DCT
5:20-cv-00165
Vetstem Biopharma Inc v. MV America LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vetstem Biopharma, Inc. (California)
- Defendant: MV America, LLC (Kentucky)
- Plaintiff’s Counsel: Wyatt, Tarrant & Combs, LLP
- Case Identification: 5:20-cv-00165, E.D. Ky., 04/20/2020
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Kentucky because Defendant is a Kentucky company with a regular and established place of business in the district, from which it makes, uses, and sells the accused products.
- Core Dispute: Plaintiff alleges that Defendant’s regenerative stem cell therapies and kits for veterinary use infringe a patent related to methods for preparing and using stem cell compositions derived from adipose tissue.
- Technical Context: The lawsuit concerns the field of regenerative veterinary medicine, specifically the use of autologous stem cells derived from an animal's own fat tissue to treat musculoskeletal conditions like osteoarthritis.
- Key Procedural History: The complaint alleges a history of competition and prior litigation between the parties in 2010 and 2014. Plaintiff also alleges it sent a notice letter with a claim chart to Defendant on October 17, 2018, putting Defendant on notice of the alleged infringement prior to the filing of the complaint.
Case Timeline
| Date | Event |
|---|---|
| 2003-10-08 | ’202 Patent Priority Date |
| 2009-12-28 | Defendant MediVet America, LLC founded |
| 2016-09-27 | ’202 Patent Issue Date |
| 2018-10-17 | Plaintiff sent notice letter to Defendant |
| 2020-04-20 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,453,202 - “Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same,” issued September 27, 2016
The Invention Explained
- Problem Addressed: The patent’s background section identifies significant limitations to the therapeutic use of adult stem cells, noting that their isolation and purification from tissue is a "tedious and expensive process" (’202 Patent, col. 1:46-48). Conventional methods often required culturing and differentiation steps that were costly, time-consuming, and could result in cell death, reducing the number of useful cells available for therapy (’202 Patent, col. 1:54-59).
- The Patented Solution: The invention claims to solve this problem by providing a streamlined method for preparing a therapeutic cell population from adipose (fat) tissue. The method involves processing the tissue to release a mixture of cells and then separating this cell mixture from the fat layer, but critically, the method omits a subsequent step of isolating the stem cells from the other cell types within that mixture (’202 Patent, col. 24:14-16). This results in a purified, but heterogeneous, cell population (the "stromal vascular fraction" or SVF) that can be prepared and administered in a shorter timeframe without the need for expansion or culturing (’202 Patent, col. 10:33-35; Compl. ¶34).
- Technical Importance: This approach departed from prior methods that focused on creating highly pure, cultured stem cell populations, offering a potentially faster, less expensive, and "same-day" therapeutic option for veterinary patients (Compl. ¶14, ¶34).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶36).
- The essential elements of independent claim 1 include:
- A method of treating inflammation at a site of a musculoskeletal injury in a mammal.
- Preparing a cell population by (i) processing adipose tissue to release cells and (ii) separating the released cells from the fat layer.
- A negative limitation: the method does not include isolating the stem cells from the other cells in the separated population.
- Providing the resulting cell population directly to the site of injury to treat the inflammation.
- The complaint expressly reserves the right to assert additional claims of the ’202 Patent (Compl. ¶45).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendant’s "Regenerative Stem Cell Therapies and Kits," also referred to as the "Accused Stem Cell Therapies" (Compl. ¶4, ¶13). This includes the "Adipose Stem Cell Procedure Kit" or "MediVet Kit" (Compl. ¶24).
