DCT
1:05-cv-00152
Pharmastem Therap Inc v. Aszlerbaum
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: PharmaStem Therapeutics, Inc. (Delaware)
- Defendant: CureSource, Inc. (South Carolina), et al.
- Plaintiff’s Counsel: Perkins Coie LLP
- Case Identification: 8:04-cv-00921, C.D. Cal., 08/04/2004
- Venue Allegations: Venue is alleged to be proper in the Central District of California based on Defendants' continuing acts of alleged direct, contributory, and induced infringement within the district.
- Core Dispute: Plaintiff alleges that Defendants' cord blood banking services infringe patents related to the cryopreservation and therapeutic use of hematopoietic stem cells.
- Technical Context: The technology involves collecting, processing, and cryopreserving hematopoietic stem and progenitor cells from neonatal umbilical cord blood for potential future therapeutic use, a commercial practice known as cord blood banking.
- Key Procedural History: The complaint notes that U.S. Patent No. 5,004,681 underwent reexamination, with a Reexamination Certificate issued on April 11, 2000. This post-issuance proceeding, which may have confirmed or amended the original claims, could be relevant to questions of claim scope and validity.
Case Timeline
| Date | Event |
|---|---|
| 1987-11-12 | Earliest Priority Date for all Patents-in-Suit |
| 1991-04-02 | U.S. Patent No. 5,004,681 Issue Date |
| 1993-08-30 | Reexamination requested for U.S. Patent No. 5,004,681 |
| 2000-04-11 | U.S. Patent No. 5,004,681 Reexamination Certificate Issue Date |
| 2002-10-08 | U.S. Patent No. 6,461,645 Issue Date |
| 2003-05-27 | U.S. Patent No. 6,569,427 Issue Date |
| 2004-08-04 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
The complaint does not specify which claims of the patents-in-suit are asserted. For the purposes of this analysis, Claim 1 of each patent is treated as the representative asserted independent claim.
U.S. Patent No. 6,569,427 - ISOLATION AND PRESERVATION OF FETAL AND NEONATAL HEMATOPOIETIC STEM AND PROGENITOR CELLS OF THE BLOOD (Issued May 27, 2003)
The Invention Explained
- Problem Addressed: The patent family addresses the significant limitations of traditional bone marrow transplantation, which is restricted by the difficulty of finding genetically matched donors and carries risks of severe or fatal complications such as graft-versus-host disease (GVHD) (’681 Patent, col. 10:21-44).
- The Patented Solution: The invention describes methods for using neonatal hematopoietic stem cells, obtained from umbilical cord and placental blood, for therapeutic purposes. By collecting these cells at birth and cryopreserving them, a perfectly matched (autologous) source of stem cells can be stored for the donor's potential future use, eliminating the compatibility issues inherent in allogeneic transplantation (’681 Patent, col. 10:45-63). The ’427 Patent specifically claims methods of using these preserved compositions to treat patients.
- Technical Importance: This technology established a method for creating a personal, perfectly matched bank of stem cells for an individual, collected non-invasively at birth, offering a powerful alternative to the national bone marrow donor registry system (’681 Patent, col. 10:56-63).
Key Claims at a Glance
- The complaint asserts method claims from the patent (Compl. ¶26). Independent Claim 1 is representative:
- A method for treating a human patient in need of hematopoietic reconstitution
- comprising introducing into the human patient a composition
- comprising a cryoprotective agent and human neonatal or fetal hematopoietic stem cells
- derived from the umbilical cord blood or placental blood of a human collected at birth of said human
- so as to provide hematopoietic reconstitution.
U.S. Patent No. 5,004,681 - PRESERVATION OF FETAL AND NEONATAL HEMATOPOIETIC STEM AND PROGENITOR CELLS OF THE BLOOD (Issued April 2, 1991)
The Invention Explained
- Problem Addressed: The patent describes the state of the art in hematopoietic reconstitution, which relies heavily on bone marrow transplantation. It notes that this procedure is "severely restricted" due to the rarity of "perfectly matched (genetically identical) donors," except in cases of identical twins (’681 Patent, col. 5:22-26). This mismatch leads to serious complications from immune rejection.
- The Patented Solution: The patent claims a therapeutic composition comprising viable hematopoietic stem cells from a single newborn's cord or placental blood, cryopreserved for later use. The specification details the collection of cord blood, separation and enrichment of stem cells, and cryopreservation techniques using agents like DMSO to maintain cell viability upon thawing for autologous (self) reconstitution (’681 Patent, Abstract; col. 12:41-54).
