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Consider Invention When Assessing Support for Claimed Range

by Art Dykhuis | Feb 29, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed in part and vacated in part a Patent Trial & Appeal Board finding that the claims at issue were either invalid under 35 U.S.C. §112 as unsupported by written description or obvious under 35 U.S.C. §103. RAI Strategic Holdings, Inc. v. Philip Morris Products S.A., Case No. 22-1862 (Fed. Cir. Feb. 9, 2024) (Chen, Stoll, Cunningham, JJ.)

RAI owns a patent with claims directed to “electrically powered smoking devices that provide an inhalable vapor by heating tobacco or other substances without significant combustion.” Philip Morris challenged the patent in a post-grant review (PGR).

The Board issued a final written decision concluding that two dependent claims, which recited limitations requiring a heating member with “a length of about 75% to about 85% of a length of the disposable aerosol forming substance,” lacked § 112 written description support. The specification disclosed ranges of 75% – 125%, 80% – 120%, 85% – 115% and 90% – 110%. The Board explained that written description support was lacking because “the claimed range is different from and substantially narrower than the specific ranges disclosed in the specification.”

The Board found that the remaining claims were unpatentable as obvious based on a combination of prior art references where the heater found in one reference, Robinson, was replaced with the heater from another, Greim. Robinson explained that its heating element could be altered and acknowledged design choices, thus inviting skilled artisans to select an alternate appropriate heating element. Greim disclosed certain advantages to its heater. Thus, the Board found that a skilled artisan would have been motivated to replace Robinson’s heater with that of Greim, rendering the claims obvious. RAI appealed.

Citing its expert, RAI argued that the ranges disclosed in the specification all centered around 100%, so that a person of ordinary skill in the art (POSITA) would not “conclude that the inventors possessed a range that went no higher than 85%[.]” The Federal Circuit began by summarizing a line of numerical range cases, including:

In re Wertheim (CCPA 1976), which found that a described range of 25% – 60%, with examples of 36% and 50%, supported a claim directed to a range of 35% – 60%.
In re Blaser (CCPA 1977), which found that a described range of 60° – 200° C supported a claim reciting a range of 80° – 200° C.
Kolmes v. World Fibers Corp. (Fed. Cir. 1997), which found that a described range of 4 – 12 turns per inch, and preference for 8 turns per inch, supported claims directed to 8 – 12 turns per inch.
In re Baird (CCPA 1965), which found that a relatively unexplained disclosure of 32 – 176° F did not support claims directed to a range from 40° to “at least as low as” 60° F.
Indivior UK v. Dr. Reddy’s Laboratories (Fed. Cir. 2021), which found that:
- Disclosure of ranges of at least 25%, at least 50% and “any” value [...]
  
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I Hear Ya: Claim Terms Not as Narrow as Features in Specification

by Ashley T. Brzezinski | Feb 29, 2024 | Patents

The US Court of Appeals for the Federal Circuit vacated a district court’s final judgment of noninfringement, finding that the district court improperly narrowed the constructions of certain claim terms to particular features recited in the specification. Promptu Sys. Corp. v. Comcast Corp., Case No. 22-1939 (Fed. Cir. Feb. 16, 2024) (Moore, Prost, Taranto, JJ.)

Promptu filed a lawsuit against Comcast alleging infringement of two patents. The patents describe and claim subject matter generally related to voice recognition but have materially different specifications. The first patent describes using remote voice recognition systems to deliver content in response to a user’s speech request (content delivery patent), while the second patent describes using remote voice recognition systems to control a user’s television set based on a user’s speech command (control patent).

The content delivery patent’s representative claim recites a method for using a “back channel containing a multiplicity of identified speech channels from a multiplicity of user sites presented to a speech processing system at a wireline node in a network supporting at least one of cable television delivery and video delivery” as well as a “method of operating at least part of a speech recognition system coupled to a wireline node in a network [for] processing a multiplicity of received identified speech channels to create a multiplicity of identified speech content.” Meanwhile, the claim of the control patent recites “a centralized multi-user voice operated television control system, comprising . . . a centralized processing station configured to receive and process second output from a multitude of television set top boxes by applying voice recognition.”

