8/10/2019 Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals, Inc., C.A. No. 14-791-GMS (D. Del. Nov. 14, 2014)

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IN THE UNITED STATES DISTRICT

COURT

FOR THE DISTRICT OF DELAWARE

AMARIN PHARACEUTICALS

IRELAND LIMITED,

Plaintiff,

v

OMTHERA PHARMACEUTICALS, INC.

and ASTRAZENECA

PHARMACEUTICALS LP,

Defendants.

OR ER

Civil Action No. 14-791-GMS

WHEREAS, the plaintiff, Amarin Pharmaceuticals Ireland Limited ( Amarin ), filed the

instant action against Omthera Pharmaceuticals, Inc. and AstraZeneca Pharmaceuticals LP

(collectively, the defendants ) on June 20, 2014 (D.I. 1);

WHEREAS, the defendants filed a Motion to Dismiss (D.I. 9)

on

July 14, 2014;

WHEREAS, on August 4, 2014, Amarin filed an Answering Brief in Opposition to the

defendants' Motion to Dismiss (D.I. 13) and, on August 18, 2014, the defendants filed a sealed

Reply (D.I. 16);

WHEREAS, on August 25, 2014, Amarin filed a Motion to Strike and Motion for Leave

to File Surreply (D.1. 18);

WHEREAS, on September 11, 2014, the defendants filed an Answering Brief in

Opposition to

Amarin s

Motion to Strike (D.I. 21) and, on September 19, 2014, Amarin filed a

Reply (D.I. 23); and

WHEREAS the court has considered the parties' briefing and the applicable law;

8/10/2019 Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals, Inc., C.A. No. 14-791-GMS (D. Del. Nov. 14, 2014)

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IT IS HEREBY ORDERED THAT:

1. The defendants' Motion to Dismiss (D.I. 9) is GRANTED;

1

and

1

Amarin seeks a declaratory judgment that the defendants' Epanova product infringes U.S. Patent No.

8,663,663 (the '662 patent ). (D.I. 1.) Amarin asserts that the action

is

ripe for judicial review because Epanova

is

approved by the FDA and

is

currently being marketed by the defendants. (D.I. 13 at 7.) Further, Amarin alleges

that the Epanova's composition, indication, and product labeling are final and fixed. (Id.)

The defendants assert that dismissal is proper under Fed.

R.

Civ. P. 12(b)(l) because Amarin's declaratory

judgment action for future inducement and contributory patent infringement is not ripe where Epanovah s not been

launched and launch is not imminent. (D.I. 10 at 5.) In the alternative, the defendants request that the court exercise

its discretion and decline to exercise jurisdiction over the action at this time. (Id.)

The Declaratory Judgment Act provides that [i]n a case of actual controversy within its jurisdiction, any

court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations

of

any interested party seeking such declaration, whether or not further relief

is

or could be sought. 28 U.S.C.

220l(a).

An

action for declaratory judgment presents a justiciable controversy when the facts alleged, under all the

circumstances, show that there

is

a substantial controversy, between parties having adverse legal interests,

of

sufficient

immediacy and reality to warrant the issuance of a declaratory judgment. Medimmune, Inc. v. Genentech., 549 U.S.

118, 127 (2007).

Amarin bears the burden of proving the existence of an Article III case or controversy. See Arkema Inc. v.

Honeywell Intern., Inc.,

706 F.3d 1351, 1356 (Fed. Cir. 2013) (citation omitted). In order to detennine an action

is

ripe the court must evaluate both the fitness of the issues for judicial decision and the hardship to the parties of

withholding court consideration. See Caraco Pharm. Labs., Ltd.

v.

Forest Labs., Inc., 527 F.3d 1278, 1294-94 (Fed.

Cir. 2008) (quoting Abbott Labs.

v.

Gardner, 387 U.S. 136, 149 (1967)).

This

is

not the first time the court has been faced with this issue and these parties. Amarin filed an initial

Complaint in the District of Delaware on March 4, 2014. (See C.A. 14-279-GMS, D.I. 1.) The defendants moved to

dismiss the case under substantially the same reasoning

as

submitted here. (See id. at D.I. 9.) On May

16,

2014,

Amarin filed an Amended Complaint

as

a result of Epanova's May

6,

2014 approval by the Food and Drug

Administration ( FDA ).