- Technical Importance: This patent disclosed the foundational concept of banking cord blood as a source of transplantable stem cells, creating a new therapeutic resource that could bypass the logistical and immunological hurdles of conventional bone marrow donation (’681 Patent, col. 10:45-53).
Key Claims at a Glance
- The complaint asserts composition claims from the patent (Compl. ¶34). The patent was reexamined, and independent Claim 1 was amended. Amended Claim 1 is representative:
- A cryopreserved therapeutic composition comprising:
- viable human neonatal or fetal hematopoietic stem cells derived from the umbilical cord blood or placental blood of a single human collected at the birth of said human,
- in which said cells are present in an amount sufficient to effect hematopoietic reconstitution of a human adult; and
- an amount of cryopreservative sufficient for cryopreservation of said cells.
Multi-Patent Capsule
- Patent Identification: U.S. Patent No. 6,461,645, ISOLATION AND PRESERVATION OF FETAL AND NEONATAL HEMATOPOIETIC STEM AND PROGENITOR CELLS OF THE BLOOD, issued October 8, 2002.
- Technology Synopsis: This patent, part of the same family as the ’681 Patent, is also directed to compositions for hematopoietic reconstitution. The claimed invention is a cryopreserved pharmaceutical composition containing viable neonatal stem cells from a single donor's cord blood, preserved in an amount sufficient for therapeutic use, combined with a pharmaceutically acceptable carrier (’645 Patent, Abstract).
- Asserted Claims: The complaint asserts composition claims (Compl. ¶30). Claim 1 is independent.
- Accused Features: The accused features are the cryopreserved cord blood units that Defendant CureSource processes and stores, which are alleged to be infringing compositions under the ’645 Patent (Compl. ¶¶ 21, 23, 30).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the cord blood banking services provided by Defendant CureSource, Inc., and the associated cord blood collection activities of the individual physician defendants (Compl. ¶¶ 21-22).
Functionality and Market Context
- The complaint alleges that CureSource provides its clients with collection kits to facilitate the collection of umbilical cord blood at birth (Compl. ¶22). The collected blood is then sent to a CureSource lab where it is tested, processed to separate the stem cells from other blood components, cryopreserved by freezing at minus 196 degrees Celsius, and stored indefinitely for potential future therapeutic use by the donor child or immediate family members (Compl. ¶¶ 23-24). CureSource is alleged to charge fees for these services (Compl. ¶22).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
U.S. Patent No. 6,569,427 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating a human patient in need of hematopoietic reconstitution... | Defendants are alleged to make, use, sell, and offer to sell the claimed methods, by providing services and collecting fees for the processing and storage of cord blood for "future therapeutic use." | ¶¶22, 26 | col. 25:35-41 |
| ...comprising introducing into the human patient a composition comprising a cryoprotective agent and human neonatal or fetal hematopoietic stem cells... | Defendants are alleged to process, cryopreserve, and store cord blood stem cells intended for future therapeutic use. Cryopreservation necessarily involves a cryoprotective agent. The complaint alleges Defendants induce this step. | ¶¶23, 26 | col. 21:25-col. 22:42 |
| ...derived from the umbilical cord blood or placental blood of a human collected at birth of said human... | The complaint states that CureSource receives and processes "collected umbilical cord blood." | ¶23 | col. 11:41-43 |
- Identified Points of Contention:
- Scope Questions: The primary question is whether providing a service to preserve stem cells for a potential future therapeutic use constitutes direct or indirect infringement of a claim directed to a "method for treating a human patient." The complaint does not allege that any defendant has actually performed the claimed step of "introducing" the composition into a patient.
- Technical Questions: What specific actions alleged in the complaint meet the legal standard for inducing infringement? The complaint alleges that Defendants' actions—providing kits, processing, and storing the cells—induce the later performance of the claimed treatment method by others.
