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“IF” is key word, but if so, yes.
Next weeks scripts will include the holiday week
Not sure what site you’re looking at, but the PR is on their site.
Put down the crack. RIP Amarin
I find it very hard to believe that Sean Tucker picked up a little over 4K shares at 6.49 and this keeps going down. He’s the CSO for fucksake. I can’t imagine news not coming, but then again, I’ve seen crazier shit happen.
That’s not the answer to my question
Has anyone ever sent IR an email? And if so, get a reply? No replies on two emails in the last two weeks. Just sent another, but not banking on a fucking response.
That’s because it’s bullshit news
Awwww. Leave CHAZ alone. It was such a “Summer of Love”. SMH
Amen right back at you. It’s not just the Left-Wing-Nut-Job Politicians. It’s also the stupid Left-Wing-Nut-Job people who live there that keep voting for these idiots.
Perfectly stated
Give it a year and it will be with NYC and Cali for people leaving.
Bullshit. Apparently you don’t know how to read Form 4’s
Idiot
Hope so. Anyone that says it’s a bull trap is an idiot. 35 million shares traded in an hour. Someone knows something
Remember what was said in the earnings report. The flu vaccine report was sent to Janssen.
Way too much volume to be a trap
Or the Flu vaccine
Some people know something
Okay Einstein. Finally able to post after a month of being in IHub jail. Haha
Please let me know when I suspension will be ending. Thanks
Did you send this to her and did you get a reply?
Expect it or hope for it? Please explain.
We knew this months ago when it was already reported. New data has not been released.
It’s all fun and games when we wake up to a press release saying they received 100 million in government funding.
That’s all that is posted right now
Case: 20-1901 Document: 14-1 Page: 1 Filed: 06/26/2020 (1 of 28)
Appeal No. 20-1901
__________________________________________________________________
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
__________________________________________________________________
AMARIN PHARMA, INC. and AMARIN PHARMACEUTICALS IRELAND LIMITED,
Plaintiffs-Appellants,
DR. REDDY’S LABORATORIES, INC. and DR. REDDY’S LABORATORIES,
v. LTD.
Defendants-Appellees. __________________________________________________________________
Appeal from the United States District Court for the District of Nevada in Case No. 2:18-cv-01596-MMD-NJK, Judge Miranda M. Du. __________________________________________________________________ JOINT MOTION TO CONSOLIDATE
APPEAL NO. 20-1901 WITH APPEAL NO. 20-1723
Jonathan E. Singer (Lead Counsel) Oliver Richards
Fish & Richardson P.C.
12390 El Camino Real
San Diego, CA 92130
Deanna J. Reichel
Fish & Richardson P.C. 3200 RBC Plaza
60 South Sixth Street Minneapolis, MN 55402
Nitika Gupta Fiorella Fish & Richardson P.C. 222 Delaware Avenue 17th Floor
Wilmington, DE 19801
Christopher N. Sipes Jeffrey B. Elikan Covington & Burling LLP 850 Tenth Street, NW Washington, DC 20001
Counsel for Plaintiffs-Appellants Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
Case: 20-1901 Document: 14-1 Page: 2 Filed: 06/26/2020 (2 of 28)
Constance S. Huttner (Lead Counsel) James P. Barabas
Caroline Sun
Beth Finkelstein
Windels Marx Lane & Mittendorf, LLP 1 Giralda Farms
Suite 100
Madison, NJ 07940
Counsel for Defendants-Appellees Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
ii
Case: 20-1901 Document: 14-1 Page: 3 Filed: 06/26/2020
(3 of 28)
FORM 9. Certificate of Interest
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
Form 9 Rev. 10/17
Amarin Pharma, Inc.
Dr. Reddy's Laboratories, Inc. 20-1901
Case No.
CERTIFICATE OF INTEREST
v.
Counsel for the: (petitioner) (appellant) (respondent) (appellee) (amicus) (name of party)
Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
certifies the following (use “None” if applicable; use extra sheets if necessary):
1. Full Name of Party Represented by me
2. Name of Real Party in interest (Please only include any real party in interest NOT identified in Question 3) represented by me is:
3. Parent corporations and publicly held companies that own 10% or more of stock in the party
Amarin Pharma, Inc. Amarin Pharma, Inc. Amarin Corporation plc
AmarinPharmaceuticalsIrelandLimited AmarinPharmaceuticalsIrelandLimited
Amarin Corporation plc
4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court (and who have not or will not enter an appearance in this case) are:
McDonald Carano LLP: Adam Hosmer-Henner; Chelsea Latino
Covington & Burling LLP: Christopher N. Sipes; Jeffrey B. Elikan; Einar Stole; Michael N. Kennedy; Megan P. Keane; Eric R. Sonnenschein; Alaina M. Whitt; Han Park; Jordan L. Moran; Daniel J. Farnoly
Santoro Whitmire, Ltd.: Nicholas J. Santoro; Jason D. Smith
FORM 9. Certificate of Interest
Form 9 Rev. 10/17
Case: 20-1901 Document: 14-1 Page: 4 Filed: 06/26/2020
(4 of 28)
5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court’s decision in the pending appeal. See Fed. Cir. R. 47. 4(a)(5) and 47.5(b). (The parties should attach continuation pages as necessary).
