BIO 2026: Biotech threatened by pressures on patent protection

At a time when U.S. biotech leadership is being challenged, the patent system that enables life-saving innovations is beset by a toxic stew of challenges.

There are concerted campaigns by commercial interests pushing myths about patents, pressures to change the patent system due to the quickly evolving nature of digital technology, and a political will on both sides of the aisle to chip away at IP protections in a misguided attempt to impact drug prices.

“It is an extremely concerning moment for IP, in particular for the biopharma industry, but in general for innovators in the United States,” according to Andrei Iancu, a former director of the U.S. Patent and Trademark Office (USPTO) and partner at Sullivan & Cromwell LLP. Iancu was a participant in a June 25 panel entitled “Patents in the Crosshairs: Confronting a Coordinated Assault on Intellectual Property,” one of several panels about IP at the 2026 BIO International Convention.

This situation represents a real threat to biotech, said Joe Franklin, Chief Legal and Policy Officer for the Biotechnology Innovation Organization (BIO) and the moderator of the panel.

“Patent law is very complicated, yet fundamental to the biotech industry,” Franklin said. “And it’s very difficult to work through some of these questions from a policy perspective because of that complexity. But it’s essential.”

Tom Stoll, Senior Director of Federal Government Affairs at Genentech, listed various threats to IP coming from regulators, legislators, and the courts. Proposed legislation that would offer harmful solutions to problems that are not really problems include four different types of laws addressing multiple patents, or “patent thickets”; legislation targeting “pay for delay” and “product hopping”; and legislation regarding “skinny labels” that seek to empower generics development by weakening IP protection.

Reasons for pressures on IP

As several panelists noted, some of the most vocal advocacy for weakening patents comes from Silicon Valley. Digital innovations become obsolete quickly, and those seeking to build new innovations based on existing programs do not want to wait 20 years for a patent to expire.

Another pressure, coming from both sides of the aisle, is the popular idea that reducing patent protections would be a way to make the drug industry more competitive and drive prices down, but this is a fallacy, panelists said.

“There’s a lot of people who believe that patents stifle competition. I would actually argue the opposite, for life sciences in particular, especially biotech, where the timelines to get to market and the cost to develop a product are extremely high,” said panelist Dede Willis, CEO of Orbit Geonomics. “The patents are actually increasing competition because they’re enabling new technologies to be funded and commercialized.”

Another fallacy behind weakening patents to reduce prices is the idea that drug makers set prices by themselves, said panelist Ipsita Smolinski, Founder & Managing Director of Capitol Street. She noted the impact that pharmacy benefit managers (PBMs), the 340B program, and other factors have on prices.

Potential solutions for patent reform

One approach to reducing pressure for patent reform from digital tech developers might be to create one system of shorter patents for software and another system providing the traditional protection prescription drugs need, according to Iancu.

“It would provide new and useful protections for those new technologies, but also leave the system alone – remove the pressure – for the technologies that need protection,” he explained.

It’s not an easy fix, according to Iancu. Achieving this kind of wide-ranging reform would be difficult and pose a lot of challenges, including for biotech innovations that involve digital innovation, he explained.

All the attacks on the patent system are happening at a time when many pro-patent lawmakers are retiring from Congress, according to Smolinski. She said it is important to educate the new lawmakers about the importance of patents. Also, drug companies themselves should add to the advocacy efforts being undertaken by BIO and other organizations.

“If we’re not engaging, we’re not doing our job,” she said.

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