Biotech is a frontier of life-changing ideas—new cures, diagnostic breakthroughs, and genetic tools that rewrite what’s possible in medicine.
But not every breakthrough can be protected.
Patent eligibility rules in biotech have long been confusing. Courts, lawmakers, and scientists often disagree on what kinds of inventions deserve protection.
And when protection is uncertain, investment slows. Risk grows. And entire areas of research get left behind.
This article explores how proposed reforms to patent eligibility could open new doors—or close them—for the future of biotech innovation.
Understanding Patent Eligibility in Biotech
What “Eligibility” Really Means
To get a patent, an invention has to meet several requirements.
It must be new. It must be useful. It must be non-obvious.
But before any of that, it must be eligible.
Patent eligibility is the first hurdle. It asks a basic question: Is this the kind of thing the law allows you to patent?
In most industries, this is straightforward.
But in biotech, it’s often anything but.
The Unique Challenge of Biotech Inventions
Biotech deals with life.
It involves genes, proteins, natural compounds, and biological systems.
Some of these things exist in nature. Some are slightly modified. Some are entirely engineered.
The problem is, courts have ruled that laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection.
That might sound reasonable. But in practice, it creates a gray area.
If a scientist isolates a gene sequence for the first time, is it a discovery—or an invention?
If a biotech company creates a diagnostic method based on a natural correlation, is that a patentable test—or just an unpatentable observation?
These questions have been debated for decades. And the answers are still evolving.
Key Cases That Shaped the Rules
The Myriad Decision
In 2013, the U.S. Supreme Court decided a major case: Association for Molecular Pathology v. Myriad Genetics.
Myriad had patented isolated DNA sequences related to the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer.
The Court ruled that naturally occurring DNA sequences, even when isolated, are not patentable.
Why? Because they exist in nature.
The ruling sent a shockwave through the biotech world.
Suddenly, a wide range of patents—based on isolated biological materials—were seen as vulnerable.
Companies that had spent years and millions of dollars developing tests were now unsure if they could defend their inventions.
Mayo and the Diagnostics Crisis
Another pivotal case was Mayo Collaborative Services v. Prometheus Laboratories (2012).
This case dealt with a method for determining the correct drug dosage based on how the body metabolizes certain compounds.
The Court struck it down, saying the process was based on a natural law—and that the additional steps were not “inventive” enough.
This ruling made it much harder to patent diagnostic methods.
Many biotech firms saw it as a death sentence for personalized medicine.
If observing how the body reacts to a drug is a “natural correlation,” and if no amount of practical application makes it patentable, how can any diagnostic tool be protected?
Since that decision, the number of new diagnostic-related patent filings has dropped. Investment in diagnostics has also declined.
Not because the science isn’t promising—but because the legal framework is too uncertain.
The Real-World Impact of Legal Uncertainty
Innovation With No Safety Net
Biotech companies often work on the edge of what’s known and what’s possible.
They explore how the body heals itself. How genetic mutations behave. How enzymes or proteins can be harnessed for therapies.
But when the rules around patent eligibility are unclear, that scientific exploration comes with added risk.
Imagine you spend ten years developing a blood test that identifies the early signs of a rare cancer.
You run trials. You collect data. You perfect the method.
But when you go to patent it, the examiner says: “This is based on a natural relationship. It’s not eligible.”
In that moment, your invention may still be real—but your business model collapses.
Investors walk away. Competitors copy freely. Your years of work offer no exclusive return.
This isn’t a rare situation. It’s one biotech innovators face every day.
And it explains why so many companies now hesitate to invest in diagnostics, biomarkers, or naturally derived treatments—even when the need is urgent and the science is sound.
Chilling Effects on Early-Stage Research
Patent eligibility doesn’t just affect the final product. It affects everything that leads to it.
Universities are especially vulnerable.
Academic labs often do the early research—the foundational discoveries that later become commercial breakthroughs.
