DCT

6:23-cv-05113

Medisca Pharmaceutique Inc v. FlackTek Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:23-cv-05113, D.S.C., 10/12/2023
  • Venue Allegations: Venue is alleged to be proper as each Defendant is a corporation organized under the laws of South Carolina and maintains a regular and established place of business in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s planetary mixers and associated container assemblies infringe six patents related to pharmaceutical compounding methods and systems.
  • Technical Context: The technology concerns devices and methods for mixing personalized pharmaceutical compositions, aiming to improve consistency, reduce contamination, and streamline the compounding process.
  • Key Procedural History: The complaint alleges that Plaintiff sent a letter to Defendant on January 8, 2020, providing notice of U.S. Patent No. 10,231,903. Plaintiff asserts that because all patents-in-suit claim priority to the same provisional application, this letter served to notify Defendant of the broader patent family.

Case Timeline

Date Event
2016-11-10 Priority Date for all Asserted Patents
2019-03-19 U.S. Patent No. 10,231,903 ('903 Patent) Issued
2019-09-24 U.S. Patent No. 10,420,705 ('705 Patent) Issued
2020-01-08 Plaintiff sent letter to Defendant identifying the '903 Patent
2020-09-08 U.S. Patent No. 10,765,600 ('600 Patent) Issued
2021-05-04 U.S. Patent No. 10,993,876 ('876 Patent) Issued
2021-08-17 U.S. Patent No. 11,090,224 ('224 Patent) Issued
2021-08-24 U.S. Patent No. 11,096,864 ('864 Patent) Issued
2023-10-12 Complaint Filed

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

U.S. Patent No. 10,420,705 - “Container Assembly”

(Issued Sep. 24, 2019)

The Invention Explained

  • Problem Addressed: The patent background describes challenges in pharmaceutical compounding, including time-consuming manual mixing, risks of cross-contamination from equipment, and product inconsistencies (Compl. ¶12). It notes that bladed mixers can introduce high shearing forces and entrain air, while device-specific mixing containers necessitate decanting, which can lead to material loss and requires cumbersome cleaning procedures (Compl. ¶¶13-14; ’705 Patent, col. 1:36 - col. 2:44).
  • The Patented Solution: The invention is a container assembly for a planetary mixer that enables mixing to occur directly within a metered-dosage dispenser (Compl. ¶17). This is achieved through an adapter that secures the smaller dispensing container inside a larger jar compatible with the mixer, thereby eliminating the need to transfer the compounded mixture after mixing (’705 Patent, Abstract; col. 3:56-65).
  • Technical Importance: This approach streamlines the compounding workflow by reducing steps, which in turn may lower the risks of material loss and cross-contamination (Compl. ¶17).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶31).
  • Claim 1 Elements:
    • A container assembly for use in a planetary mixer, comprising: a jar with an inner wall, an adapter in contact with the inner wall of the jar, a dispensing container having a tubular body and a cap, and a lid attachable to a rim of the jar;
    • wherein the adapter is configured to clamp onto the cap of the dispensing container, and to maintain the dispensing container spaced from the inner wall of the jar;
    • wherein the adapter is free of material along a longitudinal axis of the jar and has a plurality of apertures surrounding that axis; and
    • wherein the body of the dispensing container has a height-to-base ratio (HBR) between 0.75 and 1.5 at half volume and a greater HBR than the jar for the same total volume.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,765,600 - “Adapter for use in a planetary mixer”

(Issued Sep. 8, 2020)

The Invention Explained

  • Problem Addressed: The patent addresses the same problems as the ’705 Patent, focusing on the inefficiencies and risks associated with traditional compounding methods that require decanting from a mixing vessel to a separate dispensing container (’600 Patent, col. 1:36 - col. 2:44).
  • The Patented Solution: The invention claims a planetary mixer system that includes a specific geometric arrangement of a jar, an adapter, and a dispensing container. The claim defines the spatial relationships between these components, such as the container being spaced from the jar walls and bottom, crossing the jar's longitudinal axis, and extending over more than half its diameter, which is intended to ensure effective mixing dynamics (’600 Patent, Abstract; col. 2:45-56).
  • Technical Importance: By claiming the mixer system with specific geometric constraints, the invention aims to ensure that ingredients are mixed efficiently and homogeneously directly within the dispensing container (Compl. ¶17).

