This is an antitrust action filed by Plaintiffs CareFirst of Maryland, Inc., Group Hospitalization and Medical Services Inc., and CareFirst Bluechoice Inc. (collectively, “CareFirst”) alleging that Defendants Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) used monopoly power to unlawfully delay the introduction of biosimilar competitors for their drug ustekinumab (sold under the brand name “Stelara”).
CareFirst proffered Todd Clark as a pharmaceutical business expert. However, J&J filed a motion to exclude the testimony of Clark.
Marketing Expert Witness
Todd D. Clark has over thirty years of experience in the pharmaceutical industry. Before founding his own advisory firm, Clark served as Vice President of Business Development and Director of Media Services for Medicus NY, then the world’s largest pharmaceutical marketing firm.
Discussion by the Court
Clark’s expert report provided four opinions related to causation, all of which are premised on the assumption that the jury finds J&J’s challenged conduct was unlawful under antitrust law.
A. Clark’s “Reasonable Company” Framework
To begin with, J&J’s first objection applies to all four of Clark’s opinions. J&J argued that Clark’s opinions should be excluded on the ground that they are all predicated on an unreliable framework that Clark utilized in his opinions: what a “reasonable” pharmaceutical company could have done.
However, the Court rejected J&J’s overarching argument that Clark’s “reasonable” pharmaceutical company is unreliable. Basically, Clark’s focus on the conduct of a “reasonable” company reflects a well-established approach in the antitrust context for evaluating corporate decision making.
Clark drew on his more than thirty years of experience to offer a range of business options through the lens of industry practice. This approach falls within the province of acceptable testimony from an experiential expert, and it provides a reliable framework for assisting the jury in understanding the options available to companies in J&J’s position.
That Clark applied this framework to the facts of this case did not render it unreliable, especially since Clark did not purport to give an opinion on what J&J actually knew or would have actually done absent the challenged misconduct.
B. Clark’s First Opinion
Clark’s first opinion is that “[a] reasonable company in J&J’s position had options other than asserting the biosimilar manufacturing patents” that “therefore would have avoided the allegedly anticompetitive actions associated with the Momenta biosimilar patents.”
In his first opinion, Clark offers five alternative options “available to J&J or a reasonable company in the same position that would not have involved asserting the biosimilar manufacturing patents against biosimilar manufacturers and therefore would have avoided the allegedly anticompetitive actions associated with the Momenta biosimilar patents.” The five options that Clark offers are:
1) “a reasonable company in J&J’s position could have chosen not to take possession of the biosimilar manufacturing patents at the time of the Momenta acquisition or to divest them upon completing the acquisition”;
2) “a reasonable company in J&J’s position could have chosen not to maintain rights to the biosimilar manufacturing patents”;
3) “a reasonable company in J&J’s position could have chosen not to assert the biosimilar manufacturing patents”;
4) “a reasonable company in J&J’s position could have licensed the biosimilar manufacturing patents to ustekinumab biosimilar makers without also negotiating delayed market entry”; and
5) “J&J could have chosen to license or divest the biosimilar manufacturing patents to another party.”
J&J argued that each option provided by Clark should be excluded because, generally, they “amount to nothing more than conclusory assertions,” are “unsupported by any methodology,” and would not help the jury because Clark provided options other than “asserting” the Momenta patents yet Plaintiffs have expressly disavowed any challenge to J&J’s assertion of these patents.
The Court is unpersuaded by J&J’s arguments for excluding Clark’s first opinion and the five options he provides therein. Clark is an experiential expert, so his over thirty years of experience provides a foundation for understanding the business incentives around patent ownership and divestiture.
C. Clark’s Second Opinion
As for his second opinion, Clark opined that “biosimilar manufacturers could have obtained FDA approval and launched with labels that carved out ulcerative colitis treatment as covered by the ‘307 patent.”
J&J challenges Clark’s second opinion on the following two grounds: (1) because Clark is not a lawyer, he is unqualified to opine the legal risks of using a labeling carve-out, thereby making his opinion mere speculation; and (2) Clark utilized no specific methodology to conclude that skinny labels could avoid infringement, instead basing his opinion on the fact that the FDA has approved biosimilars with labeling carve-outs in the past.
According to the Court, Clark applied a reasoned, experience-based methodology to answer a business and regulatory question, not a legal one. Any concern that J&J has with his conclusions goes to weight, not admissibility.
J&J’s arguments for the exclusion of Clark’s second opinion mischaracterize the nature of the opinion as well as the methodology applied. First, Clark did not purport to offer a legal opinion about patent infringement or to assess the ultimate “legal risks” of labeling carve-outs, an issue he appropriately acknowledged during his deposition would be addressed by patent counsel.
Here, Clark offers an opinion squarely within his expertise: whether, as a matter of regulatory practice and business risk, reasonable biosimilar manufacturers would have viewed a launch under a labeling carve-out as a viable strategy notwithstanding the ‘307 patent.
