Back in 2012, a Supreme Court case called Mayo Collaborative Services v. Prometheus Laboratories changed everything about how medical inventions could be patented. If you’re building something in biotech, health tech, diagnostics, or personalized medicine, this one case is why patents today feel like a puzzle.
What Was the Mayo Case All About?
The Basics (In Simple Terms)
The Mayo case started with a company called Prometheus Laboratories.
They had a medical test. The test helped doctors figure out the right drug dose for people with certain illnesses.
It worked like this: a patient takes a drug, their blood is tested, and then doctors look at the results to adjust the dose.
Prometheus said this process was new and helpful. They got a patent for it.
Then Mayo Clinic came along. They used a similar test on their own patients. Prometheus said Mayo was infringing on their patent. So they went to court.
Here’s where things got tricky. The question wasn’t whether Mayo copied the idea.
The real issue was whether Prometheus’s idea was even the kind of thing that could be patented in the first place.
The case made it all the way to the Supreme Court.
What the Court Said
The Court looked at the patent and said no, this can’t be patented. Why? Because the test was based on a natural law.
They said the relationship between drug levels in the blood and how the body reacts is a natural thing. Nature does it on its own. You can’t patent nature.
They also said the steps around the test—giving a drug, measuring levels—were things doctors already knew how to do.
So putting them together wasn’t enough. It wasn’t considered a “real invention” under the law.
That ruling shook the world of medical patents.
Why This Ruling Mattered So Much
After the Mayo case, the rulebook changed overnight. Patents in the medical space got much harder to win.
If your invention used natural processes, data from the body, or mental steps a doctor could do, it might not qualify anymore.
This hit diagnostic tests the hardest. Especially ones that involve measuring something in the body, analyzing it, and then using that info to make a decision.
That’s basically what modern precision medicine is all about. And suddenly, it was unclear whether those ideas could be protected.
Inventors felt like the ground had shifted. You could build something life-saving, but if the law didn’t see it as “new enough” or “inventive enough,” you could be out of luck.
What It Meant for Startups and Founders
Let’s say you’re building a health tech startup. Maybe you’ve created a tool that uses blood test data and machine learning to recommend treatment plans.
That might sound like innovation. But after Mayo, a patent examiner could say, “This just applies math to a natural process.” And boom—your application gets rejected.
That’s the real danger. If your tech pulls insights from biology or applies known steps in a new way, you’re now in a gray area.
The patent office might say it’s not really an invention, just a clever use of nature and math.
For founders, this is frustrating. You’re building real things, solving real problems. But the system isn’t always set up to protect you.
And the worst part? You may not find out until months—or even years—into the process.
The Bigger Impact on Innovation
When patents are harder to get, fewer people apply. That’s exactly what happened after Mayo.
Diagnostic patents dropped. Investors got nervous. Why pour money into a startup if their core tech might be impossible to protect?
And yet, innovation didn’t stop. People kept building. But they had to be smarter, faster, and more strategic about how they protected their work.
If you’re in this space, understanding the Mayo decision isn’t just useful. It’s critical. It helps you know where the lines are—and how to stay on the right side.
How Patent Eligibility Changed After Mayo
The Rule Shift Was Subtle—but Major
Before the Mayo case, if you came up with a new process for diagnosing or treating a disease, and it worked better than what came before, you had a solid shot at getting a patent. Sure, you had to explain it well, show it was new, and prove it wasn’t obvious. But courts didn’t ask deep philosophical questions about what counted as a true “invention.”
Mayo changed that. It introduced a new way of thinking. Now, the courts and the patent office look at whether your invention is based on a law of nature, a natural phenomenon, or just abstract ideas.
If it is, they say: “Wait. You can’t just dress up nature with a few extra steps and call it an invention.”
This shift meant patents started getting judged by a different standard. And a lot of useful medical ideas no longer made the cut.
What the Supreme Court Actually Meant
Here’s the thing: the Supreme Court didn’t say, “no more patents on diagnostics.” But that’s how a lot of people interpreted it.
