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