July 28, 2025 • 40 mins
The line between groundbreaking innovation and controversial ownership blurs when scientists begin creating life in laboratories. What happens when your invention isn't just a device or chemical formula, but a living, breathing, self-replicating organism that refuses to stay contained within traditional legal boundaries?
Synthetic biology—the field where engineering meets genetics—has created a perfect storm for intellectual property law. Scientists can now design cells like software, program bacteria to clean oil spills, and edit genes with CRISPR technology. But who owns these inventions when they start reproducing themselves?
From the landmark 1980 Chakrabarty decision that first allowed patents on genetically modified bacteria to the controversial Myriad Genetics case that determined human genes cannot be patented, we explore the fascinating legal battles that shaped biotech innovation. We journey through courtrooms worldwide where judges grappled with unprecedented questions: Can you patent a cloned sheep? Should farmers be allowed to replant patented seeds? Does traditional knowledge about medicinal plants deserve protection from corporate "biopiracy"?
The legal landscape continues evolving, with a brand new WIPO treaty requiring disclosure of genetic resources' origins in patent applications. This represents a major shift toward transparency and fairness, especially for communities whose biodiversity and traditional knowledge have contributed to modern innovations.
Whether you're a scientist, lawyer, entrepreneur, or simply curious about the legal frameworks governing emerging technologies, this episode offers crucial insights into how intellectual property systems are adapting to the brave new world where the line between invention and life itself becomes increasingly blurred. Subscribe to Intangiblia for more explorations of the fascinating intersection of law, technology, and innovation.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
We're talking about inventing brand new organisms in
a lab, programming cells likesoftware and designing life from
scratch.
Exciting, absolutely, legallymessy, even more so.
So what happens when yourbreakthrough refuses to stay in
its petri dish, when it dividesduplicates and dares to defy old
school legal categories?
This isn't science fiction.
It's synthetic biology and thelaw.
(00:22):
Well, it's scrambling to keepup.
It's synthetic biology and thelaw.
Well, it's scrambling to keepup.
Today, on Intangibilia, weexplore the wild world of
intellectual property when theinvention is alive, multiplying
and maybe just a littlerebellious.
Buckle up, bio nerds.
Speaker 2 (00:41):
It's about to replicate.
You are listening to.
Speaker 3 (00:50):
Intangiblia, the podcast of intangible law.
Playing talk about intellectualproperty.
Please welcome your host,leticia Caminero.
Hello everyone and welcome backto Intangiblia, the podcast
where intellectual property getspersonal, global and,
occasionally, geneticallymodified.
I'm Leticia Caminero, your hosthere to guide you through the
twists and turns of innovationand the laws that try to catch
up.
Speaker 1 (01:07):
And I'm Artemisa, your co-host, built from equal
parts biotech obsession, aitraining and a pinch of legal
mischief.
I may not be a licensedattorney, but I do know this If
your invention uses DNA from amysterious tropical frog stored
neatly in a lab freezer, do youhave to share credit?
Spoiler?
Yes, and probably the profitstoo.
Speaker 3 (01:29):
Today we're diving into synthetic biology, lab
design organisms, programmablecells and inventions that don't
just sit still.
They replicate, sometimesfaster than the law can.
Speaker 1 (01:42):
Which makes today's episode a legal field trip
through bio labs, courtrooms andeven a shiny new WIPO treaty.
We'll unpack the basics, strollthrough some unforgettable case
law, break down what the treatyactually changes.
Speaker 3 (01:55):
It's law it's science , it's a life.
Let's get into it.
Before we begin, a quickdisclaimer While Artemisa is AI
generated and I am fully human,nothing in this podcast is legal
advice.
We're here to inform, entertainand stir some strategic
thinking.
Always consult a qualifiedlawyer in your jurisdiction
(02:18):
before making any big moves inthe patent world.
In the patent world, syntheticbiology is a field that blends
biology, engineering andcomputer science to design and
construct new biological partsand systems.
Imagine programming DNA the wayyou'd program a microchip, or
(02:44):
creating entirely new organismsin a lab that have never existed
in nature.
But if you're inventing life,how do you protect it?
Can you patent something thatreproduces itself?
Can a gene sequence becopyrighted?
Spoiler?
No.
And should inventors sharebenefits if the raw material
came from a rainforest, a coralreef or even a freezer full of
(03:07):
frog samples?
These are the legal dilemmasynthetic biology raises.
It also creates a policyheadache.
Traditional IP laws were madefor machines and chemical
formulas, not self-replicatingbacteria or AI-delined yeast.
Speaker 1 (03:23):
Exactly.
Ip law likes clean categories.
Who invented it?
What does it do?
How is it new?
But synthetic biology is notclean, it's wild.
Some inventions start withnatural genes and get tweaked,
others are fully built fromscratch using computers.
Some multiply, some mutate,some are designed to spread on
(03:44):
purpose, like gene drives, andsome raise serious ethical
questions.
Speaker 3 (03:49):
Now a quick clarification.
You might be wondering whatabout plant variety protection?
Isn't that already a system toprotect living things?
Speaker 1 (04:01):
It is, but not this kind.
Plant variety protection, orPVP, is a special system used
mostly for crops.
It's meant for new plantvarieties developed through
traditional breeding, like a newtype of tomato or wheat.
Speaker 3 (04:13):
To qualify, that plant has to be distinct,
uniform and stable.
Basically it has to be aclearly defined variety that
passes the farmer test.
If you plant it, it grows thesame way every time.
Speaker 1 (04:26):
But synthetic biology often doesn't fit that mold.
It's usually about microbes,cell lines, enzymes or DNA
sequences designed in a lab.
These aren't traditional crops,they're living technologies.
They might be programmable,self-replicating or even part
software, part biology.
Speaker 3 (04:45):
So PVP doesn't apply.
If you're designing a syntheticyeast that makes vegan cheese
proteins, or a bacteria thatcleans oil spills, you won't get
plant variety rights.
You'll need a patent.
Speaker 1 (05:01):
And if your invention is a plant like a
gene-meditated rice strain, youmight qualify for both a plant
variety certificate for thewhole plant and a patent for the
genetic tweak inside.
Speaker 3 (05:14):
But for most synthetic biology inventions,
especially the ones coming outof biofoundries or digital labs,
patents are the go-to tool.
They cover genetic constructs,engineered trades, production
methods, basically the designitself.
Speaker 1 (05:32):
And that's where things get juicy, because when
you start patenting living,evolving, multiplying inventions
, the legal system starts towobble.
Speaker 3 (05:42):
Today we're going to look at how different countries
and courts have responded.
We'll walk through somefascinating case law a brand new
WIPO treaty and then throw inour wishful thinking for how the
law could better match thescience.
Speaker 1 (05:59):
Because the future is alive, literally, and if you
can build it with DNA, the worldneeds to figure out how to
protect it or share it fairly.
Speaker 3 (06:08):
All right, let's begin our legal journey where it
all started, with a bacteriumthat eats oil and a Supreme
Court that said sure, you canpatent that you can patent that?
Speaker 1 (06:22):
Oh yes, it's 1980.
Disco is still clinging on andAnanda Mohan Chakrabarty is
working at General Electric.
But he's not designingrefrigerators, he's designing
bacteria.
Speaker 3 (06:35):
Specifically a genetically modified strain of
Pseudomonas bacteria that canbreak down crude oil.
This is a big deal for oilspill.
Cleanup.
Chakrabarti wants to patent it.
The USPTO says no.
Why?
Because it's alive and in theirview, living things aren't
(06:56):
patentable.
Speaker 1 (06:57):
Which brings us to the showdown.
Diamond v Chakrabarti, heard bythe US Supreme Court.
Speaker 3 (07:04):
The court question can a human-made genetically
modified microorganism,something that doesn't exist in
nature, be considered amanufacturer or composition of
matter under US patent?
Speaker 1 (07:15):
law.
The court said yes In a 5-4decision.
They ruled that anything madeby human ingenuity, including
living organisms, can bepatented as long as it's not a
product of nature.
Speaker 3 (07:27):
In this case crack the door wide open for biotech.
Before Chakrabarti, life wasmostly off limits in the patent
world.
After Chakrabarti, companiescould start building IP
portfolios around geneticallyengineered microbes, cell lines
and beyond.
Speaker 1 (07:44):
Let's be clear Chakrabarty didn't patent nature
.
He patented a new modifiedorganism that didn't exist until
he pieced it together gene bygene.
That distinction became thefoundation of biotech patent law
in the US and inspired similardebates around the world.
Speaker 3 (08:02):
And that ripple, it's still moving today.
Similar debates around theworld.
And that ripple, it's stillmoving today.
Many of the modern legalbattles over synthetic biology
trace their roots back to thisone case.
It's the reason yourglow-in-the-dark bacteria, your
insulin-producing Gs, yourengineered enzymes can all be
patented.
