DCT
2:22-cv-00717
University Of Pittsburgh Of Commonwealth System Of Higher Education v. Cook Myosite Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: The University of Pittsburgh—Of The Commonwealth System of Higher Education (Pennsylvania)
- Defendant: Cook Myosite, Inc. (Indiana/Pennsylvania)
- Plaintiff’s Counsel: Goodwin Procter LLP
- Case Identification: 2:22-cv-00717, W.D. Pa., 07/20/2023
- Venue Allegations: Venue is alleged to be proper in the Western District of Pennsylvania because Defendant maintains its principal place of business in the district and the alleged infringement has occurred there.
- Core Dispute: Plaintiff alleges that Defendant’s methods for manufacturing muscle-derived cell products, and the products themselves, infringe a patent related to the isolation of specific muscle progenitor cells for cardiac therapy.
- Technical Context: The technology lies in the field of regenerative medicine, specifically concerning methods to isolate and culture unique populations of muscle-derived stem/progenitor cells for therapeutic use.
- Key Procedural History: The complaint alleges that the parties operated under a patent license agreement for 18 years, during which Defendant commercialized the technology. After Defendant unilaterally terminated the license in 2020, Plaintiff alleges that Defendant’s continued use of the technology constitutes patent infringement. The complaint also notes that in response to a cease-and-desist letter, Defendant asserted it owned the patent but did not deny practicing the claimed methods.
Case Timeline
| Date | Event |
|---|---|
| 2002-02-18 | Plaintiff and Defendant enter into a patent license agreement. |
| 2006-11-28 | '423 Patent Priority Date. |
| 2009-02-23 | Date by which inventors had assigned the '423 patent application to Plaintiff. |
| 2012-07-03 | '423 Patent Issue Date. |
| 2020-12-04 | Defendant unilaterally terminates the license agreement. |
| 2021-09-02 | Plaintiff sends a cease-and-desist letter to Defendant. |
| 2021-09-15 | Defendant responds to the cease-and-desist letter. |
| 2023-07-20 | First Amended Complaint filed. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,211,423 - "Muscle derived cells for the treatment of cardiac pathologies and methods of making and using the same"
- Patent Identification: U.S. Patent No. 8,211,423, "Muscle derived cells for the treatment of cardiac pathologies and methods of making and using the same," issued July 3, 2012.
The Invention Explained
- Problem Addressed: The patent’s background section explains that prior attempts at cell-based therapy using myoblasts (muscle precursor cells) were hampered by the low survival rate of the transplanted cells (ʼ423 Patent, col. 3:13-24). It also notes that other materials used for tissue augmentation can cause adverse immunological responses or are quickly reabsorbed by the body (ʼ423 Patent, col. 2:51-3:12).
- The Patented Solution: The patent discloses a method for isolating a specific sub-population of muscle-derived progenitor cells (MDCs) that demonstrate superior long-term survival after transplantation (ʼ423 Patent, Abstract). The core of the invention is a "pre-plating" technique that separates cells based on their differential adhesion rates to a culture flask. "Rapidly adhering cells," such as fibroblasts, are removed, leaving a purified population of "slowly adhering cells" enriched with the desired MDCs (ʼ423 Patent, col. 10:11-24). The patent claims methods of using these isolated MDCs to treat cardiac conditions by improving ventricular contractility (ʼ423 Patent, col. 43:35-56).
- Technical Importance: This isolation method was designed to yield a more potent and durable cell population for therapeutic use, addressing the critical challenge of poor cell viability that had limited the effectiveness of earlier regenerative therapies (ʼ423 Patent, col. 3:13-24).
Key Claims at a Glance
- The complaint alleges infringement of at least one claim, with independent claim 1 being representative of the asserted method.
- Independent Claim 1 of the ’423 Patent recites the essential elements of a method for improving left ventricular contractility, which include:
- isolating skeletal muscle cells from a human subject;
- suspending the cells in a first culture container for a period of 30 to 120 minutes, allowing a first population of cells to adhere;
- decanting the non-adherent cells to a second culture container;
- allowing these decanted non-adherent cells to attach to the second container over a period of 1-3 days;
- isolating this second population of adhered cells, identified as muscle-derived progenitor cells (MDCs); and
- administering the MDCs to the heart of a mammalian subject.
- The complaint reserves the right to assert additional claims (Compl. ¶¶29-30).
III. The Accused Instrumentality
Product Identification
- The complaint identifies Defendant's "skMDC Skeletal Muscle-Derived Cells products" ("skMDC Products") and methods used to isolate "autologous muscle derived cells" ("AMDCs") (Compl. ¶¶15, 19).
Functionality and Market Context
- The complaint alleges that Defendant uses patented methods to isolate and prepare its AMDCs for use in its clinical trials (Compl. ¶¶19, 30). It further alleges that Defendant has made, used, sold, and offered to sell its skMDC Products, and continues to do so after terminating its license from Plaintiff (Compl. ¶¶18, 26). The complaint alleges that Defendant previously paid royalties on sales of its skMDC Products under the license agreement (Compl. ¶16).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart but alleges that Defendant’s methods of preparing its skMDC Products and AMDCs infringe at least one claim of the ’423 patent (Compl. ¶¶27, 30). The following chart summarizes the infringement theory for representative Claim 1 based on the complaint’s allegations.
