Court: District Court, D. Delaware; June 28, 2018; Federal District Court
Joseph F. Bataillon, Senior United States District Judge, is considering multiple motions in a patent infringement case involving defendant Minerva Surgical, Inc. and plaintiffs Hologic, Inc. and Cytyc Surgical Products, LLC. Minerva has filed a Motion to Dismiss the '183 Patent and the '989 Patent under Rule 12(b)(1) or for judgment on the pleadings under Rule 12(c), alongside a motion for partial summary judgment on grounds of invalidity, non-infringement, no willfulness, and no unfair competition. Hologic has countered with motions for summary judgment asserting no invalidity, infringement, and assignor estoppel. Minerva also seeks summary judgment arguing that the doctrine of equivalents does not apply to its redesign, citing prosecution history estoppel.
The case centers on allegations of patent infringement concerning U.S. Patent No. 6,872,183 ('183 Patent), which pertains to a system for detecting perforations in the uterus, and U.S. Patent No. 9,095,348 ('348 Patent), focusing on a moisture transport system for electrocoagulation. The relevant claims include claims 7, 9, 11, 13, and 14 of the '183 Patent and claim 1 of the '348 Patent.
The technology in question relates to endometrial ablation, a treatment for Menorrhagia, involving the destruction of the uterine lining. The NovaSure system, developed by NovaCept Corporation in the late 1990s, uses computerized monitoring to detect uterine perforations and employs a triangular applicator head for ablation. Minerva’s competing technology, the Minerva Endometrial Ablation System, includes an electrode array designed to ablate tissue, utilizing a fluid-permeable elastic member to manage moisture during the procedure. The '348 Patent describes an apparatus that employs this electrode array to actively or passively draw moisture away from the tissue during ablation.
The document outlines two patents: the '348 Patent, which describes a uterine treatment device, and the '183 Patent, which focuses on a system for detecting perforations in a body cavity.
Claim 1 of the '348 Patent details a device featuring an elongate member with an outer and inner sleeve, an applicator head that can transition between contracted and expanded states for transcervical insertion and uterine conformation, respectively. The applicator head contains electrodes for ablating endometrial tissue, and a handle that allows manipulation of the applicator head. Additionally, the device includes a deflecting mechanism with internal and external flexures that facilitate the transition of the applicator head's states, along with an indicator mechanism to measure uterine dimensions.
The '183 Patent involves a system that detects perforations by introducing a fluid into a body cavity, monitoring the pressure, and alerting the physician if pressure drops below a threshold during a test period. Claim 1 of this patent outlines a method that involves inserting an ablation device, inflating the uterus, monitoring for perforations, and subsequently treating the uterus. Asserted Claim 7 specifies that treatment should not occur until monitoring is completed. Claim 9 describes a method of detecting perforations where, if none are detected, ablation is allowed; if a perforation is found, ablation is prevented. Dependent Claim 11 adds a notification step if a perforation is detected, while Claim 13 specifies that inflation can occur via the ablation device, and Claim 14 identifies the ablation device as RF-based.
A pressure sensing system is integrated with a medical device through a pressure detection/signal line to monitor pressure in a body cavity, detecting whether pressure remains above a specific threshold for a set duration. If this threshold is not met, it signals a potential organ perforation. The pressure sensor monitors the pressure in the signal line, relaying data to a microprocessor. Testing criteria specify that a pressure of over 50mmHg maintained for 4 seconds constitutes a passed test.
The court has defined relevant patent terms: a pressure sensor detects force per unit area and produces an electrical signal; an applicator head applies energy to uterine tissue; an indicator mechanism shows a dimension; and one or more electrodes are electrical conductors. The term "monitoring" in claims of the '183 patent requires no further construction.
