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McDermottWill &Emery
Boston Brussels Chicago Dallas DQsseldorf Frankfurt Houston London Los Angeles Miami
Milan Munich NewYork Orange County Paris Rome Seoul Silicon Valley Washington,D.C.
Strategic alliancewithMWE China LawOffices (Shanghai)
October6, 2016
VIA HAND-DELIVERY
The Honorable Lisa R. Barton
SecretaryUnited States International Trade Commission
500 E Street, SW
Washington, DC 20436
Re:
Michael V. O'Shaughnessy
Attorney at Law
moshaughnessy® mwe.com
+1 202 756 8743-
' DOCKET
NUMBER
31^?
Office of the
k/ SecretaryInt'l Trade Commission
Certain Food Supplements and Vitamins, Including Ocular AiiliuAidaiib and CumponentsThereof and Products Containing the Same, Inv. No. 337 -TA-
Dear Secretary Barton:
Enclosed for filing, please find documents in support of a request by Kemin Industries,Inc. and KeminFoods, L.C. (collectively, "Complainants") that the U.S. International TradeCommission institutes an investigation pursuant to Section337 of the Tariff Act of 1930, asamended, concerning ocular antioxidant products, and their methods of use. Complainant'ssubmission includes the following documents:
1. One (1) original andeight (8) papercopies of Complainant's Verified Complaint,pursuant to Commission Rule 210.8(a)(l)(i).
2. One (1) electronic copy of the non-confidential exhibits to the Verified Complaint,pursuant to Commission Rules 210.9(a)(l)(i) and210.12(a)(9), including:
a. One (1) electronic certifiedcopy of each U.S. Patent Nos. 8,815,955 ("the '955patent") and 9,226,940 ("the '940 patent") as Exhibits 1 and 2 to the VerifiedComplaint, respectively, pursuant to Commission Rule 210.12(a)(9)(i); and
b. One (1) electronic certified copy of the assignment records for each of the '955and '940 patents as Exhibits 3 and4 to the Verified Complaint, respectively,pursuant to Commission Rule 210.12(a)(9)(H).
3. One (1) electronic copy of the confidential exhibits to the Verified Complaint, pursuant toCommission Rules 201.6(c) and 210.8(a)(1)(h).
4. One (1) additional copy each—two (2) additional copies total—ofthe VerifiedComplaint, the Public Interest Statement, andnon-confidential exhibits for service upon
U.S. practice conducted through McDermott Will & Emery LLP.
500 North Capitol Street, N.W.Washington DC 20001-1531 Telephone: +1 202756 8000 Facsimile: +1 202756 8087 www.mwe.com
The Honorable Lisa R. Barton
October 6, 2016
Page 2
proposed Respondents OmniActive Health Technologies and OmniActive HealthTechnologies, Inc. (collectively "Proposed Respondents") pursuant to Commission Rules201.6(c), 210.8(b), and 210.8(a)(l)(iii); and two (2) additional copies of the confidentialexhibits for service upon Proposed Respondent's counsel after they have subscribed tothe protective order.
5. One (1) additional copy each—of the Verified Complaint for service on the embassy ofIndia, pursuant to Commission Rule 210.8(a)(l)(iv).
6. One (1) electronic certified copy and three (3) additional electronic copies each of theU.S. Patent & Trademark Office prosecution histories of the '955 and '940 patents asAppendices A and C to the Verified Complaint, respectively, pursuant to CommissionRule210,12(c)(l).
7. Four (4) electronic copies of each patent and applicable pages of each technical referencementioned in the prosecution histories of the '955 and '940 patents as Appendices B andD to the Verified Complaint, respectively, pursuant to Commission Rule 210.12(c)(2).
8. A letter and certification requesting confidential treatment for the information containedin Confidential Exhibits 3aC, 4aC, 7C, 7aC-7dC, 17C, 18C, and 19C to the VerifiedComplaint, pursuant to Commission Rules 210.6(b) and 210.5(d).
9. A Statement on the Public Interest regarding the remedial orders sought by Complainantsin the Verified Complaint, pursuant to Commission Rule 210.8(b).
Please contact me with any questions regarding this filing.
Sincerely,
<~ D\ r C\ J J
Michael V. O'Shaughnessy
Counselfor Complainants Kemin Industries, Inc.and Kemin Foods, L. C.
Enclosures
McDermottWill &Emery
Boston Brussels Chicago Dallas Dusseldorf Frankfurt Houston London Los Angeles Miami Michael V. O'ShaughnessyMilan Munich New York Orange County Paris Rome Seoul Silicon Valley Washington, D.C.
Strategicalliancewith MWE China LawOffices (Shanghai) +1202 756 8743
October 6, 2016
VIA HAND-DELIVERY
The Honorable Lisa R. Barton
SecretaryUnited States International Trade Commission
500 E Street, SWWashington, DC 20436
Re: Certain Food Supplements and Vitamins, Including Ocular Antioxidants andComponents Thereof and Products Containing the Same, Inv. No. 337 -TA-_
Dear Secretary Barton:
Pursuant to Commission Rule 201.6,Complainants KeminIndustries, Inc. and KeminFoods, L.C. (collectively, "Complainants") respectfully request confidential treatment of certainconfidential business information contained in Confidential Exhibits 3aC, 4aC, 7C, 7aC-7dC,17C, 18C, and 19C to Complainants' Verified Complaint.
The information for which confidential treatment is sought is proprietary commercialinformation nototherwise available to the public. Specifically, Confidential Exhibits 3aC, 4aC,7C, 7aC-7dC, 17C, 18C, and 19C contain proprietary information regarding Complainants'domestic industry, including information relating to Complainants; manufacturing operations andprocesses, research and development, and other information ofcommercial value toComplainants.
The proprietary information described above qualified as confidential businessinformation under Commission Rule 201.6 because (1) it is not publically available; (2)unauthorized disclosure of such information could cause substantial harm to the competitiveposition ofComplainants; and (3) the disclosure of such information could impair theCommission's ability to obtain information necessary toperform its statutory function.
Please contact me with any questions regarding this request for confidential treatment.
U.S. practice conducted through McDermottWill & Emery LLP.
500 North Capitol Street, N.W. Washington DC 20001-1531 Telephone: +1 202 756 8000 Facsimile: +1 202 756 8087 www.mwe.com
The Honorable Lisa R. Barton
October 6, 2016Page 2
Sincerely,
(/
Michael V. O'Shaughnessy
Counselfor Complainants Kemin Industries^nc,and Kemin Foods, L. C.
UNITED STATES INTERNATIONAL TRADE COMMISSIONWashington, DC
In the Matter of
CERTAIN FOOD SUPPLEMENTS ANDVITAMINS, INCLUDING OCULARANTIOXIDANTS AND COMPONENTSTHEREOF AND PRODUCTS CONTAINING
THE SAME
Inv. No. 337-TA-
KEMIN INDUSTRIES, INC. PUBLIC INTEREST STATEMENT
Pursuant to Commission Rule 210.8(b), Complainant Kemin Industries, Inc. andKemin
Foods, L.C. (collectively "Kemin" or "Complainants") submit this statement addressing the
effects on the public interest ofKemin's Complaint, filed contemporaneously herewith. As
detailed below, Kemin's proposed investigation is expected to have thebeneficial effect on the
public interest ofpromoting and defending intellectual property rights inthe United States and to
have little to no adverse impact on the public interest.
