Merial Limited et al v. VELCERA INC et al

Filing 34

ORDER granting 5 Motion for Preliminary Injunction. Ordered by Judge Clay D. Land on 06/29/2012. (CGC)

IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
ATHENS DIVISION
MERIAL LIMITED and MERIAL SAS,
Plaintiffs,

*
*

vs.

*

VELCERA INC. and FIDOPHARM
INC.,

*

CASE NO. 3:12-CV-75 (CDL)
*
Defendants.
*
O R D E R
This

Order

constitutes

the

latest

chapter

in

the

intellectual property saga that may ultimately conclude with a
determination

of

who

has

the

legal

right

to

an

apparently

magical formulation for ridding our dogs and cats of fleas and
ticks.

Plaintiffs Merial Limited and Merial SAS (collectively

“Merial”) manufacture and sell a product known as Frontline Plus
pursuant

to

U.S.

Patent

No.

6,096,329

(“the

‘329

Patent”).

Frontline Plus, which is touted as the best-selling veterinary
product

in

the

world,

is

containing

the

active

ingredients

Defendants

Velcera

Inc.

a

and

parasiticide

for

fipronil

FidoPharm

dogs
and

Inc.

and

cats

methoprene.
(collectively

“Velcera”) have been working feverishly to develop and sell a
generic

version

of

Frontline

Plus

known

as

PetArmor

Plus.

Velcera’s first version of PetArmor Plus (“2011 PetArmor Plus”)
had the exact same combination of active ingredients and the

same type of inactive ingredients that exist in Frontline Plus.
In a previous contempt proceeding, the Court enjoined Velcera
from selling that version of PetArmor Plus.
issued

that

order,

Velcera

made

a

minor

After the Court
amendment

to

the

inactive ingredients, and it now seeks to sell that slightly
modified product (“2012 PetArmor Plus”) in the United States. 1
Merial has filed this patent infringement action claiming that
2012 PetArmor Plus violates its ‘329 Patent.

Velcera responds

that the ‘329 Patent is invalid under 35 U.S.C.

§§ 112 and

103(a), and that even if it is valid, the sale of 2012 PetArmor
Plus will not infringe the patent.
Presently pending before the Court is Merial’s Motion for
Preliminary Injunction (ECF No. 5).

Although Merial maintains

that 2012 PetArmor Plus violates several claims of

the

‘329

Patent, the resolution of the pending motion depends primarily
on

one

active

key

component

ingredients,

the

fipronil

“synergistic

effective

findings

fact

of

of

and

patent,
and

amounts.”
conclusions

a

requirement

methoprene,
Based
of

law,

be

on
the

that

present

the

the
in

following

Court

grants

Merial’s motion.

1

Specifically, Velcera intends to sell PetArmor Plus for Cats and
PetArmor Plus for Dogs, both of which are veterinary spot-on
treatments used to control fleas and ticks.
The current versions of
these products, which Merial claims infringe its patent, will be
referred to as 2012 PetArmor Plus. The 2011 versions will be referred
to collectively as 2011 PetArmor Plus.

2

FACTUAL AND PROCEDURAL BACKGROUND
The ‘329 Patent is assigned to Merial SAS, which granted
Merial Limited an exclusive license to the patent.
Patent

claims

protecting

topically

domestic

Specifically,
containing

the

applied

dogs
‘329

synergistic

and

(“spot-on”)
cats

Patent

from

claims

effective

compositions
fleas

spot-on

amounts

The ‘329

of

and

for

ticks.

compositions
the

pesticide

fipronil and an insect growth regulator that prevents immature
parasites from reaching reproductive maturity, as well as at
least

one

customary

spot-on

formulation

adjuvant.

The

‘329

Patent discloses a number of insect growth regulators, including
methoprene.2

Merial asserts that in the fipronil plus methoprene

compositions

disclosed

in

the

‘329

Patent,

the

two

active

ingredients are present in synergistic effective amounts.

In

other words, Merial asserts that fipronil and methoprene

are

present

in

amounts

sufficient

to

yield

synergistic

effects,

meaning that the combination achieves improved results relative
to either agent administered alone.

The spot-on composition

disclosed in the ‘329 Patent is intended to be applied to the
skin of the dog or cat, usually to the neck or between the
shoulder blades.

The active ingredients move across the body of

2

For purposes of this Order, references to methoprene include Smethoprene.

3

the animal and become concentrated in the animal’s sebaceous
glands, which are small oil-producing glands in the skin.
Merial

markets

compositions

that

combine

methoprene under the brand name Frontline Plus.

fipronil

and

Frontline Plus

is the leading veterinary flea and tick treatment in the United
States.
11.8%

Frontline

methoprene,

Plus for Cats
and

Frontline

contains 9.8% fipronil and

Plus

for

Dogs

contains

9.8%

fipronil and 8.8% methoprene.
Velcera intends to sell two new veterinary products in the
United

States:

LC-2010-3

Fipronil

and

S-Methoprene

for

Cats

(PetArmor Plus for Cats) and LC-2010-4 Fipronil and S-Methoprene
for Dogs (PetArmor Plus for Dogs).

Each 2012 PetArmor Plus

product has the exact same active ingredient formulation as the
corresponding Frontline Plus product.

Like Frontline Plus for

Cats, 2012 PetArmor Plus for Cats contains 9.8% fipronil and
11.8%

methoprene.

PetArmor

Plus

And

for

Dogs

like

Frontline

contains

9.8%

Plus

for

Dogs,

2012

and

8.8%

fipronil

methoprene.
Velcera previously launched a product called PetArmor Plus
in 2011, which it had developed in concert with Cipla Limited
(“Cipla”).

Prior to the launch of that product, Merial had

obtained a default judgment against Cipla in an action in which
Merial

alleged

that

a

Cipla

fipronil/methoprene

Protektor Plus, infringed Merial’s ‘329 Patent.

4

product,

As a result of

that default judgment, Cipla and anyone acting in concert with
Cipla was enjoined from, among other things, manufacturing or
selling any product that infringed the ‘329 Patent.

After the

issuance of that injunction, Cipla and Velcera jointly developed
and began selling 2011 PetArmor Plus.

Upon learning of that

allegedly infringing activity, Merial filed a contempt motion
against Cipla for violating the previous injunction.

Velcera

intervened in that action to protect its interests regarding
2011 PetArmor Plus.

After a hearing, the Court concluded that

Velcera acted in concert with Cipla to violate the injunction by
selling 2011 PetArmor Plus, and the Court found that the 2011
PetArmor Plus products infringed at least one claim of the ‘329
Patent.

The

Court

entered

an

injunction

against

Velcera

prohibiting Velcera from selling a veterinary product containing
fipronil

and

methoprene

development,

manufacture

Merial

v.

Ltd.

2489753,

at

*17

Contempt Order].

Cipla
(M.D.

if

Cipla

and/or

Ltd.,
Ga.

No.
June

participated

packaging

of

3:07-CV-125
21,

2011)

the

(CDL),

in

the

product.
2011

[hereinafter

WL

2011

The Court’s decision was affirmed on appeal to

the Federal Circuit.