This case is related to Amarin v. Hikma, Appeal No. 20-1723. The district court's judgment here is based on agreement to be bound by judgment in that case. The parties intend to file a motion to consolidate with that appeal.
6/26/2020
Date
Please Note: All questions must be answered
cc: Counsel of Record
/s/ Deanna J. Reichel
Signature of counsel
Deanna J. Reichel
Printed name of counsel
Reset Fields
Case: 20-1901 Document: 14-1 Page: 5 Filed: 06/26/2020 (5 of 28)
CERTIFICATE OF INTEREST
Counsel for Defendants-Appellees Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. certifies the following:
1. Full names of parties represented by me:
Dr. Reddy’s Laboratories, Inc. Dr. Reddy’s Laboratories, Ltd.
2. Name of real party in interest (Please only include any real party in interest NOT identified in Question 3) represented by me is:
N/A
3. Parent corporations and publicly held companies that own 10% or more of stock in the parties:
Dr. Reddy’s Laboratories, Inc. is a wholly owned subsidiary of Dr. Reddy’s Laboratories, S.A., which is a wholly owned subsidiary of Dr. Reddy’s Laboratories, Ltd., which is a publicly traded company. No publicly held corporation owns 10% or more of the stock of Dr. Reddy’s Laboratories, Ltd.
4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court (and who have not or will not enter an appearance in this case) are:
None.
5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court’s decision in the pending appeal. See Fed. Cir. R. 47.4(a)(5) and 47.5(b):
Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 20-1723 (Fed. Cir.)
{80250021:1}
Case: 20-1901 Document: 14-1 Page: 6 Filed: 06/26/2020 (6 of 28)
June 26, 2020 /s/ Constance S. Huttner CONSTANCE S. HUTTNER
{80250021:1}
Case: 20-1901 Document: 14-1 Page: 7 Filed: 06/26/2020 (7 of 28)
Plaintiffs-Appellants Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (collectively, “Plaintiffs-Appellants” or “Amarin”) and Defendants-Appellees Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (together, “DRL”)1 jointly move pursuant to Federal Circuit Rule 27 to consolidate the proceedings in Appeal No. 20-1901 with Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., Appeal No. 20-1723. The consent judgment from which Appeal No. 20-1901 was taken (Exhibit A attached hereto) was wholly based upon the judgment under review in Appeal No. 20-1723. The two judgments also concern the same asserted claims of the same patents-in- suit. Accordingly, judicial economy would best be served by consolidating Appeal No. 20-1901 with Appeal No. 20-1723.
The parties also request that the Court order as follows:
? No briefing will be filed in Appeal No. 20-1901;
? The current briefing schedule for Appeal No. 20-1723 will remain unchanged; and
? The outcome of Appeal No. 20-1901 will be controlled by the outcome of Appeal No. 20-1723, including any petition for rehearing or certiorari, should one be filed from Appeal No. 20-1723.
1 Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited (together, “Hikma”) are Defendants-Appellees in Appeal No. 20-1723. Hikma has indicated that it does not oppose this motion.
Case: 20-1901 Document: 14-1 Page: 8 Filed: 06/26/2020 (8 of 28)
BACKGROUND
Appeal No. 20-1723 relates to a Hatch-Waxman patent infringement suit filed by Plaintiffs-Appellants in the District of Nevada against two generic drug companies, Hikma and DRL, that filed separate Abbreviated New Drug Applications (“ANDAs”) with FDA seeking approval for generic versions of Amarin’s Vascepa® drug product (one-gram dosage strength) prior to the expiration of the patents listed in the Orange Book for Vascepa®, including the patents-in-suit. Amarin sued each generic filer in the District of Nevada, which were then consolidated for all proceedings. (See Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., No. 2:16-cv-02525-MMD-NJK (D. Nev.), ECF No. 30.) After holding a seven-day bench trial in the consolidated proceeding ending on January 28, 2020, the district court issued an opinion dated March 30, 2020, in which it found that Defendants-Appellees infringed all asserted claims, but that the asserted claims were invalid for obviousness. (Id., ECF No. 381.) The district court entered judgment accordingly the same day. (Id., ECF No. 382). Plaintiffs- Appellants timely appealed, on April 2, 2020, and the parties have each filed their respective principal briefs in Appeal No. 20-1723.
