Induced Infringement in Pharma Litigation: Supreme Court Decision in Hikma v. Amarin, Guidance for Using Skinny Labels

Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization. Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.

Mr. Irving has more than 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. Mr. Irving has served as lead counsel in many patent interferences.

Mr. Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies (Apotex, Inc., Sandoz-Novartis, and Eon Labs, Inc.) and as a division counsel for a medical device company (The Cook Group), he is known for spearheading innovative business and legal strategies to protect existing drug or device patents – or challenge those of a competitor. A prolific writer and frequent speaker, Mr. Upadhye is the author of dozens of articles and has spoken on topics dozens of times at key industry conferences nationally and internationally. Further, he writes the 1400+ page leading book on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 13th Edition (2020). 

Ms. Wang is a first-chair trial lawyer who represents biotech, pharmaceutical, and technology companies in complex and high stakes intellectual property and commercial disputes across the country. She is a go-to resource for clients in the life sciences industry, including for “bet-the-company” patent litigation (including Hatch-Waxman and biosimilar litigation), post-grant review (PGR) and inter partes review (IPR) proceedings before the United States Patent Trial and Appeal Board (PTAB), trade secrets litigation, and contract, licensing, and other commercial disputes. She also routinely advises clients on the management of their US and global patent and litigation strategies, including regularly consulting with counsel before the EPO and in the UK, Germany, and other foreign jurisdictions. Ms. Wang's practice also includes regular representation of leading industry organizations in submitting amicus curiae briefs to the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit on a variety of key IP issues. She is also a frequent speaker and writer on IP-related topics and policies and has served in leadership roles in numerous organizations including the American Intellectual Property Law Association (AIPLA), the Alan D. Lourie Boston Intellectual Property American Inn of Court, and the Asian American Lawyers Association of Massachusetts (AALAM).