1 

NOT FOR PUBLICATION 

UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY

BRAINTREE LABORATORIES, INC., 

 Plaintiff, 

v. 

NOVEL LABORATORIES, INC., 

 Defendant. 

Civil Action No. 11-1341 (PGS) 

OPINION

SHERIDAN, U.S.D.J. 

 

This matter comes before the Court upon six motions. Plaintiff Braintree Laboratories, 

Inc., (Braintree) brings two motions: (1) Motion for Summary Judgment on Defendant’s Third, 

Fourth, and Fifth Counterclaims (ECF No. 141), which seeks summary judgment on Defendant’s 

false marking and unfair competition counterclaims; and (2) Motion for Summary Judgment 

(Partial) of Infringement (ECF No. 143), which seeks summary judgment on the issues of literal, 

contributory, and induced infringement. Defendant Novel Laboratories, Inc., (Novel) brings four 

motions: (1) Motion for Summary Judgment of Non-Infringement (ECF No. 159); (2) Motion for 

Summary Judgment No. 4 (ECF No. 149), which argues that the patent in suit is invalid for 

obviousness; (3) Motion to Strike and Preclude Braintree’s “A Patient” Infringement Theory and 

the Adams Declaration (ECF No. 183); and (4) Motion Pursuant to Rule 56(e)(2) (ECF No. 198), 

which asks for the Court to deem certain facts undisputed. Oral argument was heard on 

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December 20, 2012. After considering the submissions of the parties, the decision of this Court 

is set forth for the reasons expressed below. 

This memorandum is divided into three sections. Section I lists the material facts, 

including the background of the SUPREP product at issue in the case, and the background of 

Novel’s proposed generic copy of the SUPREP product. Section II sets forth the legal standard 

on summary judgment. Section III contains the Court’s analysis of the issues raised in the 

motions. 

I 

 As most middle-aged adults know, there are few things worse than preparing for a 

colonoscopy. In order for the physician to view the colon clearly, it must be cleansed. The 

preparation for a colonoscopy includes in-taking large volumes of liquids which cause diarrhea 

and clear the colon. Since most patients dislike the taste and the large quantity of the solution 

imbibed, there was significant non-compliance with the preparation protocol. Due to the noncompliance, doctors often found that the colon was not clear enough to successfully perform the 

colonoscopy. 

At the end of the nineties, a Phospho-soda solution was invented which substantially 

reduced the quantity of solution necessary to prepare the colon. Unfortunately, this product 

caused electrolyte shifts which resulted in unexpected dangerous side effects, including heart and 

kidney failure, as well as death in certain cases. In the early 2000’s, due to the dangerous side 

effects, it was apparent that a new preparatory product was needed. 

At that time, inventors Cleveland and Fordtran designed a reduced volume colonic 

purgative formulation called SUPREP Bowel Prep Kit (SUPREP) that avoids the dangerous side 

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effects and electrolyte imbalances. On September 20, 2005, the inventors were granted U.S. 

Patent No. 6,946,149 (‘149 Patent), which was assigned to Braintree. 

 Thereafter, Braintree filed a New Drug Application (NDA) with the United States Food 

and Drug Administration (FDA), and due to the improprieties of the previous purgative, 

SUPREP was subject to intense scrutiny by the FDA. Through the clinical trials, the FDA 

sought to review the adequacy of the data to support the safety of the new product because of 

serious safety concerns with a previous laxative used to prepare patients for colonoscopies – 

Fleet’s Phospho-soda product. 

 During the clinical testing period, Braintree filed for re-examination of the ‘149 Patent 

with the United States Patent and Trademark Office (PTO) in order to clarify its claims. On June 

30, 2009, the PTO issued a reexamination certificate amending the claims. 

 On August 5, 2010, the FDA approved Braintree’s NDA No. 22372 for SUPREP. 

SUPREP is listed by the FDA in the agency’s publication Approved Drug Products with 

Therapeutic Equivalence Evaluations (commonly referred to as the “Orange Book”). The 

Orange Book indicates that the ‘149 Patent has an expiration date of April 30, 2022. 

 Expeditiously, about three months later (November 8, 2010), Novel filed an Abbreviated 

New Drug Application (ANDA) No. 202511, for a generic version of Braintree’s SUPREP, 

which, as stated in more detail infra, was an exact copy of the SUPREP product. As part of its 

application, Novel included a paragraph IV certification, which gives notice to the patent holder 

of a statutorily created act of infringement. 35 U.S.C. § 271(e)(2). 

 Braintree filed suit against Novel for infringement of the ’149 patent pursuant to 35 

U.S.C §271(e)(5) on March 9, 2011. Braintree asserts that Novel’s Drug Product will infringe 

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claims 15, 16, 18, 19, 20 and 23. Novel contends that SUPREP does not meet the patent’s 

claims, and as such, copying SUPREP is appropriate because SUPREP has no patent protection.2 

The SUPREP Product: Composition, Labeling and Administration 

SUPREP is a colon cleansing preparation kit containing two 6 ounce bottles. The dose 

for colon cleansing requires administration of the two bottles of SUPREP in the SUPREP Bowel 

Prep Kit. SUPREP is indicated for bowel cleansing prior to an adult patient having a 

colonoscopy procedure. SUPREP is an aqueous, oral solution that contains a flavoring agent. 

Each six ounce bottle of SUPREP contains 17.5 grams of sodium sulfate, 1.6 grams of 

magnesium sulfate, and 3.13 grams of potassium sulfate. SUPREP does not include phosphate. 

Each six ounce bottle of SUPREP is diluted to 16 ounces with water prior to administration. One 

bottle of SUPREP diluted to sixteen ounces is 473 ml. 

The SUPREP label states, in part: 

2 DOSAGE AND ADMINISTRATION 

SUPREP Bowel Prep Kit should be taken as a split-dose oral regimen. 

The dose for colon cleansing requires administration of two bottles of 

SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP 

solution with an additional 1 quart of water taken orally. The total volume of liquid 

required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) 

taken orally prior to the colonoscopy in the following way: 

Split-Dose (Two-Day) Regimen 

Day prior to colonoscopy: 

-A light breakfast may be consumed, or have only clear liquids on the day before 

colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. 

 

2

 Novel’s contention means that the inventors of SUPREP incorrectly described the properties of 

SUPREP in the original patent application, and that they missed the mark again upon 

reexamination. This contention is analyzed in the infringement section. See infra section III.

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-Early in the evening prior to colonoscopy: pour the contents of one bottle of 

SUPREP Bowel Prep Kit into the mixing container provided. Fill the container 

with water to the 16 oz fill line, and drink the entire amount. 

-Drink two additional containers filled to the 16 oz line with water over the next 

hour. 

Day of colonoscopy: 

-Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, 

milk, and alcoholic beverages. 

-The morning of colonoscopy (10 to 12 hours after the evening dose): pour the 

contents of the second bottle of SUPREP Bowel Prep Kit into the mixing container 

provided. Fill the container with water to the 16 oz fill line, and drink the entire 

amount. 

-Drink two additional containers filled to the 16 oz line with water over the next 

hour. 

-Complete all SUPREP Bowel Prep Kit and required water at least one hour prior 

to colonoscopy. 