I. HOW THE ARTICLES POTENTIALLY SUBJECT TO THE REQUESTEDREMEDIAL ORDERS ARE USED IN THE UNITED STATES
Kemin is a pioneer inthe agriculture, health, and nutrition markets. Through its research
and development efforts, Kemin has supplied products throughout the world that have improved
the health and nutrition ofbillions ofpeople. In this case, Kemin's efforts have resulted in
innovative technology to promote ocular health. The Accused Products identified inKemin's
Complaint are products containing ocular antioxidants for reducing retinal damage due to blue
, and ultraviolet light. Generally, the Accused Products at issue include food ingredients and
supplements comprising macular carotenoids such as lutein or zeaxanthin, or derivatives thereof.
The Accused Products are, on information andbelief, sold as stand-alone products and are
imported into the United States and sold after importation.
II. PUBLIC HEALTH, SAFETY, OR WELFARE CONCERNS RELATING TO THEREQUESTED REMEDIAL ORDERS
Kemin is not aware of any public health, safety, or welfare concerns relating to the
requested relief sought in its Complaint. Rather, the issuance of an exclusion order and cease
and desist orders against the Proposed Respondents will benefit the public interest by
encouraging the enforcement of intellectual property rights in the United States, which promotes
innovation and investment inresearch and development. The Commission has recognized a very
strong public interest in protecting intellectual property rights. See, e.g., Certain Baseband
Processor Chips and Chipsets, Transmitter and Receiver (Radio) Chips, Power Control Chips,
and Products Containing Same, Including Cellular Telephone Handsets, Inv. No. 337-TA-543,
Comm'n Op. at 148-53 (June 19, 2007) (remedial orders should bewithheld only in "limited
circumstances inwhich the public interest concerns are so great as ,to trump the public interest in
enforcement of intellectual property rights"). In the few instances in which the Commission has
found that requested remedial orders would harm the public interest enough to deny relief, "the
exclusion order was denied because inadequate supply inthe United States -by both patentee and
domestic licensees -meant that anexclusion order would deprive the public ofproducts
necessary for some important health or welfare need .... " Spansion, Inc. v. Int'l Trade Comm 'n,
629 F.3d 1331, 1360 (Fed. Cir. 2010). No such circumstances exist here.
III. LIKE OR DIRECTLY COMPETITIVE ARTICLES THAT COMPLAINANT ORTHIRD PARTIES MAKE WHICH COULD REPLACE THE SUBJECTARTICLES IF THEY WERE TO BE EXCLUDED
Consumers ofthe subject products containing ocular antioxidants for reducing retinal
damage have and will continue tohave access to competitive products, so the exclusion from
importation of the Accused Products will not harm the public interest. Kemin and Kemin's
customers can sufficiently provide such access. Forexample, Kemin has sufficient
manufacturing capacity to manufacture and distribute FloraGLO® to replace the subject articles
if they were to be excluded.
IV. ABILITY OF COMPLAINANT AND/OR THIRD PARTIES TO REPLACE THEVOLUME OF ARTICLES SUBJECT TO THE REQUESTED REMEDIALORDER IN A COMMERCIALLY REASONABLE TIME IN THE UNITEDSTATES
On information and belief,Keminand Kemin's customers have the capacity to replace
the volume ofarticles subject to the requested remedial orders either immediately orina
commercially reasonable time inthe United States. On information and belief, OmniActive
supplies about 33% ofthe lutein and zeaxanthin in the United States supplement market. Kemin
alone has the capacity to meet that additional capacity. Moreover, several other entities within
the industry would also be capable ofsatisfying any increased market demand for such products
if an exclusion order were issued against OmniActive.
V. HOW THE REQUESTED REMEDIAL ORDERS WOULD IMPACTCONSUMERS
The requested remedial orders would have little to no impact on consumers. Those
operating lawfully under the Asserted Pate'nts provide consumers with comparable offerings at
sufficient capacity.
VI. CONCLUSION
Based on the reasons provided herein, the proposed investigation ofKemin's Complaint
filed contemporaneously herewith will not adversely affect the public interest. To the contrary,
institution ofthe proposed investigation will benefit the public interest by promoting and
defending intellectual property rights in the United States.
Dated: October 6, 2016 Respectfully submitted,
Michael V. O'ShaughnessyJay ReizissRebecca Harker DuttryMcDermott Will & Emery, LLP500 North Capitol Street, NWWashington, DC 20001Telephone: (202) 756-8000
Allison E. Keradt
Davis, Brown, Koehn, Shores & Roberts, P.C.The Davis Brown Tower
215 10th Street, Suite 1300Des Moines, IA 50309Telephone: (515) 288-2500
Counselfor ComplainantKemin Industries, Inc.Kemin Foods, L.C.Kemin Worldwide Technologies, Inc.
UNITED STATES INTERNATIONAL TRADE COMMISSIONWashington, DC
In the Matter of
CERTAIN FOOD SUPPLEMENTS ANDVITAMINS, INCLUDING OCULARANTIOXIDANTS AND COMPONENTSTHEREOF AND PRODUCTS CONTAINING
THE SAME
Inv. No. 337-TA-
COMPLAINT OF KEMIN INDUSTRIES, INC. AND KEMIN FOODS, L.C,UNDER SECTION 337 OF THE TARIFF ACT OF 1930. AS AMENDED
COMPLAINANTS
Kemin Industries, Inc.
2100 Maury StreetDes Moines, Iowa 50317Telephone: (515)559-5100
Kemin Foods, L.C.2100 Maury StreetDes Moines, Iowa 50317Telephone: (515)559-5100
COUNSEL FOR COMPLAINANTS
Michael V. O'ShaughnessyJay ReizissRebecca Harker DuttryMcDermott Will & Emery, LLP
500 North Capitol Street, NWWashington, DC 20001Telephone: (202) 756-8000
PROPOSED RESPONDENTS
OmniActive Health TechnologiesPhoenix House, T-8, A Wing462 SenapatiBapat Marg, LowerPerelMumbai-400 013
India
OmniActive Health Technologies, Inc.67 East Park Place, Suite 500Morristown, NJ 07960Telephone: (973) 998-8415
Allison E. KerndtDavis, Brown, Koehn, Shores & Roberts,P.C.
