Lab Loses Its Breast Cancer Gene Patents

WASHINGTON (CN) - Myriad Genetics cannot patent the naturally occurring DNA that it isolated from the rest of the human genome to learn about breast and ovarian cancer, the Supreme Court ruled Thursday.

Myriad had filed the patents at issue when it discovered "the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes," according to the ruling.

"Mutations in these genes can dramatically increase an individual's risk of develop­ing breast and ovarian cancer," Justice Clarence Thomas wrote for the mostly unanimous court. "The average American woman has a 12- to 13-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast can­cer and between 20 and 50 percent for ovarian cancer. Before Myriad's discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in estab­lishing a woman's risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers."

Myriad can determine the typical nucleotide sequence of the BRCA1 and BRCA2 genes - and thus check for mutations - because it knows their locations.

The company also created a synthetic DNA known as complementary DNA, or cDNA, which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.

"Myriad's patents would, if valid, give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual's genome," Thomas wrote. "The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad's view, manipulating BRCA DNA in either of these fashions triggers its 'right to exclude others from making' its patented composition of matter under the Patent Act."

After the company cornered the market by filing patent-infringement suits against other entities that performed BRCA testing, Dr. Harry Ostrer, a former New York University School of Medicine researcher, filed a federal lawsuit.

He was joined by medical patients, advocacy groups and other doctors in the challenge.

A federal judge invalidated the patents at issue, including the claims related to cDNA, but the Federal Circuit reversed.

The Supreme Court ordered that appellate panel to rehear the case, however, in light of its 2011 decision Mayo Collaborative Services v. Prometheus Laboratories. In that case, the justices barred a medical lab from patenting a dosage test it created for autoimmune disease treatments.

Forced to reconsider its decision on the Myriad patents, the Federal Circuit again found that isolated DNA molecules are patent-eligible, man-made products under Section 101 of Title 35. The court also found that cDNA met the patent requirements.

Thomas and his colleagues in the majority reversed, except as to cDNA, Thursday.

"Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry," Thomas wrote.

"Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes 'new ... composition[s] of matter,' §101, that are patent eligible," he added.

Though the company found the genes "among the approximately eight million nucleotide pairs contained in a subpart of chromosome 17," Thomas said "extensive effort alone is insufficient to satisfy the demands of §101."

Justice Antonin Scalia, who joined the lead opinion in part, also wrote a separate opinion concurring in part and concurring in the judgment.

He said he did not want to join the section of the Thomas opinion that delved "into fine details of molecular biology."

"I am unable to affirm those details on my own knowledge or even my own belief," Scalia wrote. "It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature."

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