Thus, the SUPREP label instructs patients to ingest one six ounce bottle diluted to 16 

ounces with water on the day before colonoscopy, and a second six ounce bottle diluted to 16 

ounces with water on the morning before colonoscopy. In Section 12.2, entitled 

“Pharmacodynamics,” the SUPREP full prescribing labeling states, “[t[he osmotic effect of the 

unabsorbed ions, when ingested with a large volume of water, produces a copious watery 

diarrhea.” In addition to the water used to dilute the SUPREP, the label also instructs patients to 

consume a total of 64 additional ounces of water during SUPREP administration. After 

evaluating clinical data submitted by Braintree in connection with NDA No. 22372, the FDA 

approved SUPREP on August 5, 2010 as a product indicated for cleansing of the colon in 

preparation for colonoscopy in adults, and approved the language in SUPREP’s label. 

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Novel’s Proposed Generic Product is an Exact Copy of SUPREP, and its Label is Copied From 

SUPREP’s Label 

Novel’s proposed generic version of the SUPREP drug product is named Sodium Sulfate, 

Potassium Sulfate, and Magnesium Sulfate Oral Solution (the Generic Product). When 

developing the Generic Product, Novel’s objective “was to develop a Sodium Sulfate, (17.5g); 

Potassium Sulfate, (3.1g); Magnesium Sulfate, (1.6g) Oral Solution, which will meet all the

characteristics required to provide the same therapeutic effects as SUPREP.” In seeking to avoid 

the substantial clinical trials to which SUPREP was subjected, Novel’s ANDA states that Novel 

“tried to match [its] product to SUPREP” to develop a “stable and palatable formulation meeting 

all the characteristics to provide the same therapeutic effect as SUPREP.” Novel’s ANDA states 

that the Generic Product contains the “active ingredients sodium sulfate, potassium sulfate and 

magnesium sulfate in the same concentration and dosage form” as SUPREP. Novel’s ANDA 

also states that the Generic Product is a “stable and palatable formulation meeting all the 

characteristics to provide the same therapeutic effect as SUPREP.” 

The Generic Product is “exactly the same as [SUPREP] and contains the same inactive 

ingredients.” Novel’s ANDA states that “[t]here is no difference between [SUPREP] and 

Novel’s drug product formulation.” Novel’s Generic Product contains the same active 

ingredients (sodium sulfate, potassium sulfate and magnesium sulfate) in the same concentration 

as that of Braintree’s SUPREP. The Generic Product is chemically the same as SUPREP. The 

Generic Product is pharmaceutically and therapeutically equivalent to Braintree’s SUPREP. 

The only difference between SUPREP and the Generic Product is the choice of flavoring. 

Novel’s proposed label for the Generic Product is copied from the FDA approved product label 

and package insert for Braintree’s SUPREP. 

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II 

 Summary judgment is appropriate under Fed. R. Civ. P. 56(c) when the moving party 

demonstrates that there is no genuine issue of material fact and the evidence establishes the 

moving party’s entitlement to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 

317, 322-23 (1986). A factual dispute is genuine if a reasonable jury could return a verdict for 

the non-movant, and it is material if, under the substantive law, it would affect the outcome of 

the suit. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). “In considering a motion 

for summary judgment, a district court may not make credibility determinations or engage in any 

weighing of the evidence; instead, the non-moving party’s evidence ‘is to be believed and all 

justifiable inferences are to be drawn in his favor.’” Marino v. Indus. Crating Co., 358 F.3d 

241, 247 (3d Cir. 2004) (quoting Anderson, 477 U.S. at 255). 

 Once the moving party has satisfied its initial burden, the party opposing the motion must 

establish that a genuine issue as to a material fact exists. Jersey Cent. Power & Light Co. v. 

Lacey Twp., 772 F.2d 1103, 1109 (3d Cir. 1985). The party opposing the motion for summary 

judgment cannot rest on mere allegations and instead must present actual evidence that creates a 

genuine issue as to a material fact for trial. Anderson, 477 U.S. at 248; Siegel Transfer, Inc. v. 

Carrier Express, Inc., 54 F.3d 1125, 1130-31 (3d Cir. 1995). “[U]nsupported allegations . . . and 

pleadings are insufficient to repel summary judgment.” Schoch v. First Fidelity Bancorp., 912 

F.2d 654, 657 (3d Cir. 1990); see also Fed. R. Civ. P. 56(e) (requiring nonmoving party to “set 

forth specific facts showing that there is a genuine issue for trial”). Moreover, only disputes over 

facts that might affect the outcome of the lawsuit under governing law will preclude the entry of 

summary judgement. Anderson, 477 U.S. at 247-48. Summary judgment is appropriate 

“[w]here the record taken as a whole could not lead a rational trier of fact to find for the nonCase 3:11-cv-01341-PGS-LHG Document 261 Filed 01/18/13 Page 7 of 33 PageID: 23467
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moving party." Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 

(1986) (internal citation and quotations omitted). 

III 

Braintree contends that the Generic Product infringes claims 15 and 18 of the ‘149 patent, 

and will induce and contribute to infringement of claims 19, 20 and 23 of the ‘149 patent. Novel 

contends that the undisputed facts establish its entitlement to summary judgment of noninfringement. The Court will evaluate these cross motions together. First, the disputed claims 

are presented and then the acts of infringement are discussed. 

The Disputed Claims 

As amended after reexamination, claim 15 is an independent claim covering a 

composition, reciting: 

15. A composition for inducing purgation of the colon of a patient, the composition 

comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution 

comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an 

effective amount of K2SO4, wherein the composition does not produce any clinically 

significant electrolyte shifts and does not include phosphate. 

Claim 16 is a dependent claim covering a composition, reciting: 

16. A composition according to claim 15, wherein the solution comprises between about 

2 grams and about 40 grams of Na2SO4, between about 2 grams and about 20 grams of 

MgSO4, and between about 1 gram and about 10 grams of K2SO4. 

As amended after reexamination, claim 18 is an independent claim covering a 

composition, reciting: 

18. A composition for inducing purgation of the colon of a patient, the composition 

comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution 

consisting essentially of an effective amount of Na2SO4, an effective amount of MgSO4, 

and an effective amount of K2SO4, wherein the composition does not produce any 

clinically significant electrolyte shifts and does not include phosphate. 

Claim 19 is a dependent claim covering a method, reciting: 

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19. A method for inducing colonic purgation in a patient, comprising the steps of: 

(a) orally administering an effective amount of the composition of claim 18 to a patient; 

and (b) allowing the administered composition to induce colonic purgation. 

Claim 20 is a dependent claim covering a method, reciting: 

20. A method for inducing colonic purgation in a patient, comprising the steps of: 

(a) orally administering an effective amount of the composition of claim 15 to a patient; 

and (b) allowing the administered composition to induce colonic purgation. 

Claim 23 is a dependent claim covering a method, reciting: 

23. A method for inducing colonic purgation in a patient according to claim 20, wherein 

the effective amount of the composition is administered in two or more doses within a 

treatment period. 