But if that research can’t be patented, it’s much harder to fund. It’s harder to license. And it’s harder to attract partnerships with private industry.
This slows down the entire pipeline.
What begins as legal ambiguity at the patent office ends up suppressing the next generation of biotech invention.
Not because the science isn’t working—but because the system doesn’t protect the outcome.
Smaller Innovators Take the Hardest Hit
Large pharmaceutical companies have more tools to navigate complex IP systems.
They have in-house legal teams. They file in multiple countries. They hedge risk by building broad portfolios.
But smaller companies—especially startups—often have one or two core technologies.
They rely on those patents to raise capital, attract talent, and survive long enough to reach the clinic.
When eligibility is in doubt, those companies are exposed.
A single rejection, based not on novelty or usefulness but on eligibility, can end the venture.
This leads to a stark imbalance.
Big players continue. Small innovators disappear.
And with them, the bold, high-risk ideas that often move the entire industry forward.
Why Reform Is Back on the Table
The Growing Call for Clarity
For years, biotech and life sciences leaders have called for Congress to step in.
They argue that the courts have gone too far—and that the current interpretations of eligibility law are hurting not only innovation, but patients.
When diagnostic tools can’t be patented, they don’t get built. When biologic treatments can’t be protected, they get delayed.
And when the rules change every few years, companies pull back rather than push forward.
Several reform proposals have emerged in response.
Most aim to reset the boundaries of what’s considered patentable—especially in biotech, medical diagnostics, and AI-driven research.
The goal is not to allow everything.
It’s to draw clearer lines. To give inventors a path to protection if their work includes meaningful human ingenuity.
This is especially important in areas like synthetic biology, where natural and artificial systems blend.
Without reforms, these fields may never reach their full potential—not because the science is weak, but because the law is stuck in an older model.
Bipartisan Interest—and Bipartisan Tension
Interestingly, patent eligibility reform is one of the few areas that has seen bipartisan attention in recent years.
Lawmakers on both sides of the aisle recognize the stakes.
Biotech is not just about health. It’s about economic leadership. It’s about national security. It’s about preparing for the next pandemic—or preventing it altogether.
Still, the politics are tricky.
Some fear that broadening eligibility will lead to “patent thickets,” where basic scientific tools are locked up.
Others worry about ethics—especially when dealing with genes, embryos, or organisms.
These concerns are valid.
But the current system already fails on both fronts. It’s too narrow to support innovation and too vague to prevent abuse.
This is why thoughtful reform matters.
It must restore confidence without opening the door to monopolies on nature or knowledge.
And that balance starts with language—language that respects science, rewards invention, and provides real, reliable protection.
What Meaningful Reform Could Look Like
Redefining “Natural” in a Synthetic Age
At the heart of the problem is a definition—what counts as “natural”?
For decades, courts have treated naturally occurring materials, such as DNA sequences or metabolites, as unpatentable unless they are significantly altered. But in today’s biotech world, that line is too simplistic.
Many of the most valuable biotech inventions are not raw materials pulled from nature. They are highly engineered tools, processes, or molecules inspired by biology but created through human design.
Take CRISPR-based gene editing.
The building blocks may be natural, but the editing mechanisms, delivery systems, and use cases are often artificial and complex.
Under today’s legal framework, a small detail—such as whether something is “isolated” or “synthesized”—can determine whether it’s patentable or not.
That needs to change.
Reform should focus less on whether something has roots in nature and more on whether a human contribution has transformed it into something new, useful, and non-obvious.
This would better reflect the realities of modern biotech—and reward the innovation that happens at the edge of natural science.
Protecting Diagnostics Without Blocking Research
Another area ripe for reform is diagnostics.
Right now, many diagnostic methods are considered ineligible because they rely on natural relationships. For example, the idea that a certain biomarker level indicates a disease is viewed as a discovery, not an invention.
But identifying that marker, developing a reliable test, validating it clinically, and integrating it into a medical decision-making system—that’s real innovation.
