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Braintree Laboratories, Inc. v. Novel Laboratories, Inc.

United States Court of Appeals, Federal Circuit

April 22, 2014

BRAINTREE LABORATORIES, INC., Plaintiff-Appellee,
v.
NOVEL LABORATORIES, INC., Defendant-Appellant

As Amended May 5, 2014.

Page 1350

[Copyrighted Material Omitted]

Page 1351

Appeal from the United States District Court for the District of New Jersey in No. 11-CV-1341, Judge Peter G. Sheridan.

JOHN J. REGAN, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston, Massachusetts, argued for plaintiff-appellee. With him on the brief were MARK C. FLEMING, NISHAT A. SHAIKH, JENNIFER C. BROWN, and MICHAEL A. GREENE; and CHRISTOPHER R. NOYES, of New York, New York.

RONALD M. DAIGNAULT, Robins, Kaplan, Miller & Ciresi L.L.P., of New York, New York, argued for defendant-appellant. With him on the brief were DAVID LEICHTMAN, MATTHEW B. MCFARLANE and OREN D. LANGER.

Before DYK, PROST, and MOORE, Circuit Judges. Opinion for the court filed by Circuit Judge PROST. Opinion concurring in part, dissenting in part, and concurring in the result filed by Circuit Judge DYK. Dissenting opinion filed by Circuit Judge MOORE.

OPINION

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Prost, Circuit Judge .

This is a patent infringement case under the Hatch-Waxman Act. See 35 U.S.C. § 271(e)(2)(A). Defendant-Appellant Novel Laboratories, Inc. (" Novel" ) appeals the grant of summary judgment by the United States District Court for the District of New Jersey tat U.S. Patent No. 6,946,149 (" '149 patent" ) held by Braintree Laboratories, Inc. (" Braintree" ) is infringed by the composition covered by Novel's abbreviated new drug application (" ANDA" ). See Braintree Labs., Inc. v. Novel Labs., Inc., No. 11-CV-1341, 2013 WL 211252 (D.N.J. Jan. 18, 2013) (" Infringement Opinion " ). The district court entered summary judgment of infringement based on its construction of four disputed claim terms. See Braintree Labs., Inc. v. Novel Labs., Inc., No. 11-CV-1341, 2012 WL 4120907 (D.N.J. Sept. 19, 2012) (" Claim Construction Order " ). Novel challenges the district court's claim construction for two of those terms. Following a six-day bench trial on Novel's invalidity defenses, the district found that Novel failed to prove that the asserted claims were invalid. See Braintree Labs., Inc. v. Novel Labs., No. 11-CV-1341, 2013 WL 2970739 (D.N.J. June 4, 2013) (" Validity Opinion " ). Novel also appeals those findings.

Because we agree with Novel that the district court erred in its construction of the claim term " clinically significant electrolyte shifts," we reverse the district court's claim construction of that term, vacate the district court's grant of summary judgment of infringement, and remand for further factual findings to determine whether the composition covered by Novel's ANDA product infringes under the new claim construction articulated herein. Further, we affirm the district court's findings that the asserted claims of the '149 patent are not invalid.

I. Background

Braintree is a pharmaceutical company that manufactures the SUPREP® Bowel Prep Kit (" SUPREP" ), which helps to prepare patients for colonoscopies. The colon needs to be visually clear in order to successfully perform a colonoscopy, so prior to the examination patients typically drink several liters of a solution to induce diarrhea.

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By the late 1990s, two colon cleansing options existed, both of which had some disadvantages. The first option was considered the safest but required patients to drink large volumes of unappetizing isotonic prep formulas, resulting in low patient compliance. The second option was to administer a low-volume, hypertonic prep. However, this option caused severe electrolyte shifts, leading to heart failure, kidney failure, neurological impairment, and even death.

Braintree's '149 patent discloses a combination of magnesium sulfate, potassium sulfate, and sodium sulfate, which can be digested in small volumes to safely and effectively induce colonic purging without causing clinically significant electrolyte shifts. See, e.g., '149 patent abstract.

Claim 15, which the parties agree is representative, recites:

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.

Ex Parte Reexamination Certificate, '149 patent col. 2 ll. 23-30 (emphases added).

Braintree alleges that SUPREP is a commercial embodiment of the '149 patent. Novel is a generic drug manufacturer.

II. Procedural History

On November 8, 2010, Novel filed an ANDA for a proposed generic copy of SUPREP. A few months later, Novel sent Braintree a Paragraph IV certification of invalidity/noninfringement letter asserting that " each of the claims of the '149 patent is either invalid or is not infringed" by Novel's product. On March 9, 2011, Braintree filed this action seeking a declaration that Novel's ANDA product infringes the '149 patent. Novel asserted counterclaims of noninfringement and invalidity.

After construing claim terms, the district court granted summary judgment of infringement in Braintree's favor and denied Novel's motion for reconsideration, ruling that SUPREP meets all limitations of the asserted claims. See Infringement Opinion [WL] at *10. Following a bench trial regarding validity, the district court found that Novel " did not show proof that met the clear and convincing standard" that the asserted claims were anticipated, nor were they obvious or indefinite. Validity Opinion [WL] at *25-26.