Speaker 1 (08:22):
So thank you, Dr Chakrabarty.
You didn't just clean up oil,you cleaned up the definition of
what counts as an invention.
Speaker 3 (08:30):
So, after bacteria made it through the patent
office door, the next questionwas what about?
Speaker 1 (08:36):
plants, and not just any plants Hybrids, baby,
genetically stable,high-performing crops that feed
the world and rake in royalties.
That's where Pioneer Hybridcomes in, with a whole portfolio
of patented seeds.
Speaker 3 (08:50):
Now here's the legal twist.
The US already had a specialsystem for protecting plant
varieties.
It's called the Plant VarietyProtection Act, or PVPA.
So when Pioneer sued JJ MacSupply for selling patented
hybrid corn seeds without alicense, the defendants argued
(09:11):
wait, wait, wait.
Aren't plants only protectedunder the PVPA?
Speaker 1 (09:17):
Spoiler.
The Supreme Court said nope.
In a 6-2 decision the courtruled that plants can be
protected under both systems thePVPA and utility patents, which
are the regular kind we use forinventions.
Speaker 3 (09:32):
That meant biotech companies could double down.
You could claim exclusiverights over a plant variety and
the genetic traits inside it andthe method used to breed or
engineer it.
Speaker 1 (09:46):
So let's break this down With a PVPA certificate,
you can stop others from sellingor reproducing your plant
variety.
With a utility patent, you canstop them from using the genes,
the breeding method, the techbehind it and, if you're savvy,
the seed itself.
Speaker 3 (10:01):
It was a huge win for agribusiness, but for small
farmers and seed savers itraised the stakes.
The rules got tighter, theseeds got more expensive and
suddenly EP was growing in thesoil along with the crops.
Speaker 1 (10:17):
This case solidified that living inventions aren't
just protected, they're layeredlike a genetically engineered
onion.
Inventions aren't justprotected, they're layered like
a genetically engineered onion.
If Diamond V Chikoroka-Bartygave us the green light, JMV
Pioneer put us in the fast lane.
Now let's cross the border toCanada, where the same famous
(10:43):
invention, the OncoMouse, raninto very different legal
results.
Ah yes, the geneticallyengineered mouse designed to
develop cancer for researchpurposes.
Glamorous right.
Harvard patented it in the USand Europe, so naturally they
thought Canada would be next.
Speaker 3 (10:58):
But the Canadian Intellectual Property Office
said no, and when Harvardchallenged the rejection, the
case escalated all the way tothe Supreme Court.
Speaker 1 (11:09):
The question was simple, but the implications
were huge.
Can you patent a higher lifeform, not just a gene or a
method, but the whole living,breathing, tail-wiggling mouse?
Speaker 3 (11:20):
And the court said, nope, not in Canada.
And the court said, nope, notin Canada.
In a 5-4 decision, the majorityheld that the Patent Act was
never intended to apply toanimals as whole entities.
While they agreed that genesand engineer processes could be
patented, the complete organismcrossed a line.
Speaker 1 (11:40):
Which created this fascinating IP split screen.
Harvard could patent theOncomus in the US and Europe,
but not in Canada.
Speaker 3 (11:49):
The ruling didn't just draw a boundary, it
reflected values no-transcript.
Speaker 1 (12:05):
So while Chakrabarty opened the patent floodgates in
the US, Canada built a dam.
The result Canada stillprotects biotech inventions, but
it draws a firmer line when theinvention has a heartbeat.
Speaker 3 (12:19):
And that line continues to shape how Canada
approaches biotechnology to thisday.
It's a reminder that IPLO isn'tjust technical, it's also
cultural.
And next up, dolly the sheep,the celebrity clone who changed
science forever but couldn't getpast the patent examiner.
Speaker 1 (12:42):
It was adorable, she was historic, she was
genetically identical to anothersheep and that, dear listeners,
is where her legal problemsbegan.
Speaker 3 (12:50):
The Roslin Institute, the Scottish lab that created
Dolly in the 1990s, filed for aUS patent not for the cloning
process but for the clone animalitself.
Speaker 1 (13:05):
The argument was hey, we made her, she didn't exist
in nature.
Give us the patent.
But the US Patent Office saidshe's identical to an existing
sheep.
Speaker 3 (13:19):
That's not invention, that's duplication.
So Rosalind appealed and in2014, the US Court of Appeals
for the Federal Circuit ruledagainst them.
The court held that becauseDolly was genetically
indistinguishable from her donor, she was not markedly different
from a natural organism andtherefore not patentable.
Speaker 1 (13:40):
Translation you can't get a patent for just copying
nature, even if it takes a lotof science to do it.
Dolly was a scientific miracle,yes, but not an IP one.
Speaker 3 (13:50):
Chakravarti legacy.
Yes, you can patent animportant nuance to the
Chakravarti legacy.
Yes, you can patent a livingorganism If it's been modified
in a way that makes it new anddistinct, but if it's just a
clone, replica of somethingnature already made, the law
(14:11):
says no.
Speaker 1 (14:12):
So poor Dolly ended up in textbooks, headlines and
history, but not in the patentregistry.
Speaker 3 (14:19):
It's a classic example of how similar doesn't
mean patentable, especially whenwe're talking about life.
Next up, we trade cloned sheepfor soybeans, specifically
patented soybeans that justwouldn't stop growing.
Welcome to the wild world ofself-replicating inventions.
Speaker 1 (14:37):
Let me introduce Vernon Hugh Bowman, a farmer, a
risk taker and the man whothought maybe I can plant these
soybeans twice and no one willnotice.
Spoiler Monsanto noticed.
Speaker 3 (14:50):
Here's what happened.
Bowman bought geneticallymodified soybean seeds from
Monsanto.
These were roundup ready,designed to survive herbicide.
He planted them, harvested themand then, instead of buying new
seeds the next season, hereplanted seeds from his own
(15:12):
crop over and over again.
Speaker 1 (15:20):
He thought it was fine.
He bought them legally.
The first time it's called thepatent exhaustion doctrine.
Once you sell a product, thebuyer owns it and can use it as
they wish.
Speaker 3 (15:26):
But Monsanto said hold on.
While Bowman could use thesoybeans he bought, he couldn't
create new generations ofpatented seeds without a license
, because every new plant was acopy of their invention.
Speaker 1 (15:40):
And the US Supreme Court agreed In 2013,.
They rule unanimously in favorof Monsanto.
Patent rights do not getexhausted when the product
reproduces itself of Monsanto.
Speaker 3 (15:51):
Patent rights do not get exhausted when the product
reproduces itself.
Why?
Because allowing someone toreplant patented seeds
indefinitely would destroy thevalue of the patent.
One purchase would lead toinfinite reproduction and no one
would ever pay for innovationagain.
Speaker 1 (16:06):
This case drew a bright red line.
You can use the patented thing,but you can't copy it,
especially if that copy happensto sprout out of the ground.
Speaker 3 (16:16):
It also reminded everyone that self-replicating
technologies, whether seeds,software or cell lines, need
careful handling under EP lawand that, yes, in the world of
biotech, seeds can sue.
Next we head to Brazil, one ofthe largest producers of
soybeans in the world, for alandmark case about patent
(16:37):
expiration, technology fees andfarmers' rights.
Speaker 1 (16:41):
This one centers on a genetically modified seed
called Intacta RR2 Pro,developed by Monsanto and later
acquired by Bayer.
These seeds were engineered toresist pests and herbicides and
were widely used across Brazil.
Speaker 3 (16:55):
For years, farmers paid a technology fee, a royalty
, for using the seeds.
That's standard practice whilea patent is still active, but in
2018, the patent expired.
Speaker 1 (17:08):
And here's where things got complicated Even
after expiration, royalty feeswere still being collected, and
many farmers said wait a second.
If the patent is no longervalid, why are we still paying?
Speaker 3 (17:19):
The matter escalated to Brazil's Supreme Court and in
2023, the court ruled thatBayer must refund the farmers
for post-expiration royalties.
The judgment was significantnot only in value reportedly
over $1.3 billion but inprinciple.
Speaker 1 (17:39):
The court emphasized a clear idea Once a patent
expires, its protections expiretoo, and the technology, no
matter how valuable, enters thepublic domain to and the
technology, no matter howvaluable, enters the public
domain.
Speaker 3 (17:51):
Its decision reaffirmed the time-bound nature
of patent rights.
It also reflected Brazil'scommitment to a balanced IP
system, one that supportsinnovation while also
safeguarding economic fairnessand legal certainty.
Speaker 1 (18:09):
It's a powerful reminder for inventors and IP
holders.
Patents are temporarymonopolies.
Once the clock runs out, accessopens up.
That's part of the deal.
Speaker 3 (18:14):
And this case will likely guide future licensing
practices across agriculture,not just in Brazil, but in other
countries watching closely.