During the underlying district court proceeding, the district court adopted claim constructions proposed by Comcast. Based on those claim constructions, Promptu stipulated to and moved for entry of a final judgment of no infringement. After the district court granted Promptu’s motion, Promptu appealed.

Promptu challenged the district court’s construction of three claim limitations from the content delivery patent (“back channel,” “multiplicity of received identified speech channels” and “speech recognition system coupled to a wireline node”) and one claim limitation from the control patent (“centralized processing station”). In accordance with long-standing precedent, the Federal Circuit reviewed claim construction by affording the words of the claims their ordinary meaning in the context of the claims and specification.

The Federal Circuit concluded that the district court erred by narrowly construing “back channel” in the content delivery patent as being limited to a “fixed band of frequencies or time slot(s) for transmitting signals to a speech processing system or engine” because nothing in the claim language or the specification required limitation to a “fixed band of frequencies or time slot.” To the contrary, the specification of the patent disclosed the back channel broadly while recognizing the possibility of using different protocols and formats along different subsections of the path or route from user site to speech recognition system. Given the breadth of the techniques for the back channel disclosed in the specification, the Court found no reason to narrow the claims [...]

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PTO on AI Inventorship: Will the Real Natural Human Inventors Please Stand Up?

by Peter Brunovskis, PhD | Feb 22, 2024 | Patents

On February 13, 2024, the US Patent & Trademark Office (PTO) issued a notice with examination guidance and request for comment regarding inventorship in applications involving artificial intelligence (AI)-assisted inventions. The guidance reinforces the patentability of AI-assisted inventions and sets forth preliminary guidelines for determining inventorship with a focus on human contributions in this process.

The PTO released the guidance in response to President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (October 30, 2023). The executive order mandated that the PTO, within 120 days, present “guidance to USPTO patent examiners and applicants addressing inventorship and the use of AI, including generative AI, in the inventive process, including illustrative examples in which AI systems play different roles in inventive processes and how, in each example, inventorship issues ought to be analyzed.”

As in any inventorship determination for non-AI-generated inventions, “AI-assisted inventions must name the natural person(s) who significantly contributed to the invention as the inventor or joint inventor, even if an AI system may have been instrumental in the creation of the claimed invention.” As is the case for all inventions, the threshold question for inventorship in AI-assisted inventions is who made a “significant contribution” to the conception of at least one claim of the patent. For this evaluation, the Pannu factors (Federal Circuit 1998, Pannu v. Iolab Corp.) for inventorship should be considered.

With specific reference to AI-assisted inventions, the notice provides a non-exhaustive list of principles based on the Pannu factors for AI inventorship determinations:

Use of AI systems is not a barrier to inventorship. Use of an AI system does not negate a natural person making a significant contribution to an AI-assisted invention. To be an inventor, a natural person must have significantly contributed to each claim in a patent application or patent.
Recognizing a problem or obtaining a solution may be insufficient. The mere recognition of a problem or having a general goal or plan to pursue or obtain a solution from the AI input does not rise to the level of conception. The way in which a person constructs a prompt in view of the problem for eliciting a particular solution may be important for qualifying that person as an inventor.
Reduction to practice alone is insufficient. Reducing an invention to practice alone does not constitute a “significant contribution,” nor does the mere recognition and appreciation of the AI system output rise to the level of inventorship, especially where the output would be apparent to those of ordinary skill. By contrast, a significant contribution may exist where a person makes a significant contribution to the output or conducts a successful experiment from the output to create an invention.
Developing an essential building block of an AI system may be sufficient. A person developing an essential building block of an AI system to address a specific problem, where the building block is instrumental in eliciting a solution from the output, may be a proper inventor.
“Intellectual domination” over [...]

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Uncle Sam Can March In: Government Licenses Under Bayh-Dole Aren’t Subject to “Strict Timing Requirements”

by Joshua Revilla | Feb 22, 2024 | Patents

In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the government for federally funded research based on work that occurred prior to the effective date of a funding agreement. University of South Fl. Board of Trustees v. United States, Case No. 22-2248 (Fed. Cir. Feb. 9, 2024) (Reyna, Taranto, Stoll, JJ.)