The Davis Brown Tower
215 10th Street, Suite 1300Des Moines, IA 50309Telephone: (515) 288-2500
TABLE OF CONTENTS
I. INTRODUCTION 1
E. THE PARTIES 5
A. Complainants 5
B. Proposed Respondents 7
m. THE PRODUCTS AT ISSUE 8
A. The Technology 8
B. The Accused Products 9
IV. THE PATENTS AT ISSUE 10
A. The '955 Patent (U.S. Patent No. 8,815,955) 10
1. Identification of the Patent and Ownership by KeminIndustries ; 10
2. Non-Technical Description of the'955 Patent 11
B. The '940 Patent (U.S. Patent No. 9,226,940) 11
1. Identification of the Patent and Ownership by Complainant 11
2. Non-Technical Description of the '940 Patent 12
V. SPECIFIC INSTANCES OF IMPORTATION AND SALE 13
VI. UNLAWFUL AND UNFAIR ACTS COMMITTED BY PROPOSEDRESPONDENTS—PATENT INFRINGEMENT 16
A. The'955 Patent 17
B. The'940 Patent...; 18
VII. THE DOMESTIC INDUSTRY 20
A. Technical Prong - Complainants' Articles Practice at Least OneClaim of Each of the Asserted Patents in the United States 20
B. Economic Prong - Complainants' Substantial Investment in theRelevant Industry, Including Manufacturing, Engineering, and Researchand Development, Within the United States 20
VITI. HARMONIZED TARIFF SCHEDULE INFORMATION 21
LX. RELATED LITIGATION •••••21
X. RELIEF REQUESTED 22
n
DOCUMENT EXHIBIT LIST
Exhibit
No.
Description Designation
1 Certified copy of United States Patent No. 8,815,955 Public
2 Certified copy of United States Patent No. 9,226,940 Public
3 Certified copy of the Assignment for United States Patent No.8,815,955
Public
3aC Copy of recorded Security Agreement for United States PatentNo. 8,815,955
Confidential
4 Certified copy of the Assignment for United States Patent No.9,226,940
Public
4aC Copy of recorded Security Agreement for United States PatentNo. 9,226,940
Confidential
5 Kemin Annual Report Public
6 http://omniactives.com/operations Public
7C Declaration of Rich Heil Confidential
7aC Asset Spreadsheet Confidential
7bC Process Improvement Spreadsheet Confidential
7cC Profit and Loss Statement (2013-2016) Confidential
7dC Salary and Personnel Summary (2013-2016) Confidential
8 OmniActive Press Release at http://omniactives.com/press-releases/omniactive-showcases-lutemax-and-capsimax-ranges-of-products-at-biotaiwan-2015products-at-biotaiwan-2015
Public
111
Exhibit
No.
13a
13e
13g
Description
7/18/16 Press Release, "OmniActive Introduces What's YourB.L.U.E.? To Natural Products Industry Members atENGREDA2016"
10 Excerpt from OmniActive marketing campaign entitled"Lutein for Every Age," at www.luteinforeveryage.com
11 GNC Preventative Nutrition "Eye Health Formula" with 20mgLutemax 2020 Lutein (including receipt)
12 Doctor's Best "Best Lutein Dietary Supplement" withLutemax 2020 Lutein and Zeaxanthin (including receipt)
13 Claim Chart Comparing Independent Claim 1 of US PatentNo. 8,815,955 to Exemplary Accused Product of ProposedRespondent (Lutemax® 2020)OmniActive White Paper: Lutein for Every Age
13b OmniActive blog "Are you doing everything you can for youreyes"
13c Nutrition Express Lutein Order listing lutein and zeaxanthinfrom Lutemax® 2020 as ingredients
13d Omni's Lutein for Every Age marketing campaignpregnancy through infancy
Omni's Lutein for Every Age marketing campaign - aging
13f OmniActive White Paper: Protecting from Blue Light withLutein and Zeaxanthin
Special Edition: OmniActive Insights Newsletter; TheMolecular Carotenoids: An Overview
14 Claim Chart Comparing Independent Claim 1 of US PatentNo. 9,226,940 to Exemplary Accused Product of ProposedRespondent (Lutemax® 2020)
IV
Designation
Public
Public
Public
Public
Public
Public
Public
Public
Public
Public
Public
Public
Public
Exhibit
No.
Description Designation
14a OmniActive "What's Your B.L.U.E." marketing brochure Public
14b Nutrition Express Lutein Order listing lutein and zeaxanthinfrom Lutemax® 2020 as ingredients
Public
14c Omni's Lutein for Every Age marketing campaign -pregnancy through infancy
Public
14d Omni's Lutein for Every Age marketing campaign - aging Public
14e OmniActive White Paper: Protecting from Blue Light withLutein and Zeaxanthin
Public
14f Special Edition: OmniActive Insights Newsletter; TheMolecular Carotenoids: An Overview
Public
15 Claim Chart Comparing Independent Claim 1 of US PatentNo. 8,815,955 to Kemin Foods' Domestic Industry Product,FloraGLO® Lutein
Public
15a Age-Related Eye Disease Study 2 Summary Public
15b Kemin "Don't Lose SIGHT of Eye Protection" brochure Public
15c
I
Kemin "Beat the Blue" marketing brochure Public
15d Kemin's website Public i
Exhibit
No.
16a
16b
17C
18C
19C
Description
16 Claim Chart Comparing Independent Claim 1 of US Patent No.9,226,940 to Kemin Foods' Domestic Industry Product,FloraGLO® Lutein
Kemin's website
Kemin "Beat the Blue" marketing brochure
Designation
Public
Public
Public
16c Kemin technical literature: The Role of Lutein in Pregnancy Publicand Infant Care
Declaration of Elizabeth Nelson Confidential
Letter from John Kolleng Confidential
Amended and Restated Security Agreement Confidential
VI
PHYSICAL EXHIBIT LIST
Exhibit No. Description Designation
PX-1 GNC Preventative Nutrition Eye Health Formula, togetherwith the receipt of purchase
Public
PX-2 Doctor's Best "Lutein with Lutemax 2020," together with thereceipt of purchase
Public
Vll
APPENDICES
Appendix No. Description Designation
A Prosecution History for U.S. Pat. No. 8,815,955 Public
B Cited References for U.S. Pat. No. 8,815,955 Public
C Prosecution History for U.S. Pat. No. 9,226,940 Public
D Cited References for U.S. Pat. No. 9,226,940 Public
Vlll
i
INTRODUCTION
1. Kemin Industries, Inc. ("Kemin Industries") and Kemin Foods, L.C.
("Kemin Foods") (collectively, "Kemin" or"Complainants")1 respectfully file this
Complaint pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C.
§ 1337, based upon the unlawful and unauthorized importation into the United States, the
sale for importation, or the sale within the United States after importation, of certain
supplements and vitamins, including ocular antioxidants, such as certain lutein and
zeaxanthin-based supplements, and components thereof and products containing the
same, the use of which infringe at least one claim of each of U.S. Patent Nos. 8,815,955
("the '955 patent") and 9,226,940 ("the '940 patent") (collectively "the Asserted
Patents"), which are valid and enforceable United States patents. Certified copies of the
'955 patent and the '940 patent accompany this Complaint as Exhibits 1 and 2,
respectively. Certifiedcopies of the assignments of the Asserted Patents, demonstrating
that Kemin Industries is the owner of the Asserted Patents by assignment, are attached as
Exhibits 3 and 4, respectively.
