Biotech innovation isn’t just moving fast—it’s moving in ways the law wasn’t built to handle. As new discoveries reshape what’s possible in gene editing, synthetic biology, diagnostics, and therapeutics, the question isn’t just “Is it novel?” or “Is it useful?”
The question is: Can it even be patented anymore?
In the U.S. and many other countries, courts and patent offices are still trying to keep pace. What counts as patentable subject matter today may be rejected tomorrow. That’s a big deal for biotech startups, universities, and R&D-heavy companies who live and die by their IP strategy.
This article dives into how emerging biotech inventions are pushing—and sometimes breaking—traditional patent eligibility boundaries. We’ll unpack the latest challenges, explore real-world examples, and share practical strategies to navigate this evolving landscape.
The Shifting Line: What’s Considered Patentable in Biotech?
From Molecules to Methods: The Scope Keeps Changing
In biotech, the core question is whether an invention fits within what courts call “patent-eligible subject matter.” Traditionally, this meant it couldn’t be a law of nature, a natural phenomenon, or an abstract idea.
But biotech research lives in a gray area. Many breakthroughs are based on natural processes or materials found in the human body. That makes the eligibility line blurrier than ever.
The Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics shook the industry. It held that naturally occurring DNA sequences are not patentable, even if they were isolated from the body.
This caused a ripple across the sector. Suddenly, many diagnostic tests and therapeutic tools—once thought protectable—were now vulnerable.
Diagnostics Took the First Hit
Nowhere has the shift been felt more painfully than in molecular diagnostics. Companies that develop genetic tests or biomarkers to detect disease face a growing challenge. Courts have said many of these rely too much on natural correlations—like linking a genetic mutation to a disease outcome.
These correlations are often the entire value of the test. But if the court calls it a “natural law,” it can’t be patented, no matter how much work went into discovering it.
This makes investors nervous. Without patent protection, there’s no moat. And without a moat, it’s hard to fund long-term research in diagnostics.
Methods of Treatment: Still Standing, but Not Invincible
In contrast, method-of-treatment claims are still generally safe. These describe how a drug or therapy is used to treat a disease. As long as there’s a clear, concrete step—like administering a specific dose to achieve a result—it usually passes the eligibility bar.
But things get complicated if the method relies on diagnosing something first. If the court sees the diagnostic step as a “natural law,” it may strip out the whole claim, even if the treatment step is novel.
That means biotech founders and patent drafters need to be very careful in how they frame their inventions.
Synthetic Biology and the Rise of Engineered Life Forms
What’s “Natural” Anymore?
Synthetic biology is creating organisms and systems that never existed in nature. This field sits at the intersection of biology and engineering. Researchers design DNA sequences from scratch, program them to perform functions, and insert them into cells to do useful work—like producing biofuels, plastics, or medicines.
These creations aren’t “natural,” but they often mimic natural processes. That makes their patentability harder to predict.
Patent offices usually accept genetically modified organisms (GMOs) if they’re non-obvious and clearly described. But some courts still question whether they’re too close to what nature already does.
The Role of Human Ingenuity
What often tips the scale is human intervention. If the invention shows clear effort and modification that would not occur in nature—like adding new genetic parts, altering expression levels, or changing behavior—it becomes more likely to pass eligibility scrutiny.
This has prompted biotech patent lawyers to focus more on emphasizing design. It’s not enough to say something is “engineered.” The patent must show how and why the changes go beyond nature’s blueprint.
That’s where biotech companies need to work closely with their patent counsel. Getting this framing wrong can result in a rejection—even for a breakthrough discovery.
AI in Biotech: The Newest Patent Challenge
When the Inventor Isn’t Human
Biotech companies are using AI to design proteins, predict drug responses, and identify new molecules faster than ever. But what happens when the invention isn’t created by a human at all?
Courts and patent offices are still wrestling with whether AI-generated inventions qualify for patent protection. In many places, the law says the “inventor” must be a natural person. So if a machine helped generate the idea—or worse, was solely responsible—there’s uncertainty about whether it can be patented at all.
This puts biotech innovators in a tough spot. Should they list a human researcher as the inventor even if the AI did the heavy lifting? Or should they disclose the AI’s role and risk rejection?
