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

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Civ. No. 11-cv-1341 (PGS), 2013 U.S. Dist. LEXIS 78587 (D.N.J. June 4, 2013) (Sheridan, J.)

Drug Product and Patent(s)-in-Suit: SUPREP^® (sodium sulfate / potassium sulfate / magnesium sulfate oral solution); U.S. Patent No. 6,946,149 (“the ’149 patent”) 

Nature of the Case and Issue(s) Presented: The ’149 patent claims compositions and methods for cleaning the colon of a patient prior to a colonoscopy or other medical procedures without causing clinically significant electrolyte shifts. On summary judgment, Novel’s ANDA product was found to infringe the asserted claims of the ’149 patent. Here, the court conducted a six-day bench trial concerning Novel’s invalidity counterclaim. The court considered Novel’s arguments that the ’149 patent is anticipated in view of a prior art patent to Hechter; that the ’149 patent is obvious in view of the prior art as a whole; and that the claims of the ’149 patent are indefinite because each contains the word “copious,” which Novel argued is not definable in terms of how much stool constitutes a “purgation,” as the district court defined that term. The court held that the ’149 patent was not invalid.

Why Braintree Prevailed: Regarding the issue of obviousness, the court introduced each party’s respective expert and reiterated each expert’s testimony concerning the prior art. Ultimately, the court found that Braintree’s expert was more credible and adopted his opinions concerning what the prior art taught and whether a person of ordinary skill in the art would look to certain prior art references. The court found that Novel’s expert witness relied on art that (i) a person of ordinary skill in the art would not review; (ii) did not meet scientific standards; and (iii) was so brief so as to have minimal content to inform a person of ordinary skill. The court further found that the inventors conducted detailed experimentation—not routine experimentation—in coming up with their invention. The court, therefore, found that the ’149 patent was not obvious.

The ’149 patent claims an aqueous hypertonic solution. In the process for making the solution disclosed in the prior art Hechter patent, an aqueous hypertonic solution is created, but the court found that the ultimate solutions discussed in Hechter are isotonic solutions, not hypertonic. As such, Hechter did not anticipate the ’149 patent.

Finally, the court held that the word “copious,” referring to the amount of stool that is purged from the colon, was not indefinite. One of the inventors testified at trial that a copious amount “has to be substantial” and that it did “not have to be a defined volume, but it’s a large volume.” Another Braintree employee, who had been responsible for drafting the ’149 patent application, testified that copious would not be a “small volume of stool.” The court—which relied also on Justice Stewart’s famous quote “I know it when I see it!”—found that the testimony presented by Braintree did not allow Novel to meet its clear and convincing burden in support of Novel’s indefiniteness argument.