A few weeks ago, several public interest organizations including the Public Interest Patent Law Institute (PIPLI), the American Civil Liberties Union (ACLU), Electronic Frontier Foundation (EFF), Generation Patient, Public Citizen, and the R Street Institute sent a letter to U.S. Senators Dick Durbin, Chris Coons, and Thom Tillis, as well as U.S. Representatives Darrell Issa and Zoe Lofgren raising concerns with S. 2140, the Patent Eligibility Restoration Act of 2023 (PERA). PERA would take the radical step of authorizing patents on products of nature, natural laws, and abstract ideas for the first time in our country’s history. Patent eligibility limits are critical to American innovation, economic prosperity, and public health and PERA would jeopardize progress in these areas.
Natural materials and general concepts are not themselves inventions, but rather, the foundation of knowledge upon which inventions are constructed. For that reason, the Supreme Court has for over a century held that they belong to “the storehouse of knowledge of all” people, and must therefore be “free to all” and “reserved exclusively to none.” Limits on patenting foundational aspects of nature and knowledge are necessary to ensure “that patent law does not inhibit further discovery by improperly tying up the future use of these building blocks of human ingenuity.” Removing these limits now would allow companies to acquire exclusive rights to aspects of nature and information about our own bodies—a dangerous step into uncharted territory.
Of particular concern is a bill that would authorize patents on isolated human genes, such as those associated with conditions like cancer, Alzheimer’s disease, and muscular dystrophy. PERA would similarly authorize patents on isolated genes from other biological organisms, including pathogens, such as COVID-19. It would also authorize patents on any use or transmission of the information these genes convey, allowing the Patent Office to grant corporations exclusive rights to the use of life-saving medical knowledge that could help diagnose and treat people who are currently suffering, as well as to predict our risks of developing diseases in the future.
Some contend that the bill’s provision against patenting an “unmodified human gene” as it “exists in the human body” effectively mitigates the enormous harms that would result from a return to patenting human genes. Not so. Isolated genes fall outside that narrow provision because they are modified and do not exist as such in the human body. In fact, this exclusion would have no practical effect because it is impossible to use unmodified genes “as they exist in the human body,” including for medical diagnostics and other types of testing.
Patents on genetic information and uses thereof will not only limit the availability of current medical diagnostics and treatments, they will also restrict the availability of future health innovations. These patents would empower their owners to block competition from those who would otherwise offer more effective or affordable tests and treatments. This exclusionary power would, in turn, deter researchers from developing new tests and treatments for life-threatening and debilitating conditions, like cancer and Alzheimer’s disease. The result will be medical care that is more expensive, less innovative, and less accessible than it is today.
We can predict what will occur because we know what happened before the Supreme Court made clear that isolated genes are not eligible for patenting in its 2013 decision, Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad). Before that decision, one company, Myriad Genetics, had patents on isolated genetic mutations, which are highly correlated with breast, ovarian, and prostate cancers, and it used them to prevent other laboratories from developing or offering their own tests, including some which were more comprehensive and accurate.
The Supreme Court’s decision led to the invalidation of Myriad’s patents and benefited the diagnostics industry and patients almost immediately. The day the decision issued, five different laboratories announced they would provide tests for those mutations at significantly lower prices. The decrease in price—from $4,000 to between $1,000 and $2,300—and availability of tests from different providers significantly improved both the accessibility and efficacy of testing. Similar benefits were felt across the diagnostic industry as investment exploded from $6.21 billion in 2013 to over $17 billion in 2018, and a wide range of new tests for genetic conditions became available.
The joint letter opposing PERA directly addresses testimony provided at a recent Senate hearing on patent eligibility. For example, it describes a recent ACLU study showing that current patent eligibility law is clear, consistent, and predictable. According to the study, from 2013 through 2020, the Federal CircuitSee CAFC affirmed patent eligibility decisions at a higher rate than the circuit’s average and at a higher rate than validity decisions under other sections of the Patent Act. Some practitioners may not like the outcomes of patent eligibility decisions under existing law, but the evidence leaves no doubt that those outcomes are consistent and predictable.
At the hearing, many references were made to other requirements of the Patent Act, such as the requirement of non-obviousnessA requirement for patentability based on 35 U.S.C. § 103 of the Patent Act. An invention cannot be an obvious variant of something that is already known, that is, the invention must not be obvious to a "person having ordinary skill in the art" (PHOSITA). Also known as an "inventive step" outside the United States., but none of them can do what the patent eligibility requirement does: prevent patents from issuing on products and laws of nature that are new discoveries, but not human inventions.
For example, eligibility law currently prohibits a patent on the isolated gene sequence of a new COVID-19 variant with unexpected properties that developed through naturally occurring mutations. Because that variant is new and its properties are unexpected, it would not be disclosed or rendered obvious by prior work in the field. Nevertheless, the variant, and its genetic information, is a product of nature rather than a human invention.
In addition, eligibility is unique because district courts can decide patent eligibility as a question of law without resorting to expert testimony or evidence beyond the patent. As a result, meritless cases can be resolved at an early stage before huge sums of money are wasted on attorney’s fees and other litigation costs. The difference for wrongly accused defendants is enormous: motions to dismiss are decided before discovery or trial, and thus before hundreds of thousands, and more often, millions, of dollars in litigation costs are accrued.
Wiping out 150 years of case law will set the stage for countless legal battles yet to be fought while putting patients at risk of losing access to genetic information that could save their lives. With no competition, patients, payers, and health care agencies will see higher prices for less innovative testing and treatment. Big pharmaceutical companies may reap higher profits, but the American people would pay an incalculably heavy price.
We must keep working to protect patent eligibility law and all of the innovation, prosperity, and medical access it makes possible.
