Immunology Expert Witness’ Redevelopment Opinion Excluded
Posted on October 31, 2024 by Expert Witness Profiler
Plaintiff I-Mab Biopharma (“I-Mab” or “Plaintiff”) brought trade secret misappropriation claims against Defendants Inhibrx, Inc. (“Inhibrx”) and Brendan Eckelman (“Dr. Eckelman” and collectively with Inhibrx, “Defendants”).
Plaintiff asserted that Defendants misappropriated nine trade secrets (that correspond to molecules designed to treat cancer) that are referred to herein as Trade Secret 1, Trade Secret 2, Trade Secret 4, Trade Secret 5, Trade Secret 6, Trade Secret 7, Trade Secret 8, Trade Secret 9 and Trade Secret 10.
Plaintiff filed a motion to exclude certain opinions offered by Defendants’ technical expert Dr. Roland Newman.
Immunology Expert Witness
Roland Newman has extensive experience in the biotechnology industry, including experience in developing therapeutic antibodies and in the manufacturing, preclinical development and clinical planning phases. This experience includes several years employed as Vice President and Chief Scientific Officer of Tanabe Research Labs USA. His scientific experience also covers immunology, molecular biology and biochemical research in both academic and industrial environments and he has over 100 peer reviewed publications, several book chapters and 30 patents.
Discussion by the Court
A. Newman’s redevelopment opinion
One of the ways in which a claim for damages for trade secret misappropriation can be quantified is by measuring unjust enrichment; to that end, unjust enrichment can be assessed by identifying development costs that were avoided by the misappropriator but would have been incurred, if not for the misappropriation (i.e., “avoided costs”).
When Newman offered his opinion regarding Defendants’ avoided costs (the “redevelopment opinion”), Plaintiff contended that Newman’s redevelopment opinion is unreliable and lacks “fit” (and should therefore be excluded) because “the number was pulled out of thin air, the opinion ignores known R&D expenses, and the opinion fails to account for numerous categories of trade secret data and analysis.”
The Court agreed that Newman’s redevelopment opinion does not pass muster, even under Daubert‘s liberal standard for the following reasons:
- First, the paragraph at issue does not give any hint as to where Newman derives the cited cost data from.
- Second, Newman’s redevelopment opinion is also insufficient because he does not explain how it accounts for the different trade secrets at issue here. In other words, while “I-Mab’s trade secrets pertain to multiple different molecules and comprise different amounts and types of data,” Newman estimates one cost for the recreation of data from conducting a preclinical monkey toxicity study—$290,000—and applies it to each trade secret.
B. Newman’s opinions regarding Defendants’ use of the trade secrets
Newman opined that with respect to Defendants’ alleged use of Trade Secret 1, “no substantial changes were made in the clinical development path of INBRX-105” (“paragraph 116”). Plaintiff contended that this portion of paragraph 116 must be excluded because Newman cites to no supporting evidence and did not review Inhibrx’s clinical protocol amendments.
Newman also added that the amendments that Inhibrx did make were “standard practices in running a clinical trial and no significant changes to the protocol were made” (“paragraph 118”). Plaintiff contended that this portion of paragraph 118 must be excluded because Newman did not have sufficient experience to opine regarding what is standard practice with respect to amending clinical protocols and did not review the protocol amendments.
The Court does not agree that these opinions should be excluded. Newman did testify that he did not have “direct experience” amending a clinical protocol but the Court found Newman’s extensive experience in the biotechnology industry relevant. Newman described the changes that were made to the clinical protocol (and why these changes were made) and opines that certain particular modifications are standard practice in running a clinical trial. Moreover, Newman described changes that were made in the clinical development path of INBRX-105, which established the basis for his opinion that no substantial changes were made.
C. Newman’s opinions about public disclosure
Plaintiff next moved to exclude Newman’s opinions that certain of I-Mab’s trade secrets are disclosed in particular publications.
According to Plaintiff, these opinions should be excluded because Newman does not identify where in these publications Plaintiff’s trade secrets are disclosed, or because Newman’s views are just incorrect.
The Court will not exclude these opinions because Newman either included screenshots of the portions of the publications at issue that he opined contained publicly disclosed information with respect to certain trade secrets, or explained what the publicly disclosed information is in the publication at issue.
D. Newman’s opinions on ownership and reasonable measures
Finally, Plaintiff argued that Newman’s opinions regarding the ownership of Plaintiff’s trade secrets and any reasonable measures to protect them in the time period after Plaintiff’s corporate restructuring in April 2024 should be excluded, on lack-of-qualifications grounds. However, in light of the Court’s ruling that the October 2024 trial should cover events occurring prior to, but not later than, the date of the divestiture, the Court does not understand how post-divestiture reasonable measures are relevant to the conduct that will be at issue during trial. Therefore, this portion of the Motion is denied as moot.
Held
The Court granted Plaintiff’s motion only with respect to Dr. Roland Newman’s redevelopment opinion but otherwise denied it.
Key Takeaways:
- Newman’s opinion about standard practices in running a clinical trial constitutes appropriate rebuttal testimony that he is qualified to offer.
- Without any understandable explanation for how one cost for one type of study applies equally to all trade secrets at issue, Newman’s redevelopment opinion “does not fit the issues to be tried and is not helpful.”
Please refer to the blog previously published about this case:
Economics Expert Witness’ Testimony Limited Because His Zero Damages Opinion is Irrelevant
Case Details:
| Case Caption: | I-Mab Biopharma V. Inhibrx, Inc. Et Al |
| Docket Number: | 1:22cv276 |
| Court: | United States District Court, Delaware |
| Order Date: | October 21, 2024 |
