DCT
2:24-cv-02419
FMC Corp v. Sharda USA LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: FMC Corporation (Delaware)
- Defendant: Sharda USA LLC (Delaware)
- Plaintiff’s Counsel: Ice Miller LLP
- Case Identification: 2:24-cv-02419, E.D. Pa., 07/26/2024
- Venue Allegations: Venue is alleged to be proper based on Defendant residing in the district, having a regular and established place of business, transacting business, and having committed or induced acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s WINNER insecticide, a generic version of Plaintiff's HERO® product, infringes patents related to insecticidal compositions containing bifenthrin and a cyano-pyrethroid, and also infringes Plaintiff's copyright in its product label.
- Technical Context: The lawsuit concerns chemical formulations in the agricultural sciences industry, specifically dual-active-ingredient insecticides used for broad-spectrum crop protection.
- Key Procedural History: The complaint is a Verified Amended Complaint. It alleges that Defendant was put on notice of the asserted patents by, at the latest, the filing of the original complaint (ECF No. 1), which forms the basis for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2005-12-22 | Priority Date for ’416 and ’857 Patents |
| 2007-01-01 | FMC registers first HERO® product label with the EPA |
| 2015-08-18 | U.S. Patent No. 9,107,416 Issues |
| 2017-03-21 | U.S. Patent No. 9,596,857 Issues |
| 2023-09-01 | Sharda receives conditional EPA registration for WINNER |
| 2024-05-01 | FMC becomes aware of Sharda's importation |
| 2024-07-26 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,596,857 - Insecticidal and Miticidal Mixtures of Bifenthrin and Cyano-Pyrethroids, issued March 21, 2017
The Invention Explained
- Problem Addressed: The patent addresses the general need for effective chemical compositions to control insects and mites that damage agricultural crops (Compl. ¶16; ’857 Patent, col. 1:16-27). The background also notes that while potent, certain insecticides (cyano-pyrethroids) can cause undesirable side effects such as mammalian skin irritation (’857 Patent, col. 2:12-14).
- The Patented Solution: The invention is a composition that combines two types of insecticides: bifenthrin and a cyano-pyrethroid. The patent asserts that this combination produces an "unexpected increase in insecticidal activity," or synergy, which allows for effective pest control using less of each active ingredient than would be required if used alone (’857 Patent, col. 2:10-17). This reduction is presented as providing an "ecological and mammalian safety benefit" (’857 Patent, col. 2:14-17).
- Technical Importance: This synergistic approach allows for the creation of broad-spectrum insecticides that are more potent at lower concentrations, potentially reducing both environmental load and unwanted side effects (’857 Patent, col. 2:10-17).
Key Claims at a Glance
- The complaint asserts independent claims 1 (composition) and 6 (method) (Compl. ¶50).
- Independent Claim 1: An insecticidal composition comprising:
- bifenthrin
- a cyano-pyrethroid selected from a specified group (which includes zeta-cypermethrin, beta-cypermethrin, deltamethrin, etc.)
- wherein the composition has a ratio of bifenthrin:cyano-pyrethroid of from about 10:1 to about 1:100
- The complaint asserts dependent claims 2 and 3 and notes infringement of "at least" these claims, reserving the right to assert others (Compl. ¶50).
U.S. Patent No. 9,107,416 - Insecticidal and Miticidal Mixtures of Bifenthrin and Cyano-Pyrethroids, issued August 18, 2015
The Invention Explained
- Problem Addressed: As a member of the same patent family, the '416 Patent addresses the same technical problem: the need for effective, broad-spectrum insecticides for crop protection, while managing potential side effects of individual components (’416 Patent, col. 1:16-27, col. 2:8-10).
- The Patented Solution: The invention combines bifenthrin with a specific class of cyano-pyrethroids to create a composition with an "unexpected increase" in both insecticidal and miticidal (mite-killing) activity (’416 Patent, col. 2:5-13, Abstract). The specification describes this synergy as allowing for reduced quantities of the active ingredients, providing safety and ecological benefits (’416 Patent, col. 2:9-13).
