DCT

2:19-cv-04728

Vetstem Biopharma Inc v. California Stem Cell Treatment Center Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-04728, C.D. Cal., 05/30/2019
  • Venue Allegations: Venue is based on Defendant maintaining a regular and established place of business in Beverly Hills, California, within the district, where it allegedly makes, uses, and sells the accused infringing therapies.
  • Core Dispute: Plaintiff alleges that Defendant’s Regenerative Stem Cell Therapy infringes a patent related to methods of preparing and using stem cell compositions derived from adipose tissue.
  • Technical Context: The technology resides in the field of regenerative medicine, specifically concerning methods for processing a patient's own fat tissue to create a stem-cell-rich composition for therapeutic re-injection in a single, rapid procedure.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with a notice letter and a claim chart detailing the infringement on June 1, 2018. It further alleges that Defendant’s founders were aware of the underlying patent-pending technology as early as 2013 and knew of the patent’s issuance in 2016, prior to receiving the notice letter.

Case Timeline

Date Event
2003-10-08 '202 Patent Priority Date
2012-XX-XX Defendant allegedly begins commercial offering of accused therapies
2013-XX-XX Defendant's founders allegedly become aware of Plaintiff's technology
2016-09-27 U.S. Patent No. 9,453,202 issues
2017-01-01 Affiliate's related clinical study allegedly completed
2018-06-01 Plaintiff sends notice letter with claim chart to Defendant
2019-05-30 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 Sep. 27, 2016)

The Invention Explained

  • Problem Addressed: The patent's background describes the isolation and purification of stem cells from adult tissues as a "tedious and expensive process" ('202 Patent, col. 2:45-48). It notes that conventional methods involving extensive purification, culturing, and differentiation are costly and can lead to cell death and reduced function, limiting the therapeutic availability of stem cells ('202 Patent, col. 2:50-59).
  • The Patented Solution: The invention claims a streamlined method for preparing a therapeutic composition of stem cells from a patient's own adipose (fat) tissue. The core innovation is a process that involves minimal manipulation—releasing cells from the fat tissue (e.g., with enzymes) and separating them from the bulk fat (e.g., via centrifugation)—without the subsequent, time-consuming step of isolating the stem cells away from other cell types in the resulting mixture or culturing them to expand their numbers ('202 Patent, col. 10:21-28). This allows the resulting cell population to be prepared and administered back to the patient quickly, potentially within a single procedure.
  • Technical Importance: This approach countered prevailing methodologies that required costly and time-consuming culturing to obtain therapeutically useful stem cell populations, offering a potentially faster and less expensive path to autologous stem cell treatment (Compl. ¶28).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶31).
  • Independent Claim 1 requires a method of treating inflammation at a musculoskeletal injury site by:
    • Preparing a cell population by processing adipose tissue from a mammal to release cells and then separating those cells from the fat layer.
    • Critically, the method "does not include isolating stem cells... from other cells" in the mixture.
    • Providing this mixed cell population directly to the site of injury.
  • The complaint expressly reserves the right to assert additional claims (Compl. ¶37).

III. The Accused Instrumentality

Product Identification

  • Defendant’s "Regenerative Stem Cell Therapy" (Compl. ¶13).

Functionality and Market Context

  • The accused therapy is a procedure where adipose tissue is harvested from a patient via liposuction, processed, and then re-injected into the patient at a site of injury or disease, such as for osteoarthritis (Compl. ¶¶13, 16).
  • The processing is alleged to involve enzymatic digestion (using collagenase) and centrifugation to obtain a "stromal vascular fraction (SVF) cell population" (Compl. ¶¶14-15, 33). The complaint emphasizes that the entire procedure is performed as a single outpatient visit lasting approximately three to four hours, which it alleges "does not allow for additional processing... such as through culturing" (Compl. ¶¶16-17).
  • The therapy is marketed for its "anti-inflammatory and healing effects" and is offered commercially for profit, with treatments costing "generally 6 to 9 thousand dollars" (Compl. ¶¶16, 22).