The parties involved are Hologic, a Delaware corporation with headquarters in Marlborough, Massachusetts; Cytyc Surgical Products, a Massachusetts LLC and subsidiary of Hologic; and Minerva, a Delaware corporation based in Redwood City, California. The '183 Patent was issued on March 29, 2005, expiring on November 10, 2020, with inventors including Csaba Truckai, who assigned his interest in the patent to NovaCept in February 2001. Hologic acquired the '183 Patent from Cytyc on January 15, 2016. The '348 Patent, issued on August 4, 2015, expired on November 19, 2018, with similar ownership and assignment history, indicating Hologic's acquisition of both patents from Cytyc after Cytyc's purchase of NovaCept in 2004 and Hologic's acquisition of Cytyc in 2007. NovaCept developed the NovaSure system, which received FDA approval in 2001 and is marketed by Hologic.
Csaba Truckai is a founder of Minerva, which was established in 2008. He played a significant role in developing the Minerva Endometrial Ablation System (EAS), which received FDA premarket approval on July 27, 2015, and commenced commercial distribution in August 2015. The Minerva EAS, along with the NovaSure system, is designed for premenopausal women with menorrhagia due to benign causes when childbearing is complete. Hologic alleges that Minerva infringes on its '183 Patent and '348 Patent, claiming that the use of the Minerva EAS follows the method claims of the '183 Patent and that Minerva directly infringes and induces infringement among its customers. Hologic further asserts that Minerva's infringement has been willful. In response, Minerva denies all claims of infringement and contends that if any infringement occurred, it was not willful. Minerva also argues that the asserted claims are invalid due to lack of written description and enablement under 35 U.S.C. 112.
Minerva has filed a motion to dismiss Hologic's claim for infringement of the '183 Patent, asserting that the claim is moot based on a decision by the Patent and Trial Appeals Board (PTAB) in an inter partes review, which it argues extinguishes Hologic's cause of action. Hologic has appealed the PTAB's decision and contends that Minerva is estopped from claiming the patent's invalidity due to assignor estoppel, as Minerva profited from the assignment and sale of the intellectual property. This issue of assignor estoppel is also addressed in Hologic's motion for summary judgment.
A party may file a motion to dismiss for "lack of subject-matter jurisdiction" under Federal Rule of Civil Procedure 12(b)(1) due to the limited jurisdiction of federal courts, which requires a live case or controversy throughout litigation as mandated by Article III. When parties no longer have a personal stake in the outcome, the case becomes moot and must be dismissed, as moot claims lack subject matter jurisdiction. This is particularly relevant in patent cases, where the case or controversy must be assessed on a claim-by-claim basis. The court can also consider public records and documents attached to the complaint when evaluating motions for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). If a patent claim is canceled, the patentee loses the cause of action, rendering ongoing litigation moot. However, under 35 U.S.C. 141(c), parties can appeal final decisions from the Patent Trial and Appeal Board (PTAB), and the Patent Office cannot cancel claims until after the appeal process concludes. The Federal Circuit maintains that patentability is only determined after all appeals have ended.
In this case, the court dismisses Minerva's argument that the PTAB's final written order on inter partes review makes the action moot, as the patent remains uncanceled and the PTAB's finding is under appeal. Therefore, Minerva's motion to dismiss is denied, and the court will address Hologic's assignor estoppel argument in the upcoming motion for summary judgment.
Hologic filed motions to exclude certain evidence and expert testimonies in the ongoing litigation. Specifically, Hologic seeks to preclude the lay opinion of Minerva's CEO, David Clapper, regarding the market value of endometrial ablation devices, asserting it lacks the necessary scientific or technical basis. Hologic also challenges the opinions of Dr. Robert Tucker concerning invalidity and infringement, claiming they do not align with the court's claim constructions and are based on overly narrow interpretations of the invention. Additionally, Hologic contests the calculations of damages expert Blake Inglish, arguing they rely on Tucker's flawed opinions, as well as Burt Magen’s conclusions about prototype handpieces that allegedly do not infringe the '348 patent, claiming Magen's opinions are irrelevant since they pertain to designs not accused in the litigation. Furthermore, Hologic seeks to exclude Dr. Eugene Skalnyi's testimony for failing to disclose relevant facts and opinions.
