DCT

1:17-cv-00591

Bayer IP GmbH v. Cap Im Supply Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00591, D. Del., 05/22/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s generic topical animal pesticides infringe a patent covering the specific chemical formulation of Plaintiff's K9 Advantix® II product.
  • Technical Context: The technology concerns liquid chemical formulations for spot-on parasiticides used to control fleas and ticks on companion animals, a significant market in veterinary and consumer animal care.
  • Key Procedural History: The patent-in-suit, U.S. Patent No. 7,728,011, underwent an ex parte reexamination, resulting in a Reexamination Certificate issued on January 24, 2013, which confirmed the patentability of the original claims and added two new claims. The complaint also alleges that Plaintiff provided Defendant with notice of the patent prior to the lawsuit.

Case Timeline

Date Event
2002-04-02 '011 Patent Priority Date (PCT/EP02/03619)
2010-06-01 '011 Patent Issue Date
2013-01-24 '011 Patent Reexamination Certificate Issued
2015-12-03 Defendant applies to EPA for registration of accused products
2016-09-15 Plaintiff advises Defendant of the '011 Patent in a letter
2016-09-26 EPA grants Defendant conditional registration for accused products
2017-05-22 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,728,011 - Dermally Applicable Liquid Formulations for Controlling Parasitic Insects on Animals

The Invention Explained

  • Problem Addressed: The patent sought to solve the problem of creating a single, topically applied ("spot-on") formulation that was simultaneously effective against both fleas and ticks, while also being skin-friendly, storage-stable, and long-lasting (’011 Patent, col. 3:40-65). Prior art formulations were generally effective against one pest but not the other, and combining the necessary active ingredients—permethrin (aprotic) and imidacloprid analogues (protic)—into a stable, effective liquid was a technical challenge (’011 Patent, col. 3:50-58).
  • The Patented Solution: The invention is a specific liquid formulation that combines the pesticide permethrin and an imidacloprid-type compound in particular concentration ranges, using N-methylpyrrolidone (NMP) as the primary solvent (’011 Patent, Abstract; col. 2:17-26). The patent asserts that this specific combination exhibits a surprisingly synergistic ectoparasiticidal activity, meaning its combined effect is greater than the sum of its parts, allowing for reduced application rates and enhanced long-term action (’011 Patent, col. 3:33-42).
  • Technical Importance: The invention provided a single-dose, broad-spectrum treatment for multiple common ectoparasites on companion animals, simplifying treatment protocols for pet owners and veterinarians.

Key Claims at a Glance

  • The complaint asserts independent Claim 1 and dependent Claim 2 (Compl. ¶33).
  • Independent Claim 1 requires a composition comprising six components within specified weight-percentage ranges:
    • from about 35% to about 60% by weight of permethrin
    • from about 2.5% to about 12.5% by weight of imidacloprid or an imidacloprid analog
    • from about 27.5% to about 62.5% by weight of N-methylpyrrolidone
    • from 0% to about 5% by weight of water
    • from 0% to about 0.5% by weight of phenolic antioxidants
    • from 0% to about 0.5% by weight of at least one organic acid
  • The complaint does not explicitly reserve the right to assert other claims but mentions infringement of "at least claims 1 and 2" (Compl. ¶33).

III. The Accused Instrumentality

Product Identification

  • Advecta™3, PetLock®MAX, ParaDefense™ADVANCED, and Provecta™ADVANCED (Compl. ¶16).

Functionality and Market Context

  • The accused products are topical pesticide treatments for dogs designed to kill and prevent ticks, fleas, and mosquitoes (Compl. ¶16). The complaint alleges that these products are generic versions of and compete directly with Plaintiff's K9 Advantix® II product (Compl. ¶16). The complaint provides a detailed chemical composition analysis for a sample of the Advecta™3 product, which forms the primary basis for the infringement allegations against all accused products sold under the same EPA registration (Compl. ¶27). The table summarizing this analysis is a central piece of visual evidence in the complaint. (Compl. ¶27).