2. Kemin Industries is a family-owned, Iowa-based innovator in the health
and nutrition industry, committed to researching, developing, and manufacturing high-
quality supplements and food ingredients. Kemin Industries is also a member of a group
of companies that includes Kemin Foods, which acts as the manufacturing, marketing,
and selling company responsible for the sale of dietary supplements on a global basis.
Kemin Industries and Kemin Foods are sister companies wholly owned by Kemin
Worldwide Holdings, Inc., a South Dakota corporation. Through their innovative and
Exhibit 17C [Declaration of Elizabeth Nelson].
diverse product portfolio that includes health-related products, Complainants touch and
improve the lives of nearly 2.5 billion people worldwide each year. Complainants'
innovative workhas resulted in roughly 64 patents in the United States, and 193 patents
throughout the rest of the world.
3. The Asserted Patents involve technology in the field of ocular health.
Specifically, the Asserted Patents relate generally to the protection of the retina from
damage due to harmfulblue light and ultraviolet light by the use of ocular antioxidants,
such as lutein and zeaxanthin.
4. Complainants have invested significantresources into the development of
a domestic industry in articles that are protected by the Asserted Patents. This domestic
industry includes food supplements and vitamins includingocular antioxidants that
practice at least one claim of each of the Asserted Patents.
5. Proposed Respondents are OmniActive Health Technologies
("OmniActive India") and OmniActive Health Technologies, Inc. ("OmniActiveUSA")
(collectively "OmniActive" or "Proposed Respondents").
6. Proposed Respondents directly and/or indirectly infringe at least oneclaim
of each of the Asserted Patents identified below and as further detailed in <H37, 41-42,
44-45. The asserted claims are:
U.S. Patent No.Asserted Claims
8,815,9551-13
9,226,9401-13
7. Proposed 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 the Accused Products, as defined in paragraph 1 above
and as described more fully in Section V below, are unlawful under 19 U.S.C.
§ 1337(a)(l)(B)(i), in that they constitute the infringement of one or more valid and
enforceable claims of the Asserted Patents, and that a domestic industry as required by
U.S.C. §§ 1337(a)(2) and (3) exists in the United States relating to the technology
protected by the Asserted Patents.
8. Complainants seek relief from the Commission in the form of a limited
exclusion order excluding food supplements and vitamins including ocular antioxidants
the use of which infringe at least one claim of each of the Asserted Patents and which are
manufactured by or on behalf of, imported by or on behalf of, sold by importation by or
on behalf of, or sold after importation by or on behalf of any Proposed Respondents, or
any of their affiliated companies, parents, subsidiaries, or other related business entities,
or their successors or assigns, from entry for consumption into the United States, entry
for consumption from a foreign trade-zone, or withdrawal from a warehouse for
consumption, for the remaining terms of the Asserted Patents, except under license of
Complainant or as provided by law.
9. Complainants further seek as relief cease and desist orders that prohibit
Proposed Respondents and any-of their principals, stockholders, officers, directors,
employees, agents, licensees, distributors, controlled (whether by stock ownership or
otherwise) or majority-owned business entities, successors, and assigns, from either
directly engaging in or for, with, or otherwise on behalf of Proposed Respondents, (A)
3
importing or selling for importation into the United States food supplements and vitamins
including ocular antioxidants, the use of which infringe at least one claim of each of the
Asserted Patents; (B) marketing, distributing, offering for sale, selling, or otherwise
transferring, in the United States imported food supplements and vitamins including
ocular antioxidants, the use of which infringe at least one claim of each of the Asserted
Patents; (C) advertising imported food supplements and vitamins including ocular
antioxidants and methods for reducing retinal damage with the same, the use of which
infringe at least one claim of each of the Asserted Patents in the United States; (D)
soliciting U.S. agents or distributors for imported food supplements and vitamins
including ocular antioxidants, the use of which infringe at least one claim of each of the
Asserted Patents; or (E) aiding or abetting other entities in the importation, sale for
importation, sale after importation, transfer, or distribution of food supplements and
vitamins including ocular antioxidants, the use of which infringe at least one claim of
each of the Asserted Patents.
10. Complainants seek a bond imposed upon importation of infringing food
supplements and vitamins including ocular antioxidants and components thereof and
products containing the same, during the 60-day Presidential review period pursuant to
19 U.S.C. § 1337(e), (f), and (j).
11. Complainants further seek any other relief the Commission is authorized
to grant and deems appropriate.
II. THE PARTIES
A. Complainants
12. Kemin Industries is an Iowa corporation having its principal place of
business at 2100 Maury Street, Des Moines, Iowa 50317. It was incorporated in Iowa on
March 11, 1963. Kemin Foods, doing business as Kemin Health, is also an Iowa limited
liability company with its principal place of business at 2100 Maury Street, Des Moines,
Iowa 50317. It is the manufacturing, marketing and selling arm for Kemin Industries'
ocular antioxidants. Kemin Industries and Kemin Foods are sister companies wholly
owned by Kemin Holdings, a South Dakota corporation.
13. Kemin is a pioneer in the research and development of high-quality
supplements and food ingredients to promote consumer heath, the subject matter of the
asserted '955 and '940 patents. In 1961, R.W. Nelson andivlary Nelson founded Kemin
as a family business in their Iowa home with a manufacturing plant in an old wool barn.
From its humble beginnings through today, Kemin has remained committed to the
manufacture and research and development of innovative agricultural and health-related
products to aid the food, health, nutrition and personal care markets. Over fifty years
later, Kemin remains a family-owned, Iowa-based business, but has grown into a
worldwide market leader, with seven divisions, including human nutrition and health,
agricultural ingredients for feed and biosecurity, pet foods, food products, and personal
care.
14. Kemin has a long and storied history of innovation. Since the 1960s,
Kemin has conducted research to develop innovative agricultural products, beginning
with mold inhibitors and flavors, quickly growing to encompass a full line of ingredients
for animal feed throughout the United States. Kemin expanded its business in the late
1990s to includedietary supplements based on marigold flowers grown for Kemin in
India. In 2008, Kemin assembled a specialty crop group to develophighly valued
specialty crops, focused on selecting and developing proprietary plant breeds with
sustainable sources of novel, highly efficacious molecules that have strong antioxidant
and antimicrobial activities. In addition, Kemin continues to innovate in the areas of
ingredients for pet food, human food, animal feed, personal care and a line of products
supporting horticultural applications, sharing similar molecular platforms and
technologies.
15. In the 1980s Kemin shifted its research and development focus to expand
beyond the animal feed industry into the human food industry, working to inhibit mold
and bacteria in human food and to develop antioxidants. Kemin built a new innovation
center in 1983 in Des Moines to continue to study molecules and understand how they
worked inside living organisms. By 1992 Kemin had expanded to sell antioxidants in the
pet food industry. In addition, Kemin has developed new food technologies to keep
edibles fresher and more flavorful, as well as pharmaceutical dyes with colorants that are
naturally derived and nutraceuticals that maintain wellness, improveeye and cognitive
health, aid weight loss, and enhance athletic power.