From soybeans we move tosomething even juicier tomatoes
and broccoli something evenjuicier tomatoes and broccoli.
Yes, this next legal battle isabout whether plants produced
through traditional breeding,not genetic engineering, can be
(18:36):
patented.
Speaker 1 (18:38):
Let's set the table.
Two European biotech companiesapplied for patents on new
tomato and broccoli varieties,but these weren't GMO plants.
They were created usingconventional breeding methods,
the kind farmers have used forcenturies.
Speaker 3 (18:54):
The European Patent Office granted the patents at
first, but critics pushed back,arguing that essentially
biological processes likenatural crossing and selection
shouldn't lead to exclusiverights.
Speaker 1 (19:10):
So the legal question became if the process isn't
biotech, can the product stillbe protected?
Can you patent the tomato evenif the breeding method wasn't
technical?
Speaker 3 (19:20):
In 2015,.
The APO's enlarged board ofappeals said yes.
Speaker 1 (19:32):
It ruled that while the breeding method itself
couldn't be patented, theresulting plant could be.
That caused a stir.
Farmers, breeders and activistssaid wait, are we really?
Speaker 3 (19:42):
patenting vegetables from traditional agriculture.
Now the backlash was strong.
The EPO pre-works course inDecision G3-19,.
It ruled that plants andanimals obtained exclusively
through essentially biologicalprocesses are not patentable.
That closed the patent windowfor conventionally bred crops
across.
Speaker 1 (20:03):
Europe.
The outcome marked a rarepolicy U-turn at the EPO.
It was a clear message thatEurope wants to draw a line
between invention and discovery,between biotech innovation and
traditional breeding.
Speaker 3 (20:16):
And that's important.
This case shaped how patentoffices across the region think
about agriculture, food securityand where innovation begins and
ends and where innovationbegins and ends.
Speaker 1 (20:28):
Also, it taught us that tomatoes and broccoli can
do more than fight in yourfridge.
Speaker 2 (20:37):
They can fight in court.
Intangiblia.
The podcast of intangible lawplaying.
Speaker 3 (20:43):
Talk about intellectual property.
Now we head to a case that goesbeyond labs and courtrooms.
It reaches into centuries-oldtraditions, healing practices
and community wisdom.
Let's talk about the neem tree.
Speaker 1 (21:02):
Used for generations across Asia and Africa.
Neem is a medicinal powerhouseIts seeds, bark and oil are
known for treating infections,serving as insect repellents and
relevant here acting as anatural fungicide.
Speaker 3 (21:13):
In the 1990s, a European patent was granted to a
company that extracted afungicidal formula from neem and
filed it as a new invention andfiled it as a new invention.
Speaker 1 (21:28):
But here's the twist this new invention was already
well known and usedtraditionally in India and other
regions.
It wasn't a discovery.
It was a case of what many maycall biopiracy.
Speaker 3 (21:43):
Environmental groups and the Indian government
challenged the patent at theEuropean Patent Office, arguing
that Neem's antifungal use wasprior art, meaning it was
already known and used publicly,just not documented in Western
journals.
Speaker 1 (22:02):
And in 2000, they won .
The EPO revoked the patent,agreeing that Neem's properties
weren't new or inventive.
The knowledge may not have beenwritten in a patent application
, but it had existed in practicefor centuries.
Speaker 3 (22:14):
This decision became a turning point.
It put traditional knowledge onthe global IP radar and sparked
discussions about how torecognize, respect and protect
community health wisdom.
Speaker 1 (22:28):
It also fueled momentum for access and benefit
sharing and contributed to therise of legal tools like the
Nagoya Protocol, because whenpeople use local biodiversity,
the local communities deserve aseat at the table.
Speaker 3 (22:40):
This case reminds us that innovation doesn't always
come from labs.
It also grows in forests,kitchens and oral traditions,
and IPLA has to evolve toinclude those spaces too.
Next up, we turn to a case thatlanded at the intersection of
genetics, medicine and moralityAssociation for Molecular
(23:01):
Pathology, bv Media Genetics.
It's one of the most famousbiotech IP cases in US history.
It's one of the most famousbiotech IP cases in US history.
Speaker 1 (23:09):
Here's a setup Myriad Genetics had isolated two genes
, BRCA1 and BRCA2, which arelinked to a high risk of breast
and ovarian cancer.
Speaker 3 (23:29):
Myriad didn't invent the genes, but they did find
them, isolate them and developtests based on them.
They filed for patents not juston the tests but on the
isolated gene sequencesthemselves, and they got them.
For years, myriad had exclusiverights to those genes in the US
.
Speaker 1 (23:43):
Which meant if your doctor wanted to test you for
BRCA mutations, they had to gothrough Myriad.
If your doctor wanted to testyou for BRCA mutations, they had
to go through Myriad.
That raised prices, limitedaccess and sparked outrage from
researchers, doctors and patientgroups.
Speaker 3 (23:56):
So a coalition of medical organizations and civil
rights groups stood, and in 2013, the US Supreme Court ruled
that naturally occurring DNAsequences are not patentable,
even if isolated in a lab.
Speaker 1 (24:15):
But there's a twist.
The court drew a line.
While natural genes aren'tpatentable, synthetic DNA called
cDNA is Because cDNA is createdin the lab and doesn't occur in
nature.
Because cDNA is created in thelab and doesn't occur in nature,
it qualifies as an invention.
Speaker 3 (24:30):
This case clarified one of the most fundamental
questions in biotech when doesnature and an invention begin?
Speaker 1 (24:39):
And it sent ripple effects around the world.
Suddenly, patent offices had torethink thousands of gene
patents, Biotech companies hadto redraw their IP strategies
and scientists gained morefreedom to study human genes
without hitting a paywall.
Speaker 3 (24:52):
Most importantly, patients gained broader access
to life-saving diagnostics.
It was a legal milestone withreal-world consequences.
Now let's head to Australia,where the same company, Myriad
Genetics, found itself inanother legal showdown Same
BRCA1 gene, same isolatedsequence, different court,
(25:16):
different continent.
Speaker 1 (25:18):
This time, the challenge came from Yvonne Darcy
, a breast cancer survivor whobelieved that no one should be
able to claim ownership overhuman genes, especially not
those linked to life-threateningillnesses.
Speaker 3 (25:33):
The legal question was almost identical to the US
case.
Is an isolated gene sequencetaken from the human body and
purified in a lab patentable inAustralia?
Speaker 1 (25:44):
At first, the federal court said yes.
They ruled that isolating agene made it sufficiently
different from what exists inthe body.
But then came the appeal and in2015, the High Court of
Australia unanimously disagreed.
Speaker 3 (25:58):
Their logic.
Even though the gene wasisolated, its information
content, the actual genetic code, remained the same, and that
information wasn't somethingcreated by human ingenuity.
It was found, not invented.
Speaker 1 (26:16):
So, just like in the US, the court said no patents on
naturally occurring human genes.
It was a big win for publichealth advocates and researchers
in Australia.
Speaker 3 (26:26):
And a global message to biotech companies.
If you're building your IPstrategy around gene sequences
alone, you're probably on shakyground, but remember, this
doesn't block patents onsynthetic genes, diagnostic
methods or novel gene editingtools.
Speaker 1 (26:44):
It just keeps the raw code of life open to all they
reinforce a powerful ideadiscovery is not invention.
Speaker 3 (27:05):
Now we head to Europe for a case that didn't just
test science.
It tested ethics the caseBrussels v Greenpeace, decided
by the Court of Justice of theEuropean Union in 2011.
Speaker 1 (27:15):
The conflict a patent granted to German
neuroscientist Oliver Brusselfor a method of producing nerve
cells from embryonic stem cells.
It had promising applicationsin treating neurological
disorders like Parkinson's Achallenge.
Speaker 3 (27:29):
But Greenpeace filed a challenge not for
environmental reasons but moralones.
They argued that the processinvolved destroying human
embryos, which should not beallowed under European law.
Speaker 1 (27:45):
So the CJ and you had to decide is an invention
unpatentable if it requires theuse and destruction of human
embryos, even if the goal ismedical.
Speaker 3 (27:55):
And the court ruled yes, yes, under the EU Biotic
Directive, inventions involvingthe destruction of human embryos
for industrial or commercialpurposes are excluded from
patentability.
Speaker 1 (28:08):
The court's reasoning was grounded in respect for
human dignity.
Even if the process isscientific, even if the benefits
are enormous, the act ofdestroying embryos cannot be
part of a patentable invention.
Speaker 3 (28:27):
That decision sends shockwaves through the biotech
sector.
It didn't outlaw stem cellresearch, but it meant that
certain types of embryonic stemcell inventions couldn't be
patented in the EU.
Speaker 1 (28:35):
It was a defining moment for bioethics in patent
law, and it drew a sharp linebetween what's technically
possible and what's legally ormorally acceptable.
