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Leda Dunn Wettre 

lwettre@rwmlegal.com 

ROBINSON, WETTRE & MILLER LLC 

One Newark Center 

19th Floor 

Newark, NJ 07102 

973-690-5400 

Attorneys for Plaintiff 

Braintree Laboratories, Inc. 

OF COUNSEL: 

John J. Regan 

Anna E. Lumelsky 

WILMER CUTLER PICKERING 

HALE AND DORR LLP 

60 State Street 

Boston, MA 02109 

617-526-6000 

UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY 

BRAINTREE LABORATORIES, INC., 

Plaintiff, 

v. 

NOVEL LABORATORIES, INC., 

Defendant. 

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Civil Action No. _____________ 

COMPLAINT FOR PATENT 

INFRINGEMENT 

JURY TRIAL REQUESTED 

Plaintiff Braintree Laboratories, Inc. (“Braintree”) hereby alleges as follows: 

NATURE OF THE ACTION

This is an action for patent infringement of U.S. Patent No. 6,946,149, as 

reexamined (“the ’149 patent”), arising under the patent laws of the United States, Title 35, 

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United States Code, 35 U.S.C. §§ 271 and 281. This action relates to Abbreviated New Drug 

Application (“ANDA”) No. 202511, filed by Novel Laboratories, Inc. with the U.S. Food and 

Drug Administration (“FDA”) seeking approval to market a generic version of Braintree’s 

SUPREP® drug product. 

PARTIES

1. Braintree is a corporation organized and existing under the laws of the 

State of Massachusetts, with its principal place of business at 60 Columbian Street West, 

Braintree, MA 02185-0929. 

2. Upon information and belief, Novel Laboratories, Inc. (“Novel”) is a 

corporation organized and existing under the laws of the State of Delaware, having a principal 

place of business at 400 Campus Drive, Somerset, NJ 08873. According to its website 

(www.novellabs.net), Novel is a “full-service pharmaceutical company that develops, 

manufactures, markets and distributes difficult to develop, technology-driven specialty generics 

for the US and European markets.” 

3. Upon information and belief, following any FDA approval of ANDA No. 

202511, Novel will make, use, offer to sell, and/or sell the generic products that are the subject 

of ANDA No. 202511 throughout the United States, and/or import such generic products into the 

United States. 

JURISDICTION AND VENUE

4. This action arises under the patent laws of the United States, 35 U.S.C. 

§§ 100, et seq, and this Court has jurisdiction over the subject matter of this action under 28 

U.S.C. §§ 1331 and 1338(a). Venue is proper in this Court under 28 U.S.C. §§ 1391 and 

1400(b). 

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5. Based on the facts and causes alleged herein, and for additional reasons to 

be further developed through discovery, this Court has personal jurisdiction over Novel. 

6. This Court has personal jurisdiction over Novel because the company has 

a principal place of business in New Jersey. 

7. In addition, this Court has personal jurisdiction over Novel because, upon 

information and belief, Novel regularly does business in New Jersey and has engaged in a 

persistent course of conduct within New Jersey, both directly and through its affiliate, GAVIS 

Pharmaceuticals, by continuously and systematically placing goods into the stream of commerce 

for distribution throughout the United States, including New Jersey, and/or by directly selling 

pharmaceutical products in New Jersey. On its website, Novel states that GAVIS 

Pharmaceuticals consistently launches Novel products and “sells, markets, and distributes 

medicine to all major customers in the United States.” 

8. In addition, Novel has previously submitted to the jurisdiction of this 

Court and has previously availed itself of this Court by asserting counterclaims in other civil 

actions initiated in this jurisdiction. For example, Novel sought a declaratory judgment of 

invalidity and noninfringement in Salix Pharmaceuticals, Inc. v. Novel Laboratories, Inc. et al., 

No. 3:08-cv-04628-FLW-LHG (D.N.J.) and Salix Pharmaceuticals, Inc. et al. v. Novel 

Laboratories, Inc., No. 3:08-cv-02311-FLW-TJB (D.N.J.). 

BACKGROUND

9. Braintree holds approved New Drug Application (“NDA”) No. 22372 for 

SUPREP® Bowel Prep Kit (“SUPREP®”). SUPREP® is a sodium sulfate, potassium sulfate and 

magnesium sulfate osmotic laxative and was approved by the FDA on August 5, 2010. 

