Supreme Court Rules Parent DNA Sequences Cannot be Patented

The Supreme Court today ruled that because DNA is a “product of nature,” it cannot be protected by a patent—but complementary DNA made synthetically in a lab would be eligible for patent protection.

The United States Supreme Court ruled unanimously today that DNA in its natural form cannot be protected by intellectual property laws, but added that complementary DNA (cDNA) synthesized by a pharmaceutical company from originator DNA would be considered fair game for patent protection.

The decision is likely to open up more questions than it answers regarding the right to claim ownership of isolated sections of DNA. In the case before the court, the Association for Molecular Pathology challenged 7 of Myriad Genetics, Inc’s patents for the BRCA1 and BRCA2 breast cancer genes. Myriad applied for a patent for the section of DNA within chromosome 17 and 13 that code for BRCA1 and BRCA2. They also applied for a patent for the cDNA created in a lab based on these genes.

The Supreme Court determined that the isolated portion of DNA that codes for a specific mutation is not a patentable entity. However, it ruled that the cDNA that is made synthetically “does affect this informational component by removing the non-expressing portion of the DNA sequence, thus producing a non-naturally occurring DNA sequence,” noted Jason Rantanen on www.patentlyo.com. “This change in the informational content is sufficient to render the cDNA sequence patentable.”

The genetic material in cDNA is intrinsic to the genetic structure (or the “coding”) of regular DNA. The design of the manufactured cDNA is inherently based on the version that occurs in nature. In this way, although the law states that products or processes of nature cannot be patented, some scientists argue that cDNA is, in its very essence, a product of nature. Critics of the decision argue that even though cDNA is technically "altered," and introns are removed from the genetic code, the decision that cDNA is patentable is flawed because the genes that are actually expressed via the cDNA are identical to those expressed in the DNA.

“It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” noted Justice Thomas. “The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA.”

The identification of a novel gene mutation and discovery of its role in predicting the expression of disease are scientifically groundbreaking. However, the court determined that simply finding the portion of code that is responsible for these mutations does not justify a patent assignment.

“When we found the BRCA2 gene at the Institute of Cancer Research, London, our aim was that our discovery was used to help cancer patients," said Professor Alan Ashworth, chief executive of The Institute of Cancer Research, in a statement emailed before the Supreme Court Decision was issued. “Any Supreme Court ruling that continues to restrict the availability of tests for variations in individual genes in an age when whole genome analysis is becoming commonplace would be very disappointing.”