The cost of commercializing a product subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) jurisdiction is high. Carefully managing and protecting the investment in the intellectual property supporting a FIFRA registration is essential to commercial success. To reward and encourage product innovation, Congress established under FIFRA provisions for compensation rights in data submitted to support product registration. This data compensation scheme helps product registrants remain competitive by preventing excess windfalls to follow-on registrants. Data compensation is both a sword and a shield, however, and its nuanced competitive implications are often overlooked, underutilized, or misunderstood by product registrants.

Bergeson & Campbell, P.C. (B&C®) attorneys and non-attorney professionals have the legal, scientific, and business know-how that enables them effectively to represent their clients’ legal and business positions, and align them with positions taken in other global markets.

What We Do

B&C professionals have a strong track record representing clients in all aspects of FIFRA data compensation matters and at all stages. Our clients include basic data owners and follow-on, generic registrants. Sample advocacy includes:

  • Registration Protection for Data Owners –
    • Advocate for data owners against registrations obtained without appropriate data citation and compensation
  • Data Compensation Protection –
    • Assist in protecting rights to data compensation – – including data stewardship – – across jurisdictions
  • Data Compensation Maximization –
    • Assist in making compensable relevant and costly non-data call-in (DCI) data
  • Recordkeeping –
    • Consult on record maintenance to ensure maximum return on investment and preparedness for possible business disputes in the form of arbitrations and civil actions
  • Data Management –
    • Assist in effectively and strategically generating data
  • Dispute Resolution –
    • Develop and implement effective data compensation negotiation strategies for both data owners and follow-on registrants that result in agreements and avoid the significant transaction costs associated with arbitration proceedings and litigation
  • Arbitration Proceedings –
    • Analyze registrant data costs and position the registrant to maximize compensation awarded in arbitration proceedings

Representative Engagements

  • B&C professionals have negotiated and arbitrated data compensation rights for many FIFRA data owners and follow-on registrants.
  • B&C professionals design, implement, and maintain data development strategies and data protection systems to ensure their clients’ investment in data rights are monetized appropriately and managed effectively.
  • With the assistance of its consulting affiliate, The Acta Group (Acta®), B&C successfully aligns international agricultural and biocidal chemical product data programs to ensure data are optimized and developed to procure market dominance and sustained growth.
  • B&C professionals ensure FIFRA data development is undertaken in a way to minimize cost, regulatory disruption, and adverse effects reporting.