Posts tagged with: BRCA1

Blog author: kspence
posted by on Friday, August 12, 2011

Last week the Federal Circuit Court handed down what seemed to many a funny decision: that human genes are patentable. Myriad Genetics owns patents for two tumor suppressor genes, BRCA1 and BRCA2 (mutations of these genes are correlated with increased incidence of breast cancer, making them of great interest to doctors and scientists). Myriad was sued by doctors and researchers who claim that genes fall into the category of “products of nature,” which makes them unpatentable, but the court disagreed.

Myriad’s patents allow it to charge licensing fees to doctors who wish to screen their patients for BRCA1/2 mutations, and also to researchers developing drugs that would target BRCA1/2 abnormalities in breast cancers. Myriad claims that its patents allow it to recover the costs of identifying the two genes, and so are just like the patents for Velcro, ShamWow, or the Segway. Aside from the legal dispute—i.e., the majority’s facially risible argument that “the molecules as claimed do not exist in nature,” since bits of the BRCA1 gene aren’t floating around in ponds—there are two problems with the patenting of genes: a moral one and a practical one.

In his Acton monograph The Social Mortgage of Intellectual Property, David H. Carey addresses intellectual property rights vis-à-vis the distribution of medicine. He focuses on the AIDS epidemic and infectious diseases in the Third World, and presents the Vatican’s 2001 argument that the principle of solidarity supersedes patent rights where the lives of the poor are at stake, even though the long-term consequences of a suspension of intellectual property might be severe.

Admittedly, personalized cancer treatment in the United States alters the moral calculation, but the American public has made its consideration, and by the establishment of the National Cancer Institute (part of the National Institutes of Health), has decided to fund early stage cancer research publicly. Certainly in order recoup the billions of dollars of testing required to bring a cancer drug to market, companies need the assurance of patent protection, but the sequencing of a gene comes years before any drug begins testing (Myriad filed for its patents in 1994).

As Francis S. Collins, head of the NIH, explained in a recent book,

The information contained in our shared [genome] is so fundamental, and requires so much further research to understand its utility, that patenting it at the earliest stage is like putting up a whole lot of unnecessary toll booths on the road to discovery.

Whether the Supreme Court reverses the Federal Circuit’s decision, or Congress passes a law making clear the proper extent of patent protections, this intellectual property mess must be untangled.