This September, the Patent Eligibility Restoration Act (PERA) was introduced in the United States (US) House of Representatives, following its introduction in the Senate in 2023. Much of the motivation for reform has centered around modifying the requirements for an invention to be eligible for patent protection to bring US standards for eligibility in line with the patent systems in Europe and China, as stated by the bill’s sponsors. In a press release documenting introduction of the bill in the House, Representative Kevin Kiley stated, “[t]he U.S. has one of the most restrictive patent systems in the world.” After reading through the bill itself, I was left a bit skeptical. Are these arguments coming from a place of truth? Would PERA be effective in accomplishing this goal? Could passage lead to harmful consequences, including within the life sciences field?
PERA sets out to overturn a series of Supreme Court decisions which tied the eligibility question to a demonstration of making improvements to technology. The so-called judicial exceptions which the court had held unpatentable – abstract ideas, laws of nature, and natural phenomena – are done away with in the act, and replaced by narrowly tailored categories of exceptions enumerated in the text of the statute itself. The result is a new eligibility standard that erases over a decade of Supreme Court jurisprudence and greatly expands the scope of patent eligibility.
Seeing as proponents of the bill have couched their support in terms of bringing United States patent protections up to speed with that of global peers, it’s worth asking – is this the reality? In the biotechnology and life sciences space, that doesn’t necessarily seem to be the case. China explicitly excludes medical treatment and diagnosis methods from patent protection, a marked difference from the US and one which the PERA standard only exacerbates. China also has more restrictions on the eligibility of genetic material for patent protection, whereas PERA would allow patent protection for all genetic material aside from “an unmodified human gene, as that human gene exists in the body,” which would render isolation of a natural gene sufficient to provide eligibility for protection. Eligibility for inventions involving human stem cells also differ among the two countries, with the US system being friendlier to patent applicants even by the current, non-PERA standard. Patent eligibility in Japan similarly excludes claims over surgery, therapy, and diagnostic methods, as does the patent system in parts of the European Union (though isolated human DNA is patent-eligible in the EU). Apart from comparisons to a select group of developed economies, many countries globally only recently established any kind of patent protection in the domain of life sciences and pharmaceuticals, doing so under the threat of being cut off from global trade should they refuse to do so. In short, PERA would likely entrench the US’ position as the friendliest nation on earth when it comes to biotechnology and life sciences patent rights, which could have dire consequences on innovation, competition, and health care access.
Although PERA risks facilitation of anticompetitive behavior and downstream harms to patients in the biotechnology area, the US patent system does preclude protection for many forms of “software” claims – which may include applications of artificial intelligence – as being directed toward abstract ideas. This is one area in which China has recently shifted policy to relax eligibility requirements and is an area in which eligibility would be similarly broadened under the text of PERA. If the goal is to match subject matter eligibility requirements with other intellectual property offices around the globe, perhaps some iteration of PERA could be a means to do so, given varying global eligibility frameworks and recent efforts of other offices in relaxing threshold requirements in targeted, specific technology areas. It begs the question, however, is this the right objective for the US patent system to strive for? What voices have been ignored in the debate over patent policy? PERA would be a victory for big tech, big pharma, and perhaps for some patent practitioners, but at what cost to the public?