Contact Lens Infringement

Recently, a personal health care product company (“Company R”) appealed from the district court’s judgment that a multinational health care company (JJVC) and its Advance® and Oasis® contact lenses didn’t infringe Company R’s U.S. Patent No. 5,712,327 (‘327 patent) for soft gas permeable contact lens. Company R challenged the trial court’s grant of judgment as a matter of law and its denial of Company R’s motion for a new trial.

The main issue on appeal was whether Company R presented enough evidence that the contact lenses in question were “soft.”  The trial court adopted the parties’ agreed-upon definition of “soft gas permeable contact lens” as “a contact lens having a Hardness (Shore D) less than five.” The court excluded Company R’s evidence that the contact lenses in question were generally known as “soft” lenses because that evidence was not probative on whether those lenses had a Shore D Hardness of less than five.

Company R relied on the expert testimony of Dr. TB at trial.  His testimony was to establish that the lenses had a Shore D Hardness of less than five.  However, Dr. TB’s trial testimony did not match the opinions disclosed in his expert report.  JJVC moved to exclude that expert testimony on the basis that Dr. TB’s Shore D Harding testing did not comply with industry-standard protocols.  JJVC contended that the applicable standards required probing a thick button of dry lens material on a flat surface and didn’t allow for testing a stack of hydrated contact lenses around a steel ball, as TB had.  JJVC also moved for summary judgment on the grounds that no reasonable juror could conclude that the lenses in question were “soft” based on Dr. TB’s findings. The court denied the motion for summary judgment and deferred ruling on JJVC’s evidentiary motion until after Dr. TB testified at trial.

On direct examination, Dr. TB testified that he performed the steel ball Shore D Hardness test described in his expert report.  During cross examination, JJVC’s counsel asked the expert if he had tested a sufficiently thick sample of stacked lenses to comply with the industry-standard testing protocols, which was a thickness of 6 mm or more.  Dr. TB replied that he tested a stack of lenses that was 6 mm thick, not 2.54 mm as he had disclosed in his expert report.  Dr. TB said that the error in his report “might be a typo.”

Despite the “typo,” Dr. TB confirmed that he tested a stack of 24 contact lenses.  JJVC then asked him how a stack of 24 contact lenses—each .07 mm thick—could add up to 6 mm.  Dr. TB agreed that one would expect such a stack to have a thickness around 1.68 mm.  JJVC then asked Dr. TB to confirm that he did not test flat samples of the lens material. At that point, Dr. TB “suddenly changed course in the middle of cross-examination and testified that he did not follow the procedures listed in his expert report.”  He testified that he performed the Shore D Hardness testing by cutting the lenses into quarters, stacking the lens quarters on a flat surface, and then probing them. This explained how he was able to create a stack of lenses that was 6 mm thick.  None of this was in his expert report, and Dr. TB claimed that his expert report’s disclosure of the wrong Shore D Hardness test procedure was also a “typo.”

JJVC renewed its motion to exclude Dr. TB’s testimony and moved for judgment as a matter of law.  The trial court granted the motions, and struck Dr. TB’s testimony under Federal Rules of Civil Procedure 26 and 37; his expert report was insufficient to support his trial testimony.  The court also excluded Dr. TB’s testimony under Federal Rule of Evidence 702 because nothing in the record established the reliability of the testing methodology that he testified to at trial.  In light of the fact that  Dr. TB’s struck testimony was the only evidence that Company R advanced at trial to prove that the lenses in question were “soft,” the court granted judgment as a matter of law that JJVC did not infringe.  Company R appealed.

Company R argued that the trial court improperly excluded Dr. TB’s trial testimony. Company R claimed that the mistakes in Dr. TB’s report were unintended and did not harm JJVC.  In addition, it further argued that Dr. TB’s actual testing methodology was reliable because he followed industry standard testing protocols.  JJVC said that, regardless of Dr. TB’s intent, there was no justification for the expert’s late disclosure of his testing methods, and that his change in testimony significantly impaired its ability to prepare a noninfringement defense and prepare the case for trial. JJVC also asserted that Company R failed to show that Dr. TB’s undocumented testing methodology was sufficiently reliable.

The United States Court of Appeals, Federal Circuit agreed with JJVC that the court correctly granted judgment as a matter of law. Circuit Judge Kimberly Ann Moore wrote that the district court did not abuse its discretion when it excluded Dr. TB’s testimony under the Federal Rules of Civil Procedure. The purpose of the expert disclosure rule in Rule 26 is to “provide opposing parties reasonable opportunity to prepare for effective cross examination and perhaps arrange for expert testimony from other witnesses.”

Failure to comply with Rule 26(a) has significant consequences, Judge Moore wrote, including Rule 37’s “self-executing sanction.”  An expert witness may not testify to subject matter beyond the scope of the witness’s expert report unless the failure to include that information in the report was “substantially justified or harmless.” She said that the burden was on the party facing sanctions to prove that its failure to comply with Rule 26(a) was “substantially justified or harmless.” The judge held that it was undisputed that the expert failed to produce a report containing “a complete statement of all opinions the witness will express and the basis and reasons for them.”  The issue was whether, under Rule 37(c)(1), it was “substantially justified or harmless” that Dr. TB waited until trial to disclose the testing methodology that he claims he actually employed.

The trial court found that “[t]here is simply no excuse for Dr. TB waiting until cross-examination to disclose his testing procedures.”  Dr. TB submitted his expert report nearly six months prior to trial.  Leading up to trial, the contents of his expert report were the subject of his deposition and were at issue in the pre-trial briefing, including dispositive motions.  Although the adequacy of his Shore D Hardness testing methodology was in dispute before to trial, Dr. TB never attempted to add to his expert report. As the trial court observed, “Dr. TB thus apparently either did not review his expert report or forgot how he had actually performed the test.”  Judge Moore agreed that nothing in the record indicated that Dr. TB’s failure to disclose his testing methodology was substantially justified.

The Court of Appeals also rejected Company R’s argument that Dr. TB’s late disclosure was harmless.  JJVC prepared its noninfringement defense based on the methodology disclosed in Dr. TB’s expert report, and opted to challenge that methodology rather than introduce competing expert testimony. Nothing during the course of the proceedings alerted JJVC to the possibility that Dr. TB would change his testimony. Dr. TB only recanted his expert report when, after being “repeatedly challenged on cross-examination,” he was “[u]nable to explain how his written procedures complied with the standards” that govern hardness testing. While the expert characterized the errors in his report as “typo[s],” it was undisputed, Judge Moore explained, that the shift in his testimony was both substantive and substantial.  Such a late change in course significantly hampered JJVC’s ability to adequately cross-examine Dr. TB and denied it the opportunity to develop or introduce competing evidence.

The Court of Appeals concluded that the district court did not abuse its discretion in excluding Dr. TB’s trial testimony under Rule 37.  As a result, it did not address whether the court erred in excluding Dr. TB’s testimony under Federal Rule of Evidence 702.  Because the plaintiff failed to offer any admissible evidence that the accused lenses met the “soft gas permeable contact lens” limitation, the Court of Appeals affirmed the district court’s judgment that JJVC did not infringe the asserted claims of the ‘327 patent.

Rembrandt Vision Technologies, L.P. v. Johnson & Johnson Vision Care, Inc., — F.3d —-, 2013 WL 4007537 (C.A.Fed. (Fla.) Aug. 7, 2013).

By: Kurt Mattson, J.D., L.L.M.