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

April 17, 2013

GENERICally Speaking

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Civ. No. 11-1341, 2013 U.S. Dist. LEXIS 7698 (D.N.J. Jan. 18, 2013) (Sheridan, J.)

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

Nature of the Case and Issue(s) Presented: Plaintiff Braintree brought two motions for summary judgment: (i) for infringement; and (ii) dismissing defendant Novel’s false marking and unfair competition counterclaims. Novel brought two summary judgment motions: (i) non-infringement; and (ii) invalidity on the basis of obviousness. The Court granted Braintree’s motions and denied Novel’s motions for summary judgment.

Why Braintree Prevailed:  The court first addressed Braintree summary judgment motion of infringement and Novel’s summary judgment motion of non-infringement. The asserted claims, which purport to cover a pre-colonoscopy bowel prep drug, all share the following elements: (i) inducing purgation of the colon; (ii) a composition comprising from about 100 ml to 500 ml of an aqueous hypertonic solution; (iii) comprising an effective amount of the three active ingredient sulfate salts; (iv) without producing any “clinically significant electrolyte shifts;” and (v) not including phosphate. The Court first addressed whether Novel’s generic product produced any “clinically significant electrolyte shift.” It acknowledged that the construction of that term “turned into a major point of contention in the summary judgment motions” and that its original construction may have been “imprecise, and therefore must be clarified.” Ultimately, the Court determined that the element “clinically significant electrolyte shifts” concern “serious” adverse events, and not simply outside the normal upper or lower range measurement. Because SUPREP had not been associated with serious adverse events, and it was undisputed that Novel’s generic product was identical to SURPEP, it met this limitation. The Court also determined that the phrase “a patient”—which the Court interpreted to mean “one or more patients”—found in the asserted claims’ preamble supported its finding because “[t]here is no dispute that at least one patient to whom SUPREP is administered will experience, or has experienced, no clinically significant electrolyte shifts.”

SUPREP is administered in a split-dosing regimen, which means that one half dose is taken followed by a second half dose, which is administered hours (usually the next morning) later. Braintree argued that the one-half dose, which fell within the claimed volume limitation of 100-500 ml, induced purgation. Novel argued that Braintree’s theory of infringement was not only an off-label usage of the product, but that only after the entire administration of SUPREP, which was greater than the claimed volume limitation, would there be an induction of purgation. Relying on Braintree’s expert affidavit, the Court found Novel’s generic product met the “induce purgation of the colon” claim limitation. The Court reasoned that 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. Additionally, because each one-half dose falls within the 100-500 ml volume limitation, the Court found that Novel’s generic product was a composition comprising from about 100 ml to 500 ml of an aqueous hypertonic solution. Finally, for purposes of infringement, because the Court found that Novel’s generic product induced purgation without producing clinically significant electrolyte shifts, and Novel’s generic product is equivalent to SUPREP, the Court held that it must necessarily contain an “effective amount” of the active ingredients claimed in the asserted claims.

In denying Novel’s motion for summary judgment of invalidity, the Court found 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 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.”

The Court then granted Braintree’s motion for summary judgment dismissing Novel’s false marking and unfair competition counterclaims. The Court wrote that “the false marking and unfair competition counterclaims…are far beyond the Hatch-Waxman Act’s criteria for quick patent dispute adjudication” and that “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.” Ultimately, the Court reasoned that because it had granted Braintree’s summary judgment of infringement and finding that SUPREP was covered by the asserted claims, Novel could not satisfy the elements of its counterclaims.

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