Intellectual Property Litigation
Helsinn and Roche Palo Alto (Aloxi®)
Representation of Helsinn Healthcare S.A. and Roche Palo Alto LLC in two separate trial victories against Teva and Dr. Reddy's involving the Aloxi® brand drug product (market value of judgments $3.2 billion). Aloxi® is an intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting with annual sales totaling more than $600 million. In the case against Teva, following a 12-day bench trial, U.S. District Judge Mary L. Cooper 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 case is now pending appeal in the Federal Circuit. In the"paper NDA" case against Dr. Reddy's, following a 6-day bench trial, Judge Cooper issued an opinion and judgment in favor of Helsinn on infringement and validity.
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 with 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 - U.S. District Judge Peter G. Sheridan upheld the validity of Merck's compound patent, finding that its claims were valid and infringed.
Sumitomo Dainippon Pharma and Sunovion (Latuda®)
Representation of Sumitomo Dainippon Pharma Co., Ltd. and Sunovion Pharmaceuticals Inc. against Teva, Emcure, and InvaGen in ANDA patent litigation involving the Latuda® brand drug product. Latuda® is an anti-psychotic drug used to treat schizophrenia and depression in adults with bipolar disorder with 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 case is now on appeal to the Federal Circuit.
Celgene (Revlimid®)
Representation of Celgene Corporation against Natco, Arrow, Watson, and Dr. Reddy's involving Celgene's blockbuster Revlimid® brand drug product. Revlimid® is a more potent derivative of its predecessor Thalomid® and is used to treat multiple myeloma and certain blood disorders known as myelodysplastic syndromes. Revlimid® has annual sales totaling more than $6 billion. This representation is ongoing with respect to the case against Dr. Reddy's.
Sunovion Pharmaceuticals (Lunesta®)
Representation of Sunovion Pharmaceuticals (formerly Sepracor Inc.) against 10 generic pharmaceutical manufacturers (one of the largest Hatch-Waxman cases filed) in ANDA patent litigation concerning the blockbuster Lunesta® brand drug product. Lunesta® is a highly successful sleep aid with worldwide recognition of its butterfly/moth ads and 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. U.S. District Judge Dennis M. Cavanaugh issued one of the first post-Exergen decisions dismissing a generic drug manufacturer's inequitable-conduct defense.
Boehringer (Pradaxa®)
Representation of Boehringer Ingelheim against Teva, Alkem, Mylan, and Breckenridge in ANDA patent litigation involving the Pradaxa® brand drug product. Pradaxa® is an anticoagulant that prevents stroke and blood clots in patients who have atrial fibrillation. Annual sales of Pradaxa® total approximately $800 million. Boehringer prevailed on a motion to dismiss for lack of personal jurisdiction brought by Mylan in the wake of the Supreme Court's Daimler decision, which was an emerging issue in Hatch-Waxman litigation across the country and an issue of first impression in the District of New Jersey. This representation is ongoing.
University of Illinois (Prezista®)
Representation of the Board of Trustees of the University of Illinois against six generic pharmaceutical manufacturers in patent litigation involving the Prezista® brand drug product. Prezista® is an HIV treatment drug, and the University's patent covered a method of using Prezista® in combination with another drug to overcome patient resistance to HIV treatment. Prezista® has annual sales totaling approximately $230 million. The case concluded with a favorable settlement for the University.
Supernus (Oxtellar XR®)
Representation of Supernus Pharmaceuticals Inc. in a trial victory against Actavis and Watson in patent litigation involving the Oxtellar XR® brand drug product. Oxtellar XR® is a novel, 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 of Oxtellar XR® total approximately $10 million. Following a seven-day bench trial, U.S. District Judge Renee M. Bumb issued a judgment in favor of Supernus on infringement and validity. A second case against TWI Pharmaceuticals was tried in 2017 and is pending a decision by Judge Bumb.
Jazz (Xyrem®)
Representation of Jazz Pharmaceuticals against Roxane, Amneal, Par, Ranbaxy, Watson, Sun, Wockhardt, and Lupin in patent litigation involving the Xyrem® brand drug product. Xyrem® is a drug used to treat cataplexy and daytime sleepiness in narcolepsy patients with annual sales totaling approximately $130 million. This representation is ongoing and a trial is anticipated in 2018.
Johnson & Johnson-DePuy Orthopaedics (Pinnacle® and Duraloc® Acetabular Cup Systems)
Representation of DePuy (a division of New Jersey-based Johnson & Johnson) in patent litigation against Stryker involving DePuy's Pinnacle® and Duraloc® Acetabular Cup Systems, which have annual sales totaling approximately $200 million. Following a favorable Markman ruling for DePuy, Stryker conceded its infringement suit against DePuy and moved for a judgment pursuant to Fed. R. Civ. P. 54(b). DePuy successfully defeated that motion, which eventually led to Stryker withdrawing all of its infringement claims against DePuy.
Gilead (Letairis®)
Representation of Gilead Sciences, Inc. and Royalty Pharma Collection Trust against Watson, Actavis, and Sigmapharm in patent litigation involving the Letairis® brand drug product. Letairis® is an oral drug used for the treatment of pulmonary arterial hypertension with annual sales totaling approximately $595 million. The case was settled in 2017 on terms highly favorable to Gilead.
Celgene (Abraxane®)
Representation of Celgene Corporation and Abraxis Bioscience, LLC against Actavis and Cipla in ANDA litigation involving Celgene's Abraxane® brand drug product. Abraxane® is an injectable drug used to treat breast, lung, and pancreatic cancers, among others, with annual sales totaling approximately $1 billion. This representation is ongoing.
BioMarin (Kuvan®)
Representation of BioMarin Pharmaceutical Inc. and Merck & Cie against Dr. Reddy's and Par in patent litigation involving the Kuvan® brand drug product. Kuvan® is a drug used to reduce blood Phe levels in patients with Phenylketonuria with annual sales totaling approximately $60 million. The case was settled in 2017 on terms highly favorable to BioMarin.
Vivus (Qsymia®)
Representation of Vivus against Actavis and Dr. Reddy's in patent litigation involving the Qsymia® brand drug product. Qsymia® is a weight loss drug that uses a combination of phentermine and topiramate extended-release with annual sales totaling approximately $20 million. This representation is ongoing.