Literal Infringement of Claims 15 and 18 of the ’149 Patent 

There is a two-step analysis for determining patent infringement under 35 U.S.C. § 271: 

“first, the court determines the meaning of the disputed claim terms, then the accused device is 

compared to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 

483 F.3d 800, 804 (Fed. Cir. 2007) (citation omitted). For literal infringement, the accused 

product or process must “contain each limitation of the claim exactly” and there cannot be “any 

deviation from the claim.” Litton Sys. v. Honeywell, 140 F.3d 1449, 1454 (Fed. Cir. 1998); see 

also Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1330 (Fed. Cir. 2001). 

For the reasons stated below, the Court finds that the Generic Product literally infringes 

claims 15 and 18 of the ‘149 Patent, because each limitation of claims 15 and 18 is met. 

According to Novel’s admissions and the undisputed facts, there is no legitimate dispute that 

Novel’s copy of SUPREP meets each claim limitation. 

The Court begins its infringement analysis with the important fact that the Generic 

Product is exactly the same as SUPREP. Accordingly, if SUPREP is covered by the ‘149 patent 

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– if each claim limitation is met by SUPREP – then the Generic Product infringes. Below, the 

Court analyzes whether the Generic Product meets each of the claim limitations. 

The Generic Product Does Not Produce Clinically Significant Electrolyte Shifts 

The parties dispute whether the Generic Product meets the “clinically significant 

electrolyte shifts” element of claims 15 and 18 of the ‘149 Patent. Claims 15 and 18 of the ‘149 

patent both include the phrase “wherein the composition does not produce any clinically 

significant electrolyte shifts.” This phrase was one of the terms subject to a Markman ruling. At 

the Markman phase, the Court rejected both of the parties’ proposed definitions, and determined 

its own construction. The Court determined that the disputed term “clinically significant 

electrolyte shifts” meant “alterations in blood chemistry that are outside the normal upper or 

lower limits of their range or other untoward effects.” 

 As noted above, the Court’s definition is different than those proposed by the parties and 

argued for at the Markman hearing. After a thorough review of the intrinsic evidence, the Court 

found that the parties’ definitions were overly complicated, subject to broad physician review, 

and not within the intended meaning of the inventors. After the Court crafted its own definition, 

a telephone conference was held with the parties to review the definition. At that time, only 

Braintree raised an issue with the Court’s construction of the “clinically significant electrolyte 

shifts” term, and the Court responded by deleting the allegedly problematic clause3

 from the final 

opinion. Neither party challenged or requested any further clarification of the Court’s definition. 

Yet, the definition has turned into a major point of contention in the summary judgment motions 

 

3

 The Court deleted the clause, “But no one has suggested same,” from the beginning of the 

following sentence: “But no one has suggested same, hence the definition in the specification is 

more preceise than the construction of the parties, and is adopted.” 

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presently before the Court. Like the parties’ proposed constructions, the Court’s first 

construction of the term was, apparently, imprecise, and therefore must be clarified. 

 Novel claims that that clinical data produced by Braintree shows that SUPREP causes 

shifts in electrolyte levels outside the normal range in some patients. In Novel’s reading of the 

Court’s claim construction, the production of such shifts would take SUPREP outside of claims 

15 and 18. Braintree’s position on the Court’s claim construction is that it implies that 

something more than just shifts outside the normal range are needed to satisfy the claim term, 

and as such SUPREP falls within claims 15 and 18. Novel seems to ignore the phrase “or other 

untoward effects”, likely because the phrase is meant to show that electrolyte abnormalities are 

not clinically significant electrolyte shifts unless they lead to serious adverse health effects, like 

those caused by Phospho-soda. (See e.g., Supp. Lumelsky Decl., Ex. 33, Peura 2/27/12 Tr., 

140:24-142:8 (explaining how “or other” relates “untoward effects” back to alterations in blood 

chemistry)). Indeed, the Court’s claim construction opinion recognized that “other untoward 

effects” refers to the serious side effects of Phospho-soda. (See ECF. No. 130, at 10 (“It appears 

that ‘untoward effects’ may refer to those fatal side effects of the phospho soda solution because 

such side effects are referred to in the specification”)). However, since the Court’s definition 

was apparently imprecise, the Court stresses here that in its view, the term “clinically significant 

electrolyte shifts” necessarily connotes something more than just electrolyte shifts outside 

normal ranges. 

The ability to induce purgation without causing clinically significant shifts is a 

fundamental aspect of the invention. (See, e.g., '149 Patent, at Col. 1:6-12 (“This formulation is 

effective to produce colonic purging to prepare the colon for surgical or diagnostic procedures 

and surprisingly does not cause clinically significant changes in electrolyte balance”); Id. at 

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Abstract (“Unlike prior art, this composition is useful for the cleansing of the bowel . . . without 

producing clinically significant changes in bodily function”)). The formulations were designed 

to replace other colon preparations that caused “massive electrolyte and fluid shifts that are 

clinically significant to the patient,” leading to serious health problems, even death. (Id. at Col. 

2:40-44 (citing U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 

Sep. 17, 2001 (Lumelsky Decl. Ex. 8); 2002 Physician’s Desk Reference, prescribing 

information for Fleet’s Phospho Soda and InKine Pharmaceutical’s Visicol® (Lumelsky Decl. 

Ex. 7)); see also Id. at Col. 3:10-14 (“clinically significant electrolyte and fluid shifts . . . have 

been known to cause deaths.”); Id. at Col. 2:56-61 (“All of these products have been seen to 

cause clinically significant electrolyte disturbances and fluid shifts, and disturbances in cardiac 

and renal function when administered to patients”)). To accomplish this goal, the inventors 

described and claimed formulations that do not cause electrolyte shifts leading to serious health 

problems for the patient. Therefore, as stated above and suggested in the Court’s claim 

construction, the clinically significant electrolyte shifts mentioned in the patent are alterations in 

blood chemistry that are both outside the normal upper or lower limits of their range and 

accompanied by or manifested as other untoward effects, such as disturbances in cardiac and 

renal function as disclosed in the patent specification. 

SUPREP was never associated with a serious adverse event like those described in the 

FDA-approved label or in the ’149 patent – events such as cardiac abnormalities, renal failure, 

and death. (See ‘149 patent, at Col. 2:56-62 (“All of these [prior art] products have been seen to 

cause clinically significant electrolyte disturbances and fluid shifts, and disturbances in cardiac 

and renal function when administered to patients”); id. at Col. 4:23-27; see also Peura Decl. at ¶ 

72). Because SUPREP has never been associated with any serious adverse events related to 

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electrolyte abnormalities, it has not produced (and does not produce) clinically significant 

electrolyte shifts in patients. Given that Novel’s proposed version of SUPREP is a copy of 

Braintree’s product, it also will not produce clinically significant electrolyte shifts upon 

administration to a patient. As such, Novel’s claim that SUPREP does not meet the limitations 

of claims 15 and 18 solely because the electrolyte shifts were above or below normal limits lacks 

merit. 

