Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN initiatives and intensifying commercial pressures, regulatory tools are becoming an important strategic lever for shaping market entry and influencing pricing dynamics, bringing regulatory activity into closer alignment with IP, competition and commercial decision-making.
Using FDA citizen petitions as a case study, this session will examine how often underutilised regulatory mechanisms can be deployed to influence market access and shape competitive positioning, and explore how these engagement tools intersect with IP strategy and antitrust risk.
- How are companies using regulatory tools, such as FDA citizen petitions, to complement IP strategy and support long-term product protection?
- To what extent can regulatory mechanisms be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing dynamics and broader market access outcomes?
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory tools, such as citizen petitions?
Ha Kung Wong
Ha Kung Wong has over 20 years of experience practicing general intellectual property law with an emphasis on complex patent and trade secret litigation as well as IP transactions and contract negotiations for mergers, acquisitions, and collaborations in pharmaceuticals, biologics, and chemistry. Cases Mr. Wong has litigated include those related to proton pump inhibitors, allergy eye drops, anti-epileptic drugs, anti-tussive, injectable microspheres, RNAi products, and other pharmaceuticals. Mr. Wong also has extensive experience with Inter Partes Review, Post Grant Review, intellectual property counseling, pharmaceutical regulatory counseling, pre-suit investigations, licensing, and due diligence.
Mr. Wong has his BS with high distinction in Chemistry and his BS in Biochemistry from the University of Illinois Urbana-Champaign and his JD, cum laude, from the University of Notre Dame. Mr. Wong is currently an elected member of the Venable Board, is an Advisory Board Member for the Center for Biosimilars, is Treasurer, Executive Committee member, and Board Trustee for the Foundation for Advancement of Diversity in IP Law (FADIPL) and serves as faculty for the National Institute of Trial Advocacy (NITA) and Lawline.