Jorge L. Contreras

In a 1955 news show called See It Now Edward R. Murrow asked the inventor of the polio vaccine, Jonas Salk, who owned the patent to the vaccine. Salk replied, "Well, the people. There is no patent. Could you patent the sun?"
This book is about a specific case, but it's also about much more, an indictment of the current patent system. Myriad Genetics, a company held the patents on two key genes, BRCA1 and BRCA2. Everyone has those genes, but women with certain mutations in their BRCA genes face much higher risks of breast or ovarian cancer. Through its patents, Myriad had essentially cornered the market on BRCA testing. The company charged more than $3,000 for a test, and insurers didn’t always cover it. Some women weren’t able to get tested because they couldn’t afford it. And the problem went beyond cost: One woman who joined the lawsuit as a plaintiff tested positive for a BRCA mutation but before undergoing surgical removal of her ovaries wanted a second opinion; because of Myriad’s patents, no other lab could confirm the diagnosis.
The Association for Molecular Pathology along with several other medical associations, doctors and patients sued the U.S.Patent and Trademark Office and Myriad Genetics to challenge several patents related to human genetics. The suit also challenged several method patents covering diagnostic screening for the genes. Myriad argued that once a gene is isolated, and therefore distinguishable from other genes, it could be patented. By patenting the genes, Myriad had exclusive control over diagnostic testing and further scientific research for the BRCA genes. Petitioners spearheaded by the ACLU, argued that patenting those genes violated the Patent Act because they were products of nature. They also argued that the patents limit scientific progress. Section §101 limits patents to "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."
The district court granted summary judgment in favor of petitioners, holding that isolating a gene does not alter its naturally occurring fundamental qualities. (Judge Robert Sweet was ably assisted by his clerk who had an advanced degree in the bio-sciences. Sweey's opinion is worth reading as a clear exposition of both the science and the legal aspects of the case. You can read it here.)
The U.S. Court of Appeals for the Federal Circuit (specializing in patent cases, it was known as the "nerd's" court) reversed, holding that isolated genes are chemically distinct from their natural state in the human body. In March 2012, Petitioners sought certiorari; and in light of Mayo Collective Services v. Prometheus Laboratories. the U.S. Supreme Court vacated the Federal Circuit judgment and remanded, i.e., sent it back for further consideration On remand, the Federal Circuit again upheld the patentability of the BRCA genes. Again appealed to the Supreme Court which ruled unanimously that genes were not patentable although cDNA was, as it was not a product of nature.
The case was unusual in that the Solicitor General's Office took a position in opposition to that of the Patent Office which had declared that since they had permitted patenting of genes already, to reverse that would just mess up previously decided cases. That the SG's office did so, was the result of compromise worked out by many agencies brought together at the behest of Obama to determine what the position of the government should be. (It's worth remembering that Obama's mother had died of ovarian cancer at 56, fighting insurance companies until her death, and his grandmother died of breast cancer.) The compromise was orchestrated by Mark Freeman who serves a gold star for bringing such disparate parties together. It's also notable that Francis Collins, NIH director was adamantly opposed to gene patenting. He had been a co-worker with Mary Kelly and Mark Skolnick in isolating and linking the BRCA1 and BRCA2 gene mutations to breast and ovarian cancers. Skolnick had recognized the monetary potential in their discovery and founded Myriad genetics, over the opposition of Kelly and Collins, which monopolized BRCA testing and made lost of money.
There are some very appealing characters: Lori Andrews, the "Gene Queen" an attorney who was upset with the patenting of a test for Canavan Disease; Michael Crighton, whose book Next and NYT op-eds laid some of the public groundwork for the court cases; Dan Ravicher, a successful patent attorney who became disillusioned with the way patents were destroying innovation and who formed his own public interest firm to challenge patents; Tania Simoncelli, the individual most responsible for getting the ACLU interested in gene-patenting; and Chris Hansen, the ACLU attorney who argued the case before the court.
A very interesting read that raises all sorts of bioethical, medical, economic, and legal issues.… (más)

Contreras somehow turns this legal battle into a page-turner. I was consistently surprised at the basic scientific ignorance of lawyers at the ACLU, and of Supreme Court justices (maybe that shouldn't be surprising). To understand the implications of an issue, they consistently turn to speculative analogies, and this is probably a useful strategy in most of their cases. In this case, though, their analogies showed a profound ignorance of elementary science, of the kind that can't be fixed by looking up the definition of a chromosome the day before arguments.

> Hansen reserved a workroom at the ACLU to go over the patents and pick the exact claims that they would challenge. Despite the fact that they had been talking about gene patents for the last four years, until now Hansen had never actually read a patent cover to cover. In theory he knew what a patent was, but he envisioned the document itself as something akin to a car title or the deed to a house—a fancy legal document embossed with a seal that laid out the claims awarded by the Patent Office in a page or two.

> Going into that meeting, Hansen didn’t know the difference between a chromosome and a gene.

> One claim was particularly egregious—it gave Myriad the rights to a strand of DNA anywhere in the human body that shared a sequence of just fifteen base pairs (called a 15-mer) with the BRCA genes. That was outrageous—the human genome had 3.2 billion base pairs and the BRCA genes between them had about 200,000.

> “Are human genes patentable?” That was it. Only four words. Hansen thought it was probably the shortest question presented for certiorari in the history of the Court. But he liked it.

> called out the Court and counsel for their excessive use of bad analogies, writing that “Isolated human DNA is not a tree (Justice Kagan); sap from a tree (Justice Breyer); a chocolate chip cookie (Justice Sotomayor); a baseball bat (Greg Castanias); or a liver or kidney (Chris Hansen).”

> Genomic DNA in the form in which it exists in the human body is an unpatentable product of nature. Complementary DNA that is created in the laboratory is a patentable construct of humankind.

> We, therefore, conclude that merely finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible as new compositions of matter … Consequently Myriad’s patents on the BRCA genes are invalid.”… (más)