Merial Ltd. v. Cipla Ltd., Nos. 2011-1471,

2011-1472, 2012 WL 1948879 (Fed. Cir. May 31, 2012) [hereinafter
Fed. Cir. Op.].
After this Court’s contempt finding, Velcera severed ties
with Cipla and reformulated the PetArmor Plus product with a

5

minor formula amendment.

Specifically, Velcera eliminated two

inert ingredients, the crystallization inhibitors, and replaced
their lost volume by increasing the amount of an existing inert
ingredient that acted as a solvent.

Based on the similarities

between the reformulated 2012 PetArmor Plus and the previously
enjoined
against

2011

PetArmor

Velcera,

reformulated
Velcera.

Plus,

arguing

product
After

Merial

Velcera’s

violated

an

the

evidentiary

filed

a

contempt

motion

proposed

launch

of

injunction

entered

against

hearing,

the

Court

the

denied

Merial’s motion, finding Merial failed to meet its burden of
proving by clear and convincing evidence that Cipla participated
in the development of 2012 PetArmor Plus, which was a condition
of the Court’s injunction against Velcera.

See BASF AGRO B.V.

v. Cipla, Ltd., No. 3:07-CV-125 (CDL), 2012 WL 2023310, at *1,
*5

(M.D.

Ga.

June

5,

2012)

(finding

that

the

injunction

prohibited “Velcera from selling (1) a veterinary product in the
United States that (2) contains fipronil and methoprene if (3)
Cipla

participated

in

the

development,

manufacture

and/or

packaging of the product” and concluding that Merial failed to
prove that Cipla participated in the development of the product
by clear and convincing evidence).

Merial responded by filing

the present action to prevent the sale of 2012 PetArmor Plus,
contending that the product

infringes at least one claim of

Merial’s

the

‘329

Patent.

At

6

present

time,

Merial

seeks

preliminary injunctive relief until its claims can be finally
adjudicated.
DISCUSSION
The Court held an evidentiary hearing on Merial’s Motion
for Preliminary Injunction.

Based on the testimony and evidence

received at that hearing, the Court makes the following findings
of fact and conclusions of law.3
I.

Preliminary Injunction Standard
“‘A

plaintiff

seeking

a

preliminary

injunction

must

establish that he is likely to succeed on the merits, that he is
likely to suffer irreparable harm in the absence of preliminary
relief, that the balance of equities tips in his favor, and that
an

injunction

Samsung

Elecs.

is

in

the

public

Co.,

678

F.3d

interest.’”
1314,

1323

Apple,
(Fed.

Inc.

Cir.

v.

2012)

(quoting Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7,
20 (2008)).

The Court addresses each factor in turn.

3

The Court heard live testimony and received exhibits on June 21-22,
2012.
The Court also admitted the declarations of Dr. Leonore C.
Witchey-Lakshmanan (ECF No. 13-7), Dr. Jeffrey N. Clark (ECF No. 1310), Dr. Michael K. Rust (ECF No. 13-14), Dr. Dallas E. Johnson (ECF
No. 13-15), Dr. Wesley L. Shoop (ECF No. 11-3), Dr. Robert M. Hamer
(ECF No. 11-12), Donald Schwartz (ECF No. 13-9 at 9-12) and Elizabeth
C. Murphy (ECF No. 20-1). The declaration testimony and accompanying
exhibits are part of the preliminary injunction hearing record.
In
addition, the parties stipulated that testimony and exhibits received
into evidence in connection with the hearings held in BASF Agro B.V.
v. Cipla Ltd., No. 3:07-CV-125 (CDL) (M.D. Ga.) on May 16-17, 2011,
June 8, 2011 and May 21-23, 2012 would be deemed part of the record
for purposes of the preliminary injunction motion. Stipulation, June
19, 2012, ECF No. 14.

7

II.

Merial’s Likelihood of Success on the Merits
To

motion,

Merial

must establish a likelihood of success on the merits.

This

means

prevail

that

on

Merial

its

preliminary

“must

show

injunction

that

it

will

likely

prove

infringement, and that it will likely withstand challenges, if
any, to the validity of the patent.”

Titan Tire Corp. v. Case

New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009).
Velcera

“raises

infringement

or

a

substantial

validity,

question

i.e.,

asserts

concerning
an

If

either

infringement

or

invalidity defense that [Merial] cannot prove ‘lacks substantial
merit,’

the

Amazon.com,

preliminary

Inc.

v.

injunction

Barnesandnoble.com,

1350-51 (Fed. Cir. 2001).

should
Inc.,

not
239

issue.”

F.3d

1343,

Where, as here, the alleged infringer

launches “an attack on the validity of the patent, the burden is
on the challenger to come forward with evidence of invalidity,
just as it would be at trial.”
1377.

Titan Tire Corp., 566 F.3d at

“The patentee, to avoid a conclusion that it is unable to

show a likelihood of success, then has the burden of responding
with contrary evidence[.]”

Id.

“While the evidentiary burdens

at the preliminary injunction stage track the burdens at trial,
importantly
different.”

the
Id.

ultimate

question

before

the

trial

court

is

At this stage in the litigation, Velcera does

not have to persuade the Court that the ‘329 Patent is invalid;
rather, Merial must show the Court “that, despite the challenge

8

presented

to

validity,

[Merial]

nevertheless

succeed at trial on the validity issue.”

is

likely

to

Id.; accord Altanta

Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1006 (Fed.
Cir. 2009).
In support of its contention that it is likely to show at
trial that 2012 PetArmor Plus infringes its ‘329 Patent, Merial
first argues that based on the Court’s prior findings in the
contempt

proceeding,

Velcera

is

collaterally

estopped

from

asserting that 2012 PetArmor Plus does not infringe the ‘329
Patent.
not

Alternatively, Merial asserts that even if Velcera is

collaterally

estopped

from

asserting

non-infringement,

Merial is likely to show that 2012 PetArmor Plus infringes the
‘329

Patent

and

that

Merial

will

likely

withstand

challenges to the validity of the ‘329 Patent.

Velcera’s

Velcera responds

that collateral estoppel does not apply, that the ‘329 Patent is
invalid and that 2012 PetArmor Plus does not infringe the ‘329
Patent.

As discussed in more detail below, the Court rejects

Merial’s collateral estoppel argument, but the Court finds that
Velcera has not raised a substantial question concerning either
infringement or validity.
A.

Collateral Estoppel

Merial argues that Velcera is collaterally estopped from
asserting that 2012 PetArmor Plus does not infringe at least one
claim of the ‘329 Patent based on the Court’s finding in the

9

prior contempt proceeding that 2011 PetArmor Plus infringed the
‘329 Patent.

