The recent decision in Trudell Medical International Inc. v. D R Burton Healthcare, LLC by the United States Court of Appeals for the Federal Circuit highlights significant issues in intellectual property law, particularly in the realm of patent litigation. This case, which revolves around the infringement of U.S. Patent No. 9,808,588, serves as a critical reminder of the procedural and evidentiary requirements in patent disputes.

Background of the Case

Trudell Medical International Inc. (“Trudell”) sued D R Burton Healthcare, LLC (“D R Burton”) for infringement of its patent covering oscillatory positive expiratory pressure (OPEP) therapy devices. Trudell alleged that D R Burton’s vPEP®, iPEP®, PocketPEP®, and related products infringed claims 1–7, 9, and 18 of its patent. After a three-day trial, the jury found the asserted claims valid but not infringed.

Trudell appealed on multiple grounds, including the improper admission of expert testimony by Dr. John Collins, an expert retained by D R Burton. The Federal Circuit ultimately reversed the district court’s decision allowing Dr. Collins’ testimony, granted a new trial on infringement, and ordered the case to be reassigned to a different judge.

Key Legal Issues in the Case

1. Expert Testimony and Compliance with Federal Rules

One of the most significant issues in the case was the admission of expert testimony. Under Federal Rule of Civil Procedure 26(a)(2), expert reports must include a complete statement of opinions, the basis and reasons for those opinions, supporting data, and a list of prior cases where the expert has testified. Additionally, under Rule 37(c)(1), failure to disclose expert information as required by Rule 26 results in automatic exclusion unless the failure is substantially justified or harmless.

The court found that D R Burton failed to comply with these disclosure requirements, as Dr. Collins did not submit a timely expert report on noninfringement. His testimony was introduced at trial despite not being disclosed during discovery, depriving Trudell of an opportunity to challenge or cross-examine his findings adequately. The court held that this failure was neither substantially justified nor harmless, leading to the exclusion of his testimony and the ordering of a new trial.

2. Claim Construction and Expert Reliability

The Federal Circuit also addressed issues with the methodology of Dr. Collins’ testimony. The district court had construed specific claim terms, including the definition of “a vane” and “rotate relative to the opening.” Despite this, Dr. Collins provided testimony that contradicted the court’s construction, effectively redefining key claim terms. His approach was deemed unreliable under Federal Rule of Evidence 702, which requires that expert opinions be based on reliable principles and methodologies.

This aspect of the decision underscores the importance of ensuring that expert witnesses adhere to judicial claim constructions rather than reinterpreting patent terms in a manner inconsistent with the court’s ruling.

3. The Impact of Procedural Missteps on Patent Trials

Another crucial takeaway from this case is the procedural mismanagement at the district court level. The judge overseeing the case made multiple contradictory rulings regarding Dr. Collins’ testimony, initially excluding it, then allowing it, then reversing again. Additionally, comments made by the judge suggested a predisposition toward resolving the case quickly, rather than ensuring a fair trial. These concerns led the Federal Circuit to order a reassignment of the case to a different judge on remand—a rare but important corrective measure to preserve judicial impartiality.

Implications for Patent Law and Litigation Strategy

This decision has several important takeaways for patent litigants:

• Strict Compliance with Expert Disclosure Rules: Failure to provide timely and complete expert reports can lead to exclusion of testimony, which can be case-dispositive in patent disputes.
• Adherence to Claim Construction: Experts must base their testimony on the court’s claim construction and avoid introducing conflicting interpretations.
• The Role of Judicial Conduct in Patent Trials: The reassignment of this case underscores the importance of judicial impartiality and procedural fairness in complex intellectual property disputes.

Conclusion

The Trudell v. D R Burton case highlights the complexities of patent litigation, particularly in the areas of expert testimony and claim construction. For attorneys and companies engaged in intellectual property disputes, this ruling reinforces the necessity of procedural diligence, expert reliability, and fair trial practices. As the case moves forward on remand, it will be interesting to see how the new trial unfolds without the tainted expert testimony that influenced the first jury’s verdict.

By Charles Gideon Korrell