June 18, 2013
Give Justice Antonin Scalia credit for candor. In joining the unanimous decision of the Supreme Court last week that human genes cannot be patented, the justice added a brief concurring opinion. He noted how the ruling plunged “into fine details of molecular biology,” adding he is “unable to affirm those details on my own knowledge or even my own belief.”
Scalia acknowledged what the decision suggests: For all the discussion of science, Justice Clarence Thomas, writing for the court, engaged in something closer to a political exercise, succeeding in striking the right balance. The ruling reflects a clear understanding of the value of patents to a thriving biotechnology industry, yet it rejects the notion of a company essentially owning our genes, no less than a part of us.
Myriad Genetics performed a dazzling feat. Company researchers isolated a set of genes, discovering that mutations greatly increased the risk of breast and ovarian cancer. Myriad developed a test for detecting the mutations, Angelina Jolie revealing recently that she had a preventive double mastectomy after learning about her own high risk. The patent Myriad obtained on the genes delivered what amounted to a monopoly, other companies discouraged from proceeding in this area, Myriad charging a high price for the test.
No surprise that others in the biotech industry launched a lawsuit, eventually posing the question to the high court: Are the isolated genes the work of nature or an invention of researchers and thus eligible for patent protection?
In crafting its answer, the court drew a clear and useful distinction. Justice Thomas argued that “a naturally occurring DNA segment is the product of nature and not patent eligible merely because it has been isolated.” Down, thus, comes the Myriad monopoly. Already a handful of labs and companies have declared that they soon will offer genetic testing involving breast cancer.
The competition should work in favor of patients, the test becoming more affordable.
At the same time, patent protection is crucial to a strong biotech industry, an industry that increasingly has become a driver of the economy, an area where the country has a competitive advantage. There is much hope in science exploring genetics, finding new ways to detect and treat illnesses. Thus, the court held that if the natural-occurring genes were off limits, synthetic DNA created in the laboratory warranted protection.
For the industry, synthetic, or complementary, DNA offers the more promising course. Thomas noted that firms would be able to patent methods for isolating genes. The distinction is, they would be inventing things wholly new, applying the knowledge gained from genetic research.
This wasn’t an easy call, the justices reversing an appeals court that held Myriad deserved patent protection, finding the isolated genes sufficiently different. Justice Thomas and his colleagues got it right in crafting the compromise. A company shouldn’t be permitted to hold as intellectual property something as natural as genes. Now all of us will benefit from biotech firms aggressively chasing innovation, the court leaving plenty of room for ideas and inventions to flourish.