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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`DEMAND FOR JURY TRIAL
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`C.A. No. _________________
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`KANEKA CORPORATION,
`A Japanese Corporation.
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` Plaintiff,
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` v.
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`DESIGNS FOR HEALTH, INC.,
`A Delaware Corporation, and AMERICAN
`RIVER NUTRITION LLC, A Delaware
`Corporation
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` Defendants.
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`COMPLAINT
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`Plaintiff Kaneka Corporation (“Kaneka”) files this Complaint for Patent Infringement and
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`Demand for Jury Trial against Designs For Health Inc. (“DFH”) and American River Nutrition
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`LLC (“ARN”).
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`NATURE OF THE ACTION
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`1.
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`This is an action for Patent infringement under the laws of the United States, Title
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`35, United States Code by Kaneka against DFH and ARN.
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`2.
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`This action arises from DFH’s manufacture, use, offer for sale, and sale in the
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`United States of the supplements, DuoQuinol and CoQnol (“Accused Products”) which, upon
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`information and belief, were designed and developed by ARN, and manufactured, offered for sale
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`and sold by DFH under the trademarks “DuoQuinol” and/or “CoQnol” These activities infringe,
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`either literally or under the doctrine of equivalents, and induce others to infringe two Patents
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`owned by Kaneka.
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 2 of 12 PageID #: 2
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`THE PARTIES
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`3.
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`Kaneka is a Japanese Corporation with a head office at 1-12-32, Akasaka, Minato-
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`Ku, Tokyo, Japan, and a head office at 2-3-18, Nakanoshima, Kita-Ku, Osaka, Japan.
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`4.
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`DFH is a Delaware Corporation at 14 Commerce Blvd., Palm Coast, FL 32164.
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`DFH may be served with process through its registered agent, Northwest Registered Agent
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`Service Inc., 8 The Green, Ste. B, Dover, Delaware 19901.
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`5.
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`ARN is a Delaware Corporation at 333 Venture Way, Hadley, MA 01035. ARN
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`may be served through its registered agent, Northwest Registered Agent Service Inc., 8 The
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`Green, Ste. B, Dover, Delaware, 19901.
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`JURISDICTION AND VENUE
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`6.
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`7.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§1331 and 1338(a).
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`Based on the facts and causes alleged herein, and for additional reasons to be further
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`developed through discovery, this Court has personal jurisdiction over the Defendants.
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`8.
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`This Court has personal jurisdiction over DFH and ARN as both are Delaware
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`Corporations.
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`9.
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`This Court additionally has personal jurisdiction over the Defendants because upon
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`information and belief, the Defendants have knowingly directly infringed, and induced
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`infringement within this District by advertising, marketing and offering for sale the Accused
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`Products within this District, to consumers, customers, distributers, resellers, partners and/or end
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`users, and providing instructions, advertising, and/or marketing materials that facilitate, direct or
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`encourage the use of the Accused Products.
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`10. Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 3 of 12 PageID #: 3
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`Kaneka’s Innovations
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`BACKGROUND
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`11.
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` Kaneka Corporation is an international company that produces a number of
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`different products at plants around the world. It has also been the world’s premier supplier of
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`Coenzyme Q10 (“CoQ10”) supplements for more than 40 years. CoQ10 is found in every cell of
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`the human body. The human body makes CoQ10 and the cells use it to produce energy that the
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`human body needs for cell growth and cell maintenance. It also protects the body from damage
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`caused by harmful molecules. CoQ10 levels in the body decrease with age, which explains why
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`millions of people take Kaneka CoQ10 on a daily basis. Kaneka sells CoQ10 as a nutritional
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`supplement, similar to vitamins.
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`12. There are two types of CoQ10. The oxidized form is known as Ubiquinone, and the
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`reduced form is known as Ubiquinol. Kaneka was the first industrial scale manufacturer of
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`Ubiquinone, starting in 1977. When exposed to air, reduced CoQ10 (Ubiquinol) quickly
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`undergoes a chemical reaction—oxidation—and converts to oxidized CoQ10 (Ubiquinone).