’423 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of improving left ventricular contractility in a mammalian subject in need thereof comprising; (a) isolating skeletal muscle cells from a human subject, | Defendant is alleged to use patented methods to isolate autologous muscle derived cells ("AMDCs") from human subjects for its clinical trials and commercial products. | ¶19, ¶27, ¶30 | col. 43:35-37 |
| (b) suspending the human skeletal muscle cells in a medium in a first cell culture container for between 30 and 120 minutes thereby producing a cell population of adherent cells and a population of non-adherent cells; | Defendant's accused methods are alleged to include the differential pre-plating technique recited in the '423 patent to separate cell populations based on adhesion time. | ¶27, ¶30 | col. 43:38-42 |
| (c) decanting the medium and the population of non-adherent cells from the first cell culture container to a second cell culture container; | Defendant's accused methods are alleged to include the step of separating the "slowly adhering cells" by transferring them to a new container. | ¶27, ¶30 | col. 43:43-45 |
| (d) allowing the population of the decanted non-adherent cells... to attach to the walls of the second cell culture container for 1-3 days; | Defendant's accused methods are alleged to include the culturing of the "slowly adhering cells" for a period of time to allow for attachment. | ¶27, ¶30 | col. 43:45-48 |
| (e) isolating the population of cells adhered from the walls of the second cell culture container, wherein the isolated population of cells are muscle-derived progenitor cells (MDCs); and | Defendant is alleged to isolate the resulting MDCs/AMDCs for use in its products and clinical trials. | ¶19, ¶27, ¶30 | col. 43:48-51 |
| (f) administering the MDCs to the heart of the mammalian subject... | The '423 patent is titled for the treatment of "cardiac pathologies," and Defendant's alleged infringement through its "clinical trials" may involve administration to the heart as claimed. | ¶11, ¶30 | col. 43:52-54 |
- Identified Points of Contention:
- Technical Questions: A central evidentiary question for the court will be whether Defendant's proprietary manufacturing process for its AMDCs and skMDC Products practices every step of the asserted claims. The complaint makes general allegations, but discovery will be needed to determine if Defendant's specific protocols, including adhesion times (e.g., "between 30 and 120 minutes") and culture sequences, align with the claim limitations.
- Scope Questions: The case may raise the question of whether Defendant’s activities meet the preamble limitation of "improving left ventricular contractility." The court would need to determine if Defendant’s use of the cells in "clinical trials" (Compl. ¶30) is for this purpose, thereby satisfying a required element of the asserted method claim.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail to identify specific claim terms that are likely to be disputed. However, based on the technology and the nature of the dispute, the following terms may become central to the case.
The Term: "muscle-derived progenitor cells (MDCs)"
Context and Importance: The identity of the final cell population is the object of the claimed method. Practitioners may focus on this term because infringement will depend on whether Defendant's "AMDCs" fall within the patent's definition of "MDCs," which is characterized by both the specific isolation method and certain biological markers.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes MDCs in functional terms as cells showing "long-term survival following transplantation" (ʼ423 Patent, col. 4:11-12). This could support a construction that is not strictly limited to a specific list of protein markers.
- Evidence for a Narrower Interpretation: The patent provides a detailed characterization of the preferred MDCs (the "PP6" population), which express specific markers (e.g., desmin, CD34, Bcl-2, Flk-1, Sca-1) and lack others (CD45, c-Kit) (ʼ423 Patent, col. 10:11-49; Table 3). This detailed description could support a narrower construction limited to cells meeting this specific profile.
The Term: "for between 30 and 120 minutes"
Context and Importance: This temporal limitation is a specific, quantifiable step in the claimed isolation process. Practitioners may focus on this term because a deviation in Defendant's process from this time window could be a basis for a non-infringement argument.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue this range is merely exemplary of a "short" initial plating time, particularly if the specification suggests flexibility. Example 1 mentions "approximately 1 hour," which falls within the range (ʼ423 Patent, col. 33:50-51).
- Evidence for a Narrower Interpretation: The claim explicitly recites a bounded numerical range. A defendant would likely argue that this language creates a hard boundary and that any process operating outside this 30-to-120-minute window does not literally infringe.
VI. Other Allegations
- Indirect Infringement: The First Amended Complaint focuses on allegations of direct infringement by Defendant and does not explicitly plead counts of induced or contributory infringement.
- Willful Infringement: The complaint alleges willful infringement based on Defendant's long-standing, specific knowledge of the '423 patent. The factual bases alleged include the 18-year license agreement, the fact that several of the named inventors on the patent later became Defendant's employees who had assigned their rights to Plaintiff, and a cease-and-desist letter sent in September 2021 (Compl. ¶¶9, 13, 20-21, 37). These allegations pertain to both pre-suit and post-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
This dispute between a university and its former licensee will likely center on the following key questions:
- A primary issue will be one of evidentiary proof: does Defendant’s current, proprietary process for manufacturing its cell therapy products—a process developed while under license—continue to practice each and every step of the method claimed in the ’423 patent, including the specific timings and sequences of the cell-sorting technique?
- A significant legal question will concern licensee estoppel: to what extent is Defendant, after paying royalties under a license to the ’423 patent for 18 years, precluded from challenging the patent's validity or arguing that its ongoing activities do not infringe the patent's claims?
- A foundational question, prompted by Defendant’s alleged assertion of ownership in its response to a cease-and-desist letter, will be one of standing and title: does Plaintiff have full ownership and the right to sue on the ’423 patent, or is there a legitimate dispute over ownership that could impact the entire case?