Joshua A. Whitehill’s practice focuses on patent litigation and strategy in the fields of pharmaceuticals and biotechnology.
Josh has more than ten years of experience representing and counseling life science clients in patent and technology disputes in federal district court, patent office proceedings, arbitration, and appeals. He has concentrated his practice on patent litigation relating to small molecules and biological products, including generic drug litigation under the Hatch-Waxman Act and biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA). Josh also has considerable experience advising biopharmaceutical companies on patent validity and infringement, pre-litigation strategy, patent and market landscapes, freedom to operate, and risk assessment and mitigation strategies.
Josh’s patent matters have involved a wide range of life sciences, including blockbuster and orphan drugs for oncology, immunology, gastroenterology, HIV, diabetes, cardiovascular disorders, men’s and women’s health, as well as gene-editing technologies, medical devices, and vaccines. He has a degree in chemistry.
Josh’s pro bono activities include representing clients in administrative proceedings related to veteran benefits, naturalization, VAWA status, and permanent residency status.
Work Highlights
Prior to joining Kasowitz:
- Teva Pharmaceuticals in securing a favorable settlement in a patent infringement lawsuit under the Hatch-Waxman Act filed by Pfizer concerning Viagra® (sildenafil citrate). Pursuant to the settlement, Teva exclusively launched the first generic version of Viagra® in the United States, several years before patent expiry.
- Teva Pharmaceuticals in prevailing on summary judgment in district court and then on appeal in a generic vs. generic patent infringement action brought by Momenta Pharmaceuticals and Sandoz concerning competing generic versions of Sanofi’s anticoagulant Lovenox® (enoxaparin sodium).
- Cephalon in prevailing at trial in Hatch-Waxman litigation against numerous defendants seeking to market generic versions of Cephalon’s cancer drug Treanda® (bendamustine hydrochloride).
- Teva Pharmaceuticals in prevailing at trial in a Hatch-Waxman litigation filed by Merck Sharp & Dohme concerning Teva’s proposed generic version of Nasonex® (mometasone furoate) nasal spray.
- Celltrion and Teva Pharmaceuticals in securing favorable settlements in patent litigation under the BPCIA and inter parties review (IPR) proceedings against Genentech concerning the companies’ biosimilars of Rituxan® (rituximab), an oncology and immunology drug, and Herceptin® (trastuzumab), a drug for Her2+ breast cancer.
- Boehringer Ingelheim in IPR proceedings concerning a biological product.
- Fresenius Kabi in securing a favorable settlement in Hatch-Waxman litigation against Onyx Therapeutics concerning a generic version of multiple myeloma drug Kyprolis® (carfilzomib).
- Teva Pharmaceuticals in securing a favorable settlement in Hatch-Waxman litigation against Janssen Pharmaceuticals and the United States concerning a generic version of HIV drug Prezista® (darunavir).
- Actavis in securing a favorable settlement in Hatch-Waxman litigation against multiple plaintiffs concerning a generic version of Relistor® (methylnaltrexone bromide), a drug for opioid-induced constipation.
- Teva Pharmaceuticals in securing a favorable settlement in Hatch-Waxman litigation against AstraZeneca concerning a generic version of diabetes drug Byetta® (exenatide).
- Teva Pharmaceuticals in securing a favorable settlement in Hatch-Waxman litigation against Novo Nordisk concerning a generic version of women’s health drug Vagifem (estradiol).