Hatch-Waxman Act/ANDA Litigation
Indivior and Aquestive Therapeutics (Suboxone®)
Representation of Indivior Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. against Dr. Reddy's, Alvogen, Par, and Teva in Hatch-Waxman patent litigation involving Suboxone® sublingual film brand drug product, which treats opioid dependency (annual worldwide sales totaling more than $1 billion). In these hotly-contested matters, Indivior and Aquestive were able to enjoin at-risk launches of generic product by obtaining a TRO against Alvogen and both a TRO and a preliminary injunction against Dr. Reddy's, as well as defeating three post-TC Heartland transfer motions brought by Dr. Reddy's, Alvogen, and Teva.
Sumitomo Dainippon Pharma and Sunovion (Latuda®)
Representation of Sumitomo Dainippon Pharma Co., Ltd. and Sunovion Pharmaceuticals Inc. against Teva, Emcure, and InvaGen in Hatch-Waxman patent litigation involving the Latuda® brand drug product, an anti-psychotic drug, which treats schizophrenia and depression in adults with bipolar disorder (annual sales totaling approximately $1 billion). The case concluded after a favorable Markman ruling forced the defendants to concede infringement and validity of Sunovion's patent. The court's ruling was appealed to the Federal Circuit and was affirmed in April of 2018 in favor of Sumitomo and Sunovion.
Celgene (Otezla®)
Representation of Celgene Corporation against Mankind, Torrent, Glenmark, MSN, Teva, Prinston, Emcure, Macleods, Aurobindo, Hetero, Cipla, Alkem, Zydus, Unichem, Dr. Reddy's, Amneal, Pharmascience in Hatch-Waxman patent litigation involving the Otezla® brand drug product, which treats moderate to severe plaque psoriasis (annual worldwide sales totaling more than $1.5 billion).
Helsinn and Roche Palo Alto (Aloxi®)
Representation of Helsinn Healthcare S.A. and Roche Palo Alto LLC against Teva and Dr. Reddy's in Hatch-Waxman patent litigation involving the Aloxi® brand drug product, an intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (annual sales totaling more than $600 million). In the case against Teva, following a 12-day bench trial, the court issued a 167-page opinion and judgment in favor of Helsinn on infringement and validity, upholding Helsinn's patents over multiple claims of obviousness and the on-sale bar provisions of the America Invents Act, which was an issue of first impression due to changes in the AIA. The trial decision was reversed on appeal at the Federal Circuit. After granting a writ of certiorari, the U.S. Supreme Court affirmed the Federal Circuit in early 2019.
Mitsubishi Tanabe and Janssen (Invokana® and Invokamet®)
Representation of Mitsubishi Tanabe Pharma Corp., Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, Janssen Research and Development, LLC, and Cilag GmbH International against Aurobindo, Macleods, InvaGen, Prinston, Dr. Reddy's, Hetero, Apotex, MSN, Laurus Labs, Indoco, Zydus, Sandoz, Teva, and Lupin in Hatch-Waxman patent litigation involving the Invokana® and Invokamet® brand drug products, which treat diabetes (annual sales totaling more than $1 billion).
Celgene (Pomalyst®)
Representation of Celgene Corporation against Par, Teva, Hetero, Aurobindo, Apotex, Mylan, Synthon, and Breckenridge in Hatch-Waxman patent litigation involving the Pomalyst® brand drug product, which treats multiple myeloma (annual worldwide sales totaling approximately $2 billion).
Merck (Emend® IV)
Representation of Merck Sharp & Dohme Corp. in a trial victory against Sandoz Inc. in Hatch-Waxman patent litigation involving the Emend® IV brand drug product (market value of judgment in excess of $1.5 billion). Emend® IV is an intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (annual sales totaling more than $400 million). Following a bench trial that took place over the course of two weeks -- and with just two days to spare before the 30-month stay expired -- the court upheld the validity of Merck's compound patent, finding that its claims were valid and infringed.
Sunovion Pharmaceuticals (Lunesta®)
Representation of Sunovion Pharmaceuticals (formerly Sepracor Inc.) against 10 generic pharmaceutical manufacturers in Hatch-Waxman patent litigation concerning the Lunesta® brand drug product, a highly successful sleep aid (annual sales totaling approximately $1 billion). The case concluded at the Federal Circuit with a precedent-setting judgment of infringement and dismissal of all inequitable-conduct defenses in favor of Sunovion. Prior to the appeal, the district court issued one of the first post-Exergen decisions dismissing a generic drug manufacturer's inequitable-conduct defense.
Jazz (Xyrem®)
Representation of Jazz Pharmaceuticals against Roxane, Amneal, Par, Ranbaxy, Watson, Sun, Wockhardt, and Lupin in Hatch-Waxman patent litigation involving the Xyrem® brand drug product, which treats cataplexy and daytime sleepiness in narcolepsy patients (annual sales totaling approximately $130 million).
Supernus (Oxtellar XR®)
Representation of Supernus Pharmaceuticals Inc. in two trial victories against Actavis and Twi Pharmaceuticals in Hatch-Waxman patent litigation involving the Oxtellar XR® brand drug product, a once-daily antiepileptic drug indicated for adjunctive therapy for the treatment of seizures in adults and in children 6 to 17 years of age (annual sales totaling approximately $10 million). Following two separate bench trials, the court issued judgments in favor of Supernus on infringement and validity. Both trial decisions were appealed to the Federal Circuit and were affirmed in favor of Supernus.
Vivus (Qsymia®)
Representation of Vivus against Actavis and Dr. Reddy's in Hatch-Waxman patent litigation involving the Qsymia® brand drug product, an extended-release weight loss drug that uses a combination of phentermine and topiramate (annual sales totaling approximately $20 million).