16. For more than five decades, Kemin has been dedicated to using plant
science to create specialty ingredients, including those thatenhance nutrition and health
for humans and animals. Kemin has developed proprietary technology to gently retrieve
ingredients from their source plants for greater retention of their effective properties,
employing various extraction methods, including a process that uses only purified water,
centrifugation and driers.
17. With the advances disclosed in the '955 and'940 patents, Complainants
have discovered the importance of protecting the human eye from damage due to the
ever-increasing abundance of blue and ultraviolet light produced by televisions, computer
monitors, and mobile devices. This technology has now formed an integral part of
Complainants' business platform. A copy of Kemin's Annual Report accompanies this
Complaint as Exhibit 5. Further information regarding Complainants' products and
services can be found at Complainants' website www.kemin.com.
18. Complainants operate principally within the United States, with their
facilities located in Des Moines, Iowa devoted to research, development, manufacturing,
packaging and distribution of lutein and zeaxanthin products, including FloraGLO®.
Complainants devote significant resources to continued innovation within the United
States and derive significant revenue from their activities in North America (primarily the
United States). For further details relating to such facilities and activities, See Ex. 7C
[Confidential Declaration of Rich Heil].
B. Proposed Respondents
19. On information and belief, OmniActive India is a corporation organized
under the laws of India with its principal place of business at Phoenix House, T-8, A
Wing, 462 Senepati Bepat Marg, Lower Parel, Mumbai - 400 013, India.
20. On Information and belief, OmniActive India is the parent company of
OmniActive USA and other OmniActive entities.
21. On information and belief, OmniActive USA is a corporation organized
under the laws of Delaware with its principal place of business at 67 East Park Place,
Suite 500, Morristown, NJ 07960. On information and belief, OmniActive USA is a
wholly owned sales subsidiary of OmniActive India, and is an importer and/or distributor
of the Accused Products that are sold under brand names such as Lutemax® 2020. See,
e.g., Ex. 6 [http://omniactives.com/operations] and Ex. 8 [http://omniactives.com/press-
releases/omniactive-showcases-lutemax-and-capsimax-ranges-of-products-at-biotaiwan-
2015] ("The company's manufacturing operations are located at multiple sites in India
and are cGMP and HACCP system compliant.").
22. On information and belief, OmniActive India has imported the Accused
Products and is responsible, directly or indirectly, for at least OmniActive USA's
infringing activities. OmniActive India owns and/or controls manufacturing and sales
subsidiaries that manufacture, import, and/or distribute the Accused Products sold under
brand names that OmniActive USA owns or licenses. See, e.g., Exs. 8 and 9.
OmniActive India also owns and/or controls manufacturing facilities at which the
Accused Products may be made under contract. See id.
III. THE PRODUCTS AT ISSUE
A. The Technology
23. In general, the lens of the human eye focuses light like a magnifying glass
onto the macula (the pigmented area near the center of the retina), and acts as a prism to
separate the wavelengths of visible light into blue light, green light, and red light. Blue
light, which has the highest wavelength and energy level, is focused on the front of the
macula. When this high energy light contacts the sensitive tissue of the retina, it results
8
in the generation of harmful free-radicals and reactive oxygen species. These free-
radicals and reactive oxygen species can cause considerable damage to the
photoreceptors in the retina, and result in vision loss. This potential for damage has
become an even greater concern, given the increasing abundance of blue and ultraviolet
light, which is emitted by computer screens, mobile devices, and LED lightbulbs.
Moreover, the blue and ultraviolet light can be particularly problematic when a subject
exhibits certain ocular conditions such as astigmatism, hyperopia (farsightedness), or
presbyopia (age-related farsightedness). In such subjects, the light is not properly
focused onto the retina and high-energy blue light improperly becomes focused directly
on the sensitive tissue of the retina.
24. . The Asserted Patents generally relate to methods of using ocular
antioxidants (including, but not limited to, lutein and zeaxanthin) to prevent and treat
damage to the eye due to light. Specifically, the Asserted Patents claim methods of
treating or reducing the potential for such damage due to blue light through the use of
ocular antioxidants, including macular carotenoids such as lutein, zeaxanthin, and
zeaxanthin isomers.
B. The Accused Products
25. The Accused Products are generally supplements and food ingredients that
include macular carotenoids (such as lutein, zeaxanthin, and zeaxanthin isomers) that
have been sold for importation, imported, and/or sold after importation by Proposed
Respondents in the United States for use to support eye health specifically by acting as
powerful antioxidants and filtering high-energy blue light. Ex. 9 [7/18/16 Press Release.
"OmniActive Introduces What's Your B.L.U.E.? To Natural Products Industry Members
9
at ENGREDA 2016"] and Ex. 10 [Excerpt from OmniActive marketing campaign
entitled "Lutein for Every Age," at www.luteinforeveryage.com]. Pursuant to 19 C.F.R.
§ 210.12(a)(12), specific non-limiting examples of the Accused Products include an
OmniActive product sold under the trade name Lutemax® 2020, components thereof, and
products containing the same. See Exs. 11 and 12 [labels of products containing
Lutemax 2020, including GNC Preventative Nutrition "Eye Health Formula" and
Doctor's Best "Best Lutein Dietary Supplement"].
IV. THE PATENTS AT ISSUE
A. The '955 Patent (U.S. Patent No. 8,815,955)
1. Identification of the Patent and Ownership by Kemin Industries
26. Kemin Industries owns by valid assignment the entire right, title, and
interest in the'955 patent entitled, "Method of Treating Ocular Disorders," which issued
on August 26, 2014. 2 See Ex. 1. The'955 patent issued to inventor Richard Roberts
from United States Patent Application No. 13/238, 939, filed on September 21, 2011. It
expires on April 15, 2032.
27. Pursuant to Commission Rule 210.12(a)(9)(i), a certified copy of the'955
patent is attached as Exhibit 1. Pursuant to Commission Rule 210.12(a)(9)(h), a certified
copy of the recorded assignments of the '955 patent is attached as Exhibit 3.
28. Pursuant to Commission Rule 210.12(c), four copies of the prosecution
history of the'955 patent, as well as four copies of each patent and applicable pages of
each technical reference mentioned in the prosecution history, are attached as Appendices
2 Kemin Industries owns all right, title, and interest in the asserted patents. See Exs. 3, 3aC, 4,4aC, 18C, and 19C.
10
3
A and B, respectively. A certified copy of the prosecution history has been requested
from the U.S. Patent and Trademark Office and will be provided to the Commission upon
receipt.
2. Non-Technical Description of the'955 Patent
29. The'955 patent has thirteen claims: one independent claim and twelve
dependent claims.