Without patent protection, diagnostic developers struggle to secure funding. And without funding, the test doesn’t reach patients.
At the same time, critics worry that too much protection in diagnostics could block downstream research. If someone patents a gene or a method, others might be afraid to explore related ideas.
The solution isn’t to ban patents.
It’s to write them carefully.
Reform should include guidelines on claim scope—encouraging protection for applied methods while ensuring research use remains open.
This balance is possible. It just requires lawmakers and agencies to work closely with scientists and IP experts to write rules that reflect both innovation and access.
Why Biotech Needs This Reform Now
The Stakes Are Higher Than Ever
Biotechnology is not some far-off promise.
It’s here. It’s active. And it’s already saving lives.
We now use engineered proteins that can turn off cancer cell growth with surgical precision. We’re rewriting human DNA to prevent hereditary diseases before a child is even born. In laboratories across the world, scientists are growing real tissue from stem cells, using bacteria to digest industrial waste, and programming cells to behave like tiny, biological computers.
This is no longer science fiction—it’s daily reality in research institutions and startup labs alike.
But these breakthroughs don’t happen in a vacuum. They require time. Talent. And above all, funding.
No investor will commit tens of millions of dollars to a decade-long biotech project if they aren’t sure that the final product will be protectable. No startup will pour years into perfecting a diagnostic tool if it can be copied the moment it works.
Without strong, reliable patent protection, the risk becomes too great.
And when capital retreats, science slows. What suffers isn’t just the pace of innovation—but the quality of life, and sometimes the chance to save it.
Reform isn’t a luxury. It’s a necessity.
If we continue to deny protection to some of the most promising biotech inventions simply because they’re built on biological insight, we don’t just slow down the market—we stall out the future.
We lose more than potential revenue. We lose health solutions. We lose tools to improve global food security. We lose methods to clean air, water, and soil. We lose a chance at climate resilience.
Patent eligibility reform is not just a matter for policy scholars or attorneys.
It’s about whether we build the world we’re capable of creating—or let it slip through our fingers.
The Global Competition Is Moving Fast
Innovation doesn’t pause because one country has ambiguous laws.
While U.S. inventors are navigating outdated interpretations of patent eligibility, other nations are sprinting forward.
China, for example, has made biotech a national priority. It has introduced aggressive R&D subsidies, built dozens of biotech-focused innovation zones, and streamlined its patent process to favor clarity and speed—especially in emerging tech and life sciences.
In China’s patent system, rules on eligibility are clearly defined and updated in coordination with industrial policy goals. This predictability gives inventors confidence—and investors the reassurance that their returns will be protected.
The European Patent Office (EPO), though known for its conservative approach, offers more consistency than the current U.S. system. In key biotech areas like diagnostic testing and biological processes, the EPO provides a clearer path to patentability—even if that path is narrow.
What does this mean in practice?
It means that when U.S. biotech companies develop something novel, they’re increasingly filing first overseas. They’re forming partnerships in Asia. They’re raising capital in Europe. And they’re scaling in regions that promise stronger IP protection and faster commercialization pathways.
This isn’t about tax rates or manufacturing costs. It’s about legal certainty.
And if the U.S. doesn’t respond soon, it risks losing its position as the global hub of biotech.
Not because it lacks talent. Not because it lacks ambition. But because it lacks the clarity needed to support those things.
Who Must Act—and How
Congress Can Set the Foundation
The most powerful reform tool sits in Congress’s hands: legislation.
The courts interpret the law. But Congress writes it.
Section 101 of the U.S. Patent Act defines what is eligible for protection. Today, its vague language—combined with a decade of unpredictable court rulings—has created confusion that chills investment and slows down progress.
Modernizing Section 101 doesn’t require a complete overhaul. It just requires targeted, well-drafted updates to bring it in line with 21st-century science.
Reform could:
- Affirm that inventions based on natural materials—like DNA or proteins—are patentable when they are used in a way that involves human ingenuity and has clear utility.