But the Court’s decision rests not only on the above clarification of the claim 

construction, but also on the definition of “a patient” in the preamble of claims 15 and 18, and 

the Court’s opinion that it applies to the clause “wherein the composition does not produce any 

clinically significant electrolyte shifts in a patient” of the claims.4 Consistent with Federal 

Circuit precedent, the Court agrees with Braintree’s contention that the term “a” as it appears in 

the preamble of claims 15 and 18 means one or more. See KCJ Corp., 223 F.3d at 1356; see also 

Baldwin Graphic Sys., 512 F.3d at 1342 (Fed. Cir. 2008). The ‘149 patent does not appear to 

provide a special definition of the term “a” to suggest a different meaning. While Novel asserts 

that KCJ Corp. and Baldwin Graphic Sys. do not support defining “a” as “one or more” in claims 

15 and 18 because, unlike in those cases, “a” in claims 15 and 18 does not follow the term 

“comprising”, the Court does not read those cases in such a limited fashion. 

“[A] claim preamble has the import that the claim as a whole suggests for it.” Bell 

Commc’ns Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). 

“If the claim preamble, when read in the context of the entire claim, recites limitations of the 

claim, or, if the claim preamble is necessary to give life, meaning, and vitality to the claim, then 

the claim preamble should be construed as if in the balance of the claim.” Pitney Bowes, Inc. v. 

 

4

 Novel moves to bar this argument on the ground it violates the Local Patent Rules. See, 

discussion infra at p. 29. 

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Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (internal citations and quotations 

omitted). The question of whether a preamble is limiting “involves examination of the entire 

patent record to determine what invention the patentee intended to define and protect.” Rowe v. 

Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). 

The preambles of claims 15 and 18 read: “[a] composition for inducing purgation of the 

colon of a patient.” Given that the Court has held the definition of “a” is “one or more”, the term 

“a patient” means one or more patients. As such, based on its review of the entire patent record 

before it, the Court finds that “a patient” is a limitation of the claims, as it appears that the 

administration of the composition and evaluation of the electrolyte levels in claims 15 and 18 

were meant to be done on a per patient basis. Accordingly, the Court finds that the “a patient” 

limitation applies to the “wherein the composition does not produce any clinically significant 

electrolyte shifts in a patient” element of the claims. 

There is no dispute that at least one patient to whom SUPREP is administered will 

experience, or has experienced, no clinically significant electrolyte shifts. There is also no 

dispute that the Generic Product is exactly the same as SUPREP and contains the same inactive 

ingredients. Accordingly, for this additional reason, the Court holds that Braintree has 

demonstrated that its product, and the Generic Product, meets the “clinically significant 

electrolyte shifts” element of claims 15 and 18 of the ‘149 patent.5

 

The Generic Product Induces Purgation of the Colon of a Patient 

Claims 15 and 18 require a composition that will induce purgation of the colon when it is 

administered to a patient. (‘149 Patent, at claims 15 and 18). The Court construed the claim 

 

5

 Novel has not had the opportunity to review the Court’s clarification of its claim construction 

contained in this opinion. Therefore, as the Court stated at oral argument on December 20, 2012, 

Novel may raise any arguments that stem from the Court’s analysis supra in a motion for 

reconsideration. 

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term “purgation” to mean “an evacuation of a copious amount of stool from the bowels after oral 

administration of the solution.” Novel essentially makes two arguments regarding the 

“purgation” claim limitation: (1) Novel argues that while two bottles may cause a purgation, one 

bottle of SUPREP – meets the volume limitations of the claims at issue – does not cause a 

purgation; and (2) Novel argues that, while administration of two bottles for colon cleansing is 

the indicated use for SUPREP, administration of one bottle of SUPREP to cause purgation is an 

“off-label use”, and therefore can never infringe the disputed claims. 

The Court holds that the Generic Product meets the “purgation” claim limitation. One 

bottle of the SUPREP product, used as directed, is sufficient to induce a “purgation,” as the 

Court has construed the term. (See Supp. Peura Decl. ¶ 125). While Novel argues that one bottle 

of SUPREP does not cause a purgation, it offers no evidence whatsoever, save for unsworn 

argument, to refute Braintree’s evidence and to support its contention. While some of the 

evidence cited by Braintree does not support the contention that one bottle of SUPREP causes a 

purgation,6

 the affidavit of Braintree’s expert, Dr. Peura, clearly states that one bottle of the 

SUPREP product, used as directed, is sufficient to induce a purgation. Braintree has shown that 

no genuine issue of material fact exists as to whether SUPREP causes colonic purgation, so it is 

Novel’s burden to offer admissible evidence that a genuine fact issue compels a trial, not just 

“some metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio 

Corp., 475 U.S. 574, 586, 106 S. Ct. 1348, 89 L. Ed. 2d 538 (1986). By failing to submit any 

affirmative evidence that shows SUPREP or the Generic Product does not induce colonic 

purgation, Novel has failed to meet its burden as to this claim limitation. 

 

6

 Braintree cites to Novel’s proposed label and the testimony of Scott Talbot, James Garegnani, 

Dr. Johanson, and Dr. Goldfarb to support its contention that one bottle of SUPREP (or one 

bottle of Novel’s copy of SUPREP) will induce colonic purgation in a patient. However, very 

little of the cited evidence is specific to the effects of one bottle of SUPREP. 

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 In addition, Novel’s argument that administration of one bottle of SUPREP to cause 

purgation is an “off-label use”, and therefore can never infringe the disputed claims, is without 

merit. As this Court recognized in its Claim Construction Order, purgation is the method to 

achieve the goal of colon cleansing. (See ECF. No. 130 at 6; see also Supp. Peura Decl. ¶ 125). 

Because purgation is the method by which SUPREP achieves the FDA-approved indication of 

colon cleansing, purgation cannot be an off-label use for SUPREP. As Braintree points out, 

Novel’s argument is akin to an assertion that using an asthma medication that improves breathing 

is off-label if it works by reducing airway inflammation; reduction of airway inflammation is the 

method by which the medication achieves the goal of improved breathing. The cases Novel cites 

in support of its assertion do not involve methods to achieve an FDA-approved indication, and 

are therefore inapplicable. The cases also relate to method of use claims only – in each case, the 

claims at issue covered specific uses of a drug to treat disease, not the drug composition itself. 

See Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1319 (Fed. Cir. 2012); 

AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1048, 1057 (Fed. Cir. 2010); Warner-Lambert 

Co. v. Apotex Corp., 316 F.3d 1348, 1352 (Fed. Cir. 2003); Allergan v. Alcon Labs., 324 F.3d 

1322, 1323 (Fed. Cir. 2003). These cases provide no guidance to the Court with respect to drug 

composition claims, such as claims 15 and 18, as nothing in the cited cases addresses the fact 

that here, Novel intends to make, offer to sell, and sell a product that directly infringes the ‘149 

patent. 

The Generic Product is a Composition Comprising from About 100 ml to About 500 ml 

of an Aqueous Hypertonic Solution 

Claims 15 and 18 require a composition comprising from about 100 ml to about 500 ml 

of an aqueous hypertonic solution. For the following reasons, the Generic Product meets this 

claim limitation. Novel’s copy of SUPREP is an aqueous hypertonic solution. (Response to 

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Request For Admission No. 25; Johanson 9/6/12 Tr. at 252:22-253:5; Goldfarb 9/14/12 Tr. At 

242:13-25; Peura Decl. at ¶¶ 64-65). Novel’s copy of SUPREP requires that a patient ingest 

“two bottles of an oral solution,” each of which will be 6 ounces diluted to 16 ounces when 

consumed. (See e.g., Response to Request For Admission No. 28). Sixteen ounces is equivalent 

to 473 ml, which is within the claimed range of claims 15 and 18 of the ‘149 patent. (See

Response to Request for Admission Nos. 33 and 34). 