In response, Minerva defends the admissibility of Clapper's testimony under Rule 701, disputes Hologic's claims regarding Tucker's application of claim construction, and supports the relevance of Inglish's analysis and Magen's conclusions. Minerva also motions to preclude the opinions of Karl Leinsing regarding validity and infringement, arguing that he improperly relied on legal standards for claim construction. Hologic counters that Leinsing correctly analyzed the claims based on the court's constructions and the relevant patent disclosures. Minerva further challenges Leinsing's reliance on unverified internet data concerning Bernoulli's principle, to which Hologic responds that Leinsing's opinions are valid as they are supported by both technical documents and established principles. Lastly, Minerva disputes Leinsing's opinions on copying, while Hologic maintains that Leinsing is permitted to rebut Minerva's expert testimonies on that matter.
Rule 702 of the Federal Rules of Evidence outlines the criteria for the admissibility of expert witness testimony. An expert must be qualified through knowledge, skill, experience, training, or education and their testimony must aid the trier of fact in understanding evidence or determining facts. The testimony must be based on sufficient facts or data, adhere to reliable principles and methods, and the expert must have reliably applied these methods to the case facts. District court judges serve a screening role to ensure the reliability and relevance of expert testimony as mandated by the Daubert standard, which requires an inquiry into the proposed testimony's reliability. The Third Circuit Court of Appeals specifies several factors for evaluating reliability, including testability of the hypothesis, peer review status, error rates, standards for technique operation, general acceptance, the relationship to established reliable methods, the expert's qualifications, and non-judicial applications of the method. Expert opinions must be grounded in scientific methods rather than subjective beliefs or speculation. Daubert's principles apply to both scientific and non-scientific expert testimony, emphasizing the evaluation of methodology over conclusions.
Sound methodology and relevant evidence may lead to disputes about testimony's weight instead of admissibility. Under Rule 701, non-expert witness opinion testimony must be based on personal perception, aid in understanding or fact determination, and avoid scientific or specialized knowledge. Lay opinions must meet specific criteria for admissibility. Some evidence may not be suitably evaluated pretrial, making motions in limine appropriate to exclude clearly inadmissible evidence. In contrast, challenges to the probative value of evidence pertain to its weight, a matter for the trier of fact. The written description under 35 U.S.C. § 112 focuses on the specification to assess the inventor's possession of the claimed invention. Knowledge of skilled artisans can clarify the specification but cannot introduce limitations not explicitly stated therein. The court tends to view Hologic's challenges as relating to evidence weight rather than admissibility and finds no need to rule on Hologic's motion at this time, as the evidence is not particularly relevant to current motions. The court did not rely on the contested witness testimony for its determinations, and aspects concerning damages will be addressed in future motions. Minerva's objections are similarly seen as matters of weight rather than admissibility.
The court rejects Minerva's interpretation of Leinsing's testimony regarding 35 U.S.C. 112, stating it pertains solely to the specifications' content rather than unlisted teaching limitations. Minerva's challenge related to the Bernoulli principle is also dismissed, as it is an established principle in physics, supported by additional testimony and exhibits. Both motions to preclude are denied without prejudice, allowing for reassertion later.
Regarding Minerva's motion to preclude opinions on copying and independent development, the court finds it unjustified. Minerva acknowledges that Leinsing does not claim the Minerva EAS is a copy of the NovaSure system, and its own expert aligns with Leinsing's views. The court notes that Minerva's EAS incorporates distinct technology and considers the issue moot for the current motion, suggesting the matter can be revisited at trial depending on the relevance of Leinsing's testimony.
Minerva also disputes Hologic's expert Barry's damages testimony, arguing he misapplied lost profits and reasonable royalty standards. The court states it cannot assess the relevance of this evidence pretrial but acknowledges that Minerva's concerns could lead to cautionary instructions. The evidence will be admitted only if it meets legal relevance criteria and outweighs potential prejudice as per Fed. R. Evid. 403.