University of South Florida (USF) owns a now-expired patent directed to transgenic mice expressing a certain gene causing an accelerated pathology for Alzheimer’s disease. The patent’s subject matter was conceived while the two named inventors worked at USF, but both inventors transitioned their work to the Mayo Clinic prior to the first actual reduction to practice of the claimed invention. The mice remained at USF, under the care of USF professors, while the named inventors continued to oversee the project from Mayo. The first actual reduction to practice occurred while the inventors were at Mayo.

While the named inventors were still at USF, one inventor submitted a grant application to the National Institutes of Health (NIH). The NIH awarded the inventors (while they were still at USF) a grant covering the mouse project. After the inventors moved to Mayo but prior to the award grant, the designated grantee changed from USF to Mayo. In November 1997, Mayo and USF entered into a subcontract whereby Mayo would pay USF for grant-covered work occurring at USF.

USF sued the United States alleging infringement of the mouse patent by a third party with the government’s authorization and consent. The third party was producing and using mice covered by the patent for the government. The US asserted a license defense under the Bayh-Dole Act, which gives the government a license to practice certain federally funded inventions. The Claims Court granted judgment to the US under its license defense, determining that USF operated pursuant to an implied contract with Mayo based on the understanding that Mayo would use funding from the NIH grant to pay USF for work done there. The Claims Court therefore determined that USF was a contactor with an implied subcontract that was a funding agreement under Bayh-Dole. Since the invention was therefore invented by a government contractor operating under a funding agreement, it was a “subject invention” that was first actually reduced to practice under a government contract. Therefore, under Bayh-Dole, the government was entitled to a license. USF appealed, arguing that the invention was not a “subject invention” within the meaning of § 202(c)(4) of Bayh-Dole.

USF argued that to trigger § 202(c)(4), a funding agreement must be in place at the time of the relevant work and there was no implied agreement in April 1997, the time the work that led to the reduction to practice commenced. The Federal Circuit determined that the November 1997 subcontract was adequate to support entitlement to claim a government license under § [...]

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We Meant It – No Incorporation by Reference

by Karen Gover | Feb 22, 2024 | Patents

The US Court of Appeals for the Federal Circuit issued a sua sponte order regarding the impermissibility of incorporating by reference arguments from one brief into another, especially when doing so causes the brief to exceed the permitted word count. Promptu Sys. Corp. v. Comcast Cable Commc’ns, LLC, Case No. 22-1093 (Fed. Cir. Feb. 16, 2024) (Moore, CJ; Prost, Taranto, JJ.) (per curiam).

On January 11, 2024, the Federal Circuit heard oral arguments in four related cases involving Promptu and Comcast. During oral argument, the Court asked counsel for the appellee to submit a brief within 10 days, totaling no more than 10 pages, to show why he should not be sanctioned for attempting to incorporate by reference multiple pages – almost 2,000 words – of argument from the brief in one case into another, thereby causing the brief to exceed the word limit.

The Federal Circuit recounted that it has “repeatedly held” that incorporating by reference to exceed word count is not permitted, citing its holdings on this issue in Microsoft v. DataTern (2014) and more recently in Medtronic v. Teleflex Life Sciences (2023). Appellee counsel responded that he was unaware of the Microsoft decision until the appellant’s reply brief had already been filed. The Court accepted his assertion but noted with disapproval that the precedential Microsoft decision admonished “the exact same law firm before us now for the exact same behavior,” and that once made aware of the Microsoft decision, counsel did nothing to remedy the impropriety.

Practice Note: The Federal Circuit did not award sanctions against appellate counsel but sternly warned future litigants that it is improper to incorporate by reference arguments from one brief into another unless in compliance with Fed. R. App. P. 28, and that such incorporation is never permitted if it results in exceeding the applicable word limit. The Court stated that going forward, such a violation “will likely result in [an award of] sanctions.”

