A Patent, a Blood Test, and 20 Years of Waiting
Ablood test now helps doctors decide, in about 15 minutes, whether a patient with a suspected brain injury needs a CT scan. It took about 20 years to get there.
That gap between scientific promise and clinical use tells us more about American innovation policy than most congressional hearings ever will.
At one such hearing earlier this week, members of the Senate Judiciary Committee returned to one of the most consequential and least understood questions in innovation policy. Which inventions qualify for patent protection? The hearing focused on S. 1546, the Patent Eligibility Restoration Act (PERA), Congress’ latest attempt to resolve more than a decade of confusion over Section 101 of the Patent Act.
The debate turned on statutory text, Supreme Court precedent, and competing theories of patent policy. Senators heard about abstract ideas, laws of nature, diagnostic methods, and judicial exceptions to patent eligibility. Those questions matter, but they can quickly drift away from the inventions and patients affected by them.
To see the stakes, the committee need look no further than a trauma bay at UPMC Presbyterian Hospital in Pittsburgh.
Physicians there can now use a blood test to help determine whether an adult with a suspected traumatic brain injury needs a CT scan. Instead of relying only on visible symptoms or sending every patient for costly imaging, doctors can measure two proteins released into the bloodstream after brain injury. Those proteins are glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1).
The test gives physicians objective biological evidence in one of emergency medicine’s most difficult diagnostic settings. Until recently, it remained a scientific aspiration.
Its 20-year path to patients captures both the strengths of the American life-sciences system and the institutional burdens that can slow it down. Abbott’s i-STAT TBI test emerged through university research, federal funding, patents, startups, venture capital, technology transfer, clinical trials, strategic acquisitions, Food and Drug Administration (FDA) review, and entrepreneurial judgment. It also encountered the uncertainty created by judicial decisions that narrowed patent eligibility for diagnostic inventions.
The history of the test reaches well beyond diagnostics. It shows how people and institutions make costly decisions under profound uncertainty to create knowledge that did not exist before. It also shows why innovation policy should be judged by whether it helps today’s discoveries become tomorrow’s treatments.