Novel argues that Braintree has admitted to the PTO and in publications co-authored by 

one of the ‘149 patent inventors that the volume of SUPREP solution needed for inducing 

purgation of the colon is 946 milliliters, i.e., two bottles of SUPREP each diluted to 16 ounces. 

However, these alleged admissions do nothing to contradict the fact that, as explained above, one 

bottle of SUPREP is sufficient to cause purgation of the colon. Given that one bottle is sufficient 

to induce purgation, there is no genuine dispute that the Generic Product constitutes a 

composition of from about 100 ml to about 500 ml of an aqueous hypertonic solution, as 

required by the claims. 

The Generic Product Comprises an Effective Amount of Na2SO4, an Effective Amount of 

MgSO4, and an Effective Amount of K2SO4 

Claims 15 and 18 require an “effective amount” of three sulfate salts. “Effective 

amount” has been construed to mean “the amount and combination of salt necessary to produce a 

colonic purgation, while not producing clinically significant electrolyte shifts.” (ECF. No. 130 at 

9). Therefore, no specific amount of each sulfate salt is required; all that is required is that the 

three salts be used in combination in such a way that produces purgation but does not cause 

clinically significant electrolyte shifts. As it is undisputed that SUPREP and the Generic Product 

contain the three sulfate salts, it is also beyond dispute that SUPREP and the Generic Product 

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meet this claim limitation if it can be shown – as it has – that the “induces purgation” and 

“clinically significant electrolyte shifts” limitations are also met. 

Accordingly, for the reasons set forth above, the Court holds that the Generic Product 

literally infringes claims 15 and 18 of the ‘149 patent. 

Induced and Contributory Infringement 

The Court now analyzes Braintree’s additional claims of induced and contributory 

infringement. 

Induced Infringement of Claims 19, 20 and 23 of the ‘149 Patent 

“Whoever actively induces infringement of a patent shall be liable as an infringer.” 35 

U.S.C. § 271(b). A claim of induced patent infringement arises where “the alleged infringer 

knowingly induced infringement and possessed specific intent to encourage another's 

infringement.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 2010 WL 4286284, at *12 (Fed. 

Cir. 2010) (quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006)); see also 

C.R. Bard, Inc. v. Advanced Cardiovascular Syss., Inc., 911 F.2d 670, 675 (Fed. Cir.1990) (“A 

person induces infringement under § 271(b) by actively and knowingly aiding and abetting 

another's direct infringement”) (citation omitted). 

“Intent can be shown by circumstantial evidence, but the mere knowledge of possible 

infringement will not suffice.” Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1328 (Fed. 

Cir. 2009) (citation omitted). As such, a plaintiff alleging induced infringement must satisfy the 

“rigorous” standard of demonstrating that the defendant had a specific intent to encourage 

infringement. Best Med. Intern., Inc. v. Accuray, Inc., 2010 U.S. Dist. LEXIS 128367, 2010 WL 

5053919, at *6 (W.D. Pa. Dec. 2, 2010) (citing Broadcom Corp. v. Qualcomm Inc., 543 F.3d 

683, 697-98 (Fed. Cir. 2008)). 

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Claims 19 and 20 of the ‘149 patent claim methods for using the compositions of claims 

15 and 18. Specifically, claim 19 claims a method for inducing colonic purgation in a patient, 

comprising two steps: (1) orally administering an effective amount of the composition of claim 

18 to a patient; and (2) allowing the administered composition to induce colonic purgation. 

Claim 20 claims a method for inducing colonic purgation in a patient, comprising two steps: (1) 

orally administering an effective amount of the composition of claim 15 to a patient; and (2) 

allowing the administered composition to induce colonic purgation. Braintree argues that there 

is no legitimate dispute that Novel intends to, and will induce, patients and doctors using the 

Generic Product to infringe claims 19 and 20. 

As set forth above, the Generic Product includes an effective amount of the composition 

of claims 15 and 18, has the same active ingredients in the same amounts as SUPREP, and will 

induce colonic purgation if taken as directed. In addition, physicians and patients are instructed 

to administer the Generic Product in a manner that induces colonic purgation. Finally, Novel has 

admitted that it intends for doctors and patients to use the Generic Product according to its 

proposed product label and package insert, and its generic copy will be sold with a proposed 

product label and package insert that are copied from Braintree’s FDA-approved label. 

Novel’s proposed label instructs patients to drink two bottles of solution both the evening 

before colonoscopy and the day of colonoscopy. That is, the Generic Product – which infringes 

claims 15 and 18 – will be orally administered twice (in two bottles) during a treatment period. 

Therefore, through its proposed label, Novel intentionally induces patients to ingest a 

composition infringing claims 15 and 18. 

In addition, as stated above, if a patient ingests the Generic Product according to its 

proposed label, the product will cause colonic purgation, and the label clearly informs patients 

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and doctors that the Generic Product cleans the colon by causing diarrhea. Thus, the purpose of 

Novel’s proposed labeling is to instruct patients to take the solution orally and to allow the 

composition to induce purgation of the colon. 

Therefore, it is beyond dispute that Novel, through its proposed label, induces 

infringement of claims 19 and 20 of the ‘149 patent by instructing patients and doctors to: (1) 

orally administer an effective amount of the composition of claims 15 and 18 to a patient; and (2) 

allow the administered composition to induce colonic purgation. 

Claim 23 of the ’149 patent is a method for inducing colonic purgation in a patient 

according to claim 20, where the composition is administered in two or more doses within a 

treatment period. If approved by the FDA, Novel’s proposed label will instruct and induce 

patients to practice each and every element of claim 23. As stated above, each bottle of the 

Generic Product, if administered according to the proposed label, meets the limitations of Claim 

20. With respect to the additional claim element “the effective amount of the composition is 

administered in two or more doses within a treatment period,” patients taking the Generic 

Product as directed by Novel’s label will directly infringe claim 23, and Novel’s proposed 

labeling induces such infringement. Novel’s label instructs patients to practice claim 20 twice in 

the treatment period – in the evening and again the next morning. Furthermore, Novel intends 

for patients to follow the regimen described in its proposed label. As stated above, consumption 

of each bottle of Novel’s copy of SUPREP induces purgation, thereby satisfying the limitations 

of claim 23. 

As stated above, any patient who uses the Generic Product in accordance with the explicit 

instructions in Novel’s proposed label will directly infringe each and every element of claims 19, 

20, and 23 of the ‘149 patent. “[T]he requisite intent to induce infringement may be inferred 

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from all of the circumstances.” Broadcom, 543 F.3d at 699. “In the context of specific intent, it 

is irrelevant that some users may ignore the warnings in the proposed label. The pertinent 

question is whether the proposed label instructs users to perform the patented method.” 

AstraZeneca, 633 F.3d at 1060. Therefore, Novel’s specific intent to induce infringement can be 

inferred from the proposed label as a matter of law, as the proposed label explicitly instructs 

patients to use the Generic Product in a manner that will directly infringe the claims. Novel 

intended to cause the acts that constitute direct infringement, and Novel knew or should have 

known that its action would cause the direct infringement. See id. at 699. 

