Loly G. Tor K&L GATES LLP One Newark Center, 10th Fl.

Newark, NJ 07102 P: 973-848-4034 F: 973-848-4001 loly.tor@klgates.com Attorneys for Plaintiffs UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

NESTLÉ HEALTH SCIENCE S.A., and CM&D PHARMA LIMITED, Plaintiffs, v. MASTIX MEDICA, LLC, Defendant.

Civil Action No.: __________ COMPLAINT JURY TRIAL DEMANDED

Plaintiffs Nestlé Health Science S.A. (“Nestlé”) and CM&D Pharma Limited (“CM&D”) by and through their attorneys, K&L Gates LLP, bring this action against Defendant Mastix Medica, LLC (“Mastix”) to obtain preliminary and permanent injunctive relief, actual damages, treble damages, attorneys’ fees, and costs for Mastix’s willful patent infringement. NATURE OF THE ACTION 1. This is an action arising under the patent laws of the United States, 35 U.S.C. §§ 1

et seq., and is brought by Plaintiffs against Mastix for Mastix’s infringement of U.S. Patent No. 7,815,898 (“‘898 Patent”) (the “Patent in Suit”). THE PARTIES 1. Nestlé is a Swiss corporation with a principal place of business in the United

States at 12 Vreeland Road, Florham Park, New Jersey, 07932.

2. England. 3. 4.

CM&D is a British corporation with a principal place of business in London,

CM&D is a wholly-owned subsidiary of Nestlé. On information and belief, Mastix is a Maryland limited liability corporation with

a principal place of business at 10711 Gilroy Road, Hunt Valley, Maryland 20131. JURISDICTION AND VENUE 5. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and

1338(a) because this action arises under the patent laws of the United States. 6. This Court has general and specific personal jurisdiction over Mastix. Mastix has

continuous and systematic contacts in New Jersey by way of Mastix’s advertisement and promotion of its products and services, sales of Mastix products and services, distribution of Mastix products, and services rendered in New Jersey. 7. Mastix has committed acts of infringement, including acts that constitute induced

infringement or contributory infringement, in this Judicial District. Specifically, RenaGum, identified and discussed below, is offered for sale and sold by Mastix and used by Mastix and its customers and end users throughout this District. 8. Venue is proper in this Court under 28 U.S.C. § 1391(b) and 1400(b). NESTLÉ’S INTERACTIONS WITH MASTIX 9. At some time prior to July 17, 2013, Mastix became aware of the ‘898 Patent,

which is assigned to CM&D. 10. At some time prior to July 17, 2013, Mastix became aware that Nestlé is the

corporate parent of CM&D.

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11.

At some time prior to July 17, 2013, Mastix engaged its attorney, Royal W. Craig

at the law firm of Ober, Kaler, Grimes & Shriver, P.C. in Baltimore, Maryland, to analyze the ‘898 Patent. 12. On or prior to July 17, 2013, Mr. Craig drafted a letter to Nestlé on behalf of

Mastix. Mr. Craig sent that letter to Nestlé on July 17, 2013. 13. In the July 17, 2013 letter, Mr. Craig informed Nestlé that Mastix “intends to

begin sales of a chewing gum in the United States comprising an effective amount of chitosan for treating hypophosphatemia.” 14. The July 17, 2013 letter further asserted that “to specifically avoid infringement

of [the ‘898 Patent], our client’s gum will be packaged with explicit instructions to chew after a meal, not on an empty stomach.” 15. The July 17, 2013 letter further requested that Nestlé “expeditiously determine

whether or not you have any intention to assert the patent against our client” and to “state a nonfrivolous infringement basis in sufficient detail to inform our decision.” 16. The July 17, 2013 letter gave Nestlé an August 1, 2013 date by which to respond,

absent which Mr. Craig stated that “we shall advise our client to commence sales.” 17. On July 25, 2013, Nestlé responded to Mastix’s July 17, 2013 letter with a letter

requesting additional information to enable Nestlé to fully assess whether Mastix’s contemplated sales would be in violation of the ‘898 Patent. 18. 19. RenaGum. Mastix did not respond to Nestlé’s July 25, 2013 letter. Instead, at least as early as August 8, 2013, Mastix announced the availability of

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20.