Minerva's motion to strike Leinsing's supplemental expert declaration is also denied. The court deems the report not particularly relevant and notes Minerva had a chance to address the new information. The court did not rely on it for its decision and finds the motion moot, allowing for potential reassertion at trial if the opinions remain pertinent.
Hologic seeks summary judgment asserting that Minerva's defenses against patent validity are barred by assignor estoppel. The foundational argument is based on Truckai, Minerva's founder, who had previously assigned his patent rights related to the Minerva EAS to NovaCept, which was sold to Hologic's predecessor. Hologic emphasizes Truckai's undisputed role as both an inventor and a key executive at Minerva, involved in developing a product that competes directly with Hologic using patented technology he sold. Hologic contends that allowing Minerva to challenge the validity of the patents would be unjust, given Truckai's prior assignments and the significant value he received.
Assignor estoppel is defined as an equitable principle preventing an assignor from later claiming that the assigned patent rights are invalid or worthless, thus protecting the interests of the assignee. This doctrine was affirmed by the Federal Circuit, which maintains that it also applies to parties in privity with the assignor, like a company founded by the assignor. The determination of privity relies on a balance of equities, reflecting the fairness of allowing such claims post-assignment.
An inventor who assigns their invention to an employer may face limitations on their ability to contest patent validity if they later join a competing company. The applicability of assignor estoppel, which prevents the inventor from challenging the patent's validity, hinges on the relationship between the inventor and the new company, with closer ties favoring the application of the doctrine. Founders and executive officers are typically considered in privity with their companies, establishing a strong basis for assignor estoppel. The doctrine is intended to prevent an inventor from benefiting from a prior representation of a patent's validity while subsequently attempting to negate that representation for personal advantage.
Assignor estoppel generally arises in the context of anticipation or obviousness defenses but does not restrict an assignor from defending against patent infringement claims in other ways, such as introducing prior art to argue that the accused device does not infringe. The court, in evaluating the relationship between Truckai and Minerva, found privity based on Truckai's broad assignment of patent rights, which was later sold for a substantial sum. Minerva's argument against the applicability of assignor estoppel, based on a balance-of-equities assertion regarding overly broad claims by Hologic, was dismissed as the court favored Hologic's claim construction.
Consequently, assignor estoppel was deemed applicable to Minerva's defenses against Hologic's patent infringement claims. Additionally, Minerva has argued that the asserted claims are invalid for failing to meet the written description and enablement requirements of 35 U.S.C. § 112.
Hologic argues for summary judgment asserting "no invalidity," contending that Minerva misapplies the court's claim construction by conflating flow sensors and pressure sensors, particularly in relation to Hologic's Uterine Integrity Test (UIT) and the accused EAS. The legal framework stipulates that the burden of proving patent invalidity lies with the challenger, requiring clear and convincing evidence as per Impax Labs, Inc. v. Aventis Pharma, Inc. A patent's specification must adequately describe the invention, enabling skilled individuals to reproduce it, in accordance with 35 U.S.C. § 112. This written description must demonstrate that the inventor possessed the claimed invention at the time of filing, requiring an objective assessment from the viewpoint of a person skilled in the relevant field. While known information may be utilized to fulfill the written description requirement, it is crucial that the specification clearly discloses the invention. The necessary detail for compliance varies with the complexity of the claims, and while compliance is generally a factual inquiry, it can be resolved via summary judgment if no reasonable juror could rule for the nonmoving party. The claims filed contribute to the specification's compliance, emphasizing that trivial details obvious to skilled individuals need not be included. Additionally, a patent does not need to describe every unclaimed feature of an infringing product, and applicants are not obligated to detail every potential embodiment of their invention.
A patent's specification must enable those skilled in the art to make and use the claimed invention without undue experimentation, as established in relevant case law. It is not required to disclose well-known aspects of the art, and the patent's claims, not the accused device, must be enabled. The enablement requirement is satisfied if any mode of practicing the invention is disclosed, and a skilled individual should be able to do so without undue experimentation. Several factors can be considered to determine whether undue experimentation is necessary, including the quantity of experimentation, guidance provided, presence of working examples, nature of the invention, state of the prior art, skill level of those in the art, predictability of the art, and breadth of the claims. However, it is not necessary for a court to evaluate all these factors to conclude that a disclosure is enabling.
