Pesticide Data Compensation under FIFRA
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.
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. Sheryl Dolan is widely recognized as a top FIFRA registration expert.
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:
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