In an April 10 decision, the U.S. District Court for the Middle District of North Carolina ruled that FIFRA precludes claims of copyright infringement for the required parts of the labels of “me-too” registered products. The decision was issued in Syngenta Crop Protection, LLC v. Willowood, LLC., a lawsuit in which Syngenta alleged that Willowood had willfully and knowingly violated copyright protections of one of its product labels when Willowood used substantial portions of the label for a generic me-too version of the product in question. The North Carolina District court decision rejected the conclusions of the U.S. District Court for the Eastern District of Pennsylvania issued in a previous case, FMC Corp. v. Control Solutions, Inc., involving similar claims of copyright infringement of the pesticide label.
In a very lengthy 2005 decision, the Pennsylvania District court found that Control Solutions, Inc. had willfully infringed on the copyright of the label of one of FMC’s proprietary pesticide products (TalstarOne). The court stated, “…To quickly enter the same market, defendant CSI took an impermissible short-cut. Instead of investing the resources necessary to develop an independent product label, CSI simply appropriated FMC’s existing copyrighted labels. Wholesale copying, as CSI did with FMC’s label, is not consistent with the statutes, regulations or process mandated by the EPA for having a me-too pesticide registered to permit the sale of a generic pesticide product.” The Pennsylvania District court issued a temporary injunction against CSI “to prevent further sales or facilitation of sales of any product utilizing a product label that has been approved by the EPA…based upon a me-too submission by CSI that consists of a product label based on the virtually verbatim copying of the TalstarOne label.”
However, in its recent ruling, the North Carolina District court found the decision issued in 2005 to be “unconvincing,” concluding instead that federal pesticide law “contemplates that a [generic] applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright…Congress intended a narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.”
The issue of copyright infringement as it pertains to a generic registrant’s use of a basic manufacturer’s product label for a me-too pesticide has been a contentious legal topic over the years. Shortly after the decision in FMC Corp. v. Control Solutions, Inc., CPDA wrote a July 11, 2005 letter to Susie Hazen who was then OPPTS Deputy Assistant Administrator at EPA. In its letter, CPDA voiced concerns that the court decision could trigger a deluge of me-too label changes submitted to the Agency by companies seeking to avert the possibility of copyright infringement legal action brought by the original manufacturer. CPDA also pointed out the difficulties inherent in making each product label different from other labels so as to avoid the risk of infringing on the copyright while at the same time making sure that any variations would not confuse the user.
EPA responded with a letter agreeing with these and other concerns raised by CPDA. In its letter, the Agency affirmed the practice of the Office of Pesticide Programs (OPP) under FIFRA Section 3(c)(7)(A) to encourage me-too product labels to be identical or substantially similar to the labels of the products on which their registrations are based. EPA emphasized that similar products need to communicate use instructions and warnings in a clear and consistent manner to ensure that the products are used appropriately. The Agency cautioned that variations on the label for similar products could diminish EPA’s ability to enforce pesticide labeling in a consistent manner thus defeating the primary purpose of labeling. CPDA will continue to keep a watchful eye on any further legal developments on this issue should they occur.