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In a landmark decision, the U.S Supreme Court ruled last Thursday that companies cannot patent human DNA. Contending this case is Myriad Genetics, who claimed that because they had discovered and isolated two human DNA genes, named BRCA1 and BRCA2, they could put a patent on their use.

The court found that naturally occurring, yet isolated, DNA was not eligible for patenting. However, the court ruled that synthetic DNA, called cDNA, is patent eligible.

Section 101 of the Patent Act provides:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

While the court did recognize that Myriad had discovered an important and useful gene, they went on to claim that simply separating these genes from their genetic material is not an act of invention. Although Myriad went into extensive details of the effort involved in isolating these genes, the court ruled that effort alone is not enough to satisfy Section 101 of the Patent Act.

In regards to synthetic DNA, which contains the same protein coding information found in natural DNA but omits portions within the DNA segment, the court ruled it as being patent eligible. The court held that this kind of DNA (cDNA) is not a “product of nature” and is therefore eligible.

Uncertainty still remains in this dilemma. The patentability of other molecules produced in nature, such as small molecule drugs or protein therapeutics was not discussed in this decision and issues relating to such could arise in the future.

Author: Sean Foley, Legal Trainee, Bridgehouse Law Charlotte