In the case at hand, the court determined that Minerva's invalidity defenses are barred by assignor estoppel, and even if they were not, their argument for summary judgment on invalidity lacks merit. Minerva's claim that the patents needed to provide enablement for the accused device's plasma formation feature is unfounded, as the claims do not mention this feature. The court also rejected Minerva's contention that practicing the invention would require undue experimentation, noting that Minerva did not provide sufficient evidence to support this. The court concluded that any required experimentation would involve commonly known techniques. Furthermore, Minerva's expert testimony did not contradict Hologic's evidence that a skilled individual would recognize the use of a flow sensor as a pressure sensor. Conclusory assertions from Minerva's expert do not create a genuine issue of material fact, and the court reaffirmed its previous ruling that exemplary embodiments do not define "the invention" in the manner Minerva suggested.
Minerva's criticisms of the patent descriptions focus on exemplary embodiments and reiterate previously dismissed arguments that would unduly restrict the claims. The court determines that Minerva's Section 112 arguments are based on a flawed interpretation of the claims, failing to align with the court's constructions. It concludes that Minerva has not met its burden of proving invalidity by clear and convincing evidence regarding the "applicator head indicator mechanism" and "one or more electrodes." Minerva's claims about undue experimentation are deemed irrelevant to the enablement analysis, which should assess the specification's guidance on constructing a device for monitoring uterine perforations using a pressure sensor. Hologic successfully demonstrated that the disclosures of the '183 and '348 Patents adequately describe the claims as interpreted by the court. The court finds that no reasonable jury could conclude that Minerva has met its burden of proof regarding claim descriptions related to monitoring perforations. Consequently, Hologic's motion for summary judgment declaring no invalidity is granted, while Minerva's corresponding motion is denied.
On the issue of Minerva's motion for summary judgment regarding the doctrine of equivalents and prosecution history estoppel, Minerva argues that Hologic's claims were previously rejected as obvious, prompting Hologic to amend claim 19 by adding details about the handle to overcome the rejection. Minerva contends that this amendment invokes prosecution history estoppel, preventing Hologic from using the doctrine of equivalents for infringement claims. Hologic counters that Minerva is improperly seeking an advisory opinion and asserts that Minerva's modified product has not been commercialized. The law states that patent scope includes equivalents to the claims and that prosecution history estoppel requires consideration of the patent application proceedings in the PTO.
Estoppel in patent law serves as a rule of construction, requiring claims to be interpreted in light of those that have been canceled or rejected. The doctrine of equivalents allows a patentee to claim minor alterations not captured in the original patent claim, but if a patentee narrows a claim in response to a rejection, they cannot argue that the surrendered aspects are equivalent to the issued claims. The Supreme Court has consistently applied prosecution history estoppel when claims are amended for specific reasons, such as avoiding prior art or addressing obviousness issues. An amendment that narrows a patent's scope can trigger estoppel, while purely cosmetic changes do not. A patentee who narrows a claim for patent approval effectively disavows broader subject matter.
In the case of Minerva's motion regarding the '348 Patent, it contends that Hologic’s addition of the 'pivot point' limitation to overcome prior art rejection precludes reliance on the doctrine of equivalents in litigation. However, the court finds no clear and unmistakable surrender of all equivalents related to the pivot point limitation and deems the added detail as only tangentially relevant to patentability. The limitation seems more pertinent to the now-unissued '989 Patent than to the '348 Patent. Furthermore, the court agrees with Hologic that addressing the handle redesign would constitute an improper advisory opinion, as the product is not marketed and is not alleged to infringe Hologic's patent.