IV. Analysis of Infringement Allegations

'011 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition for controlling parasites on an animal comprising: The Advecta™3 product is a topical pesticide for dogs (Compl. ¶16). ¶16 col. 13:30-41
a. from about 35% to about 60% by weight of permethrin; Analysis of the Advecta™3 product shows it contains 45.02% permethrin (Compl. ¶27). ¶27, 28 col. 13:33-34
b. from about 2.5% to about 12.5% by weight of imidacloprid...; Analysis of the Advecta™3 product shows it contains 8.80% imidacloprid (Compl. ¶27). ¶27, 28 col. 13:35-36
c. from about 27.5% to about 62.5% by weight of N-methylpyrrolidone; The accused product contains 18.88% NMP and 17.47% dimethyl sulfoxide (DMSO). The complaint alleges this 36.35% mixture is "insubstantially different from and equivalent to" the claimed NMP solvent. ¶29, 30 col. 13:37-38
d. from 0% to about 5% by weight of water; Analysis of the Advecta™3 product shows it contains 0.39% water (Compl. ¶27). ¶27, 28 col. 13:39
e. from 0% to about 0.5% by weight of phenolic antioxidants; and Analysis of the Advecta™3 product shows it contains 0.11% butylated hydroxytoluene, which the patent identifies as a suitable phenolic antioxidant (’011 Patent, col. 7:16-23). ¶27, 28 col. 13:40
f. from 0% to about 0.5% by weight of at least one organic acid. Analysis of the Advecta™3 product shows it contains 0.03% citric acid, which the patent identifies as a preferred organic acid (’011 Patent, col. 7:29-35). ¶27, 28 col. 13:41
  • Identified Points of Contention:
    • Equivalency Question: The primary point of contention appears to be the "N-methylpyrrolidone" (NMP) limitation. The accused products allegedly contain NMP, but at a concentration (18.88%) below the claimed range of 27.5-62.5% (Compl. ¶29). To bridge this gap, the complaint alleges that the combination of NMP with another solvent, DMSO, creates a mixture that is "equivalent" to the claimed NMP concentration (Compl. ¶30). This raises the core question of whether a mixture of two solvents can infringe a claim limitation reciting a single solvent in a specific concentration range under the doctrine of equivalents.
    • Technical Question: The complaint asserts that the NMP and DMSO mixture is equivalent in "properties that are relevant to performance as the major solvent" (Compl. ¶30). The case may require factual development regarding the chemical properties and function of DMSO as a solvent in this specific formulation compared to NMP.

V. Key Claim Terms for Construction

  • The Term: "N-methylpyrrolidone"
  • Context and Importance: This term is central because the defendant's product does not appear to literally meet the claimed concentration range for this specific solvent. The plaintiff's infringement theory relies on arguing that a mixture of NMP and another solvent (DMSO) is equivalent to the claimed element (Compl. ¶30). The construction of this term—specifically, whether it can be interpreted to encompass chemically similar solvents or is strictly limited to the single named compound—will be critical to the doctrine of equivalents analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The complaint does not point to specification language supporting a broad construction, instead relying on an equivalency theory. A party might argue that the patent's emphasis is on the overall function of a skin-friendly formulation that can dissolve both active ingredients, suggesting the specific choice of NMP is not the only way to achieve the invention.
    • Evidence for a Narrower Interpretation: The patent claims explicitly and repeatedly name "N-methylpyrrolidone" as the solvent, and the specification describes it as a component of the invention (’011 Patent, col. 2:22; col. 7:4-9). The examples provided in the patent also consistently list NMP as the solvent (’011 Patent, col. 8-10, Examples 1-18). This specificity may support a narrow construction that the claimed solvent is NMP and not a mixture including other compounds like DMSO.

VI. Other Allegations

  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the ’011 Patent. Specifically, Plaintiff alleges it sent a letter to Defendant on September 15, 2016, advising it of the patent (Compl. ¶19, 34). The allegation is that Defendant continued its infringing activities despite this notice (Compl. ¶34).

VII. Analyst’s Conclusion: Key Questions for the Case

This case appears to be a classic branded-versus-generic pharmaceutical dispute centered on a chemical formulation patent. The resolution will likely depend on two main issues:

  1. A central question will be one of infringement by equivalents: can the accused products' solvent mixture (NMP and DMSO) be proven to perform substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed concentration of NMP alone? The complaint's direct reliance on this doctrine for a key limitation frames this as the primary battleground.

  2. A key legal question will be one of claim scope: will the court narrowly construe "from about 27.5% to about 62.5% by weight of N-methylpyrrolidone" to mean that the recited concentration must be met by NMP alone, or could the scope be interpreted more functionally? The answer will likely determine the viability of the doctrine of equivalents argument.

  3. While not a focus of the complaint, the patent's validity will likely be challenged by the defendant. The prior ex parte reexamination, which confirmed the patentability of the asserted claims, may strengthen the plaintiff's position on this front, but it does not preclude a new validity challenge in district court.