When did the idea of open science capture the imagination of researchers? A seminal moment in the history of open science occurred in 1982 with the creation of the public GenBank at Los Alamos National Laboratory(LANL). In 1992, functional management responsibility for the exponentially growing library of genetic sequences was transferred to the newly founded National Center for Biotechnology Information(NCBI) at the National Library of Medicine (NLM). As one of the earliest components of the NCBI library of data resources, including PubMed, GenBank has grown exponentially, anchoring national and international contributions of gene expressions and partnering with the International Nucleotide Sequence Database Collaboration , which is comprised of the DNA DataBank of Japan (DDBJ), the European Molecular Biology Laboratory (EMBL), and GenBank.
As the practice of medicine and biomedical research increasing looks to the genome and genetic anomalies as the cause of illness, the availability of genes to study on an open and equal basis should be obvious.
But wait… publishers and inventors have always known where to find profit in information.
And on July 29, 2011, the Federal Circuit ruled that the isolated genes for breast cancer were patentable subject matter. This reversed a previous ruling in the U.S. District Court for the Southern District of New York which came to the logical conclusion that I started this blog post with (as reported on the Law.com blog):
Two isolated genes closely associated with breast and ovarian cancers are unpatentable, a New York federal judge ruled Monday. The judge decided that the two genes, once separated from the lengthy DNA sequence, cannot be considered sufficiently new and useful to be deemed patentable. The case was closely watched by the medical community and cancer patients who argued that the two genes in dispute, BRCA1 and BRCA2, should not be patented and privately owned.
The 2010 ruling also attracted the attention of 60 Minutes:
In the more recent July 2011 ruling on The Association for Molecular Pathology v. United States Patent and Trademark Office , the previous District court ruling was overturned in part, and upheld in part. The appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. Part of the conclusion in the ruling cited precedent of genetic patenting:
“In this case, the PTO has issued patents directed to DNA molecules for almost thirty years. In the early 1980s, the Office granted the first human gene patents. See Eric J. Rogers, Can You Patent Genes? Yes and No, 93 J. Pat. & Trademark Off. Soc’y 19 (2010). It is esti-mated that the PTO has issued 2,645 patents claiming “isolated DNA” over the past twenty-nine years, J.A. 3710, and that by 2005, had granted 40,000 DNA-related patents covering, in non-native form, twenty percent of the genes in the human genome, Rogers, supra at 40. In 2001, the PTO issued Utility Examination Guidelines, which reaffirmed the agency’s position that isolated DNA molecules are patent eligible, 66 Fed. Reg. 1092-94 (Jan. 5, 2001), and Congress has not indicated that the PTO’s position is inconsistent with § 101. If the law is to be changed, and DNA inventions excluded from the broad scope of § 101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress.”
One of the parties to this litigation on the side of non-patenting was the American Civil Liberties Union(ACLU). According to the ACLU, “patents on human genes violate the First Amendment and patent law because genes are “products of nature” and therefore can’t be patented….A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.”
The ACLU and the other losing Plaintiffs have appealed the Appellate Court ruling to the U.S. Supreme Court. There is a Facebook page for those that don’t want their genes patented.
Now I have really loaded you up with background, but the main event I wanted to share is a video recording (click on the watch video link) of a Yale Law School Information Society Project forum that has spokespersons for both the plaintiff coalition and the company that owns the patent for BRAC1 and BRAC2, Myriad Genetics:
- Chris Hansen, the lead attorney on the case for the ACLU
- Richard Marsh, the General Counsel of Myriad Genetics
- Rochelle Dreyfuss, Pauline Newman Professor of Law at NYU
- Dr. Allen Bale, the Director of the DNA Diagnostic Lab and Professor of Genetics at the Yale School of Medicine.
Whether the choose to acknowledge it, the plaintiffs represent the collision of open science and the First Amendment. Is gene expression human expression?