Lost Connection: Preliminary Injunction Against Unreleased Product Is a No-Go

by Tessa Kroll | Feb 15, 2024 | Patents

Addressing a preliminary injunction motion directed to a competitor’s yet-to-be-released product, the US Court of Appeals for the Federal Circuit determined that the district court did not abuse its discretion in finding that the patent holder failed to establish irreparable harm based on speculative evidence. SmartSky Networks, LLC v. Gogo Bus. Aviation, LLC, Case No. 23-1058 (Fed. Cir. Jan. 31, 2024) (Cunningham, Chen, Hughes, JJ.) (non-precedential).

SmartSky Networks and Gogo Business Aviation are competing aviation network providers that offer air-to-ground in-flight internet networks for aircrafts. SmartSky sued Gogo in early 2020, alleging that Gogo’s 5G network infringed four patents related to wireless in-flight internet connections. SmartSky also moved to preliminarily enjoin Gogo from selling its 5G network, which is not yet operational and has yet to be released. In late 2022, the district court denied SmartSky’s motion for preliminary injunction, finding that SmartSky had not shown a likelihood of success or irreparable harm. SmartSky appealed.

SmartSky first moved to supplement the record with new materials relevant to market share, sales and switching costs. The Federal Circuit first denied SmartSky’s motions to supplement the record, noting that it would not consider new evidence on appeal absent extraordinary circumstances, such as instances where the court can take judicial notice of new facts or where the facts would alter the appropriateness of injunctive relief. Because the district court found no likelihood of irreparable harm, despite acknowledging that SmartSky had shown consumer stickiness and direct competition between the parties, the Court concluded that documents related to market share, sales and switching costs would not alter the appropriateness of injunctive relief. The Court further declined to take judicial notice of the facts, which were subject to dispute.

The Federal Circuit then turned to SmartSky’s argument that the district court erred in finding no likelihood of irreparable harm from lost sales and market share, price erosion, lost reputation and goodwill, and lost research and development and investments. Regarding lost sales, SmartSky argued that the district court ignored Gogo’s sales of AVANCE L5 equipment (used for Gogo’s 4G and 5G networks) and that Gogo’s 5G network was not “yet-to-be-released” because it had been on sale since late 2021. The Court found these arguments unpersuasive. The Court noted that SmartSky did not dispute that Gogo had yet to launch its 5G network and found that the district court did not abuse its discretion in concluding that any such sales were quantifiable. As for AVANCE L5, the Court observed that the equipment was currently sold as part of Gogo’s unaccused 4G network, and that the alleged harm would only occur if Gogo launched its 5G network and customers upgraded. Thus, the Court found that any harm from the sales of AVANCE L5 was highly speculative, particularly because the parties are not the only two players in the market and customers may have other non-infringing options.

SmartSky next argued that the district court ignored testimony that customers used Gogo’s pricing to negotiate discounts from SmartSky. The Federal Circuit disregarded this [...]

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Sliced and Diced: Operating Manuals Are Printed Publications

by Keval Amin | Feb 15, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s non-obviousness determination, finding that the Board erred in determining that an operating manual did not qualify as printed publication prior art. Weber, Inc. v. Provisur Technologies, Inc., Case Nos. 22-1751; -1813 (Fed. Cir. Feb. 8, 2024) (Reyna, Hughes, Stark, JJ.)

Provisur owns two patents related to advanced high-speed mechanical slicers used in food processing facilities that precisely slice and package food items such as meats and cheeses. The key components recited in the patent claims are a “loading apparatus” designed to load food items, a “feeding apparatus” responsible for supplying food items to a slicer, and a “stop gate” intended to regulate the assembly of food items prior to their entry into the slicing mechanism.

Weber filed inter partes review (IPR) petitions challenging the validity of several claims of the patents based on certain operating manuals. During the IPR proceedings, the Board determined that Weber’s operating manuals did not qualify as prior art printed publications because they were distributed selectively and subject to confidentiality restrictions. The Board also concluded that the prior art combinations, which included Weber, failed to disclose crucial claim limitations, notably the “disposed over” and “stop gate” limitations. The Board found the challenged claims not unpatentable. Weber appealed.