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`Kaneka was the first manufacturer in the world to succeed in the development of technology to
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`stabilize Ubiquinol so that it did not quickly oxidize when exposed to air. Kaneka began sales of
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`Ubiquinol in the U.S. in 2006. Kaneka has been awarded a number of patents covering its
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`Ubiquinol products and due to that patent protection Kaneka is the only company that has the
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`legal right to produce and sell Ubiquinol in the United States. DFH admits that the Accused
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`Products are a form of Ubiquinol. (See Exhibit C)
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`13. During its 40 year history of producing CoQ10 products, Kaneka has supported
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`hundreds of CoQ10 clinical research studies at universities and hospitals around the globe.
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`Kaneka has focused its research support by working with top, independent academic research
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 4 of 12 PageID #: 4
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`institutions conducting research into the functionality and health benefits of all forms of CoQ10 to
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`ensure that the CoQ10 products made by Kaneka are safe and effective. All CoQ10 products made
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`by Kaneka have satisfied all applicable FDA standards and other government agency
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`requirements for safety and efficacy. Kaneka has ensured the safety and efficacy of its CoQ10
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`products for the entire 40 year history of producing these products.
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`14. Over this 40 year period, Kaneka has been granted over 37 U.S. Patents covering
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`the production of CoQ10 products, and numerous CoQ10 related Patents issued in other countries
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`around the world.
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`The Asserted Patents
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`15. United States Patent No. 7,145,044 (the “’044 Patent”) titled “Method Of
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`Producing Reduced Coenzyme Q10 Using Solvent with High Oxidation-Protective Effect” was
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`duly issued on December 5, 2006, and remains unexpired. A true and correct copy of the ’044
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`Patent is attached as Exhibit A and is assigned to and owned by Kaneka Corporation.
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`16. United States Patent No. 7,829,080 (the “’080 Patent”) titled “Stabilization Method
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`Of Reduced Coenzyme Q10” was duly issued on November 9, 2010, and remains unexpired. A
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`true and correct copy of the ’080 Patent is attached hereto as Exhibit B and is assigned to and
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`owned by Kaneka Corporation.
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`The DFH Infringing Product and Activities
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`17. The Accused Products are DuoQuinol and CoQnol. DFH admits that DuoQuinol
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`is a form of Ubiquinol, derived from Ubiquinone through a process involving the use of
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`geranygeraniol (GG) and ascorbyl palmitate. (See Exhibit C.) Upon information and belief, the
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`DuoQuinol product was designed and developed by Dr. Barrie Tan, the founder of ARN. ARN
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`then provided DFH the information required to produce DuoQuinol on a commercial scale, and
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 5 of 12 PageID #: 5
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`the production was done by Ashley-Martin Manufacturing, the DFH manufacturing unit.1 DFH
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`markets, advertises, offers for sale, and sells the Accused Products under the name CoQnol.
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`18. Defendant ARN has induced the direct infringement of DFH by designing and
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`developing the DuoQuinol product and providing DFH with the information required to produce
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`DuoQuinol on a commercial scale. Upon information and belief, Ashley-Martin Manufacturing,
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`the DFH manufacturing unit, does not have the experience to design and develop a new type of
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`Ubiquinol like the DuoQuinol product. A review of the employees at Ashley-Martin
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`Manufacturing on Linked In shows a number of employees with manufacturing and production
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`experience, but none with a research background. In contrast, Dr. Tan has a PhD in
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`Chemistry/Biochemistry, and the ARN website states that Dr. Tan’s mission “is to deliver the
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`highest quality nutritional products based on sound scientific research.” Dr. Tan is also very
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`familiar with Kaneka Corporation. In the 2015-2016 time period, Kaneka Corporation entered
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`into business discussions with ARN. During those discussions Dr. Tan acknowledged that he
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`knew Kaneka very well and followed the company closely. Dr. Tan also acknowledged that he
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`had followed the science and chemistry of CoQ10 all of his life. ARN is also very familiar with
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`the world of patents and patent litigation, as ARN has over 13 issued patents and pending patent
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`applications, and ARN is currently the plaintiff in a patent infringement case in the Central
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`District of California. Accordingly, upon information and belief, ARN had the expertise to
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`design and develop a new form of Ubiquinol, and to provide that information to DFH. As Dr.
