On March 15, 2016, District Judge Alison J. Nathan granted defendant Breckenridge Pharmaceutical, Inc.’s (“Breckenridge”) motion for summary judgement of noninfringement of plaintiff Braintree Laboratories Inc.’s (“Braintree”) U.S. Patent No. 6,946,149 (the “‘149 patent”).  Breckenridge had sought FDA approval of a generic version of Braintree’s SUPREP colon cleansing solution, which Braintree alleged infringed the ‘149 patent.

The ‘149 patent is directed to both “a composition for inducing purgation of the colon of a patient” and the method for doing so.  The composition claim requires that it “compris[e] from about 100 mL to about 500 mL of an aqueous hypertonic solution . . . .”  Breckenridge argued that it did not infringe the composition claim because its generic version consisted of 946 mL of solution, more than is claimed by the patent.  Braintree argued that because the solution is ingested over two doses (each 473 mL), each use was within the claim’s 100 mL to 500 mL limitation.  Braintree also argued that because it had made this argument successfully in a separate infringement action against another generic manufacturer in the District of New Jersey, which the Federal Circuit affirmed in Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. 2014), Breckenridge was precluded from arguing otherwise.  Judge Nathan disagreed, noting that the Federal Circuit had not addressed Breckenridge’s specific argument. Reaching the merits of the motion, the court agreed with Breckenridge that the specification and prosecution history both indicated that the volume measurement was taken of the solution as a whole.  Thus, the generic product could not infringe either the independent composition claims or the dependent method claims.

Breckenridge also argued successfully that the method that the FDA approved for its generic product was not covered by the ‘149 patent’s method claim, and so the claim could not be infringed by its generic product.

Case:  Braintree Labs. Inc. v. Breckenridge Pharm., Inc., No. 12-CV-6851 (AJN) (S.D.N.Y. Mar. 15, 2016).  The patent-in-suit is U.S. Patent No. 6,946,149.