- Technical Importance: The invention provides a dual-action formulation that targets both insects and mites with enhanced potency, offering a single product solution for multiple types of agricultural pests (’416 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claims 1 (composition), 5 (method), and 11 (composition) (Compl. ¶81).
- Independent Claim 1: A miticidal composition comprising:
- bifenthrin
- a cyano-pyrethroid selected from a specified group (which includes zeta-cypermethrin, deltamethrin, etc.)
- wherein the weight ratio of bifenthrin to cyano-pyrethroid is from 10:1 to 1:30
- The complaint asserts numerous dependent claims and reserves the right to assert others (Compl. ¶81).
III. The Accused Instrumentality
Product Identification
The accused product is Sharda's WINNER insecticide (Compl. ¶1).
Functionality and Market Context
The complaint alleges that WINNER is a liquid insecticide formulation containing 11.25% bifenthrin and 3.75% zeta-cypermethrin by weight (Compl. ¶27). An image of the WINNER product label provided in the complaint confirms these active ingredients and percentages (Compl. ¶27, p. 8). The complaint alleges the product is a "stable composition" and points to the product's Safety Data Sheet (SDS), which describes it as a "clear liquid" that is "Stable under recommended storage conditions" (Compl. ¶30, ¶31, ¶58). The WINNER product is positioned as a lower-cost, "me-too" generic equivalent of FMC's HERO® insecticide, which the complaint identifies as a commercial embodiment of the asserted patents (Compl. ¶20, ¶22, ¶24).
IV. Analysis of Infringement Allegations
’857 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An insecticidal composition comprising bifenthrin... | The WINNER product is an insecticidal composition that, according to its own label, contains 11.25% bifenthrin by weight. | ¶56, ¶27 | col. 2:30-33 |
| ...and a cyano-pyrethroid selected from the group consisting of acrinathrin, cycloprothrin, deltamethrin, tralomethrin, fenvalerate, cyfluthrin, beta-cyfluthrin, flucythrinate, alpha-cypermethrin, beta-cypermethrin, theta-cypermethrin, zeta-cypermethrin... | The WINNER product label states it contains 3.75% zeta-cypermethrin, which is an explicitly listed member of the claimed group of cyano-pyrethroids. An excerpt of the accused product label is shown in the complaint (Compl. p.8). | ¶55, ¶56 | col. 14:13-19 |
| ...wherein the composition has a ratio of bifenthrin:cyano-pyrethroid of from about 10:1 to about 1:100. | The complaint calculates the ratio of the active ingredients (11.25% bifenthrin to 3.75% zeta-cypermethrin) as 3:1, which falls within the claimed range of "about 10:1 to about 1:100." | ¶57 | col. 14:20-22 |
’416 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A miticidal composition comprising bifenthrin... | The WINNER product contains bifenthrin and is advertised for controlling mites. The complaint references the WINNER product label, which includes "Twospotted Spider Mite" as a controlled pest for cotton (Compl. p. 13). | ¶87, ¶90 | col. 14:46-47 |
| ...and a cyano-pyrethroid selected from the group consisting of deltamethrin, cyfluthrin, alpha-cypermethrin, zeta-cypermethrin, lambda-cyhalothrin, and esfenvalerate... | The WINNER product label states it contains 3.75% zeta-cypermethrin, which is an explicitly listed member of the claimed group. An excerpt of the WINNER label showing the ingredients is included in the complaint (Compl. p. 18). | ¶89, ¶90, ¶95 | col. 14:48-55 |
| ...wherein the weight ratio of bifenthrin to cyano-pyrethroid is from 10:1 to 1:30. | The complaint alleges the product's ratio of 11.25% bifenthrin to 3.75% zeta-cypermethrin is 3:1, which is within the claimed range of 10:1 to 1:30. | ¶91 | col. 14:55-57 |
Identified Points of Contention
- Scope Questions: The complaint presents a direct, literal infringement theory based on the accused product's own label. A potential point of dispute may center on the term "composition." A defendant could argue that its product does not meet the requirements of a "composition" as taught by the patents (e.g., arguing it lacks stability). However, the complaint preemptively addresses this by citing the accused product's SDS, which states it is a "clear liquid" and "Stable under recommended storage conditions" (Compl. ¶30, ¶31).
