Association for Molecular Pathology v. Myriad Genetics, Inc.

Background

Myriad Genetics discovered the precise location and sequence of two human genes, BRCA1 and BRCA2, linked to higher breast and ovarian cancer risk. Myriad obtained patents claiming isolated DNA segments and lab-made cDNA, and enforced those patents against researchers and testing labs. Doctors, patients, and advocacy groups sued to declare the composition claims invalid under the Patent Act, arguing genes are products of nature. Lower courts issued conflicting rulings, and the Supreme Court took the case to resolve whether isolated DNA or cDNA can be patented.

Reasoning

The Court asked whether isolating a naturally occurring gene makes it a patentable invention. The majority held that isolated DNA segments are products of nature and are not patent eligible merely because they were removed from the genome. By contrast, cDNA is created in the lab by removing non-coding regions (introns) and is not naturally occurring, so cDNA can be patented. The opinion relied on prior decisions that discoveries of natural phenomena alone are not patentable and rejected deference to the Patent Office’s past practice on gene patents.

Real world impact

Under this ruling, companies cannot claim ownership of naturally occurring gene sequences themselves, which allows other labs and researchers to study and test those genes without infringing composition claims. Firms can still seek patents on lab-made cDNA and on novel methods or applications, so some commercial incentives remain. The decision narrows patent protection around human genes while leaving method claims and altered genetic sequences for separate consideration.

Dissents or concurrances

Justice Scalia joined the judgment but noted separately that he would not address detailed molecular biology; he agreed that the isolated DNA claimed matches natural DNA and that cDNA is a synthetic creation, supporting the Court’s outcome.