Addressing the issue of whether composition and method of use
claims covered a half dose, or were instead limited to the full
dose, the US District Court for the Southern District of New York
concluded that the claims were limited to the full dose and granted
defendant Breckenridge’s motion for summary judgment of
non-infringement. Braintree Labs Inc. v. Breckenridge
Pharmaceutical, Inc., Case Nos. 12-cv-6851 (S.D.N.Y. March 15,
2016) (Nathan, J.).
Breckenridge filed an abbreviated new
drug application (ANDA) seeking approval from the US Food and Drug
Administration (FDA) for a generic version of its drug Suprep®
(sodium sulfate, potassium sulfate and magnesium sulfate), which is
a laxative indicated for “cleansing of the colon in
preparation for colonoscopy in adults.” Braintree filed suit
contending that Breckenridge’s ANDA product would infringe
its ‘149 patent, which covers compositions for inducing
“purgation” of the colon and methods of using the
claimed