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`1 Upon information and belief, the manufacturing unit of DFH goes by the name of Ashley-Martin
`Manufacturing. Ashley-Martin Manufacturing LLC was initially formed in Delaware on
`November 6, 2006. On March 31, 2015, Ashley-Martin Manufacturing LLC merged with DFH,
`with DFH continuing as the surviving company.
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 6 of 12 PageID #: 6
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`Tan followed the science and chemistry of CoQ10 all of his life ARN also had to know that
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`Kaneka Corporation was the only company producing Ubiquinol. Also based on ARN’s
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`experience with patents and patent litigation, ARN had to know that Kaneka had a number of
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`patents covering Ubiquinol. Therefore, when ARN provided information to DFH on how to
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`produce DuoQuinol, it intentionally aided and encouraged DFH to directly infringe Kaneka
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`Corporation’s Ubiquinol patents, and thereby induced the direct infringement of DFH.
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`Alternatively, if ARN did not take steps to investigate the patents held by Kaneka covering
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`Ubiquinol products, it was unquestionably willfully blind in failing to conduct that investigation.
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`19. The Defendants have either induced infringement or infringed directly one or more
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`claims of the Asserted Patents and continue to infringe (literally and under the doctrine of
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`equivalents), directly, indirectly, and/or through agents or intermediaries by making, using,
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`offering for sale and/or selling the Accused Product in the United States.
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`20. The DFH customers (including distributors and retailers) have infringed and/or
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`continue to infringe (literally and under the doctrine of equivalents) directly, indirectly, and/or
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`through agents or intermediaries, one or more claims of the Asserted Patents by using, offering
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`for sale, and/or selling the Accused Product in the United States.
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`21. The DFH infringement has caused, is causing, and will continue to cause Kaneka
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`to suffer damage, and Kaneka is entitled to recover damages in an amount proven at trial, but no
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`less than a reasonable royalty as provided by 35 U.S.C. § 284.
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 7 of 12 PageID #: 7
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`COUNT I
`(Direct Infringement of the ’044 Patent by DFH)
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`22. Kaneka incorporates each of the preceding paragraphs as if fully set forth herein.
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`23. DFH has been and is now directly infringing claims 1 and 13 of the ’044 Patent,
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`either literally or under the doctrine of equivalents, in violation of 35 U.S.C. § 271(a) by making,
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`using, offering for sale, and/or selling in the United States the Accused Products that infringe the
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`claims of the ’044 Patent.
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`24. By way of example, claim 13 of the ’044 Patent reads as follows:
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`“13). A reduced coenzyme Q10 crystal with a reduced coenzyme Q10 /oxidized
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`coenzyme Q10 weight ratio of not lower 96/4”.
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`25. Exhibit D shows the tests done by Kaneka on the reduced Q10 ratio in the CoQnol
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`capsules produced and sold by DFH. Exhibit D includes three separate reports labeled Analysis
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`Report 1, Analysis Report 2 and Analysis Report 3. Table 1 in Report 1 shows that the reduced
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`Q10 ratio was 99.7, more than the claimed requirement of not lower than 96/4. Reports 2 and 3
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`show that the reduced Q10 found in the CoQnol capsule is crystalized. DFH thereby directly
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`infringes claim 13 of the ’044 Patent.
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`26. DFH’s direct infringement of Claims 1 and 13 of the ’044 Patent is further detailed
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`in the claim charts attached as Exhibit E.
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`27. DFH has been, and is now, indirectly infringing the ’044 Patent in violation of 35
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`U.S.C. § 271(b) by actively inducing the direct infringement of the ’044 Patent by their
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`distributors, retailers and customers, including at least by making, using, offering for sale and/or
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`selling the Accused Products in the United States.