Surprised that Mastix had decided to proceed with the launch of RenaGum despite

Nestlé’s request for additional information, Nestlé, by outside counsel, sent a letter to Mastix, via its outside counsel, on August 19, 2013. 21. In the August 19, 2013 letter, Nestlé’s outside counsel informed Mastix that

Mastix’s actions, including its sales, promotion, and instructions regarding RenaGum, induce users of RenaGum to directly infringe the ‘898 Patent by instructing users to use RenaGum in an infringing manner. 22. Nestlé’s August 19, 2013 letter also requested that Mastix terminate its infringing

acts, and to confirm that Mastix had terminated its infringing acts. 23. As of the filing of this Complaint, Mastix has not informed Nestlé that it has

terminated its infringing sales. MASTIX’S PROMOTION OF RENAGUM 24. with chitosan. 25. Mastix promotes RenaGum by stating that it is a sugar-free gum that is chewed According to Mastix, RenaGum is a pleasant tasting chewing gum formulated

for 15 minutes after a meal. 26. According to Mastix, RenaGum “is for use as an integral component of the

clinical management of kidney (renal) disease.” 27. According to Mastix, RenaGum is not meant to replace generic phosphate binding

drugs, which are generally taken with meals, but to complement them. 28. According to Mastix, when RenaGum is chewed, “the chitosan combines with

phosphate found in saliva and then in the digestive tract after the saliva is swallowed.”

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29.

According to Mastix, RenaGum is designed as a chewing gum as opposed to a

pill, meaning it does not add to the heavy pill burden patients already take with their meals. 30. Mastix applies a label to RenaGum instructing the user to “Chew one piece after a

meal, not on an empty stomach. Chew one piece for 15 minutes and then discard.” FIRST CLAIM: INFRINGEMENT OF U.S. PATENT NO. 7,815,898 31. herein. 32. On October 19, 2010, the United States Patent and Trademark Office duly and Plaintiffs incorporate Paragraphs 1 through 31 of its Complaint as if fully set forth

legally issued the ‘898 Patent, entitled “Oral Compositions for Absorption of Phosphorous Compounds.” A copy of the ‘898 Patent is attached as Exhibit A. 33. 34. CM&D is the owner, by assignment, of the ‘898 Patent. Mastix has infringed and is infringing, directly or indirectly, literally or under the

doctrine of equivalents, the ‘898 Patent by making, using, offering to sell, and/or selling within the United States, and/or importing into the United States, without authority, RenaGum. 35. ‘898 Patent. 36. In addition to directly infringing the ‘898 Patent, Mastix, with knowledge of the Use of RenaGum as directed by Mastix infringes at least Claims 1 and 11 of the

‘898 Patent and with knowledge that the acts of users of RenaGum constitute infringement of the ‘898 Patent, has indirectly infringed at least Claims 1 and 11 by actively inducing its customers and end users to practice the methods of Claims 1 and 11. 37. Mastix is also liable for contributory infringement because use of RenaGum by

end users constitutes direct infringement, and because RenaGum has no substantial noninfringing uses.

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38. 39.