Second, Clark’s opinion rests on a sufficiently reliable methodology. His report devotes substantial analysis to the history and mechanics of labeling carve-outs, the FDA’s guidance encouraging such practices, and the real-world experience of biosimilar and generic manufacturers launching under a labeling carve-out.
D. Clark’s Third Opinion
As for his third opinion, Clark opined that “absent the allegedly anticompetitive behavior, there would have been no patent-related barrier to earlier availability of ustekinumab biosimilars.”
J&J challenged Clark’s third opinion as conclusory, arguing that it should be excluded because (1) Clark is not an expert in the pertinent art of biosimilar manufacturing and thus is unqualified, and (2) Clark did not conduct any analysis that would allow him to conclude whether biosimilar manufacturers faced patent-related barriers to entry.
The Court held that Clark’s third opinion concerning patent-related barriers to biosimilar entry is appropriate expert testimony because it does not purport to resolve questions of patent infringement but instead offers an industry-based assessment of the patent landscape absent the alleged misconduct. First, Clark does not opine whether any biosimilar would infringe particular patent claims or analyze biosimilar manufacturing methods—tasks that would require the legal or technical expertise he does not claim to possess. Rather, his opinion is limited to whether, during the relevant period, any patents other than those challenged here would have presented a practical barrier to biosimilar entry once FDA licensure was obtained. Where the record shows that no other unexpired Stelara patents could have delayed competition, Clark’s expertise in pharmaceutical markets is sufficient to support that conclusion.
Second, Clark’s opinion is reliable and is not, contrary to J&J’s argument, unsupported ipse dixit. He grounds his analysis in contemporaneous evidence, including J&J’s own statements, litigation positions, and employee testimony describing the scope and significance of the relevant patents.
E. Clark’s Fourth Opinion
As for his fourth opinion, Clark opined that a “reasonable company in J&J’s position would have launched an ‘authorized biologic’ if only one biosimilar had entered the market following expiration of the ‘734 patent.”
J&J argued Clark’s fourth opinion is (1) not reliable because Clark merely recites record evidence in concluding that J&J would have launched an authorized biologic version of Stelara, and (2) not helpful for the jury because reciting the facts of a case without any analysis does nothing to assist the jury.
Regarding reliability, Clark does not merely summarize J&J’s internal materials. Rather, he synthesizes those materials with his extensive experience in pharmaceutical markets and his review of industry literature to explain why, under well-understood competitive dynamics, a reasonable company in J&J’s position would have had strong incentives to launch an authorized biologic if only a single biosimilar entered the market in September 2023.
Accordingly, because Clark explained the rationale behind his conclusions and applied his specialized knowledge to interpret complex business records and competitive incentives, the Court held that his testimony will help the jury understand when and why companies launch authorized biologics.
F. Due Diligence Process
Finally, the parties disagree over whether the opinions Clark offers in his rebuttal expert report concerning the Momenta acquisition due diligence process are supported. In his rebuttal report, Clark opined that, through its pre-acquisition diligence process, “J&J could draw a connection between [the Momenta manufacturing patents] and the potential to delay follow-on versions of Stelara from reaching the market” at the time it acquired Momenta.
J&J challenged Clark’s opinions about the Momenta acquisition due diligence process as speculative and unsupported.
In response, CareFirst argued that Clark’s opinions on the Momenta acquisition due diligence process are admissible because they are grounded in extensive contemporaneous evidence showing that a reasonable company in J&J’s position could have been prompted to investigate these patents during due diligence.
The Court agreed with CareFirst: J&J’s objections to Clark’s opinions regarding the Momenta acquisition due diligence process go to weight, not admissibility, and are therefore appropriate for cross-examination rather than exclusion. Clark’s rebuttal opinions are grounded in record evidence, and they address what a reasonable company in J&J’s position could have discerned or investigated during the pre-acquisition due diligence process.
Held
The Court denied J&J’s motion to exclude the testimony of Todd Clark.
Key Takeaway:
By explaining what a reasonable company could have done instead of the challenged conduct, Clark’s testimony helps the jury understand the competitive landscape and the range of options available to companies in J&J’s position. As CareFirst notes, Clark does not opine whether a reasonable company in J&J’s position “would choose a particular option, but rather that there were multiple rational business options available” and that “none of those options would unlawfully delay biosimilar entry.”
Thus, Clark’s testimony provided helpful context for the jury to evaluate whether the challenged conduct was exclusionary, and any risk of confusion can be addressed through cross-examination rather than exclusion.
Case Details:
| Case Caption: | Carefirst Of Maryland, Inc., Et Al. V. Johnson & Johnson, Et Al |
| Docket Number: | 2:23cv629 |
| Court Name: | United States District Court, Virginia Eastern |
| Order Date: | December 23, 2025 |
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