- Technical Questions: A key technical aspect of the patents is the "unexpected increase" in insecticidal activity (synergy) (’857 Patent, col. 2:10-11). While this is often central to validity arguments (i.e., whether the invention is non-obvious), a defendant might attempt to import this functional requirement into the claims. This raises the question of whether infringement requires proof that the accused WINNER product itself exhibits synergistic effects, or if it is sufficient that it meets the structural and ratio limitations of the claims.
V. Key Claim Terms for Construction
The Term: "composition"
- Context and Importance: This term appears in all asserted independent composition claims. Its construction is critical because if defined narrowly to require specific properties (e.g., long-term stability, specific emulsification characteristics), a defendant could argue its generic product does not qualify, even if the active ingredients and ratios match. Practitioners may focus on this term to create a non-infringement defense where one does not appear to exist on the face of the product label.
- Intrinsic Evidence for a Broader Interpretation: The specification describes numerous types of formulations, including "dusts," "wettable powders," "emulsifiable concentrates (ECs)," "granules," and "simple solutions," suggesting "composition" is a broad term encompassing many forms of admixture (’857 Patent, col. 3:63–col. 5:8).
- Intrinsic Evidence for a Narrower Interpretation: The patent uses qualifiers like "homogeneous liquid compositions" and "free flowing admixtures" when describing specific embodiments (’857 Patent, col. 4:3-4, col. 4:35-36). A defendant may argue these passages imply that a "composition" must possess a degree of stability and uniformity beyond a simple mixture.
The Term: "about" (e.g., "from about 10:1 to about 1:100")
- Context and Importance: This term, present in claim 1 of the ’857 Patent, defines the boundary of the claimed ratio. While the accused product's alleged 3:1 ratio is well within this range, the construction of "about" is a frequent subject of litigation. Its interpretation determines the precise numerical scope of the claim and could become relevant if discovery reveals product batches with ratios closer to the claimed endpoints.
- Intrinsic Evidence for a Broader Interpretation: The specification discloses a very wide range of "1/99 to 99/1" and a preferred range of "from 1/4 to 4/1," suggesting the inventors contemplated significant flexibility and that "about" should be given its ordinary, flexible meaning (’857 Patent, col. 3:49-53).
- Intrinsic Evidence for a Narrower Interpretation: A defendant could argue that the meaning of "about" should be informed by the specific ratios tested and presented in the patent's data tables, which include discrete ratios such as 2:1, 1:1, 1:2, 1:3, and 1:4 (’857 Patent, Table 2). This could be used to argue for a more constrained interpretation of the term.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement of the method claims. It states that Sharda's product label for WINNER instructs end-users to apply the composition to a locus to control unwanted insects and mites, thereby directing them to perform the steps of the patented methods (Compl. ¶68, ¶104-105). The complaint cites specific instructions from the WINNER label, such as applying the product "at an interval of 3-4 days until pest numbers are reduced to acceptable levels" to control boll weevil (Compl. ¶68).
- Willful Infringement: The complaint alleges willful infringement based on Sharda having actual notice of the patents and the infringement allegations "at least" since the filing of the original complaint in the action (Compl. ¶78, ¶147).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of validity versus infringement: Given that the accused product is alleged to be a "me-too" generic with an identical formulation to the patentee's commercial embodiment, the primary legal battle will likely focus on the validity of the patents-in-suit (e.g., on grounds of obviousness), rather than on non-infringement.
- A key question of claim scope will be whether the functional advantage described in the specification—the "unexpected increase in insecticidal activity"—is an implicit limitation of the composition claims. The court will need to determine if infringement requires only meeting the structural and ratio elements, or if it also requires proof that the accused product exhibits the synergistic effect that forms the stated basis for the invention's patentability.
- An evidentiary question will be the determination of harm and damages. Assuming the patents are found valid and infringed, the dispute will shift to quantifying the economic impact, including establishing a basis for injunctive relief based on irreparable harm and calculating a reasonable royalty or lost profits in a market with a branded product and its direct generic competitor.