Natural DNA is not patentable but cDNA is-US Supreme Court

Protein _dna_images

The epic saga of Association for Molecular Pathology v. Myriad Genetics has finally come to an end on 13th June 2013. The United States Supreme Court has unanimously ruled that naturally occurring isolated human genes cannot be patented, but that a synthetic DNA sequence, known as complimentary DNAs (cDNA)—are eligible for protection. Earlier, we had reported on this blog Myriad case, ‘Can genes be Patentable? related to gene sequence patentability. This decision is a big relief for scientists, following the court case between Myriad (BRCA test and Angelina Jolie’s story) and Association for Molecular Pathology. Now, what is the implication of this case and how it’s going to affect us? Let’s understand in the light of BRCA gene case.

Human gene takes the shape of a “DNA double helix.” Each strand in the helix consists of chemically joined nucleotides. These nucleotide sequences contain the information necessary to create amino acid chains – the proteins molecule.  Now, the nucleotides that code for proteins are known as “exons,” and those that do not are known as “introns.” We can isolate specific DNA segments from mammalian cell, that is the genomic DNA (gDNA) containing both exon and intron.  gDNA is the product of nature, not patent-eligible subject matter under section 101 of the US Patent Act.

On the other hand, we can synthetically create exons-only strands known as composite DNA (cDNA). So the court ruled that cDNA or ‘synthetic DNA’ sequences are different from their natural counterpart, and are patentable.

Myriad Genetics, obtained several patents for two human genes: BRCA1  and BRCA2, mutations of which can cause serious disruption to the open reading frame of the transcriptional unit and are linked to an increased risk of breast and ovarian cancer. Patents legally entitled Myriad Genetics for the life of the patent to exclude all others from using these genes in breast & ovarian cancer research, diagnostics, and further treatment.

The court ruling outcome is very clear that having an open access to the genome could result in increased competition, development of new technologies, falling cost of kits, and greater relief for low-income patients. This decision favoured those eagerly waiting for personalized, gene-based approaches to medical care.

This decision can have a telling impact on biotech research. It draws a delicate balance between incentives to develop new technologies for companies and guarding the interest of scientists with open access to the genome.

However, the decision throws many  unanswered questions than that answer, such as how the ‘Product of Nature’ doctrine would be applicable to substance like,  purified gDNA that has been altered in some other way, other isolated natural substance like proteins, cell lines etc. Let’s see how the patent landscape unfolds in this arena, we will track as it arises.

Picture Courtesy: Google Pictures

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One Response so far.

  1. Normally I do not read post on blogs, however I would like to say that this write-up very pressured me to try and do it! Your writing style has been amazed me. Thank you, quite nice article.

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