The
data
is
frightening.
The
average
age
of
folks
in
the
U.S.
diagnosed
with
colorectal
cancer
has
dropped
in
the
past
15
years
to
67
from
72.
According
to
one
of
our
country’s
leading
cancer
hospitals,
MD
Anderson,
“[n]early
one
in
nine
new
colon
cancer
cases
and
one
in
five
new
rectal
cancer
cases
occur
in
people
under
age
50.”
The
problem
is
so
acute
that
the
hospital
has
had
to
start
a
“Young-Onset
Colorectal
Cancer
Program,”
and
is
leading
a
clinical
trial
tracking
young
patients
faced
with
this
dread
diagnosis
as
they
battle
to
survive
the
disease.
Unfortunately,
the
rise
in
cases
has
even
dipped
down
into
the
20-29
age
cohort
—
with
many
of
the
diagnoses
of
young-onset
colorectal
cancer
patients
not
being
made
until
the
cancer
has
not
only
taken
root,
but
spread.
While
the
causes
of
this
rise
have
not
yet
been
pinpointed
with
accuracy,
it
is
likely
that
multiple
factors
are
at
play,
from
lifestyles
and
diet
to
genetic
predispositions.
Meanwhile,
the
gold
standard
screening
mechanism
for
colorectal
cancer
—
colonoscopy
—
only
starts
getting
recommended
(i.e.,
covered
by
insurance)
for
those
45
and
up,
except
for
those
with
a
genetic
disposition
or
who
suffer
from
inflammatory
bowel
conditions
like
Crohn’s
disease.
In
short,
it
is
up
to
young
people
(and
older,
for
that
matter)
to
educate
themselves
on
the
risk
factors
for,
and
the
early
symptoms
of,
colorectal
cancer,
on
top
of
getting
colonoscopies
when
screening
guidelines
recommend
them
—
and
to
take
quick
action
if
any
troubling
symptoms
arise.
Because
the
invasive
nature
and
preparation
required
for
a
colonoscopy
can
be
a
(bad)
excuse
for
the
around
40%
of
our
fellow
Americans
who
(wrongly)
just
wing
it
and
don’t
get
screened,
there
has
long
been
a
need
for
noninvasive
early
detection
mechanisms
for
colorectal
cancer,
particularly
for
those
in
the
over-45
category.
Putting
aside
the
fact
that
getting
a
colonoscopy
is
not
that
bad
—
and
surely
better
than
treatment
for
a
later-detected
tumor
as
a
result
of
delayed
screening
—
the
simple
truth
is
that
the
more
options
patients
have
for
screening
the
better.
In
that
respect,
the
introduction
of
Cologuard
after
FDA-approval
in
2014
has
been
a
gamechanger.
It
is
estimated
that
Cologuard
generated
close
to
$2
billion
in
revenue
for
its
manufacturer,
Exact
Sciences,
in
2024
alone.
At
around
$500
or
so
per
test,
that
means
a
lot
of
people
are
getting
screened
for
colorectal
cancer
that
might
not
otherwise
be
doing
so,
but
for
a
simple,
noninvasive,
at-home
test
like
Cologuard.
Not
surprisingly,
Exact
has
protected
Cologuard
with
dozens
of
patents,
as
would
be
expected
for
a
blockbuster
product.
And
where
there
is
a
blockbuster
product,
competitors
are
often
not
far
behind.
Enter
ColoSense,
which
was
approved
by
the
FDA
in
2024,
but
is
not
yet
available
to
order.
That
may
change
soon,
however,
as
ColoSense’s
manufacturer
Geneoscopy
has
partnered
with
testing
giant
Labcorp
to
administer
the
test
upon
launch.
Fearing
that
outcome,
Exact
filed
a
Delaware
patent
infringement
lawsuit
against
Geneoscopy
in
November
2023,
with
a
companion
motion
for
a
preliminary
injunction
that
is
still
awaiting
decision.
In
the
meantime,
the
case
has
proceeded
into
discovery,
with
trial
set
for
November
2026.
While
it
will
be
interesting
to
see
how
the
case
plays
out,
including
how
the
PI
motion
is
disposed
of,
the
first
big
decision
related
to
the
dispute
just
came
out
of
a
different
forum,
the
PTAB.
