How serious is the situation? Will the latest legislation improve things?
"America was the first country to recognize copyrights and patents in its constitution, and industries built on intellectual property produce over 40 percent of US GDP whilst supporting tens of millions of jobs.
Now, however, a handful of Supreme Court decisions have excluded entire categories of invention from patentability. US investment in diagnostic technologies fell $9.3 billion below expected levels, as a result of depriving American innovators of rights and protections enjoyed by their counterparts in Asia and Europe.
In one much-cited example, a molecular diagnostics company developed non-invasive prenatal testing that allowed fetal DNA to be collected from the mother’s blood, replacing invasive in-utero testing that risks pregnancy loss. The judge called it a “meritorious invention” but was compelled to invalidate patents because the circulating DNA is a natural phenomenon, and the test was well understood. The discovery was beyond the reach of patent eligibility. Competitors were immediately empowered to duplicate the technique.
The result has been a decline in innovation, ceding America’s global leadership in critical areas like medical diagnostics to our foreign partners and rivals. The bipartisan Patent Eligibility Restoration Act of 2025 (PERA) attempts to rectify this by clarifying what inventions can be protected under the US Patent Act Section 101. PERA is before the Senate Judiciary Committee and would define clear statutory exceptions to patentable subject matter that would replace broad and vague judge-made exceptions. ..."
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