In an August 1, 2025, precedential ruling (FMC Corporation v. Sharda USA, LLC, No. 24-2335 (Fed. Cir. Aug. 1, 2025)), the U.S. Court of Appeals for the Federal Circuit vacated a temporary restraining order granted by the U.S. District Court in the Eastern District of Pennsylvania. The Federal Circuit held that the district court’s construction of the claim term “composition” erroneously required that the composition be “stable,” based on statements in an earlier provisional application that were deliberately omitted from the asserted patents.
The Federal Circuit’s ruling reinforces the importance of drafting choices – including the specification, prosecution history and priority applications – in determining claim scope. This decision serves as a reminder that strategic drafting across all stages of the patent application process is essential to both enforcement and validity.
Background
FMC holds two patents – U.S. Patent Nos. 9,107,416 and 9,596,857 – covering insecticidal compositions comprising a combination of bifenthrin and a cyano-pyrethroid. These active ingredients are found in HERO®, an insecticide marketed by FMC to combat more than 45 yield-robbing pests affecting key crops such as corn and soybeans.
FMC filed a suit for patent infringement against Sharda, alleging that Sharda’s product WINNER, which contains bifenthrin and zeta-cypermethrin (a cyano-pyrethroid), infringes these patents. FMC sought a temporary restraining order and preliminary injunction. The district court granted FMC’s motion, and Sharda timely appealed.
Key Issues
Claim Construction
The central dispute focused on the meaning of the claim term “composition.” FMC argued that the term should be construed to include only stable compositions, citing a shared priority to an earlier provisional application that discusses problems in the prior art in successfully achieving physically stable mixtures and the importance of stability to ensure that small amounts are effective.
Sharda countered that adding a stability requirement improperly narrowed the claims, arguing that the disputed term should be given its plain and ordinary meaning.
The district court agreed with FMC, reasoning that simple combinations of bifenthrin and zeta-cypermethrin are unstable and ineffective, while the asserted patents describe the claimed combination as having “unexpected insecticidal activity.” Accordingly, the district court construed “composition” to mean a stable formulation.
The Federal Circuit reversed, finding that while the provisional application referenced “stability” and “stable compositions,” these statements had been “culled” from the specification of the asserted patents. The court reasoned:
“A skilled artisan would find that evolution meaningful: every textual reference in the provisional application that a skilled artisan might reasonably have relied upon for interpreting “composition” as covering only stable compounds was removed from the asserted patents. A skilled artisan, in light of such deletions in the prosecution history, would not understand “composition” as claimed in the asserted patents to cover only stable formulations.”
The court analogized this case to DDR Holdings, LLC v. Priceline.com LLC, 122 F.4th 911 (Fed. Cir. 2024), where the deletion of key definitional language in the specification was deemed “highly significant.” The court emphasized that such progression from the provisional application to the patent specification reflects “an evolution of the applicant’s intended meaning of the claim term.”
Anticipation and Obviousness
Based on its construction of “composition” as requiring stability, the district court rejected Sharda’s anticipation and obviousness arguments, holding that the prior art disclosed only unstable compositions, which did not fall within the scope of the asserted claims.
The Federal Circuit disagreed, finding that the district court erred by grafting a stability requirement onto the term “composition,” and that the anticipation and obviousness analyses of the district court were therefore flawed.
The Federal Circuit vacated the preliminary injunction and remanded the case for reconsideration of Sharda’s invalidity defenses, emphasizing that “[a]n accused infringer ‘need not make out a case of actual invalidity’ to avoid a preliminary injunction but need only show a substantial question of invalidity.” (Quoting Natera, Inc. v. NeoGenomics Lab’ys, Inc., 106 F.4th 1369, 1374 (Fed. Cir. 2024).)
Implications of the Ruling
This decision underscores the importance of precise and strategic patent drafting, particularly in how claim terms are defined and supported. It highlights that omissions or changes from provisional applications – especially those related to claim terms – can significantly influence claim construction.
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