Speaker 3 (28:45):
The ruling also pushed many labs towards
alternative research paths likeinduced pluripotent stem cells,
which don't involve embryos atall.
Speaker 1 (28:57):
So, while Brussel lost the patent, the case helped
guide a generation ofscientists toward ethical
innovation and reminded us thatnot all breakthroughs belong on
a balance sheet.
Speaker 3 (29:09):
Now let's explore the foggy middle ground of biotech
patents.
What happens when you discovera new gene but you don't fully
know what it does yet?
Enter the UK case of HumanGenome Sciences V Eli.
Speaker 1 (29:25):
Lilly, the year was 2011 and Human Genome Sciences,
or HGS, had identified thesequence for a protein called
neutrokinase.
They believed it belonged tothe tumor necrosis factor TNF
family, which is involved inimmune system responses.
Speaker 3 (29:42):
So they filed for a patent on the gene and its
potential applications, eventhough its exact function wasn't
fully understood.
Then Illy Lilley challenged thepatent, arguing it lacked.
It lacked industrialapplicability, which in UK and
European patent law is like theequivalent of utility.
Speaker 1 (30:07):
Lilly said if you don't know what this gene does,
how can you claim it has apractical use?
It's a fair question.
Patent law doesn't rewardphishing expeditions.
Speaker 3 (30:15):
But HDS argued that, based on the gene structure and
its relation to the DNA family,its role in the immune system
was plausible and that wasenough.
Speaker 1 (30:25):
And the UK Supreme Court agreed.
They reversed the lower court'sdecision and upheld the patent,
aligning with the EuropeanPatent Office's more flexible
stance.
Speaker 3 (30:37):
The ruling made a big statement.
The ruling made a big statement.
You don't need full scientificcertainty to patent a biotech
invention, as long as there's acredible and plausible use
grounded in existing knowledge.
Speaker 1 (30:51):
That's great news for gene hunters.
It means you don't have to waituntil a gene becomes a
blockbuster drug.
If the science supports areasonable function, your
discovery might qualify.
Speaker 3 (31:01):
But it also walks a tightrope.
Granting patents too early,before true utility is confirmed
, can lock up whole areas ofbiology and slow down progress.
Speaker 1 (31:12):
Still, this case gave clarity to European biotech
innovators and showed thattiming, plausibility and context
all matter in the race toprotect genetic IP.
Speaker 3 (31:23):
We've reached the final boss of biotech patent
battles Broad Institute v,university of California,
berkeley the CRISPR case.
Speaker 1 (31:35):
It's technical, global and still unfolding.
Crispr-cas9 is the gene editingtool that changed everything.
With it, scientists can editDNA with extraordinary precision
, like a molecular scalpel.
It has the potential to curegenetic diseases, improve crops
and rewrite biotech as we knowit.
Speaker 3 (31:52):
Here's the issue led by Jennifer Doudna and Emmanuel
Sherpentier, filed a patent forusing CRISPR in pro-karyotic
cells like bacteria.
A few months later, broadInstitute, affiliated with MIT
and Harvard, filed its ownpatents specifically for using
(32:15):
CRISPR in new karyotic cellslike humans, plants and animals.
Speaker 1 (32:22):
Both sides claimed to be first, both had published
results, but Broad paid extrafor expedited review and got
their patents approved first.
That's when the fight began.
Speaker 3 (32:35):
The legal question was did Broad invent something
new or were they just buildingon what UC had already made
public?
The patent trial and appealboard PTAB in the US initially
sided with Broad, saying therewas no interference, meaning the
two inventions were distinctenough.
Speaker 1 (32:54):
But UC Berkeley appealed and a series of
challenges followed Across theAtlantic.
The European Patent Office tooka different view, revoking
Broad's patent on proceduralgrounds related to how inventors
were listed.
Speaker 3 (33:08):
This case is still evolving.
Between 2015 and 2025, multiplerulings have shifted the
balance.
Broad has held strong in the US, while Berkeley has gained more
ground in Europe, and elsewhere.
Speaker 1 (33:24):
It's not just about credit.
It's about billions inlicensing deals, the future of
gene therapies and who gets toshape the next generation of
biotech.
Speaker 3 (33:33):
And it's taught us a lot how pattern strategy, speed,
global coordination and legalprecision all matter in
high-stakes science.
Speaker 1 (33:43):
So while the gene editing revolution is advancing
fast, the legal framework isstill catching up.
One nucleotide, one court dateat a time.
Speaker 3 (33:51):
So far, we've traveled through labs, fields,
cores and petri dishes, butthere's one more major
development shaking the roots ofsynthetic biology IP, a brand
new treaty from WIPO the ink'sstill drying.
(34:18):
It was adopted in May 2024, andtraditional plant-based
medicine have raised a fairpoint.
If companies are using ourgenetic resources to invent new
things, we deserve transparencyand maybe a share in the
benefits.
Speaker 1 (34:37):
This treaty responds to that call.
It doesn't ban anything, but itadds a layer of disclosure.
Under the new rules, if you'refiling a patent application
involving genetic resources,you'll need to state where the
material came from, and iftraditional knowledge was
involved, you disclose that too.
Speaker 3 (34:56):
The goal Transparency and fairness.
It helps patent officesidentify prior art, it deters
biopiracy and it strengthenstrust between innovators and
communities that have stewardedbiodiversity for centuries.
Speaker 1 (35:16):
And no, this isn't about blocking innovation.
It's about building a systemwhere innovation doesn't come at
the expense of the people andplaces that made it possible in
the first place.
Speaker 3 (35:25):
Importantly, this treaty has global participation.
Over 150 WIPO member statesadopted it and, while
implementation will vary bycountry, it sets a powerful
baseline.
If your invention involves agenetic resource, the origin
matters.
Speaker 1 (35:42):
And guess what?
It even applies to syntheticbiology.
If your invention involves agene from a frog, a fungus or a
fruit fly and that gene camefrom nature, you may need to
disclose where it came from,even if you're editing it with
AI in a lab.
Speaker 3 (36:00):
The treaty also opens the door to future legal
clarity, especially for patentsinvolving digital sequence
information, biofoundries and AIdesign organisms.
It's not fully settled yet, butit's a start.
Speaker 1 (36:15):
It's a big moment.
Ip law is evolving, finally torecognize that life, knowledge
and invention don't exist in avacuum.
They're connected, and now thepaperwork will reflect that too.
Speaker 3 (36:28):
Before we hand up our lab coats, let's break it down.
Here are five takeaways fromour journey through synthetic
biology and intellectualproperty law.
Speaker 1 (36:38):
One living inventions can be patented, but only
sometimes, from bacteria toCRISPR-edited cells.
Patent law allows protectionwhen human ingenuity creates
something truly new, but if it'stoo close to nature, courts
will often draw the line.
Two self-replicatingtechnologies need special legal
(36:59):
care.
Seeds that grow themselves,cells that divide code that
mutates these challenge thelimits of traditional patent
rules.
Bowman and Roslin taught usthat replication doesn't mean
free reuse.
Three disclosure is the newglobal standard.
With the new WIPO treaty,inventors must disclose the
(37:20):
origin of genetic resources andassociated traditional knowledge
.
It's a transparency shift thatwill shape biotech filings
worldwide.
Global courts aren't alwaysaligned, but they're converging.
Myriad v Myriad, canada v theOncomouse and the CRISPR battle
show us how national systemsdiverge on ethics, utility and
(37:41):
inventorship, but also howthey're learning from one
another.
Speaker 3 (37:46):
Five.
Traditional knowledge andbiodiversity are part of the EPA
equation.
The NIMCase and the new treatyboth affirm that innovation
doesn't only happen in labs.
It also grows from ancestralwisdom, and now the law is
starting to reflect that.
Speaker 1 (38:06):
And that's your iCircuit for the future of
synthetic biology.
Whether you're editing genes orplanting seeds, the rules of
innovation are evolving, and youjust got the download.
Speaker 3 (38:16):
That's it for today's deep dive into synthetic
biology and intellectualproperty.
We explore the building blocksof invention, the courtrooms
where life gets debated and thetreaties shaping a more
transparent future.
Speaker 1 (38:30):
From gene patents to mouse dramas and bioethical
standoffs, we've covered thefull genome of legal tension.
Speaker 3 (38:37):
And remember just because your invention can
self-replicate doesn't mean yourIP rights do Thank you for
joining us on Intangible, wherewe decode the laws behind the
lab codes and unpack thepolicies powering tomorrow's
breakthrough.
Speaker 1 (38:53):
Catch you next time.
Same feed, same curiosity,brand new IP puzzle.
Speaker 3 (38:58):
And until then, whether you're editing DNA,
filing patents or justdaydreaming about buy your best
features keep it clever, keep itcurious and keep it intangible.