Novel was aware of the ‘149 patent when it filed ANDA 202411 with its proposed 

labeling. Novel is seeking FDA approval to market the Generic Product with proposed labeling 

that would instruct others to directly infringe claims 19, 20, and 23 of the ‘149 patent. It is easily 

inferred that Novel knew or should have known that its actions would cause patients to directly 

infringe the claims. Upon gaining FDA approval, Novel will provide instructions directing 

patients to perform the actions that will directly infringe the claims 19, 20 and 23 of the ‘149 

patent. Moreover, there is no way for patients to use the Generic Product in a way that does not 

infringe at least claims 19 and 20. Thus Novel’s intent to induce infringement of the ‘149 patent 

is apparent. 

 Contributory Infringement of Claims 19, 20, and 23 of the ‘149 Patent 

Section 271(c) prohibits the sale of a product that can be used in a patented method if the 

product is “not a staple article or commodity of commerce suitable for substantial noninfringing 

use.” A defendant is thus liable for contributory infringement if: (1) it sells or offers for sale a 

material component of a composition for use in a patented method; and (2) the component is not 

a staple article or commodity of commerce suitable for substantial non-infringing use. See 35 

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U.S.C. 271(c). The Generic Product will contribute to the infringement of claims 19, 20, and 23 

of the ‘149 patent because the Generic Product has no substantial noninfringing uses, and is 

known by Novel to be especially made to practice the asserted method claims of the patent in 

suit. See i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 850-851 (Fed. Cir. 2010). There is no 

dispute that Novel is aware of the infringing use of the Generic Product. The Generic Product 

also constitutes a material part of claims 19, 20 and 23 of the ‘149 patent, as the Generic Product 

is the sole physical object necessary to practice these claims. In seeking approval to market the 

Generic Product, Novel demonstrated knowledge that the Generic Product is especially made or 

adapted for use in infringement of the ‘149 patent, and it is not a “staple article of commerce 

suitable for substantial noninfringing use.” Ricoh Co., Ltd. v. Quanta Computer Inc., 550 F.3d 

1325, 1337 (Fed. Cir. 2008). 

A generic product designed to treat the same disorders as the branded product and 

matching the branded product’s indications has no substantial noninfringing use. See Wyeth v. 

Sandoz, Inc., 703 F. Supp. 2d 508, 522-23 (E.D.N.C. 2010). Here, the Generic Product can be 

used only to infringe because the only FDA-authorized use for SUPREP, and thus for Novel’s 

identical proposed copy of SUPREP, is the patented use: “an osmotic laxative indicated for 

cleansing of the colon in preparation for colonoscopy in adults.” Novel is barred by federal law 

from selling a federally regulated drug for any other use. See 21 C.F.R. § 202.1(e)(4). 

Therefore, the Generic Product would have an identical indication as SUPREP, and thus, would 

have no substantial noninfringing use. Accordingly, the Generic Product will contribute to the 

infringement of claims 19, 20, and 23 of the ‘149 patent. 

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Motion for Summary Judgment on Invalidity 

Also before the Court is the Motion for Summary Judgment No.4: Invalidity Based on 

Obviousness. (ECF No. 149). Defendants seek to have the asserted claims declared invalid. 

Defendants assert that summary judgment is warranted on the grounds of obviousness, stating 

that "[t]he ‘149 patent claims nothing more than known cathartic agents. A person of ordinary 

skill, based on available knowledge taught by the prior art, could have determined with 

reasonable predictability and routine experimentation how to combine those known purgatives 

into a drug covered by the asserted claims." 

To prevail on a defense of invalidity for obviousness, Defendants must demonstrate by 

clear and convincing evidence that the differences between the subject matter sought to be 

patented and the prior art are such that the subject matter as a whole would have been obvious at 

the time the invention was made to a person having ordinary skill in the art to which said subject 

matter pertains. 35 U.S.C. § 103(a). "A party seeking to invalidate a patent based on 

obviousness must demonstrate 'by clear and convincing evidence that a skilled artisan would 

have been motivated to combine the teachings of the prior art references to achieve the claimed 

invention, and that the skilled artisan would have had a reasonable expectation of success in 

doing so.'" Id. (citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). 

The Supreme Court has enumerated four factors to be considered by courts to assess 

whether an invention is obvious. Takeda v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356-57 

(Fed. Cir. 2007) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). The four factors 

are: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the 

differences between the claimed subject matter and the prior art; and (4) secondary 

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considerations, or "objective indicia of non-obviousness." Id.; see also KSR Int'l Co. v. Teleflex 

Inc., 550 U.S. 398, 405 (2007). 

In KSR International Co. v. Teleflex Inc., the Supreme Court cautioned against (1) a rigid 

application of the teaching, suggestion and motivation (TSM) test, and (2) a rigid application of 

using an "obvious to try" analysis when there is pressure to solve a problem with "a finite 

number of identified, predictable solutions.” 550 U.S. 398, 127 S. Ct. 1727, 1741-42 (2007). 

Instead, the Court advocated a “common sense” approach to determining obviousness. See id. at 

1741-43. Specifically, the Court explained that "any need or problem known in the field of 

endeavor at the time of invention and addressed by the patent can provide a reason for combining 

elements in the manner claimed.” Id. at 1742. The Court reasoned that, “if a technique has been 

used to improve one device, and a person of ordinary skill in the art would recognize that it 

would improve similar devices in the same way, using the technique is obvious unless its actual 

application is beyond his or her skill.” Id. at 1740. However, even in light of the new approach 

advocated by KSR, this Court must be cautious to avoid the use of hindsight when considering 

Defendant's obviousness argument. Thus, 

[i]n conducting an obviousness analysis, [a] factfinder should be aware . . . of the 

distortion caused by hindsight bias and must be cautious of arguments reliant upon ex 

post reasoning. This is because the genius of invention is often a combination of known 

elements that in hindsight seems preordained. 

In re Omeprazole Patent Litig., 490 F. Supp. 2d 381, 2007 U.S. Dist. LEXIS 39670, at *400-01 

(S.D.N.Y. May 31, 2007) (citation omitted) (quoting KSR, 550 U.S. at 420); see also 

Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985). 

This Court finds that genuine issues of material fact exist in this case, including but not 

necessarily limited to: the scope, content and teaching of the prior art; differences between the 

prior art and the ‘149 Patent; whether the prior art demonstrated that the use of sulfate salts as 

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hypertonic solutions was predictable; and secondary considerations such as whether there was a 

long felt need for, or failure of others or unexpected results in the development of the claimed 

invention. Accordingly, these factual disputes preclude a finding at the summary judgment 

stage. These disputes present complicated questions of fact best resolved at trial. Defendant's 

motion is therefore denied. 

Motion for Summary Judgment on Defendant’s Counterclaims 

Braintree moves for summary judgment on Novel’s third, fourth, and fifth counterclaims. 