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SUPREP® is indicated for bowel cleansing prior to an adult patient having a colonoscopy 

procedure. 

10. Pursuant to 21 U.S.C. § 355 (b)(i) and attendant FDA regulations, the ’149 

patent has been listed in connection with SUPREP® in the FDA’s publication, Approved Drug 

Products with Therapeutic Equivalence Evaluations, which is referred to as the “Orange Book.” 

SUPREP®, or its use or formulation, is covered by one or more claims of the ’149 patent. 

THE ‘149 PATENT

11. Braintree is the lawful owner by assignment of the ’149 patent, entitled 

“Salt Solution for Colon Cleansing,” duly and legally issued by the U.S. Patent and Trademark 

Office on September 20, 2005. The ‘149 patent was the subject of an ex parte reexamination 

procedure that was requested on October 15, 2008. A reexamination certificate was issued by 

the U.S. Patent and Trademark Office on June 30, 2009. As a result of the reexamination, it was 

determined that claims 1, 6, 8-9, 13-14, 17 and 21 were cancelled, claims 2-4, 7, 10, 15 and 18 

were determined to be patentable as amended, and claims 5, 11-12, 16, 19-20 and 22-23, each 

dependent on an amended claim, were also determined to be patentable. A true and correct copy 

of the ’149 patent and its reexamination certificate are attached hereto as Exhibit A. The claims 

of the ’149 patent are valid and enforceable. 

12. The ‘149 patent, inter alia, claims a composition and a method for use of 

the composition to cleanse the colon. 

13. The ‘149 patent expires on March 7, 2023, which includes the associated 

patent term adjustment. 

14. Braintree, as the owner of the entire right, title and interest in the ‘149 

patent, possesses the right to sue for infringement of the ‘149 patent. 

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INFRINGEMENT BY NOVEL

15. By letter dated January 25, 2011 (“Novel Notice Letter”), Novel notified 

Braintree that Novel had submitted ANDA No. 202511 to the FDA under Section 505(j) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)) seeking approval to engage in the 

commercial manufacture, use, or sale and/or importation of the sodium sulfate, potassium sulfate 

and magnesium sulfate oral lavage solution currently listed in the Orange Book for SUPREP®, 

prior to the expiration of the ’149 patent. 

16. By filing ANDA No. 202511, Novel has represented to the FDA that the 

components of its proposed generic sodium sulfate, potassium sulfate and magnesium sulfate 

oral solution, 17.5g/3.13g/1.6g per bottle, have the same active ingredients as those of the 

corresponding components of SUPREP®, have the same route of administration, dosage form, 

and strengths as the corresponding components of SUPREP®, and are bioequivalent to the 

corresponding components of SUPREP®. 

17. Novel has committed an act of infringement pursuant to 35 U.S.C. 

§ 271(e)(2) by filing ANDA No. 202511 under 21 U.S.C. § 355(j) seeking approval to engage in 

the commercial manufacture, use and/or sale of generic sodium sulfate, potassium sulfate, 

magnesium sulfate oral lavage solution before the expiration of the ’149 patent. 

18. Braintree is entitled under 35 U.S.C. § 271(e)(4) to full relief from 

Novel’s acts of infringement, including an Order by this Court ensuring that the effective date of 

any approval of ANDA No. 202511, relating to Novel’s proposed generic oral lavage solution, 

shall not be earlier than the expiration of the exclusivity afforded the ‘149 patent. 

19. This Complaint is being filed before the expiration of the forty-five day 

period from the day after Braintree received the Novel Notice Letter. 

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COUNT I (INFRINGEMENT OF THE ’149 PATENT BY NOVEL)

20. Each of the preceding paragraphs 1 through 19 is incorporated as if fully 

set forth. 

21. Novel’s submission of ANDA No. 202511 to obtain approval to engage in 

the commercial manufacture, use, offer to sell, or sale of sodium sulfate, potassium sulfate and 

magnesium sulfate oral solution prior to the expiration of the ’149 patent constitutes 

infringement of one or more of the claims of the ’149 patent under 35 U.S.C. § 271(e)(2)(A). 

