Novartis Pharmaceuticals Corp. v. Handa Pharmaceuticals, Inc.
Unverified- Docket:
- 1:22-cv-00352
- Filed:
- 2022-03-21
Suit against Handa Pharmaceuticals asserting the '405 patent; details and outcome not verified from the narrative.
Plaintiff
8 cases as plaintiff.
Novartis Pharmaceuticals Corp. is the U.S. operating subsidiary of Novartis AG, the Swiss multinational pharmaceutical group headquartered in Basel, Switzerland (founded 1996 via the merger of Ciba-Geigy and Sandoz). The U.S. arm is based in East Hanover, New Jersey. Novartis AG is publicly traded on the NYSE and SIX Swiss Exchange (ticker: NVS), with a market cap of roughly $269 billion, revenue of about $56.7 billion in FY2025, and approximately 75,000–78,000 employees (post-2023 spinoff of its generics unit, Sandoz).
Operations. Novartis discovers, develops, manufactures, and markets innovative prescription medicines across four core therapeutic areas: cardiovascular–renal–metabolic, immunology, neuroscience, and oncology. Major marketed brands include Entresto (heart failure), Cosentyx (psoriasis and related inflammatory conditions), Kesimpta (multiple sclerosis), Kisqali (breast cancer), Promacta, Pluvicto, Leqvio, Tafinlar, and Mayzent. The company also operates the Novartis Institutes for BioMedical Research.
Patent-litigation posture. This is squarely an operating company, not an NPE: it develops and sells real products and holds the underlying patents. The case data show 8 tracked appearances, all as plaintiff and none as defendant — a profile typical of a brand pharmaceutical manufacturer enforcing its Orange Book patents. All eight are Hatch-Waxman (ANDA) infringement suits against generic drugmakers seeking FDA approval to market copies of Novartis products before patent expiry. Cases cluster heavily in the U.S. District Court for the District of Delaware, the standard venue for Hatch-Waxman litigation, with appeals reaching the Federal Circuit and Supreme Court.
Notable cases. The tracked docket includes suits against generic challengers such as Handa Pharmaceuticals (siponimod/Mayzent), Apotex (dabrafenib/Tafinlar), Accord Healthcare, HEC Pharm (appealed to the Supreme Court), Teva, Sun Pharma, Mylan, and Handa Neuroscience. External context: the Entresto patent battles were consolidated into MDL No. 2930 in Delaware and produced bench-trial rulings on validity (e.g., Novartis v. Hetero USA, 2024), while Novartis has reported settling Kisqali compound-patent litigation with generic entrants. (Sources: Novartis 20-F and investor materials; Fortune; US News; PitchBook; public dockets.)
Watchlist
Email-only, free, anonymous. We'll notify you when Novartis Pharmaceuticals Corp. files another patent-infringement lawsuit. One-click unsubscribe from any alert.
Suit against Handa Pharmaceuticals asserting the '405 patent; details and outcome not verified from the narrative.
ANDA/Hatch-Waxman suit against Apotex asserting the '405 patent; resolved by confidential settlement licensing entry before patent expiry.
Appeal from D. Del. 1:18-cv-01043. The Federal Circuit first affirmed validity and infringement on January 3, 2022, then on rehearing vacated and reversed, holding the '405 patent claims invalid for lack of written description (38 F.4th 1013). Rehearing en banc was denied and mandate issued approximately October 18, 2022.
Petition for certiorari from the Federal Circuit's invalidation of the '405 patent; emergency stay of mandate was granted by Chief Justice Roberts on 2022-09-29; certiorari was denied (143 S. Ct. 1748).
ANDA suit against Teva (ANDA No. 208008) asserting the '405 patent; filed around 2018-07-16 and settled.
ANDA suit against Sun Pharma entities asserting the '405 patent; filed around 2018-07-16 and settled.
ANDA suit against Mylan (ANDA No. 208005) asserting the '405 patent; settled with proposed consent judgment and injunction filed 2020-10-26; later dispute over post-CAFC launch led to TRO entered 2022-10-11.
Suit against Handa entities asserting the '405 patent and also US 10,543,179. Handa sought summary judgment on the '405 patent after the Federal Circuit's June 2022 invalidation; final disposition not verified.