Mastix was aware of the ‘898 Patent prior to July 17, 2013. Mastix was aware of its infringement of the ‘898 Patent prior to instructing its

counsel to send the July 17, 2013 letter to Nestlé. 40. Mastix was also aware that its promotional activities induced its end users to

infringe the ‘898 Patent at least as early as August 8, 2013, when it announced the availability of RenaGum. 41. Mastix was made further aware that its acts constituted induced infringement of

the ‘898 Patent by Nestlé’s counsel’s August 19, 2013 letter. 42. Patent. 43. Mastix induces its customers’ direct infringement of the ‘898 Patent by advising Mastix is currently aware that its acts constitute induced infringement of the ‘898

users of RenaGum that RenaGum is designed to complement generic phosphate binding drugs which are generally taken with meals. 44. Mastix further induces its customers’ direct infringement of the ‘898 Patent by

advising users of RenaGum that the chitosan combines with phosphate found in saliva and then the digestive tract after the saliva is swallowed, which supports using RenaGum separate from meals. 45. Mastix further induces its customers’ direct infringement of the ‘898 Patent by

marketing RenaGum as a chewing gum, which by definition cannot be taken with meals. 46. Mastix further induces its customers’ direct infringement of the ‘898 Patent by

instructing end users to chew RenaGum after a meal. 47. Accordingly, Mastix knows that RenaGum is especially made for use in

infringing at least Claims 1 and 11 of the ‘898 Patent.

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48. 49. ‘898 Patent. 50.

RenaGum is not a staple article of commerce. RenaGum is not suitable for substantial non-infringing uses with regard to the

Plaintiffs have been and continue to be damaged by Mastix’s infringement of the

‘898 Patent, in an amount to be determined at trial. 51. Plaintiffs have suffered irreparable injury for which there is no adequate remedy

at law and will continue to suffer such irreparable injury unless Mastix’s infringement of the ‘898 Patent is preliminarily and permanently enjoined by this Court. 52. 53. Mastix’s infringement of the ‘898 Patent is, and has been, willful. Mastix’s infringement of the ‘898 Patent is exceptional, and thus, pursuant to 35

U.S.C. §285, entitles Plaintiffs to their reasonable attorneys’ fees and costs incurred in prosecuting this action. RELIEF REQUESTED WHEREFORE, Plaintiffs pray for the following judgment and relief against Mastix: A. B. That Mastix has infringed the Patent in Suit; That Mastix, its officers, agents, and employees, and those persons in active

concert or participation with any of them, and their successors and assigns be preliminarily and permanently enjoined from infringement of the Patent in Suit, including by a preliminary and permanent injunction against making, using, offering to sell, and selling within the United States, importing into the United States, and instructing users to use any products in such a way as would be covered by the Patent in Suit; C. That Plaintiffs be awarded all damages adequate to compensate them for Mastix’s

infringement of the Patent in Suit, such damages to be determined by a jury, and if necessary to

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adequately compensate Plaintiffs for the infringement, an accounting and treble damages as a result of Mastix’s willful infringement; D. That Plaintiffs be awarded pre-judgment and post-judgment interest at the

maximum rate allowed by law; E. That this case be declared an exceptional case within the meaning of 35 U.S.C.

§285 and that Plaintiffs be awarded their reasonable attorney fees, expenses, and costs incurred in connection with this action; and F. and proper. JURY DEMAND Plaintiffs hereby demand a trial by jury on all issues so triable. Dated: August 23, 2013 Respectfully submitted, /s/ Loly G. Tor Loly G. Tor K&L GATES LLP One Newark Center, 10th Fl. Newark, NJ 07102 P: 973-848-4034 F: 973-848-4001 loly.tor@klgates.com Of Counsel: Robert M. Barrett Jason A. Engel Benjamin E. Weed K&L GATES LLP 70 W. Madison St., Suite 3100 Chicago, IL 60602 P: 312-372-1121 F: 312-827-8000 robert.barrett@klgates.com jason.engel@klgates.com benjamin.weed@klgates.com That Plaintiffs be awarded such other and further relief as this Court deems just

ATTORNEYS FOR PLAINTIFFS NESTLÉ HEALTH SCIENCE S.A. AND CM&D PHARMA LIMITED -8-

LOCAL RULE 11.2 CERTIFICATION I hereby certify that the matter in controversy in this action is not the subject of any other action pending in any Court or of any pending arbitration or administrative proceeding.

/s/ Loly G. Tor

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