On Jan. 22, 2019, Federal Circuit upheld (Rule 36 Judgment) a lower court ruling that Amneal’s proposed ANDA product of Precedex infringes a valid Hospira patent & remaining patents are invalid. 

Previously, on Jan 22, 2018, District court of Delaware found 3 patents invalid & infringed and remaining 1 patent valid & infringed by Amneal (reported here on this blog). Specifically, Plaintiff (Hospira) asserted claims 3 and 4 of U.S. Patent No. 8,242,158; claim 4 of U.S. Patent No. 8,338,470; claim 5 of U.S. Patent No. 8,455,527 and claim 6 of U.S. Patent No. 8,648,106. The’ 158, ‘470, and’ 106 patents each describe ready-to-use pharmaceutical compositions of dexmedetomidine disposed within a sealed glass container.  Considering all of the evidence, court concluded that defendant has proven by clear and convincing evidence that claims 3 and 4 of the ‘158 patent, claim 4 of the ‘470 patent, and claim 5 of the ‘527 patent are invalid as obvious but it has failed to provide clear and convincing evidence that claim 6 of the ‘ 106 patent is invalid. Particularly, court determined that the defendant failed to establish inherency of the “about 2%” limitation”. With respect to infringement court held that Amneal infringes the asserted claims of the patents including ’106 patent as a matter of law.