Hologic, Inc. v. Minerva Surgical, Inc.

Decision Date22 April 2020
Docket Number2019-2054, 2019-2081
Citation957 F.3d 1256
Parties HOLOGIC, INC., Cytyc Surgical Products, LLC, Plaintiffs-Appellants v. MINERVA SURGICAL, INC., Defendant-Cross-Appellant
CourtU.S. Court of Appeals — Federal Circuit

Matthew Wolf, Arnold & Porter Kaye Scholer LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by Jennifer Sklenar, Marc A. Cohn.

Robert N. Hochman, Sidley Austin LLP, Chicago, IL, argued for defendant-cross-appellant. Also represented by Jillian Stonecipher, Caroline A. Wong ; Olivia M. Kim, Edward Poplawski, Wilson Sonsini Goodrich & Rosati, Los Angeles, CA; Vera Elson, Palo Alto, CA.

Before Wallach, Clevenger, and Stoll, Circuit Judges.

Additional views filed by Circuit Judge Stoll.

Stoll, Circuit Judge.

These appeals require us to grapple with the doctrine of assignor estoppel, an equitable doctrine that prevents a party who assigned a patent to another from later challenging the validity of the assigned patent in district court. There are two patents-in-suit and each presents a different assignor estoppel issue. For the first patent, we consider whether the district court erred in holding that assignor estoppel does not bar the assignor from relying on our court’s affirmance of the Patent Trial and Appeal Board’s final decision invalidating the asserted patent claims in an inter partes review proceeding. For the second patent, we review the district court’s summary judgment that assignor estoppel bars the assignor from asserting invalidity of the assigned second patent in district court. Based on our precedent, which we are bound to follow, we conclude that the district court did not err in either respect.

BACKGROUND
I

Hologic, Inc. and Cytyc Surgical Products, LLC (collectively, "Hologic") sued Minerva Surgical, Inc. for infringement of certain claims of its U.S. Patent Nos. 6,872,183 and 9,095,348, which relate to procedures and devices for endometrial ablation. Endometrial ablation is a treatment wherein the lining of the uterus is destroyed in order to treat menorrhagia, or abnormally heavy menstrual bleeding.

The ’183 patent is titled "System and Method for Detecting Perforations in a Body Cavity," and describes and claims methods for determining the presence of uterine perforations, or holes, prior to ablation. "[T]he presence of a perforation in the uterus could result in inadvertent passage of the ablation device through the perforation and out of the uterus into the bowel."183 patent col. 1 ll. 38–41. The ’183 patent solves this problem by "provid[ing] a mechanism by which a physician can evaluate whether perforations are present in [the uterus] before" ablation. Id. at col. 1 ll. 43–46. Claim 9, the only asserted independent claim of the ’183 patent, recites:

9. A method of detecting a perforation in a uterus, comprising the steps of:
passing an inflation medium into the uterus;
monitoring for the presence of a perforation in the uterus using a pressure sensor;
if no perforation is detected during the monitoring step, permitting ablation of the uterus using an ablation device; and
if a perforation is detected during the monitoring step, preventing ablation of the uterus.

Id. at col. 8 ll. 39–48.

The ’348 patent is titled "Moisture Transport System for Contact Electrocoagulation," and describes and claims an ablation device. The claimed device eliminates the problem of "steam and liquid buildup at the ablation site" associated with prior art devices, and also "allows the depth of ablation to be controlled" and "automatically discontinues ablation once the desired ablation depth has been reached."348 patent col. 2 ll. 25–30. Claim 1, the only claim of the ’348 patent at issue in this appeal, recites:

1. A device for treating a uterus comprising:
an elongate member having a proximal portion and a distal portion, the elongate member comprising
an outer sleeve and an inner sleeve slidably and coaxially disposed within the outer sleeve;
an applicator head coupled to the distal portion, the applicator head defining an interior volume and having a contracted state and an expanded state, the contracted state being configured for transcervical insertion and the expanded state being configured to conform to the shape of the uterus, the applicator head including one or more electrodes for ablating endometrial lining tissue of the uterus;
a handle coupled to the proximal portion of the elongate member, wherein the handle comprises a frame, a proximal grip and a distal grip pivotally attached to one another at a pivot point and operably coupled to the applicator head so that when the proximal grip and the distal grip are moved closer together, the applicator head transitions from the contracted state to the expanded state;
a deflecting mechanism including flexures disposed within the applicator head, the flexures including first and second internal flexures and first and second external flexures, the first and second external flexures being coupled to the outer sleeve and the first and second internal flexures being coupled to the inner sleeve, wherein the deflecting mechanism is configured so that translating the inner sleeve relative to the frame causes the applicator head to transition from the contracted state to the expanded state; and
an indicator mechanism operably coupled to the inner sleeve, the indicator mechanism configured to indicate a dimension of the uterus .