Specifically, Merial maintains that Velcera is

collaterally estopped from contesting Merial’s contention that
the active ingredient concentrations of 9.8% fipronil and 8.8%
methoprene contained in 2012 PetArmor Plus for Dogs and 9.8%
fipronil and 11.8% methoprene contained in 2012 PetArmor Plus
for

Cats

active

constitute

ingredients

“synergistic

and

that

2012

effective

amounts”

PetArmor

Plus

of

the

formulation

includes at least one customary spot-one adjuvant.
For collateral estoppel to apply, Merial must establish the
following:
“(1) the issue at stake was identical to the one
involved in the prior litigation; (2) the issue had
been actually litigated in the prior suit; (3) the
determination of the issue in the prior litigation was
a critical and necessary part of the judgment in that
action; and (4) the party against whom the earlier
decision is asserted had a full and fair opportunity
to litigate the issue in the earlier proceeding.”
Bayer AG v. Biovail Corp., 279 F.3d 1340, 1345 (Fed. Cir. 2002)
(quoting In re McWhorter, 887 F.2d 1564, 1566 (11th Cir. 1989)
(per

curiam));

see

also

id.

(noting

that

“[b]ecause

the

application of collateral estoppel is not a matter within the
exclusive

jurisdiction

of

[the

Federal

Circuit,

the

Federal

Circuit] applies the law of the circuit in which the district
court

sits,

the

Eleventh

Circuit

citation omitted).

10

in

this

case.”)

(internal

Although
proceeding,

the

in

Court

which

did

determine

Velcera

was

a

in

the

party,

prior

that

contempt

the

active

ingredient concentrations of 9.8% fipronil and 8.8% methoprene
contained in 2011 PetArmor Plus for Dogs and 9.8% fipronil and
11.8% methoprene contained in 2011 PetArmor Plus for Cats are
synergistic effective amounts of the active ingredients, that
determination was based, at least in part, on factual findings
that were established due to Cipla’s default.

See 2011 Contempt

Order, 2011 WL 2489753, at *11 (noting that Cipla’s product,
Protektor

Plus,

contained

“9.7%

fipronil

liquid

and

11.8%

methoprene” and that the “percentages admittedly, by virtue of
the

default,

existed

in

‘synergistic’

amounts.”).

Since

Velcera, as an intervenor in the contempt action, had to accept
the facts established by Cipla’s default in that proceeding, it
never had the opportunity to fully litigate those issues.

See

Fed. Cir. Op., 2012 WL 1948879, at *12 (rejecting Velcera’s
argument that it did not have a full and fair opportunity to
contest invalidity or infringement of the original product in
the

contempt

intervenor

in

proceeding
this

because

action,

“Velcera,

joined

as

an

unsolicited

subject

to

all

prior

determinations of fact and law that preceded its intervention”
and recognizing that “for purposes of this litigation, the 2008
default judgment against Cipla established, among other things,
that

the

‘329

patent

was

not

11

invalid

and

was

infringed

by

Cipla’s Protektor Plus product”).

Although Velcera was stuck

with those default admissions in the contempt proceeding, they
do not follow Velcera to this new infringement action.

Thus,

Velcera is not collaterally estopped from contesting any of the
elements of infringement in this action, including the issues of
whether the active ingredients exist in synergistic effective
amounts and whether its 2012 PetArmor Plus products contain at
least one customary spot-on adjuvant.
B.

Validity of ‘329 Patent

The Court must next determine whether Merial is likely to
withstand

Velcera’s

Patent.

Velcera

challenges
asserts

to

that

the

validity

Merial

of

cannot

the

‘329

establish

a

likelihood of success on the merits because the ‘329 Patent is
invalid under 35 U.S.C. § 112 (“§ 112”) and 35 U.S.C. § 103(a)
(Ҥ

103(a)”)

enabling

(§

for

four

112),

(2)

reasons:
the

‘329

(1)

the

Patent

‘329
does

Patent
not

is

not

contain

an

adequate written description (§ 112), (3) the ‘329 Patent is
invalid
Patent

due
is

to

indefinite

invalid

for

claims

(§

obviousness

112),

based

and
upon

(4)
prior

the

‘329

art

(§

103(a)).
As a preliminary matter, the Court notes that the ‘329
Patent is entitled to a presumption of validity because patents
are presumed to be valid, 35 U.S.C. § 282, and because the ‘329
Patent

was

confirmed

pursuant

to

12

a

reexamination

proceeding.

See Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331, 1342
(Fed. Cir. 2003) (finding, based on the presumption of validity
and

the

fact

that

the

patent

had

been

subjected

to

reexamination, that the patentee had established that it was
reasonably likely to withstand a validity challenge).

Though

the confirmation following reexamination is not dispositive of
the ‘329 Patent’s validity, the fact that it was issued and then
confirmed pursuant to a reexamination proceeding does suggest
that the ‘329 Patent is not invalid due to obviousness and that
the ‘329 Patent satisfies § 112’s requirements of enablement,
written

description

and

definite

claims.

Even

without

this

presumption of validity, the Court concludes, as explained in
more detail in the following discussion, that Merial has carried
its burden of showing that Velcera’s invalidity defenses lack
substantial merit for purposes of preliminary injunctive relief.
See

Titan

Tire

infringer’s

Corp.,

burden

to

566

F.3d

establish

at
a

1377

(discussing

substantial

alleged

question

of

validity and patentee’s burden to establish that the invalidity
defense lacks substantial merit).
1.

Enablement Requirement

“The first paragraph of 35 U.S.C. § 112 requires that the
specification of a patent must enable a person skilled in the
art to make and use the claimed invention.”
F.2d

731,

735

(Fed.

Cir.

1988).

13

“To

In re Wands, 858
be

enabling,

the

specification of the patent must teach those skilled in the art
how to make and use the full scope of the claimed invention
without undue experimentation.”

Plant Genetic Sys., N.V. v.

DeKalb Genetics Corp., 315 F.3d 1335, 1339
(internal quotation marks omitted).

(Fed. Cir. 2003)

In other words, the “test

of enablement is whether one reasonably skilled in the art could
make or use the invention from the disclosures in the patent
coupled

with

information

experimentation.”

known

in

the

art

without

undue

United States v. Telectronics, Inc., 857 F.2d

778, 785 (Fed. Cir. 1988); accord In re ‘318 Patent Infringement
Litig., 583 F.3d 1317, 1323 (Fed. Cir. 2009).
determined

as

application.”

of

the

effective

filing

date

“Enablement is
of

the

patent’s

In re ‘318 Patent Infringement Litig., 583 F.3d

at 1323.
In this action, Velcera contends that the specification of
the ‘329 Patent does not teach a person of ordinary skill in the
art

to

make

or

use

the

invention,

a

composition

containing

synergistic amounts of fipronil and methoprene, without undue
experimentation.

The

Court

notes

that

“[e]nablement

precluded by the necessity for some experimentation.”
Wands,

858

F.2d

at

736.

The

key

question

is

is

In re

whether

experimentation needed to practice the invention is undue.
at 737.

not

the
Id.

“Factors to be considered in determining whether a

disclosure would require undue experimentation . . . include (1)

14

the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and (8)
the breadth of the claims.”

Id.

To evaluate enablement, as well as the other invalidity
defenses, the parties rely on expert testimony from witnesses
they contend are persons of ordinary skill in the art.