They said: if your idea is based on something natural, like how the body reacts to a drug, you can’t just add routine steps like “test the blood” or “compare the result” and expect a patent. That’s not enough. You need something more.
But they never defined what “something more” meant.
And that’s where the trouble started.
The Chaos That Followed
After Mayo, lower courts and the patent office had to figure out what to do. Some examiners started rejecting tons of patent applications in diagnostics, biotech, even software. They weren’t sure where the line was—so they played it safe.
Some courts did the same. They used Mayo to throw out patents they might have allowed before. In many cases, the rulings felt inconsistent. One judge would allow a patent. Another would reject a nearly identical one.
This uncertainty made everything harder. Startups didn’t know what to expect. Investors didn’t know how to evaluate IP. Even patent attorneys weren’t sure how to draft claims that would survive.
Real-World Example: What Would Fail Today
Imagine you invent a test that looks at two proteins in the blood. Based on their levels, your software tells doctors how likely it is that a patient will have a heart attack in the next 6 months.
That sounds incredibly helpful, right?
But under the Mayo standard, you might run into trouble. The court or the examiner might say:
The proteins are natural markers.
Measuring them is a routine lab test.
Using their levels to predict something is just applying a natural law.
Unless you’ve added some truly new step—like a unique chemical reaction or a brand-new kind of analysis—the patent might not fly.
It’s not that your idea isn’t useful. It’s that the system now asks: did you invent something totally new, or just discover something about how nature works?
And that distinction is what has tripped up so many founders.
How Some Startups Adapted
The smart ones didn’t give up. They shifted how they approached patents.
Instead of just describing what their invention does, they focused on how it does it. They highlighted the unique tech under the hood.
They filed stronger claims that avoided natural laws.
Or they focused on other parts of their system that were more clearly technical—like new data processing methods or hardware.
They also worked closely with attorneys who understood the new playbook. People who knew how to write patents that could survive in this post-Mayo world.
If you’re building in this space, you need to do the same.
How to Navigate Patent Eligibility After Mayo
Don’t Panic—Just Get Clear
If you’re working on a medical or diagnostic invention, the Mayo decision doesn’t mean you’re out of options.
It just means you need to be smart about how you frame your idea.
The big mistake founders make is thinking that having a great product is enough. But with patents, it’s not just what you build—it’s how you describe it.
You have to show that your invention does more than use nature. You have to show it adds something new—something human-made that changes the game.
The law calls it an “inventive concept.” But don’t worry about that term. Just think of it like this: What part of your invention wouldn’t exist without your brain making it happen?
That’s what you need to focus on.
Tell the Story of the Tech, Not the Result
Let’s say your system analyzes data from patients and gives doctors a score that helps with diagnosis.
If you just say, “we look at natural signals and give a recommendation,” that won’t fly.
But if you explain a new way of processing the data, or a novel software model that turns raw input into something actionable, that’s better.
You’re not just describing a natural law. You’re showing a human-created method that makes the system smarter or more effective.
Even small technical details can help. The way your model is trained. The method you use to normalize data. The way your system flags uncertainty. All of that can support your case.
So go deep. Show how your solution works under the hood. That’s where your best patent material lives.
Use the Right Strategy From the Start
The biggest risk isn’t rejection—it’s wasting time.
Some startups file broad, vague patents hoping to cover everything.
But after Mayo, that’s risky. If your claims are too general, they’re easier to knock out as being “just nature plus known steps.”
Instead, work with someone who understands this landscape and can help you focus. Maybe you patent the part of your system that processes inputs.
Maybe it’s the interface. Maybe it’s the way your model updates over time.
What matters is that you’re aiming at something clearly technical. Something you built. Something that wasn’t obvious before.
Start there. Get that patent first. Then expand.
Why This Still Matters
You might be thinking: if patents are so tricky now, why bother?
