Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Syngenta Crop Protection v. Willowood, Nos. 2018-1614, -2044 (Dec. 18, 2019), holding that the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) does not necessarily require a generic registrant to copy the label of a registered product, and thus only conflicts with the Copyright Act to the extent some element of a label is protected under copyright law and necessary for approval of the generic product.
Syngenta sued certain Willowood entities for infringement of its fungicide compound patents and infringement of its copyrights in its fungicide product labels. The district court dismissed the copyright claims, holding claims under the Copyright Act, which prohibits unauthorized reproduction of protected elements of a valid copyright, are precluded by FIFRA, which provides for expedited EPA review of generic pesticide applications when the proposed generic “would be identical or substantially similar in composition and labeling” or would “differ in composition and labeling” “only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.” The court relied on SmithKline Beecham v. Watson Pharms., where the Second Circuit held the Hatch-Waxman Act governing generic drug approval “require[s] producers of generic drugs to use the same labeling as was approved for, and is used in, the sale of the pioneer drug” and, therefore, trumps the copyright laws.
The Federal Circuit vacated and remanded. The Court first noted the presumption that a later-enacted statute does not repeal an earlier one, and thus preclusion will only be found where the statutes are in “irreconcilable conflict,” which is “a ‘rarity.’” The Court then concluded the district court’s determination on preclusion was premature. The Court reasoned that FIFRA, unlike the Hatch-Waxman Act, does not “require a me-too registrant to copy the label of a registered product,” and thus only conflicts with the Copyright Act to the extent some particular element of Syngenta’s label is both protected under copyright law and necessary for the expedited approval of the generic pesticide product. The Court noted that this determination “requires this court to review the merits of Syngenta’s copyright claims, which the district court did not reach.” The Court explained that only after this analysis on remand, which would include consideration of traditional copyright doctrines such as fair use and merger, could the district court then address whether FIFRA precludes Syngenta’s copyright claims.