Vita Herb Nutriceuticals Inc v. Lonza Group AG

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Vita-Herb Nutriceuticals, Inc. (North American Corp., p.b. Placentia, CA)
  • Defendant: Lonza Greenwood, LLC. (U.S. Corp., p.b. Greenwood, SC)
  • Plaintiff’s Counsel: Law Office of J. Curtis Edmondson; Cotman IP Law Group, APLC
• Case Identification: 6:23-cv-01829, D.S.C., 03/03/2025
• Venue Allegations: The case was transferred to the District of South Carolina. Venue is alleged to be proper based on Defendant's significant business presence, regular and established place of business, and commission of infringing acts within the district.
• Core Dispute: Plaintiff alleges that Defendant’s capsule filling and sealing machines and related processes infringe patents directed to methods for sealing two-piece capsules, particularly for protecting sensitive contents like probiotics.
• Technical Context: The technology concerns the manufacturing of sealed gelatin or vegetable-based capsules, a common dosage form in the pharmaceutical and nutraceutical industries, with a focus on preventing leakage and protecting contents from oxygen degradation.
• Key Procedural History: The complaint alleges a history of pre-suit interactions, including multiple demonstrations of Plaintiff’s patented “NPIB” process to individuals who were employees of Capsugel, Inc. before its 2017 acquisition by Defendant Lonza, and who subsequently became Lonza employees. Further demonstrations were allegedly given to other Lonza employees in the summer of 2023. The case was transferred from another district on January 31, 2024.

Case Timeline

Date	Event
2002-09-26	Priority Date for '060 and '082 Patents
2014-09-30	'082 Patent Issued
2014-11-25	'060 Patent Issued
2017-01-01	Capsugel acquired by Lonza (approximate year)
2023-06-29	Lonza Greenwood LLC files a separate complaint mentioned in background
2023-07-07	Email from Lonza employee acknowledging discussion of Plaintiff's patents
2023-07-15	Demonstration of NPIB process to Lonza employees (approximate date, "Summer of 2023")
2024-01-31	Court orders transfer of the case to the District of South Carolina
2025-03-03	Amended Complaint Filed

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

U.S. Patent No. 8,895,060 - Methods and Apparatus for Sealing Capsules

Issued November 25, 2014

The Invention Explained

• Problem Addressed: The patent background describes persistent leaking problems with conventional two-piece hard shell capsules used for oil-based liquids in the dietary supplement field. Existing solutions, such as adding viscosity-enhancing agents or applying an external "band," are described as time-consuming and expensive post-production treatments that require extra steps like visual inspection and washing ('060 Patent, col. 2:45-62).
• The Patented Solution: The invention proposes a multi-stage method to create a better seal. The core is a "Nitrogen Purge Instant Bonding (NPIB)" system where a capsule cap is purged with a gas, a sealing solution is applied to the cap's seam, and the cap and body are joined in a vertical position to create an "instant" bond. A subsequent step involves applying an "overlay medium" to selected portions of the now-sealed capsule to provide a substantially leak-proof seal ('060 Patent, Abstract; Fig. 1). The process aims to prevent the capsule's liquid contents from contaminating the seam area prior to sealing ('060 Patent, col. 2:50-3:2).
• Technical Importance: The described method aims to improve the reliability and efficiency of manufacturing liquid-filled two-piece capsules, a critical challenge for delivering oil-based nutraceuticals and pharmaceuticals ('060 Patent, col. 2:45-49).

Key Claims at a Glance

• The complaint asserts infringement of at least Claim 1 (Compl. ¶41).
• Independent Claim 1 is a method claim with the following key elements:
  • purging a capsule cap with a gas by injecting said gas into said capsule cap;
  • coating a seam of said capsule cap with a sealing solution;
  • sealing a capsule body to said capsule cap to form a capsule by securing said capsule cap to said capsule body in a vertical position to produce an instant bonding at said seam; and
  • applying an overlay medium solution to selected portions of said capsule.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,846,082 - Probiotic and Preservative Uses of Oil-Emulsified Probiotic Encapsulations

Issued September 30, 2014

The Invention Explained

• Problem Addressed: The patent identifies the challenge of maintaining the viability of probiotic bacteria (Lactic Acid Bacteria or LAB) from manufacturing through to consumption. Factors like oxygen, humidity, and temperature can compromise cell viability, reducing the product's shelf life and efficacy ('082 Patent, col. 2:4-16).
• The Patented Solution: The invention describes an "anaerobic encapsulation system" that uses a "Nitrogen-Purge, Instant-Bonding (NPIB)" process. This method involves combining the probiotics with specific prebiotic edible oils and then packaging this mixture in a two-piece capsule that is purged with an anaerobic gas (like nitrogen) and sealed to be oxygen-free. The process steps, illustrated in Figure 5 of the patent, are designed to protect the oxygen-sensitive probiotics ('082 Patent, Abstract; col. 2:50-63).
• Technical Importance: This technology seeks to enhance the stability and shelf life of probiotic supplements, which are widely used for their health benefits but are notoriously difficult to keep viable ('082 Patent, col. 2:39-44).

