Category Archives: Law

Identity Theft 2.0

So awhile ago I wrote a blog for the RiAus about genetic discrimination aligned with genome sequencing and I thought I would post it up on my blog so people can read it too.

It was originally posted on [http://riaus.org.au/articles/identity-theft-2-0/] the RiAus page on June 25th, 2013

 

Identity Theft 2.0 – The Next Generation In Next Gen Sequencing

Do you remember that scene in Minority Report with Tom Cruise, where after his eye transplant he walks into a Gap store? Upon entering, his eyes are scanned, and the virtual sales assistant says

“Hello Mr. Yakamoto, welcome back to the Gap. How’d those assorted tank tops work out for you?” – Minority Report, 2002

Though that may have seemed far-fetched when the movie came out in 2002, today, technology like that may be just around the corner. Though we may not be ready for personalised advertisements on subway lines or tailored shopping assistants when we enter a store, with advancements in sequencing technology, we are now able to understand more about our genetic make-up.

Data from the National Human Genome Research Institute show that sequencing a genome in January of this year cost $5,671, costing only 6 cents per megabase (megabase = 1 million DNA bases, or DNA code ‘letters’), in comparison to 9 cents per megabase (total genome $7,666) at the same time last year. If the cost continues to decrease at the same rate, sooner rather than later, the dream of a $1000 genome will be a reality.Identity Theft 2.0 – The Next Generation in Next Gen Sequencing

However, with sequencing becoming so cheap and readily accessible, what sort of consequences may arise from having your genome sequenced? Yes, it would be beneficial to know which of the drugs currently on the market would aid in the treatment of an ailment you may have, or the probability of contracting a disease. But once an individual’s genome has been sequenced, how confidential is that information?

What will happen once sequencing becomes more readily accessible? Will it be open to the entire population or will it be like “The Island” where only the rich and famous have access to the technology to protect them from harm? If it is more readily accessible, will it become universal and then who will pay for it?

It has been hypothesised that one day an individual will be able to carry their entire genetic information on a card, similar to a credit card. In fact, Howard Jacob already proudly boasts that he carries his full genome on an app on his tablet! With this information literally at our fingertips, how safe are we from identity theft or genetic persecution? Theoretically, pharmaceutical companies can use this information to skew research to the most financially beneficial drug products, focusing on creating drugs that would be used by the greatest number of individuals. But most importantly is the potential use of that information by groups such as insurers, employers, the military or adoption agencies.

In one scene from the movie Philadelphia, Tom Hanks recites a verdict from the Supreme Court that stated that the Federal Vocational Rehabilitation Act of 1973 prohibits discrimination against otherwise qualified handicapped persons who are able to perform the duties required by their employment. That got me wondering whether such legislation existed for discrimination against individuals who have undergone genetic testing. The Genetic Information Non-discrimination Act of 2008, or GINA, is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health. This new law prevents discrimination from health insurers and employers, however, there are certain circumstances not covered by the law. GINA does not apply to employers fewer than 15 employees. Also it does not extend to the US military or any related health insurance, such as the TRICARE military health system, the Veterans Health Administration or the Federal Employees Health Benefit Program. Lastly, the law does not cover long-term care insurance, disability insurance or life insurance.

As a society, certain qualities should always be protected, particularly those individual and immutable qualities that are impossible or very difficult to change. Of all the qualities we share as a population, whether it be race, national origin, skin colour or even gender, what is more immutable than our genes? Outside of medical procedures, we are stuck with the genes that we have been born with. They’re not something that we have chosen for ourselves, but rather DNA that we have inherited from our parents.

Unlike the US, in Australia we do not have any specific legislation to protect us from the legal and ethical dangers of genetic testing. Instead we incorporate this protection into our existing legislation. For example, additions and modifications have been made the Disability Discrimination Act 1992 to include disabilities that “may exist in the future (including because of a genetic predisposition to that disability)”.

But as the science progresses so quickly, I’m still haunted by the possibility of a ‘Gattaca’ style world where our genetic code does decide who we can marry, what job we can hold or even where we can live. Would you want to live there?

By Rakshet Sachdev

Feature image “DNA representation” sourced from Flickr and authored by Andy Leppard

 

Tell me what you think.

– Written by Rakshet Sachdev
Find more of my in-cohesive ramblings on twitter @rakshet

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Copyright Infringement

What’s yours is mine, and what’s mine is yours. Apparently that wasn’t true till only recently.