There’s no clear answer yet. But one safe approach is to ensure a human plays a meaningful part in selecting, interpreting, or refining the AI output. That way, the claim can still be tied to human ingenuity.
New Kinds of Claims, New Risks
AI is also enabling new kinds of biotech tools—like predictive disease models or virtual screening platforms. These inventions often walk the line between software and life sciences.
Some are being rejected as “abstract ideas,” especially if they involve data analysis or simulations. To avoid this, the claims need to anchor the software function to a physical result—like producing a compound or triggering a biological change.
This takes careful claim drafting and a deep understanding of how courts apply the “abstract idea” test. It’s one of the fastest-changing areas in patent law today.
CRISPR and Gene Editing: The Eligibility Puzzle
Editing Life at the Genetic Level
CRISPR is one of the most important biotech breakthroughs in the last two decades. It gives scientists the power to cut and edit genes with precision. This can lead to treatments that fix mutations directly in the body’s DNA.
But from a patent perspective, CRISPR has opened the door to complex challenges.
Because the tool is built from naturally occurring bacterial proteins, courts have questioned whether CRISPR-based inventions are too close to nature. The science may be cutting-edge, but the legal framework lags behind.
How the Claims Are Written Matters
In CRISPR patent applications, how the invention is described makes a big difference.
If the claim focuses only on the CRISPR components themselves, it may be seen as too close to a natural system. But if the claim emphasizes how those components are used in new and specific ways—like modifying a target gene in a novel manner—it’s more likely to be approved.
Biotech startups using CRISPR need to be extra careful with how they structure their patent claims. They must show a clear distinction between what nature provides and what human design creates.
It’s not about hiding the natural part—it’s about making the inventive step obvious.
The Impact of Federal Circuit and Supreme Court Decisions
When Courts Redefine the Rules
In the U.S., patent eligibility is heavily influenced by court decisions—especially from the Supreme Court and the Court of Appeals for the Federal Circuit.
Cases like Mayo Collaborative Services v. Prometheus Labs and Alice Corp. v. CLS Bank reshaped how eligibility is evaluated. These decisions introduced a two-step test that asks: (1) Is the claim directed to a law of nature or abstract idea? And if so, (2) Does it add “something more” to make it inventive?
This test has been widely criticized in biotech circles because it’s vague. What counts as “something more”? The courts have not always been clear.
A Chilling Effect on Innovation
The uncertainty caused by these rulings has made some biotech investors cautious. If a discovery can be challenged or invalidated due to eligibility, even after a patent is granted, that weakens its commercial value.
Startups now need to think not just about getting patents, but about keeping them valid through the life of the product.
This puts more pressure on how the application is written from the start. It’s not just about describing the invention—it’s about defending its place in the current legal system.
Global Differences in Biotech Patent Standards
The U.S. Isn’t the Only Game in Town
While the U.S. has taken a narrow view on biotech patent eligibility, other countries have different rules.
In Europe, for example, the European Patent Office allows patents on diagnostic methods and naturally derived molecules—as long as they meet the standard tests for novelty and inventive step. They don’t use the same “natural law” test that U.S. courts do.
This creates a strange situation. A biotech company may get a patent in Europe but be denied protection for the same invention in the U.S.
Strategies for Multinational Protection
Because of this, biotech companies must plan their patent strategies across borders.
For example, if a diagnostic method is too risky to protect in the U.S., filing first in Europe may offer stronger rights. If the invention is data-heavy, it may be better to focus on trade secrets in the U.S. and file patents elsewhere.
Working with IP counsel who understands these differences is crucial. The timing, wording, and country choices all play into the long-term value of a biotech portfolio.
No one-size-fits-all approach works anymore. You need a smart, adaptive plan.
The Push for Legislative Reform
Calls for Clarity from Congress
In recent years, lawmakers and industry groups have pushed for changes to U.S. patent law—specifically to make biotech inventions more clearly eligible.
Several bills have been introduced to clarify Section 101 of the Patent Act. These proposals aim to remove the current judicial tests and go back to a simpler standard: if an invention is new, useful, and not obvious, it should be patentable.
So far, these efforts have not passed. But the momentum is growing. Many experts believe change is coming, especially as the biotech industry grows more critical to public health and economic growth.
