UNITED S T A T E S I N T E R N A T I O N A L T R A D E COMMISSION WASHINGTON, D.C.

In the Matter of Investigation No. 337-TACERTAIN KRILL OIL PRODUCTS AND KRILL M E A L FOR PRODUCTION OF , KRILL OIL PRODUCTS i

V E R I F I E D C O M P L A I N T O F A K E R B I O M A R I N E A N T A R C T I C AS AND A K E R BIOMARINE MANUFACTURING, L L C UNDER S E C T I O N 337 O F T H E T A R I F F A C T O F 1930, AS A M E N D E D COMPLAINANT

RESPONDENTS

Aker BioMarine Antarctic AS Oksenoyveien 10 P.O. Box 496. N-1327 Lysaker, Norway Telephone: + 47 24 13 00 00 Facsimile: + 47 24 13 01 10

Olympic Holding AS Fosnavag Brygge Holmsildgata 12 Fosnavag, Norway Telephone: +47 70 08 12 00

Aker BioMarine Manufacturing, LLC 4494 Campbell Rd Houston, TX 77041 Telephone: (713)462-3316 C O U N S E L F O R COMPLAINANT Adam R. Hess Andrew F. Pratt Jonathan L. Falkler Venable

LLP

575 7th Street, N W Washington, DC 20004 Telephone: (202) 344-4389 Facsimile: (202) 344-8300 Alper T. Ertas Venable

LLP

505 Montgomery Street, Suite 1400 San Francisco, CA 94111

Rimfrost AS Vagsplassen, 6090 Fosnavag, Norway Telephone: +47 70 08 12 00 Emerald Fisheries AS Fosnavag Brygge 6090 Fosnavag, Norway Telephone: +47 70 08 12 00 Avoca Inc. 841 Avoca Farm Rd. Merry Hill, North Carolina 27957 Telephone: (252) 482-2133 Rimfrost USA, LLC 841 Avoca Farm Rd. Merry Hill, North Carolina 27957 Telephone: (252) 482-2133 Rimfrost New Zealand Limited 20 Oxford Street Richmond 1

Nelson, NZ 7020 Telephone: +64 3-546 0160 Bioriginal Food & Science Corp. 102 Melville Street, Saskatoon, Saskatchewan, Canada S7J ORl Telephone: +1 (306) 975-1166

2

Table of Contents Page I.

INTRODUCTION

1

II.

THE PARTIES

4

Complainants

4

A. i.

Alcer BioMarine Antarctic AS

4

ii.

Aker BioMarine Manufacturing LLC

5

B.

Respondents and Their Relationships

6

i.

Olympic Holding AS

6

ii.

Rimfrost AS

7

1.

Rimfrost AS Controls the Production of Ethanol-Extraction Infringing Products

7

2.

Rimfrost AS Controls the Production of Concentrate Infringing Products

9

iii.

Emerald Fisheries AS

10

iv.

Avoca Inc

11

v.

Rimfrost USA, LLC

12

vi.

Rimfrost NZ Limited

12

vii.

Bioriginal Food & Science Corp

12

III.

THE PRODUCTS A T ISSUE

13

IV.

THE ASSERTED PATENTS AND NONTECHNICAL DESCRIPTIONS OF THE INVENTIONS w.

14

A.

Non-Technical Description of the Asserted Patents

14

B.

Identification of the Asserted Patents and Ownership by Complainant

14

C.

Foreign Counterparts to the Asserted Patents

15

D.

Licenses

16

THE DOMESTIC INDUSTRY

16

Complainants' Investments in the Domestic Industry

16

; . B.

Complainants' Practice of the Asserted Patents

17

VI.

SPECIFIC INSTANCES OF IMPORATION AND SALE

17

VII.

UNLAWFUL AND UNFAIR ACTS COMMITTED BY RESPONDENTS

19

VIII.

RELATED LITIGATION

23

IX.

RELIEF REQUESTED

24

V. A.

1

EXHIBIT LIST NO.

DESCRIPTION

1

Certified Copy of U.S. Patent No. 9,028,877

2

Certified Copy of U.S. Patent No. 9,078,905

3

Certified Copy of U.S. Patent No. 9,072,752

4

Certified Copy of U.S. Patent No. 9,320,765

5

Certified Copy of U.S. Patent No. 9,375,453

6

Certified Assignment Records for U.S. Patent No. 9,028,877

7

Certified Assignment Records for U.S. Patent No. 9,078,905

8

Certified Assignment Records for U.S. Patent No. 9,072,752

9

Certified Assignment Records for U.S. Patent No. 9,320,765

10

Certified Assignment Records for U.S. Patent No. 9,375,453

11

Foreign Counterparts to the Asserted Patents

12

'877 Patent Infringement Claim Chart

13

'905 Patent Infringement Claim Chart

14

'752 Patent Infringement Claim Chart

15

'765 Patent Infringement Claim Chart

16

'453 Patent Infringement Claim Chart

17

Image of Sports Research Antarctic Krill Oil made with Superba2

18C

Confidential '877 Patent Domestic Industry Claim Chart

19C

Confidential '905 Patent Domestic Industry Claim Chart

20C

Confidential '752 Patent Domestic Industry Claim Chart

21C

Confidential '765 Patent Domestic Industry Claim Chart

22C

Confidential '453 Patent Domestic Industry Claim Chart

23C

Confidential Declaration of Martin Amholdt Regarding Domestic Industry Investments

24C

Confidential Declaration of Svein Ivar Holm Regarding Domestic Industry Activities