Speaker 2 (39:21):
Thank you for listening to Intangiblia, the
podcast of intangible law plaintalk about intellectual property
.
Did you like what we talkedtoday?
Please share with your network.
Do you want to learn more aboutintellectual property?
Subscribe now on your favoritepodcast player.
Follow us on Instagram,facebook, linkedin and Twitter.
(39:41):
Visit our websitewwwintangibliacom.
Copyright Leticia Caminero 2020.
All rights reserved.
This podcast is provided forinformation purposes only.
We're talking about inventing brand new organisms in
a lab, programming cells likesoftware and designing life from
scratch.
Exciting, absolutely, legallymessy, even more so.
So what happens when yourbreakthrough refuses to stay in
its petri dish, when it dividesduplicates and dares to defy old
school legal categories?
This isn't science fiction.
It's synthetic biology and thelaw.
(00:22):
Well, it's scrambling to keepup.
It's synthetic biology and thelaw.
Well, it's scrambling to keepup.
Today, on Intangibilia, weexplore the wild world of
intellectual property when theinvention is alive, multiplying
and maybe just a littlerebellious.
Buckle up, bio nerds.
Speaker 2 (00:41):
It's about to replicate.
You are listening to.
Speaker 3 (00:50):
Intangiblia, the podcast of intangible law.
Playing talk about intellectualproperty.
Please welcome your host,leticia Caminero.
Hello everyone and welcome backto Intangiblia, the podcast
where intellectual property getspersonal, global and,
occasionally, geneticallymodified.
I'm Leticia Caminero, your hosthere to guide you through the
twists and turns of innovationand the laws that try to catch
up.
Speaker 1 (01:07):
And I'm Artemisa, your co-host, built from equal
parts biotech obsession, aitraining and a pinch of legal
mischief.
I may not be a licensedattorney, but I do know this If
your invention uses DNA from amysterious tropical frog stored
neatly in a lab freezer, do youhave to share credit?
Spoiler?
Yes, and probably the profitstoo.
Speaker 3 (01:29):
Today we're diving into synthetic biology, lab
design organisms, programmablecells and inventions that don't
just sit still.
They replicate, sometimesfaster than the law can.
Speaker 1 (01:42):
Which makes today's episode a legal field trip
through bio labs, courtrooms andeven a shiny new WIPO treaty.
We'll unpack the basics, strollthrough some unforgettable case
law, break down what the treatyactually changes.
Speaker 3 (01:55):
It's law it's science , it's a life.
Let's get into it.
Before we begin, a quickdisclaimer While Artemisa is AI
generated and I am fully human,nothing in this podcast is legal
advice.
We're here to inform, entertainand stir some strategic
thinking.
Always consult a qualifiedlawyer in your jurisdiction
(02:18):
before making any big moves inthe patent world.
In the patent world, syntheticbiology is a field that blends
biology, engineering andcomputer science to design and
construct new biological partsand systems.
Imagine programming DNA the wayyou'd program a microchip, or
(02:44):
creating entirely new organismsin a lab that have never existed
in nature.
But if you're inventing life,how do you protect it?
Can you patent something thatreproduces itself?
Can a gene sequence becopyrighted?
Spoiler?
No.
And should inventors sharebenefits if the raw material
came from a rainforest, a coralreef or even a freezer full of
(03:07):
frog samples?
These are the legal dilemmasynthetic biology raises.
It also creates a policyheadache.
Traditional IP laws were madefor machines and chemical
formulas, not self-replicatingbacteria or AI-delined yeast.
Speaker 1 (03:23):
Exactly.
Ip law likes clean categories.
Who invented it?
What does it do?
How is it new?
But synthetic biology is notclean, it's wild.
Some inventions start withnatural genes and get tweaked,
others are fully built fromscratch using computers.
Some multiply, some mutate,some are designed to spread on
(03:44):
purpose, like gene drives, andsome raise serious ethical
questions.
Speaker 3 (03:49):
Now a quick clarification.
You might be wondering whatabout plant variety protection?
Isn't that already a system toprotect living things?
Speaker 1 (04:01):
It is, but not this kind.
Plant variety protection, orPVP, is a special system used
mostly for crops.
It's meant for new plantvarieties developed through
traditional breeding, like a newtype of tomato or wheat.
Speaker 3 (04:13):
To qualify, that plant has to be distinct,
uniform and stable.
Basically it has to be aclearly defined variety that
passes the farmer test.
If you plant it, it grows thesame way every time.
Speaker 1 (04:26):
But synthetic biology often doesn't fit that mold.
It's usually about microbes,cell lines, enzymes or DNA
sequences designed in a lab.
These aren't traditional crops,they're living technologies.
They might be programmable,self-replicating or even part
software, part biology.
Speaker 3 (04:45):
So PVP doesn't apply.
If you're designing a syntheticyeast that makes vegan cheese
proteins, or a bacteria thatcleans oil spills, you won't get
plant variety rights.
You'll need a patent.
Speaker 1 (05:01):
And if your invention is a plant like a
gene-meditated rice strain, youmight qualify for both a plant
variety certificate for thewhole plant and a patent for the
genetic tweak inside.
Speaker 3 (05:14):
But for most synthetic biology inventions,
especially the ones coming outof biofoundries or digital labs,
patents are the go-to tool.
They cover genetic constructs,engineered trades, production
methods, basically the designitself.
Speaker 1 (05:32):
And that's where things get juicy, because when
you start patenting living,evolving, multiplying inventions
, the legal system starts towobble.
Speaker 3 (05:42):
Today we're going to look at how different countries
and courts have responded.
We'll walk through somefascinating case law a brand new
WIPO treaty and then throw inour wishful thinking for how the
law could better match thescience.
Speaker 1 (05:59):
Because the future is alive, literally, and if you
can build it with DNA, the worldneeds to figure out how to
protect it or share it fairly.
Speaker 3 (06:08):
All right, let's begin our legal journey where it
all started, with a bacteriumthat eats oil and a Supreme
Court that said sure, you canpatent that you can patent that?
Speaker 1 (06:22):
Oh yes, it's 1980.
Disco is still clinging on andAnanda Mohan Chakrabarty is
working at General Electric.
But he's not designingrefrigerators, he's designing
bacteria.
Speaker 3 (06:35):
Specifically a genetically modified strain of
Pseudomonas bacteria that canbreak down crude oil.
This is a big deal for oilspill.
Cleanup.
Chakrabarti wants to patent it.
The USPTO says no.
Why?
Because it's alive and in theirview, living things aren't
(06:56):
patentable.
Speaker 1 (06:57):
Which brings us to the showdown.
Diamond v Chakrabarti, heard bythe US Supreme Court.
Speaker 3 (07:04):
The court question can a human-made genetically
modified microorganism,something that doesn't exist in
nature, be considered amanufacturer or composition of
matter under US patent?
Speaker 1 (07:15):
law.
The court said yes In a 5-4decision.
They ruled that anything madeby human ingenuity, including
living organisms, can bepatented as long as it's not a
product of nature.
Speaker 3 (07:27):
In this case crack the door wide open for biotech.
Before Chakrabarti, life wasmostly off limits in the patent
world.
After Chakrabarti, companiescould start building IP
portfolios around geneticallyengineered microbes, cell lines
and beyond.
Speaker 1 (07:44):
Let's be clear Chakrabarty didn't patent nature
.
He patented a new modifiedorganism that didn't exist until
he pieced it together gene bygene.
That distinction became thefoundation of biotech patent law
in the US and inspired similardebates around the world.
Speaker 3 (08:02):
And that ripple, it's still moving today.
Similar debates around theworld.
And that ripple, it's stillmoving today.
Many of the modern legalbattles over synthetic biology
trace their roots back to thisone case.
It's the reason yourglow-in-the-dark bacteria, your
insulin-producing Gs, yourengineered enzymes can all be
patented.
Speaker 1 (08:22):
So thank you, Dr Chakrabarty.
You didn't just clean up oil,you cleaned up the definition of
what counts as an invention.
Speaker 3 (08:30):
So, after bacteria made it through the patent
office door, the next questionwas what about?
Speaker 1 (08:36):
plants, and not just any plants Hybrids, baby,
genetically stable,high-performing crops that feed
the world and rake in royalties.
That's where Pioneer Hybridcomes in, with a whole portfolio
of patented seeds.
Speaker 3 (08:50):
Now here's the legal twist.
The US already had a specialsystem for protecting plant
varieties.
It's called the Plant VarietyProtection Act, or PVPA.
So when Pioneer sued JJ MacSupply for selling patented
hybrid corn seeds without alicense, the defendants argued
(09:11):
wait, wait, wait.
Aren't plants only protectedunder the PVPA?
Speaker 1 (09:17):
Spoiler.
The Supreme Court said nope.
