 gene, which puts her at high
risk of developing breast cancer. She relied on a gene-screening test
by Myriad Genetics, a biotechnology company based in Utah, US. Myriad
Genetics holds nine patents for the related BRCA1 and BRCA2 genes, and
it is the only American company allowed to test for those two genes.

In 2009, a case was filed challenging Myriad Genetics patents, by a
not-for-profit scientific body, the Association for Molecular
Pathology (AMP), along with some 20 other plaintiffs including the
American Civil Liberties Union (ACLU). The case has reached the US
Supreme Court, which has heard arguments and is expected to give its
ruling in June.

The issues are complex. In the simplest terms, should patents for
specific human genes be allowed? The US Patent and Trademark Office
(USPTO) says genetic material can be the basis for a patent if a
particular gene, or molecule, is isolated from its natural state and
processed through purifying steps that separate the gene from other
molecules naturally associated with it.

However, the USPTO guidelines may violate a basic premise: one cannot
patent an abstract idea or a natural law. For example, Bayes theorem,
which is used to calculate the probability of diseases developing in
cases like Jolies, cannot be patented. Nor, as one US Justice said,
could a company patent common substances such as salt, sugar and
flour, although it could patent a recipe with those ingredients.

This debate should have occurred 30 years ago, in the early 1980s.
That was when the first bio-genetic patents were granted. Companies
like Genentech received patents for insulin and human growth hormones.
Weill Cornell Medical College (Cornell University) estimates that over
40 per cent of the human genome has already been patented. Over
100,000 existing biotech patents could be affected by the US Supreme
Courts decision, one way or other.

A gene patent is applied for by a company (or a university lab), which
isolates and identifies the fragment of DNA (deoxyribonucleic acid),
which makes up the specific gene. The gene can then be synthesised by
the use of messenger RNA (ribonucleic acid). This isolated synthetic
gene is known as complementary DNA (cDNA), as opposed to genetic DNA
(gDNA), which is the naturally occurring version.

The argument is that cDNA is a distinct, synthetic substance. Patent
applications are always for both cDNA and gDNA. If only cDNA was
patent-worthy, researchers could work around by using gDNA to isolate
and develop cDNA, via a different set of processes. If both patents
are granted, the holder has the exclusive right to research that gene.
(It cannot demand licence fees from people who possess that gene
naturally a misgiving thats often voiced when this subject is
discussed!)

There have been multitudes of such patents and they are vastly
profitable. Genentechs insulin patents delivered over $2 billion in
revenues before expiring in 2005; the company owns over 10,000 patents
in related areas. The self-testing pioneer, 23andMe, which offers a
DNA-mapping kit for $99, also has the exclusive right to a test for
Parkinsons disease.

Bio-patents hold for 20 years. The usual complicated pros and cons of
intellectual property rights apply. On the one hand, there is
incentive for investing in research. On the other hand, a patent
holder may charge usurious monopolistic fees, and further research
into the gene may be impeded.

Myriad Genetics patents are due to expire in 2015. The company claims
it spent more than $500 million in R&D. It charges $4,000 for the BRCA
tests. An entire human genome sequencing for over 23,000 genes can now
be done for about $1,000. Researchers at John Hopkins and Yale have
developed free software, which can be used to test for the two
specific BRCA genes.

The University of California, San Francisco, has helped found an
open-access genetic database on the premise that gene isolation is not
much different conceptually from cutting a leaf off a tree and
patenting the leaf. The US Department of Justice has also declared
that it does not support the patenting of naturally occurring genes.

Its possible that despite this, the US Supreme Court will rule in
favour of Myriad Genetics and current patenting practices will
continue. Or it may restrict patents only to cDNA. Or it may rule in
favour of the AMP, ACLU, et al. The last two decisions would cause a
tectonic shift in bio-patenting.

The healthcare implications are enormous, as are the implications for
basic research. It is worth pointing out that several key medical
innovations were deliberately not patented and that helped in their
mass adoption. For example, Penicillin wasnt patented (though a method
of mass production was later on). When Jonas Salk was asked why he
refused to patent the polio vaccine, he responded, One cant patent the
sun.
--
Saurav Datta

Twitter: SauravDatta29


"To those who believe in resistance, who live between hope and
impatience and have learned the perils of being unreasonable. To those
who understand enough to be afraid and yet retain their fury."

Sent from my Amazon Kindle Fire

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