Supreme Court Strikes Down Patents on Natural Genes

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You can’t patent a gene that occurs in nature, but you can patent one that you create. That’s the gist of the U.S. Supreme Court’s ruling today in a closely watched case that may have sweeping consequences for the biotech industry.

Myriad Genetics was defending patents it held on two gene mutations linked to increased risk of breast and ovarian cancer. “It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy” the standard for patent eligibility, the court found. Justice Clarence Thomas wrote the opinion, with eight justices agreeing and Justice Antonin Scalia concurring.

The court affirmed protections for synthetic sequences of genetic material known as composite DNA, or cDNA. These are sequences engineered in the lab to include only the potent parts of DNA that create proteins, leaving out the inert strands that occur in natural DNA.

The ruling’s implications are wide-ranging, as Bloomberg’s Greg Stohr reports:

“The U.S. Supreme Court restricted the ability of companies to patent human genetic sequences, ruling in a case that tested a decades-old practice and raised questions about thousands of biotechnology, agricultural and drug patents. …

“The ruling marks an important moment for patent law, with implications for the growing field of personalized medicine and efforts to map the human brain and discover new uses for embryonic stem cells.

“The decision is a partial victory for doctors’ groups and patient advocates that accused Myriad of using its patents to block clinical testing and research. Biotechnology, agriculture, and drug industries backed Myriad in the case, telling the court that gene patents have led to valuable treatments.”

Richard Wolfe at USA Today offers more background:

“The complex scientific case was perhaps the most important on the high court’s calendar other than its more celebrated cases involving same-sex marriage, voting rights and affirmative action. …

“Since 1984, the U.S. Patent and Trademark Office has granted more than 40,000 patents tied to genetic material. Armed with those patents, Myriad has tested more than 1 million women since the late 1990s for mutations that often lead to breast and ovarian cancer.

“Most women who want testing must pay its price—$3,340 for the breast cancer analysis and $700 for an additional test that picks up a genetic link in about 10% of women who test negative the first time. Myriad officials say about 95% of its patients receive insurance coverage, often without co-payments, so that most patients pay only about $100.

“Myriad and a broad array of industry trade groups argued that without patent protection, research and development would dry up. Doctors, geneticists, women’s health groups and cancer patients contended that competition would lower prices, improve outcomes and lead to more discoveries.”

One of the gene mutuations at the heart of the case, known as BRCA1, is the genetic variance that led actress Angelina Jolie to have a preventive double-mastectomy earlier this year.

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