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Copyright law protects the contents of a label for a pesticide, and a generic manufacturer therefore cannot simply copy the brand-name-maker’s label verbatim, a federal judge has ruled. In her 77-page opinion in FMC Corp. v. Control Solutions Inc., U.S. District Judge Gene E.K. Pratter issued a preliminary injunction in which she ordered a generic manufacturer to cease using the copied label and to destroy all existing copies. If the injunction is upheld, the practical effect will be that CSI will be required to pull its generic product from the market for at least three months as it undergoes the rigorous process to win approval for a new label it writes on its own. According to court papers, insecticide labels are often hefty documents — sometimes coming in the form of a 10-page booklet — and are strictly controlled by federal law. Every label must be approved by the Environmental Protection Agency before a product hits the shelves. But Pratter found that the EPA regulations are not so strict that they require generic manufacturers to issue identical labels. Instead, Pratter found that the label itself is an “original work of authorship” protected by copyright law, and that generic manufacturers must therefore do their own work in drafting a label that satisfies the EPA. “To quickly enter the same market, defendant CSI took an impermissible shortcut,” Pratter wrote. “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,” Pratter wrote. The ruling is a victory for attorneys Abbe F. Fletman, Robert F. Zielinski and Kelly Dobbs Bunting of Wolf Block Schorr & Solis-Cohen. In the suit, FMC contends that in the early to mid-1980s, it developed bifenthrin, a chemical that kills termites and other pests. The product was marketed under the brand name TalstarOne Multi-Insecticide and quickly became one of FMC’s best selling products. After the patent on bifenthrin expired, the suit says, generic producers were free to market their own bifenthrin products. But in early 2005, the suit says, FMC learned that CSI was marketing a bifenthrin product under the name Bifen I/T with a label that is “virtually identical” to FMC’s label. The only differences between CSI’s label and FMC’s, the suit says, is the substitution of the name of the generic product. The suit alleges that “the process of creating a pesticide label involves creativity, time and money, and reflects many years of careful product development and stewardship.” TalstarOne’s label, the suit says, is a 10-page booklet in small type that contains “specific and detailed directions for use, directions for storage and disposal, information about application rates, precautionary statements and narrative text describing first-aid instructions and environmental, physical and chemical hazards.” The suit alleges that FMC “spent more than 13 years and nearly $400,000 in the process of developing the TalstarOne label before it was ready to be made available to customers in the form of released label packaging.” And since TalstarOne was launched, the suit says, FMC has spent more than $1 million promoting it. Pratter found that CSI began distributing Bifen I/T more than five years after FMC’s patent on bifenthrin expired. The product contains the exact ingredients, in the identical proportions as TalstarOne, Pratter found, and is therefore “functionally equivalent” to it. Pratter also found that the label for Bifen I/T was prepared and submitted to the EPA as part of a so-called “me-too” submission in which the agency grants an expedited review of labels with significantly similar content to labels for products that are already on the market. CSI’s lawyers, Jeffrey L. Squires and Amy M. Morton of Garvey Schubert Barer in Washington, D.C., argued that it is a common practice for those seeking registration of generic pesticide products to engage in essentially verbatim copying of the content of labels for the earlier-registered pesticide on which the generic product is based. Pratter disagreed, saying “CSI suggests that such outright copying is what EPA requests and expects in evaluating applications to register generic products for sale.” Instead, Pratter found there was “no evidence, statute or regulation that permits or authorizes such direct infringement or plagiarism. Nor is there any indication within the applicable statutes and regulations to provide support for CSI’s proposition that copyright law is to be pre-empted in the context of consumer or commercial product labels.” CSI also argued that the EPA would be forced to use significant additional resources to review “me-too” labels if they needed to compare language that is different from the original label or presented at different places on the label. The task would be burdensome, CSI argued, since the EPA would be required constantly to determine whether the alternative language has the same meaning as the language originally approved by EPA for the pioneer product. Pratter rejected that argument, too, saying, “without a doubt, checking two documents merely to determine whether they are identical is not difficult. That is not the task assigned to the EPA reviewing staff, and this court has more faith and confidence in the EPA’s abilities.” Pratter found there was no reason to doubt that EPA workers have the education, skill and experience to determine, in a side-by-side comparison, whether the language in purportedly similar labels has the same import. Finally, CSI argued that under the type of drafting that FMC insists is appropriate and consistent with copyright law, an expedited EPA review would become an impossibility. Pratter found that argument was flawed because FMC presented evidence in the injunction hearing of instances in which the EPA has been able to comply with the regulatory expedited time requirements when approving a me-too label application that “consisted of language drafted to merely be substantially and substantively similar without being a near-verbatim copy.” A CSI executive, Pratter said, testified that CSI copied FMC’s label “because CSI desired quicker entry and distribution into the bifenthrin-based pesticide market than it could enjoy if CSI took the time and expended effort to create its own label and submit it for EPA approval.” Pratter lauded the witness for his honesty, but faulted him on his understanding of the law. “This is a candid explanation of CSI’s motives, but candor does not make up for the fact that it is not a valid or legal defense to copyright infringement,” Pratter wrote. Pratter concluded that FMC was entitled to an injunction because it had shown that it is likely to succeed on its copyright claim and that it will be irreparably harmed if the infringing label is allowed to stay on the market during the litigation. “To not grant the preliminary injunction would reward CSI’s blatant copyright infringement,” Pratter wrote.

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