Friday, June 14, 2013

SCOTUS Gets One Right: Humans are not patentable

The issue in Association for Molecular Pathology (AMP) et al. v. Myriad Genetics, Inc.(Myriad), et al., is whether a corporation can patent a human gene. The gene is question may hereafter be known as the Angelina Jolie gene. That's a better name than BCA1/2, to which it is referred by geneticists. Jolie discovered through an analysis of her chromosomes that she possessed mutations of this gene that are a strong positive indicator for breast cancer and ovarian cancer.

The case was brought by AMP against Myriad. AMP sought to use the Jolie gene for treatment but discovered that Myriad had taken out a patent on the gene. Myriad's fee for use was very high. AMP (and the other complainants) challenged the constitutionality of such a patent.

Under the law, patents can only be issued for materials not found in nature. The US Patent Office (PTO) issued a patent on Myriad's representation that the removal of the gene from a chromosome in which it is found in the human body rendered it somehow “not found in nature”. This logic would make it possible to patent a branch by removing it from a tree, since branches do not exist in nature except on a tree. Myriad claimed that the severing of connections to the rest of the chromosome made the gene patentable. The PTO agreed with Myriad's lawyers in their pursuit of this dubious patent.

Several commenters have complained about the technical complexity of the Court's written decision. I find this odd because most SCOTUS decisions are littered with legalese that is incomprehensible to the average college graduate. The laws of a country should be understood by its people.

Antonin Scalia (in a separate 1-paragraph, concurring opinion) also objected to the scientific terms included in the Court's opinion, written by his longtime collaborator on the Court, Justice Thomas. Scalia claims that he is unable to affirm the technical details of the opinion by his own knowledge or even his own belief.

Scalia made a good point here, but he failed to recuse himself because of his confessed ignorance of science. At least he admits his ignorance. Yet in the next sentence he says that, while BCA1/2 is not patentable because it is not found in nature, cDNA is patentable because it is not. Scalia says he has no knowledge of the science, nor even a belief. He therefore cannot have an educated opinion about the subject matter of this case.

CDNA is a material that scientists produce from DNA. Its production is somewhat like the mathematical determination of the square root of a number. Starting with the DNA, a scientist takes a number of well-understood steps to produce a cDNA, or complementary DNA. Just as there is only one square root for a real number, there is only one cDNA for a human gene segment.

The patent office does not grant patents for the square root of two, for example, nor for the process by which we obtain the square root of two. These are the building blocks of mathematics, without which there can be no progress in mathematics. Yet SCOPUS reaffirms here that a compound that stands in the path of further research can be patented, thus stifling progress.

The true importance of this decision was immediately recognized by journalists. Thousands, perhaps millions, of women who could not afford the extortionate prices charged by Myriad for cancer screening, may now be rescued from an early grave. The US is a country of laws, but it is a country of people first. We cannot condone business practices that result in the enrichment of a single corporation at the expense of human lives being needlessly lost.

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