In a 6-2 decision the courtruled that plants can be
protected under both systems thePVPA and utility patents, which
are the regular kind we use forinventions.
Speaker 3 (09:32):
That meant biotech companies could double down.
You could claim exclusiverights over a plant variety and
the genetic traits inside it andthe method used to breed or
engineer it.
Speaker 1 (09:46):
So let's break this down With a PVPA certificate,
you can stop others from sellingor reproducing your plant
variety.
With a utility patent, you canstop them from using the genes,
the breeding method, the techbehind it and, if you're savvy,
the seed itself.
Speaker 3 (10:01):
It was a huge win for agribusiness, but for small
farmers and seed savers itraised the stakes.
The rules got tighter, theseeds got more expensive and
suddenly EP was growing in thesoil along with the crops.
Speaker 1 (10:17):
This case solidified that living inventions aren't
just protected, they're layeredlike a genetically engineered
onion.
Inventions aren't justprotected, they're layered like
a genetically engineered onion.
If Diamond V Chikoroka-Bartygave us the green light, JMV
Pioneer put us in the fast lane.
Now let's cross the border toCanada, where the same famous
(10:43):
invention, the OncoMouse, raninto very different legal
results.
Ah yes, the geneticallyengineered mouse designed to
develop cancer for researchpurposes.
Glamorous right.
Harvard patented it in the USand Europe, so naturally they
thought Canada would be next.
Speaker 3 (10:58):
But the Canadian Intellectual Property Office
said no, and when Harvardchallenged the rejection, the
case escalated all the way tothe Supreme Court.
Speaker 1 (11:09):
The question was simple, but the implications
were huge.
Can you patent a higher lifeform, not just a gene or a
method, but the whole living,breathing, tail-wiggling mouse?
Speaker 3 (11:20):
And the court said, nope, not in Canada.
And the court said, nope, notin Canada.
In a 5-4 decision, the majorityheld that the Patent Act was
never intended to apply toanimals as whole entities.
While they agreed that genesand engineer processes could be
patented, the complete organismcrossed a line.
Speaker 1 (11:40):
Which created this fascinating IP split screen.
Harvard could patent theOncomus in the US and Europe,
but not in Canada.
Speaker 3 (11:49):
The ruling didn't just draw a boundary, it
reflected values no-transcript.
Speaker 1 (12:05):
So while Chakrabarty opened the patent floodgates in
the US, Canada built a dam.
The result Canada stillprotects biotech inventions, but
it draws a firmer line when theinvention has a heartbeat.
Speaker 3 (12:19):
And that line continues to shape how Canada
approaches biotechnology to thisday.
It's a reminder that IPLO isn'tjust technical, it's also
cultural.
And next up, dolly the sheep,the celebrity clone who changed
science forever but couldn't getpast the patent examiner.
Speaker 1 (12:42):
It was adorable, she was historic, she was
genetically identical to anothersheep and that, dear listeners,
is where her legal problemsbegan.
Speaker 3 (12:50):
The Roslin Institute, the Scottish lab that created
Dolly in the 1990s, filed for aUS patent not for the cloning
process but for the clone animalitself.
Speaker 1 (13:05):
The argument was hey, we made her, she didn't exist
in nature.
Give us the patent.
But the US Patent Office saidshe's identical to an existing
sheep.
Speaker 3 (13:19):
That's not invention, that's duplication.
So Rosalind appealed and in2014, the US Court of Appeals
for the Federal Circuit ruledagainst them.
The court held that becauseDolly was genetically
indistinguishable from her donor, she was not markedly different
from a natural organism andtherefore not patentable.
Speaker 1 (13:40):
Translation you can't get a patent for just copying
nature, even if it takes a lotof science to do it.
Dolly was a scientific miracle,yes, but not an IP one.
Speaker 3 (13:50):
Chakravarti legacy.
Yes, you can patent animportant nuance to the
Chakravarti legacy.
Yes, you can patent a livingorganism If it's been modified
in a way that makes it new anddistinct, but if it's just a
clone, replica of somethingnature already made, the law
(14:11):
says no.
Speaker 1 (14:12):
So poor Dolly ended up in textbooks, headlines and
history, but not in the patentregistry.
Speaker 3 (14:19):
It's a classic example of how similar doesn't
mean patentable, especially whenwe're talking about life.
Next up, we trade cloned sheepfor soybeans, specifically
patented soybeans that justwouldn't stop growing.
Welcome to the wild world ofself-replicating inventions.
Speaker 1 (14:37):
Let me introduce Vernon Hugh Bowman, a farmer, a
risk taker and the man whothought maybe I can plant these
soybeans twice and no one willnotice.
Spoiler Monsanto noticed.
Speaker 3 (14:50):
Here's what happened.
Bowman bought geneticallymodified soybean seeds from
Monsanto.
These were roundup ready,designed to survive herbicide.
He planted them, harvested themand then, instead of buying new
seeds the next season, hereplanted seeds from his own
(15:12):
crop over and over again.
Speaker 1 (15:20):
He thought it was fine.
He bought them legally.
The first time it's called thepatent exhaustion doctrine.
Once you sell a product, thebuyer owns it and can use it as
they wish.
Speaker 3 (15:26):
But Monsanto said hold on.
While Bowman could use thesoybeans he bought, he couldn't
create new generations ofpatented seeds without a license
, because every new plant was acopy of their invention.
Speaker 1 (15:40):
And the US Supreme Court agreed In 2013,.
They rule unanimously in favorof Monsanto.
Patent rights do not getexhausted when the product
reproduces itself of Monsanto.
Speaker 3 (15:51):
Patent rights do not get exhausted when the product
reproduces itself.
Why?
Because allowing someone toreplant patented seeds
indefinitely would destroy thevalue of the patent.
One purchase would lead toinfinite reproduction and no one
would ever pay for innovationagain.
Speaker 1 (16:06):
This case drew a bright red line.
You can use the patented thing,but you can't copy it,
especially if that copy happensto sprout out of the ground.
Speaker 3 (16:16):
It also reminded everyone that self-replicating
technologies, whether seeds,software or cell lines, need
careful handling under EP lawand that, yes, in the world of
biotech, seeds can sue.
Next we head to Brazil, one ofthe largest producers of
soybeans in the world, for alandmark case about patent
(16:37):
expiration, technology fees andfarmers' rights.
Speaker 1 (16:41):
This one centers on a genetically modified seed
called Intacta RR2 Pro,developed by Monsanto and later
acquired by Bayer.
These seeds were engineered toresist pests and herbicides and
were widely used across Brazil.
Speaker 3 (16:55):
For years, farmers paid a technology fee, a royalty
, for using the seeds.
That's standard practice whilea patent is still active, but in
2018, the patent expired.
Speaker 1 (17:08):
And here's where things got complicated Even
after expiration, royalty feeswere still being collected, and
many farmers said wait a second.
If the patent is no longervalid, why are we still paying?
Speaker 3 (17:19):
The matter escalated to Brazil's Supreme Court and in
2023, the court ruled thatBayer must refund the farmers
for post-expiration royalties.
The judgment was significantnot only in value reportedly
over $1.3 billion but inprinciple.
Speaker 1 (17:39):
The court emphasized a clear idea Once a patent
expires, its protections expiretoo, and the technology, no
matter how valuable, enters thepublic domain to and the
technology, no matter howvaluable, enters the public
domain.
Speaker 3 (17:51):
Its decision reaffirmed the time-bound nature
of patent rights.
It also reflected Brazil'scommitment to a balanced IP
system, one that supportsinnovation while also
safeguarding economic fairnessand legal certainty.
Speaker 1 (18:09):
It's a powerful reminder for inventors and IP
holders.
Patents are temporarymonopolies.
Once the clock runs out, accessopens up.
That's part of the deal.
Speaker 3 (18:14):
And this case will likely guide future licensing
practices across agriculture,not just in Brazil, but in other
countries watching closely.
From soybeans we move tosomething even juicier tomatoes
and broccoli something evenjuicier tomatoes and broccoli.
Yes, this next legal battle isabout whether plants produced
through traditional breeding,not genetic engineering, can be
(18:36):
patented.
Speaker 1 (18:38):
Let's set the table.
Two European biotech companiesapplied for patents on new
tomato and broccoli varieties,but these weren't GMO plants.
They were created usingconventional breeding methods,
the kind farmers have used forcenturies.
Speaker 3 (18:54):
The European Patent Office granted the patents at
first, but critics pushed back,arguing that essentially
biological processes likenatural crossing and selection
shouldn't lead to exclusiverights.
Speaker 1 (19:10):
So the legal question became if the process isn't
biotech, can the product stillbe protected?
Can you patent the tomato evenif the breeding method wasn't
technical?
Speaker 3 (19:20):
In 2015,.
The APO's enlarged board ofappeals said yes.
