Congress has taken the first step towards fixing a key problem with patent policy that has crippled the diagnostics industry and disrupted development of other life science inventions, but its proposed solution falls short for biotechs.
The problem lies in competing interests from tech and life science companies in Section 101 of the Patent Act, which defines the minimum threshold for patentable inventions.
The tech goliaths want to keep eligibility criteria narrow: their goal is to easily strike down inventors or competitors hoping to gain by patenting elements used in the big players’ software and products. Life science companies want wide eligibility, to protect inventions essential to making money in diagnostics and personalized medicine.
Through a series of conflicting Supreme Court decisions interpreting Section 101 over the past decade, patent eligibility criteria have become increasingly narrow.
“It's currently very difficult to get patents issued in areas like diagnostics and medical devices, and there's a huge cloud over previously issued patents because you can't predict which will survive an attack on eligibility,” said Paul Michel, former chief judge of the U.S. Court of Appeals for the Federal Circuit (CAFC).
The result, he said, is stifled innovation and redirected investment to countries with broader eligibility (see “101 Problems With Patent Eligibility”).
In April, Congress gave the hobbled diagnostics industry its first glimmer of