(ECF No. 141). Novel’s third counterclaim alleges, inter alia, “[b]y listing the ‘149 patent in the 

Orange Book and marking its product inserts with the ‘149 patent, Braintree falsely marked its 

prescription SUPREP product under 35 U.S.C. § 292. Braintree listed the ‘149 patent in the 

Orange Book as covering SUPREP and marked the ‘149 patent on its product inserts for 

SUPREP with an intent to deceive the public.” (ECF No. 63, ¶ 134). Novel’s fourth 

counterclaim alleges unfair competition under Section 43(a) of the Lanham Act, 15 U.S.C. § 

1125(a), in that, inter alia, “Braintree’s actions in falsely marking SUPREP with the ‘149 patent, 

and listing the ‘149 patent in the Orange Book in connection with SUPREP, constitute unfair 

competition and false advertising in violation of Section 43(a) of the Lanham Act, 15 U.S.C. § 

1125(a).” (ECF No. 63, ¶ 193). Novel’s fifth counterclaim alleges, inter alia, “Braintree has 

made representations to the public, or caused such representations to be made, that SUPREP is 

covered by one or more claims of the ‘149 patent,” and Braintree’s “acts and conduct . . . 

constitute unfair competition and unfair business practices contrary to the laws of the State of 

New Jersey.” (ECF No. 63, ¶¶ 200, 204). Braintree moves for summary judgment of Novel’s 

third, fourth, and fifth counterclaims. (ECF No. 141). 

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Initially, the Court notes that Novel’s third, fourth, and fifth counterclaims all stem from 

Braintree’s alleged false or improper listing of the ‘149 patent in the Orange Book as covering 

SUPREP, and alleged false or improper marking of SUPREP with the ‘149 patent. The HatchWaxman Act provides an aggressive trial procedure for patent infringement and invalidity 

claims. Here, the false marking and unfair competition counterclaims raised by Novel, 

especially with respect to damages issues, are far beyond the Hatch-Waxman Act’s criteria for 

quick patent dispute adjudication. 

Further, Novel’s counterclaims do not appear to comport with the limited counterclaims 

available under the Hatch-Waxman Act for improper listing of a patent in the Orange Book. See

21 U.S.C. § 355(j)(5)(C)(ii)(I). Other district courts in this district have reached a similar 

conclusion in Hatch-Waxman Act cases where the defendant brought a counterclaim for patent 

misuse in which the underlying facts alleging the improper listing of a patent in the Orange Book 

were substantially similar to Novel’s false marking and unfair competition counterclaims. See 

Takeda Pharmaceutical Co., Limited v. Zydus Pharmaceuticals USA, Inc., 2011 WL 2115819 

(D.N.J., May 25, 2011); Schwarz Pharma, Inc. v. Teva Pharmaceuticals USA, Inc., 2005 WL 

4158850 (D.N.J., February 4, 2005). 

Notwithstanding the above, even if the Hatch-Waxman Act does not preclude Novel’s 

third counterclaim alleging false marking under 35 U.S.C. § 292, Novel cannot satisfy the 

requisite elements of this claim. To set forth a claim for false marking under 35 U.S.C. § 292, 

Novel must demonstrate: (1) marking of an unpatented article, and (2) intent to deceive the 

public. Given that the Court has granted summary judgment for Braintree on its infringement 

claims, it is clear that SUPREP is covered by ‘149 patent. As such, Novel cannot satisfy the first 

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element of its false marking counterclaim, as it cannot establish the false marking of an 

unpatented article. 

Similarly, even if the Hatch-Waxman Act does not preclude Novel’s fourth counterclaim 

alleging unfair competition under Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), Novel 

cannot satisfy the requisite elements of this claim. Section 43(a) of the Lanham Act states, in 

part: 

Any person who, on or in connection with any goods or services, 

or any container for goods, uses in commerce any word, term, 

name, symbol, or device, or any combination thereof, or any false 

designation of origin, false or misleading description of fact, or 

false or misleading representation of fact, which . . . in commercial 

advertising or promotion, misrepresents the nature, characteristics, 

qualities, or geographic origin of his or her or another person's 

goods, services, or commercial activities, shall be liable in a civil 

action by any person who believes that he or she is or is likely to 

be damaged by such act. 15 U.S.C. § 1125(a)(1)(B). 

Liability under Section 43(a)(1)(B) of the Lanham Act arises where the claimant makes a 

commercial message or statement that is either (1) literally false, or (2) literally true but is 

ambiguous such that it has the tendency to deceive consumers. Novartis Consumer Health, Inc. 

v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 586 (3d Cir. 2002). Here, 

since the Court has previously awarded summary judgment to Braintree on its infringement 

claims, Novel cannot satisfy the above-listed elements of its unfair competition claim under 

Section 43(a) of the Lanham Act. 

Further, the parties seem to agree that with respect to a “claim under section 43(a) of the 

Lanham Act stemming from a patentee’s marketplace activity in support of his patent,” Novel 

“must first establish that the activity was undertaken in bad faith.” Judkins v. HT Window 

Fashion Corp., 529 F.3d 1334, 1338 (Fed. Cir. 2008); see also Zenith Elecs. Corp. v. Exzec, Inc., 

182 F.3d 1340, 1353 (Fed. Cir. 1999). Novel noted that “[a] clear case of bad faith can be made 

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out if the patent holder knows that the patent is not infringed and yet represents to the 

marketplace that a competitor is infringing. Id.; see also D.P. Wagner Manufacturing , Inc. v. 

Pro Patch Sys., Inc., 434 F. Supp. 2d 445, 461 (S.D. Tex. 2006)” (parenthetical omitted). (ECF 

No. 181, p. 32-33). Since the Court has previously awarded summary judgment to Braintree on 

its infringement claims, Novel cannot establish bad faith here. 

Finally, even if the Hatch-Waxman Act does not preclude Novel’s fifth counterclaim 

alleging unfair competition under New Jersey law, Novel has failed to establish the required 

elements of this claim. With the exception of the interstate commerce requirement, “the 

elements of the unfair competition torts proscribed by New Jersey law and by section 43(a) of 

the Lanham Act are the same.” SK&F, Co. v. Premo Pharm. Labs., Inc., 625 F.2d 1055, 1066 

(3d Cir. 1980). As such, the Court’s analysis and conclusions with respect to Novel’s fourth 

counterclaim alleging unfair competition under Section 43(a) of the Lanham Act, which are set 

forth above, apply with full force to Novel’s fifth counterclaim alleging unfair competition under 

New Jersey law. 

Accordingly, the Court grants Braintree’s motion for summary judgment on Novel’s 

third, fourth, and fifth counterclaims, as these claims appear to be beyond the scope of this 

Hatch-Waxman Act litigation and lack merit. 

Defendant’s Rule 56(e) Motion 

 

In a motion pursuant to rule 56(e) motion, Novel asserts that certain of Braintree’s 

responses to Novel’s proposed Undisputed Facts under Local Civil Rule 56.1 are “[i]nsufficient,” 

and that the Court should “deem those facts undisputed.” (ECF No. 199 at 4, 7). 