Weber argued that the Board erred in determining that the operating manuals were insufficiently accessible to constitute printed publications, specifically contending that the Board misapplied the Federal Circuit’s 2009 decision in Cordis Corp. v. Boston Scientific Corp. The Court agreed. It explained that unlike Cordis, where academic monographs were limited to distribution among a select few, Weber’s operating manuals were intended for distribution to purchasers of the machines and others to provide instructions on food slicer usage and maintenance. The Court explained that the evidence in the form of delivery records and email exchanges showed that manuals were available to customers upon purchase or request. The Federal Circuit also noted that the manuals were not bound by any confidentiality restrictions. The Court thus concluded that the operating manuals qualified as printed publications.

Turning to claim construction, the Federal Circuit reversed the Board’s interpretation of the “disposed over” and “stop gate” limitations. Consistent with long-standing precedent, the Court emphasized the importance of examining intrinsic evidence, including the claims themselves, the specification and the patent’s prosecution history. Weber argued that the claims’ language implied a broader feed apparatus positioning over the loading apparatus without strict alignment requirements. Supported by expert opinions, Weber contended that neither the claim language nor the specification mandated direct alignment. The Court agreed with Weber. The Court emphasized that “disposed over” demanded only a general positioning of the feed apparatus above the loading apparatus, not a direct positioning as the Board had construed.

Similarly, concerning the “stop gate” limitation, the Federal Circuit agreed that the Board’s determination was not supported by substantial evidence because evidence, such as the manuals, disclosed the claimed conveyer mechanism in a manner sufficient to establish its [...]

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Even a Non-Explicit Claim Construction Can Be Erroneous

by Brennen Baylor | Feb 15, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision finding the challenged patent claims not obvious over the prior art. The Court found that the Board, after concluding that no claim construction was required, implicitly construed the claim limitation at issue and did so erroneously. Google LLC v. EcoFactor, Case Nos. 22-1750; -1767 (Fed. Cir. Feb. 7, 2024) (Reyna, Taranto, Stark, JJ.)

Google filed a petition for inter partes review (IPR) challenging claims of an EcoFactor patent related to dynamic climate control systems that factor outside weather conditions and thermal conditions inside the home to balance comfort and energy savings. The challenged claims define a method for reducing the cycling time of a climate control system involving “retrieving a target time at which [the] structure [(e.g., a house)] is desired to reach a target temperature.” The challenged method claims recite a step of “determining a first time prior to said target time at which [the] climate control system should turn on to reach the target temperature by the target time.” The relevant claim limitation reads:

[D]etermining a first time prior to said target time at which said climate control system should turn on to reach the target temperature by the target time based at least in part on [i] said one or more thermal performance values of said structure, [ii] said performance characteristic of said climate control system, [iii] said first internal temperature, [iv] said first external temperature, and [v] the forecasted temperature.

During the IPR proceedings, the parties disputed whether a prior art reference disclosed a method involving determining a first time prior to the target time based on a first internal temperature. Google argued that the prior art taught a calculation of a first time prior to the target time based on thermal performance values (input [i]) calculated from internal temperature values (input [iii]). EcoFactor argued that each of the inputs in the claim limitation was a distinct value not dependent on or calculated from any other input. Based on the claim language, the Board determined that claim construction was unnecessary and concluded that inputs [i] – [v] of the relevant claim limitation were separate inputs using different data. The Board concluded that Google had not shown that the challenged claims were unpatentable, reasoning that Google’s theory of obviousness relied on a single input as the basis for both input [i] and input [iii].

Google appealed. Google argued that although the Board stated that no construction was necessary, it incorrectly construed the claim limitation to require five discrete inputs.

The Federal Circuit agreed with Google, finding that the Board’s assessment of the claim limitation implicitly established the claim scope by requiring inputs [i] – [v] to be completely separate. The Court reasoned that the plain claim language did not provide any indication that none of the listed inputs could be based on any other input(s). Imputing this requirement into the limitation was therefore an act of claim construction.

The Federal [...]