During the pendency of the consolidated action described above, DRL filed an amended ANDA seeking approval of a 500 mg dosage strength of Vascepa®, for which Amarin had recently obtained approval. This triggered a separate paragraph
2
Case: 20-1901 Document: 14-1 Page: 9 Filed: 06/26/2020 (9 of 28)
IV notice and a new lawsuit involving most of the same patents as the consolidated
action, which Amarin also filed in the District of Nevada. (Complaint for Patent
Infringement, Amarin Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., No. 2:18-cv-
01596 (D. Nev. Filed Aug. 24, 2018), ECF No. 1.) On October 12, 2018, the
parties to the new action filed a stipulation and proposed order (Exhibit B attached
hereto) which (a) acknowledged that the infringement and validity issues presented
by the new 500 mg dosage strength litigation were substantially identical to those
in the ongoing consolidated actions; (b) agreed that the prevailing party in the
consolidated action would be entitled to a corresponding consent judgment in the
500 mg dosage strength action; and (c) asked the court to stay the 500 mg dosage
strength action until the outcome of the consolidated action. The district court
entered the requested stay. (See Order Granting Joint Stipulation Regarding
Agreement to be Bound by Judgment in Related ANDA Litigation, No. 2:18-cv-
01596, ECF No. 27.) No further action took place in the 500 mg action until after
the district court entered judgment in the consolidated action on March 30, 2020.
After that judgment, the parties agreed to enter a corresponding consent judgment
in the 500 mg action. (Exhibit C.) The district court entered the consent judgment
2
on May 4, 2020.
consent judgment on May 22, 2020.
Plaintiffs-Appellants filed a timely Notice of Appeal from the
2 The consent judgment does not address two claims that were invalidated in the (continued...)
3
Case: 20-1901 Document: 14-1 Page: 10 Filed: 06/26/2020 (10 of 28)
DISCUSSION
By this motion, Plaintiffs-Appellants and Defendants-Appellees respectfully request that this Court consolidate Appeal No. 20-1901 with Appeal No. 20-1723. Consolidation of appeals is appropriate where the appeals are related and can be briefed and argued jointly. See, e.g., VirnetX Inc. v. Mangrove Partners Master Fund, Ltd., No. 17-1368 (Fed. Cir. Dec. 22, 2016).
Here, the appeals involve the same asserted claims from the same patents-in- suit, and therefore involve the same factual and legal issues. Consolidation of the appeals would conserve valuable judicial resources because the issues on appeal in Appeal No. 20-1901 will be resolved by Appeal No. 20-1723. The sole basis for the consent judgment in this action is the judgment under review in Appeal No. 20- 1723, and the mandate in Appeal No. 20-1723, whatever its content, will similarly dispose of the issues in Appeal No. 20-1901, but for any petition for certiorari. Given the identical nature of these matters, the parties have also agreed that (1) no additional briefing is required in the consolidated appeals; (2) consolidation will cause no delay in the schedule of Appeal No. 20-1723; and (3) the outcome of Appeal No. 20-1901 will be controlled by the outcome of Appeal No. 20-1723.
judgment in the consolidated action, because those claims require administration of 1 g capsules, which does not apply to the 500 mg dosage strength.
4
Case: 20-1901 Document: 14-1 Page: 11 Filed: 06/26/2020 (11 of 28)
Accordingly, in the interest of judicial economy, this Court should consolidate Appeal No. 20-1901 with Appeal No. 20-1723.
CONCLUSION
For the reasons set forth above, Plaintiffs-Appellants and Defendants- Appellees respectfully request that this Court consolidate Appeal No. 20-1901 with Appeal No. 20-1723, maintain the current briefing schedule Appeal No. 20-1723, and order that no briefs are to be filed in Appeal No. 20-1901.
Dated: June 26, 2020
/s/ Constance S. Huttner
Constance S. Huttner WINDELS MARX LANE & MITTENDORF, LLP
1 Giralda Farms
Suite 100
Madison, NJ 07940 Telephone: (973) 966-3200 Facsimile: (973) 966-3250
Counsel for Defendants-Appellees Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
/s/ Deanna J. Reichel
Deanna J. Reichel
FISH & RICHARDSON P.C.
60 South Sixth Street, Suite 3200 Minneapolis, MN 55402 Telephone: (612) 335-5070 Facsimile: (612) 288-9696
Counsel for Plaintiffs-Appellants Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
5
Case: 20-1901 Document: 14-1 Page: 12 Filed: 06/26/2020 (12 of 28)
CERTIFICATE OF SERVICE
I hereby certify that I electronically filed the foregoing document with the Clerk of the United States Court of Appeals for the Federal Circuit by using the Court’s CM/ECF filing system.
I certify that all participants in the case are registered CM/ECF users and that all counsel were served via CM/ECF on June 26, 2020.
/s/ Deanna J. Reichel
Deanna J. Reichel
6
Case: 20-1901 Document: 14-2 Page: 1 Filed: 06/26/2020 (13 of 28)
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Case: 20-1901 Document: 14-2 Page: 2 Filed: 06/26/2020 (14 of 28) Case 2:18-cv-01596-MMD-NJK Document 30 Filed 05/04/20 Page 1 of 4
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP
5371 Kietzke Lane
Reno, NV 89511
Tel.: (775) 324-4100 / Fax: (775) 333-8171 Email: mrounds@bhfs.com,
rcudnik@bhfs.com
Constance S. Huttner (admitted pro hac vice) Frank D. Rodriguez (admitted pro hac vice) James Barabas (admitted pro hac vice) Caroline Sun (admitted pro hac vice)
Beth Finkelstein (admitted pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP
1 Giralda Farms, Suite 100
Madison, NJ 07940
Tel: (973) 966-3200 / Fax: (973) 966-3250 Email: chuttner@windelsmarx.com,
frodriguez@windelsmarx.com jbarabas@windelsmarx.com, csun@windelsmarx.com, bfinkelstein@windelsmarx.com
Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
AMARIN PHARMA, INC., et al., Plaintiffs,
v.