25

Rimfrost Flow Chart for Production of Accused Products

26

Screenshot From Presentation by Rimfrost AS 1

27

Transcript of Presentation by Rimfrost AS

28

Photos of Accused Products Produced by Ethanol Extraction

29

Specification Sheet for Rimfrost Sublime PL60 Product with Annotations

30

Testing Results from Spectral Services - Infringement

31

Testing Results from Craft Laboratories - Infringement

32

Olympic Seafood AS (Now Rimfrost AS) Website Printout

33

Importation Records for OlyMeg Krill Meal

34

Olympic Seafood AS (Now Rimfrost AS) Website Printout

35

"RIMFROST Launch New High-Phospholipid Krill Extract for EU Market"

36

"Avoca, Olympic Seafood Form Krill Oil Joint Venture" Press Release Printout

37

"Bioriginal to Distribute New Krill Collection" Press Release Printout

38C

Confidential Testing Results from Spectral and Craft Testing Technical D I

39

Letter from Edvard Braskke to Rimfrost New Zealand Limited

40

Letter notifying Delaware Defendant parties of all patents

41

"The Difference is Clear" pamphlet

42

"Formulation of Tablets with Omega-3 Phospholipids From K r i l l "

43

District Court Complaint (Original)

44

Sore Sunnmore District Court Judicial Assessment, Case No. 14069596SKJSOSU

PX-1

Physical Exhibit - Swanson Rimfrost Krill Oil Softgels

2

I.

INTRODUCTION 1.

Complainants Aker BioMarine Antarctic AS ("Aker BioMarine") and Aker

BioMarine Manufacturing, LLC ("Aker Manufacturing") request that the United States International Trade Commission institute an investigation into violations of Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, by Proposed Respondents Olympic Holding 1

2

3

A S ; Rimfrost AS; Emerald Fisheries AS; Rimfrost USA, LLC; Avoca Inc.; Bioriginal Food & 4

5

Science Corp.; and Rimfrost New Zealand Limited (collectively "Respondents"). This Complaint is based on Respondents' unlawful and unauthorized importation into the United States, sale for importation, and/or sale within the United States after importation of krill oil products and krill meal for the production of laill oil products that infringe, either literally or under the doctrine of equivalents, at least one or more claims of the following United States patents: U.S. Patent No. 9,028,877 ("the '877 patent") Exhibit 1, U.S. Patent No. 9,078,905 ("the '905 patent") Exhibit 2, U.S. Patent No. 9,072,752 ("the '752 patent") Exhibit 3, U.S. Patent No. 9,320,765 ("the '765 patent") Exhibit 4, and U.S. Patent No. 9,375,453 ("the '453 patent") Exhibit 5 (collectively the "Asserted Patents"). Copies of the Certified Asserted Patents are attached as Exhibits 1-5, respectively. 2.

In the Southern Ocean, off the coast of Antarctica, Antarctic krill (Euphausia

superba) can be found in large quantities, ranging from 300-500 million metric tons of biomass. The krill feeds on phytoplankton during the short Antarctic summer, and during the winter its food supply is limited to ice algae, bacteria, marine detritus as well as depleting body protein for energy. These conditions help to make the laill an ideal source of omega-3 fatty acids, ether and 1 2 3 4 5

"Olympic Holding" "Emerald" "Rimfrost USA" "Bioriginal" "Rimfrost NZ"

1

non-ether phospholipids, and astaxanthin. The problem, however, is that obtaining these substances from krill requires overcoming biological and environmental factors that begin to degrade these substances immediately after krill is caught and killed. 3.

Aker BioMarine is an industry-recognized market leader in the innovation,

production, formulation, and sale of krill oil products for the pharmaceutical and nutraceutical markets. To achieve this position, Alcer BioMarine developed and patented processes that yield a krill oil product having high levels of omega-3 fatty acids, ether and non-ether phospholipids, triglycerides, and astaxanthin. In the concentrations found in the patented products, these bioactive substances have been shown to provide a variety of health benefits in both humans and animals, including anti-inflammation, antioxidant effects, reduced insulin resistance, and improved blood lipid profile. These products, which practice the Asserted Patents, include Superba™, Superba2™, and SuperbaBoost™ (collectively, the "Superba Products" or the "Domestic Industry Products"). 4.

Aker BioMarine's Superba Products, which are substantially produced in its

processing plant in the United States, were developed over many years of research and development, and the investment of substantial sums, including many millions of dollars invested for production in the United States. 5.

However, Aker BioMarine's success has bred not only competition, but copyists

as well. As explained below, Respondents sought to compete in the krill oil market by replicating Aker BioMarine's manufacturing processes. To achieve that end, one Respondent hired Aker BioMarine's former senior scientist to assist with implementing virtually the same krill oil manufacturing processes, from catch to capsule. Respondents' infringing krill oil products are thus produced using Aker BioMarine's patented processes to create the infringing

2

krill oil products. 6.

Respondents manufacture abroad, import, sell after importation into the United

States, and/or sell or offer for sale after importation into the United States certain krill oil products and krill meal for the production of krill oil to produce and sell two classes of krill oil products (collectively, "Infringing Products") that infringe, literally or under the doctrine of equivalents, the following claims of the Asserted Patents (independent claims in bold): U.S. Patent No. 9,028,877 9,078,905 9,072,752 9,320,765 9,375,453

7.

Asserted Claims 1-4, 7-9,11-13, 16-18 1-4, 6, 7, 9-11,12,15-17,18,19 1,7, 11-13 1-5, 7, 9-12, 14, 15, 19-21, 23, 25-29, 31, 33-36, 38, 39, 43-45, 47 1, 5-10, 12,14-17, 19, 20, 24-6, 28, 30-32, 33-36, 39-43, 46-49,51,52,56-58, 60

Complainants have an existing domestic industry under 19 U.S.C. § 1337(a)(2)

and (3) through at least their investments in plant, equipment, labor, and capital relating to articles protected by the Asserted Patents. 8.