30. The'955 patent generally relates to methods of treating ocular disorders
with ocular antioxidants, and more particularly to treating increased age-related macular
degeneration ("AMD") in subjects, including subjects with hyperopia or astigmatism,
with ocular antioxidants/ AMD is a disease associated with aging that gradually
destroys the central region of the retina (the macula), and results in the loss of sharp,
central vision, and even blindness. It has been discovered that blue light (such as the
light from LED light bulbs, computer screens, and mobile device screens) contributes to
the destruction of the macula. The invention claimed in the '955 patent consists of a new
and important method of preventing such damage (and associated vision loss) by the
administration of ocular antioxidants (such as lutein, zeaxanthin, and zeaxanthin
isomers). These ocular antioxidants help form a protective coating over the retina to
prevent penetration and damage by harmful blue light.
B. The '940 Patent (U.S. Patent No. 9,226,940)
1. Identification of the Patent and Ownership by Complainant
31. Kemin Industries owns by valid assignment the entire right, title, and
interest in the '940 patent entitled, "Method of Treating Ocular Disorders," which issued
The text of this Complaint is not intended to interpret the meaning or limit the scope of theclaims of the Asserted Patents.
11
on January 5, 2016.4 The '940 patent issued to inventor Richard Roberts from United
States Patent Application No. 14/307,684, filed on June 18, 2014. The '940 patent is a
divisional of United States Patent Application No. 13/238,939, filed on September 21,
2011, which claims priority to United States Provisional Application No. 61/384,958,
filed on September 21, 2010. The '940 patent expires on September 21, 2031.
32. Pursuant to Commission Rule 210.12(a)(9)(i), a certified copy of the '940
patent is attached as Exhibit 2. Pursuant to Commission Rule 210.12(a)(9)(h), a certified
copy of the recorded assignment of the '940 patent is attached as Exhibit 4.
33. Pursuant to Commission Rule 210.12(c), four copies of the prosecution
history of the '940 patent, as well as four copies of each patent and applicable pages of
each technical reference mentioned in the prosecution history, are attached as Appendices
C and D, respectively. A certified copy of the prosecution history has been requested
from the U.S. Patent and Trademark Office and will be provided to the Commission upon
receipt.
2. Non-Technical Description of the '940 Patent
34. The '940 patent has thirteen claims: one independent claim and twelve
dependent claims.
35. The '940 patent generally relates to methods of reducing blue and
ultraviolet light damage to the eye of subjects, including in subjects with certain eye
conditions (namely, presbyopia, hyperopia, or astigmatism), by administering ocular
antioxidants. Blue and ultraviolet light is emitted by LED light bulbs, computer screens,
4Kemin Industries owns all right, title, and interest in the asserted patents. SeeExs. 3, 3aC, 4,4aC, 18C, and 19C.
12
and mobile devices, which have become increasingly ubiquitous. The blue and
ultraviolet lights, however, have the shortest wavelengths, and as a result, exhibit the
highest energy and greatest potential to induce damage to the eye by absorption of
photosensitizers and/or induction of free radicals. It has been discovered that blue light
contributes most significantly to the destruction of the macula in subjects with conditions
such as astigmatism, hyperopia, or presbyopia. The invention claimed in the '940 patent
consists of a new and important method of preventing such damage (and associated
vision loss) by the administration of ocular antioxidants (such as lutein and zeaxanthin).
These ocular antioxidants help form a protective coating over the retina to prevent
penetration and damage by harmful light.
SPECIFIC INSTANCES OF IMPORTATION AND SALE
36. On information and belief, one or more of Proposed Respondents
manufacture the Accused Products and pertinent components thereof in India. See, e.g.,
Ex. 6 [http://omniactives.com/operations] and Ex. 9 [http://omniactives.com/press-
releases/omniactive-showcases-lutemax-and-capsimax-ranges-of-products-at-biotaiwan-
2015] ("The company's manufacturing operations are located at multiple sites in India
and are cGMP and HACCP system compliant.").
37. On information and belief, one or more of Proposed Respondents, directly
or through agents acting on behalf of Proposed Respondents or their customers, directly
or indirectly infringe the Asserted Patents by manufacturing, importing into the United
States, selling or offering for sale for importation into the United States, and/or selling
within the United States after importation the Accused Products, containing lutein and
zeaxanthin supplements, including Lutemax 2020®. These Accused Products are
13
available throughout the UnitedStates at major mass retailers, including General
Nutrition Centers ("GNC") and the Vitamin Shoppe. See, e.g., Exs. 11 and 12. The
specific instances of importation of the Accused Products set forth below areexamples of
the unlawful importation and/or sale after importation of infringing articles.
38. As a first example, Complainants obtained from a General Nutrition
Center store in Des Moines, Iowa, a sample of GNC Preventative Nutrition Eye Health
Formula (model number 00722112), which explicitly states that it contains the Accused
Products, 20 mg OmniActive brand lutein supplements (Lutemax® 2020 Lutein). Ex. 11.
A physical example of the GNC Preventative Nutrition Eye HealthFormula, together
with the receiptof purchase within the United States, is submitted as Physical Exhibit
PX-1.
39. As a second example, Complainants obtained from a Vitamin Shoppe in
Des Moines, Iowa, a sample of Doctor's Best "Lutein with Lutemax 2020" (model
number 753950003705), which explicitly states that it contains the Accused Products, 20
mg OmniActive brand lutein supplements and 4mg zeaxanthin (Lutemax® 2020 Lutein).
Ex. 12 (see excerpt below, a lutein supplement containing Lutemax® 2020, sold next to a
lutein supplement containing FloraGLO®).
14
40. A physical example of the Doctor's Best "Lutein with Lutemax 2020,"
together with the receipt of purchase within the United States, is submitted as Physical
Exhibit PX-2.
41. In addition, Proposed Respondents engage.in a specific marketing
campaign intending to promote and direct the use of lutein and zeaxanthin products to
protect and treat the eye using the Accused Products. For example, in a campaign
entitled "What's Your B.L.U.E.?," Proposed Respondents explain that blue light
"bombards our eyes daily," and can reach "deep into the eye and can harm the macula.'
See Ex. 9. Proposed Respondents continue that "Lutein and zeaxanthin isomers are
known as the 'macular carotenoids' and support eye health by acting as powerful
antioxidants and filtering high-energy blue light." Id. Proposed Respondents instruct
that "Lutemax 2020 is lutein with enhanced levels of zeaxanthin isomers ... to help-
15
protect the eyes against harmful high-energy blue light." Id. On information and belief,
Proposed Respondents have actively engaged and encouraged existing and potential
customers to promote and direct the use of lutein and zeaxanthin products toprotect and
treat the eye using theAccused Products. On information and belief, Proposed
Respondents have provided existing customers with marketing materials, including the
"What's YourB.L.U.E.?" marketing campaign materials. Further, Proposed
Respondents' existing customers have used these materials to promote and direct the use
of lutein andzeaxanthin products to protect and treat the eye using the Accused Products.
Oninformation and belief, Proposed Respondents' existing customers actively promote
and direct the use of lutein and zeaxanthin products to protect and treat the eye using the
Accused Products, including publishing marketing materials prepared by Proposed
Respondents.
