Yes, the Patent System Is Broken: The Human Genomics Edition

From Genome Medicine (boldface mine; open access):

The scope and eligibility of patents for genetic sequences have been debated for decades, but a critical case regarding gene patents (Association of Molecular Pathologists v. Myriad Genetics) is now reaching the US Supreme Court. Recent court rulings have supported the assertion that such patents can provide intellectual property rights on sequences as small as 15 nucleotides (15mers), but an analysis of all current US patent claims and the human genome presented here shows that 15mer sequences from all human genes match at least one other gene. The average gene matches 364 other genes as 15mers; the breast-cancer-associated gene BRCA1 has 15mers matching at least 689 other genes. Longer sequences (1,000 bp) still showed extensive cross-gene matches. Furthermore, 15mer-length claims from bovine and other animal patents could also claim as much as 84% of the genes in the human genome. In addition, when we expanded our analysis to full-length patent claims on DNA from all US patents to date, we found that 41% of the genes in the human genome have been claimed. Thus, current patents for both short and long nucleotide sequences are extraordinarily non-specific and create an uncertain, problematic liability for genomic medicine, especially in regard to targeted re-sequencing and other sequence diagnostic assays.

Let me translate into English. Because the U.S. courts, in their infinite wisdom, have allowed people to establish patent rights from sequences as short as 15 nucleotides (e.g., “ATGCGTACGGGGCCGATT”), essentially every human gene is covered by a patent.

I don’t even want to think what it could possibly be like for bacteria–so much for rapid diagnostics.

That the courts decided that the sun could be patented has to have been one of the dumbest technology-related decisions in recent history.

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5 Responses to Yes, the Patent System Is Broken: The Human Genomics Edition

  1. Most of this is simply untrue, to be honest. For one thing, the 15mer claimed in Myriad’s patents are for genes associated with breast cancer; if you were testing for a gene containing that 15mer outside of breast cancer that wouldn’t be covered in their patent. I doubt a court in the land would let a case that attempted to enforce the claim get very far. You can’t just claim a gene, you have to show the use for that claimed gene.

    What’s more, I am incredibly skeptical of their claim that 41% of the human genome is patented. Jensen and Murray came up with a figure of 20% that looks like a massive overcalculation now that Chris Holman has been poking at the data: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1894715, http://www.nature.com/nbt/journal/v30/n3/full/nbt.2146.html

    I believe that Chris and Bob Cook-Deegan have a project going to look through the entire Jensen and Murray data set to see what a more accurate number will be.

    The real IP problem facing genomics is not patents, which have a limited life and require public disclosure, it’s giant proprietary databases of genotype-phenotype associations that are commercial trade secrets and have no public disclosure requirements. Even when Myriad’s patents expire (assuming they triumph in the Supreme Court) they’ll still make money from BRCAnalysis because their data on what each mutation means clinically is so great.

    • Maude says:

      As a human geneticist and an amateur bioethicist, trained abroad and working in a developing country as a biomedical scientist and educator, I find this article very disturbing regardless of the actual % of human genome that is patentable. The analyses could be done by anyone/group for this magic % number, until the cows come home. What makes me angry and very sad, is this mad pursuit of $$$, patents and ‘intellectual property’ by commercial companies, insitutions, individuals & support shown by legal and judicial processes in the USA and perhaps elsewhere. It seems so bereft of compassion or respect for the ‘common’ Homo sapiens, the majority of whom live in developing countries who fall in low or middle income groups. I hope some sense will prevail and we find more human ways of doing things.

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