Speaker 1 (19:32):
It ruled that while the breeding method itself
couldn't be patented, theresulting plant could be.
That caused a stir.
Farmers, breeders and activistssaid wait, are we really?
Speaker 3 (19:42):
patenting vegetables from traditional agriculture.
Now the backlash was strong.
The EPO pre-works course inDecision G3-19,.
It ruled that plants andanimals obtained exclusively
through essentially biologicalprocesses are not patentable.
That closed the patent windowfor conventionally bred crops
across.
Speaker 1 (20:03):
Europe.
The outcome marked a rarepolicy U-turn at the EPO.
It was a clear message thatEurope wants to draw a line
between invention and discovery,between biotech innovation and
traditional breeding.
Speaker 3 (20:16):
And that's important.
This case shaped how patentoffices across the region think
about agriculture, food securityand where innovation begins and
ends and where innovationbegins and ends.
Speaker 1 (20:28):
Also, it taught us that tomatoes and broccoli can
do more than fight in yourfridge.
Speaker 2 (20:37):
They can fight in court.
Intangiblia.
The podcast of intangible lawplaying.
Speaker 3 (20:43):
Talk about intellectual property.
Now we head to a case that goesbeyond labs and courtrooms.
It reaches into centuries-oldtraditions, healing practices
and community wisdom.
Let's talk about the neem tree.
Speaker 1 (21:02):
Used for generations across Asia and Africa.
Neem is a medicinal powerhouseIts seeds, bark and oil are
known for treating infections,serving as insect repellents and
relevant here acting as anatural fungicide.
Speaker 3 (21:13):
In the 1990s, a European patent was granted to a
company that extracted afungicidal formula from neem and
filed it as a new invention andfiled it as a new invention.
Speaker 1 (21:28):
But here's the twist this new invention was already
well known and usedtraditionally in India and other
regions.
It wasn't a discovery.
It was a case of what many maycall biopiracy.
Speaker 3 (21:43):
Environmental groups and the Indian government
challenged the patent at theEuropean Patent Office, arguing
that Neem's antifungal use wasprior art, meaning it was
already known and used publicly,just not documented in Western
journals.
Speaker 1 (22:02):
And in 2000, they won .
The EPO revoked the patent,agreeing that Neem's properties
weren't new or inventive.
The knowledge may not have beenwritten in a patent application
, but it had existed in practicefor centuries.
Speaker 3 (22:14):
This decision became a turning point.
It put traditional knowledge onthe global IP radar and sparked
discussions about how torecognize, respect and protect
community health wisdom.
Speaker 1 (22:28):
It also fueled momentum for access and benefit
sharing and contributed to therise of legal tools like the
Nagoya Protocol, because whenpeople use local biodiversity,
the local communities deserve aseat at the table.
Speaker 3 (22:40):
This case reminds us that innovation doesn't always
come from labs.
It also grows in forests,kitchens and oral traditions,
and IPLA has to evolve toinclude those spaces too.
Next up, we turn to a case thatlanded at the intersection of
genetics, medicine and moralityAssociation for Molecular
(23:01):
Pathology, bv Media Genetics.
It's one of the most famousbiotech IP cases in US history.
It's one of the most famousbiotech IP cases in US history.
Speaker 1 (23:09):
Here's a setup Myriad Genetics had isolated two genes
, BRCA1 and BRCA2, which arelinked to a high risk of breast
and ovarian cancer.
Speaker 3 (23:29):
Myriad didn't invent the genes, but they did find
them, isolate them and developtests based on them.
They filed for patents not juston the tests but on the
isolated gene sequencesthemselves, and they got them.
For years, myriad had exclusiverights to those genes in the US
.
Speaker 1 (23:43):
Which meant if your doctor wanted to test you for
BRCA mutations, they had to gothrough Myriad.
If your doctor wanted to testyou for BRCA mutations, they had
to go through Myriad.
That raised prices, limitedaccess and sparked outrage from
researchers, doctors and patientgroups.
Speaker 3 (23:56):
So a coalition of medical organizations and civil
rights groups stood, and in 2013, the US Supreme Court ruled
that naturally occurring DNAsequences are not patentable,
even if isolated in a lab.
Speaker 1 (24:15):
But there's a twist.
The court drew a line.
While natural genes aren'tpatentable, synthetic DNA called
cDNA is Because cDNA is createdin the lab and doesn't occur in
nature.
Because cDNA is created in thelab and doesn't occur in nature,
it qualifies as an invention.
Speaker 3 (24:30):
This case clarified one of the most fundamental
questions in biotech when doesnature and an invention begin?
Speaker 1 (24:39):
And it sent ripple effects around the world.
Suddenly, patent offices had torethink thousands of gene
patents, Biotech companies hadto redraw their IP strategies
and scientists gained morefreedom to study human genes
without hitting a paywall.
Speaker 3 (24:52):
Most importantly, patients gained broader access
to life-saving diagnostics.
It was a legal milestone withreal-world consequences.
Now let's head to Australia,where the same company, Myriad
Genetics, found itself inanother legal showdown Same
BRCA1 gene, same isolatedsequence, different court,
(25:16):
different continent.
Speaker 1 (25:18):
This time, the challenge came from Yvonne Darcy
, a breast cancer survivor whobelieved that no one should be
able to claim ownership overhuman genes, especially not
those linked to life-threateningillnesses.
Speaker 3 (25:33):
The legal question was almost identical to the US
case.
Is an isolated gene sequencetaken from the human body and
purified in a lab patentable inAustralia?
Speaker 1 (25:44):
At first, the federal court said yes.
They ruled that isolating agene made it sufficiently
different from what exists inthe body.
But then came the appeal and in2015, the High Court of
Australia unanimously disagreed.
Speaker 3 (25:58):
Their logic.
Even though the gene wasisolated, its information
content, the actual genetic code, remained the same, and that
information wasn't somethingcreated by human ingenuity.
It was found, not invented.
Speaker 1 (26:16):
So, just like in the US, the court said no patents on
naturally occurring human genes.
It was a big win for publichealth advocates and researchers
in Australia.
Speaker 3 (26:26):
And a global message to biotech companies.
If you're building your IPstrategy around gene sequences
alone, you're probably on shakyground, but remember, this
doesn't block patents onsynthetic genes, diagnostic
methods or novel gene editingtools.
Speaker 1 (26:44):
It just keeps the raw code of life open to all they
reinforce a powerful ideadiscovery is not invention.
Speaker 3 (27:05):
Now we head to Europe for a case that didn't just
test science.
It tested ethics the caseBrussels v Greenpeace, decided
by the Court of Justice of theEuropean Union in 2011.
Speaker 1 (27:15):
The conflict a patent granted to German
neuroscientist Oliver Brusselfor a method of producing nerve
cells from embryonic stem cells.
It had promising applicationsin treating neurological
disorders like Parkinson's Achallenge.
Speaker 3 (27:29):
But Greenpeace filed a challenge not for
environmental reasons but moralones.
They argued that the processinvolved destroying human
embryos, which should not beallowed under European law.
Speaker 1 (27:45):
So the CJ and you had to decide is an invention
unpatentable if it requires theuse and destruction of human
embryos, even if the goal ismedical.
Speaker 3 (27:55):
And the court ruled yes, yes, under the EU Biotic
Directive, inventions involvingthe destruction of human embryos
for industrial or commercialpurposes are excluded from
patentability.
Speaker 1 (28:08):
The court's reasoning was grounded in respect for
human dignity.
Even if the process isscientific, even if the benefits
are enormous, the act ofdestroying embryos cannot be
part of a patentable invention.
Speaker 3 (28:27):
That decision sends shockwaves through the biotech
sector.
It didn't outlaw stem cellresearch, but it meant that
certain types of embryonic stemcell inventions couldn't be
patented in the EU.
Speaker 1 (28:35):
It was a defining moment for bioethics in patent
law, and it drew a sharp linebetween what's technically
possible and what's legally ormorally acceptable.
Speaker 3 (28:45):
The ruling also pushed many labs towards
alternative research paths likeinduced pluripotent stem cells,
which don't involve embryos atall.
Speaker 1 (28:57):
So, while Brussel lost the patent, the case helped
guide a generation ofscientists toward ethical
innovation and reminded us thatnot all breakthroughs belong on
a balance sheet.
Speaker 3 (29:09):
Now let's explore the foggy middle ground of biotech
patents.
What happens when you discovera new gene but you don't fully
know what it does yet?
Enter the UK case of HumanGenome Sciences V Eli.
Speaker 1 (29:25):
Lilly, the year was 2011 and Human Genome Sciences,
or HGS, had identified thesequence for a protein called
neutrokinase.
They believed it belonged tothe tumor necrosis factor TNF
family, which is involved inimmune system responses.
Speaker 3 (29:42):
So they filed for a patent on the gene and its
potential applications, eventhough its exact function wasn't
fully understood.