Until Then: Navigating the Uncertainty
Until reform arrives, biotech startups must work within the existing framework. That means getting creative—not with the science, but with the legal framing.
Strong patent claims today focus on real-world applications, specific steps, and engineered systems. They avoid vague descriptions or high-level correlations. And they work hard to show the human hand in the invention.
It’s not ideal, but it’s the reality. And the startups who learn to navigate this space well will have a major edge.
AI and Machine Learning in Biotech: The New Frontier
When Data Becomes the Discovery
One of the newest frontiers in biotech is the use of artificial intelligence and machine learning. These tools don’t just assist research—they now help create insights that lead to real-world treatments. For example, AI can help predict how a drug molecule will interact with certain proteins in the body, or it can identify unknown disease patterns by scanning huge data sets.
But here’s the issue: is an AI-generated output patentable if it’s not created by a human in the traditional sense? Patent law in most countries still requires a human inventor. And that raises a major question about eligibility for biotech companies using these tools.
If the AI is critical to the invention but not listed as an inventor, courts may ask whether the invention is really new in a legal sense—or just a reorganization of data.
Framing the Inventive Step
To solve this problem, biotech innovators must be very careful in how they present AI-driven inventions in their patent filings. It’s not enough to say “our algorithm discovered a new compound.” Instead, the application should show how the company built the system, trained it, and applied its results in a specific, useful way.
You’re not patenting the algorithm—you’re patenting what you did with its help. That subtle framing shift can make the difference between approval and rejection.
Biotech companies that use AI must still root their claims in human judgment and engineering. This gives the invention legal standing while still reflecting the power of the AI.
The Role of Enablement and Written Description
Explaining Complex Science in Simple Language
Another issue that affects patent eligibility in biotech is how clearly an invention is explained. Patent law requires that an invention be “enabled” in a way that a person skilled in the field could recreate it based on the description. It also must include a “written description” that fully captures the invention.
This is where many biotech patents fall short.
Because the science is complex and sometimes evolving, inventors often struggle to explain how something works in simple, reproducible terms. They rely too much on high-level concepts or broad statements, which the courts can reject for being too vague.
Be Precise, Even If the Science Is New
To get around this, biotech startups must take the time to describe their processes in a very clear, technical way—even if the discovery feels groundbreaking. They need to define terms, include examples, and show why the invention is more than just a scientific idea.
This doesn’t mean revealing trade secrets. It means giving the patent office and the courts enough substance to see that the idea is real, useful, and specific.
And as eligibility continues to evolve, clear writing becomes not just good practice—but a survival tool.
Patenting Natural Products and Derivatives
A Longstanding Tension with Nature
Many biotech discoveries still come from nature—plants, microbes, or compounds found in marine life. These natural products often have strong therapeutic properties, making them the basis for powerful new drugs.
But U.S. law draws a hard line: if something exists in nature exactly as claimed, it cannot be patented. This was the result of the Myriad Genetics decision, which ruled that isolated DNA segments identical to what’s found in the human body are not patentable.
The ruling shocked the biotech world and set off a wave of confusion around what counts as “natural” versus “engineered.”
Creating Patentable Derivatives
To be eligible, companies now focus on derivatives or modifications—changing the natural compound in a way that gives it new properties or improved function. For example, chemically altering a molecule to improve its delivery inside the body, or binding it to another compound to enhance its therapeutic value.
The key is to highlight the transformation.
You can’t patent nature itself, but you can patent what you do with it, as long as it’s truly inventive and not obvious to others in the field. That makes the boundary between discovery and innovation razor-thin—but manageable if the invention is clearly defined.
Diagnostics and the “Natural Law” Challenge
Diagnosing Is Not the Same as Treating
Another hot topic in biotech eligibility is diagnostic methods. These tests are essential for modern medicine. They tell us whether a gene mutation is present, how likely someone is to develop a disease, or whether a treatment will work.
But the courts have made it incredibly hard to patent diagnostics. Why? Because many diagnostic methods are based on relationships between natural events—like a mutation and a disease risk. Courts say this is just applying a natural law, which is not patentable.
This position has been widely criticized by scientists, legal experts, and industry groups.