DR. REDDY’S LABORATORIES, INC. and DR. REDDY’S LABORATORIES, LTD.,
Defendants.
Case No. 2:18-cv-01596-MMD-NJK
[PROPOSED] JUDGMENT
Case: 20-1901 Document: 14-2 Page: 3 Filed: 06/26/2020 (15 of 28) Case 2:18-cv-01596-MMD-NJK Document 30 Filed 05/04/20 Page 2 of 4
1 The parties (Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
2 (collectively, “DRL”) and Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland
3 Limited (collectively, “Amarin”)) have stipulated to be bound by the Court’s judgment in the related
4 action of Amarin Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., No. 2:16-cv-02562 (D. Nev. Filed
5 Nov. 4, 2016), consolidated with Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., No.
6 2:16-cv-02525 (D. Nev. Filed Oct. 31, 2016). See C.A. No. 2:18-cv-01596, ECF No. 27. In light of
7 the Court’s March 30, 2020 Order and Judgment in favor of Defendants, C.A. No. 2:16-cv-02525
8 (the “2525 Action”), ECF No. 382, IT IS HEREBY ORDERED that:
9 1. Because of the parties’ agreement that the judgment in the 2525 Action will be binding
10 in this action, the Court enters judgment on infringement in this action based on the judgment in the
11 2525 Action as follows: The filing of ANDA No. 209499 infringed the following claims: Claims 1
12 and 16 of U.S. Patent No. 8,293,728; Claim 14 of U.S. Patent No. 8,318,715; Claims 1 and 8 of U.S.
13 Patent No. 8,357,677; Claim 1 of U.S. Patent No. 8,367,652; and Claims 1 and 5 of U.S. Patent
14 8,518,929.
15 2. Because of the parties’ agreement that the judgment in the 2525 Action will be binding
16 in this action, the Court enters judgment on obviousness in this action in favor of Defendants and
17 against Plaintiffs on the same grounds as the judgment in the 2525 Action, in which the following
18 claims were adjudicated as invalid as obvious under 35 U.S.C. § 103: Claims 1 and 16 of U.S. Patent
19 No. 8,293,728; Claim 14 of U.S. Patent No. 8,318,715; Claims 1 and 8 of U.S. Patent No. 8,357,677;
20 Claim 1 of U.S. Patent No. 8,367,652; and Claims 1 and 5 of U.S. Patent 8,518,929.
21 3. All other claims, including with respect to U.S. Patent Nos. 8,377,920; 8,415,335;
22 8,426,399; 8,440,650; 8,524,698; 8,546,372; and 8,617,594, are dismissed without prejudice.
23 4. Plaintiffs expressly reserve and retain any and all rights to appeal from this judgment,
24 and otherwise to seek appropriate modification of this judgment, should the final judgment in the
25 2525 Action be vacated and/or reversed by the United States Court of Appeals for the Federal Circuit
26 (see C.A. No. 2:18-cv-01596, ECF No. 27 ¶¶ 4-6). Defendants will not oppose a request to modify
27 this judgment to correspond with any modification of the judgment in the 2525 Action, either by this
28 Court or on appeal.
Case: 20-1901 Document: 14-2 Page: 4 Filed: 06/26/2020 (16 of 28) Case 2:18-cv-01596-MMD-NJK Document 30 Filed 05/04/20 Page 3 of 4
1 5. JUDGMENT IS ENTERED accordingly in favor of Defendants and against Plaintiffs. 2
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Judge Miranda Du
United States District Court, District of Nevada
Dated: _M__a_y_4_,_2_0_2_0____
________________________
For DRL:
/s/ Beth Finkelstein
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP
5371 Kietzke Lane
Reno, NV 89511
Telephone: (775) 324-4100 Facsimile: (775) 333-8171 E-mail: mrounds@bhfs.com
rcudnik@bhfs.com
Constance S. Huttner (pro hac vice) Frank D. Rodriguez (pro hac vice) James Barabas (pro hac vice) Caroline Sun (pro hac vice)
Beth Finkelstein (pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP
1 Giralda Farms, Suite 100 Madison, NJ 07940
Tel: (973) 966-3200
Email: chuttner@windelsmarx.com
frodriguez@windelsmarx.com jbarabas@windelsmarx.com csun@windelsmarx.com bfinkelstein@windelsmarx.com
Attorneys for Defendants Dr. Reddy’s Labora- tories, Inc. and Dr. Reddy’s
Laboratories Ltd.