The

Court

and

finds

that

two

of

Merial’s

experts,

Drs.

Witchey

Clark, are exceptionally well qualified to opine about the ‘329
Patent as persons of ordinary skill in the art.

Dr. Witchey is

a pharmaceutical product formulator with impeccable credentials
that

include

both

qualifications.

educational

and

practical

experience

She is a chemical engineer with a Bachelor of

Science and a Master of Science in chemical engineering from The
Ohio State University and a Ph.D. in chemical engineering from
North Carolina
twenty

State University.

years

of

experience

Dr. Witchey has more than
in

pharmaceutical

product

development, including ten years of researching and developing
formulations

of

animal

health

care

products,

emphasis in ecto- and endo-parasitic control.
exceptionally
product

well

formulation

qualified
and

in

the

development,

15

area

with

particular

Dr. Clark is also
of

including

animal
the

health
use

of

chemical parasiticides to combat fleas and ticks in dogs and
cats.

Dr. Clark has a Bachelor of Science in biochemistry from

the University of Massachusetts, a Ph.D. in biochemistry from
the

Massachusetts

Institute

of

Technology,

and

a

Doctor

of

Veterinary Medicine from the University of Tennessee-Knoxville.
He has more than thirty years of experience in animal and human
health

pharmaceutical

product

discovery

and

development,

including more than twenty-five years in animal health product
development

with

a

focus

on

parasite

control

using

novel

chemotherapeutic agents.
In addition to their impressive curricula vitae, the Court
was persuaded by the live testimony of Drs. Witchey and Clark,
including their manner of testifying, their demeanor, and their
grasp of the issues.

The Court found them to be refreshingly

candid scientists attempting to educate the Court and not simply
retained expert witness advocates.

The Court also finds that

their testimony was essentially unimpeached.

On the other hand,

Velcera’s ordinary skill in the art expert did not match Drs.
Witchey and Clark in qualifications or persuasiveness.
the

Court

found

him

to

be

a

qualified

Although

parasitologist,

his

credentials do not match those of Drs. Witchey and Clark insofar
as the issues in this patent litigation are concerned.
became

particularly

clear

when

he

was

effectively

through the use of a patent which he authored.

16

This

impeached

That patent was

broader,
Patent,

more
yet

indefinite,

Velcera’s

and

expert

less

enabling

criticized

the

than
‘329

the

‘329

Patent

for

deficiencies that were glaringly more pervasive in the patent
which he authored.
Based on the testimony of Drs. Witchey and Clark, the Court
is satisfied that Merial is likely to succeed in establishing
that

the

‘329

Patent

meets

the

enablement

requirement

and

teaches a person of ordinary skill in the art to make or use the
invention without undue experimentation.
primarily a formulation patent.

The ‘329 Patent is

According to Dr. Witchey, the

expert formulator, the ‘329 Patent gives very specific guidance
in

terms

containing

of

practicing

synergistic

the

patent

amounts

of

to

develop

fipronil

a

composition

and

methoprene.

Based on her expertise and her reading of the ‘329 Patent, Dr.
Witchey testified that it would take a person of ordinary skill
in the art a few days or a couple of weeks to develop a handful
of formulations to be handed off to a parasitologist for further
testing.

Furthermore, Dr. Clark testified that, based on the

teachings of the ‘329 Patent, it would take a person of ordinary
skill in the art no more than five or six months from start to
finish

to

develop

an

embodiment

of

the

‘329

Patent.

In

contrast, Dr. Clark testified that without the ‘329 Patent, it
would be a major research project to develop such a product,
taking a person of ordinary skill in the art several years.

17

Based

on

all

of

this

evidence,

the

Court

is

satisfied

that

Merial is likely to withstand Velcera’s challenge to enablement
by

establishing

ordinary

skill

composition

that
in

the

containing

the

‘329

art

to

Patent
make

synergistic

teaches
use

or

a

the

invention,

of

fipronil

amounts

person

of
a

and

methoprene, without undue experimentation.
2.

Written Description Requirement

Section

112

also

requires

that

a

patent

specification

“shall contain a written description of the invention, and of
the manner and process of making and using it, in such full,
clear, concise, and exact terms as to enable any person skilled
in the art to which it pertains, or with which it is most nearly
connected, to make and use the same.”
written

description

“must

clearly

35 U.S.C. § 112.

allow

persons

of

The

ordinary

skill in the art to recognize that [the inventor] invented what
is claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc) (alteration in original)
(internal quotation marks omitted).
disclosure

‘conveys

to

those

“The test is whether the

skilled

in

the

art

that

the

inventor had possession of the claimed subject matter as of the
filing date.’”

Streck, Inc. v. Research & Diagnostic Sys.,

Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012) (quoting Ariad, 598
F.3d at 1351).
invention

is

While a mere wish or plan to obtain the claimed
not

sufficient

to

18

meet

the

written

disclosure

requirement,

“the

written

description

requirement

‘does

not

demand either examples or an actual reduction to practice; a
constructive

reduction

to

identifies

the

claimed

description

practice

requirement.’”

that

invention
Id.

in

can

a

definite

satisfy
Ariad,

(quoting

the
598

way

written
F.3d

at

1352.
Velcera
written

contends

description

that

the

because,

‘329

Patent

although

it

has

a

states

deficient
that

the

invention relates to a novel composition to control fleas on
cats

and

dogs

parasiticides,”
Patent

No.

“based
Prelim.

6,096,329

on
Inj.

col.

1

a

synergistic

Hr’g
l.

Ex.

10-11,

combination

PX-700,
ECF

of

United

No.

States

31-15

(“‘329

Patent”), the patent did not disclose any testing for synergy
and did not disclose a synergistic compound.
that

the

‘329

Patent

merely

recites

“a

Velcera asserts

description

of

the

problem to be solved while claiming all solutions to it and . .
. cover any compound later actually invented and determined to
fall within the claim’s functional boundaries—leaving it to the
pharmaceutical industry to complete an unfinished invention.”
Ariad, 598 F.3d at 1353.
The

Federal

Circuit

has

“made

clear

that

the

written

description requirement does not demand either examples or an
actual

reduction

to

practice;

a

constructive

reduction

to

practice that in a definite way identifies the claimed invention

19

can satisfy the written description requirement.”

Id. at 1352.

A specification that describes an invention in terms of ranges
does not fail the written description requirement as long as the
claimed composition is selected from ranges disclosed in the
written description and as long as the written description is
sufficient to show a person of ordinary skill in the art that
the inventor possessed the claimed composition as of the filing
date.

Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d

989, 997 (Fed. Cir. 2000).
According to Drs. Witchey and Clark, the specification of
the

‘329

Patent

discloses

explicitly

identified

compounds

(fipronil and methoprene), as well as a solution to the problem
(fipronil
Patent

and

teaches

together,

that

that

synergistic.
exact

methoprene

composition

specific

synergistic

fipronil

they

While

in

can
the

methoprene

translocate

specification

claimed,

combination

and

of

the

amounts).

and
does

not

ingredients,

‘329

be

used

they

can

that

specification

active

The

are

describe

the

discloses
ratios

a
and

concentrations of the active ingredients, a limited selection of
adjuvants, preferred embodiments and dosage amounts.
of

prophetic

examples

disclosed

in

the

‘329

The types

Patent

“are

routinely used in the chemical arts, and they certainly can be
sufficient

to

satisfy

the

written

description

requirement,”

Ariad, 598 F.3d at 1357, so long as there is evidence that a

20

person of ordinary skill in the art would be able to identify
the chemical composition based on the specification’s functional
description.

See id. at 1354 (noting that the Federal Circuit

in Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed.
Cir. 2004) held a patent invalid because the patentee did not
present any evidence that a person of ordinary skill in the art
would

be

able

to

identify

any

compound

specification’s vague description).

based

on

the

Based on the testimony of

Drs. Witchey and Clark, the Court is satisfied that Merial will
likely succeed in showing that the written description of the
‘329 Patent is sufficient to show a person of ordinary skill in
the art that the inventor possessed the claimed composition as
of the filing date.

Therefore, the Court concludes that Merial

is likely to withstand Velcera’s written description challenge.
3.
In

Definiteness Requirement

addition

to

the

enablement

and

written

description

requirements, § 112 requires that the specification “conclude
with one or more claims particularly pointing out and distinctly
claiming the subject matter which the applicant regards as his
invention.”
requirement

35 U.S.C. § 112.
is

to

“inform

The purpose of the definiteness

the

public

of

the

bounds

of

the

protected invention, i.e., what subject matter is covered by the
exclusive rights of the patent.”
Inc.

v.

M-I

LLC,

514

F.3d

1244,

21

Halliburton Energy Servs.,
1249

(Fed.

Cir.

2008).

“Otherwise, competitors cannot avoid infringement, defeating the
public notice function of patent claims.”

Id.

A claim is

invalid as indefinite under § 112 if the claim is not amenable
to construction.

Honeywell Int’l, Inc. v. Int’l Trade Comm’n,

341 F.3d 1332, 1338 (Fed. Cir. 2003).
presumed

valid,

a

claim

is

indefinite

“Because a claim is
only

if

the

claim

is

insolubly ambiguous, and no narrowing construction can properly
be adopted.”

Id. at 1338-39 (internal quotation marks omitted).

In addition, “[a] claim is indefinite if its legal scope is not
clear enough that a person of ordinary skill in the art could
determine whether a particular composition infringes or not.”
Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1384
(Fed. Cir. 2003).
Velcera contends that the ‘329 Patent does not provide a
person of ordinary skill in the art with enough information to
determine

which

methoprene

are

Velcera’s

spot-on
synergistic

arguments

raises

compositions
and

thus

concerns

with

fipronil

infringing.
with

the

One

tests

and
of

Merial

proffered in support of its assertion that Frontline Plus is an
embodiment of the ‘329 Patent that contains synergistic amounts
of fipronil and methoprene.

According to Velcera, those tests

did not show synergy at all tested time points, so a composition
may fall outside the claim scope depending on the test method.
The

Federal

Circuit

rejected

a

22

similar

argument

in

Geneva

Pharmaceuticals,

finding

that

the

term

“synergistically

effective amount” is a functional limitation that encompasses
dosages that yield synergy and that “once a particular amount
yields

synergy

under

any

circumstance,

‘synergistically effective.’”

that

amount

is

Geneva Pharm., 349 F.3d at 1384

(finding that patent was not invalid for indefiniteness but was
invalid for “nonstatutory double patenting”).
Velcera
provide
whether

a

asserts

indication

an

further

of

given

that

the

the

type

composition

is

of

‘329

Patent

testing

to

does

not

determine

synergistic.

Velcera

acknowledges, however, that there are a number of ways to test
for synergy.

Moreover, the testimony of Drs. Witchey and Clark

establishes that a person of ordinary skill in the art would
know how to conduct tests to determine whether a composition has
synergistic

amounts

of

fipronil

and

methoprene.

Therefore,

Merial is likely to establish that the ‘329 Patent is clear
enough

that

determine

a

person

whether

a

of

ordinary

particular

skill

in

composition

the
of

art

could

fipronil

and

methoprene is synergistic and thus infringes the ‘329 Patent.
For these reasons, the Court finds that Merial is likely to
withstand Velcera’s challenge to definiteness.
4.

Non-Obviousness Requirement

Velcera contends that even if the ‘329 Patent satisfies the
§ 112 requirements, the patent is invalid for obviousness.

23

A

patent is invalid for obviousness “if the differences between
the subject matter sought to be patented and the prior art are
such that the subject matter as a whole would have been obvious
at the time the invention was made to a person having ordinary
skill

in

the

art.”

35

U.S.C. §

103(a).

In

determining

obviousness, the courts consider (1) “the scope and content of
the prior art”, (2) “differences between the prior art and the
claims

at

pertinent

issue,”
art”

and

(3)

“the

(4)

level

objective

of

ordinary

evidence

of

skill

in

the

nonobviounsess.

Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18
(1966).

Objective

evidence

of

nonobviousness

includes

such

“secondary considerations as commercial success, long felt but
unsolved needs, [and] failure of others.”

Id. at 17.

In support of its assertion that the ‘329 Patent is invalid
for obviousness, Velcera points to two published patents: U.S.
Patent

No.

5,597,429

(“Senbo

Patent”)

and

U.S.

Patent

No.

5,236,934 (“Gladney Patent”).

It is significant that the U.S.

Patent

(“USPTO”)

and

Trademark

Office

considered

the

Senbo

Patent during the initial prosecution of the ‘329 Patent and
also

during

difficult”

the

for

an

obviousness

when

prior

that

art

reexamination
alleged

the
was

because

infringer

alleged

to

infringer

before

24

the

it
show

is

invalidity

“attempts

patent

“especially

to

examiner

rely

for
on

during

prosecution.”

Glaxo Grp. Ltd. v. Apotex, Inc., 376 F.3d 1339,

1348 (Fed. Cir. 2004).
Velcera

contends

that

the

Senbo

Patent

teaches

“nearly

every element of the claims” of the ‘329 Patent except the spoton composition and that Gladney discloses a spot-on composition,
so the two references together disclose every component of the
asserted claims, except synergy.

As Velcera concedes, the Senbo

Patent does not teach or mention spot-on compositions, and it
does not disclose a composition where the active ingredients are
present in synergistic effective amounts.

Moreover, based on

the evidence presented to the Court, including the testimony of
Dr.

Witchey,

ordinary

skill

the
in

Senbo
the

Patent
art

does

how

to

not

teach

produce

an

a

person

effective

of
(or

synergistic) formulation of fipronil and methoprene that could
be applied as a spot-on treatment and distributed

around an

animal’s body through translocation.
Though the Gladney Patent offers the idea for a spot-on
treatment, it teaches a locally-applied formulation of a high
concentration of a pyrethroid for treatment of ecto-parasites,
such as fleas, on mammals.