Respondents' activities with respect to the importation into the United States, the

sale for importation into the United States, and/or the sale within the United States after importation of certain krill oil products and krill meal for the production of krill oil products described more fully infra, are unlawful under 19 U.S.C. § 1337(a)(l)(B)(i)-(ii) in that they constitute infringement of the valid and enforceable Asserted Patents, and/or are made, " produced, or processed under, or by means of, a process covered by the claims of a valid and enforceable United States patent. 9.

Complainants seek relief from the Commission in the form of limited exclusion

orders under 19 U.S.C. § 1337(d) excluding from entry into the United States infringing krill oil

3

products and krill meal for the production of krill oil products that are manufactured domestically or abroad, sold for importation, imported, and/or sold in the United States after importation by or on behalf of the Respondents. Complainants further seek cease and desist orders under 19 U.S.C. § 1337(f) prohibiting Respondents from conducting any of the following activities in the United States: importing, selling, marketing, advertising, distributing, transferring (except for exportation), or soliciting U.S. agents or distributors, or aiding and abetting other entities in the importation, sale for importation, sale after importation, transfer (except for exportation), or distribution of krill oil products and krill meal for production of krill oil products that infringe the Asserted Patents. Complainants also request that an appropriate bond be set for the 60-day Presidential Review Period. I I . T H E PARTIES A. Complainants i . Aker BioMarine Antarctic AS 10.

Complainant Aker BioMarine is a Norwegian corporation with its principal place

of business at Oksenoyveien 10. N-1327 Lysaker, Norway. 11.

Aker BioMarine is a Norwegian fishing and biotech company that has been

harvesting krill and producing krill meal and krill oil for the animal, fish feed, food, dietary supplement and pharmaceutical industries in its current form and through its predecessor corporations since 2003. Over many years of research and development, and after the investment of over 300 million dollars, Aker BioMarine built its supply chain for Icrill in the Antarctic to become a leading supplier of krill products worldwide. 12.

Aker BioMarine develops, markets, and sells its Superba Products produced from

sustainably harvested and traceable Antarctic krill caught and partially processed on board its

4

two harvesting vessels, "Saga Sea" and "Antarctic Sea". Using a unique technology called ECOHARVESTING® that brings live krill onboard for processing, the freshly-caught krill is first processed into krill meal aboard the vessels, and then processed into the Superba Products at the Houston, Texas processing plant of Complainant Alcer Manufacturing. 13.

Not only does Aker's harvesting technology improve the quality of the rapidly

degrading krill brought onboard, it also successfully prevents the unnecessary by-catch such as birds and sea mammals and reduces the wastage incurred by traditional methods. As a result of its innovative and environmentally friendly processes, Aker BioMarine was the first krill harvester to be awarded the Marine Stewardship Council Certification, exemplifying its commitment to sustainable fishing of krill. 14.

Aker BioMarine has cooperated with the World Wildlife Fund for Nature for over

a decade, and in January 2015 Alcer BioMarine established the Antarctic Wildlife Research Fund together with WWF Norway and the Antarctic and Southern Ocean Coalition. AWR will raise donations from commercial and private partners in order to facilitate and promote research on the Antarctic ecosystem, and a Science Advisory Group will evaluate, and prioritize scientific research proposals for the Board of the Fund. ii. Aker BioMarine Manufacturing L L C 15.

Complainant Alcer Manufacturing was established in 2013 as a U.S.-based Icrill

oil processing plant to produce the patented Superba Products from krill meal supplied by Complainant Aker BioMarine produced aboard the Saga Sea and Antarctic Sea vessels. 16.

Aker Manufacturing was originally formed as a joint venture between Aker

BioMarine and Naturex, S.A. On May 2, 2016 Naturex divested from Alcer Manufacturing, and Aker BioMarine now owns one hundred percent of Aker Manufacturing.

5

17.

Aker Manufacturing has and continues to produce many metric tons of the

patented Superba Products in the United States from krill meal produced and supplied by Alcer BioMarine. Presently, Aker supplies well over half the Icrill oil sold in the U.S. market. Additional details regarding Alcer Manufacturing are provided in the Domestic Industry section below, and.in the declarations of Svein Ivar Holm (Exh. 24) and Martin Arnlioldt (Exh. 23). B. Respondents and Their Relationships i. Olympic Holding AS 18.

Respondent Olympic Holding is a Norwegian corporation with its principal place

of business at Fosnavag Brygge Holmsildgata 12, N-6099, Fosnavag, Norway. Olympic Holding is the parent corporation.of Rimfrost AS. 19.

Upon information and belief, Stig Rune Rem0y established Olympic Holding.

Mr. Remoy is a major shareholder and is chainnan and only member of the board of Olympic Holding. Mr. Remoy is also board member or chairman of the board of most of Olympic Holding's subsidiaries, and is a board member of Respondent Rimfrost AS, and chairman of the board of Respondent Emerald Fisheries. 20.

Upon information and belief, ownership of Emerald Fisheries has been at

different times attributed to each of Olympic Holding and Rimfrost AS. 21.

Upon information and belief, Olympic Holding has supplied a large amount of

capital into Emerald Fisheries, and has rescued Emerald Fisheries from a continual bankruptcy situation. Exh. 44 at 8. 22.

Upon information and belief, Olympic Holding controls its subsidiaries Rimfrost

AS, Emerald Fisheries, Rimfrost NZ and Rimfrost USA regarding the infringing acts described in this Complaint. For example, upon information and belief, Emerald Fisheries has represented

6

that it could produce krill oil, but does not because Olympic has decided that extraction should be performed by a separate company. Exh. 44 at 4. ii. Rimfrost AS 23.

Respondent Rimfrost AS is a Norwegian corporation with its principal place of

business at Vagsplassen, 6090 Fosnavag, Norway. Rimfrost AS was formerly known as Olympic Seafood AS and is a wholly owned subsidiary of Olympic Holding. 1. Rimfrost AS Controls the Production of Ethanol-Extraction Infringing Products 24.

