For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge.
A growing source of competition is China, where science can move quickly and cheaply. The Asia Society—a global organization dedicated to understanding Asia’s role in the world—reported last year that Chinese biotechs recruit trial patients two to three times faster than their U.S. counterparts, and recent government reforms have dropped clinical trial approval timelines from 60 days to 30. Meanwhile, an analysis by GlobalData earlier this year suggested that trials in China are 50-60% cheaper than in the U.S.
It means that so-called fast followers in China can have a significant advantage if they can identify and build on innovations emerging from slower, more expensive regulatory environments.
Lawyer Dean Farmer, Ph.D., who advises small and midsize biotechs on patent strategy, said he often meets with biotech leadership teams to coach them on how to keep parts of their pipeline under the radar—or even misdirect competitors.
This is more typically required for especially competitive indications or modalities, and Farmer suggested that even companies operating in stealth mode can inadvertently reveal key signals. Conference abstracts, C-suite messaging, listings on the federal trials database, and even hiring patterns can offer clues about a company’s R&D direction and timeline.
“A lot of companies think they’re in stealth when they’re not,” Farmer said. “When I worked for a fund, part of our R&D strategy was to monitor competitors and begin filing early patents based on signals—even without knowing the exact chemistry.”
Omar Khalil, managing partner at early-stage life sciences VC firm Santé Ventures, also voiced the anxiety that being too open about your research can increase the risk of someone beating you to market.
“The concern is that things take longer here in the U.S., and if you publicize what you're doing, it may lay the path for somebody to follow you or do something similar,” Khalil said.
“If they can do it faster and cheaper, you're creating competition for yourself,” he added.
Khalil cited the example of Pheast Therapeutics as a cautionary tale of how this process can play out. The biotech was launched on the back of work by Stanford researcher Irv Weissman, Ph.D., who had published a paper in Nature in 2019 describing the CD24 signaling pathway as a promising target for cancer immunotherapy.
This line of research would eventually lead to Pheast launching a phase 1 study of its anti-CD24 monoclonal antibody, PHST001, for solid tumors in April 2025. But by that point Shanghai-headquartered Antengene had long claimed the prize of taking the first CD24 drug into the clinic courtesy of its own candidate, called ATG-031, which entered phase 1 in 2023.
Farmer also pointed to the rush into the PD-1 inhibitor space in recent years as a prime example of how biopharmas will scramble for an exciting modality.
“What I started seeing over and over again was competitors showing up before they should have been able to,” Farmer said. “Not with the same asset, not with the same data—but positioned. And that forces a different question: how did they get there first?”
So how should small biotechs protect their fledgling therapies from unwanted competition?
Farmer said it begins with a comprehensive patent strategy—ensuring coverage not just for your core asset, but for adjacent scientific territory as well. He advises clients to consider related pathways or variations on their central idea and file additional patents to cover those possibilities.
In fact, Farmer said he will sometimes advise a company to “head fake” by submitting a cheap patent filing on an asset or program that the company knows it is going to kill in order to misdirect any fast followers.
“People see that you publish quickly, which is a signal that usually means it is important,” he explained.
While biotech leaders can’t outright lie, they can use their public statements to highlight a lower-priority candidate and throw off competitors who are watching closely.
Daniel Shores, a patent lawyer who founded Rothwell Figg’s Boston office, agrees that robust patents are critical. Shores has written about IP litigation, including disputes surrounding COVID-19 vaccines—an area marked by intense fast-follower activity.
“You want to go for the broadest possible claims in your patent,” he told Fierce. “If you're the first entrant, that's your greatest opportunity.”
“While competing companies may want to build on your idea, if your claims are strong enough to cover the foundational technology, they won’t be able to,” Shores added. “The biotech market in the U.S. is a blood sport.”
In addition to building a robust patent bulwark, biotechs have to exercise caution with their public communications. Statements from executives or investors can inadvertently reveal strategic direction.
Farmer reflected on a CEO client who went off-script during a conference presentation, accidentally name-dropping an asset that the company was working on but hadn’t yet protected with a patent. Farmer said he remembers fielding calls from people at the conference about the CEO’s comments and later discovered that a competitor had filed a patent for a similar drug soon afterwards.
While Farmer can’t say for certain that the CEO’s comments were directly responsible for the patent filing, he cited it as an example of how biotech leaders need to be intentional in their actions to navigate a hyper-competitive environment.