Patenting Genes: Human Invention or Product of Nature?
Leading up to the debate on gene patenting, this week marks the 60th anniversary of the discovery of the DNA double helix. On April 25th, 1953 the work of James Watson, Francis Crick, Maurice Wilkins, Rosalind Franklin and other colleagues on the structure of DNA was published in Nature. Without this milestone achievement, we wouldn’t have been able to make the incredible advancements we have in genetics and medicine, and we wouldn’t be having the discussion on whether genes are patentable. In the past couple of years, the fields of genomics and epigenomics have grown tremendously, and data gathered from studies in these fields have led to a better understanding of various genetic diseases and cancer. As more discoveries are being made in academic and biotechnology institutions, patenting certain technologies has also increased, which will certainly affect future healthcare and therapeutics. However, what about being able to patent sequences of human genes, instead of technologies? Does it promote or hinder innovation in medical genetics and diagnostics?
A recent article in Science reported on the US Supreme Court hearing a case involving Myriad Genetics, a diagnostic company, regarding their patents on two genes, BRCA1 and BRCA2, that are implicated in breast and ovarian cancer. The patents cover the genomic sequences and any gene mutations found in BRCA1 (chromosome 17 location) and BRCA2 (chromosome 13 location), as well as methods for locating the mutations. Evidence for BRCA1 being linked to breast cancer was published in 1990 by King’s lab at UC Berkeley. Soon after this report, the BRCA1 gene (in 1994) and BRCA2 gene (in 1995) were patented by Myriad Genetics and their collaborators. Myriad Genetics uses these genes as part of their breast/ovarian cancer risk platform, BRCAnalysis®, in clinical diagnostic labs.
In this case, Association for Molecular Pathology (AMP) vs Myriad Genetics Inc, AMP claims that these genes are not patentable as they are a “product of nature.” On the other hand, Myriad challenges that their patents on BRCA1 and BRCA2 are valid because the sequences they patented are not “products of nature”, and only exist after these genes were extracted from the tissue and manipulated in vitro, referring to the cDNA sequences that were patented rather than the genomic DNA sequence, and are therefore “human inventions”. When questioned about the incentive for having gene patenting ruled out, Christopher Hansen, AMP’s attorney, stated that “When you lock up a product of nature, it prevents industry from innovating and making new discoveries.” Furthermore, a spokesperson from the Obama Administration, Solicitor General Donald Verrilli gave the government’s view of patenting genes, stating that the isolated gene is not patentable however cDNA should be patentable as “cDNA is an artificial creation in the laboratory that doesn’t correspond to anything in your body.”
At the end of the hearing, the Justices were still doubtful about patenting human genes but tended to lean towards the idea that cDNA is patent eligible. However, more deliberation is needed and the court will come to a decision June 30th regarding the issue of patentability of human genes.
The topic of whether genes can be patented has become an interesting political conversation within the scientific community. How will it affect the progression on research of patented genes? Will this affect other research labs or companies working on the same gene? How will this influence the future of healthcare reform and patient treatment? What do you think? Voice your opinion in the poll and in the comment section below.
“Can Human Genes Be Patented?” ScienceInsider. 2013 April 17. http://news.sciencemag.org/scienceinsider/2013/04/can-human-genes-be-patented.html?ref=hp
“Justices Appear Skeptical Of Patenting Human Genes” NPR. 2013 April 15. http://www.npr.org/blogs/health/2013/04/15/177369914/Justices-Appear-Skeptical-Of-Patenting-Human-Genes
Hall JM, Lee MK, Newman B, Morrow JE, Anderson LA, Huey B, & King MC (1990). Linkage of early-onset familial breast cancer to chromosome 17q21. Science (New York, N.Y.), 250 (4988), 1684-9 PMID: 2270482
WATSON JD, & CRICK FH (1953). Molecular structure of nucleic acids; a structure for deoxyribose nucleic acid. Nature, 171 (4356), 737-8 PMID: 13054692