Opinion: The U.S. must fix its innovation engine: the patent system

If your car starts to smoke and sputter, you’d take it to an auto repair shop right away. The U.S. patent system — the engine driving the country’s innovation economy for more than 200 years — is sputtering and smoking. Yet its path to the mechanic is being blocked by an inane Supreme Court ruling.

American innovators are no longer promised reliable and effective rights for the fruits of their labors. In 2014, the Supreme Court reinterpreted laws that have been enacted by Congress since 1790 and created a stricter test for receiving patents for innovations in health care and high tech. This test makes it incredibly easy for the U.S. Patent and Trademark Office (USPTO) to reject applications, or for judges to invalidate patents already granted by the office.

The Supreme Court’s two-step test requires, first, that a patent does not cover an abstract idea or law of nature, like Einstein’s discovery of E=mc2. Abstractions like it are not patentable technologies — the “useful arts” that the Constitution authorizes Congress to promote with the patent laws. In the second step, if an application does claim an abstract idea, it might still be valid if it contains an additional “inventive concept” that applies this abstraction in an eligible technology. For example, physicists Enrico Fermi and Leo Szilard applied E=mc2 to invent a nuclear reactor, for which they received a patent in 1955.

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Since 2014, courts have used the Supreme Court’s tests to find numerous discoveries or inventions to be abstract ideas. Applying them, courts have invalidated more than 1,000 issued patents. The impact at the USPTO has been even greater: prospective patentees have abandoned more than 60,000 applications.

This has hit the biotech sector particularly hard. Life-saving medicines and treatments — the results of decades of research and billions in investments — are now routinely denied patent protections. In one study, 47% of abandoned applications in the life sciences were for treatments of diseases like cancer, Alzheimer’s, diabetes, and heart failure.

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In one significant case, a federal court invalidated a patent on a groundbreaking prenatal diagnostic test that used a mother’s blood to check for genetic disorders in her baby. This test made the invasive procedure of amniocentesis unnecessary, eliminating higher risk of miscarriage from the procedure and saving newborns from suffering and death due to lethal genetic conditions. This innovative medical test was born of the biotech revolution that started in the early 1980s and was supported by the patent system. The biotech company asked the Supreme Court to reverse the cancellation of its patent and reconsider the 2014 legal test that had spawned this — and many other — tragedies for innovators. The court declined to take the case.

Many industrial and mechanical inventions are also regularly denied patent protections. In one notorious case, a court invalidated a patent on a new method for making a better automobile axle.

A bipartisan reform effort underway in Congress aims to amend the law and nullify the Supreme Court’s test for patentable inventions. Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.) have released a draft bill to reform patent laws. In an unprecedented commitment of time and energy to a single issue in patent law, they held three days of hearings in June 2019 with 45 witnesses. I was one of them. Representatives from biotech and high-tech companies, former judges, former government officials, and scholars overwhelmingly testified to the pressing need for reform.

But the reform effort has stalled. A primary reason is misleading rhetoric by reform opponents, who prefer a weakened patent system. Big Tech companies use the smokescreen of a fight against “patent trolls” to protect the status quo, which offers them easy access to new technologies left unprotected by patents.

Opponents also argue that this reform effort seeks to revive patents on human genes, which the Supreme Court banned in 2013. This argument has paid off, inciting health care and civic groups like the American Civil Liberties Union to oppose the reform movement in a mistaken belief it would help patients. Given its effectiveness as political rhetoric, reform opponents keep resurrecting this claim; one recent op-ed accused reform advocates of seeking to “revive gene patenting.”

But that charge is false. At the hearings, Coons stated on the record: “Our proposal would not change the law to allow a company to patent a gene as it exists in the human body.” Tillis also criticized this “false narrative” infecting the discussions and undermining the reform effort. He stated that “we do not intend to patent human genes.” In their op-eds and articles, reform opponents have not quoted a single reform advocate who says it will bring back human gene patents, confirming that this is indeed a false narrative.

The United States was once recognized as having the world’s gold-standard patent system. David Kappos, a former director of the U.S. Patent and Trademark Office, has said that the U.S. patent system was “the greatest innovation engine the world has known.” False claims about reviving gene patents should not be allowed to derail a crucial effort to get this vital innovation engine firing on all cylinders again.

Adam Mossoff is a patent law expert and law professor at George Mason University and a senior fellow at the Hudson Institute.

Source: STAT