Key Claims at a Glance

  • The complaint asserts at least independent claim 15 (Compl. ¶44).
  • Claim 15 Elements:
    • A planetary mixer comprising a motor, a holder, and a jar containing a dispensing container secured to an adapter;
    • wherein (i) the adapter maintains the dispensing container spaced from the inner wall and bottom of the jar;
    • (ii) a gap is provided between the top of the jar and the cap of the dispensing container;
    • (iii) a part of the cap is further from the bottom of the jar than a part of the body of the dispensing container;
    • (iv) the body of the dispensing container crosses the longitudinal axis of the jar; and
    • (v) the dispensing container extends over more than half the diameter of the jar.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,090,224 - “Adaptor for a dispensing container in a planetary mixer”

(Issued August 17, 2021)

  • Technology Synopsis: This patent claims an adapter and dispensing container combination. The invention focuses on the dimensional relationship between the container's cap and a cavity in the adapter configured to receive it, specifying that a passageway in the adapter is narrower than the cap's width.
  • Asserted Claims: At least Claim 1 (Compl. ¶57).
  • Accused Features: The accused products are alleged to be an adapter and dispensing container combination with the claimed dimensional characteristics (Compl. ¶¶58-59).

U.S. Patent No. 11,096,864 - “Adapter for a dispensing container in a planetary mixer”

(Issued August 24, 2021)

  • Technology Synopsis: This patent also claims an adapter and dispensing container combination. The claimed invention focuses on dimensional relationships, including a cavity in the adapter for receiving the container's cap that is wider than the cap, and a passageway extending from the cavity that is narrower than the cap.
  • Asserted Claims: At least Claim 1 (Compl. ¶70).
  • Accused Features: The accused products are alleged to be an adapter and dispensing container combination that meets the specific dimensional limitations of the claim (Compl. ¶¶71-72).

U.S. Patent No. 10,231,903 - “Pharmaceutical compounding methods and systems”

(Issued March 19, 2019)

  • Technology Synopsis: This patent claims a compounding method. The method involves using a planetary mixer's superimposed revolution and rotation movements to melt gelatin gum base pieces without external heat, creating a pourable liquid that can be molded into a desired shape (e.g., a troche).
  • Asserted Claims: At least Claim 19 (Compl. ¶83).
  • Accused Features: The complaint alleges that Defendant’s SpeedMixer is configured and advertised to perform this claimed melting method without added heat (Compl. ¶¶25-26, 84-85).

U.S. Patent No. 10,993,876 - “Pharmaceutical compounding methods and systems”

(Issued May 4, 2021)

  • Technology Synopsis: This patent claims a compounding method involving the use of superimposed revolution and rotation movements. The method is directed at dispersing solid or semi-solid particles to obtain a melt without external heat, which can then be molded.
  • Asserted Claims: At least Claim 13 (Compl. ¶95).
  • Accused Features: The accused SpeedMixer products are alleged to perform the claimed compounding method (Compl. ¶96).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant’s “SpeedMixer” planetary mixers, associated containers, and a jar and adapter assembly identified as the “TOPI-CLICK® HOLDER, FLACKTEK SPEEDMIXER ® (35-5784)” (Compl. ¶¶21-22).
  • Functionality and Market Context: The SpeedMixer is a planetary mixer that performs mixing through superimposed revolution and rotation movements (Compl. ¶25). The TOPI-CLICK® holder is alleged to be a reusable adapter that allows users to mix pharmaceutical preparations directly inside a “Topi-Click 35 mL applicator,” which is a metered-dosage dispenser (Compl. ¶23). The complaint alleges this assembly is placed within a larger FlackTek container and then into the SpeedMixer for processing (Compl. ¶23). Defendant allegedly advertises the SpeedMixer for applications including "Compounding and Pharma" and for its ability to "melt and blend 'without heat needed'" (Compl. ¶¶20, 26). This an instructional video screenshot shows a user placing the holder assembly into the SpeedMixer (Compl. ¶24).

