Structuring Non-Infringement Opinions and Reducing Risk of Patent Infringement: Key Considerations and Provisions

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). 

Mr. Waters concentrates his practice on drafting and prosecuting patents for mechanical and electrical innovations. In particular, he has experience with patent issues relating to GPS, Internet and e-commerce, semiconductor devices and processing methods, and telecommunications. While Mr. Waters’ practice focuses on patent drafting and prosecution, he also has experience with patent litigation, having defended multiple patent infringement lawsuits. Mr. Waters also has experience in conducting due diligence investigations and drafting opinions.