Braintree Labs., Inc. v. Novel Labs., Inc.

• Decision Date: 18 January 2013
• Docket Number: Civil Action No. 11-1341 (PGS)
• Parties: BRAINTREE LABORATORIES, INC., Plaintiff, v. NOVEL LABORATORIES, INC., Defendant.
• Court: U.S. District Court — District of New Jersey

BRAINTREE LABORATORIES, INC., Plaintiff, v. NOVEL LABORATORIES, INC., Defendant.

Civil Action No. 11-1341 (PGS)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

January 18, 2013

NOT FOR PUBLICATION

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 onDecember 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 non-compliance, 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 sideeffects 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 infringeclaims 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.¹

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.

-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.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 ^REP and contains the same inactive ingredients." Novel's ANDA states that "[t]here is no difference between ^REP 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...