Based on the evidence presented to

the Court, including the testimony of Dr. Witchey, the Gladney
patent does not teach a person of ordinary skill in the art to
try fipronil and methoprene together in a spot-on composition in
synergistic amounts or otherwise.

25

In fact, according to Dr.

Witchey, based on the properties of pyrethroids compared to the
properties of fipronil and the fact that the Gladney Patent
teaches that translocation is achieved through a relatively high
concentration
teaches

away

of

a

from

pyrethroid,
attempting

the
a

Gladney

spot-on

Patent

actually

composition

using

fipronil.
For all of these reasons, the Court finds that the Senbo
Patent and the Gladney Patent do not indicate that a person of
ordinary skill in the art would have perceived a reasonable
expectation of success in terms of formulating an efficacious
spot-on composition using fipronil and methoprene.

Thus, the

Senbo Patent and the Gladney Patent do not render obvious the
teachings of the ‘329 Patent.
As part of the obviousness analysis, the Court must also
consider

secondary

considerations

of

nonobviousness.

E.g.,

TriMed, Inc. v. Stryker Corp., 608 F.3d 1333, 1343 (Fed. Cir.
2010).

“Such evidence may often establish that an invention

appearing to have been obvious in light of the prior art was
not.”

Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed.

Cir. 2012) (internal quotation marks omitted).

“These objective

criteria thus help turn back the clock and place the claims in
the

context

secondary
results,

that

led

to

considerations
copying,

their
of

commercial

invention.”

nonobviousness
success,

26

Id.

Relevant

include

unexpected

praise

by

others,

and

long-felt need.

Id. at 1379.

Velcera cannot seriously dispute

that Merial’s Frontline Plus products, which embody the ‘329
Patent

as

discussed

in

more

detail

below,

have

enjoyed

tremendous commercial success due to the combination of fipronil
and methoprene compared with fipronil-only products, have been
copied by others, and have received significant industry praise.
Velcera also cannot seriously dispute that the Frontline Plus
products met a long-felt industry need for a product that is
efficacious against ticks and against fleas in both their larval
and adult forms, is easy to apply, does not wash off, and is
long lasting.

The Court is therefore persuaded that Merial has

offered significant objective evidence of nonobviousness.
For all of these reasons, the Court concludes that Merial
has

established

that

it

will

likely

withstand

Velcera’s

obviousness challenge to the ‘329 Patent.
5.
For
Merial

Conclusion Regarding Validity

the

reasons

has

shown

set

that

forth
it

will

above,

the

likely

Court

finds

withstand

that

Velcera’s

invalidity challenges to the ‘329 Patent.
C.

Infringement of ‘329 Patent

The Court now turns to

the question whether Merial has

established that it is likely to succeed on the merits of its
infringement

claim.

To

meet

this

burden,

Merial

must

demonstrate that it is likely to show that 2012 PetArmor Plus

27

infringes

at

least

one

claim

of

the

‘329

Patent.

Merial

contends that 2012 PetArmor Plus infringes at least one or more
of Claims 4, 26, 77 and 85 of the ‘329 Patent and that Velcera
will induce infringement of at least one or more of Claims 101,
106, 107 and 108 of the ‘329 Patent.

A determination of patent

infringement

determine

requires

the

Court

to

the

scope

and

meaning of the patent’s claims and then compare the claims to
the allegedly infringing product.

E.g., PSC Computer Prods.,

Inc. v. Foxconn Int’l, Inc., 355 F.3d 1353, 1357 (Fed. Cir.
2004).

For purposes of this Order, the Court focuses on Claim

4, which was the main claim addressed during the preliminary
injunction hearing.
Claim 4 of the ‘329 Patent is a dependent claim of Claim 1.
Claim 1 of the ‘329 Patent requires three elements to infringe:
(1)

a

“synergistic

“synergistic

effective

amount

of

a

amount[]”

compound

of

which

fipronil,
mimics

(2)

a

juvenile

hormones,” and (3) “at least one customary spot-on formulation
adjuvant.”

‘329 Patent col. 10 l. 11-15.

Claim 4 limits “the

compound which mimics juvenile hormones” to methoprene.
col. 10 l. 26-28.
“synergistic
effective

methoprene.

Thus, Claim 4 of the ‘329 Patent requires a

spot-on

amounts”

Id.

or

composition”
“synergistic

that

contains

amounts”

of

“synergistic
fipronil

and

Therefore, to establish infringement, Merial must

show that 2012 PetArmor Plus contains synergistic amounts of

28

fipronil

and

adjuvant.

methoprene,

as

well

as

at

least

one

spot-on

At this stage in the litigation, Velcera does not

dispute that 2012 PetArmor Plus contains fipronil, methoprene
and

at

least

infringement

one

spot-on

depends

adjuvant.

upon

whether

Velcera’s
2012

challenge

PetArmor

Plus

to
(or

Frontline Plus, for that matter) contains synergistic amounts of
fipronil and methoprene.
The parties do not appear to have a serious dispute as to
the

meaning

of

“synergistic

amounts”

preliminary injunction motion.

for

purposes

of

the

Based on the plain meaning of

the term “synergistic,” for purposes of this Order, the Court
finds that the term “synergistic amounts” means amounts that
yield synergistic effects and that “synergistic” means greater
than

the

expected

“synergistic”

means

additive
that

effect.

the

In

combination

of

other

words,

fipronil

and

methoprene achieves improved results relative to the additive
results when the agents are administered independently.

The

parties’ chief disagreement relates to whether the products at
issue in this action actually contain synergistic amounts of
fipronil and methoprene.
To establish that 2012 PetArmor Plus infringes the ‘329
Patent,

Merial

synergistic
undisputed

must

amounts
that

show
of

Merial

that

2012

fipronil
has

not

29

PetArmor

and
tested

Plus

contains

methoprene.
2012

PetArmor

It

is

Plus.

Rather, Merial argues that for purposes of evaluating whether
fipronil and methoprene exist in synergistic effective amounts,
2012 PetArmor Plus has the same synergistic effective amounts of
fipronil and methoprene as 2011 PetArmor Plus
PetArmor

Plus

has

the

same

synergistic

and

effective

fipronil and methoprene as Frontline Plus.

that 2011
amounts

of

Merial asserts that

Frontline Plus is an embodiment of the ‘329 Patent that was
designed and manufactured based on the teachings of the ‘329
Patent, which included the Declaration and synergy studies of
Dr. Alan Marchiondo as part of the patent history.
Merial,

Frontline

amounts

of

Plus

fipronil

has

and

the

same

methoprene

According to

synergistic

that

the

studies

Marchiondo showed were synergistically effective.
according

to

Merial,

the

Marchiondo

studies

support a finding that such synergy exists in
Plus.

effective
of

Dr.

Therefore,

showing

synergy

2012 PetArmor

Velcera argues that 2012 PetArmor Plus is a different

formulation
deductive

from

reasoning

Frontline
is

Plus,

flawed.

and

More

therefore,

Merial’s

significantly,

Velcera

maintains that the Marchiondo studies are flawed and do not show
synergy.