Finding the Workaround
To secure protection, inventors now have to build diagnostic patents around how the result is obtained—not just what the result shows.
That might include new methods of sample preparation, improved lab techniques, or using the data in a way that leads directly to treatment. These add-ons show that the method isn’t just observing nature—it’s using human insight and intervention to produce something new and useful.
If the diagnostic method includes an actionable step—something that changes the course of care—it has a better shot at surviving legal challenges.
Synthetic Biology and New Life Forms
Rewriting the Blueprint of Life
One of the most exciting, and at the same time legally complex, fields in biotech is synthetic biology. This area goes beyond modifying existing organisms. It involves building new life forms from scratch using designed genetic sequences.
Think of it as programming DNA like software. Scientists are no longer just editing what nature gave us. They are writing new genetic codes to create organisms that don’t exist in nature.
But when these engineered cells or organisms are presented for patenting, they face tough scrutiny.
Is this organism “man-made” enough? Or is it still too close to nature to qualify for a patent?
That’s where the legal line gets blurry again. Courts and patent examiners want to know if the synthetic construct is truly different from anything found in the natural world—and if the function it performs is new and not obvious.
The Importance of Human Engineering
To qualify for a patent, synthetic biology inventions must show deliberate engineering. The DNA sequence must be custom-designed with specific results in mind. Random mutation or trial-and-error approaches don’t hold the same legal weight.
Companies also need to show how the organism works, how it’s controlled, and what problem it solves.
This ties back to the earlier theme of enablement: the invention must be teachable and reproducible. And most importantly, it must reflect human creativity, not just natural possibility.
CRISPR and Gene Editing: Sharp Tools in a Blurry Legal Space
Who Owns a Snip of DNA?
CRISPR-Cas9 and related gene editing tools have transformed biotech. These tools let scientists cut and modify DNA with incredible precision. But they’ve also triggered fierce legal fights over who owns what—and whether the edits themselves are patentable.
In some countries, CRISPR-related patents have been granted for the tool and its use in specific organisms. In others, the use of CRISPR inside human cells has faced tighter scrutiny, especially when it involves changes that mimic natural mutations.
At the heart of this issue is a bigger legal concern: is editing something already found in nature really new?
Scope of Claims Matters More Than Ever
The patentability of gene editing often depends on how the invention is framed. If the patent claims a new use, a new guide sequence, or a new delivery method, it’s more likely to be seen as patentable.
But if the patent simply says “we used CRISPR to cut this gene,” and that gene is known, the claim may fail.
For startups working with gene editing, the lesson is clear: focus on specific applications, tailored methods, and measurable improvements.
Broad claims get rejected. Narrow claims that solve specific problems tend to pass.
Software Meets Biotech: A New Patent Puzzle
From Wet Lab to Code
Biotech companies today often combine biology with software. They use machine learning to predict protein structures. They build platforms that simulate drug interactions. Some even let researchers run lab experiments remotely through automated systems.
But this creates another legal twist.
Software is notoriously hard to patent in many regions. And combining it with biotech doesn’t always make it easier.
The core question becomes: is the software doing something that is truly inventive in the biotech space, or is it just processing biological data?
Protecting Platforms and Pipelines
To get a patent, biotech companies using software must show that the tool has a clear, technical impact on a biological process. For example, a platform that identifies novel drug targets more accurately than existing methods may qualify.
But just visualizing data, organizing lab results, or automating common tasks might not.
The claims must be grounded in biology. And the software’s role must be specific, not generic.
This is especially important for digital therapeutics and bioinformatics platforms. These tools often drive value for biotech startups—but that value can vanish without strong IP protection.
International Eligibility: Not All Standards Match
What Works in the U.S. Might Not Work in Europe
Patent eligibility isn’t universal. The rules vary by country, which creates both risk and opportunity for biotech companies.
In the U.S., the standards have tightened in recent years, especially around natural laws and diagnostic methods. Europe, on the other hand, sometimes allows broader protection for biotech inventions—especially when they are applied in a technical, industrial context.
Asia has its own rules as well. In China, for example, biotech patents are booming, but gene editing involving human embryos faces stricter limits.
So, companies must build a patent strategy that matches their target markets.
