Patentability Debate: Naturally Occurring DNA and Gene Patents

The validity of gene patents covering isolated DNA sequences, methods for diagnosing cancer predisposition through mutated DNA sequences, and drug identification methods using isolated DNA sequences were challenged in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. The district court initially deemed the claims as non-patentable, but the decision was reversed by the United States Court of Appeals for the Federal Circuit, leading to an appeal before the Supreme Court.

The Supreme Court of the United States faced a crucial question: Can naturally occurring DNA be patented? While diagnostic claims were already under scrutiny, the U.S. Patent Office had been accepting patents on isolated DNA sequences as compositions of matter.

In the case, Myriad Genetics, Inc., a startup research institute, and its partners discovered the BRCA1 and BRCA2 genes, which are associated with an increased risk of developing breast cancer. Myriad Genetics, Inc. claimed patents on the isolated BRCA genes, along with complementary DNA (cDNA) and diagnostic primers.

Critics argued that Myriad Genetics, Inc. had merely isolated the genes without making any modifications, and that the isolated genes functioned similarly to their natural counterparts. The broadening or narrowing of subject-matter eligibility in gene patents would have significant implications for inventors’ incentives and public access to information. The Supreme Court’s judgment in this case expanded the scope of patentable subject matter.

In the Court’s opinion, delivered by Justice Clarence Thomas, it was held that naturally occurring DNA segments are products of nature and not eligible for patents solely based on isolation. However, cDNA, which is a synthetic creation, is eligible for patent protection as it is not naturally occurring. The Court also noted that the processes used by Myriad Genetics, Inc. to isolate DNA were well-established and widely used at the time, making them non-patentable under 35 U.S.C. 101.

Justice Antonin Scalia, in his dissenting opinion, argued that the portion of DNA isolated from its natural state, sought to be patented, is identical to the naturally occurring DNA. Conversely, he acknowledged that complementary DNA (cDNA) is a synthetic creation not typically found in nature.