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Chris is a founding partner of Green, Griffith & Borg-Breen LLP. A seasoned IP trial lawyer with over 30 years of experience in IP law, his practice concentrates on pharmaceuticals, chemicals, medical devices and biotechnology. He has been lead counsel in trials and appeals, representing both patentees and defendants, before the U.S. District Courts and the Federal Circuit.
A Hatch-Waxman expert, he partners with clients to provide strategic formulation, portfolio and pre-litigation counseling concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications.
With expertise gained by representing brand and generic companies, he provides strategies and opinions (validity, freedom-to-operate) directed toward attaining client goals, whether this involves API/excipient selection, trade dress, formulation attributes, or labeling, and then works with clients to execute the desired strategy – whether this involves litigation in the federal courts, IPRs or arbitration.
Chris has been instrumental in obtaining favorable outcomes. Recently, he was counsel for Horizon in successful Hatch-Waxman litigations concerning PENNSAID® 2% against several ANDA challengers, resulting in settlements with favorable generic entry dates and judgment of infringement/not invalid against Actavis/TEVA. He also was counsel for Dexcel in a successful declaratory judgment action against Takeda involving Dexcel’s 505(b)(2) OTC lansoprazole product. Other successful outcomes include the first generic for PLENDIL® and the invalidation of Orange Book patents on GENERESS FE®.
Chris and his team are also skilled in inter partes reviews (IPRs). He also has significant experience in navigating the 505(b)(2) pathway, including advising clients on PIV certification, Orange Book issues, related FDA issues, and portfolio development. Due diligence also is a strength.
Key Practice Areas:
- Filing & Prosecution
- IP Office Proceedings
- IP Transactions
- Strategy & Advisory
- Pharmaceuticals inc Biotechnology + Life Sciences
Last updated 17th April 2018