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 that generate, or cite to, data.
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 and Follow-On Applicants
- Advocate for data owners against registrations obtained without appropriate data citation and compensation
- For those entering the pesticide market by citing to data, ensure that the compensation paid is reasonable and limited to data that is compensable and supports the specific product being registered
- 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 negotiations, 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
Our Experience
B&C attorneys have substantial experience developing and implementing strategies for market entrants and long-time players alike in managing effectively their competitive positions in the market. We help develop strategies to meet clients’ business and commercial needs in the marketplace, creatively use FIFRA’s antitrust provisions to optimum advantage to achieve our clients’ commercial goals, assist with managing data compensation needs, and represent clients in data compensation negotiations and arbitration proceedings. B&C has authored dozens of publications addressing the evolution of precedential cases and issues that data owners and follow-on registrants confront in data compensation negotiations. These articles are born of real-world experience with dozens of FIFRA matters that have been managed successfully to our clients’ competitive and commercial gain.
Lynn L. Bergeson, Managing Partner, has earned an international reputation for her deep and expansive understanding of FIFRA and she employs a highly sophisticated, nuanced approach to problem solving as she assists corporations, trade associations, and business consortia to commercialize new technologies, access new markets, extend the commercial life of an efficacious chemical product, obtain a derogation of a chemical use, or secure a competitive advantage in a new market or territory.
Lisa M. Campbell, Partner, offers an unparalleled breadth and depth of experience and expertise in finding and implementing solutions to challenging pesticide and chemical product regulatory issues. She has assisted clients in negotiating unique data compensation agreements and arrangements that are tailored to particular commercial needs, and obtained an arbitration award that for the first time took into account a “risk premium” factor, which has become a consideration in subsequent data compensation negotiations and arbitrations.
Lisa R. Burchi, Of Counsel, delivers more than 25 years of experience in FIFRA data compensation issues, representing both data owners and follow-on applicants. She has assisted in successfully negotiating settlement agreements to resolve data compensation obligations as well as steering clients through the binding arbitration process mandated by FIFRA when settlement cannot be reached. She also assists clients in determining and substantiating study costs and the amount of compensation owed for reliance on certain data. Senior Associate Kelly N. Garson assists the B&C team in developing strategies to represent clients during data compensation proceedings.
B&C professionals also include non-attorney experts. James V. Aidala, Senior Government Affairs Consultant, has over 30 years of experience in the field, including serving as Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) and on Capitol Hill working on pesticide issues. Mr. Aidala also provides expert witness services on data compensation matters.
Dana S. Lateulere, a Regulatory Consultant with over 30 years of FIFRA registration experience, including a decade with the EPA Office of Pesticide Programs (OPP), has extensive experience with data compensation analysis. Dana also provides expert witness services on data compensation issues. Heather F. Collins, MS, a Regulatory Consultant with a focus on FIFRA registration, has vast experience with data compensation analysis and is skilled in optimizing data generation for clients in a cost-effective way. Meibao Zhuang, Ph.D., Senior Scientist/Regulatory Consultant, evaluates data reliance options and compensation impacts to optimize regulatory strategy for new pesticide product data generation and submission. Dr. Zhuang has conducted comprehensive reviews of EPA databases to analyze underlying data packages submitted for FIFRA pesticide and new active ingredient registrations.
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 global 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.