5:37 PM
May 09, 2019
 |  BC Innovations  |  Product Development

Congress pushes to reform patent eligibility, biotechs say not enough

Hopes for revitalizing diagnostics are on hold, as biotechs ask Congress for bigger patent reforms.

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 hope when a bipartisan, bicameral group released a framework to reform Section 101.

The framework released by Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.), plus Representatives Doug Collins (R-Ga.), Hank Johnson (D-Ga.) and Steve Stivers (R-Ohio), is a step in the right direction, but in its effort to avoid opposition from the tech industry, it fails to address the issues it set out to solve for biotech, according to Michel, three IP attorneys, and a biotech representative who spoke with BioCentury.

But they said there are ways to revise the framework to make more diagnostic inventions patentable without creating new issues for tech companies, and the forward momentum is cause for optimism.

Coons and Tills are soliciting feedback on the framework, and revisions will be discussed at a roundtable discussion this month.

101 complications

Biotech's problems with Section 101 began when a series of Supreme Court decisions narrowed the scope of patentable inventions to exclude three categories: laws of nature, natural phenomena and abstract ideas.

Conflicting court decisions regarding Section 101 added onto the problems.

Two of the most controversial Supreme Court rulings involved diagnostics and personalized medicine.

In the 2012 Mayo Collaborative Services v. Prometheus Laboratories Inc. ruling,...

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