Last July, the Court of Appeals for the Federal Circuit, which is the penultimate authority in patent cases, overturned a lower court decision and declared that genes are patent-eligible subject matter. In a twist, however, the court affirmed that diagnostic methods using the patented genes to detect breast or ovarian cancer are patent-ineligible subject matter. It was a pyrrhic victory for Myriad Genetics because its $3,340 cancer test is primarily protected by its patented, but now-invalidated, diagnostic methods.
Patent law provides four conditions for an invention to be granted a patent. It must be: (1) patent-eligible subject matter; (2) useful; (3) new; and (4) not obvious. The Myriad case addresses the first condition of patentability.
Specific categories of patent-eligible subject matter have existed since 1793, namely: process, machine, manufacture and composition of matter. A product of nature, however, cannot be patented even if its existence was unknown. In 1980, the U.S. Supreme Court in the Diamond v. Chakrabarty case held that genetically altered living organisms are patentable as "manufactures" or "composition of matter." The Court reasoned that the patented bacterium was not a product of nature because human beings made it.
The conflict in the Myriad case started when a woman, a single mother from Massachusetts, was unable to access the diagnostic methods provided by Myriad because Myriad refused to work with her health insurer. Instead, she would have to go outside her health plan and pay for the diagnostics herself, which she could not afford.
The Myriad lawsuit was headed by the American Civil Liberties Union after it formulated an intriguing legal theory crossing patent law and civil liberties concerns. Specifically, the ACLU's position is that the temporary patent monopoly blocks the flow of information to better society. Thus, it implicates the First Amendment's guarantee of free speech. In essence, the ACLU argued that what Myriad really had patented is knowledge.
The legal theory of the ACLU reveals humankind's imperfect understanding of genes. Specifically, the question is whether a gene is a molecular structure or information encoded in the molecular structure. The crux of the ACLU's legal theory is that genes are pieces of information of humankind and no one should own them, whereas the winning argument at the Federal Circuit is that Myriad's patented genes were "markedly different" in their chemical structure from the genes found inside the body. Thus, Myriad's isolated genes were not a product of nature because human beings made them, and therefore, they are patentable.
The structural representation of genes has gained credence since the identification of DNA as genetic material by James Watson and Francis Crick in 1953. Genes were confirmed to exist as segments of DNA. Soon, however, the informatics representation contended to be the dominant model, famously treating DNA as a four-letter text representing the four types of molecules: adenine (abbreviated as A), cytosine (C), guanine (G) and thymine (T). The informatics representation is enticing as it provides a narrative explaining how the world and humankind came to be in their present form.
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