Respectfully submitted,
For Amarin:
McDONALD CARANO LLP /s/ Adam Hosmer-Henner
Adam Hosmer-Henner (NSBN 12779) Chelsea Latino (NSBN 14227)
100 West Liberty Street, 10th Floor Reno, NV 89501
(775) 788-2000 ahosmerhenner@mcdonaldcarano.com clatino@mcdonaldcarano.com
23
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Christopher N. Sipes (admitted pro hac vice) Jeffrey B. Elikan (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
18 Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
19 Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice)
20 Daniel J. Farnoly (admitted pro hac vice) COVINGTON & BURLING LLP
21 One CityCenter, 850 Tenth Street, NW Washington, DC 20001
22 (202) 662-6000
csipes@cov.com, jelikan@cov.com, es-
tole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com, hpark@cov.com, jmo- ran@cov.com, dfarnoly@cov.com
25
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Nicholas J. Santoro (NSBN 532) 26 Jason D. Smith (NSBN 9691)
SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
(702) 948-8771
2
Case: 20-1901 Document: 14-2 Page: 5 Filed: 06/26/2020 (17 of 28) Case 2:18-cv-01596-MMD-NJK Document 3209 Filed 05/041/20 Page 4 of 4
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jsmith@santoronevada.com 2
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Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
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Case 2:18-cv-01596-MMD-NJK
Document 27
Filed 10/19/18
Page 1 of 5
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD.
10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
Tel: (702) 948-8771 / Fax: (702) 948-8773 E-mail: nsantoro@santoronevada.com, jsmith@santoronevada.com
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (pro hac vice pending) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel: (202) 662-6000 / Fax: (202) 662-6291 E-mail: csipes@cov.com, estole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com
Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
AMARIN PHARMA, INC. and AMARIN PHARMACEUTICALS IRELAND LIMITED,
Plaintiffs, v.
DR. REDDY’S LABORATORIES, INC. and DR. REDDY’S LABORATORIES, LTD.,
Defendants.
Case No.: 2:18-cv-01596-MMD-NJK
JOINT STIPULATION AND [PROPOSED] ORDER
REGARDING AGREEMENT TO BE BOUND BY JUDGMENT IN RELATED ANDA LITIGATION
Whereas on July 11, 2018, Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”) provided notice to Plaintiffs Amarin Pharma, Inc. and
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Amarin Pharmaceuticals Ireland Limited (collectively, “Amarin”) that DRL had submitted to the U.S. Food and Drug Administration (“FDA”) an Amendment to Abbreviated New Drug Application (“ANDA”) No. 209499, for 500 mg icosapent ethyl capsules purportedly bioequivalent to Amarin’s VASCEPA® product (“DRL’s 500 mg ANDA product”), containing a Paragraph IV certification with respect to U.S. Patent No. 8,293,728, U.S. Patent No. 8,318,715, U.S. Patent No. 8,357,677, U.S. Patent No. 8,367,652, U.S. Patent No. 8,377,920, U.S. Patent No. 8,415,335, U.S. Patent No. 8,426,399, U.S. Patent No. 8,440,650, U.S. Patent No. 8,518,929, U.S. Patent No. 8,524,698, U.S. Patent No. 8,546,372, and U.S. Patent No. 8,617,594 (collectively, the “Patents-in-Suit”);
Whereas DRL’s ANDA No. 209499, namely, Icosapent Ethyl, Oral Capsules, 1 Gram (“DRL’s 1 g ANDA product”), is currently the subject of the matter styled Amarin Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc, No. 2:16-cv-02562 (D. Nev. filed Nov. 4, 2016), consolidated with Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., No. 2:16-cv-02525 (D. Nev. filed Oct. 31, 2016) (the “Consolidated 1 g Action”);
Whereas in the Consolidated 1 g Action, Amarin has alleged that DRL’s 1 g ANDA product infringes the Patents-in-Suit, as well as U.S. Patent Nos. 8,399,446 and 8,431,560;
Whereas Amarin has brought the above-captioned action, Case No. 2:18-cv-01596, asserting that DRL’s 500 mg ANDA product infringes the Patents-in-Suit;
Whereas DRL has represented that the formulation of DRL’s 500 mg ANDA product is identical to the formulation of DRL’s accused 1 g ANDA product;
Whereas DRL has represented that the proposed prescribing information for DRL’s 500 mg product is identical to the prescribing information for DRL’s 1 g ANDA product;
Whereas DRL and Amarin anticipate that the factual and legal issues surrounding alleged infringement of the Patents-in-Suit by DRL’s 500 mg ANDA product will be substantially identical to the issues surrounding alleged infringement of the Patents-in-Suit by DRL’s accused 1 g ANDA product;
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Case: 20-1901 Document: 14-2 Page: 9 Filed: 06/26/2020 (21 of 28) Case 2:18-cv-01596-MMD-NJK Document 27 Filed 10/19/18 Page 3 of 5
Whereas DRL and Amarin anticipate that the factual and legal issues surrounding alleged invalidity of the Patents-in-Suit in the above-captioned case, No. 2:18-cv-01596, will be substantially identical to the issues surrounding alleged invalidity in the Consolidated 1 g Action;
Therefore, DRL and Plaintiffs jointly agree and stipulate as follows:
1. The final judgment of this Court in the Consolidated 1 g Action on the merits of Amarin’s contentions of alleged infringement of the Patents-in-Suit by DRL’s 1 g ANDA product shall also be binding on DRL and Amarin as though that judgment were also made in the above-captioned case, No. 2:18-cv-01596, as to DRL’s 500 mg ANDA product.