On
July
9,
2025,
the
PTAB
cancelled
all
20
issued
claims
of
Exact’s
‘781
patent,
one
of
the
two
patents
asserted
by
Exact
against
Geneoscopy
in
the
pending
Delaware
lawsuit.
After
first
agreeing
with
Exact’s
proposal
for
the
applicable
level
of
skill
in
the
art,
the
PTAB
determined
that
no
claim
construction
was
necessary
to
reach
its
decision
on
the
‘781
patent’s
validity.
After
a
quick
overview
of
the
prior
art
at
issue,
the
panel
then
zeroed
in
on
a
dispositive
issue
in
the
IPR,
the
question
of
whether
there
was
a
nexus
between
Exact’s
evidence
of
secondary
considerations
of
nonobviousness
and
the
challenged
claims.
To
Exact’s
chagrin,
the
question
was
answered
in
the
negative
and
the
challenged
claims
were
found
obvious.
To
start,
the
panel
confirmed
that
the
burden
of
proof
was
on
the
patentee,
Exact,
to
show
a
nexus
existed.
Unsurprisingly,
Exact
pointed
to
Cologuard
as
the
product
required
for
nexus,
supporting
its
position
with
expert
testimony
regarding
the
disclosure
of
the
Cologuard
Patient
Guide
and
the
limitations
of
the
patent
claims.
In
addition,
Exact
pointed
to
Cologuard’s
boffo
sales
as
evidence
of
commercial
success,
alongside
the
fact
that
Cologuard
represented
a
welcome
advance
in
screening
options
for
colorectal
cancer
—
with
the
attendant
prizes
and
industry
acclaim
that
follow
such
advances.
Lastly,
Exact
argued
that
the
“ColoSense
Collection
Kit
contains
the
same
elements
as
Exact
Science’
successful
Cologuard
Collection
Kit.”
In
response,
Geneoscopy
pointed
to
the
robust
patent
portfolio
protecting
Cologuard
to
undercut
the
suggestion
that
it
was
the
‘781
patent
carrying
the
load
for
Cologuard’s
success.
In
particular,
the
PTAB
noted
that
Exact
itself
had
made
arguments
in
other
patent
applications
that
“later-claimed
inventions
were
the
reasons
for
Cologuard’s
success
and
satisfaction
of
the
long-felt
need.”
As
a
result,
the
PTAB
determined
that
“Cologuard
is
not
coextensive
with
the
challenged
claims,
and
no
nexus
between
the
product
and
the
challenged
claims
is
shown
on
this
record.”
From
there,
it
was
quick
work
for
the
panel
to
find
obviousness
based
on
the
extensive
prior
art
raised
by
Geneoscopy.
Ultimately,
this
IPR
decision
illustrates
the
challenges
faced
by
companies
like
Exact
in
terms
of
surviving
obviousness
challenges
against
individual
patents
in
a
larger
portfolio,
especially
where
that
portfolio
is
constructed
of
patents
claiming
incremental
innovations.
At
a
minimum,
Exact’s
loss
of
one
of
the
two
patents
it
chose
to
assert
in
its
Delaware
patent
case
will
embolden
Geneoscopy
to
continue
to
fight
against
Exact’s
patents
as
it
works
to
compete
in
the
marketplace.
Without
rooting
for
an
outcome
in
the
case,
considering
the
huge
need
for
effective
colorectal
screening
mechanisms,
we
can
only
hope
that
patient
choice
in
this
area
continues
to
expand.
When
it
comes
to
the
fight
against
colorectal
cancer,
Exact’s
failure
to
meet
the
exacting
nexus
standard
could
prove
the
public’s
gain…
Please
feel
free
to
send
comments
or
questions
to
me
at
[email protected]
or
via
Twitter:
@gkroub.
Any
topic
suggestions
or
thoughts
are
most
welcome.
Gaston
Kroub
lives
in
Brooklyn
and
is
a
founding
partner
of Kroub,
Silbersher
&
Kolmykov
PLLC,
an
intellectual
property
litigation
boutique,
and Markman
Advisors
LLC,
a
leading
consultancy
on
patent
issues
for
the
investment
community.
Gaston’s
practice
focuses
on
intellectual
property
litigation
and
related
counseling,
with
a
strong
focus
on
patent
matters.
You
can
reach
him
at [email protected] or
follow
him
on
Twitter: @gkroub.