America’s first patent statutes date to the 18th century, when steam engines and cotton gins were cutting-edge. The law that defines what inventions are patentable was written in 1793, and its operative language has not been substantively revised since. It’s little wonder, then, that in recent years, confusion has reigned over what can and cannot be patented.
The Constitution calls on Congress to “promote the progress of science and useful arts” by securing exclusive rights for inventors. But how should that apply to genetic blood tests that detect disease biomarkers? What about software that allocates bandwidth across a 5G network? Or artificial intelligence?
Under current law, the answers aren’t clear. The Supreme Court has stepped in to try and craft workable rules, but has only confused matters further. Only Congress can adequately clarify our patent laws, and the time to do so is now — before we lose any more of our global competitive edge.
A brief review of how the Supreme Court has clouded the question over the past 15 years reveals how critical it is to proceed.
In the first of four key cases, 2010’s Bilski v. Kappos, the court held that a finance firm’s method for reducing risk in commodities trading was ineligible for a patent. But the court didn’t clarify which, if any, new business processes are eligible.
Next, in Mayo v. Prometheus, SCOTUS determined that medical diagnostic tests aren’t eligible for patents on the supposed grounds that mere measurement and observation of physical qualities isn’t enough. The decision gutted investment in testing research, ceding ground to inventors and developers in countries like China and South Korea, where such patent protections apply to medical devices created for the purpose of diagnosis.
Then came Association for Molecular Pathology v. Myriad Genetics, which ruled ineligible for patents all human genetic sequences that occur naturally — including those isolated outside the body in order to develop new genetic therapies. Once again, the court’s ruling disrupted an entire avenue of research, this time in gene editing.
Finally, in 2014, the court ruled in Alice Corp v. CLS Bank International that novel banking methods, because they are “abstract ideas,” were ineligible for patents. The case, alongside Bilski, was widely interpreted to restrict patent eligibility for software applications.
In all these cases, the Supreme Court muddied the waters by introducing elements of the U.S. Code governing the tests for whether an invention deserves a patent — including questions of novelty, obviousness and specificity — into the more basic question spelled out in Section 101 of the code about inventions eligible for patent consideration at all.
For example, the court has held that, because anyone can make an observation, inventions based on observations aren’t patentable. Yet invention is always about making observations.
Just look to Thomas Edison, who scoured the world making observations about what happens to a substance through which an electrical charge passes in a vacuum. He observed that doing so with a bamboo filament produced bright light. Eureka, the light bulb — developed inseparably from observation. If patents are to mean anything, surely discoveries like Edison’s must be eligible.
In 2019, on my watch, the U.S. Patent and Trademark Office issued guidelines that clarified many of these eligibility issues for patent officials. But the courts aren’t bound by executive branch procedures, and the confusion stemming from these Supreme Court decisions still governs in lower courts hearing cases on patent challenges and infringement.
It will take a change in the law to set matters right. That’s the gap the Patent Eligibility Restoration Act (PERA) fills.
PERA removes ambiguity and uncertainty by stating that an invention is eligible for patent consideration unless it falls into certain specifically restricted categories. It also indirectly instructs the courts to refrain from second-guessing on Section 101 ineligibility beyond the specified restrictions.
PERA rules out patents on genes, but it doesn’t rule out patent eligibility for innovative systems to isolate and purify them outside the body, which are essential to developing genetic therapies. Likewise, PERA specifies that biomarkers — knowledge that certain genetic sequences indicate risk of disease — are ineligible for patents. But the specific use of innovative biomarkers in tests is eligible.
Note that eligibility is just the threshold. To earn patent protection, an invention must meet additional, well-established criteria of novelty, non-obviousness and complete description. But whole categories of inventions will no longer be deemed ineligible based on standards developed for the additional tests.
By reasserting congressional authority over patent eligibility rules, PERA would provide the certainty needed to restart investment and restore U.S. leadership across multiple spheres, from biomedicine to computer science. That’s just what American innovation needs.
Andrei Iancu served as the undersecretary of Commerce for intellectual property and director of the U.S. Patent and Trademark Office from 2018 to 2021. He is co-founder and co-chairman of the Council for Innovation Promotion.
