abbreviated new drug application

Following a four-day bench trial before him in Shire Orphan Therapies LLC et al. v. Fresenius Kabi USA, LLC, Civil Action No. 15-1102-GMS (D.Del. June 5, 2018), and having considered the entire record in the case and the applicable law, The Honorable Gregory M. Sleet issued the Court’s Memorandum setting forth the findings of fact

By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on the Pleadings of defendants Macleods Pharmaceuticals, Ltd. and Macleods Pharma USA, Inc. (collectively, “Macleods”).

Plaintiff Amgen filed the patent infringement

By Memorandum Order entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al., Civil Action No. 14-1203-LP (D.Del. October 16, 2017), the Court denied Defendants motion for attorneys’ fees and expenses under 35 U.S.C. § 285. 35 U.S.C. § 285 provides that, in “exceptional” patent cases, a

Following a three-day bench trial in the matter on June 5-7, 2017 and after having considered the entire record in the case and the applicable law, the Court, through Trial Opinion, entered by The Honorable Richard G. Andrews in Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc., Civil Action No. 15-451-RGA (D.Del. October 13,

Following a five-day bench trial in the matter in February 2017 and after having considered the entire record in the case and the applicable law, the Court, through Memorandum, entered by The Honorable Gregory M. Sleet in Tris Pharma, Inc. v. Actavis Laboratories FL, Inc., Civil Action No. 14-1309-GMS (consolidated) (D.Del. September 6, 2017),

By Memorandum Order entered by The Honorable Leonard P. Stark in UCB, Inc., et al. v. Watson Laboratories, Inc. et al., Civil Action No. 14-1083-LPS-SRF (D.Del., May 19, 2017), the Court denied Defendants’ motion for reargument of its Order entered on December 5, 2016, in which the Court denied Plaintiffs’ request for a stay,

By Memorandum Opinion entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civil Action No. 14-1203-LPS (D.Del. March 6, 2017), the Court granted Defendants’ motion for summary judgment of non-infringement of the asserted claims of U.S. Patent No. 6,955,821 (“the ‘821 patent”) and U.S. Patent No. 7,838,032 (“the

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Recro Gainesville LLC v. Actavis Laboratories FL, Inc., Civil Action No. 14-1118-GMS (D.Del. February 24, 2017)(consolidated), the Court, following a three-day bench trial and having considered the entire record in the case and the applicable law, concluded that Actavis’ proposed ANDA products infringe

By Memorandum Opinion entered by The Honorable Sue L. Robinson in Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 14-874-SLR (D.Del., November 16, 2016), the Court found the asserted claims of U.S. Patent No. 6,127,353 (“the ‘353 patent”) are valid but that defendant does not infringe the asserted claims

By Memorandum Opinion entered by the The Honorable Sue L. Robinson in Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., et al., Civil Action No. 14-1268-SLR (D.Del., May 18, 2016), the Court granted Defendants’ motion to dismiss Plaintiff’s first amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) after finding that Plaintiff’s claims