Rimfrost AS began its efforts to replicate Aker BioMarine's patented processes

and products at least as early as 2011 when it hired Aker BioMarine's former senior scientist, Inge Bruheim, Ph.D., who is also the first named inventor of each Asserted Patent. Dr. Bruheim is currently research director at Rimfrost AS. Dr. Bruheim was aware of the applications that issued into the Asserted Patents before and at the time he was hired by Rimfrost AS. 25.

When leaving Aker BioMarine in 2009, Dr. Bruheim was aware of Aker

BioMarine's then-current business strategy and processing techniques, facilities, and capabilities. Specifically, Dr. Bruheim knew that Aker BioMarine had initially processed denatured krill product in New Zealand with a supercritical fluid extraction process and later had transitioned to an ethanol extraction process through Naturex in France. After Dr. Bruheim was hired, Rimfrost AS ultimately transitioned from processing denatured krill product with a supercritical fluid extraction process in New Zealand to an ethanol extraction process in North Carolina by Avoca and Rimfrost USA. 26.

Upon information and belief, Respondent Rimfrost AS controls the entire

manufacturing process of the Infringing Products from catch to capsule, including through controlling the actions of Respondents Emerald Fisheries, Avoca, Rimfrost NZ, and Rimfrost

7

USA. Rimfrost AS has stated that "[w]e are proud to say that we control the entire value chain from Icrill collecting to product and we can guarantee 100% traceability" (Exh. 41 at 9) and that it provides " [ f j u l l traceability and control over raw material and processing" through "vertical integration" (Exh. 42 at 29). As explained by Dr. Bruheim i n a Rimfrost AS video, Rimfrost AS "owns the vessel Juvel" and "Juvel is a highly specialized and unique vessel with a highly unique technology onboard to produce high quality krill products." Exh. 27. Rimfrost AS explains that it "is in charge of daily operations and crew management of Juvel." Exh. 41 at 3. In a slide showing "an overview of what we are doing aboard Juvel", Dr. Bruheim explains how the Icrill caught by the Juvel is heated and dried to make krill meal, then shipped to the United States for krill oil production through ethanol extraction:

f

Y

T

•

R I M F R O S T S U B L I M E A n t a r c t i c k. ill o i l

RIMFROST RIMfROST

GENTLE AND SHORT TWO-STEP PBOCES! OF RIMFROST SUBLIME , StnllE n o m i

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t ' i . : ' . i u i Hi.-

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Exh. 26. 27.

This process is shown in more detail in a Rimfrost AS process flow chart shown

below, which makes clear how Rimfrost catches and processes raw krill into krill meal aboard the Juvel, and then imports the Icrill meal into the United States for processing into the Infringing

8

Products by using a fluid (i.e. ethanol) extraction process:

RIMFROST FLOW CHART A N T A R C T I C KRILL P R O D U C T S F R O M O L Y M P I C S E A F O O D AS

Raw material: Fresh AntaTE6cltrin Hot vvater and Poodgreds «nyme

Step l i On-board the specialized

X

krill-cattectEng vtaei Muyrf

BJ2YMATK7 HVDKCH.YSS

r.'^nu'AtiDfJOF

Step 2 Extraction in USA t

Exh. 25 28.

The products produced by the above-described ethanol extraction process include,

for example, Swanson Rimfrost Krill Oil™ as well as private label versions of Rimfrost Sublime™ (the "Ethanol-Extraction Infringing Products") that are sold in the United States by Respondent Bioriginal to retail customers such as Swanson Health Products who thereafter sell to consumers. See Exhs. 12 -16 (Claim charts for the Asserted Patents). 2. Rimfrost AS Controls the Production of Concentrate Infringing Products

29.

In addition to krill oil products produced in accordance with the process described

above, Rimfrost AS and/or Rimfrost USA imports and sells or distributes after importation a 9

concentrated krill oil product known as "Sublime 60" and "Sublime PL 60" that infringes at least the '752 patent (the "Concentrate Infringing Products"), as well as other Asserted Patents. On information and belief, these products are manufactured in New Zealand by Respondent Rimfrost New Zealand, at the direction of Rimfrost AS and Rimfrost USA, through a supercritical fluid process. The Concentrate Infringing Products contain higher levels of phospholipids than the krill oil products produced in accordance with the ethanol extraction process described above. On information and belief, Rimfrost New Zealand has sold for importation, and Rimfrost AS or Rimfrost USA has imported, the Concentrate Infringing Products into the United States. iii. Emerald Fisheries AS 30.

Respondent Emerald Fisheries AS is a Norwegian corporation with its principal

place of business at Fosnavag Brygge, 6090 Fosnavag, Norway. Emerald Fisheries is a wholly owned subsidiary of Rimfrost AS. Emerald is, upon information and belief, the registered owner of the Juvel. However, Emerald appears to be an alter ego of Rimfrost AS, which claims to own the Juvel, as stated above, and refers to it as "our vessel 'Juvel'" on its YouTube channel:

10

Our vessel "Juvel" undocking from ASTICAN Shipyard, Las Palmas mm

Rimfrost Krill

»""«°» u S S E i S -

31.

2

13,501 views

As explained on Olympic's website Exh. 34, Respondent "Emerald Fisheries is

the company that owns the Icrill collecting vessel 'Juvel' and where the crew is employed. A l l the krill raw material for all the Rimfrost Krill Collection is produced on-board the vessel 'Juvel' with full traceability from Icrill that are collected in an environmentally sustainable manner."

6

The Rimfrost Krill Collection includes the Ethanol-Extraction Infringing Products and Concentrate Infringing Products, as well as other krill products. iv. Avoca Inc. 32.