Local Civil Rule 56.1 provides that a party moving for summary judgment “shall furnish 

a statement which sets forth material facts as to which there does not exist a genuine issue, in 

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separately numbered paragraphs citing to the affidavits and other documents submitted in 

support of the motion.” In response, the summary judgment opponent “shall furnish . . . a 

responsive statement of material facts,” in which the opponent “cit[es] to the affidavits and other 

documents submitted in connection with the motion.” L. Civ. R. 56.1. Federal Rule of Civil 

Procedure 56 governs motions for summary judgment. Rule 56(a) provides that “[a] party may 

move for summary judgment,” and states the circumstances in which summary judgment is 

appropriate. The remaining sections of Rule 56 provide procedures and parameters for 

evaluating summary judgment motions. See Fed. R. Civ. P. 56(b)-(h). Among these, Rule 56(e) 

provides for a variety of possible remedies where, on a motion for summary judgment, “a party 

fails to properly support an assertion of fact or fails to properly address another party’s assertion 

of fact as required by Rule 56(c).” 

Novel’s 56(e) arguments are without merit. Braintree’s response to each of the alleged 

“undisputed” facts has a legitimate basis. Braintree, as is its right, has legitimately disputed the 

facts that Novel complains about in its 56(e) motion, even though many are not material to 

summary judgment. Braintree is not obligated to admit facts it considers to be untrue. In 

addition, where supposed “uncontested” facts contain vague, ambiguous and imprecise language, 

a party may refrain from admitting them. 

Accordingly, Novel’s Rule 56(e) motion is denied. 

Defendant’s Motion to Strike 

Novel filed a motion to strike to (1) preclude Braintree from relying on its argument 

concerning the term “a patient” and strike portions of the Expert Reply Report of David Peura, 

M.D., and (2) strike the entirety of the Declaration of David G. Adams in Support of Braintree 

Laboratories, Inc.’s Motion for Summary Judgment on Novel Laboratories, Inc.’s Third, Fourth, 

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and Fifth Amended Counterclaims (“the Adams Declaration”), because Braintree failed to 

disclose its position that the asserted claims of the ‘149 patent are infringed on a per patient 

basis. As stated above, and for the following reasons, Novel’s motion is denied. 

Braintree’s “A Patient” Argument 

In the District of New Jersey, the “Local Patent Rules” emphasize early disclosure of 

infringement and invalidity contentions for patent cases arising under the Hatch-Waxman Act. 

Local Patent Rule 3.6 sets out disclosure requirements for generic drug patent litigation arising 

under the Hatch-Waxman Act, including infringement contentions for identified Asserted 

Claims. L. Pat. R. 3.6(g). The rules require leave of court for amendments to contentions, 

disclosures, or documents required to be filed or exchanged. L. Pat. R. 3.7. In addition, Federal 

Rule of Civil Procedure 26 provides that in civil litigation in general parties are expected to 

disclose aspects of their cases during the discovery process. See e.g., Fed. R. Civ. P. 26(e). The 

Rules provide that a party may be sanctioned for failing to make timely disclosures of required 

information or to supplement disclosures based on new information. See Fed. R. Civ. P. 

37(c)(1)(C). Sanction for failing to disclose required information include prohibiting 

introduction of such withheld information in evidence and striking pleadings in whole or in part. 

See Fed. R. Civ. P. 37(b)(2)(A). 

Federal Rule of Civil Procedure 12(f) permits a party to move to strike from any pleading 

“any insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” Fed. 

R. Civ. P. 12(f). “A court possesses considerable discretion in disposing of a motion to strike 

under Rule 12(f).” Kim v. Baik, 2007 U.S. Dist. LEXIS 13553 (D.N.J. Feb. 27, 2007) (quoting 

River Road Dev. Corp. v. Carlson Corp., No. 89-7037, 1990 U.S. Dist. LEXIS 6201, 1990 WL 

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69085, at *2 (E.D.Pa. May 23, 1990)). Moreover, motions to strike are disfavored and usually 

will be denied. 

Here, contrary to Novel’s argument, Braintree sufficiently disclosed its infringement. For 

example, in its Infringement Contentions, Braintree put Novel on notice that Novel’s copy of 

SUPREP meets the “a patient” limitation of the asserted claims. Braintree’s proposed 

construction of the term “clinically significant electrolyte shifts”, which used the term “a 

subject” instead of the term “any patient” found in Novel’s construction, also achieved the same. 

As Novel was on notice of Braintree’s theory, Novel’s assertion that Braintree’s conduct will 

prejudice Novel is baseless. In addition, Novel’s assertion that the Local Patent Rules require 

more than Braintree provided is without merit. Nothing in the Local Rules, or the caselaw, 

requires a patent holder to explain the meaning of every claim term – especially a term, like “a”, 

that has a well-established meaning in patent law – or to identify “a patient” as a term requiring 

construction. 

The Adams Declaration 

The Court also declines to grant Novel’s motion to strike with respect to the Adams 

Declaration. The Adams Declaration is admissible because it is factual evidence that is helpful 

to the trier of fact. See Fed. R. Evid. 702; Fed. R. Evid. 704; Kumho Tire Co. v. Carmichael, 526 

U.S. 137, 149 (1999); Berckeley Inv. Group, Ltd. v. Colkitt, 455 F.3d 195, 217-19 (3d Cir. 2006). 

Admissibility of expert testimony is committed to the broad discretion of the trial court. See 

Berckeley, 455 F.3d at 217 (“The District Court has discretion to determine whether expert 

testimony will help the trier of fact”). 

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 Federal Rule of Evidence 702, governing the admissibility of expert evidence, provides: 

A witness who is qualified as an expert by knowledge, skill, experience, training, or 

education may testify in the form of an opinion or otherwise if: 

(a) the expert's scientific, technical, or other specialized knowledge will help the 

trier of fact to understand the evidence or to determine a fact in issue. 

(emphasis added). Federal Rule of Evidence 704 provides that “[a]n opinion is not objectionable 

just because it embraces an ultimate issue.” The touchstone of admissibility of expert evidence 

is thus helpfulness. See also Berckeley, 455 F.3d at 217 (“The District Court has discretion to 

determine whether expert testimony will help the trier of fact”). 

 While testimony as to the governing law of the case, or whether a party complied with its 

legal duties arising under a particular law, is not admissible, attorneys may provide expert 

testimony on the custom and practice of a regulated industry and the negotiations of regulated 

parties with regulators in an area governed by a statutory framework. See id. at 217-18. Indeed, 

courts often permit testimony as to the practice and procedures of a government agency, such as 

the USPTO. See, e.g., Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1361 n.2 

(Fed. Cir. 2008). Here, the Adams Declaration is helpful to the trier of fact because it provides 

factual evidence as to the practices and procedures under Hatch-Waxman and FDA Law and 

their interaction with the patent regime. The Adams Declaration is also helpful because it 

contains factual evidence of the FDA’s conduct towards SUPREP and Novel’s ANDA. Finally, 

nothing in the Federal and Local Rules or case law negates the admissibility of the Adams 

Declaration. Accordingly, Novel’s motion to strike is denied. 

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Conclusion 

 For the reasons stated above, Braintree’s motion for summary judgment of infringement 

is granted, and Novel’s motion for summary judgment of non-infringement is denied. 

Braintree’s motion for summary judgment on Novel’s third, fourth, and fifth counterclaim is also 

granted. Novel’s motion for summary judgment on invalidity, and its motion to strike and Rule 

56(e) motion are also denied. 

 s/Peter G. Sheridan 

 PETER G. SHERIDAN, U.S.D.J. 

January 18, 2013 

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