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 8 of 12 PageID #: 8
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`28. As a consequence of DFH’s infringement of the ‘044 Patent, Kaneka has suffered,
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`is suffering, and will continue to suffer, damages in an amount not yet determined, but no less than
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`a reasonable royalty.
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` COUNT II
` (Direct Infringement of the ’080 Patent by DFH)
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`29. Kaneka incorporates each of the preceding paragraphs as if fully set forth herein.
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`30. DFH has been, and is now, directly infringing claims 1, 5 and 15 of the ’080 Patent,
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`either literally or under the doctrine of equivalents, in violation of 35 U.S.C. § 271(a) by making,
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`using, offering for sale, and/or selling in the United States the Accused Products that infringe the
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`claims of the ’080 Patent.
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`31. By way of example, claim 5 of the ’080 Patent reads or follows;
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`“5) A reduced coenzyme Q10-containing composition, comprising reduced
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`coenzyme Q10 and one or both of (a) and (b): (a) not less than 1.5 wt % to not more
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`than 99 wt % of reduced coenzyme Q9 relative to reduced coenzyme Q10, and (b)
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`reduced coenzyme Q11, wherein not less than 0.01 wt % of reduced coenzyme Q10
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`is contained in the composition, and wherein the proportion of reduced coenzyme
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`Q10 relative to the total amount of coenzyme Q10 is not less than 90 wt %.”
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`32. DFH produces and sells DuoQuinol/CoQnol which is reduced coenzyme Q10.
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`Exhibit D, Report 1, are Kaneka’s test results on CoQnol capsules produced and sold by DFH.
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`The tests show in Table 1 that the proportion of reduced coenzyme Q10, relative to the total amount
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`of coenzyme Q10 was 99.7% and Table 2 shows that 88ug of Q11 was present in the CoQnol
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`capsule. Accordingly, DFH directly infringes claim 5 of the ’080 Patent. For the same reasons,
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`DFH also directly infringes at least claims 1 and 15 of the ’080 Patent.
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`-8-
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 9 of 12 PageID #: 9
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`33.
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`DFH’s infringement of Claims 1, 5, and 15 of the ’080 Patent is further detailed in
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`Exhibit E.
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`34.
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`DFH has been, and is now, indirectly infringing the ’080 Patent in violation of
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`§ 271(b) by actively inducing the direct infringement of the ’080 Patent by their distributors,
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`retailers and customers, including at least by making, using, offering for sale, and/or selling the
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`Accused Products.
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`35.
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`As a consequence of DFH’s infringement of the ’044 Patent, Kaneka has suffered,
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`is suffering, and will continue to suffer, damages in an amount not yet determined, but no less than
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`a reasonable royalty
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`COUNT III
`(Induced Infringement by ARN of the ’046 and ’080 Patents)
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`36. Kaneka incorporates each of the proceeding paragraphs as if fully set forth herein.
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`37. Upon information and belief, ARN has been, and currently is, inducing
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`infringement of the ’044 and ’080 Patents in violation of 35 USC § 271(b) by knowingly
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`encouraging and aiding DFH to make, use, sell or offer to sell the Accused Products in the United
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`States which directly infringes the ’044 and ’080 Patents.
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`38. The Supreme Court in Global-Tech Appliances Inc. v SEB S.A., 563 U.S. 754
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`(2011) held that induced infringement under 271(b) requires knowledge that the induced acts
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`constitute patent infringement, but also held that the required knowledge could be shown under
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`the doctrine of “willful blindness.” The Supreme Court found two basic requirements to show
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`“willful blindness:” (1) the defendant must subjectively believe that there is a high probability
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`that a fact exists and (2) the defendant must take deliberate actions to avoid learning of that fact.