Respondent Avoca Inc. is a North Carolina corporation with its principal place of

business at 841 Avoca Farm Rd., Merry Hill, North Carolina 27957. On infonnation and belief, Avoca performs at least ethanol extraction and other production services for Rimfrost AS according to Rimfrost AS's specifications, to convert the krill meal produced onboard the Juvel into krill oil, which is later sold as the Infringing Products. As explained on Olympic's website, 6

http://www.olympicseafood.coni/?page_id=295

11

"extraction is performed by Avoca in a cGMP facility. Avoca is the world's premier botanical 7

extraction company through its extensive extraction and purification technologies." Exh. 34 On information and belief, one or more of Respondent Avoca or Rimfrost USA or Bioriginal contracts for encapsulation services through a toll manufacturing agreement with a third party. = = ^ ^ - — - ^ - ^ = v ? = R i m f r o s t USA, L L C 33.

Respondent Rimfrost USA is a Delaware limited liability company with its

principal place of business at 841 Avoca Farm Rd. Merry Hill, North Carolina 27957. Rimfrost USA is a joint venture between Rimfrost AS and Avoca. 34.

Olympic's website explains that "[t]he joint venture Rimfrost USA, LLC

combines the prowess of Olympic group in producing raw krill material with the expertise of Avoca in extraction process. The company is responsible for the ethanol extraction of the 8

Rimfrost Sublime Krill O i l . " Exh. 34 Upon information and belief, Olympic Holding and Rimfrost AS control Rimfrost USA regarding the infringing acts described in this Complaint. vi. 3 5.

Rimfrost New Zealand Limited

Respondent Rimfrost NZ is a New Zealand corporation with its principal place of

business at 20 Oxford Street, Richmond, Nelson, NZ 7020. Rimfrost NZ was formerly known as Olympic Biotech Limited, and is a wholly owned subsidiary of Olympic Holding either directly or through Rimfrost AS or another subsidiary. Upon information and belief, Rimfrost NZ has manufactured at least the Rimfrost Sublime PL60 product that infringes the Asserted Patents, and -further sells these products for importation into the United States. vii. 36. 7 8

Bioriginal Food & Science Corp.

Complainant is informed and believes, and on that basis alleges, that Respondent

http://ww\v.olympicseafood.com/?page_id=295 http://www.olympicseafood.com/?page_id=295

12

Bioriginal is a Canadian corporation with its principal place of business at 102 Melville Street, Saskatoon, Saskatchewan, Canada S7J ORl. On information and belief, Respondent Bioriginal is the distributor for U.S. sales of the Infringing Products that include at least the Ethanol Infringing Products, some of which are sold in retail stores under the name Swanson Rimfrost Krill Oil and under private label. HI. T H E PRODUCTS A T ISSUE 37.

Pursuant to Commission Rule 210.12(a)(12), the products at issue include krill

meal for use in producing krill oil to be taken as a dietary supplement. The products at issue also include Icrill oil made from krill meal (including krill oil in capsule form) that can be taken as a dietary supplement. The krill oil products at issue include particular levels of omega-3 fatty acids, lipases, phospholipases, ether phospholipids, triglycerides, and astaxanthin. 38.

Respondents' infringing products include at least the Ethanol-Extraction Accused

Product that include the Swanson Rimfrost Krill Oil™ product sold to Swanson Health Products by Bioriginal. Respondents' infringing products also include other Rimfrost Sublime™ products sold by Bioriginal to other retailers who then sell those products under private label. These infringing products are manufactured by or at the direction of Olympic Holding and Rimfrost AS, Emerald, Rimfrost USA and Avoca from krill meal supplied by or from Emerald Fisheries to Rimfrost USA and Avoca. 39.

The infringing products also include the Concentrate Infringing Products that

include the Sublime PL60 product produced by Rimfrost NZ in New Zealand and sold for importation into the United States, and sold by Rimfrost AS and Rimfrost USA after importation in the United States (collectively, the "Infringing Products"). On information and belief, these infringing products are manufactured by Rimfrost NZ from krill meal supplied by or from

13

Emerald Fisheries, and imported into the United States by Rimfrost NZ or by or on behalf of Rimfrost AS or Rimfrost USA. IV. T H E A S S E R T E D P A T E N T S AND N O N T E C H N I C A L DESCRIPTIONS OF T H E INVENTIONS 9

A.

Non-Technical Description of the Asserted Patents

40.

The Asserted Patents are all continuations of the same parent application, and

share a common specification. The Asserted Patents relate generally to krill oil products and methods of maldng krill oil products. The common specification describes methods for treating laill to denature the lipases and phospholipases present in krill, and extracting the oil with a polar solvent to produce krill oil having certain characteristics. The produced krill oil products, which include krill oil capsules, contain specific ranges of ether and non-ether phospholipids, triglycerides, omega-3 fatty acids, and/or astaxanthin. The claims, of the Asserted Patents are drawn to such krill oil products, and well as systems methods related to their production. B.

Identification of the Asserted Patents and Ownership by Complainant

41.

Aker BioMarine owns by assignment the entire right, title and interest in the ' 877

Patent entitled "Bioeffective Krill Oil Compositions," which issued on May 12, 2015. Exh. 1. 42.

Aker BioMarine owns by assignment the entire right, title and interest in the '905

Patent entitled "Bioeffective Krill Oil Compositions," which issued July 14, 2015. Exh. 2. 43 .

Aker BioMarine owns by assignment the entire right, title and interest in the '752

Patent entitled "Bioeffective Krill Oil Compositions," which issued on July 7, 2015. Exh. 3. 44.

Aker BioMarine owns by assignment the entire right, title and interest in the '765

Patent entitled "Bioeffective Krill Oil Compositions," which issued on April 26, 2016. Exh. 4 9

The non-technical descriptions of the patents are given to provide a general background of the Asserted Patents. The statements are not intended to be, and should not be understood to be, madeforthe purposes of claim construction.