The Court first addresses the Marchiondo studies and

then turns to the differences between 2012 PetArmor Plus and
Frontline Plus.
In

the

Marchiondo

Declaration,

Dr.

Alan

Marchiondo,

a

parasitologist who worked for Merial, reported to the USPTO that

30

studies

conducted

under

his

supervision

showed

that

certain

fipronil/methoprene compositions yielded synergistic results and
that

the

more

fipronil/methoprene

ovicidally

composition[s]
alone.”
(B),

ECF

active

compositions

for

comprising

an

just

were

fipronil

“surprisingly

extended

period

or

than

(S)-methoprene

Prelim. Inj. Hr’g Ex. PX-716, Marchiondo Decl. ¶ 8(A) &
No.

31-17.

It

is

undisputed

that

the

Marchiondo

Declaration summarized in vivo studies on dogs and cats, among
other studies.

It is also undisputed that the in vivo dog study

tested the efficacy of 10% fipronil and 9% methoprene alone and
in

combination

efficacy

of

combination.

and

10%

that

the

fipronil

in

and

vivo

12%

cat

study

methoprene

tested

alone

and

the
in

The results of the in vivo dog study, which found

a synergistic effect due to the combination of 10% fipronil and
9% methoprene, were peer reviewed and published by D.R. Young et
al. in the Veterinary Parasitology Journal (“Young Article”).
The question for the Court is whether the Marchiondo Declaration
and

the

underlying

composition

of

studies

fipronil

and

reasonably
methoprene

establish
in

these

that

a

amounts

is

synergistic.
Dr. Witchey and Dr. Clark, two distinguished persons of
ordinary skill in the art with exceptional qualifications and
extensive

relevant

experience,

reviewed

the

Marchiondo

Declaration and the underlying studies, as well as the Young

31

Article.

They

concluded

that

the

research

methodology

is

standard for this type of parasiticide test and that the studies
were run using good laboratory practices and a sufficient number
of animals and data points.

There was also testimony that Dr.

Marchiondo is a very well respected parasitologist and that the
studies

summarized

in

his

Declaration

had

a

level

reproducibility that is indicative of reliability.

of

The Young

Article was peer reviewed and published, which gives it another
indicia of reliability.

Drs. Witchey and Clark testified that

the data in the Marchiondo declaration and underlying studies
supports Dr. Marchiondo’s conclusions of synergy, and Merial’s
statistical expert, Dr. Dallas Johnson, reviewed the data and
concurred that it supported a conclusion of synergy.
Velcera’s statistical expert, Dr. Robert Hamer, whom the
Court found to be well qualified, criticized the statistical
analysis in the Marchiondo Declaration and the Young Article,
but he did not opine that no synergy exists.

While Dr. Hamer’s

criticisms do raise legitimate concerns and cause some pause by
the factfinder, the Court notes that Merial’s burden is not to
prove the elements of its claim at this stage of the proceedings
with

the

precise

exactitude

typically

expected

of

a

Ph.D.

statistician; rather, Merial’s burden is to prove that it is
likely to prove its claims at trial.

32

The
evidence

Court
is

admissions

also

not
by

the

observes
only

that

statistical

evidence

Velcera’s

Chief

on

this

and

scientific

issue.

Previous

Executive

Officer,

Dennis

Steadman, also support the conclusion that Marchiondo’s studies
show synergy and that the amounts of fipronil and methoprene in
Frontline

Plus

and

in

the

PetArmor

synergistic effective amounts.

Plus

products

exist

in

Mr. Steadman previously admitted

that if the ‘329 Patent is valid, then the 2011 version of
PetArmor

Plus

infringes

it.

E.g.,

Fed.

1948879, at *14 (Fed. Cir. May 31, 2012).

Cir.

Op.,

2012

WL

For 2011 PetArmor

Plus to infringe the ‘329 Patent, then it must have fipronil and
methoprene
admission
implicitly

in
is
an

synergistic
not

just

amounts;

an

admission

therefore,

admission

that

2011

of

Mr.

Steadman’s

infringement

PetArmor

Plus

but

is

contained

fipronil and methoprene in synergistic effective amounts.
This admission also corroborates the Marchiondo studies.
It is undisputed that 2011 PetArmor Plus contained the exact
same concentration of active ingredients as Frontline Plus: 9.8%
fipronil and 8.8% methoprene in PetArmor Plus and Frontline Plus
for Dogs and 9.8% fipronil and 11.8% methoprene in PetArmor Plus
and Frontline Plus for Cats.

Furthermore, there is no material

difference

of

in

the

amounts

fipronil

and

methoprene

in

Frontline Plus compared to the amounts Marchiondo found to be
synergistically effective.

The Marchiondo Declaration and the

33

underlying

studies

methoprene

are

composition

support

for

use

conclusion

synergistic

in

the

effective

on

cats

contains

that

fipronil

amounts

10%

and

when

the

and

12%

fipronil

methoprene and the composition for dogs contains 10% fipronil
and 9% methoprene.
products
nearly

contain

active

identical

Marchiondo

As previously noted,

to

ingredient

the

Frontline

concentrations

that

the

Declaration

concentrations

and

the

are

in

the

discussed
studies:

underlying

Plus

Frontline

Plus for Dogs contains 9.8% fipronil and 8.8% methoprene, and
Frontline

Plus

methoprene.
between

Cats

contains

9.8%

fipronil

and

11.8%

According to Dr. Witchey, the difference of 0.2%

the

Marchiondo

for

and

active
the

ingredient
active

concentrations

ingredient

tested

concentrations

in

by
the

Frontline Plus products would not make a difference in terms of
synergistic efficacy.

Therefore, Merial is likely to show that

2011

contains

PetArmor

Plus

fipronil

and

methoprene

in

synergistically effective amounts.
The Court must next determine whether Merial is likely to
show

that

2012

PetArmor

Plus

likewise

methoprene in synergistic amounts.
Plus was recently reformulated.

contains

fipronil

and

As discussed above, PetArmor

2012 PetArmor Plus contains the

exact same active ingredient formulation as Frontline Plus and
the

2011

version

of

PetArmor

Plus:

9.8%

fipronil

and

8.8%

methoprene in PetArmor Plus for Dogs and 9.8% fipronil and 11.8%

34

methoprene in PetArmor Plus for Cats.
2012

PetArmor

Plus

and

2011

The difference between

PetArmor

Plus

is

that

the

2011

version contained two inert ingredients that the current version
does not, and the volume of those ingredients was replaced with
an

increase

Specifically,

in
in

volume
the

of

2012

another

formulation

inert

of

ingredient.

PetArmor

Plus,

the

crystallization inhibitors that were present in the 2011 version
have

been

removed

Transcutol P.

and

replaced

with

an

increased

volume

of

According to Velcera, this modification changed

the delivery mechanism for the active ingredients.

There is

persuasive evidence, however, that the change to the inactive
ingredients does not have a material effect on the synergy of
fipronil
version

and
of

methoprene.
PetArmor

In

Plus,

seeking

Velcera

approval

for

the

2012

represented

to

the

U.S.