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: Defendant's therapy is used to treat conditions like arthritis and is marketed for its "anti-inflammatory... effects" at sites of musculoskeletal disease. ¶¶16, 33 col. 15:50-57
(a) preparing a cell population comprising adipose tissue-derived stem cells... by a method comprising: (i) processing adipose tissue obtained from the mammal to release cells therein... Defendant harvests adipose tissue (lipoaspirate) from a human patient and processes it using enzymatic digestion to release an SVF cell population. ¶¶13-14, 33 col. 15:62-67
(ii) separating the cells released in (i) from the fat layer... Defendant allegedly uses centrifugation to separate the released SVF cell population from the fat layer of the lipoaspirate. ¶¶14, 33 col. 16:1-6
wherein said method does not include isolating stem cells separated in (a)(ii) from other cells separated in (a)(ii). The complaint alleges the short, single-visit duration of the procedure (3-4 hours) does not permit further processing steps like culturing or other methods that would isolate a pure stem cell population. ¶17 col. 16:13-16
and (b) providing the cell population of (a)(ii) directly to the site of the musculoskeletal injury or disease in the mammal... The separated SVF cell population is allegedly loaded into syringes and injected into the patient at the site of the musculoskeletal condition being treated. ¶¶16, 27, 33 col. 16:8-12
  • Identified Points of Contention:
    • Scope Questions: The central dispute may focus on the negative limitation "does not include isolating stem cells... from other cells." A question for the court will be whether Defendant's process of using centrifugation and filtering to produce an SVF population constitutes "isolating" as the term is used in the patent. The patent's own definition of "purified" as distinct from "isolated" may be highly relevant to this question ('202 Patent, col. 8:10-14).
    • Technical Questions: A factual question may arise regarding the precise steps of Defendant's SVF preparation protocol. The complaint alleges a process that maps closely to the claims, but the specific parameters (e.g., centrifugation speeds, filtration methods) could be scrutinized to determine if they achieve a level of cell separation that could be characterized as "isolating."

V. Key Claim Terms for Construction

  • The Term: "isolating stem cells... from other cells"
  • Context and Importance: This negative limitation is the lynchpin of the infringement case. If Defendant’s process is found to perform this "isolating" step, it would not infringe Claim 1. The definition of "isolating" is therefore critical. Practitioners may focus on this term because it distinguishes the patented "quick and simple" method from more complex, traditional lab-based purification techniques.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Plaintiff's likely position): The patent repeatedly contrasts the invention with prior art methods that involved extensive purification and culturing ('202 Patent, col. 2:45-59). The specification also explicitly states that "purification of cells... does not indicate that the cells are purified or isolated from all other tissue components," suggesting "isolating" is a distinct, more rigorous step than the simple "purification" (removal from bulk tissue) achieved by the invention ('202 Patent, col. 8:10-14). This supports a reading where "isolating" means creating a substantially homogenous stem cell population via techniques like cell sorting or expansion via culturing.
    • Evidence for a Narrower Interpretation (Defendant's potential position): A defendant could argue that any process that substantially enriches the concentration of stem cells relative to other cell types in the SVF mixture qualifies as "isolating." The patent's use of the term "purified" throughout, while defined, could be argued to create ambiguity when read in light of the negative limitation.

VI. Other Allegations

  • Willful Infringement: The complaint alleges that Defendant's infringement has been willful. This allegation is based on claims that Defendant’s founders had knowledge of the patent-pending technology since 2013 and of the issued patent "shortly after its issuance in 2016" (Compl. ¶24). The willfulness claim is further supported by the allegation that Plaintiff sent a notice letter with a detailed claim chart on June 1, 2018, after which Defendant allegedly continued its infringing activities without justification (Compl. ¶¶23, 40).

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

  • A core issue will be one of definitional scope: does the term "isolating," in the context of the patent's negative limitation, refer only to advanced laboratory techniques like culturing-to-purity or cell-sorting, or can it be construed more broadly to cover the centrifugation and filtering steps allegedly used in the accused therapy to create a stromal vascular fraction (SVF)?
  • A key evidentiary question will center on willfulness: what evidence exists to substantiate the complaint's claim of long-standing, pre-suit knowledge of the patent by the Defendant's principals, and how did the Defendant respond to the 2018 notice letter? The timeline and nature of these interactions will be central to determining whether any infringement was objectively reckless.