Dallas patent attorney Chris Cauble recently spoke to Medtech Insight about potential changes to the U.S. patent code that could benefit software and medical device developers. 

Many patent attorneys, software developers, and medical device manufacturers are hopeful that 2020 will be the year that a new bill will address the long overdue struggle to patent software innovations in the U.S.

Much of the issue relates back to the 2014 Supreme Court ruling in Alice Corp v. CLS Bank International, which held that electronic methods and computer programs for financial-trading systems were not considered patentable because they were abstract ideas. Since the ruling, software developers across numerous industries have had a much harder time obtaining patents from the USPTO.

Meanwhile, a new offshoot of the medical device industry has emerged. Dubbed “digital health,” this new field provides significant overlap between medical and tech fields and includes cutting-edge software as a medical device (SaMD) products. The field is surging.

Members of Congress are currently drafting language that would help address the issues facing the digital health and other fields reliant on software patents. Led by Senators Thom Tillis and Chris Coons, the draft would update portions of Sections 100, 101, and 112 of the U.S. patent code.

Their bill would allow more flexibility in the kinds of technologies that are patent eligible, and would not automatically reject processes that are deemed abstract ideas or automating laws of nature.

“What Congress wants to do is get rid of all of the judicial exceptions that were created by the Supreme Court in the last couple of years that have thrown the patent system into turmoil,” says Cauble. “Basically, if it’s something that’s touched by human hands then it’s patentable, and the patentability issue will then move back to focusing on novelty and non-obviousness issues.”

The issues arising here certainly affect smaller companies who do not have the resources or experience to handle the intricacies of the current laws, but large companies are not immune from Alice, either.   

“Some of the larger medical device companies have run into this issue where they’ve had their patents invalidated, such as methods for diagnoses — methods that use human ingenuity to determine these naturally occurring correlations and then determine a diagnosis — that have been knocked out of patentability,” says Cauble.

Still, Cauble remains cautiously optimistic about the bill’s chances. “It’s one of those issues that isn’t as controversial as some of the other stuff that gets introduced,” he says. “If they can get it to committee, I can see it moving pretty quickly.”

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