Minerva's new handle design is not relevant to the current infringement issue, and Minerva has not established its entitlement to summary judgment. Hologic seeks summary judgment, asserting Minerva failed to present a genuine factual dispute regarding its infringement of Hologic's '348 Patent, specifically that the Minerva EAS embodies the first claim of the patent. Hologic focuses on the fifth limitation of the claim, arguing that Minerva's "PFA Width Indicator" qualifies as an indicator mechanism measuring uterine dimensions. Additionally, Hologic claims Minerva’s EAS infringes the '183 Patent through its use of a pressure sensor for detecting perforations.
In contrast, Minerva argues for a summary judgment of no infringement, asserting Hologic cannot demonstrate that its UIT meets the court's definition of a "pressure sensor" for two reasons: the flow sensor does not detect force per unit area, and its output does not correspond to an electrical signal as required. Minerva contends its flow sensor measures flow rate rather than pressure, which is insufficient for the claim's monitoring step. The court clarified that a pressure sensing system must be fluidly connected to monitor pressure within a body cavity and alert users of potential perforations. The evidence presented indicates that Hologic has sufficiently shown prima facie evidence of infringement by Minerva’s EAS.
The patentee bears the burden of proving infringement by a preponderance of the evidence, as established in *Centricut, LLC v. Esab Group, Inc.*, with patent infringement and invalidity being distinct issues (*Medtronic, Inc. v. Cardiac Pacemakers, Inc.*). The infringement determination follows a two-step process: the court first construes the asserted claims, then the trier of fact assesses whether the accused product meets these claims either literally or under the doctrine of equivalents. This application of claims to the accused device is factual, with a focus on claim language supported by the written description and prosecution history. A patent can be granted for an improvement that infringes another patent. Although not a strict rule, the Federal Circuit emphasizes the importance of expert testimony in complex technology cases, indicating that a patentee cannot overcome summary judgment on literal infringement without such testimony.
In this case, Minerva's non-infringement arguments were rendered moot after the court rejected its incorrect claim constructions. Hologic demonstrated that Minerva's accused product infringes the asserted claims based on the court's constructions. Minerva's arguments, which centered on differences in its device not covered by the patents, were deemed improvements. The court's defining of "pressure sensor" in claim 9 of the '183 Patent as a device that detects a force per unit area and outputs an electrical signal was pivotal. Minerva's claim that detection must be direct was countered by the specification, which does not necessitate direct measurement. The uncontroverted facts indicated that Minerva's device, using Bernoulli's equation, indirectly detects pressure, aligning with the court's interpretation.
Minerva's flow sensor acts as a pressure sensor by detecting pressure through flow rate. The company acknowledges that its Minerva EAS device meets all but one limitation of the asserted patent claims regarding uterine ablation methods. No reasonable jury could conclude that the essential steps—insert an ablation device, flow an inflation medium, and treat the disorder—are not performed with the Minerva EAS. Additionally, Minerva concedes that the treating step is delayed until after the monitoring step, as specified in Claim 7 of the '183 Patent.
Regarding Claim 9, the only significant dispute is about the use of a pressure sensor to monitor for uterine perforation. Minerva agrees that its EAS detects perforations and facilitates the inflation medium's entry into the uterus, as well as the conditional ablation based on perforation detection. Minerva's arguments against the monitoring requirement are dismissed due to prior court claim construction. Furthermore, the court notes that Minerva's assertions about differentiating its device through argon gas and plasma energy are irrelevant, as these elements are not part of Hologic's claims.
The existence of Minerva's own patent does not negate potential infringement of Hologic's patents, as established by precedent, which states that having a separate patent on a device does not inherently avoid infringement. Evidence indicates that Minerva has directly infringed on Hologic's patents by having consultants perform infringing procedures in promotional materials, as well as producing manuals and training resources that instruct on the use of the infringing EAS. Minerva also induces and contributes to its customers' infringement by providing components intended for infringing uses. Consequently, the court rules that the evidence supports Hologic's claim of infringement, granting Hologic's motion for summary judgment while denying Minerva's motion.
Additionally, Minerva seeks summary judgment on Hologic's unfair competition claims.