Then Illy Lilley challenged thepatent, arguing it lacked.
It lacked industrialapplicability, which in UK and
European patent law is like theequivalent of utility.
Speaker 1 (30:07):
Lilly said if you don't know what this gene does,
how can you claim it has apractical use?
It's a fair question.
Patent law doesn't rewardphishing expeditions.
Speaker 3 (30:15):
But HDS argued that, based on the gene structure and
its relation to the DNA family,its role in the immune system
was plausible and that wasenough.
Speaker 1 (30:25):
And the UK Supreme Court agreed.
They reversed the lower court'sdecision and upheld the patent,
aligning with the EuropeanPatent Office's more flexible
stance.
Speaker 3 (30:37):
The ruling made a big statement.
The ruling made a big statement.
You don't need full scientificcertainty to patent a biotech
invention, as long as there's acredible and plausible use
grounded in existing knowledge.
Speaker 1 (30:51):
That's great news for gene hunters.
It means you don't have to waituntil a gene becomes a
blockbuster drug.
If the science supports areasonable function, your
discovery might qualify.
Speaker 3 (31:01):
But it also walks a tightrope.
Granting patents too early,before true utility is confirmed
, can lock up whole areas ofbiology and slow down progress.
Speaker 1 (31:12):
Still, this case gave clarity to European biotech
innovators and showed thattiming, plausibility and context
all matter in the race toprotect genetic IP.
Speaker 3 (31:23):
We've reached the final boss of biotech patent
battles Broad Institute v,university of California,
berkeley the CRISPR case.
Speaker 1 (31:35):
It's technical, global and still unfolding.
Crispr-cas9 is the gene editingtool that changed everything.
With it, scientists can editDNA with extraordinary precision
, like a molecular scalpel.
It has the potential to curegenetic diseases, improve crops
and rewrite biotech as we knowit.
Speaker 3 (31:52):
Here's the issue led by Jennifer Doudna and Emmanuel
Sherpentier, filed a patent forusing CRISPR in pro-karyotic
cells like bacteria.
A few months later, broadInstitute, affiliated with MIT
and Harvard, filed its ownpatents specifically for using
(32:15):
CRISPR in new karyotic cellslike humans, plants and animals.
Speaker 1 (32:22):
Both sides claimed to be first, both had published
results, but Broad paid extrafor expedited review and got
their patents approved first.
That's when the fight began.
Speaker 3 (32:35):
The legal question was did Broad invent something
new or were they just buildingon what UC had already made
public?
The patent trial and appealboard PTAB in the US initially
sided with Broad, saying therewas no interference, meaning the
two inventions were distinctenough.
Speaker 1 (32:54):
But UC Berkeley appealed and a series of
challenges followed Across theAtlantic.
The European Patent Office tooka different view, revoking
Broad's patent on proceduralgrounds related to how inventors
were listed.
Speaker 3 (33:08):
This case is still evolving.
Between 2015 and 2025, multiplerulings have shifted the
balance.
Broad has held strong in the US, while Berkeley has gained more
ground in Europe, and elsewhere.
Speaker 1 (33:24):
It's not just about credit.
It's about billions inlicensing deals, the future of
gene therapies and who gets toshape the next generation of
biotech.
Speaker 3 (33:33):
And it's taught us a lot how pattern strategy, speed,
global coordination and legalprecision all matter in
high-stakes science.
Speaker 1 (33:43):
So while the gene editing revolution is advancing
fast, the legal framework isstill catching up.
One nucleotide, one court dateat a time.
Speaker 3 (33:51):
So far, we've traveled through labs, fields,
cores and petri dishes, butthere's one more major
development shaking the roots ofsynthetic biology IP, a brand
new treaty from WIPO the ink'sstill drying.
(34:18):
It was adopted in May 2024, andtraditional plant-based
medicine have raised a fairpoint.
If companies are using ourgenetic resources to invent new
things, we deserve transparencyand maybe a share in the
benefits.
Speaker 1 (34:37):
This treaty responds to that call.
It doesn't ban anything, but itadds a layer of disclosure.
Under the new rules, if you'refiling a patent application
involving genetic resources,you'll need to state where the
material came from, and iftraditional knowledge was
involved, you disclose that too.
Speaker 3 (34:56):
The goal Transparency and fairness.
It helps patent officesidentify prior art, it deters
biopiracy and it strengthenstrust between innovators and
communities that have stewardedbiodiversity for centuries.
Speaker 1 (35:16):
And no, this isn't about blocking innovation.
It's about building a systemwhere innovation doesn't come at
the expense of the people andplaces that made it possible in
the first place.
Speaker 3 (35:25):
Importantly, this treaty has global participation.
Over 150 WIPO member statesadopted it and, while
implementation will vary bycountry, it sets a powerful
baseline.
If your invention involves agenetic resource, the origin
matters.
Speaker 1 (35:42):
And guess what?
It even applies to syntheticbiology.
If your invention involves agene from a frog, a fungus or a
fruit fly and that gene camefrom nature, you may need to
disclose where it came from,even if you're editing it with
AI in a lab.
Speaker 3 (36:00):
The treaty also opens the door to future legal
clarity, especially for patentsinvolving digital sequence
information, biofoundries and AIdesign organisms.
It's not fully settled yet, butit's a start.
Speaker 1 (36:15):
It's a big moment.
Ip law is evolving, finally torecognize that life, knowledge
and invention don't exist in avacuum.
They're connected, and now thepaperwork will reflect that too.
Speaker 3 (36:28):
Before we hand up our lab coats, let's break it down.
Here are five takeaways fromour journey through synthetic
biology and intellectualproperty law.
Speaker 1 (36:38):
One living inventions can be patented, but only
sometimes, from bacteria toCRISPR-edited cells.
Patent law allows protectionwhen human ingenuity creates
something truly new, but if it'stoo close to nature, courts
will often draw the line.
Two self-replicatingtechnologies need special legal
(36:59):
care.
Seeds that grow themselves,cells that divide code that
mutates these challenge thelimits of traditional patent
rules.
Bowman and Roslin taught usthat replication doesn't mean
free reuse.
Three disclosure is the newglobal standard.
With the new WIPO treaty,inventors must disclose the
(37:20):
origin of genetic resources andassociated traditional knowledge
.
It's a transparency shift thatwill shape biotech filings
worldwide.
Global courts aren't alwaysaligned, but they're converging.
Myriad v Myriad, canada v theOncomouse and the CRISPR battle
show us how national systemsdiverge on ethics, utility and
(37:41):
inventorship, but also howthey're learning from one
another.
Speaker 3 (37:46):
Five.
Traditional knowledge andbiodiversity are part of the EPA
equation.
The NIMCase and the new treatyboth affirm that innovation
doesn't only happen in labs.
It also grows from ancestralwisdom, and now the law is
starting to reflect that.
Speaker 1 (38:06):
And that's your iCircuit for the future of
synthetic biology.
Whether you're editing genes orplanting seeds, the rules of
innovation are evolving, and youjust got the download.
Speaker 3 (38:16):
That's it for today's deep dive into synthetic
biology and intellectualproperty.
We explore the building blocksof invention, the courtrooms
where life gets debated and thetreaties shaping a more
transparent future.
Speaker 1 (38:30):
From gene patents to mouse dramas and bioethical
standoffs, we've covered thefull genome of legal tension.
Speaker 3 (38:37):
And remember just because your invention can
self-replicate doesn't mean yourIP rights do Thank you for
joining us on Intangible, wherewe decode the laws behind the
lab codes and unpack thepolicies powering tomorrow's
breakthrough.
Speaker 1 (38:53):
Catch you next time.
Same feed, same curiosity,brand new IP puzzle.
Speaker 3 (38:58):
And until then, whether you're editing DNA,
filing patents or justdaydreaming about buy your best
features keep it clever, keep itcurious and keep it intangible.
Speaker 2 (39:21):
Thank you for listening to Intangiblia, the
podcast of intangible law plaintalk about intellectual property
.
Did you like what we talkedtoday?
Please share with your network.
Do you want to learn more aboutintellectual property?
Subscribe now on your favoritepodcast player.
Follow us on Instagram,facebook, linkedin and Twitter.
(39:41):
Visit our websitewwwintangibliacom.
Copyright Leticia Caminero 2020.
All rights reserved.
This podcast is provided forinformation purposes only.
Popular Podcasts
24/7 News: The Latest
The latest news in 4 minutes updated every hour, every day.
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
The Clay Travis and Buck Sexton Show
The Clay Travis and Buck Sexton Show. Clay Travis and Buck Sexton tackle the biggest stories in news, politics and current events with intelligence and humor. From the border crisis, to the madness of cancel culture and far-left missteps, Clay and Buck guide listeners through the latest headlines and hot topics with fun and entertaining conversations and opinions.