Everything Compliance-Episode 63, the Novartis edition
Episode 150 -- Novartis Settles False Claims Act and Anti-Kickback Cases for $729 Million
Daily Compliance News: July 2, 2020-the Novartis Pays More edition
Compliance into the Weeds: Episode 178-the Novartis FCPA Enforcement Action
Episode 148 -- A Review of the Novartis and Alcon FCPA Enforcement Action
In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more
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® (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
In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...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
NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 18-1043-KAJ (D. Del. August 10, 2020) (Jordan, J.)... Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 9,187,405 (“the ’405...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
Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 104969 (D. Del. June 24, 2019) (Stark, 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. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 101106 (D. Del. June 17, 2019) (Stark, J.)....more
Case Name: Novartis Pharma Co. v. West-Ward Pharms. Int’l, No. 2018-1434, 2019 U.S. App. LEXIS 14122 (Fed. Cir. May 13, 2019) (Circuit Judges Stoll, Plager, and Clevenger presiding; Opinion by Stoll, J.) (Appeal from D. Del.,...more
Case Name: Novartis AG v. Ezra Ventures LLC, Fed. Cir. No. 2017-2284, 2018 U.S App. LEXIS 34459 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Moore, Chen, and Hughes presiding; Opinion by Chen, J.) (Appeal from D. Del., Stark,...more
Case Name: Novartis Pharms. Corp v. Breckenridge Pharm. Inc., No. 2017-2173, 2018 U.S. App. LEXIS 34462 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Prost, Wallach, and Chen; Opinion by Chen, J.) (Appeal from D. Del., Andrews,...more
Case Name: Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd., 15-cv-474-RGA, 2017 U.S. Dist. Lexis 205600 (D. Del. Dec. 14, 2017) (Andrews, J.)....more
Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more
Last week, the California Supreme Court in T.H. v. Novartis Pharmaceuticals Corp., became the first state high court to recognize the doctrine of “innovator liability,” unanimously holding that brand-name prescription drug...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
Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229...more
Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more
Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more
The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more