IANCU
From page A4
netic therapies.
Finally, in 2014, the court ruled in Alice Corp v. CLS Bank International that novel banking methods, because they are 'abstract ideas,' were ineligible for patents. The case, alongside Bilski, was widely interpreted to restrict patent eligibility for software applications.
In all these cases, the Supreme Court muddied the waters by introducing elements of the U.S. Code governing the tests for whether an invention deserves a patent — including questions of novelty, obviousness and specificity — into the more basic question spelled out in Section 101 of the code about inventions eligible for patent consideration at all.
For example, the court has held that, because anyone can make an observation, inventions based on observations aren't patentable. Yet invention is always about making observations.
It will take a change in the law to set matters right. That's the gap the Patent Eligibility Restoration Act (PERA) fills.
PERA removes ambiguity and uncertainty by stating that an invention is eligible for patent consideration unless it falls into certain specifically restricted categories.
PERA rules out patents on genes, but it doesn't rule out patent eligibility for innovative systems to isolate and purify them outside the body, which are essential to developing genetic therapies. Likewise, PERA specifies that biomarkers — knowledge that certain genetic sequences indicate risk of disease — are ineligible for patents. But the specific use of innovative biomarkers in tests is eligible.
Note that eligibility is just the threshold. To earn patent protection, an invention must meet additional, well-established criteria of novelty, nonobviousness and complete description. But whole categories of inventions will no longer be deemed ineligible based on standards developed for the additional tests.
By reasserting congressional authority over patent eligibility rules, PERA would provide the certainty needed to restart investment and restore U.S. leadership across multiple spheres, from biomedicine to computer science.
Andrei Iancu served as the undersecretary of Commerce for intellectual property and director of the U. S. Patent and Trademark Office from 2018 to 2021. He is cofounder and co- chairman of
the Council for Innovation Promotion.
