DCT
2:23-cv-05268
INNOMED Tech Inc v. UCLA Health
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: INNOMED Technologies, Inc. (California)
- Defendant: UCLA Health and Akira Ishiyama (California)
- Plaintiff’s Counsel: Entralta PLLC.
- Case Identification: 2:23-cv-05268, C.D. Cal., 07/03/2023
- Venue Allegations: Venue is asserted based on Defendants doing business in the district and a substantial part of the events giving rise to the patent infringement claims having taken place in the district.
- Core Dispute: Plaintiff alleges that Defendants' medical practice of treating Bell's Palsy patients infringes a patent related to administering intravenous immunoglobulin (IVIG) for the condition.
- Technical Context: The dispute concerns a method-of-treatment patent in the field of neurology, focusing on therapies for acute peripheral facial palsy, commonly known as Bell's Palsy.
- Key Procedural History: The complaint alleges that one of the patent's inventors, Dr. John Joseph, personally informed Defendant Dr. Ishiyama of the invention and asked him to test the treatment on a patient. Following a successful trial, Defendants allegedly continued to use the method on other patients without consent and with knowledge of the patent's existence, forming the basis for the willfulness allegation.
Case Timeline
| Date | Event |
|---|---|
| 2019-02-07 | '789 Patent Priority Date |
| 2021-08-10 | '789 Patent Issue Date |
| 2023-07-03 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,083,789 - "IVIG Treatments for Bell's Palsy"
Issued August 10, 2021.
The Invention Explained
- Problem Addressed: The patent's background section notes that Bell's palsy involves acute unilateral facial weakness and that existing treatments, such as steroids and antiviral therapy, may require a recovery period of "2 weeks to 4 months" (’789 Patent, col. 1:33-40). The patent asserts that "more effective therapeutic treatments for Bell's Palsy patients are needed" (’789 Patent, col. 2:49-51).
- The Patented Solution: The invention is a method for treating Bell's Palsy by administering a "therapeutically effective amount" of human intravenous immunoglobulin (IVIG), which can be co-administered with a steroid such as prednisone (’789 Patent, Abstract; col. 2:10-22). The stated goal is to achieve patient recovery in less time than with conventional treatments (’789 Patent, col. 3:56-59).
- Technical Importance: The technology proposes using IVIG, an immunomodulatory agent, as an "improved treatment for Bell's Palsy and associated symptoms" to provide more rapid patient recovery (’789 Patent, col. 2:51-53).
Key Claims at a Glance
- The complaint asserts infringement of "the '789 Patent claims" without specifying particular claims (Compl. ¶16). Independent claim 1 is central to the patent.
- The essential elements of independent claim 1 are:
- A method for treating Bell's Palsy disease in a subject in need thereof, the method comprising:
- administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG) to a subject,
- wherein the immunoglobulin is co-administered with a steroid.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is a medical treatment method allegedly performed by Defendants UCLA Health and Akira Ishiyama (Compl. ¶¶14, 16).
Functionality and Market Context
The complaint alleges that Defendants used "the inventive treatment method using IVIG to treat patients suffering with Bell's Palsy" (Compl. ¶14). This allegedly occurred after an inventor on the patent, Dr. John Joseph, informed Defendant Ishiyama about the invention and asked him to trial the treatment on a patient (Compl. ¶12). After observing that the treatment "worked better to resolve Bell's Palsy than currently used treatments," Defendants are alleged to have used the method on at least nine other patients (Compl. ¶¶12-14). The complaint characterizes the invention as having "incredible value" (Compl. ¶13).
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement theory is based on narrative allegations. No probative visual evidence provided in complaint.
'789 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating Bell's Palsy disease in a subject in need thereof, the method comprising: | Defendants allegedly used an "inventive treatment method...to treat patients suffering with Bell's Palsy." | ¶14 | col. 1:15-17 |
| administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG) to a subject, | The accused method is described as "using IVIG to treat patients." | ¶14 | col. 2:13-16 |
| wherein the immunoglobulin is co-administered with a steroid. | The complaint alleges use of the "inventive treatment method," which the patent defines as requiring co-administration of IVIG with a steroid. | ¶14 | col. 15:28-34 |
Identified Points of Contention
- Technical Questions: A primary question is what evidence exists to show that Defendants performed every step of the asserted claims. The complaint alleges the use of IVIG to treat Bell's Palsy (Compl. ¶14) but does not specifically allege the co-administration of a steroid, which is a required limitation of independent claim 1. The infringement case may depend on whether the "inventive treatment method" shown to Defendants and subsequently used by them can be proven to have included this step.
V. Key Claim Terms for Construction
"co-administered"
- Context and Importance: This term is a critical limitation in independent claim 1. The infringement analysis will turn on whether the Defendants' alleged actions constitute "co-administration" of IVIG and a steroid. Practitioners may focus on this term because the complaint's factual allegations mention only the use of IVIG.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's specification contemplates scenarios where "the IVIG is administered separately from a steroid" (’789 Patent, col. 5:21-22), which could suggest that "co-administered" does not strictly require simultaneous delivery or a single formulation. Example 1 describes a patient already on prednisone who is then "co-administered a single dose of IVIG at 2 g/kg and 60 mg prednisone," suggesting the term may cover concurrent therapies (’789 Patent, col. 13:38-40).
- Evidence for a Narrower Interpretation: The language of Claim 1, which recites "administering a therapeutically effective amount of a composition comprising human intravenous immunoglobulin (IVIG)...wherein the immunoglobulin is co-administered with a steroid," could be argued to require that both agents are part of the same therapeutic event.
"therapeutically effective amount"
- Context and Importance: This term defines the dosage required by the method. Proving infringement will require showing that the dosage allegedly used by Defendants falls within the scope of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses extremely wide dosage ranges, such as "about 0.001 g/kg/day to about 10 g/kg/day" for IVIG, which could make it easier for the Plaintiff to establish that this limitation is met (’789 Patent, col. 10:9-11).
- Evidence for a Narrower Interpretation: A party could argue that the term should be interpreted more narrowly in light of the patent’s working examples, which describe a specific IVIG dose of "2 g/kg" (’789 Patent, col. 13:38, 13:51).
VI. Other Allegations
Indirect Infringement
The complaint makes a conclusory allegation of "inducement to infringe" but does not provide specific facts to support a theory of inducement, such as evidence of instructions or encouragement directed to a third party (Compl. ¶16). The core allegations focus on direct infringement by the named Defendants.
Willful Infringement
The complaint alleges that Defendants' infringement was willful based on purported pre-suit knowledge of both the invention and the patent (Compl. ¶¶14-15). The factual basis for this claim is the allegation that an inventor, Dr. John Joseph, personally informed Defendant Dr. Ishiyama of the invention, asked him to test it, and that Defendants continued to use the method after the patent issued "with full knowledge of the patents existence" (Compl. ¶¶12, 14).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: What factual evidence will be produced to demonstrate that Defendants' medical practice involved every element of the asserted claims, particularly the "co-administered with a steroid" limitation of Claim 1, which is not explicitly detailed in the complaint's factual narrative?
- A key question for willfulness will be the nature of pre-suit knowledge: Centered on the allegation that an inventor personally disclosed the technology to the Defendants, the analysis will likely focus on what exactly was communicated and whether the Defendants' subsequent actions, with alleged knowledge of the issued patent, rose to the level of objective recklessness required to support a finding of willful infringement.