Because even with the Mayo decision, patents still matter—a lot. Especially if you’re raising money, building partnerships, or entering a competitive space.
A good patent can stop others from copying you. It can help you stand out to VCs. It can let you move fast, knowing your edge is protected. And with PowerPatent, you can get there faster—with less hassle.
You don’t need to be a legal expert. You just need a smart strategy and a team that knows how to play by the new rules.
What Courts Look for After Mayo
The Two-Part Test That Changed Everything
After the Mayo decision, the courts came up with a test to figure out if something is eligible for a patent.
It’s called the Alice/Mayo test (yep, another case later joined the mix). But don’t worry, we’ll keep it simple.
Here’s how the test works in plain English.
Step one: Is your idea based on something natural, a law of nature, or something abstract—like math or a concept?
If yes, then step two: Does your idea add something extra that makes it feel like a real invention, not just a dressed-up version of a natural process?
If the answer is no to both—your idea is natural, and you didn’t add enough—that’s where patents get denied.
This test has become the big hurdle for anything in diagnostics, AI, biotech, or health tech. And it’s why writing your patent the right way matters more than ever.
What Doesn’t Work (According to the Courts)
If your patent just says, “we observe something in the body, think about it, and then make a decision,” the courts say that’s not enough.
If you use a computer or software but don’t explain anything new about how it works, that’s also not enough.
If you apply a known process (like taking blood, measuring it, and comparing it to a number), that’s still not enough.
It’s not about what your invention does. It’s about whether it adds something truly new. Something that transforms the process or makes it different in a way only a human could invent.
That’s what the courts want to see.
What Does Work (If You Do It Right)
If you can show that your system does something technical and unique—like a new way to process, analyze, or display medical data—you’re in better shape.
If your invention improves how a machine works, speeds up diagnosis, or changes the way data is handled behind the scenes, that helps a lot.
Courts want to see something concrete. Something you built—not just discovered. That’s what keeps your patent alive.
And it all comes down to how you tell the story. The details matter.
Why the Patent Office Can Be Inconsistent
Even though Mayo is the law, how it’s applied still varies. One examiner might say yes to your claims. Another might reject them—even if they’re similar.
That’s frustrating, but it’s real. The system is still figuring itself out. That’s why it helps to have a strategy that’s flexible. One that can handle pushback, respond to objections, and still move your patent forward.
You don’t need a hundred claims. You just need strong ones, backed by a clear explanation that fits the current law.
And that’s exactly what PowerPatent helps you do—combine smart software with real legal expertise, so you don’t waste time or money guessing.
How Mayo Affects Different Types of Medical Inventions
Diagnostic Tests Got Hit the Hardest
The Mayo case was about a diagnostic method. So it’s no surprise that diagnostics felt the biggest shock.
If your test involves measuring something in the body—blood levels, gene expression, biomarkers—and then making a decision based on that, you’re in tricky territory.
The courts now say those kinds of inventions often rely too heavily on natural relationships.
That’s a problem because modern medicine relies on those exact tools.
Personalized health, predictive care, and remote diagnostics all depend on analyzing biological data and turning it into insight.
But legally, that insight has to come from something more than just applying math to nature.
So now, to get a patent on a diagnostic test, you need to dig deeper. You need to show something special—like a new method for analyzing the signal, a new kind of sensor, or an improvement in how the data is used.
Without that, you risk getting stuck in the same trap as Prometheus did in the Mayo case.
Digital Health and AI in Medicine
Let’s say your app uses artificial intelligence to look at medical images and flag disease risks. Sounds smart, right?
But in the eyes of the patent system, the risk is that the AI is just doing what a radiologist might do—spotting patterns and drawing conclusions.
If your patent claims are written too broadly, they could be seen as just mental steps done by a machine.
To avoid that, you need to focus on what’s new in the process. Is your algorithm doing something innovative?
Is there a new step in how the data is handled, how it’s filtered, or how the output is generated?
The key is to show a technical improvement—not just a clever idea.