III. Discussion

This appeal concerns challenges to the district court's claim constructions, its grant of summary judgment regarding infringement, and its findings following a bench trial regarding validity. Regarding claim construction, Novel argues that the district court misconstrued the claim terms " purgation" and " clinically significant electrolyte shifts." Based on these erroneous claim constructions, Novel argues that the district court improperly granted Braintree's motion for summary judgment on infringement. Regarding validity, Novel argues that the district court erred when it failed to find that (1) U.S. Patent No. 4,975,286 (" Hechter" ) anticipates the asserted claims of the '149 patent; (2) the prior art, as understood by a person of skill in the art, renders the asserted claims obvious; and (3) the asserted claims are invalid because the term " purgation" is indefinite under 35 U.S.C. § 112, ¶ 2. We address each of Novel's challenges in turn.

A. Claim Construction

Claim construction is a question of law, Markman v. Westview Instruments, Inc.,

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52 F.3d 967, 976-79 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), that we review de novo without deference. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-55 (Fed. Cir. 1998) (en banc).

1. Purgation

The district court construed " purgation" to mean " an evacuation of a copious amount of stool from the bowels after oral administration of the solution." Claim Construction Order [WL] at *6. In adopting this construction, the district court rejected Novel's argument that " purgation means cleansing," concluding that " [a]lthough cleansing is a term in the specification of the '149 [p]atent, [the asserted claims] clearly adopt purgation as the methodology to improve visualization of the colon." [WL] at *3.

On appeal, the parties dispute the construction of the claim term " purgation" because the asserted claims cover compositions " comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution." Ex Parte Reexamination Certificate, '149 patent col. 2 ll. 24-26. Braintree sells SUPREP in a kit containing two six-ounce bottles of concentrated solution, along with a dilution cup. A patient must dilute each of the two six-ounce bottles with ten ounces of water to form two sixteen-ounce solutions. Each of those half-dose sixteen ounce solutions has a total volume of 473 mL, which is within the range found in the asserted claims of the '149 patent, but Braintree concedes that neither dose accomplishes a full cleansing. Thus, Braintree's " one bottle" infringement theory asserts that one (half-dose) bottle of SUPREP, diluted with water to become a sixteen ounce solution, falls within the asserted claims. This infringement theory can prevail if purgation means the " evacuation of a copious amount of stool from the bowels after oral administration of the solution," which is something less than a full cleansing.

Novel argues that SUPREP does not infringe the asserted claims if " purgation" means cleansing, because a full cleansing only occurs after ingesting 946 mL of solution (i.e., two doses). Pointing to the specification, Novel alleges that the physiological event that the inventor contemplated was cleansing the colon for a colonoscopy. See, e.g., '149 patent title, abstract. Novel also relies on a passage in the specification which indicates that a dosage amount is " effective" only if it produces a clean colon in preparation for a colonoscopy or other surgical procedures. Id. at col. 5 ll. 19-24 (" Optimally, the effective dose may be divided and administered, to the patient in two, or more administrations over an appropriate time period. Generally, 2 doses administered of equal portions of the effective dose, separated by 6 to 24 hours produce satisfactory purgation." ). Thus, Novel argues that an effective amount of solution must cleanse the colon.

Novel also points to Braintree's 2010 patent term extension request, where Braintree represented to the U.S. Patent and Trademark Office (" PTO" ) that " [t]he SUPREP product is an osmotic laxative for cleansing ( i.e., purging ) of the colon . . . ." J.A. 22172 (emphasis added). Therefore, Novel argues that Braintree's representation that purgation is equivalent to cleansing reflects the proper construction of " purgation."

While we have considered all of Novel's arguments supporting its proposed construction of " purgation," we find them unpersuasive. " In construing claims, the analytical focus must begin and remain centered on the language of the claims themselves, for it is that language that the patentee chose to use to 'particularly point[] out and distinctly claim[] the subject matter which the patentee regards as

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his invention.'" Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (quoting 35 U.S.C. § 112, ¶ 2 (1975), amended by 35 U.S.C. § 112(b)). The asserted claims here only require that the compositions " induce" (i.e., bring about or start) diarrhea. The claims do not contain language that requires achieving a fully cleansed colon for a colonoscopy. Thus, while cleansing is the goal specifically articulated in the specification, it is not a claim requirement. See Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010) (citation omitted) (" There is an inference . . . that two different terms used in a patent have different meanings." ).

Novel's reliance on the claim term " effective amount" is also misplaced. The district court construed " effective amount" as an amount of solution " necessary to produce a colonic purgation, while not producing clinically significant electrolyte shifts," and Novel has not challenged this construction. Claim Construction Order [WL] at *5. Since an " effective amount" only requires purgation and not a full cleansing, it is consistent to construe purgation as an evacuation of a copious amount of stool. Although the specification contemplates a scenario in which an effective amount could produce a full cleansing, it does so only in terms of a preferred embodiment. See Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1342 (Fed. Cir. 2010) (citation omitted) ( " '[I]t is improper to read limitations from a ...


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