Environmental Protection Agency that the change to the inactive
ingredients was merely a minor formulation change.
Dr.

David

Research
testified
confirmed

M.
and

Petrick,

Velcera’s

Development

that
that

Velcera
the

and
had

Executive

Regulatory
tested

formulation

2012
change

Vice

Furthermore,
President

Affairs,
PetArmor
to

the

of

previously
Plus

and

inactive

ingredients did not “negatively impact either product efficacy
or overall aesthetics.”

Prelim. Inj. Hr’g Ex. PX-755, Petrick

Decl. ¶ 19, ECF No. 31-28.

According to Dr. Witchey, because

2012 PetArmor Plus is as efficacious as the 2011 version, the

35

minor formulation change to the inactive ingredients did not
affect the synergy of the active ingredients.

Based on this

evidence, the Court finds that Merial is likely to succeed in
showing that 2012 PetArmor Plus contains synergistic amounts of
fipronil

and

methoprene

plus

at

least

one

spot-on

adjuvant,

which means that Merial is likely to show that PetArmor Plus
infringes at least Claim 4 of the ‘329 Patent.

Accordingly, the

Court concludes that Merial is likely to succeed on the merits
of its infringement claim.
III. Other Preliminary Injunction Elements
Having found that Merial is likely to withstand Velcera’s
challenges to the validity of the ‘329 Patent and is likely to
succeed on the merits of its infringement claim, the Court must
address the remaining preliminary injunction factors.

Thus, the

Court must determine whether Merial has established that it is
likely to suffer irreparable harm in the absence of preliminary
injunctive

relief, that the

balance of equities tips in

its

favor and that an injunction is in the public interest.
The Court finds that Merial has demonstrated that Velcera’s
planned
Merial

sale
by

of

causing

2012

PetArmor

Merial

to

Plus

lose

will

market

irreparably
share.

The

injure
Court

previously found that Velcera’s 2011 launch of PetArmor Plus
resulted in an irreparable injury to Merial.
Order, 2011 WL 2489753, at *15.

36

2011 Contempt

The Court concluded that the

introduction of a generic fipronil and methoprene product like
PetArmor Plus would result in considerable loss of market share
to

Merial

and

that

Velcera’s

marketing

strategy

specifically

targeted Frontline Plus, touting that PetArmor Plus is exactly
like Frontline Plus but less expensive.

Id.

The Court further

found that there is not an adequate remedy at law for injuries
such as loss of market share and brand recognition.
The

Court

also

heard

testimony

in

the

Id.

context

of

this

year’s contempt action that the 2011 launch of 2011 PetArmor
Plus caused a loss of Merial’s market share for Frontline Plus,
caused price erosion effects to Frontline Plus and negatively
impacted veterinarians’ attitudes toward

Frontline

Plus, thus

reducing the likelihood that they would recommend Frontline Plus
for their patients.
PetArmor

Plus,

strategy

for

targeting

With regard to the planned 2012 launch of

there

2012

Frontline

is

evidence

PetArmor
Plus.

that

Plus

includes

Based

on

the

Velcera’s
plans
adverse

marketing

to

continue

effects

to

Merial due to the 2011 launch of PetArmor Plus and Velcera’s
plan to continue targeting Frontline Plus, the Court concludes
that if the 2012 launch of 2012 PetArmor Plus is not enjoined,
Merial is likely to suffer adverse effects similar to those it
suffered in 2011, including loss of market share, price erosion
and

loss

of

recommendations

from

veterinarians.

For

these

reasons, the Court finds that Merial will suffer irreparable

37

harm if Velcera is not enjoined from selling 2012 PetArmor Plus,
so this factor weighs in favor of a preliminary injunction.
The

balance

preliminary
patent

of

hardships

injunction.

rights

is

also

Merial’s

strong.

weighs

interest

Though

Velcera

in
in

favor

of

enforcing

argues

that

a
its
an

injunction requiring Velcera to stop its launch plans would harm
Velcera financially, as the Federal Circuit has noted, “[o]ne
who elects to build a business on a product found to infringe
cannot be heard to complain if an injunction against continuing
infringement destroys the business so elected.” Broadcom Corp.
v. Qualcomm Inc., 543 F.3d 683, 704 (Fed. Cir. 2008).
the

Court

notes

that

2012

PetArmor

Plus

is

not

Moreover,

yet

on

the

market, and enjoining the launch of the product would be far
less

burdensome

than

already on the market.

enjoining

sales

of

a

product

that

is

Finally, the Court has set an expedited

trial date for November of this year, so the length of the
preliminary injunction is likely limited to five months.
all of these reasons, the balance of hardships

For

supports the

issuance of a preliminary injunction.
The final question is whether the public interest weighs in
favor of a preliminary injunction.
observed,

even

though

“the

public

As the Court has previously
may

benefit

from

a

lower

priced fipronil/methoprene product if . . . Velcera were allowed
to” sell PetArmor Plus, “the public is also served by enforced

38

compliance with . . . the United States patent laws.”
Contempt Order, 2011 WL 2489753, at *16.

2011

The Court thus finds

that the public interest factor weighs in favor of a preliminary
injunction.
PRELIMINARY INJUNCTION
Based on the foregoing findings of fact and conclusions of
law, Merial’s Motion for Preliminary Injunction (ECF No. 5) is
granted

and

injunction:

the

Court

issues

the

following

preliminary

Until further order of the Court, Velcera Inc. and

FidoPharm Inc., as well as those acting in concert with either
of

them

and

who

have

knowledge

of

this

Order,

are

hereby

enjoined from making, using, offering for sale, selling, causing
to

be

sold,

or

otherwise

launching

in

the

United

States,

Velcera’s 2012 PetArmor Plus products, LC-2010-3 Fipronil and SMethoprene

for

Cats

(PetArmor

Plus

for

Cats)

and

LC-2010-4

Fipronil and S-Methoprene for Dogs (PetArmor Plus for Dogs).
SECURITY
Federal

Rule

of

Civil

Procedure

65

provides

that

a

preliminary injunction may be issued “only if the movant gives
security in an amount that the court considers proper to pay the
costs and damages sustained by any party found to have been
wrongfully enjoined or restrained.”

Fed. R. Civ. P. 65(c).

The

parties stipulated prior to trial that the issue regarding the
amount and nature of any security would be addressed after the

39

Court

issued

injunction.

its

ruling

on

the

motion

for

preliminary

Therefore, the Court finds that the preliminary

injunction is effective today, and the parties shall address the
security issue as follows.

Within fourteen days of today’s

Order, Velcera shall file a motion for security setting out what
it seeks as reasonable security and the basis for its request.
Merial shall file a response to that motion within fourteen days
of being served with that motion.

The Court will then decide

the appropriate nature and amount of security to be given.

IT IS SO ORDERED, this 29th day of June, 2012.
S/Clay D. Land
CLAY D. LAND
UNITED STATES DISTRICT JUDGE

40