Public Interest Patent Law Institute

View Original

Letting Companies Patent Human Genes and Thought Processes Is a Terrible—and Terrifying—Idea

Alex Moss | August 4, 2022

Instead of addressing the health and economic crises our country faces, Senator Thom Tillis of North Carolina has announced the “Patent Eligibility Restoration Act of 2022”—a bill that will enrich drug companies by giving them the right to patent human genes and thought processes. Everyone who values public health and personal autonomy should join the fight to stop this bill from becoming law.

Despite its name, this bill proposes a radical and unprecedented expansion of patent protection. Since our country’s founding, the categories of patentable subject matter have been limited to new and useful processes, machines, manufactures, and compositions of matter. The Supreme Court has long recognized these limits implicitly exclude that that humans did not and could not invent: natural phenomena, natural laws, and abstract ideas. More recently, it has confirmed these limits bar patents on human genes, bodily functions, and thought processes—the building blocks of 21st century science.

The Tillis bill tosses these limits out the window and replaces them long-winded and deceptively expansive provisions. For example, the bill prohibits patenting “an unmodified gene, as that gene exists in the human body,” and defines “unmodified” to exclude a gene that is “isolated, purified, enriched” or “otherwise employed.” Put together, these provisions permit patents on any isolated human gene or method of using a gene, whether isolated or not. They impose no limits at all.

If enacted, the ramifications would be downright dystopian. For example, most people have a gene that allows their bodies to make lactase, an enzyme for digesting the sugar in milk. Under the Tillis bill, a company could obtain one patent on the gene in isolation and another on a method of using the gene to aid the digestion of dairy products. The first patent passes because it covers a gene in isolation, not as it exists in a human body. The second passes because it covers the use, or employment, of a gene. Whoever owns these patents would have exclusive rights to make, use, and sell any test or treatment involving the gene. They would even have the right to sue someone for drinking a glass of milk without getting sick—or to sue dairy farms for inducing this kind of “infringement.”

The bill is just as permissive of patents on thought processes. Instead of prohibiting patents on abstract ideas, as existing law does, the bill would prohibit patenting “a mental process performed solely in the human mind.” This would permit patents on methods that the law has never allowed—for good reason. Imagine going to the doctor because of persistent headaches. The doctor prescribes an MRI, examines the resulting image, and diagnoses you with brain cancer. Under the Tillis bill, that is a patentable diagnostic method. Because it requires an MRI machine, it’s not performed solely in the human mind. No prohibition applies. Companies could patent practically any diagnostic method that requires non-mental steps like using an MRI machine or collecting blood samples.  

Existing law saves us from such absurd and dangerous patents. We know patents like these are dangerous because we’ve seen similar patents restrict access to health care and needlessly endanger human lives. For example, before the Supreme Court confirmed that human genes are not patentable, one company, Myriad, got patents on isolated forms of the BRCA1 and BRCA2 genes. These genes are associated with a particularly high risk of breast and ovarian cancer. Myriad’s patents gave it exclusive rights to make and use tests for these genes to give people information about their risk of developing cancer. As a result, tests for BRCA1 and BRCA2 were unnecessarily expensive and inaccessible while those that were available from companies other than Myriad gave people misleadingly incomplete information about their risk of getting cancer.  

That changed as soon as the Supreme Court confirmed that isolated gene sequences are not patentable. The day the decision came down, five laboratories announced they would offer their own tests for the BRCA genes. As a result, tests quickly became more affordable and life-saving health information became more accessible to women of all income levels. The decision also fostered a competitive and robust genetic testing industry that continues to flourish. The decision continues to benefit us today: it prevented anyone from patenting genetic variants of COVID-19 that could have impaired the development and accessibility of tests, vaccines, and treatments.

The Tillis bill would open the floodgates to patents we already know are harmful to public health. Doing so might benefit drug companies, but individual Americans will pay for those benefits with their money, autonomy, and health. Together, we have the power to stop that from happening: call your Senator’s office and tell them not to let companies patent your body or your mind.