Id.

at D.I. 15.) The court held a scheduling teleconference with the parties on June

16,

2014 during which time the pending Motion to Dismiss was discussed. (See

id.

at D.I. 23.) Shortly thereafter, on

June 20, 2014, the instant action was filed by Amarin. (D.I. 1. On June 27, 2014, Amarin filed a Notice of Voluntary

Dismissal in the 14-279 action. (C.A. 14-279-GMS, D.I. 21.) Amarin's filing of the instant action was understood

by

the court

as

an attempt

to

cure defective jurisdiction

in

its original Complaint; specifically, the fact that EpanovaTM

had not yet been approved by the FDA at the time of the original filing. While the court finds that FDA approval of

Epanova does provide some amount

of

support for Amarin's position

it is

not dispositive.

A declaratory judgment plaintiff must allege significant, concrete steps to conduct infringing activity. See

Cat Tech LLC

v.

TubeMaster, Inc., 528 F.3d 871, 880 (Fed. Cir. 2008). In Arkema

Inc. v.

Honeywell Intern., Inc., the

Federal Circuit found that the declaratory judgment plaintiff had concrete plans to supply a product for concededly

infringing uses when it had already marketed the product, had responded to supply requests, and wished to enter

supply contracts with customers. 706 F.3d 1351, 1357 (Fed. Cir. 2013). For purposes of this Order, the court accepts

Amarin's assertion that marketing efforts for the accused product are ongoing. Recognizing that evaluating

justiciability

in patent cases

is

a very fact-dependent exercise, the court detennines that the defendants' advanced

marketing

of

the accused product

is

insufficient to meet Amarin's burden

in

this specific instance. See Matthews Int'

Corp.

v. Biosafe Eng'g, LLC, 695 F.3d 1322, 1328 (Fed. Cir. 2012) ( In detennining whether a justiciable controversy

is

present, the analysis must be calibrated to the particular facts of each case. ).

The claims at issue in the '662 patent are limited to method of use claims. Infringement of a method claim

occurs when a party perfonns all of the steps of the process See Ricoh

Co. v.

Quanta Computer Inc., 550 F.3d

1325, 1333 (Fed. Cir. 2008) (citation omitted). The defendants argue that the alleged acts of infringement of the

patent's method claims turn on physiological responses that have not occurred, in patients that do not yet exist,

operating under the care of unidentified doctors, who have not yet prescribed a drug that

is

not yet on the market and

carmot, therefore, provide the requisite immediacy.

(See

D.I.

10

at 5.) The court agrees and concludes that any

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8/10/2019 Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals, Inc., C.A. No. 14-791-GMS (D. Del. Nov. 14, 2014)

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2.

Amarin's Motion to Strike and Motion for Leave to File Surreply (D.I. 18 is

DENIED as Moot.

Dated: November

1 7,

2014

judicial determination as to whether Epanova

TM

could infringe the method claims would constitute an advisory

opinion. See Arctic Corner, Inc v United States,

845

F.2d 999, 1000 (Fed. Cir. 1998) ( At the heart o the 'case or

controversy' requirement is the prohibition against advisory opinions. ). The Federal Circuit came to the same

conclusion in Matthews even after the accused products had been sold. See 695 F.3d at 1330. Here, as in Matthews,

it is unclear when any even arguably infringing activity will occur. d As such, the dispute lacks the immediacy

necessary to support the exercise o declaratory judgment jurisdiction. d (citation omitted).

Amarin alleges that withholding consideration o the Complaint will have an immediate and substantial

impact on the company and that its only recourse

is

the speedy resolution

o

this action on the merits. (D.I. 13 at 18.)

In addition, Amarin asserts that [a]lthough Defendants tell this Court that Epanova's launch date is 'uncertain'

(D.I.

10 at 5), they have made no representations that they will not sell the accused product within the timeframe

o

this lawsuit. (D.I. 13 at 10.) While it is possible that Epanova could enter the market within the timeframe o

this lawsuit the court does not find that assertion sufficient to prove launch o the product

is

imminent.

t is

not

unreasonable to expect that this case could take two years to bring to trial. As the product's launch date remains

uncertain, any potential future infringement

is

not sufficiently immediate to support the exercise

o

declaratory

judgment jurisdiction. Moreover, the defendants specifically advised Amarin's counsel that the Epanova product

would not be launched in 2014 and offered to provide notice to Amarin before any controversy could have been

imminent. (See D.I. 13 at 5 n.3.) The court is persuaded by the defendants' representations to provide notice to

Amarin prior to product launch. The court relies on those representations to defeat Amarin's declaratory judgment

claims and, as a result, those representations are binding as a matter

o

udicial estoppel. See Organic Seed Growers

and Trade Ass n

v

Monsanto Co., 718 F.3d 1350, 1358 (Fed. Cir. 2013).

The court concludes that Amarin has not satisfied the case or controversy requirement and, therefore, finds

dismissal o the case is warranted.

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