Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation. After all, communications with regulatory bodies are often performed by...more
BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more
Adrenalin® (epinephrine injection) - Case Name: Par Pharm., Inc. v. Hospira, Inc., No. 2020-1273, 2020 WL 6846347 (Fed. Cir. Nov. 23, 2020) (Circuit Judges Dyk, Taranto, and Stoll presiding; Opinion by Taranto, J.)...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more
Case Name: Belcher Pharms., LLC v. Hospira, Inc., No. 17-775-LPS, 2020 WL 1650535 (D. Del. Mar. 31, 2020) (Stark, J.) - Drug Product and Patent(s)-in-Suit: epinephrine injection; U.S. Patent No. 9,283,197 (“the ’197...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
WHILE THE DISTRICT COURT’S FINDING OF LITERAL INFRINGEMENT WAS REVERSED, THE FEDERAL CIRCUIT AFFIRMED THE DISTRICT COURT’S FINDING OF INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENT BECAUSE THE NARROWING AMENDMENT WAS...more
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....more
Case Name: Eli Lilly & Co. v. Hospira, Inc., Civ. No. 12-3460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550 (S.D. Ind. June 15, 2018) (Pratt, J.)....more
Case Name: Hospira, Inc. v. Amneal Pharms. LLC, No. 15-cv-697, 2018 U.S. Dist. LEXIS 9307 (D. Del. Jan. 22, 2018) (Andrews, J.)....more
Case Name: The Medicines Co. v. Hospira, Inc., 2014-1469, 2014-1504 (Fed. Cir. Feb. 6, 2018) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Andrews, J.)....more
Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more