Archives For law

Orac is reporting that a planned Congressional hearing into the National Vaccine Injury Compensation Program has been canceled. This is unambiguously good news; the hearing was probably a political favor being done for anti-vaccine cranks who despise the NVICP. Their hatred for the Program can be confusing, given how much better it is for their position than the alternative.

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Today the United States Supreme Court issued a unanimous ruling on a case very important to genetics research and medicine.*

In ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS, INC., the Supreme Court addressed the question of whether genes could be patented. The defendant, Myriad Genetics, had identified and patented two very important genes implicated in breast and ovarian cancer: BRCA1 and BRCA2. Their patents meant that they had exclusive rights to sell genetic tests to identify the cancer-causing mutations in these genes, and controlled any research on them.

The Supreme Court ruled against Myriad Genetics. In their opinion, written by Justice Thomas, they stated that:

“a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

cDNA has an identical sequence to the original gene, but has been synthesized from a messenger RNA copy of the gene with the non-coding portions (introns) removed. Here is a little tutorial that explains more about cDNA. (Perhaps Justice Scalia should watch it.**) Having a direct ‘read-out’ of the coding bits of a gene is necessary for many molecular biology applications, and this ruling is important to biotech companies (who have been patenting cDNA all this time).

This ruling is excellent news. It recognizes that the human genome isn’t ‘property’, which would have had a seriously detrimental effect on future genetics research and personalized medicine. It also means that all companies offering screens for cancer-causing variants can finally include BRCA1 and BRCA2 along with other genes tested. That will hopefully improve access to genetic information for many women with concerns about familial histories of breast and ovarian cancer, and allow them to make informed decisions about their health in advance of cancer appearing.

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*There’s a lot of discussion going on among geneticists about how badly the Supreme Court bungled the science. And it’s true that they made a lot of errors. However, I’d point out that most of us geneticists in turn probably don’t understand a lot about patent law.

**Justice Scalia issued a very odd opinion in which he agreed with the other justices about the outcome but as to the details of molecular biology:

” I am unable to affirm those details on my own knowledge or even my own belief.”

Belief? It’s perfectly reasonable to admit you don’t understand the science, but it seems strange to state that you may not believe it. This isn’t exactly controversial stuff. I’m very curious why he chose that word.

Further reading:
SCOTUS blog on the ruling: http://www.scotusblog.com/2013/06/opinion-recap-no-patent-on-natural-gene-work/

A nice discussion of the issues: http://www.pbs.org/wgbh/nova/next/body/gene-patents-and-personalized-medicine/

Do you want access to all government-funded genetic research results? You can download whatever you want (for free) here: http://www.ncbi.nlm.nih.gov/genbank/