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`The Supreme Court specifically said that “[u]nder this formulation a willfully blind defendant is
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 10 of 12 PageID #: 10
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`one who takes deliberate actions to avoid conforming a high probability of wrongdoing and can
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`almost be said to have actually known the critical facts.” The critical fact here is whether Dr. Tan
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`believed there was a high probability that Kaneka had patents covering the production of
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`Ubiquinol.
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`39. As set forth above, during the 2015-2016 business discussions Dr. Tan revealed
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`that he was well aware of Kaneka and Kaneka’s products, including Ubiquinol and we quote; “I
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`know of Kaneka, I know them very well and I follow the company closely.” “They provide high
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`quality ingredients and they are a market leader.” “I am intrigued by Kaneka, I have been
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`following the science and chemistry of CoQ10 all of my life and it is a passion of mine.” “I told
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`Mr. (Kaneka employee name deleted) about my interests in CoQ10 and how I see CoQ10 and QH
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`as good complementary products for (product name deleted).” To be clear QH is another name
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`for Ubiquinol. Obviously Dr. Tan was very familiar with Kaneka, Kaneka’s CoQ10 products,
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`including Ubiquinol, and certainly had to know that Kaneka was the only company with the right
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`to sell Ubiquinol in the United States due to Kaneka’s patents covering Ubiquinol. Dr. Tan was
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`also well aware of the value of patent protection as ARN is currently asserting an ARN patent in
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`the Central District of California and ARN has been granted a number of U.S. patents. With this
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`knowledge, ARN proceeded to aide and encourage DFH to produce the Ubiquinol Accused
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`Products in the United States in a manner that ARN knew, or should have known, but for willful
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`blindness, that the Ubiquinol Accused Products would infringe, or have a high probability of
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`infringing one or more of Kaneka’s patents, which cover the production of Ubiquinol. Kaneka
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`therefore alleges that ARN has been, and currently is, inducing the direct infringement of the ’044
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`and ’080 Patents by DFH.
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`-10-
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 11 of 12 PageID #: 11
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`40. As a consequence of ARN inducing infringement of the ’044 and ’080 Patents,
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`Kaneka has suffered, is suffering, and will continue to suffer, damages in an amount not yet
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`determined, but no less than a reasonable royalty
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`PRAYER FOR RELIEF
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`WHEREFORE, Kaneka requests the following relief:
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`a)
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`b)
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`A judgment that DFH has directly infringed the ’044 and ’080 Patents;
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`A judgment that ARN has induced direct infringement of the ’044 and ’080
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`Patents;
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`c)
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`Damages adequate to compensate for Defendants infringement but, in no
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`d)
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`e)
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`event, less than a reasonable royalty on past and future infringing sales;
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`An award of Kaneka’s costs and expenses in this action,
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`Entry of a preliminary and permanent injunction, pursuant to 35 U.S.C.
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`§ 283 enjoining each of the Defendants, and all of their respective agents,
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`servants, officers, directors, employees, and all other persons acting in
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`concert with them, directly or indirectly, from any further acts of
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`infringement.
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`Such further and other relief as this Court may deem just and
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`DEMAND FOR A JURY TRIAL
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`Pursuant to Rule 38 of the Federal Rules of Civil Procedure, Kaneka demands a trial by
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`jury on all issues triable as of right by a jury proper.
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`-11-
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`Case 1:21-cv-00209-UNA Document 1 Filed 02/16/21 Page 12 of 12 PageID #: 12
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`BAYARD, P.A.
`
`/s/ Stephen B. Brauerman
`Stephen B. Brauerman (#4952)
`Ronald P. Golden III (#6254)
`600 N. King Street, Suite 400
`Wilmington, DE 19899
`Tel: (302) 655-5000
`sbrauerman@bayardlaw.com
`rgolden@bayardlaw.com
`
`By:
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`Date: February 16, 2021
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`OF COUNSEL
`Keith D. Nowak
`William F. Sondericker
`Gerald W. Griffin
`CARTER LEDYARD & MILBURN, LLP
`Two Wall Street
`New York, New York 10005
`212-238-8610
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`
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`-12-
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