America’s first patent laws date from the 18th century, when steam engines and cotton gins were at the cutting edge. The law that defines which inventions are patentable was written in 1793 and its operational text has not been extensively revised since. It is therefore not surprising that in recent years there has been confusion over what can and cannot be patented.

The Constitution calls Congress to “promote the progress of science and useful arts” by guaranteeing exclusive rights to inventors. But how should this apply to genetic blood tests that detect disease biomarkers? What about software that allocates bandwidth on a 5G network? Or artificial intelligence?

Under current law, the answers are unclear. The Supreme Court stepped in to try to come up with enforceable rules, but only made things even more confusing. Only Congress can adequately clarify our patent laws, and the time to do so is now, before we further lose our global competitive advantage.

A brief review of how the Supreme Court has muddied the issue over the past 15 years reveals how critical it is to move forward.

In the first of the four key cases, that of the 2010s Bilski v. Kapposthe court ruled that the method used by a financial company to reduce risks in commodity trading was not eligible for patent. But the court did not specify which, if any, new business processes qualify.

Then, in Mayo versus PrometheusSCOTUS has determined that medical diagnostic tests are not eligible for patents on the grounds that simple measurement and observation of physical qualities is not sufficient. The ruling slashed 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 at diagnostic purposes.

Then came Association for Molecular Pathology against Myriad Geneticswhich ruled that all naturally occurring human genetic sequences, including those isolated outside the body in order to develop new genetic therapies, were ineligible for patenting. Once again, the court’s decision has disrupted an entire avenue of research, this time in the field of gene editing.

Finally, in 2014, the court ruled Alice Corp vs. CLS Bank International that new banking methods, because they are “abstract ideas”, were not eligible for patent. The case, like Bilski’s, has been widely interpreted as limiting patent eligibility for software applications.

In all of these cases, the Supreme Court muddied the waters by introducing elements of the U.S. Code governing the criteria for determining whether an invention merits a patent—including questions of novelty, obviousness, and specificity—into the question more fundamental set out in article 101 of the Code. code on inventions eligible for patent examination.

For example, the court ruled that because anyone can make an observation, inventions based on observations are not patentable. However, inventing always involves making observations.

Just think of Thomas Edison, who traveled the world observing what happens to a substance crossed by an electric charge in a vacuum. He observed that this with a bamboo filament produced a bright light. Eureka, the light bulb, developed inseparably from observation. If patents are to be meaningful, discoveries like Edison’s must surely qualify.

In 2019, under my leadership, the U.S. Patent and Trademark Office issued guidelines that clarified many of these eligibility issues for patent agents. But the courts are not bound by executive branch procedures, and confusion resulting from these Supreme Court decisions still reigns in lower courts hearing patent challenges and infringement cases.

It will take a change in the law to rectify the situation. This is the gap Patent Eligibility Restoration Act (PERA) fills up.

PERA eliminates ambiguity and uncertainty by stating that an invention is eligible for patent examination unless it falls into certain specifically restricted categories. It also indirectly asks courts to refrain from questioning ineligibility under Section 101 beyond specified restrictions.

PERA excludes patents on genes, but does not exclude patent eligibility for innovative systems for isolating and purifying them outside the body, which are essential for the development of genetic therapies. Likewise, PERA clarifies that biomarkers – the knowledge that certain genetic sequences indicate disease risk – are not eligible for patents. But the specific use of innovative biomarkers in tests is eligible.

Note that eligibility is only a threshold. To qualify for patent protection, an invention must meet additional well-established criteria of novelty, non-obviousness and complete description. But entire categories of inventions will no longer be considered ineligible based on standards developed for additional testing.

By reaffirming Congress’s authority over patent eligibility rules, PERA would provide the certainty needed to revive investment and restore American leadership in multiple fields, from biomedicine to computing. This is exactly what American innovation needs.

Andrei Iancu served as Under Secretary 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-chair of the Council for Advancing Innovation.

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