Sharing is Caring? Sourced from SingularityHub
Sharing is Caring?
Sourced from SingularityHub

On June 13, 2013 the Supreme Court of the United States decided on the case of the Association for Molecular Pathology v. Myriad Genetics. The case was challenging three different sets of claims in regards to issued patents that were owned or controlled by Myriad Genetics. Those patents covered isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences and thirdly methods to identify drugs using those isolated DNA sequences. 

In a unanimous decision, the Supreme Court ruled that Myriad’s claims to isolated genes was invalid, that merely isolating a gene found in nature does not make it patentable. Justice Clarence Thomas delivered the opinion of the Court stating that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.”

Complementary DNA Sourced from Wikipedia
Complementary DNA
Sourced from Forbes

Of the total estimated 30,000 genes in an individuals genome, it is estimated that 20% of those genes have been patented by private companies, government organisations or even individuals. Two of those genes, BRCA1 and BRCA2 were patented and owned by Myriad Genetics before the Supreme Court verdict. BRCA1 and BRCA2 are genes whose mutations are associated with an elevated risk for breast cancer. The patents argued by Myriad covered any gene that contained strands as small as 15 nucleotides long, therefore having the possibility of granting the company an effective monopoly over BRCA genes even if it contained significant mutations of interest to researchers.

Patentable? Sourced from SingularityHub
Patentable?
Sourced from SingularityHub

Started in 1980 with Diamond v. Chakrabarty where a GE engineer developed a bacterium capable of breaking down crude oil, filed a patent for it and was awarded said patent as the bacterium was man-made and therefore constituted as an invention. Human gene patenting worked on similar logic, that if the applicant had isolated and purified the genetic material, it constituted as an invention (well in part at least). Even if the isolated strand was identical to DNA sequences found in nature, the proponents for the patents argued that protection was essential for strong investment in genetic research and thus progress in the field.

Previously due to patents, other biotechnology companies were unable to develop competing breast cancer tests that may have potentially been more effective determine if a women is a carrier of the mutations that predispose her to breast or ovarian cancer. Also, by monopolising the market on BRCA1 and 2 testing, Myriad were able to charge upwards of $4000 for testing. Since the Supreme Court verdict, a number of different Biotechnology companies have announced new BRCA tests that cost a fraction of that by Myriad, so now women would have the opportunity of garnering second opinions before performing protective surgery. 

Though the ruling of the Supreme Court may have been right, the Science they used was not quite there. In their first paragraph, the ruling states:

The nucleotides that code for amino acids are ‘exons,’ and those that do not are ‘introns.’

The encoding process for DNA into a protein involves RNA. DNA is first copied into RNA, which then have large chunks or ‘introns’ discarded. The remaining sequence is what is known as ‘exons.’ Nucleotides that encode for amino acids are contained within the exons, and it is not uncommon for a large proportion of those nucleotides in the exon to be ignored when coding amino acids.

A 2nd (and 3rd) error found in the Courts writing refers to the synthesis of cDNA. The Court writes:

They [scientists] can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA).

cDNA contains only the exons that occur in DNA, omitting the intervening introns

Neither of those statements are scientifically correct. Firstly, cDNA stands for complementary DNA, DNA which is produced that complements the original strand. That means that each nucleotide is replaced with its complement. Therefore, cDNA has nothing to do with exons as the DNA strand would contain both introns and exons. To create cDNA of only exons, a complement of mature messenger RNA would be used.

Besides the words chosen to describe the science, questions arise directly relating to the science itself. Since cDNA only contains exons, by adding non-coding introns onto a strand of DNA, would that circumvent patents on cDNA strands? Would ruling need to then be re-issued to look at such deviations that may arise in the future?

Though the United States may have ruled against Myriad Genetics, both the European Union and Australia thought otherwise. Countries under the European Patent Organisation (under the directive  98/44/EC [the Biotech Directive]) allows for the patenting of natural biological products, including gene sequences, as long as they are “isolated from [their] natural environment or produced by means of a technical process.” 

In February 2013, Judge John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent over the BRCA1 gene. However, the ruling is being appealed to the Full Bench of the Federal Court.

Who Owns You?
Who Owns You?

In my personal opinion though, no company should have the right to patent your genes, because theoretically then each individual is committing genetic piracy and technically enslaved to corporations. If you do not own 20% of the genes in your body, that means a part of you is owned by another entity, which is in form, slavery. Theoretically as well, every cell that replicates or even if you have a child, you are performing a form of piracy as you are copying a an “item” that is owned by another individual.

I now throw it to you guys:
– Do you think the Supreme Court ruling will have an affect on the progression of genetic research?
– Do you think that leaving cDNA patentable still leaves companies able to circumvent the system?

– Written by Rakshet Sachdev

Find more of my in-cohesive ramblings on twitter @rakshet