14

45.

Aker BioMarine owns by assignment the entire right, title and interest in the '453

Patent entitled "Bioeffective Krill Oil Compositions," which issued on June 28, 2016. Exh. 5. 46.

Aker BioMarine is the full title holder and owner of the Asserted Patents. Only

Aker BioMarine has the right to sue as to the Asserted Patents, and there are no security interests in the Asserted Patents. 47.

Pursuant to Commission Rule 210.12(a)(9)(h), a copy of the recorded assignment

of the '877 patent to Complainant and copies of all other recorded assigmnents of the '877 patent are attached as Exhibit 6. A copy of the recorded assignment of the '905 patent to Complainant and copies of all other recorded assignments of the '905 patent are attached as Exhibit 7. A copy of the recorded assignment of the '752 patent to Complainant and copies of all other recorded assignments of the '752 patent are attached as Exhibit 8. A copy of the recorded assignment of the '765 patent to Complainant and copies of all other recorded assignments of the '765 patent are attached as Exhibit 9. A copy of the recorded assignment of the '453 patent to Complainant and copies of all other recorded assignments of the '453 patent are attached as Exhibit 10. 48.

Pursuant to Commission Rule 210.12(c), one certified copy and four additional

copies of the prosecution histories of the Asserted Patents, as well as four copies of the applicable pages from each technical reference cited in the prosecution history, are attached as Appendices A through J, respectively.. C. Foreign Counterparts to the Asserted Patents 49.

Pursuant to Commission Rule 210.12(a)(9)(v), Complainants submit the attached

list of foreign patents, foreign patent applications (not already issued as a patent), and each foreign patent application that has been denied, abandoned, or withdrawn corresponding to the Asserted Patents. See Exh. 11.

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D. Licenses 50.

Complainant Aker Manufacturing possesses a license to manufacture products

that practice the Asserted Patents according to the specifications of Complainant Aker BioMarine under a Toll Manufacturing Agreement. Exh. 23 (Amholdt Declaration) at Exh. C. The Asserted Patents have never been licensed to any third parties. V. T H E D O M E S T I C INDUSTRY 51.

There is a domestic industry as defined under at least 19 U.S.C. § 1337(a)(3)(A) -

(B) comprising continuing significant investments in plant and equipment, and employment of labor and capital. A. Complainants' Investments in the Domestic Industry 52.

Complainants engage in a broad range of qualifying domestic industry activities

in the United States directed to articles protected by the Asserted Patents. These articles include the Superba Products that comprise the Domestic Industry Products, which are substantially produced in the Houston, Texas factory of Complainant Aker Manufacturing. As discussed below, the Domestic Industry Products each practice at least one valid claim of each of the Asserted Patents. More specifically, the Superba and Superba2 product practice at least the '877, '905, '765, and '453 patents, and the SuperbaBoost product practices at least the '752 patent. 53.

Complainants have made and continue to make significant investments in plant

and equipment with respect to the processing of krill meal to produce the Domestic Industry Products that practice the Asserted Patents. 54.

Complainants have made and continue to make significant and substantial

investments in labor and capital with respect to the processing of krill meal to produce the Domestic Industry Products that practice the Asserted Patents.

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55.

Complainants' domestic activities directed to the Domestic Industry Products take

place and have taken place almost entirely at their Houston, Texas processing plant. 56.

Complainants' investments and activities are significant in absolute tenns and

relative to Complainants' overall operations, taking into account the nature of such expenditures. 57.

Complainants' investments and activities are important to the protected articles,

particularly where the Domestic Industry Products are substantially processed and produced domestically. Moreover, Complainants' investments and activities are significant in the context of comparable products, the company's overall investments, and the relevant marketplace. 58.

The activities described above are explained in more detail in the declarations of

Martin Amholdt (Exh. 23) and Svein Ivar Holm (Exh. 24). 59.

The investments and activities described above constitute a domestic industry

under at least Section 337(a)(3)(A)-(B). B. Complainants' Practice of the Asserted Patents 60.

Complainants' processes and products practice numerous claims of each of the

Asserted Patents. Claim charts showing at least one representative, claim of the Asserted Patents by at least one Domestic Industry Product are attached as Exhibits 18 to 22 respectively. VI. S P E C I F I C INSTANCES OF IMPORATION AND S A L E 61.

Respondents import, sell for importation, and/or sell within the United States after

importation infringing krill oil products and krill meal for the production of infringing krill oil .products. The specific instances of importation of infringing krill oil products and krill meal for the production of infringing krill oil products set forth below are illustrative and non-exhaustive examples of the Respondents' unlawful importation of infringing products. 62.

Upon information and belief, Olympic Holding, Rimfrost AS, and Emerald

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Fisheries act in concert to prepare and provide denatured krill product. Specifically, the EthanolExtraction Infringing Products are manufactured at the direction of Rimfrost AS in part aboard the Juvel, which, though owned by Respondent Emerald Fisheries, is claimed by Rimfrost AS as its own vessel. See Exh. 27. Krill meal produced according to patented steps aboard the Juvel is then shipped to Avoca in North Carolina for processing into the Infringing Products at the direction of Rimfrost AS and Rimfrost USA, both of whom are controlled by Respondent Olympic Holding. 63.

A separate infringing process is carried out on the Concentrate Infringing

Products, which are produced using krill meal prepared aboard the Juvel. On information and belief, that product is manufactured by Rimfrost NZ in New Zealand and sold for importation into the United States by Rimfrost NZ, and imported into the United States by Respondents Rimfrost AS and Rimfrost USA, all of whom are controlled by Respondent Olympic Holding. On information and belief, Rimfrost AS and Rimfrost USA do not currently sell large-scale commercial quantities in the United States, but they have at least distributed sample quantities of the Concentrate Infringing Product to customers and potential customers in the United States. These activities are corroborated by press accounts reporting that the Concentrate Infringing Product was launched to United States customers at the Supply Side West trade show in Las Vegas, Nevada, in November of 2015.