2. The final judgment of this Court in the Consolidated 1 g Action on the merits of the contentions of alleged invalidity of the Patents-in-Suit shall also be binding on DRL and Amarin as though that judgment were also made in the above-captioned case, No. 2:18-cv- 01596.
3. Subject to the approval of the Court, the above-captioned case, No. 2:18-cv- 01596, is stayed pending the final decisions of this Court in the Consolidated 1 g Action on the merits of Amarin’s contentions of alleged infringement of the Patents-in-Suit by DRL’s 1 g ANDA product and alleged invalidity of the Patents-in-Suit.
4. DRL and Amarin will request that upon a final, merits decision of this Court on the alleged infringement of the Patents-in-Suit by DRL’s 1 g ANDA product or on the alleged invalidity of the Patents-in-Suit, a corresponding judgment be entered by this Court in the above-captioned case, No. 2:18-cv-01596. DRL and Amarin shall retain the right to appeal said judgment in the above-captioned case, No. 2:18-cv-01596, and to argue on appeal the merits of the underlying judgment in the Consolidated 1 g Action.
5. This stipulation shall not affect the ability of DRL or Amarin to maintain, make, or oppose any argument in the Consolidated 1 g Action or in any appeal from that litigation concerning the claims and defenses in that litigation.
6. Should the judgment in the Consolidated 1 g Action be modified on appeal or otherwise, DRL and Amarin shall have the right to request a corresponding modification of the
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Case: 20-1901 Document: 14-2 Page: 10 Filed: 06/26/2020 (22 of 28) Case 2:18-cv-01596-MMD-NJK Document 27 Filed 10/19/18 Page 4 of 5
judgment entered in this Court in the above-captioned case, No. 2:18-cv-01596, pursuant to Federal Rule of Civil Procedure 60(b)(5), and DRL and Amarin agree not to oppose such a request that corresponds to the modifications of the judgment in the Consolidated 1 g Action.
7. Should the Patents-in-Suit, or any claim therein, be cancelled or found unpatentable by the Patent and Trademark Office or held invalid in any other judicial proceeding with preclusive effect, after no further appeal in said proceeding can be taken except a petition for writ of certiorari in the Supreme Court of the United States, DRL shall have the right to request a corresponding modification of the judgment entered in this Court in the above-captioned case, No. 2:18-cv-01596, pursuant to Federal Rule of Civil Procedure 60(b)(5), and Amarin agrees not to oppose such a request that corresponds to the modifications of the judgment in said proceeding.
DATED: October 12, 2018
/s/ Jason D. Smith
Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD.
10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
Tel: (702) 948-8771 / Fax: (702) 948-8773 Email: nsantoro@santoronevada.com, jsmith@santoronevada.com
Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (pro hac vice pending) Megan P. Keane (admitted pro hac vice)
Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice) COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW Washington, DC 20001
Tel: (202) 662-6000 / Fax: (202) 662-6291 Email: csipes@cov.com, estole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com
Respectfully submitted,
/s/ Constance S. Huttner
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP 5371 Kietzke Lane
Reno, NV 89511
Tel.: (775) 324-4100 / Fax: (775) 333-8171 Email: mrounds@bhfs.com, rcudnik@bhfs.com
Constance S. Huttner (pro hac vice forthcoming) Dmitry V. Shelhoff (pro hac vice forthcoming) Caroline Sun (pro hac vice forthcoming)
Beth Finkelstein (pro hac vice forthcoming) BUDD LARNER, P.C.
150 John F. Kennedy Parkway
Short Hills, NJ 07078
Tel: (973) 379-4800 / Fax: (973) 379-7734 Email: chuttner@buddlarner.com, dshelhoff@buddlarner.com, csun@buddlarner.com, bfinkelstein@buddlarner.com
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Case: 20-1901 Document: 14-2 Page: 11 Filed: 06/26/2020 (23 of 28) Case 2:18-cv-01596-MMD-NJK Document 27 Filed 10/19/18 Page 5 of 5
Attorneys for Plaintiffs Amarin Pharma, Inc. and Attorneys for Defendants Dr. Reddy’s Laboratories,
Amarin Pharmaceuticals Ireland Limited Inc. and Dr. Reddy’s Laboratories, Ltd.
The joint stipulation regarding agreement to be bound by judgment in related ANDA litigation
(ECF No. 23) is granted.
