After a number of roundtable discussions and three hearings with eight hours of testimony from 45 diverse witnesses, Sens. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) said their bill to correct the U.S. Supreme Court's stifling patent eligibility rulings needs some refinement before it's officially introduced in the House and Senate.

In the final Senate subcommittee hearing on the draft bill Tuesday, Tillis outlined four issues that need to be addressed as they work on the final bill – clarifying definitions for key terms such as "utility" and "fields of technology," rethinking proposed changes to functional claim requirements under § 112(f) of the Patent Act, enhancing the research exemption and countering what Tillis called a false and misleading narrative put out by the American Civil Liberties Union (ACLU) and its allies that the bill would allow patents on human genes.

"We're not going to touch your genes, ACLU. So problem solved," Tillis said. He pointed out that if a discovery or invention isn't new, it can't be patented. "We all know that the human genome has actually been mapped. It's available for public use. So let's stop what I consider to be efforts to derail what we're doing," Tillis added, as he invited those who don't want to reform the patent eligibility threshold to work with lawmakers to make the bill better.

"I want to do this quickly," Tillis said. His plan is to introduce a final version of the bipartisan bill after the July 4 congressional recess.

The goal of the bill is to address the uncertainty created by the Supreme Court in its decisions in Bilski, Mayo, Myriad and Alice about the scope of what is eligible for patent protection. In narrowing that scope, the court has made it more difficult, if not impossible, to patent diagnostics, personalized medicine advances and uses of artificial intelligence (AI) and quantum computing.

According to testimony presented last week in the first two hearings before the Senate Judiciary Subcommittee on Intellectual Property (IP), the court's decisions have transformed what was a threshold patent eligibility question into the end-all and be-all of patentability, slamming the door on U.S. patents for inventions and discoveries that are granted patents elsewhere. (See BioWorld, June 6, 2019.)

Much of the concern has been in the sphere of diagnostics, which have been all but closed off to patents because of the Supreme Court's decisions that effectively removed discoveries, such as associations between genes and disease, from the patent realm because of their basis in nature. Coons noted that some stakeholders have suggested the solution to the court's precedence should be narrowly confined to diagnostics.

That's not enough, responded Laurie Hill, vice president of IP at Roche Holding AG's Genentech Inc. Today's breakthroughs in medicine rely on mimicking the body's natural functions and responses, combining AI with bioinformatics, utilizing the microbiome and harnessing the power of real-world data. But under the Supreme Court's expansion of what constitutes abstract ideas and natural phenomena, all of those advances could be ineligible for patents, Hill said.

Think of the future

In reforming § 101 patent eligibility, Congress needs to think about future technologies as well, said Gonzalo Merino, vice president and chief IP counsel for Regeneron Pharmaceuticals Inc. "We're at the cusp of innovation in this area, and the law should not be in the way," he told Coons and Tillis.

Corey Salsberg, vice president and global head of IP affairs at Novartis AG, echoed that sentiment. U.S. patent "eligibility law is on a collision course with the future of medicine," he said. But it's not just a problem for the future; it's already happening.

Novartis' patent claims for a new digital microscope for use in ophthalmic surgery were found ineligible on the grounds that a physical primary lens coupled with an image sensor is an abstract idea, Salsberg said. The company's claims to a specific laser device system applied to a human tissue region in surgery, coupled with a control computer to calculate tissue gas levels and adjust the lasers as needed, also were rejected as an abstract idea. And its claims to a novel osteoarthritis treatment made up of a modified protein was considered an ineligible natural phenomenon, even though the sequence differed from any natural protein and the desired medical effect was present only with the modified product.

Since the Supreme Court's decisions earlier this decade, "'laws of nature,' 'natural phenomena' and 'abstract ideas' – once constrained to the types of universal constants that almost everyone agrees should not be patent-eligible (e.g., 'a new mineral discovered in the earth,' 'a new plant found in the wild,' 'E=mc2' and 'the law of gravity') – have become so untethered from their sensible origins that we no longer know what they mean," Salsberg said.

Those who oppose patent reform in favor of the status quo claim broadening patent eligibility would lead to deeper patent thickets, resulting in longer monopolies and higher prices. And if diagnostics companies could patent discoveries of gene-disease associations, they could block research on the genes and confirmative testing, such as Myriad Genetics Inc. did with the BRCA genes, the opponents have said.

Hindering innovation

Tillis and Coons said they have no intention of overruling the court's central holding in Myriad, which established that genes, as they exist in the human body, are not eligible for patent protection. But they want to support research into the natural world that could produce groundbreaking, patentable cures, diagnostics and other advances.

They recognized that a line needs to be drawn to encourage innovation and discovery without restricting research into creative ways to build on those discoveries.

Maintaining the status quo would hinder innovation, several witnesses testified Tuesday, as it could discourage investment or push innovation to China and Europe, where patents are available on such discoveries and inventions. Another option is that, if denied patents, companies will hold their discoveries and patents as trade secrets that would never be disclosed.

"Without patents, people will turn to trade secrets, which I think we can all agree are the nemesis to transparency," said Robert DeBerardine, chief IP counsel for Johnson & Johnson.

David Spetzler, president and chief scientific officer for Claris Lifesciences Ltd., agreed. The current system "is incentivizing us to keep secrets," he said, and that is detrimental to future innovation. By requiring inventors to share their discoveries and inventions, patents facilitate and advance R&D, he added.

Without valid patents, companies likely would be reluctant to collaborate or partner on future innovations, as there would be no way of protecting their current IP, said Manny Schecter, chief patent counsel for IBM.