A U.S. rejection doesn’t always mean a global dead-end. But a global view should guide early decisions on how inventions are defined and protected.
Draft for Global Flexibility
The most effective patent applications now consider multiple jurisdictions from the start.
That means avoiding legal language that is too narrow or too tied to one country’s logic. It also means describing the invention in a way that meets the technical effect standards used in Europe and the enablement requirements demanded in the U.S.
This is especially vital for biotech companies aiming to license their inventions globally.
A strong international patent filing strategy is no longer optional—it’s a core business asset.
Navigating the Patent Office Mindset
How Examiners Think About Biotech
Understanding how patent examiners think can change how biotech applications are written and defended. Examiners are trained to look at inventions through the lens of prior art — what came before — and whether something is too close to nature or too obvious to qualify for protection.
In biotech, many rejections come not because the invention lacks value, but because the application doesn’t clearly draw a line between discovery and invention. A great example is diagnostic methods. Examiners may say identifying a natural biomarker isn’t enough. But if the method uses that biomarker in a specific, repeatable, and beneficial way — that’s where patent eligibility can shift.
Teaching the Examiner With Clarity
Many strong biotech patents succeed not because the technology is new, but because the description helps the examiner understand what makes it inventive. This is why detailed data, multiple working examples, and clear technical advantages are key. The more “real-world” the invention looks, the stronger it stands in front of legal tests.
Startups that work closely with skilled patent counsel can often reframe what looks like a simple natural discovery into a practical method or system that has commercial and technical significance. This is the heart of good biotech patenting — taking raw scientific insight and turning it into a legal asset that supports business growth.
The Rise of Patent Litigation in Biotech
Why Lawsuits Are Increasing
As biotech startups attract more investment and deliver market-ready innovations, the risk of litigation also rises. In many sectors — like personalized medicine or synthetic biology — there are overlapping patent claims. Companies often find themselves accused of infringement, even if they’ve independently developed their technology.
The issue isn’t just legal. It’s strategic. Many companies use litigation as a way to slow down rivals, pressure licensing deals, or test the strength of a patent portfolio.
So, when you’re building a biotech patent, you’re not just protecting an idea — you’re preparing for the battlefield.
Strength in Specificity
Litigation often comes down to the words in the patent. General claims are easier to challenge. Specific, detailed claims — especially those that link biology to a clear industrial use — tend to hold up better in court.
For biotech founders, this means early decisions about how an invention is described can shape their future freedom to operate.
Focusing on specific sequences, structures, or manufacturing steps helps carve out legal territory that is harder for others to enter — or dispute.
Biotech’s Push to Change the Rules
The Call for Legislative Reform
As patent eligibility has tightened in the U.S., the biotech industry has pushed back. Many leaders are urging Congress to change the law — to restore stronger protections for diagnostics, gene editing, and naturally-derived medicines.
They argue that current standards discourage innovation. If discovering a new disease biomarker isn’t protectable, fewer companies will invest in early-stage research.
Efforts to pass laws like the “Patent Eligibility Restoration Act” reflect this tension between science and the law. So far, progress has been slow. But the debate itself is shaping how patent offices and courts treat emerging biotech applications.
Building for What’s Next
While the legal rules may evolve, startups can’t wait. The best strategy is to build patent portfolios that are resilient now, but flexible enough to adapt later.
That means including a mix of patent types — from method claims to composition claims to systems that combine biology with engineering. It also means documenting development milestones in a way that proves novelty and utility, even in a changing legal landscape.
By aligning IP strategy with scientific and commercial goals, biotech companies can move with confidence — not fear.
Final Takeaways for Biotech Founders
The world of biotech is moving fast. But the law doesn’t always keep up. Patent eligibility has become a moving target, shaped by court rulings, examiner discretion, and political debate. Yet, the companies that succeed aren’t the ones that wait. They’re the ones who find clarity in the gray zones.
To build a valuable, defendable biotech portfolio today, founders must:
- Treat IP as a business tool, not just a legal formality.
- Frame inventions in terms of use, application, and human intervention.
- Avoid abstract claims — focus on tangible impact.
- Plan globally, draft with flexibility, and protect what makes your tech commercially distinct.
Because in biotech, the future belongs not just to the bold, but to the prepared.