42. The Accused Products are sold for importation, imported into the United
States, or sold after importation into the United States.
43. Discovery is expected to reveal additional specific acts of Proposed
Respondents' importation, sale for importation, or sale after importation ofthe Accused
Products.
VI. UNLAWFUL AND UNFAIR ACTS COMMITTED BY PROPOSEDRESPONDENTS—PATENT INFRINGEMENT
44. On information and belief, OmniActive India manufactures abroad, sells
for importation into the United States, and/or imports into the United States, and
OmniActive USA sells within the United States after importation, Accused Products that
infringe at least one claim of each of the Asserted Patents.
16
45. In addition, OmniActive is aware of the Asserted Patents because these
patents were specifically identified in a July 20, 2016 correspondence from Complainants
to them that preceded the filing of this Complaint, and because OmniActive filed a
Complaint for declaratory judgment in the United States District Court for the District of
New Jersey based on the Asserted Patents on August 15, 2016. OmniActive directly or
indirectly infringes the Asserted Patents by making, using, selling, offering for sale, and
importing articles covered by claims of the Asserted Patents. Moreover, OmniActive is
aware of the Asserted Patents, at least because it was provided with a copy of this
Complaint via registered mail as of the date of its filing.
A. The '955 Patent
46. On information and belief, the Accused Products infringe 1-13 of the '955
patent.
47. Further, on information and belief, OmniActive induces other users of the
Accused Products to infringe claims 1-13 of the '955 patent with the specific intent to
encourage their infringement by, inter alia, marketing the Accused Products, and by
creating and/or distributing supplements, food ingredients, and/or similar materials
(including carotenoids such as lutein and zeaxanthin) with instructions on using the
Accused Products.
48. Further, on information and belief, OmniActive contributes to the
infringement of claims 1-13 of the '955 patent because, interalia, OmniActive knows
that the Accused Products embody a material part of the claimed inventions of the '955
patent, that they are specially made or specially adapted for use in an infringement of
these claims, and that they are not staple articles of commerce suitable for substantia';
17
non-infringing use. For example, on information and belief, the AccusedProducts use
lutein and zeaxanthin, among others.
49. Further, on information and belief, at least some users of the Accused
Products use the Accused Products in a manner that directly infringes at least one claim
of each of the Asserted Patents.
50. A sample claim chart comparing the asserted independent claim 1 of the
'955 patent to the Accused Products is attached as Exhibit 13.
B. The '940 Patent
51. On information and belief, the Accused Products infringe claims 1-13 of
the'940 patent.
52. Further, on information and belief, OmniActive induces other users of the
Accused Products to infringe claims 1-13 of the '940 patent with the specific intent to
encourage their infringement by, inter alia, marketing the Accused Products, and by
creating and/or distributing supplements, food ingredients, and/or similar materials
(including carotenoids such as lutein and zeaxanthin) with instructions on using the
Accused Products.
53. Further, on information and belief, OmniActive contributes to the
infringement of claims 1-13 of the '940 patent because, inter alia, OmniActiveknows
that the Accused Products embody a material part of the claimed inventions of the '940
patent, that they are specially made or specially adapted for use in an infringement of
these claims, and that they are not staple articles of commerce suitable for substantial
non-infringing use. For example, on information and belief, the Accused Products use
lutein and zeaxanthin, among others.
18
54. Further, on information and belief, at least some users of the Accused
Products use the Accused Products in a manner that directly infringes at least one claim
of each of the Asserted Patents.
55. A sample claim chart comparing each asserted independent claim of the
'940 patent to the Accused Products is attached as Exhibit 14.
56. In summary, Proposed Respondents unlawfully sell for importation,
import, and/or sell after importation into the United States Accused Products, and
products containing the same, that directly or indirectly infringe at least the patent claims
listed below:
U.S. Patent No./
Accused
Products
Asserted
Claims
IndependentClaims
Accused PartiesInfringement
Type
8,815,955
(Roberts)
Accused Ocular
Antioxidant
Products
1-13 1 OmniActive Direct and/or
Indirect
9,226,940
(Roberts)
Accused Ocular
Antioxidant
Products
1-13 1 OmniActive Direct and/or
Indirect
57. Further discovery may reveal that other products manufactured, sold for
importation into the United States, imported into the United States, and/or sold after
importationwithin the United States by ProposedRespondents infringe the claims of the
Asserted Patents. Further discovery may also reveal that additional claims of the Asserted
Patents are infringed by Proposed Respondents' products.
19
VII. THE DOMESTIC INDUSTRY
58. A domestic industry exists in the United States as required by 19 U.S.C. §
1337 (a)(3)(A), (B) and (C) because Complainants have made (1) significant investment
within the United States in plant and equipment and (2) significant employment within
the United States of labor or capital, including engineering, manufacturing, and research
and development. Specific non-limiting examples of such investments are provided
below.
A. Technical Prong - Complainants' Articles Practice at Least One Claim ofEach of the Asserted Patents in the United States
59. Kemin Foods manufactures and sells within the United States nutritional
supplements comprising lutein and zeaxanthin. Specifically,Kemin Foods makes and
sells aproduct sold under the trade name FloraGLO®. FloraGLO® is manufactured in
Complainants' plant in Des Moines, Iowa, and is sold throughout the UnitedStates as a
component of other products, including Opti-Vue, sold by the Vitamin Shoppe. Kemin
Foods further engages in a marketing campaign throughout the United States,
encouraging the use ofFloraGLO® to prevent eye damage' due to blue and ultraviolet
light.
60. Claim charts demonstrating how Kemin Foods' current FloraGLO®
products (including lutein and zeaxanthin) are coveredby a claimof the '955 and '940
patentare attached as Exhibits 15 and 16. As theseproducts practice at leastoneclaim of
each of the '955 patent and '940 patent, they satisfy the requirements of 19U.S.C. §
1337(a)(B)(ii).
B. Economic Prong - Complainants' Substantial Investment in the RelevantIndustry, Including Manufacturing, Engineering, and Research andDevelopment, Within the United States
20
61. Complainants have made significant investments in plant, equipment,
labor and capital in the United States with respect to the Asserted Patents in the form of
capital assets, plant and equipment, manufacturing, and labor.
62. Complainants continue to invest heavily in research and development and
manufacturing in the United States. Complainants' investments in plant, equipment,
labor, and capital dedicated to research and development and manufacturing related to the
technology in the patents-at-issue, as well as revenues resulting from these investments,
are detailed in the attached declaration. See Ex. 7C [Rich Heil Declaration].
Vm. HARMONIZED TARIFF SCHEDULE INFORMATION
63. On information and belief, the articles subject to this Complaint are
classified under at least the following headings and subheadings of the Harmonized Tariff
Schedule ("HTS") ofthe United States: 130219 (including,' but not limited to subheading
420100), 330190, 121190, and 091030. These HTS numbers are illustrative only and are
not intended to restrict the scope of this investigation.