U.S. Patent No. 5,004,681 Infringement Allegations
| Claim Element (from Independent Claim 1 as amended) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A cryopreserved therapeutic composition... | CureSource is alleged to cryopreserve and store umbilical cord blood for "future therapeutic use." | ¶¶21, 23 | col. 7:21-27 |
| ...viable human neonatal or fetal hematopoietic stem cells... | The alleged purpose of the cryopreservation and storage is for future use, which requires the cells to remain viable. | ¶24 | col. 7:1-7 |
| ...derived from the umbilical cord blood or placental blood of a single human collected at the birth of said human... | The complaint alleges CureSource receives and processes "collected umbilical cord blood." | ¶23 | col. 11:41-43 |
| ...in which said cells are present in an amount sufficient to effect hematopoietic reconstitution of a human adult... | The complaint alleges the cells are stored for "potential future use by the child or members of the immediate family," but does not plead specific facts regarding the quantity of cells stored. | ¶24 | col. 51:1-8 |
| ...and an amount of cryopreservative sufficient for cryopreservation of said cells. | CureSource is alleged to preserve the cells by freezing them at minus 196 degrees Celsius for an indefinite time, a process that requires a sufficient amount of a cryoprotective agent. | ¶23 | col. 21:35-42 |
- Identified Points of Contention:
- Scope Questions: The central dispute may focus on the functional limitation "in an amount sufficient to effect hematopoietic reconstitution of a human adult." The complaint does not provide specific facts (e.g., cell counts) to demonstrate that the stored units meet this requirement.
- Technical Questions: What evidence will be required to prove that each accused cord blood unit contains a "sufficient" number of stem cells? This will likely depend on expert testimony and data regarding cell viability and concentration post-thaw.
V. Key Claim Terms for Construction
The Term: "an amount sufficient to effect hematopoietic reconstitution of a human adult" (from ’681 Patent, Claim 1)
Context and Importance: This term defines a critical threshold for infringement of the composition claims. The outcome of the case may depend on whether the cord blood units processed and stored by CureSource contain a quantity and concentration of viable stem cells that meets this functional requirement. Practitioners may focus on this term because it is not defined by a precise numerical value, making its construction central to the scope of the patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests that cord blood is a particularly potent source of stem cells, stating that "the reconstituting capacity of cord blood hematopoietic cells may be higher than that of an equal number of bone marrow cells" (’681 Patent, col. 51:44-46). This could support an interpretation where a lower cell count from cord blood is "sufficient" compared to bone marrow.
- Evidence for a Narrower Interpretation: The specification provides a detailed quantitative analysis comparing the number of colony-forming units (CFU-GM) needed for successful bone marrow transplants (ranging from 2-425×10⁴) with the amounts found in collected cord blood samples (’681 Patent, col. 51:1-8). This reference to established clinical data could support a narrower construction requiring a specific, quantifiable threshold of progenitor cells.
The Term: "treating a human patient" (from ’427 Patent, Claim 1)
Context and Importance: The infringement allegation against the defendants, who provide storage services rather than medical treatment, hinges on the scope of this term. The dispute will likely involve whether actions preparatory to a potential future medical procedure fall within the scope of a method claim for "treating."
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's detailed description frames the entire process, from collection to cryopreservation to eventual use, in a therapeutic context. The "Therapeutic Uses" section describes the utility of the invention for a wide range of diseases, which could support viewing the entire service as part of a method of treatment (’681 Patent, col. 25:35-41).
- Evidence for a Narrower Interpretation: The claim language itself requires the step of "introducing into the human patient a composition." This explicit step suggests that the act of "treating" is the administration of the cells, not the antecedent acts of collecting and storing them. The patent distinguishes between the cryopreservation step and the "therapeutic uses" step (’681 Patent, col. 2:2-3).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants contributorily infringe and/or induce infringement of all asserted patents (Compl. ¶¶ 26, 30, 34). The factual basis appears to be that by providing collection kits, processing the cord blood, and storing it for future therapeutic use, Defendants are actively encouraging and enabling the eventual direct infringement of the method claims by medical professionals, and are creating the infringing compositions for others to use.
- Willful Infringement: The complaint makes a conclusory allegation that infringement "has been and continues to be willful and deliberate" for all three patents (Compl. ¶¶ 27, 31, 35). The complaint does not allege specific facts to support this claim, such as pre-suit knowledge of the patents-in-suit.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional scope: What factual evidence is required to establish that a cryopreserved cord blood unit contains stem cells "in an amount sufficient to effect hematopoietic reconstitution of a human adult"? The resolution of this question will determine the evidentiary burden for proving infringement of the key composition claims.
- A key legal question will be one of infringement liability: Can a commercial entity that provides the service of collecting, processing, and storing cord blood for potential future therapeutic use be held liable for infringing a patent claim directed to a "method for treating a human patient," an act performed, if at all, by third-party medical professionals at a later date?