IT IS SO ORDERED. ___________________________________
UNITED STATES JUDGE DATED:__1_0_/1_9_/_2_0_1_8__________________
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Case: 20-1901 Document: 14-2 Page: 12 Filed: 06/26/2020 (24 of 28)
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Case: 20-1901 Document: 14-2 Page: 13 Filed: 06/26/2020 (25 of 28) Case 2:18-cv-01596-MMD-NJK Document 29 Filed 05/01/20 Page 1 of 4
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP
5371 Kietzke Lane
Reno, NV 89511
Tel.: (775) 324-4100 / Fax: (775) 333-8171 Email: mrounds@bhfs.com,
rcudnik@bhfs.com
Constance S. Huttner (admitted pro hac vice) Frank D. Rodriguez (admitted pro hac vice) James Barabas (admitted pro hac vice) Caroline Sun (admitted pro hac vice)
Beth Finkelstein (admitted pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP
1 Giralda Farms, Suite 100
Madison, NJ 07940
Tel: (973) 966-3200 / Fax: (973) 966-3250 Email: chuttner@windelsmarx.com,
frodriguez@windelsmarx.com jbarabas@windelsmarx.com, csun@windelsmarx.com, bfinkelstein@windelsmarx.com
Attorneys for Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
AMARIN PHARMA, INC., et al., Plaintiffs,
v.
DR. REDDY’S LABORATORIES, INC. and DR. REDDY’S LABORATORIES, LTD.,
Defendants.
Case No. 2:18-cv-01596-MMD-NJK [PROPOSED] JUDGMENT
Case: 20-1901 Document: 14-2 Page: 14 Filed: 06/26/2020 (26 of 28) Case 2:18-cv-01596-MMD-NJK Document 29 Filed 05/01/20 Page 2 of 4
1 The parties (Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
2 (collectively, “DRL”) and Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland
3 Limited (collectively, “Amarin”)) have stipulated to be bound by the Court’s judgment in the related
4 action of Amarin Pharma, Inc. v. Dr. Reddy’s Laboratories, Inc., No. 2:16-cv-02562 (D. Nev. Filed
5 Nov. 4, 2016), consolidated with Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., No.
6 2:16-cv-02525 (D. Nev. Filed Oct. 31, 2016). See C.A. No. 2:18-cv-01596, ECF No. 27. In light of
7 the Court’s March 30, 2020 Order and Judgment in favor of Defendants, C.A. No. 2:16-cv-02525
8 (the “2525 Action”), ECF No. 382, IT IS HEREBY ORDERED that:
9 1. Because of the parties’ agreement that the judgment in the 2525 Action will be binding
10 in this action, the Court enters judgment on infringement in this action based on the judgment in the
11 2525 Action as follows: The filing of ANDA No. 209499 infringed the following claims: Claims 1
12 and 16 of U.S. Patent No. 8,293,728; Claim 14 of U.S. Patent No. 8,318,715; Claims 1 and 8 of U.S.
13 Patent No. 8,357,677; Claim 1 of U.S. Patent No. 8,367,652; and Claims 1 and 5 of U.S. Patent
14 8,518,929.
15 2. Because of the parties’ agreement that the judgment in the 2525 Action will be binding
16 in this action, the Court enters judgment on obviousness in this action in favor of Defendants and
17 against Plaintiffs on the same grounds as the judgment in the 2525 Action, in which the following
18 claims were adjudicated as invalid as obvious under 35 U.S.C. § 103: Claims 1 and 16 of U.S. Patent
19 No. 8,293,728; Claim 14 of U.S. Patent No. 8,318,715; Claims 1 and 8 of U.S. Patent No. 8,357,677;
20 Claim 1 of U.S. Patent No. 8,367,652; and Claims 1 and 5 of U.S. Patent 8,518,929.
21 3. All other claims, including with respect to U.S. Patent Nos. 8,377,920; 8,415,335;
22 8,426,399; 8,440,650; 8,524,698; 8,546,372; and 8,617,594, are dismissed without prejudice.
23 4. Plaintiffs expressly reserve and retain any and all rights to appeal from this judgment,
24 and otherwise to seek appropriate modification of this judgment, should the final judgment in the
25 2525 Action be vacated and/or reversed by the United States Court of Appeals for the Federal Circuit
26 (see C.A. No. 2:18-cv-01596, ECF No. 27 ¶¶ 4-6). Defendants will not oppose a request to modify
27 this judgment to correspond with any modification of the judgment in the 2525 Action, either by this
