Unsurprisingly, major healthcare issues like abortion, drug pricing reform and care access have risen to the top of the conversation around the 2024 presidential election campaign.

However, a debate over a relatively obscure piece of legislation that would protect certain patents from government restrictions toils behind the scenes.

Last year, bipartisan Sens. Chris Coons, (D-DE), and Thom Tillis, (R-N.C.), introduced a bill dubbed the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. 

PREVAIL is designed to limit federal oversight of patent approvals – all in the name of fueling innovation and economic growth, the lawmakers argue.

The bill states that its purpose is to invest in inventors in the U.S. and protect the property rights of those inventors.

In effect, PREVAIL would limit the power of the Patent Trial and Appeal Board (PTAB), a federal tribunal established in 2012 that reviews patent applications and determines whether they’re viable. The board was specifically created to challenge wrongful patents.

The draft legislation would also allow companies to maintain patents on products that were already known or considered obvious to scientists in that respective field, as opposed to companies being required to limit patents to entirely original products.

PREVAIL was introduced in tandem with the Patent Eligibility Restoration Act (PERA), which would remove the requirement that a product be entirely the result of human activity rather than a natural process in order to receive a patent. 

As it relates to the pharma industry, this law could allow companies to patent isolated genes, for example.

Opponents of the bills argue that pharma companies would be able to hike up drug costs higher under the legislation, as well as find ways to prevent generic competition through so-called wrongful patents.

According to the Center for Strategic and International Studies (CSIS), PTAB was originally established to prevent actors “who abuse the patent system to eliminate and extort competitors” while also stifling innovation by “preying on start-ups, small businesses and inventors” that typically lack the resources to pursue a costly litigation option.

In a letter sent to congressional leaders this week, the Campaign for Sustainable Rx Pricing, an advocacy organization that includes healthcare providers and pharmacy benefit managers (PBMs), outlined its objection to the legislation.

The statement suggests the PREVAIL Act would limit the government’s “capacity to review patentability claims,” weaken the inter partes review process and strengthen the ability of brand-name drugmakers to extend “monopoly protections.”

“The PREVAIL Act would inevitably result in patients paying the high cost of brand-name prescription drugs for longer than even occurs today,” the organization stated. 

Despite the criticism, supporters of the bill — including Coons and Tillis — have argued that it would reform a system that drags down innovation and burdens companies with PTAB trials.

The text of the bill notes that the legislation would take aim at the unintended consequences of the 2011 reform of patent laws, which the bill sponsors claim drove down investment in innovation and “frustrate the purpose of those patent law reforms.”

The debate over the bill comes as the Federal Trade Commission (FTC) has spent the last year cracking down more on “sham patents” in the pharma industry. 

In particular, the FTC has sought to challenge more than 100 patents of drug products that it claims were improperly listed in the FDA’s so-called Orange Book, a resource of the drugs approved by the agency.