Minerva argues that Hologic's four unfair competition claims are based on the same premise: that Minerva's sales team misleadingly referred to its EAS as the "new NovaSure" or "from the makers of NovaSure." Minerva contends that Hologic's claims are legally insufficient due to a lack of evidence for the alleged deceptive statements and an inability to demonstrate causation or harm. Minerva also claims that any disparaging comments made were merely puffery. In response, Hologic asserts that Minerva did not adequately address its disparagement claim and argues that it has demonstrated a likelihood of confusion resulting from Minerva's actions, suggesting that a jury should determine this issue. Hologic has evidence that Minerva employees accessed Hologic's confidential information, made disparaging remarks, hired former NovaSure sales representatives, employed misleading sales tactics, and advised customers to breach Hologic contracts.
Under Section 43(a) of the Lanham Act, which prohibits false designations of origin and false advertising, a plaintiff must prove ownership of a valid trademark, unauthorized use of the mark in interstate commerce that likely causes confusion, and resulting injury to their commercial interests. The likelihood of confusion standard is factual, making summary judgment inappropriate if a jury could reasonably find confusion. The Delaware Deceptive Trade Practices Act (DTPA) prohibits false or misleading representations that disparage another's goods or services and creates a likelihood of confusion. The DTPA requires a lower burden of proof than the Lanham Act, as it does not necessitate proof of competition or actual confusion to succeed in a claim. The DTPA aims to combat unfair or deceptive trade practices that disrupt another's business operations.
The court has determined that there are genuine issues of material fact regarding Minerva's motion for summary judgment related to Hologic's claims of deceptive trade practices. Key issues include the nature and extent of alleged misrepresentations, deception, and confusion, which require credibility assessments for resolution. Consequently, Minerva is not entitled to summary judgment on these claims.
Regarding Minerva's motion for summary judgment on willful infringement, the court found that there are genuine factual disputes. Minerva argues there are no material facts supporting willful infringement, citing that the patents were issued after their product development and a lack of evidence for deliberate copying. Hologic counters that it relies on Minerva's pre-issuance conduct to demonstrate willfulness and claims genuine factual issues exist concerning copying and good faith.
The law states that enhanced damages under 35 U.S.C. § 284 are reserved for egregious infringement and can be awarded based on the subjective willfulness of the infringer, regardless of objective recklessness. The determination of willfulness hinges on the actor's intent, which must be inferred from the circumstances, with no strict rules barring findings of willfulness when product development predates patent issuance.
The court concluded that a jury could find Minerva acted despite being aware of or ignoring the risk of infringement. Therefore, the resolution of willfulness is also left to the fact-finder, resulting in the denial of Minerva's motion for summary judgment. An appropriate order will follow.
The '989 Patent is no longer relevant to the case. Hologic has filed a motion to strike certain exhibits submitted by Minerva, arguing they contain improper attorney arguments and exceed page limits, but the court views these as demonstrative exhibits and has not relied on them in its summary judgment decision; therefore, the motion is denied as moot. Both parties have requested oral arguments on pending motions, but the court finds them unnecessary and denies the request.
Minerva is asserting that a redesign of its handle serves as a noninfringing alternative for damages. Hologic has accused Minerva of various claims including unfair competition under 15 U.S.C. § 1125, deceptive trade practices under Delaware law, common law unfair competition, and tortious interference with business relations. Conversely, Minerva has counterclaimed against Hologic for similar allegations, including unfair competition, deceptive trade practices, interference with contractual relations, breach of contract, and trade libel. Hologic's motion to bifurcate the trial regarding these issues is denied.
The '348 Patent claims priority to a series of earlier applications dating back to 1998, which share a common specification but have different claims. The '183 Patent and its related applications also share a common specification. Minerva had previously raised arguments regarding the '989 Patent, but it is no longer at issue. Additionally, Hologic's amended complaint includes claims under the Lanham Act and Delaware law, alleging that Minerva disparages Hologic's prior products and interferes with business relationships.