Exh. 35. Exhibit 33 includes importation records

showing importation of OlyMeg, which is Rimfrost AS's tradename for krill meal produced .onboard the Juvel. On information and belief, the Juvel fishes for krill exclusively in the Southern Ocean, and the OlyMeg krill meal produced aboard the Juvel is the exclusively used to produce the Ethanol Extraction Infringing Products and the Concentrate Infringing Products. 64.

After production of the Ethanol-Extraction Infringing Products at Respondent

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Avoca's facilities, Respondent Bioriginal sells the products to its customers, including the Ethanol Extraction Infringing Products purchased in the United States. 65.

Photographs of exemplary Infringing Products offered for sale and purchased

from a retailer in the United States are attached as Exhibit 28. 66.

Complainants believe that the Infringing Products fall under one or more of the

following classifications of the Harmonized Tariff Schedule ("HTS") of the United States: • 0511.91.00. This HTS identification is illustrative and not exhaustive. The identification is not intended to limit the scope of the Investigation, nor is it intended to restrict the scope of any exclusion order or other remedy ordered by the Commission. VII. 67.

U N L A W F U L AND UNFAIR ACTS C O M M I T T E D B Y RESPONDENTS The Respondents unlawfully sell for importation, import, and/or sell after

importation into the United States Icrill oil products that infringe the Asserted Patents and Icrill meal that is processed to produce the Infringing Products. 68.

Based on information discovered through investigation, the Respondents infringe,

literally or under the doctrine of equivalents, at least claims 1-4,7-9, 11-13, 16-18 ofthe'877 patent. 69.

Based on information discovered tlirough investigation, the Respondents infringe,

literally or under the doctrine of equivalents, at least claims 1-4, 6, 7, 9-11, 12,15-17,18, 19 of the '905 patent. 70.

Based on information discovered through investigation, the Respondents infringe,

literally or under the doctrine of equivalents, at least claims 1, 7, 11-13 of the '752 patent. 71.

Based on information discovered through investigation, the Respondents infringe,

literally or under the doctrine of equivalents, at least claims 1-5, 7, 9-12, 14, 15, 19-21, 23, 25-

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29, 31, 33-36, 38, 39, 43-45, 47 of the '765 patent. 72.

Based on information discovered through investigation, the Respondents infringe,

literally or under the doctrine of equivalents, at least claims 1, 5-10, 12,14-17, 19, 20, 24-6, 28, 30-32, 33-36, 39-43, 46-49, 51, 52, 56-58, 60 of the '453 patent. 73.

Claim charts showing the asserted claims of the '877 patent, '905 patent, '752

patent, '765 patent, and '453 patent practiced by the Infringing Products are attached as Exhibits 12-16 respectively. 74.

Importation of the Infringing Products infringe, literally and under the doctrine of

equivalents, the Asserted Patents when imported into the United States in violation of 337(a)(l)(B)(i). Importation of the infringing products further includes importation of Accused Products that are made, produced, and/or processed under, or by means of, a process covered by process claims of the '877 and '453 Patents in violation of Section 337(a)(l)(B)(ii). 75.

Respondents also infringe the Asserted Patents pursuant to 35 U.S.C. § 271(b)-

(c), literally and under the doctrine of equivalents. The Icrill meal produced aboard the Juvel, shipped to the U.S. by Rimfrost AS, and processed at Respondent .Avoca is a composition for use in practicing Complainants' patented processes, constituting a material part of the Infringing Products, and Respondents know that the imported krill meal is especially made or especially adapted for use in infringing the Asserted Patents, and is not a staple article or commodity of commerce suitable for substantial non-infringing use. 76.

Upon information and belief, Olympic Holding through its actions set forth above

including sales of infringing products to Rimfrost USA through its agent Rimfrost AS and establishing a sales channel, actively and knowingly induces direct infringement in violation of 35 U.S.C. § 271(b). Olympic Holding has notice that offers for sales and sales by Rimfrost

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USA, Bioriginal, and Swanson Health Products constitute direct infringement, and specifically intends for them to directly infringe through sales of the Ethanol Extraction Infringing Products. Upon information and belief, Olympic Holding controls the actions of Rimfrost AS, and through Rimfrost AS, controls the actions of Emerald and Rimfrost USA. 77.

Upon information and belief, Rimfrost AS, through its actions set forth above,

including sales of infringing products to Rimfrost USA and establishing a sales channel, actively and knowingly induces direct infringement in violation of 35 U.S.C. § 271(b). Rimfrost AS has notice that offers for sale and sales by Rimfrost USA, Bioriginal, and Swanson Health Products constitute direct infringement, and specifically intends for them to directly infringe through sales of the Ethanol Extraction Infringing Products. Upon information and belief, Rimfrost AS controls the actions of Rimfrost USA. 78.

Upon information and belief, Rimfrost NZ, through its actions set forth above,

including at least distributing infringing products in the United States after importation, directly infringes in violation of 35 U.S.C. § 271(a). Rimfrost NZ has notice that offers for sale and sales by Rimfrost USA constitute direct infringement, and specifically intends for them to directly infringe through distribution, i f not sales and offers for sale, of the Concentrate Infringing Products. Upon information and belief, Rimfrost AS controls the actions of Rimfrost NZ. 79.