28 Court or on appeal.
Case: 20-1901 Document: 14-2 Page: 15 Filed: 06/26/2020 (27 of 28) Case 2:18-cv-01596-MMD-NJK Document 29 Filed 05/01/20 Page 3 of 4
1 5. JUDGMENT IS ENTERED accordingly in favor of Defendants and against Plaintiffs. 2
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Judge Miranda Du
United States District Court, District of Nevada
Dated: ______________
________________________
For DRL:
/s/ Beth Finkelstein
Michael D. Rounds (Nev. Bar No. 4734) Ryan J. Cudnik (Nev. Bar No. 12948) BROWNSTEIN HYATT FARBER
SCHRECK, LLP
5371 Kietzke Lane
Reno, NV 89511
Telephone: (775) 324-4100 Facsimile: (775) 333-8171 E-mail: mrounds@bhfs.com
rcudnik@bhfs.com
Constance S. Huttner (pro hac vice) Frank D. Rodriguez (pro hac vice) James Barabas (pro hac vice) Caroline Sun (pro hac vice)
Beth Finkelstein (pro hac vice) WINDELS MARX LANE &
MITTENDORF, LLP
1 Giralda Farms, Suite 100 Madison, NJ 07940
Tel: (973) 966-3200
Email: chuttner@windelsmarx.com
frodriguez@windelsmarx.com jbarabas@windelsmarx.com csun@windelsmarx.com bfinkelstein@windelsmarx.com
Attorneys for Defendants Dr. Reddy’s Labora- tories, Inc. and Dr. Reddy’s
Laboratories Ltd.
Respectfully submitted,
For Amarin:
McDONALD CARANO LLP /s/ Adam Hosmer-Henner
Adam Hosmer-Henner (NSBN 12779) Chelsea Latino (NSBN 14227)
100 West Liberty Street, 10th Floor Reno, NV 89501
(775) 788-2000 ahosmerhenner@mcdonaldcarano.com clatino@mcdonaldcarano.com
23
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Christopher N. Sipes (admitted pro hac vice) Jeffrey B. Elikan (admitted pro hac vice) Einar Stole (admitted pro hac vice)
Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice)
18 Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice)
19 Han Park (admitted pro hac vice)
Jordan L. Moran (admitted pro hac vice)
20 Daniel J. Farnoly (admitted pro hac vice) COVINGTON & BURLING LLP
21 One CityCenter, 850 Tenth Street, NW Washington, DC 20001
22 (202) 662-6000
csipes@cov.com, jelikan@cov.com, es-
tole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com, hpark@cov.com, jmo- ran@cov.com, dfarnoly@cov.com
25
27 28
Nicholas J. Santoro (NSBN 532) 26 Jason D. Smith (NSBN 9691)
SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135
(702) 948-8771
2
Case: 20-1901 Document: 14-2 Page: 16 Filed: 06/26/2020 (28 of 28) Case 2:18-cv-01596-MMD-NJK Document 29 Filed 05/01/20 Page 4 of 4
1 nsantoro@santoronevada.com
jsmith@santoronevada.com 2
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Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited
3
Please let me know if the link works
70, 10,10,10
He’s a complete doucebag. Ignore the idiot.
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
v.
Case No.
CERTIFICATE OF INTEREST
Counsel for the:
? (petitioner) ? (appellant) ? (respondent) ? (appellee) ? (amicus) ? (name of party)
certifies the following (use “None” if applicable; use extra sheets if necessary):
1. Full Name of Party
Represented by me
2. Name of Real Party in interest
(Please only include any real party
in interest NOT identified in
Question 3) represented by me is:
3. Parent corporations and
publicly held companies
that own 10% or more of
stock in the party
4. The names of all law firms and the partners or associates that appeared for the party or amicus now
represented by me in the trial court or agency or are expected to appear in this court (and who have not
or will not enter an appearance in this case) are:
Amarin Pharma, Inc. Hikma Pharmaceuticals USA
20-1723
Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd.
Dr. Reddy's Laboratories, Ltd. None None
Dr. Reddy's Laboratories, Inc. None Dr. Reddy's Laboratories, Ltd.
Dr. Reddy's Laboratories, Inc. None Dr. Reddy's Laboratories, S.A.
Budd Larner, P.C.: Dmitry V. Shelhoff, Frank D. Rodriguez
Windels Marx Lane & Mittendorf, LLP: Frank D. Rodriguez
Brownstein Hyatt Farber Schreck, LLP: Michael D. Rounds, Ryan J. Cudnik
Case: 20-1723 Document: 47 Page: 1 Filed: 06/16/2020
FORM 9. Certificate of Interest Form 9
Rev. 10/17
5. The title and number of any case known to counsel to be pending in this or any other court or agency
that will directly affect or be directly affected by this court’s decision in the pending appeal. See Fed. Cir.
R. 47. 4(a)(5) and 47.5(b). (The parties should attach continuation pages as necessary).
Date Signature of counsel
Please Note: All questions must be answered
Printed name of counsel
cc:
Amarin Pharma, Inc. v. Dr. Reddy’s Labs., Inc.,
No. 2:18- cv-01596-MMD-NJK (D. Nev.)
6/16/2020 /s/ Constance S. Huttner
Constance S. Huttner
Counsel of Record
I would imagine more is coming
Looks like they added attorneys. I think
Pacer Update:
Amended Certificate of Interest for Appellees Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd.. Service: 06/16/2020 by email. [701681] [20-1723] [Constance Huttner] [Entered: 06/16/2020 06:48 PM]
Gotcha. Makes sense