- Clarify that diagnostic methods, including those based on biological signals or natural correlations, are patentable when the method includes meaningful application, development, or processing steps that go beyond simply “observing nature.”
- Codify protections for scientific research and non-commercial exploration, so that basic science can remain open while commercial applications are rewarded.
This kind of legislative clarity wouldn’t open the floodgates to abstract or frivolous patents.
Instead, it would allow companies, researchers, and investors to know what’s fair game—and what isn’t.
More importantly, it would send a signal to the world that the U.S. is ready to lead the next generation of biotech.
The Courts Must Refocus on Purpose
Until Congress acts, the courts still have an essential role.
Judges interpreting patent law must return to the core principle that underpins the entire system: encouraging useful innovation.
In recent years, the judiciary—especially the Supreme Court—has become overly focused on rigid categories like “natural law” or “abstract ideas.” But these labels are not always helpful in a biotech context.
Biotech is messy. It builds on biology, but it transforms it.
When a scientist takes a biological insight and uses it to design a test, build a treatment, or create a platform for discovery, that’s invention. That’s the very thing the patent system exists to protect.
Rather than blocking patents based on philosophical categories, courts should ask simple, practical questions:
Does this invention solve a problem?
Does it involve meaningful human input?
Does it enable something useful that wasn’t possible before?
If yes, eligibility should not be the obstacle.
The U.S. needs a judicial approach that reflects the reality of modern science—not one that forces biotech into outdated legal boxes.
The Industry Must Stay Engaged
Lawmakers and judges aren’t scientists. And they’re not always surrounded by inventors.
That’s why the biotech community must keep speaking up.
Biotech firms, university researchers, IP attorneys, and venture capitalists must all help shape the future of patent law.
That means more than just filing lawsuits or lobbying behind closed doors. It means engaging the public. Submitting written testimony to Congress. Publishing clear, non-technical explanations of what’s at stake. Partnering with policy centers and think tanks to develop credible reform proposals.
When the biotech industry stays silent, the legal system moves without it.
And when it speaks up only in emergencies, the law responds too slowly.
But if it stays engaged consistently, constructively, and visibly—reform becomes possible.
And with the right voices in the right rooms, we can build a patent system that protects discovery, drives investment, and delivers real solutions to real human needs.
The Courts Must Refocus on Purpose
In the meantime, the courts also have a role.
Judges interpreting eligibility law need to refocus on what the patent system is meant to do: encourage useful innovation.
Rather than parsing phrases like “natural law” or “abstract idea” to deny patents, courts should ask: does this invention represent real human ingenuity? Does it solve a problem? Does it move the field forward?
If the answer is yes, eligibility should not be the barrier.
Complexity shouldn’t disqualify innovation. Nor should elegance.
We need a judicial mindset that respects the nature of scientific progress—and the incentives required to drive it.
The Industry Must Stay Engaged
Finally, biotech companies, researchers, and entrepreneurs need to keep raising their voices.
That means submitting testimony, writing opinion pieces, joining coalitions, and working directly with lawmakers.
Too often, legal systems lag behind technology because inventors stay quiet. They don’t enter the debate until it’s too late.
But reform is still possible.
And the more the industry participates now, the more likely we’ll get a system that works—for discovery, for business, and for society.
Conclusion: Reforming Eligibility to Unlock a Better Future
Patent law isn’t just legal theory. It’s part of the infrastructure of innovation.
When that infrastructure breaks, ideas stall. Investment stops. And breakthroughs never reach the people who need them.
In biotech, this isn’t just a technical problem. It’s a human one.
Every year that patent eligibility remains broken, we lose potential cures, tests, and tools.
We lose lives. We lose progress. We lose time.
Reforming patent eligibility won’t fix everything.
But it will restore confidence. It will attract capital. It will give scientists a reason to keep reaching.
And that’s how we get to the next era of biotech—one where life-saving inventions are not only possible, but protectable.
