Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more
Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.) Drug Product and Patent(s)-in-Suit: Entresto®...more
Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more
Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more
Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more
Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more
Case Name: Piramal Healthcare US Ltd. v. Novartis Pharms. Corp., No. 19-12651 (SRC), 2020 U.S. Dist. LEXIS 38849 (D.N.J. Mar. 5, 2020) (Chesler, J.)....more
Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more
Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more