Functionality and Market Context
- The complaint alleges that the accused therapies are same-day, outpatient procedures used to treat musculoskeletal conditions such as osteoarthritis in animals (Compl. ¶13, ¶17, ¶26). The process allegedly involves surgically harvesting adipose tissue from the animal patient, processing it "to obtain a cell population comprising ADSCs [adipose-derived stem cells]," and reinjecting the resulting cell population at the site of injury (Compl. ¶14). This processing is alleged to involve enzymatic digestion and centrifugation to separate the Stromal Vascular Fraction (SVF) from the fat (Compl. ¶18, ¶39). The complaint alleges the goal of the therapy is to "provide potent anti-inflammatory effect" at the site of treatment (Compl. ¶17).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating inflammation at a site of a musculoskeletal injury or disease in a mammal, comprising: (a) preparing a cell population comprising adipose tissue-derived stem cells... | Defendant's therapies are used to treat musculoskeletal conditions like osteoarthritis and soft tissue injuries in animals by preparing and using a cell population from adipose tissue (fat). | ¶13, ¶17, ¶39 | col. 23:50-57 |
| (i) processing adipose tissue obtained from the mammal to release cells therein... | Defendant's personnel process harvested adipose tissue, including by treating it with an enzyme, to release a "desired SVF cell population." | ¶39 | col. 24:58-67 |
| (ii) separating the cells released in (i) from the fat layer... | Defendant's process uses centrifugation to separate the SVF cell population from the fat layer. | ¶39 | col. 24:1-7 |
| wherein said method does not include isolating stem cells separated in (a)(ii) from other cells separated in (a)(ii). | Plaintiff alleges that once separated, the Defendant's cell population is not processed further to isolate the stem cells from other cells within the population. | ¶33 | col. 24:14-16 |
| (b) providing the cell population of (a)(ii) directly to the site of the musculoskeletal injury or disease in the mammal to treat the inflammation... | The separated SVF cell population is loaded into syringes and injected into the patient at the site of musculoskeletal injury to reduce inflammation and effect pain relief. | ¶39 | col. 24:8-13 |
- Identified Points of Contention:
- Scope Questions: The central dispute may turn on the negative limitation: "does not include isolating stem cells... from other cells." The court will have to determine whether Defendant’s process—which uses enzymatic digestion and centrifugation to create an SVF population—constitutes "isolating stem cells" in a manner prohibited by the claim.
- Technical Questions: A factual question will be what Defendant’s accused process actually entails. The complaint alleges on "information and belief" that the process does not further isolate stem cells (Compl. ¶33, ¶39), but the specific purification, filtering, or separation steps performed by Defendant will be critical evidence for determining infringement of the negative limitation.
V. Key Claim Terms for Construction
- The Term: "isolating stem cells... from other cells"
- Context and Importance: This negative limitation is the defining feature distinguishing the claimed invention from prior art methods that sought to create a pure stem cell line. The entire infringement analysis may hinge on whether Defendant's process of producing SVF is found to perform the prohibited "isolating" step. Practitioners may focus on this term because if Defendant's standard SVF preparation method is construed as "isolating stem cells," the non-infringement argument could be strong.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (of what is not done): The patent specification contrasts the invention with prior methods that involve "isolating stem cells, e.g., using antibodies specific to stem cell surface markers from other cells, and/or culturing the cells" (’202 Patent, col. 1:49-52). A party could argue that "isolating" should be construed to mean these specific, targeted purification techniques, and that general separation like centrifugation does not count as "isolating stem cells from other cells."
- Evidence for a Narrower Interpretation (of what is not done): The patent describes its resulting composition as a heterogeneous population that may include "red blood cells, white blood cells, neutrophils, monocyte/macrophages, fibroblasts, fibroblast-like cells, lymphocytes, and basophils" (’202 Patent, col. 9:48-50). A party could argue that any process that substantially removes these other cell types to enrich the stem cell concentration would constitute the prohibited "isolating" step, regardless of the specific technique used.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant induces infringement by providing its veterinary customers with kits, equipment, enzymes, protocols, and on-site training that instruct them on how to perform the allegedly infringing method (Compl. ¶43). The complaint also alleges contributory infringement, stating that Defendant’s kits are "especially designed for use in performing the Accused Stem Cell Therapies" and have "no substantial non-infringing use" (Compl. ¶44).
- Willful Infringement: The willfulness allegation is based on alleged knowledge of the ’202 Patent and the infringement claims. The complaint cites a history of prior litigation between the parties (Compl. ¶30) and, more specifically, a notice letter with a claim chart sent to Defendant’s president on October 17, 2018 (Compl. ¶29, ¶47). The complaint alleges that Defendant’s continued infringement after receiving this notice was objectively reckless (Compl. ¶48).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and scope: can the negative limitation "does not include isolating stem cells... from other cells" be read to encompass a process that uses centrifugation and other techniques to produce a stromal vascular fraction (SVF)? The case may turn on whether creating SVF—a standard process in the field—is considered "isolating stem cells" as prohibited by the claim, or simply purifying a mixed cell population as allowed by it.
- A key evidentiary question will concern willfulness and damages: what was the nature of the prior litigation between the parties, and what was Defendant’s response to the 2018 notice letter and claim chart? Evidence of a long-standing awareness of Plaintiff’s technology and a failure to investigate or alter conduct after specific notice of infringement could support the claim for willful infringement and potential for enhanced damages.