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Pesticide Data Compensation under FIFRA

Overview:

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.

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 market place, 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 principals Lynn Bergeson and Lisa Campbell, and B&C counsel Lisa Burchi, have 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 borne of real-world experience with dozens of FIFRA matters that have been managed successfully to our clients’ competitive and commercial gain.

B&C professionals also include non-attorney experts. James Aidala has over 30 years experience in the field, including serving as Assistant Administrator of EPA’s 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.

Heather Collins, M.S., a Regulatory Consultant with a focus on FIFRA registration, has extensive experience with data compensation analysis and is skilled in generating data for clients in a cost effective way. 

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.  

 

• Biobased Chemicals and Biofuels
• Biotechnology
• Chemical Regulation under TSCA
• Chemical Regulation under FIFRA
• Consortia Management
• Endocrine Disruptors
• Expert Witness Services
• FDA Regulation of Food Contact and Packaging Material
• Fumigants
• GHS Services
• Global Chemical Regulatory Services
• Global Legal Services
• International Trade Issues
• Mergers and Acquisitions/Due Diligence
• Metals
• Nanotechnology
• Other Special Regulatory Programs
• Pesticide Data Compensation under FIFRA
• Pesticide Regulation under FIFRA
• Public Policy
• Regulation of Dietary Supplements
• Transport of HazMat and Dangerous Goods
• Water Quality