DCT

1:17-cv-00175

Bayer IP GmbH v. Hartz Mountain Corp

Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00175, D. Del., 02/17/2017
  • Venue Allegations: Venue in the District of Delaware is alleged based on Defendant Hartz conducting continuous business in the state and Defendant CAP IM Supply being incorporated in Delaware.
  • Core Dispute: Plaintiff alleges that Defendants’ topical flea treatment products for companion animals infringe a patent covering specific chemical formulations for parasiticides.
  • Technical Context: The technology concerns aqueous formulations for topical animal parasiticides, a field with a significant consumer market for pet care products.
  • Key Procedural History: The complaint alleges that Defendant Hartz was aware of Plaintiff's patent portfolio as early as January 2014, over three years prior to the complaint's filing. It also notes that the EPA granted Hartz registrations for the accused products in October 2014, based in part on data previously submitted by Bayer.

Case Timeline

Date Event
1998-02-23 ’938 Patent Priority Date
2008-06-10 ’938 Patent Issue Date
2013-Late / 2014-Early Hartz allegedly applied to the EPA for product registration
2014-01-10 Hartz allegedly sent a letter to Bayer acknowledging awareness of its patents
2014-10-27 EPA granted Hartz registrations for accused products
2015-05-22 CAP IM allegedly notified Bayer of its intent to rely on Bayer's EPA studies
2017-02-17 Complaint Filing Date

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

U.S. Patent No. 7,384,938 - "Aqueous Formulations of Parasiticides for Skin Applications," issued June 10, 2008

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of creating liquid parasiticide formulations for dermal application on animals that remain stable at very low temperatures, preventing the active ingredients from precipitating out of the solution (U.S. Patent No. 7,384,938, col. 1:15-20).
  • The Patented Solution: The invention is a specific multi-component chemical formulation. It claims that the "surprising" addition of a small, specific amount of water (2.5% to 15% by weight) to a solution containing an active ingredient (like imidacloprid) and a combination of specific organic solvents "results in a considerable improvement in the low-temperature stability of the formulation" (’938 Patent, col. 6:62-67). The formulation requires defined concentration ranges for the active ingredient, water, specific alcohols or pyrrolidones, and specific cyclic carbonates or lactones (’938 Patent, col. 18:30-col. 19:18).
  • Technical Importance: Achieving low-temperature stability ensures product efficacy and shelf-life for products that are shipped and stored in diverse and uncontrolled climate conditions, which is critical for mass-market consumer goods (Compl. ¶12).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims," with a specific allegation regarding "at least claim 1" (Compl. ¶¶ 27, 28).
  • Independent Claim 1 of the ’938 Patent recites the essential elements of the formulation:
    • An agonist or antagonist of nicotinic acetylcholine receptors of insects (e.g., imidacloprid) in a concentration of 1% to 20% by weight.
    • Water in a concentration of 2.5% to 15% by weight.
    • Solvents from the group of alcohols and optionally substituted pyrrolidones, in a concentration of at least 20% by weight.
    • Solvents from the group of cyclic carbonates and lactones, in a concentration of 5% to 50% by weight.
    • Optionally, other auxiliaries.
  • The complaint reserves the right to assert other claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' topical pesticide products sold under the tradenames Advecta™II, Para/Defense™, and PetLock®II (Compl. ¶¶ 18-20).

Functionality and Market Context

These products are topical treatments for fleas on dogs and cats that allegedly compete directly with Plaintiff's Advantage® II product (Compl. ¶¶ 18-20). The complaint alleges that Defendants market the accused products as being bioequivalent to Plaintiff's product. The complaint references a screenshot from the Advecta website, which allegedly states that its product "'Contains the Same Active Ingredients Used in Advantage® II'" (Compl. ¶18).

IV. Analysis of Infringement Allegations

’938 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a) agonists or antagonists of the nicotinic acetylcholine receptors of insects in a concentration of from 1 to 20% by weight based on the overall weight of the formulation... The accused products allegedly contain imidacloprid, an agonist of the nicotinic acetylcholine receptors. ¶28 col. 5:44, col. 18:32-34
b) water in a concentration of from 2.5 to 15% by weight based on the overall weight of the formulation; The accused products allegedly contain water. ¶28 col. 19:3-5
c) solvents selected from the group consisting of alcohols and optionally substituted pyrrolidones, in a concentration of at least 20% by weight based on the overall weight of the formulation; The accused products allegedly contain "alcoholic... solvents." ¶28 col. 19:6-9
d) solvents selected from the group consisting of cyclic carbonates and lactones, in a concentration of from 5 to 50% by weight based on the overall weight of the formulation; The accused products allegedly contain "cyclic carbonate solvents." ¶28 col. 19:10-13

Identified Points of Contention

  • Technical Questions: A primary factual dispute will likely concern whether the accused products meet the specific concentration ranges required by each element of Claim 1. The complaint alleges the presence of the required chemical components but does not provide quantitative data for the accused products' formulations. The infringement theory appears to rely heavily on Defendants' marketing claims of equivalence to Bayer's own product, which may or may not have an identical formulation.
  • Scope Questions: The case may raise questions about the scope of the term "formulation," as all concentrations are calculated based on its "overall weight." The parties may dispute which components are included in this calculation, potentially altering whether the accused products meet the claimed percentage ranges.

V. Key Claim Terms for Construction

  • The Term: "formulation"
  • Context and Importance: The definition of this term is critical because all claimed concentration limitations are "based on the overall weight of the formulation" (’938 Patent, col. 18:34-35). Practitioners may focus on this term because the inclusion or exclusion of unlisted ingredients (e.g., impurities, preservatives, or other excipients) in the "overall weight" calculation could determine whether the accused products literally infringe.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "comprising" in the claim preamble is open-ended, suggesting the formulation can include unlisted elements (’938 Patent, col. 18:31). Furthermore, element (e) explicitly allows for "optionally, auxiliaries," which supports the idea that the "formulation" is not limited to just the components of (a)-(d) (’938 Patent, col. 19:14).
    • Evidence for a Narrower Interpretation: The patent's abstract and detailed description repeatedly emphasize the combination of the four main components (a-d) as constituting the core of the novel, stable composition (’938 Patent, Abstract; col. 1:21-39). A party could argue that for calculation purposes, the "formulation" should be defined by the essential components that give rise to the claimed low-temperature stability.

VI. Other Allegations

  • Willful Infringement: The complaint alleges that Defendants acted with knowledge of the ’938 Patent, making the infringement willful (Compl. ¶28). The allegation is supported by a specific factual claim that Hartz sent a letter to Bayer on January 10, 2014, stating it was "well aware of Bayer's U.S. patent holdings relating to the use of imidacloprid" (Compl. ¶28). This alleges pre-suit knowledge of the relevant patent landscape.

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

  • A key evidentiary question will be one of quantitative analysis: does the chemical composition of the accused Advecta, Para/Defense, and PetLock products fall within the specific percentage-by-weight ranges for each component as recited in Claim 1 of the ’938 Patent? The resolution of this question will depend on discovery and expert analysis of the products' formulations.
  • A central legal issue will be one of scienter and willfulness: did Defendants have pre-suit knowledge of the ’938 Patent, and if so, did they proceed to infringe without a reasonable basis for believing they would not be liable? The complaint’s reference to a 2014 letter from Hartz directly puts this question of subjective intent at the forefront of the case.