Dole, Bayh bipartisan collaboration 40 years ago unlocks commercial potential of federal research

TOPEKA — Betsy de Parry was diagnosed in 2002 with an incurable form of non-Hodgkin’s lymphoma and initial chemotherapy treatments intended to slow progress of the disease were failures.

Her fate was altered when her oncologist, University of Michigan researcher Mark Kaminski, discovered and developed a breakthrough cancer therapy that saved her life. The treatment directly attacking cancer cells was available in part due to enactment Dec. 12, 1980, of a patent and trademark reform law sponsored by U.S. Sen. Bob Dole, a Kansas Republican, and U.S. Sen. Birch Bayh, an Indiana Democrat. It’s referred to as the Bayh-Dole Act and was a lasting achievement in the lame-duck days of President Jimmy Carter’s hold on the White House.

The law facilitated creation and commercialization of a wide range of everyday products, but of significance to de Parry it included development of more than 200 new medicines.

De Parry recalled that she and her husband, Alex, cried as the drugs flowed into her body. It felt like an injection of hope. Ten years ago, she was able to personally thank Bayh, who served in the U.S. Senate from 1963 to 1981.

“No words could express the gratitude and joy that my husband and I feel every day,” said de Parry, who is cancer free 18 years later. “The fruits of this bipartisan legislation really are counted in the multitude of people, like me, who are living normal, healthy lives.”

In 40 years under the University and Small Business Patent Procedures Act of 1980, the public research-and-development sector has been revolutionized. It enabled universities, small businesses and nonprofits that received federal grants to retain ownership of patented inventions and license those patents to private firms. These start-ups were better positioned to turn promising laboratory concepts into marketed real-life products. The royalty revenue also helped draw private-sector investment to the process.

The federal government had accumulated at least 28,000 patents prior to enactment of the Bayh-Dole Act. Less than 5% of these patents were licensed commercially, meaning good ideas were sitting on the shelf. Patents had piled up since World War II as President Harry Truman led the charge to increase federal support on research. But the government’s policy was to retain title to inventions and to issue nonexclusive licenses to businesses.

Instead of hoarding patents in Washington, D.C., and clogging the commercialization pipeline, the 1980 law has expanded U.S. economic output by $1.7 trillion, supported 5.9 million jobs and launched more than 13,000 start-up companies.

Lame-duck maneuvering

Bayh, who died in March 2019, and Dole were convinced the period of transition from Carter to President-elect Ronald Reagan didn’t have to be wasted. They collaborated to remove partisan roadblocks to the patent overhaul. Staff members of both lawmakers dealt with House and Senate objections to the bill, which also authorized federal agencies to grant exclusive licenses to inventions already held by the government.

Bayh had lost a re-election campaign as did Carter, but Dole made sure the Reagan administration appreciated the economic and scientific potential of the law.

Dole said lives were changed — including de Parry’s — by incentivizing work of pharmaceutical companies to bring to the table more than 200 medicines. He said the same framework could prove useful for companies working on COVID-19, because federal agencies supporting their research won’t be waiting on the sidelines to capture the findings and inhibit private industry from moving ahead with product development.

“I was proud to partner with Birch Bayh, who really spearheaded the legislation,” Dole said on a webinar tied to the 40th anniversary. “Served us well since it’s passage, but it’s taken a great deal of work to protect it.”

Chris Bayh, son of the former U.S. senator, said his father viewed the Bayh-Dole Act as one of his most significant accomplishments because of the impact on science. It proved political bipartisanship isn’t a dirty word, he said. It also showed what can get done by determined elected officials and their staff in Washington against the ticking clock of a presidential transition, he said.

“That lesson was that the work and dedication and determination of just a few people, especially a few young people, make a huge difference in the lives of so many,” Chris Bayh said.

Joe Allen, who served as a staff member for Sen. Bayh in 1980, said the alternation of federal law was necessary to reverse the country’s slide into industrial irrelevance.

He said the public and private sectors have worked together for four decades to translate basic scientific research into lifesaving drugs and medical devices, internet and GPS technologies, rechargeable lithium-ion batteries, and countless other innovations, especially in the life sciences.

“Bayh-Dole made the United States the engine of global innovation,” said Allen, who is executive director of a coalition celebrating the 40th anniversary. “The act reinvigorated research and development in America, spawning breakthrough discoveries ranging from high-yield crops to advanced medicines.”

Passage of the law during the lame-duck session wasn’t a given, because Senate rules required a unanimous vote. Carter signed the bill on the last day he was legally allowed to weigh in. There is lingering opposition to Bayh-Dole, he said.

“There are still those opposed. They’re trying to re-establish Washington micromanagement,” Allen said. “It’s still under attack. It could still disappear.”