IP Law Daily, PATENT—Fed. Cir.: Preliminary injunction against Indian competitor vacated in FMC Corp.’s infringement lawsuit, (Aug 1, 2025)

By Saurabh Kashyap, B.A., M.A., LL.B., LL.M.

District court’s erroneous construction of patent claim term “composition” undermined its preliminary findings.

The U.S. Court of Appeals for the Federal Circuit vacated a preliminary injunction imposed on Sharda USA, LLC in a patent infringement dispute initiated by FMC Corporation. The Federal Circuit held that the district court had erred in construing the key claim term “composition” in FMC’s insecticide patents to mean only “stable compositions,” based on references to physical stability found in an earlier provisional application and a related patent. The appellate court found this construction legally erroneous because the asserted patents intentionally omitted all references to stability, suggesting that the term “composition” was meant to encompass both stable and unstable mixtures (FMC Corp. v. Sharda USA, LLC, No. 24-2335 (Fed. Cir. Aug. 1, 2025)).

Background. The plaintiff/appellee, FMC Corporation, is a global agrochemical company engaged in the manufacture and sale of crop protection products. It holds patents covering novel insecticidal compositions. The defendant/appellant, Sharda USA, LLC, is the U.S. affiliate of Sharda Cropchem Ltd., an India-based agrochemical company. Sharda develops and markets generic pesticides, including its WINNER insecticide containing bifenthrin and zeta-cypermethrin—active ingredients claimed in FMC's asserted patents.

In this lawsuit, FMC asserted its U.S. Patent Nos. 9,107,416 (the ’416 patent) and 9,596,857 (the ’857 patent), both titled Insecticidal and Miticidal Mixtures of Bifenthrin and Cyano-Pyrethroids. These patents claim synergistic compositions combining bifenthrin with a cyano-pyrethroid, including zeta-cypermethrin, within specified weight ratios. The claimed formulations are said to offer “unexpected insecticidal activity.” Both patents derive from U.S. Provisional Application No. 60/752,979 and share a common specification. Representative claim 1 of the ’416 patent recites a miticidal composition comprising bifenthrin and a cyano-pyrethroid selected from a group of six specified compounds.

FMC filed this lawsuit alleging infringement of the asserted patents by Sharda's WINNER product. FMC initially moved for a temporary restraining order (TRO) and preliminary injunction, which the district court denied on procedural grounds. However, in its ruling, the court construed "composition" as limited to "stable compositions," based on references to physical stability in the '979 provisional application and FMC's related U.S. Patent No. 8,153,145 (the ’145 patent). Relying on that construction, the district court rejected Sharda’s anticipation and obviousness defenses and granted a renewed TRO that converted to a preliminary injunction under Rule 65(b)(2). Sharda appealed.

Claim construction. The Federal Circuit held that the district court erred in reading a “stability” limitation into the term “composition.” The court emphasized that while the ’979 provisional application and the ’145 patent discussed physical stability, FMC deliberately excluded all such references from the asserted patents’ specifications. Citing DDR Holdings, LLC v. Priceline.com LLC, 122 F.4th 911 (Fed. Cir. 2024), the appellate court stated that deleting "stability" references from the parent application strongly indicated a changed intent regarding claim scope. The court also relied on MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363 (Fed. Cir. 2017), reinforcing the interpretive significance of specification changes made during prosecution. Consequently, the Federal Circuit held that “composition” should be afforded its plain and ordinary meaning, which includes both stable and unstable formulations.

Anticipation. The court next addressed Sharda’s invalidity challenge based on anticipation by a 1996 reference (McKenzie), which disclosed pesticide mixtures containing bifenthrin and zeta-cypermethrin. The district court had concluded that McKenzie did not anticipate the asserted claims because it disclosed only “unstable” mixtures—formulations falling outside the court’s construction of “composition.” Reversing this finding, the Federal Circuit reiterated that the correct standard for opposing a preliminary injunction is whether the accused infringer has raised a “substantial question” of invalidity, not whether invalidity is conclusively established. Referencing Arthrocare Corp. v. Smith & Nephew, Inc., 406 F.3d 1365 (Fed. Cir. 2005), the court also criticized the district court’s dismissal of McKenzie’s less effective embodiments, observing that any embodiment meeting all claim limitations can anticipate, regardless of whether it is preferred.

Obviousness. On obviousness, the district court had summarily rejected Sharda's arguments "for similar reasons" as its anticipation finding. The Federal Circuit found this reasoning flawed, since the incorrect claim construction undermined the district court's prima facie obviousness analysis. Moreover, the district court emphasized the alleged "unexpected superior performance" of the claimed compositions without weighing that evidence against the full obviousness inquiry. Citing Genentech, Inc. v. Sandoz Inc., 55 F.4th 1368 (Fed. Cir. 2022), the court reiterated that secondary considerations must be assessed in the context of a proper prima facie case. The appellate court instructed the district court on remand to reconsider whether Sharda’s invalidity arguments raise a substantial question of obviousness.

Written description. Sharda had argued that, under the district court’s narrow construction of “composition,” the asserted patents lacked sufficient written description under 35 U.S.C. § 112. Because the Federal Circuit rejected the narrow construction, it declined to address the Section 112 challenge. However, it implicitly signaled that such a challenge would gain traction only under a narrowed claim scope.

Thus, the Federal Circuit vacated the district court’s preliminary injunction and remanded the case for reconsideration.

The Case is No. 24-2335.

Judge: Chen, R.

Attorneys: Lucas M. Walker (MoloLamken LLP) for FMC Corp. Mircea Tipescu (Coplan & Aronoff LLP) for Sharda USA, LLC.

Companies: FMC Corp.; Sharda USA, LLC

Cases: Patent FedCirNews PennsylvaniaNews