Upon information and belief, Emerald Fisheries, through its actions set forth

above including sales of laill meal to Rimfrost AS and Rimfrost NZ, actively and knowingly induces direct infringement in violation of 35 U.S.C. § 271(b). Emerald Fisheries has notice that offers for sales and sales by Rimfrost USA, Bioriginal, and Swanson Health Products constitute direct infringement, and specifically intends for them to directly infringe through sales of the Ethanol Extraction Infringing Products. Emerald fisheries also has notice that offers for sale and

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sales by Rimfrost NZ of the Concentrate Infringing Product constitutes direct infringement, and specifically intends for them to directly infringe through sales of the Concentrate Infringing Product. Exh.s 39 and 40. 80.

Upon information and belief, Avoca, through its actions set forth above including

provision of krill product to Rimfrost USA and Bioriginal, actively and knowingly induces direct infringement in violation of 35 U.S.C. § 271(b). Avoca has notice that sales by Rimfrost USA, Bioriginal, and Swanson Health Products constitute direct infringement, and specifically intends for them to directly infringe through sales and supply of the Ethanol Extraction Infringing Products. 81.

Upon information and belief, Bioriginal, through its actions set forth above

including sales of Icrill product to retail customers such as Swanson Health Products who thereafter sell to consumers, actively and knowingly induces direct infringement in violation of 35 U.S.C. § 271(b). Bioriginal has notice that sales by retail customers such as Swanson Health Products constitute direct infringement, and specifically intends for Swanson Health Products to directly infringe through sales and supply of the Infringing Products. 82.

Upon information and belief, Respondents through their actions set forth above,

contributorily infringe in violation of 35 U.S.C. § 271(c). The. Icrill meal produced aboard the Juvel, shipped to the U.S. by Rimfrost AS, processed at Avoca, and provided to Bioriginal, who redistributes to customers is a composition for use in practicing AKBM's patented processes, constituting a material part of the Infringing Products, and Olympic Holding, Rimfrost AS, Emerald Fisheries, and Bioriginal know that the imported krill meal is especially made or especially adapted for use in infringing the Asserted Patents, and is not a staple article or commodity of commerce suitable for substantial non-infringing use.

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83.

Notice to Respondents of their infringing activities includes the district court

complaint filed against Respondents concerning two Asserted Patents (Exh. 43), a letter to counsel for Respondents notifying Respondents that their products and activities further infringe the other three Asserted Patents (Exh. 40), and a letter to Rimfrost NZ notifying it that its Rimfrost Sublime PL60 product further infringes the '765 Patent (Exh. 39). 84.

Upon information and belief, Respondents also had notice that their activities

constituted infringement as of the issuance of the Asserted Patents. In 2011, Dr. Inge Bruheim, the first named inventor of the Asserted Patents and a former Aker BioMarine employee, was hired by Olympic Seafood AS (now Rimfrost AS). Dr. Bruheim was aware of the applications that issued into the Patents-in-Suit before and at the time he was hired by Rimfrost AS. Upon information and belief, Mr. Bruheim was also aware of their issuance because he contacted A K B M between September 2014 and January 2016 requesting payment for the issuance of his patents under Norwegian law governing compensation for inventions. After issuance of the Asserted Patents, Respondents knew or reasonably should have known that their activities constituted infringement. 85.

Upon information and belief, Respondents through their actions set forth above,

actively and knowingly induce infringement in violation of 35 U.S.C. § 271(b). 86.

Upon information and belief, Respondents through their actions set forth above,

contributorily infringe in violation of 35 U.S.C. § 271(c). • VIII. 87.

RELATED LITIGATION The '877 and '905 patents are currently the subject of patent litigation in the

United States District Court for the District of Delaware. Complainant Aker BioMarine filed suit against Respondents on January 22, 2016 alleging that Respondents are liable for infringement of

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the '877 and '905 patents pursuant to 35 U.S.C. § 271. The case number is l:16-cv-00035-LPSCJB. This litigation has not yet passed the pleading stage. IX.

R E L I E F REQUESTED

WHEREFORE, by reason of the foregoing, Complainants respectfully request that the United States International Trade Commission: (a)

institute an investigation pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, with respect to Respondents' violations of that section based on the importation into the United States, sale for importation, and/or the sale within the United States after importation of Respondents' products that infringe the Asserted Patents;

(b)

set a target date of no more than 16 months;

(c)

schedule and conduct a hearing on permanent relief pursuant to 19 U.S.C. § 1337(c) for the purposes of receiving evidence and hearing argument concerning whether there has been a violation of Section 337, and following the hearing, to determine that there has been a violation of Section 337;

(d)

issue a limited exclusion order, pursuant to 19 U.S.C. § 1337(d) forbidding entry into the United States of Respondents' krill oil products and krill meal for production of Icrill oil products that infringe one or more claims of the Asserted Patents;

(e)

issue cease and desist orders, pursuant to 19 U.S.C. § 1337(f), prohibiting the Respondents and their related companies or divisions from conducting any of the following activities in the United States: importing, selling, marketing, advertising, distributing, transferring (except for exportation), and/or soliciting

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U.S. agents or distributors for, krill oil products and krill meal for production of krill oil products covered by one or more claims of the Asserted Patents; (g)

set an appropriate bond rate during the 60-day Presidential Review Period; and

(h)

issue such other and further relief as the Commission deems just and proper under the law, based upon the facts determined by the investigation and the authority of the Commission.

Dated: August 12, 2016

Respectfully submitted,

By: Adam R. Hess [email protected] Andrew F. Pratt [email protected] Jonathan L. Falkler JLFalkler@venable. com VENABLE LLP 575 7th Street, N W Washington, D.C. 20004 Telephone: (202) 344-4389 Facsimile: (202) 344-8300 Alper T. Ertas Venable

LLP

505 Montgomery Street, Suite 1400 San Francisco, CA 94111 Telephone: (415) 343-3214 Facsimile: (415) 653-3755 Counsel for Complainants Aker BioMarine Antarctic AS and Aker BioMarine Manufacturing, LLC

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