By Andrew Karpan

Law360 (March 8, 2021, 8:09 PM EST ) Four members on the U.S. Senate intellectual property subcommittee have told the U.S. Patent and Trademark Office that current eligibility rules are having "a dramatic negative impact" on aspiring patent owners, including medical researchers combating the ongoing coronavirus pandemic.

Half of the current eight members of the Senate Judiciary Subcommittee on Intellectual Property signed off on a letter to acting USPTO Director Drew Hirshfeld on Friday, saying that a lack of "consistency and clarity" in recent patent eligibility rulings are putting the country at "risk [of] losing our place as the global innovation leader."

"We can no longer continue to ignore the fact that current eligibility jurisprudence has had a dramatic negative impact on investment, research, and innovation," the senators wrote, including the subcommittee's ranking member Sen. Thom Tillis, R-N.C., and Sen. Chris Coons, D-Del.

Recent court decisions following the U.S. Supreme Court's last two major forays into the issue of patent eligibility "foreclose protection entirely" for certain fields in the life sciences sector, the lawmakers said. The two rulings the senators highlighted — Alice Corp. v. CLS Bank International and Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. — had tightened eligibility rules around inventions that merely cover abstract ideas and laws of nature, respectively.

The rulings in lower courts since have gone too far, the lawmakers said. They connected these issues to the efforts of researchers to create products that would better diagnose and combat cases of the novel coronavirus.

"At a time when the United States is struggling to contain and treat the worst global pandemic in more than one hundred years, it is simply astounding that current jurisprudence makes it virtually impossible to obtain many patents in the diagnostic methods and precision medicine sectors," they said.

Absent from the bipartisan group, however, was the subcommittee's new chair, Sen. Patrick Leahy, D-Vt. David Carle, a spokesman for Leahy's office, on Monday declined to comment on the letter, but told Law360 that "Chairman Leahy supports a strong and inclusive IP system that incentivizes innovation and protects creators."

After Leahy took over as subcommittee chair last month, legal experts told Law360 that the senator, who co-authored the Leahy-Smith America Invents Act in 2011, is likely to be less focused on clarifying patent eligibility laws than Coons or Tillis.

On Friday, the senators asked the patent office to publish a report on the current state of eligibility jurisprudence and have those findings back to the subcommittee within a year.

The letter from the senators came a day after a trade group representing patent owners, the Intellectual Property Owners Association, echoed those concerns in a public letter addressed to Leahy and Tillis, as well as to Reps. Hank Johnson, D-Ga., and Darrell Issa, R-Calif., who helm the Subcommittee on Courts, Intellectual Property and the Internet in the House.

"The jurisprudence … has detrimentally affected areas such as precision medicine & artificial intelligence and risks a chilling effect on further developments and investment in these critical technologies," the trade group said.

But the state of that jurisprudence may well change if the Supreme Court decides to wade into the deep divide among the full Federal Circuit about whether an American Axle driveshaft patent should have been invalidated for claiming a natural law. The justices have been wary of tackling the issue lately, turning down several eligibility cases last year, including one that had the backing of the U.S. Solicitor General.

Last week, the high court received no fewer than nine amicus briefs urging the justices to take it on this time, including one authored by Tillis, whose brief was co-signed by former Federal Circuit Chief Judge Paul Michel and former USPTO Director David Kappos.

Tillis, who chaired the subcommittee for two years before the last election, also voiced his concern over the issue back in January, telling the U.S. Chamber of Commerce that "patent eligibility jurisprudence is in shambles."

A representative for the USPTO told Law360 on Monday that "we look forward to working with the senators and others to assess the impacts of patent eligibility jurisprudence on innovation and investment."

--Additional reporting by Dani Kass and Ryan Davis. Editing by Nicole Bleier.

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