Key Points:

• The Court treated an expert's qualifications as a threshold admissibility question for the judge, not a matter of weight or credibility — even in a bench trial.
• Citing the expert's repeated deposition admissions that he lacked expertise in genetics, cancer cell biology, clinical trial interpretation, and cancer treatment, the Court limited the medicinal chemist's trial testimony to medicinal chemistry.
• Hatch-Waxman and pharmaceutical patent litigants should take this as a reminder to match each expert's opinions to that expert's training.

A recent New Jersey decision shows how an expert's own deposition admissions can shrink his trial testimony. Treating qualification as a threshold question under amended Federal Rule of Evidence 702, the Court confined a pharmaceutical patent expert to his core field — even though no jury would hear the case.

Expert testimony is often critical for patent litigation, as the trier of fact may benefit from expert explanations of technical concepts underpinning the issues in the case such as infringement and invalidity of the patents-in-suit. Cases can often involve multiple experts with knowledge in different fields or areas, such as pharmacology, oncology, chemistry, and many more.

A decision from a visiting judge in the DNJ narrowing an expert’s proposed testimony provides a key reminder that the court must act as a gatekeeper to ensure the expert is qualified, the expert’s methods are reliable, and that the opinions fit the disputed issues in the case.

Background

In an ANDA litigation concerning the proposed offering of a generic version of the anticancer therapeutic LYNPARZA® (olaparib) tablets, plaintiffs asserted several patents, including U.S. Patent Number 8,859,562 (the ’562 patent). The ’562 patent is titled “Use of RNAI Inhibiting PARP Activity for the Manufacture of a Medicament for the Treatment of Cancer,” and is “relate[d] to the use of an agent that inhibits the activity of an enzyme which mediates the repair of [deoxyribonucleic acid (DNA)] strand breaks in the treatment of certain forms of cancer[,] in particular breast cancer.”

Plaintiffs filed a Motion to Exclude the opinions of Dr. Dana Ferraris, a medicinal chemist. Following briefing, Judge Jennifer Choe-Groves, visiting the DNJ from the Court of International Trade, granted plaintiffs’ motion.

The Court’s Analysis

The Court began its analysis by discussing Federal Rule of Evidence 702, which permits a witness “qualified as an expert by knowledge, skill, experience, training, or education” to testify in the form of an opinion, provided that “the proponent demonstrates to the court that it is more likely than not that”:

• the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
• the testimony is based on sufficient facts or data;
• the testimony is the product of reliable principles and methods; and
• the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.

The Court noted that the “party that proffers the expert testimony bears the burden of establishing its admissibility by a preponderance of the evidence.” The Court stated it must act “as a gatekeeper to prevent expert testimony from running afoul of Rule 702, even when the matter will not be tried before a jury.”

In a bench trial context, the Court noted, even though concerns about allowing in broad expert testimony are diminished, the trial judge does not relinquish her gatekeeping function.

Third Circuit precedent establishes a “trilogy of restrictions” on expert testimony — namely qualification, reliability and fit. The opinion focused on the first factor – qualification.

“It is black-letter law,” the Court emphasized, “that for a witness to be qualified to testify as an expert, the witness [must] possess specialized expertise.”

Plaintiffs emphasized that Dr. Ferraris is a medicinal chemist, which plaintiffs described as “someone who studies the chemistry of medicines: making molecules, designing them, [and] testing them in vitro, i.e., testing molecules in laboratory vessels rather than in living things (in vivo) or in human patients.” However, plaintiffs argued that Dr. Ferraris’ expert reports “go far beyond the field of medicinal chemistry,” and “testimony proffered on genetics, cancer biology, clinical trial interpretation, and the treatment of cancer are inadmissible areas outside of Dr. Ferraris’ areas of expertise.” Plaintiffs requested any proposed testimony beyond medicinal chemistry be struck.

Importantly, plaintiffs emphasized deposition testimony by Dr. Ferraris in which he “expressly concedes he is not an expert in the fields about which defendants have asked him to opine,” specifically citing admissions by Dr. Ferraris that “he is not an expert in genetics, cancer biology, clinical trial interpretation, and the treatment of cancer.”

In response, defendants argued that “the challenge to Dr. Ferraris’ testimony is an inappropriate attack on his credibility,” noting “[w]hether he modestly agrees he is not formally an expert by training in certain specific subject matter is not dispositive.” Defendants clarified that Dr. Ferraris’ experience is “broadly related to the entire field of PARP-1 inhibitors and their use in the treatment of cancer, as well as drug development from soup to nuts that have gone through clinical trials, including one receiving FDA approval.”

Thus, according to defendants, the issue of “whether Dr. Ferraris could be more qualified in a particular area goes only to the weight of his testimony, not its admissibility.”

The Court’s analysis was guided by the Federal Circuit’s 2023 decision in EcoFactor, Inc. v. Google LLC. The EcoFactor Court held that a 2023 amendment to FRE 702 clarified “that the proponent of expert testimony bears the burden of establishing its admissibility and to emphasize that an expert’s opinion must stay within the bounds of a reliable application of the expert’s basis and methodology.”

Accordingly, the Court focused here “on the question of whether Dr. Ferraris is a qualified expert and whether his proposed testimony is within the bounds of a reliable application of his expert basis.”

The Court found especially persuasive “Dr. Ferraris’ own repeated admissions that he is not an expert by training in the fields of genetics, cancer cell biology, clinical trial interpretation, and the treatment of cancer.” The Court agreed with plaintiffs’ argument that, “[s]omeone who admittedly lacks expertise in the interpretation of clinical trials should not be allowed to interpret them at trial.” The Court further emphasized the 2023 amendment to FRE 702, “which stated in an Advisory Committee note that judges should apply Rule 702 as gatekeepers for admissibility, rather than weighing the evidence.”

The Court held that “[a]lthough EcoFactor did not directly address the qualifications of an expert witness…the gatekeeping functions of admissibility under amended Rule 702 should not be subsumed by a preference to regard the expert’s testimony by credibility or the weight of the evidence.”

The Court further concluded that “it is appropriate to evaluate Dr. Ferraris’ qualifications under the admissibility standards of Rule 702, rather than evaluating his testimony as a matter of credibility or weight of the evidence.” The Court found that “Dr. Ferraris admitted repeatedly that he is not a trained expert in the fields of genetics, cancer cell biology, clinical trial interpretation, and the treatment of cancer.”

Accordingly, the Court held that “Dr. Ferraris should be allowed to testify only in areas of his training and expertise, which is medicinal chemistry.”

Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

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