Id. at col. 19 ll. 9–42 (emphases added to highlight disputed claim terms on appeal).

II

In 1993, Csaba Truckai co-founded the company NovaCept, Inc. In the late 1990s, Mr. Truckai and his design team at NovaCept developed a medical device called the NovaSure system. NovaSure, which received approval for commercial distribution from the U.S. Food and Drug Administration in September 2001, detects perforations in the uterus by applying carbon dioxide gas to the uterus and measuring any flow of gas out of the uterus. NovaSure uses an application head with a triangular shape designed to conform to the shape of the uterus and which ablates the endometrial lining throughout the cavity in two minutes or less. NovaSure also provides a moisture transport function with a vacuum used to remove steam and moisture from the cavity during energy delivery. NovaSure is indicated for use in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. It is undisputed that NovaSure incorporates the patented technology in this case.

Both the ’183 and ’348 patents list Mr. Truckai as an inventor. In August 1998, Mr. Truckai assigned his interest in U.S. Patent Application No. 09/103,072, an application from which the ’348 patent claims priority, as well as all continuation applications, to NovaCept. In February 2001, Mr. Truckai assigned his interest in U.S. Patent Application No. 09/710,102, an application from which the ’183 patent claims priority, as well as all continuation applications, to NovaCept.

In 2004, Cytyc Corporation acquired NovaCept for $325 million. NovaCept assigned its patent rights, including rights to continuation applications, to Cytyc. Hologic acquired Cytyc in 2007. The continuation application that issued as the ’183 patent was filed in May 2004 and issued in March 2005. The continuation application that issued as the ’348 patent was filed in August 2013 and issued in August 2015. Hologic is the current assignee of the ’183 and ’348 patents and markets and sells the NovaSure system throughout the United States.

Mr. Truckai left NovaCept and, in 2008, founded the accused infringer in this case, Minerva. Mr. Truckai served as Minerva’s President, Chief Executive Officer, and a member of its Board of Directors. Mr. Truckai and others at Minerva developed the Endometrial Ablation System (EAS), which received FDA approval in 2015. Minerva’s EAS is approved for the same indication as Hologic’s NovaSure system. Minerva began commercial distribution of the EAS in August 2015.

III

In November 2015, Hologic sued Minerva in the U.S. District Court for the District of Delaware, alleging that Minerva’s EAS and the use thereof infringed certain claims of the ’183 and ’348 patents. In addition to asserting the invalidity defenses of lack of enablement and failure to provide an adequate written description in district court, Minerva also filed petitions for IPR in the Patent Office, challenging the patentability of the asserted ’183 patent claims, as well as those of the ’348 patent, in view of prior art. The Board instituted review of the ’183 patent, but denied review of the ’348 patent.

Shortly after the district court issued its claim construction decision in April 2017, the Board issued its final written decision in the parallel IPR proceeding, holding the ’183 patent claims unpatentable as obvious. See generally Minerva Surgical, Inc. v. Hologic, Inc. , No. IPR2016-00868, 2017 WL 6404966 (P.T.A.B. Dec. 15, 2017). Hologic appealed the Board’s decision to this court.

Around the same time, Minerva requested that the district court dismiss as moot Hologic’s claim for infringement of asserted claims 7, 9, 11, 13, and 14 of the ’183 patent. The district court denied Minerva’s request, concluding that the "patent has not been cancelled" and the Board’s "finding is on appeal and does not have preclusive effect as to this action unless and until the appeal is resolved." Hologic, Inc. v. Minerva Surgical, Inc. , 325 F. Supp. 3d 507, 519 (D. Del. 2018) ( Summary Judgment Op. ).

Hologic, for its part, moved for summary judgment that the doctrine of assignor estoppel bars Minerva from challenging the validity of the ’183 and ’348 patent claims in district court. The district court granted Hologic’s motion for both patents. After "[c]onsidering the balance of equities and the relationship of Minerva and Truckai," the district court found that "Truckai is in privity with Minerva" and that "assignor estoppel applies to Minerva’s defenses to Hologic’s patent infringement claims." Summary Judgment Op. , 325 F....

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