Understanding the Impact of Carve-Out Regulations and Recent Legal Developments on Generic Drug Approval and Patent Protection.
The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.
Furthermore, as other skinny-labeling-related cases continue to emerge which emphasize the need for legal professionals, businesses, and other practitioners to remain up to date with recent developments to successfully navigate this area of law.
Join distinguished experts Jason A. Lief (Windels Marx) and Ha Kung Wong (Venable LLP) for an in-depth discussion on the latest developments impacting Hatch-Waxman litigation. The speakers will share valuable insights, including practical advice and strategies, to help navigate the dynamic legal landscape in this field.
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Partner at Windels Marx Lane & Mittendorf, LLP
Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion-dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence. Beyond litigation, Jason also counsels clients on various intellectual property issues. Jason’s approach is to partner with clients to comprehensively understand the scientific, legal and business concerns they face. Listening to clients and asking the right questions is the key to winning. As Jason often says, “litigation is the art of the question.
Partner at Venable LLP
Ha Kung Wong practices general intellectual property (IP) law with an emphasis on complex patent and trade secret litigation, as well as IP transactions and contract negotiations for mergers, acquisitions, vendor agreements, and collaborations in pharmaceuticals, biologics, chemistry, medical devices, digital health, and artificial intelligence. Cases Ha Kung has litigated include those related to proton pump inhibitors, anti-epileptic drugs, anti-tussives, ADHD medications, injectable microspheres, RNAi products, antibiotics, and other pharmaceuticals. Ha Kung also has extensive experience with inter partes review, post-grant review, IP counseling, pre-suit investigations, licensing, and due diligence, including patent strength and freedom-to-operate analyses.