That means not just saying, “we use AI.” You need to show how your AI works in a way that makes the system better, faster, or more accurate. That’s what gets you closer to patent eligibility.
Therapeutics and Drug Delivery
Here’s where Mayo has less power. If you invent a new drug or a new way to deliver it into the body, those are still patentable—because they involve physical structures and clear chemical inventions.
But even here, you have to be careful.
If your claims focus on how the drug affects the body in a way that’s just describing a natural effect, you could run into trouble.
That’s especially true if your patent says something like, “this drug lowers inflammation by X amount”—without showing a novel mechanism or delivery method.
The smarter move is to focus on what’s different: a new formulation, a new delivery route, or a new compound. That keeps your claims anchored in invention—not in natural law.
Wearables and Sensors
These often do well, as long as you focus on the hardware or data processing.
If your device collects new types of data, or if you process it in a unique way, that can support a strong patent.
But again, don’t just say “we monitor health.” Say how you do it differently from everyone else.
It could be a new type of sensor. A smarter algorithm for detecting signals. A method for reducing noise in real time.
Whatever it is, make sure your patent application focuses on that part. That’s where the magic lives—and where your protection begins.
How to Build a Strong Patent Strategy in a Post-Mayo World
Step One: Know What You’re Really Protecting
The first thing to get clear on is what part of your invention is the real breakthrough.
A lot of founders make the mistake of thinking everything they’ve built should be in one patent. But that’s risky—especially now.
Instead, zoom in.
Ask yourself: what’s the part of this system that’s most unique? Is it how you collect the data? How you analyze it? How your model adjusts over time? Is it a software feature? A hardware component?
Find the piece that wouldn’t exist without your work—and that others would try to copy if they could.
That’s what you want to protect first.
Because in today’s patent world, it’s not about having the most claims. It’s about having the right ones.
Step Two: Write for Today’s Rules
This is where PowerPatent really shines. Because writing a patent isn’t just about filling out a form—it’s about telling a story that fits the law.
Your story needs to make it crystal clear that your invention is not just an observation, a thought, or a natural result. It’s a real, man-made solution that brings something new to the table.
That means showing:
How your tech works under the hood
What’s different compared to old methods
What technical problem it solves (not just medical)
How your system improves performance, reliability, or efficiency
Even if your idea uses biology, the story should be technical. Grounded in how your system operates—not just what it shows.
And yes, that takes work. But it’s work that pays off.
Step Three: Expect Pushback (and Be Ready for It)
Let’s be real: even with a great patent application, you might still get a rejection at first. That’s normal. The patent office is cautious these days—especially with medical tech.
But a rejection isn’t the end. It’s the start of a conversation.
If you’ve filed well—with solid claims, strong technical support, and a clear explanation—then you’ve got room to push back. To argue. To refine. To keep going.
This is where a lot of startups stumble. They take a rejection personally. Or they don’t know how to respond. Or their application was too weak to fight for.
That’s why PowerPatent is built for this exact moment. With smart tools and real legal oversight, we help you stand your ground—without wasting months or thousands on endless back-and-forth.
Step Four: Think Bigger Than One Patent
Even though Mayo made patents harder to get, it also forced founders to think more strategically.
Instead of filing one giant patent that tries to cover everything, many smart startups now file smaller, tighter patents—each one focused on a clear technical win.
Then, as the product grows and evolves, they add more.
This creates a wall of protection around your tech. It also lets you move faster. You can file early, test the waters, and build a portfolio as your product matures.
It’s agile IP. And in this new world, it works better.
Wrapping It Up
The Supreme Court’s decision in the Mayo case didn’t kill innovation in diagnostics, digital health, or biotech. But it did force founders to level up. To be sharper, smarter, and more strategic about how they protect what they’re building.
Yes, the rules got tougher. You can’t just patent natural insights or broad ideas. You need to show the tech. The method. The magic in the machine. You need to file patents that stand on solid ground, not wishful thinking.
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