Hologic, Inc., et al. v. Minerva Surgical, Inc.

Docket No. 2019-2054, -2081 (https://cafc.uscourts.gov/opinions-orders/19-2054.OPINION.8-11-2022_1990706.pdf)

STOLL, CLEVENGER, WALLACH

August 11, 2022

Brief Summary:   On remand from SCOTUS, assignor estoppel decision affirmed as asserted claim not broader than assigned claim. Summary:  This case is on remand from SCOTUS which vacated the FC’s prior judgment affirming the DC’s grant of summary judgment (SJ) of no invalidity of claim 1 of US 9,095,348 to Hologic based on the doctrine of assignor estoppel, which precludes an assignor from challenging the validity of an assigned patent.  Here, the FC was required to “determine whether claim 1 is ‘materially broader’ than the claims assigned to Hologic such that assignor estoppel should not apply”.  The technology-at-issue relates to a device used to treat abnormal uterine bleeding (menorrhagia) (an endometrial ablation device) that was owned by NovaCept, Inc.  In 1998, a NovaCept founder (Mr. Truckai) filed the’072 patent application directed to the device with some claims reciting “a ‘fluid permeable elastic member’ to pass moisture away from the tissue, while on claim-claim 31- did not.”  Mr. Truckai’s interest was assigned to NovaCept which was then acquired by Cytyc Corp. in 2004 with a warranty from NovaCept that “it had ‘no present knowledge from which it could reasonably conclude’ that the assigned intellectual property rights were invalid or unenforceable”.  Hologic, the current assignee of the ‘348 patent, acquired Cytyc in 2007.  Mr. Truckai left NovaCept and founded Minerva in 2008 which developed the Endometrial Ablation System (EAS) that was approved by the FDA in 2015 and began to be commercially distributed.  Hologic asserted Minerva infringed ‘348 claim, which in this opinion the FC compared to claim 31 of the ‘072 application to determined whether assignor estoppel applied.  The DC found that assignor estoppel applied, prevented Minverva from asserting its “various invalidity defenses, including lack of enablement and written description”, and granted SJ of no invalidity and infringement of ‘348 claim 1 to Hologic (“Hologic I”).  In 2020, the FC affirmed the DC’s findings (Hologic, FC 2020 (“Hologic II”)).  Minerva petitioned SCOTUS, “arguing that the doctrine of assignor estoppel ‘finds no support in the statute, [the Supreme] Court’s decisions, or the policies the Patent Act serves’” and “the Court to consider “not only whether to abandon the doctrine entirely, but also whether to retain the doctrine with clearly defined, narrow limits.”  SCOTUS “granted certiorari and declined Minerva’s request to ‘discard this century-old form of estoppel,’ but in doing so clarified that assignor estoppel ‘comes with limits’” and that “‘there is no ground for applying assignor estoppel’ ‘when the assignor has made neither explicit nor implicit representations in conflict with an invalidity defense’” (Minerva, US 2021 (“Hologic III”) (“If Hologic’s new claim is materially broader than the ones [Mr.] Truckai assigned, then [Mr.] Truckai could not have warranted its validity in making the assignment. And without such a prior inconsistent representation, there is no basis for estoppel.”))  The FC panel considered the ‘348 claim 1, the specification, and the prosecution history to determine whether “claim 1 of the ’348 patent is ‘materially broader’ than claim 31 of the ’072 application” and found that it is not, and therefore affirmed the DC decision.

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.