IV. Analysis of Infringement Allegations

  • '705 Patent Infringement Allegations: The complaint alleges that the accused jar, adapter, and dispenser assembly meets all limitations of claim 1 of the '705 Patent (Compl. ¶33). An image of the accused assembly shows a dispenser held inside a larger jar by an adapter-like component (Compl. ¶33). The complaint refers to an infringement chart in Appendix A, which was not filed with the complaint (Compl. ¶34).
  • '600 Patent Infringement Allegations: The complaint alleges that the combination of the SpeedMixer and the accused container assembly meets all limitations of claim 15 of the '600 Patent, which claims a planetary mixer system with specific geometric features (Compl. ¶46). The complaint includes an image of various SpeedMixer models, which allegedly provide the claimed motor and holder for subjecting the container assembly to the required movements (Compl. ¶46, Ex. 17). The complaint refers to an infringement chart in Appendix B, which was not filed with the complaint (Compl. ¶47).
  • Identified Points of Contention:
    • Scope Questions: A primary question may be one of claim scope: does the accused "TOPI-CLICK® HOLDER" function as the claimed "adapter," and does its interaction with the dispenser's cap constitute "clamping" as required by claim 1 of the ’705 Patent?
    • Technical Questions: The infringement analyses will depend on factual evidence regarding the specific geometries and spatial relationships of the accused assembly. For example, a court may need to determine if the accused dispensing container has the specific "height-to-base ratio" recited in claim 1 of the ’705 Patent, and whether it "crosses the longitudinal axis of the jar" and "extends over more than half the diameter of the jar" as required by claim 15 of the ’600 Patent.

V. Key Claim Terms for Construction

  • The Term: "adapter" (’705 Patent, claim 1; ’600 Patent, claim 15)

  • Context and Importance: This term is central to the apparatus claims, as it describes the component that interfaces between the mixer-compatible jar and the dispensing container. The infringement dispute may turn on whether Defendant's "holder" falls within the scope of this term. Practitioners may focus on this term because the complaint identifies the accused "TOPI-CLICK® HOLDER" as the infringing structure (Compl. ¶22).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the adapter's function broadly as being "configured to clamp to the metered-dosage dispenser" and "to keep the metered-dosage dispenser away from the inner wall of the jar" (’705 Patent, Abstract). This functional language may support a broad construction covering any structure that performs these roles.
    • Evidence for a Narrower Interpretation: The specification discloses specific embodiments of the adapter, such as one "in the form of a disk with an aperture" (’705 Patent, col. 5:14-15) and others with prong-like structures (col. 6:33-34, Figs. 18A-B). A party might argue that the term should be limited to these disclosed structures or their equivalents.

  • The Term: "clamp onto the cap" (’705 Patent, claim 1)

  • Context and Importance: This phrase defines the mechanism by which the adapter secures the dispensing container. The nature of this connection—whether it requires a specific mechanical action or includes a friction fit—will be critical.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent uses the term "clamp" without extensive definition, which could support an interpretation covering any method of firmly securing the cap, including by friction or compression.
    • Evidence for a Narrower Interpretation: An embodiment is described where "resilient and slightly outwardly biased" prongs are "compressed radially inwardly" to secure the container (’705 Patent, col. 7:29-42). A party could argue this disclosure limits the meaning of "clamp" to a compressive gripping action, as opposed to a simple friction fit.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement based on Defendant's instructions to customers and end users through "instruction videos, manuals, and other information provided on FlackTek's websites" (Compl. ¶¶38, 51). It further alleges contributory infringement, asserting that the SpeedMixer and container assembly are "especially made or especially adapted for use in an infringement" and are "not staple articles and have no substantial, non-infringing use" (Compl. ¶¶39, 52).
  • Willful Infringement: The complaint alleges willfulness based on pre-suit knowledge. It pleads that a January 8, 2020 letter gave Defendant actual notice of the '903 Patent and that, because all asserted patents share a common priority application, Defendant "could easily identify each of the Asserted Patents" from that single notice and was therefore aware or should have been aware of the other patents prior to the suit's filing (Compl. ¶¶27, 40, 53).

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

  • A core issue will be one of definitional scope: can the term "adapter," as defined in the patents, be construed to cover Defendant’s accused "holder" product, and does the interaction between the holder and the dispenser constitute "clamping" as required by the claims?
  • A second central question will be one of evidentiary proof: does the accused container assembly, when used in the SpeedMixer, meet the specific, multi-part geometric and positional limitations recited in the asserted claims, such as those relating to height-to-base ratio, spacing from jar walls, and crossing the jar's longitudinal axis?
  • A key legal question for willfulness will be whether notice of one patent in a family is sufficient to establish pre-suit knowledge of other, subsequently-issued family members for the purpose of proving willful infringement, as the complaint alleges.