Endo Par Innovation Co.
v. BPI Labs, LLC

Case Name: Endo Par Innovation Co. v. BPI Labs, LLC, C.A. No. 8:23-cv-1953-WFJ-TGW, 2024 WL 730478 (M.D. Fla. Feb. 22, 2024) (Jung, J.) 

Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents Nos. 9,119,876 (“the ’876 patent”) and 9,295,657 (“the ’657 patent”)

Nature of the Case and Issue(s) Presented: Endo holds an NDA on Adrenalin. Adrenalin is a clear, colorless, sterile parental solution containing the active ingredient L-epinephrine and is intended for intramuscular or subcutaneous administration, and it’s primarily used for emergency treatment of anaphylactic reactions. In 2012, FDA expressed a number of concerns regarding the epinephrine formulation in Adrenalin, and the fact that it can degrade and react with other ingredients to form epinephrine sulfonic acid (“ESA”), or can racemize in aqueous solution to form D-epinephrine, both of which cause a decrease in the effective concentration of the active ingredient. This could decrease the potency of the drug and if left unaddressed, might become “unacceptable to patients suffering from emergency anaphylaxis who need potent medication in a short period of time.” Endo modified the Adrenalin formulation resulting in lower impurity levels and improved potency over a longer period of time or shelf life, and submitted supplemental NDAs for its reformulated product. The patents-in-suit cover the modified epinephrine compositions, methods of administration, and methods of making the same.

BPI holds an NDA for epinephrine injection, which FDA approved on July 29, 2014. BPI also recently submitted to FDA a supplement that is currently unapproved. On July 17, 2023, BPI sent Endo its First Notice Letter explaining why the patents-in-suit were invalid or not infringed. Endo notified BPI that the letter was deficient and did not include an offer of confidential access. BPI sent a Second Notice Letter on August 9, 2023. Endo maintained that the Second Notice Letter remained deficient because it ”failed to provide, for each claim of the Patents-in-Suit, a full and detailed explanation of why the claim is not infringed or is invalid or unenforceable.” Endo also noted that BPI did not provide Endo the entire NDA or the supplement and that relevant parts were redacted.

Endo sued BPI for infringement. BPI moved to dismiss or, in the alternative, moved for a more definite statement. The court denied BPI’s motion.

Why Endo Prevailed: All that is required to state a claim for infringement pursuant to 35 U.S.C. § 271(e)(2) are Plaintiff’s: (i) interest in the patent-in-suit; (ii) receipt of a paragraph IV certification; (iii) knowledge that an ANDA or NDA has been filed in the FDA; and (iv) contention that the defendant’s proposed product will infringe. Endo has alleged each of those elements. Par Pharmaceuticals is the assignee of the patents-in-suit, Par Innovations is their exclusive licensee, and Par Sterile is the holder of the NDAs. Endo received the First and Second Notice Letters. BPI holds an NDA in which it sought to supplement seeking approval from the FDA. Finally, Endo’s complaint alleges that BPI’s proposed product infringes the asserted claims of the patents-in-suit. Nothing more is required under § 271(e)(2).

The court also denied BPI’s relief under Rule 12(e). Federal courts disfavor motions for a more definite statement in view of the liberal pleading requirements set forth in Fed. R. Civ. P. 8. If a complaint “indicates generally the type of litigation involved, it is sufficient to put the Defendants on notice.” Endo’s complaint accomplishes this goal and is sufficient to allow BPI to prepare a responsive pleading.