IX. RELATED LITIGATION
64. The Asserted Patents are the subject of a Civil Action in the United States
District Court for the District of New Jersey, filed on August 15, 2016, by OmniActive
USA, naming Kemin Industries as a Defendant. OmniActive Health Technologies, Inc. v.
KeminIndustries, Inc., 2016-cv-04988-CCC-JBC (D.N.J, filed August 15, 2016). The
action is pending.
65. Kemin Foods and OmniActive Health Technologies, Inc. have also been
involved in prior litigation on unrelated patents. Kemin Foods, L.C. et al v. OmniAcrive
Health Technologies, Inc., 8:07-cv-01308-VMC-TGW (M.D. Fla. filed July 25, 2007).
21
66. On information and belief, the Asserted Patents have not been the subject
of any other court or agency litigation, domestic or foreign.
X. RELIEF REQUESTED
WHEREFORE, by reason of the foregoing, Complainants respectfully request that the
United States International Trade Commission:
(a) institute an immediate investigation pursuant to Section 337 of the Tariff
Act of 1930, as amended, 19 U.S.C. § 1337, into the violations by
Proposed Respondents of Section 337 arising from the importation into the
United States, and/or sale for importation, and/or sale within the United
States after importation, of Proposed Respondents' products that infringe
at least one claim of each of U.S. Patent Nos. 8,815,955 and 9,226,940;
(b) schedule and conduct a hearing, pursuant to 19 U.S.C. § 1337(c), for
purposes of receiving evidence and hearing argument concerning whether
there has been a violation of Section 337 of the Tariff Act of 1930, as
amended; and, following the hearing, determine that there has been a
violation of Section 337 of the Tariff Act of 1930, as amended;
(c) issue a limited exclusion order, pursuant to 19 U.S.C. § 1337(d)(1),
excluding from entry for consumption into the United States, entry for
consumption from a foreign trade-zone, or withdrawal from a warehouse
for consumption, supplements and vitamins, including ocular antioxidants
and components thereof and products containing the same, that infringe at
least one claim of each of U.S. Patent Nos. 8,815,955 and/or 9,226.940
and which are manufactured by or on behalf of, or imported by or on
22
behalf of Proposed Respondents, or any of their affiliated companies,
parents, subsidiaries, or other related business entities, or their successors
or assigns, for the remaining terms of the Asserted Patents, except under
license of Complainants or as provided by law;
(d) issue permanent cease-and-desist orders, pursuant to 19 U.S.C. § 1337(f),
directing Proposed Respondents and any of their principals, stockholders,
officers, directors, employees, agents, licensees, distributors, controlled
(whether by stock ownership or otherwise) or majority-owned business
entities, successors, and assigns, from either directly engaging in or for,
with, or otherwise on behalf of Proposed Respondents, (A) importing or
selling for importation into the United States supplements or food
ingredients, the use of which infringe at least one claim of each of U.S.
Patent Nos. 8,815,955 and/or 9,226,940; (B) marketing, distributing,
offering for sale, selling, or otherwise transferring, in the United States
imported supplements or food ingredients, the use of which infringe at
least one claim of each of U.S. Patent Nos. 8,815,955 and/or 9,226.940;
(C) advertising imported supplements or food ingredients in the United
States, the use of which infringe at least one claim of each of U.S. Patent
Nos. 8,815,955 and/or 9,226,940; (D) soliciting U.S. agents or distributors
for supplements or food ingredients, the use of which infringe at least one
claim of each of U.S. Patent Nos. 8,815,955 and/or 9,226,940; or (E)
aiding or abetting other entities in the importation, sale for importation.
sale after importation, transfer, or distribution of supplements or food
23
ingredients, the use of which infringe at least one claim of each of U.S.
Patent Nos. 8,815,955 and/or 9,226,940;
(e) issue a bond upon importation of infringing food supplements and
vitamins including ocular antioxidants and components thereof and
products containing the same, during the 60-day Presidential review
period pursuant to 19 U.S.C. § 1337(e), (f), and (j); and
(f) grant all such other and further relief as the Commission has authority to
grant and deems appropriate under the law, based upon the facts
complained of herein and as determined by the Investigation.
Dated: October 6, 2016 Respectfully submitted,
OA/<
Michael V. O'ShaughnessyJay ReizissRebecca Harker DuttryMcDermott Will & Emery, LLP
500 North Capitol Street, NWWashington, DC 20001Telephone: (202) 756-8000
Allison E. Kerndt
Davis, Brown, Koehn, Shores & Roberts, P.C.The Davis Brown Tower
215 10th Street, Suite 1300Des Moines, IA 50309Telephone: (515) 288-2500
Counselfor ComplainantsKemin Industries, Inc.
Kemin Foods, L. C.
24
VERIFICATION OF THE COMPLAINT
I. Elizabeth Nelson, declare in accordance with 19 C.F.R. §§210.4 and 210.12(a), under
penalty of perjury, that the following statements are true:
1. I am the Vice President and General Counsel of Kemin Industries, Inc., Secretary for
Kemin Foods L.C, Secretary for Kemin Holdings L.C. and I am duly authorized to sign
this Complaint on behalf of Complainants;
2. I have read the foregoing Complaint;
3. To the best of my knowledge, information, and belief, based upon reasonable inquiry, the
foregoing Complaint is well founded in fact and is warranted by existing law or by a non-
frivolous argument for the extension, modification, or reversal of existing law or the
establishment of new law;
4. The allegations and other factual contentions have evidentiary support or are likely to
have evidentiary support after reasonable opportunity for further investigation or
discovery; and
5. The foregoing Complaint is not being filed for an improper purpose, such as to harass or
to cause unnecessary delay or needless increase in the cost of litigation.
Executed this J day of October, 2016.
Elizabeth Nelson
UNITED STATES INTERNATIONAL TRADE COMMISSIONWASHINGTON, DC.
In the Matter of ))
CERTAIN FOOD SUPPLEMENTS AND )VITAMINS, LNCLUDLNG OCULAR )ANTIOXIDANTS AND COMPONENTS - )THEREOF AND PRODUCTS ) Investigation No. 337-TACONTAINING THE SAME )
CERTIFICATION
I, Michael V. O'Shaughnessy, counsel for Kemin Industries, Inc. and Kemin Foods, L.C.(collectively, "Complainants"), declare:
1. I am duly authorized by Complainants to execute this certification.
2. I have reviewed Confidential Exhibits 3aC, 4aC, 7C, 7aC-7dC, 17C, 18C, and 19C toComplainants' Verified Complaint, for which Complainants seek confidentialtreatment.
3. To the best of my knowledge, information, and belief, founded after a reasonableinquiry, substantially-identical information to that contained in ConfidentialExhibits 3aC, 4aC, 7C, 7aC-7dC, 17C, 18C, and 19C to the Verified Complaint isnot available to the public. I declare, under the penalty of perjury, that theforegoing is true and correct.
Executed October 6, 2016
Michael V. O'Shaughnessy
Counselfor Complainants Keminjtp.Inc. and Kemin Foods, L.C.