22. Upon information and belief, Novel had actual and constructive 

knowledge of the ’149 patent prior to filing ANDA No. 202511 and was aware that the filing of 

its ANDA with the FDA constituted an act of infringement of the ’149 patent. 

23. Upon information and belief, use of generic sodium sulfate, potassium 

sulfate and magnesium sulfate oral solution in accordance with and as directed by the proposed 

labeling in ANDA No. 202511 for that product would infringe one or more claims of the ’149 

patent. 

24. Upon information and belief, Novel knows that its generic sodium sulfate, 

potassium sulfate and magnesium sulfate oral solution and the proposed labeling for that product 

are especially made or adapted for use in infringing the ’149 patent, and that the generic sodium 

sulfate, potassium sulfate and magnesium sulfate oral solution and the proposed labeling are not 

suitable for substantial noninfringing use. Upon information and belief, Novel plans and intends 

to, and will, induce and/or contribute to the infringement of the ’149 patent immediately and 

imminently upon approval of ANDA No. 202511. 

25. Upon FDA approval of Novel’s ANDA No. 202511, Novel will infringe 

the ’149 patent by making, using, offering to sell, and selling generic sodium sulfate, potassium 

sulfate and magnesium sulfate oral solution in the United States and/or importing such solution 

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into the United States, and by actively inducing and contributing to infringement by others, in 

violation of 35 U.S.C. § 271(a)-(c), unless enjoined by the Court. 

26. If infringement of the ’149 patent by Novel is not enjoined, Plaintiff will 

suffer substantial and irreparable harm for which there is no remedy at law. 

PRAYER FOR RELIEF

WHEREFORE, Plaintiff prays that this Court grant the following relief: 

1. A judgment that one or more claims of the ’149 patent are infringed by 

Novel’s submission of ANDA No. 202511, and that the making, using, offering to sell, or selling 

in the United States, or importing into the United States, of generic sodium sulfate, potassium 

sulfate and magnesium sulfate oral solution by Novel will infringe, actively induce infringement, 

and/or contribute to the infringement of the ’149 patent; 

2. An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective 

date of any approval of ANDA No. 202511 shall be a date which is not earlier than the 

expiration date of the ’149 patent, including any extensions and/or additional periods of 

exclusivity to which Plaintiff is or becomes entitled; 

3. An order permanently enjoining Novel, its affiliates, subsidiaries, and each 

of its officers, agents, servants and employees and those acting in privity or concert with it, from 

making, using, offering to sell, or selling in the United States, or importing into the United 

States, generic sodium sulfate, potassium sulfate and magnesium sulfate oral solution until after 

the expiration date of the ’149 patent, including any extensions and/or additional periods of 

exclusivity to which Plaintiff is or becomes entitled; 

4. Such further and other relief as this Court deems proper and just, including 

any appropriate relief under Title 35 and costs of this litigation. 

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JURY DEMAND

Plaintiff demands a trial by jury on all issues for which a right to a jury trial may exist. 

OF COUNSEL: 

John J. Regan 

Anna E. Lumelsky 

WILMER CUTLER PICKERING 

HALE AND DORR LLP 

60 State Street 

Boston, MA 02109 

617-526-6000 

Dated: March 9, 2011 

/s/ Leda Dunn Wettre 

Leda Dunn Wettre 

lwettre@rwmlegal.com 

ROBINSON, WETTRE & MILLER LLC 

One Newark Center 

19th Floor 

Newark, NJ 07102 

973-690-5400 

Attorneys for Plaintiff 

Braintree Laboratories, Inc. 

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CERTIFICATION PURSUANT TO L. CIV. R. 11.2

I hereby certify that the matter in controversy is not the subject of any other action 

pending in any court, or of any pending arbitration or administrative proceeding. 

OF COUNSEL: 

John J. Regan 

Anna E. Lumelsky 

WILMER CUTLER PICKERING 

HALE AND DORR LLP 

60 State Street 

Boston, MA 02109 

617-526-6000 

Dated: March 9, 2011 

/s/ Leda Dunn Wettre 

Leda Dunn Wettre 

lwettre@rwmlegal.com 

ROBINSON, WETTRE & MILLER LLC 

One Newark Center 

19th Floor 

Newark, NJ 07102 

973-690-5400 

Attorneys for Plaintiff 

Braintree Laboratories, Inc. 

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