Bardy Diagnostics, Inc. v. iRhythm Technologies, Inc.

Summary

The U.S. District Court for the District of Delaware grants both parties leave to amend their pleadings in a patent infringement action. The court permits iRhythm Technologies to supplement its counterclaims with infringement claims concerning two patents issued after the pleadings deadline and permits Bardy Diagnostics to add inequitable conduct defenses and unenforceability counterclaims based on information obtained in discovery. The court finds good cause under Rule 16 and determines that the proposed amendments satisfy Rule 15 without undue prejudice or futility.

Holdings

1. Good cause existed under Rule 16(b)(4) to permit iRhythm to amend because the two patents did not exist when the pleadings closed and iRhythm acted reasonably and promptly once the basis for amendment existed.
2. Rule 15(d), rather than Rule 15(a), governed iRhythm's request, and supplementation was appropriate because the new patent claims involved the same patent families, common specifications, and the same accused product without undue prejudice.
3. Bardy showed good cause under Rule 16(b)(4) because it could not reasonably have pleaded inequitable conduct with the particularity required by Rule 9(b) before obtaining the necessary discovery.
4. The proposed inequitable-conduct allegations were pleaded with sufficient particularity to avoid futility under Rule 9(b).

Questions Presented

1. Whether iRhythm showed good cause under Rule 16(b)(4) to modify the scheduling order and could supplement its counterclaims under Rule 15(d) to assert infringement claims concerning patents issued after the pleadings deadline.
2. Whether iRhythm's proposed supplemental infringement claims arose sufficiently from the same transactions or occurrences, technology, patent families, and accused product to warrant supplementation under Rule 15(d).
3. Whether Bardy showed good cause under Rule 16(b)(4) to amend its answer after the deadline when discovery supplied the factual basis needed to plead inequitable conduct with the particularity required by Rule 9(b).
4. Whether Bardy's proposed inequitable-conduct defenses and unenforceability counterclaims were futile or unduly prejudicial.

Disposition

other