Key Claims at a Glance

• The complaint asserts infringement of at least Claim 1 (Compl. ¶55).
• Independent Claim 1 is a method claim with the following key elements:
  • filling a capsule body with a composition while said capsule body is in a vertical orientation;
  • purging a capsule cap with an anaerobic gas by injecting said anaerobic gas into said capsule cap;
  • applying a sealing solution to said capsule cap before securing said capsule cap to said capsule body while said capsule body is in said vertical orientation; and
  • securing said capsule cap onto said capsule body in said vertical orientation to produce an instant bonding... thereby anaerobically encapsulating said composition.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

• The accused products are Defendant's CFS 1000, CFS 1200, and CFS 1500 machines and the encapsulation processes they perform (Compl. ¶26).

Functionality and Market Context

• The complaint alleges these are lab-scale and commercial-scale capsule liquid filling and sealing machines (Compl. ¶37, ¶43). The functionality is centered on filling two-piece capsules with compositions (such as lipid-based formulations) and sealing them (Compl. ¶43, ¶47). The complaint references a product brochure for the CFS 1200, which notes a "nitrogen purge option is available" and describes the machine as enabling "tamper-proof, semi-solid or liquid filled capsule dosage forms" (Compl. ¶43). A YouTube video is also cited, which allegedly demonstrates the machine's operation, including filling, sealing with a "micro spray," and applying heat in a warming tunnel (Compl. ¶45, ¶48). The complaint alleges these machines are manufactured in Belgium and/or Germany and imported into the United States (Compl. ¶35).

IV. Analysis of Infringement Allegations

'060 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
purging a capsule cap with a gas by injecting said gas into said capsule cap	The accused CFS 1200 machine offers a "nitrogen purge option" for this purpose. The complaint includes a screenshot from the product brochure stating "Nitrogen purge option available." (Compl. ¶43).	¶43, ¶44	col. 4:35-50
coating a seam of said capsule cap with a sealing solution	The accused process uses a "precise micro spray of sealing solution" that is drawn into the space between the cap and body by capillary action.	¶45	col. 4:40-43
sealing a capsule body to said capsule cap... in a vertical position to produce an instant bonding at said seam	The accused machine functions with vertically oriented 2-piece capsules, as shown in a screenshot from a YouTube video (Compl. ¶49). The complaint alleges the process fuses the cap and body together to create a seal.	¶46, ¶49	col. 5:8-13
applying an overlay medium solution to selected portions of said capsule	The accused process uses a "spray (which is a medium) to provide a better seal that is substantially leak proof." The complaint cites a YouTube video as evidence for this step.	¶50, ¶51	col. 5:13-18

Identified Points of Contention

• Scope Questions: Claim 1 recites two distinct solution application steps: "coating... with a sealing solution" and "applying an overlay medium solution." The complaint appears to reference the same "micro spray" from the YouTube video as evidence for both steps (Compl. ¶45, ¶51). This raises the question of whether the accused process performs two separate steps as required by the claim, or a single application that Plaintiff characterizes as meeting two limitations.
• Technical Questions: What constitutes "instant bonding" as claimed? The patent suggests this occurs "at the time when cap and body are joined" ('060 Patent, col. 4:40-43). The complaint, however, alleges that after joining, "gentle heat is then applied in the warming tunnel, which fuses the cap and body together" (Compl. ¶48). The timing and mechanism of this "fusing" by heat versus the claimed "instant bonding" may be a central point of dispute.

'082 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
filling a capsule body with a composition while said capsule body is in a vertical orientation	The accused machine is a "sealing and capsule filing machine" that works with a vertically oriented 2-piece capsule. The complaint includes a screenshot from a video showing this orientation (Compl. ¶59).	¶57-59	col. 12:44-46
purging a capsule cap with an anaerobic gas by injecting said anaerobic gas into said capsule cap	The product brochure for the accused CFS 1200 discloses that a "Nitrogen purge option available," which the complaint alleges meets this limitation as nitrogen is an anaerobic gas.	¶60	col. 12:46-48
applying a sealing solution to said capsule cap before securing said capsule cap to said capsule body while said capsule body is in said vertical orientation	The accused machine applies a "precise micro spray of sealing solution into the space between the cap and the body" before the components are fused by heat. The complaint includes a diagram from a video titled "Microspray of Sealing Solution" (Compl. ¶61).	¶61	col. 12:49-53
securing said capsule cap onto said capsule body... to produce an instant bonding... thereby anaerobically encapsulating said composition	The accused machine joins the cap and body, and gentle heat is applied in a warming tunnel to fuse them, which the complaint alleges creates the claimed bond and results in anaerobic encapsulation.	¶62, ¶63	col. 12:54-61

Identified Points of Contention

• Scope Questions: What is the scope of "anaerobically encapsulating"? The defendant may argue that an optional "nitrogen purge" feature does not necessarily achieve the functional outcome of "anaerobically encapsulating" the contents to the degree contemplated by the patent specification.
• Technical Questions: Does the accused process meet the specific sequence of Claim 1, which requires "applying a sealing solution... before securing said capsule cap"? The evidence in the complaint (the YouTube video) will need to be scrutinized to determine if the timing of the spray application relative to the joining of the capsule halves matches the claim language precisely.

V. Key Claim Terms for Construction

• The Term: "instant bonding" ('060 Patent, Claim 1; '082 Patent, Claim 1)

• Context and Importance: This term is critical because it defines the mechanism and timing of the seal formation. The complaint alleges bonding occurs when heat is applied after the cap and body are joined (Compl. ¶48, ¶63), whereas the patent language suggests the bond forms "at the time when the capsule cap and capsule body are joined" ('082 Patent, col. 12:56-58). Practitioners may focus on this term because the dispute may turn on whether a subsequent heating step falls within the scope of "instant bonding."

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent abstract refers to a "nitrogen-purge, instant bonding encapsulation method" as the overall system ('082 Patent, Abstract). A party could argue this term describes the entire process outcome, not just a single moment, and could encompass a rapid heating step integral to that process.
  • Evidence for a Narrower Interpretation: The detailed description of the process in Figure 5 and the accompanying text describes the sealing solution being applied, followed by the cap and body being "assembled," resulting in a sealed capsule, all before any mention of a final state with a gas bubble ('082 Patent, Fig. 5; col. 12:49-61). This could support a definition limited to the chemical/physical bonding from the sealing solution itself, occurring at the moment of contact.

• The Term: "overlay medium solution" ('060 Patent, Claim 1)

• Context and Importance: This term appears as the final step in Claim 1 of the '060 patent, distinct from the initial "sealing solution." Its construction is key to determining if the accused process performs all the required steps. Practitioners may focus on this term because the complaint's evidence for this step (a "spray to provide a better seal") could potentially be argued by the defense to be the same as, or part of, the initial "sealing solution" step, meaning a required claim element is missing.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent describes the overlay medium's purpose is to "provide a substantially leak-proof seal" and that it is applied to "selected portions of the capsule" ('060 Patent, Abstract). A party might argue any subsequent application of a substance that improves the seal meets this definition, regardless of its composition.
  • Evidence for a Narrower Interpretation: The claim structure itself presents "coating... with a sealing solution" and "applying an overlay medium solution" as two sequential and distinct limitations. This strongly suggests they are not the same thing. The specification further states the overlay is applied "thereafter" the initial sealing, reinforcing its nature as a separate, subsequent step ('060 Patent, col. 4:13-15).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), stating that Defendant provides the accused machines to customers and distributors with the specific intent that they be used in an infringing manner (Compl. ¶53, ¶66). The complaint references marketing materials like a product brochure and a YouTube video, which could be construed as instructions for using the machines to perform the patented methods (Compl. ¶43, ¶45).
• Willful Infringement: The complaint alleges that Defendant's infringement has been willful, wanton, and deliberate (Compl. ¶71). The factual basis for this allegation is extensive, citing numerous instances of alleged pre-suit knowledge. This includes multiple demonstrations of the patented process to individuals who later became Lonza employees after an acquisition (Compl. ¶14-20), as well as a demonstration to other Lonza employees in the summer of 2023 after they were "reminded of its patented status" (Compl. ¶23). The complaint also cites a July 2023 email from a Lonza manager allegedly acknowledging the patents and stating they were being reviewed (Compl. ¶29).

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

The resolution of this case appears to hinge on several central questions of claim interpretation and factual evidence.

• A core issue will be one of temporal scope and mechanism: Can the term "instant bonding," which the patents suggest occurs at the moment of joining, be construed to cover a process where the final seal is allegedly created by a subsequent heating step in a "warming tunnel"?
• A second key issue will be one of distinction between steps: Does the "micro spray" described in Defendant's marketing materials constitute both the "sealing solution" and the separate "overlay medium solution" required by Claim 1 of the '060 patent, or does the accused process omit a claimed step?
• Finally, a critical evidentiary question for willfulness will be the effect of pre-suit knowledge: What was the specific technical information disclosed during the alleged demonstrations to Defendant's current and former employees, and how does that information map to the elements of the asserted claims?