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Carolina Calling: Sources of Proof Favor Transfer

by Benjamin Ediger, Ph.D. | Feb 8, 2024 | Patents

The US Court of Appeals for the Federal Circuit vacated a district court order denying transfer, finding that the sources of proof, compulsory process and localized interest factors all favored transfer. In re Honeywell Int’l Inc., Case No. 23-152 (Fed. Cir. Jan. 26, 2024) (Dyk, Bryson, Taranto, JJ.) (per curiam) (nonprecedential)

Lone Star SCM Systems filed a lawsuit against Honeywell in the Western District of Texas, Waco Division (West Texas) asserting infringement of four patents related to radio frequency identification technology. Honeywell moved to transfer the suit to the Western District of North Carolina (West Carolina), where Hand Held Products, a Honeywell subsidiary that designed, manufactured, imported and sold certain accused products, is headquartered. Honeywell argued that it had identified five potential Hand Held witnesses who would be subject to the transferee’s subpoena power and that relevant and material evidence would be more likely to exist in the transferee district.

The district court denied Honeywell’s motion. The district court analyzed public- and private-interest factors outlined in the Fifth Circuit’s 2008 In re Volkswagen of Am. decision and concluded that although Lone Star could have brought its suit in West Carolina, Honeywell had failed to demonstrate that West Carolina was clearly more convenient. The district court acknowledged that the bulk of the evidence was located in West Carolina but ultimately concluded that the convenience to potential party witnesses favored West Texas, pointing to several Lone Star witnesses who resided in the Northern District of Texas. The court found that the public-interest factors were neutral or similarly offsetting. The district court also found that West Carolina’s local interest favored transfer, but judicial efficiency did not because a transfer would have required relocating this suit away from two co-pending Lone Star infringement suits.

Honeywell petitioned the Federal Circuit for a writ of mandamus. The Federal Circuit determined that the district court’s denial of Honeywell’s transfer motion was patently erroneous. The Federal Circuit explained that the district court’s findings regarding potential party witness convenience and judicial efficiency were contrary to recent Fifth Circuit and Federal Circuit precedent. Regarding the potential party witnesses, the Federal Circuit cited the Fifth Circuit’s 2023 In re TikTok decision, explaining that it was improper to place witnesses residing outside of West Texas but still within the state of Texas on par with those residing in West Carolina. Regarding judicial efficiency, the Federal Circuit found that Lone Star’s position differed little from the circumstances that the Federal Circuit considered in its 2021 In re Samsung Elecs. decision, where the other suits involved different defendants with different hardware and software. Consistent with Samsung, the Federal Circuit concluded that Lone Star’s co-pending suits did not favor West Texas because the other cases were likely to involve significantly different discovery, evidence and issues. The Federal Circuit vacated the district court’s decision and ordered the district court to grant Honeywell’s transfer motion.

Rules of Evidence Require Weighing Relevance of Evidence Against Potential Prejudice

by Karen Gover | Feb 8, 2024 | Life Sciences, Patents

The US Court of Appeals for the First Circuit affirmed the exclusion of a drug patent in a medical malpractice case, finding that the highly technical language of the patent would more likely confuse a lay jury than be probative of the issues in the case. Ward v. Schaefer, Case No. 22-1547 (1st Cir. Jan. 29, 2024) (per curiam).

In 2018 Edmund Ward sued his doctor, Ernst Schaefer, claiming that Dr. Schaefer had fraudulently induced Ward to participate in an experimental drug protocol and had otherwise failed to obtain his informed consent. Ward was born with a rare genetic disorder that caused his body to not produce a blood enzyme, lecithin-cholesterol acyltransferase (LCAT), that is critical for cholesterol production. As a result, Ward was at risk of kidney failure and would require either regular dialysis or a kidney transplant. When Ward met Dr. Schaefer, Ward’s condition was deteriorating. Dr. Schaefer suggested that Ward might be a suitable candidate for an experimental enzyme therapy with a drug called ACP-501, and Ward, under an expanded access application, was granted permission to start an experimental protocol.

Ward traveled from his home in Massachusetts to a National Institutes of Health (NIH) facility in Bethesda, Maryland, to receive infusions of ACP-501 and was monitored by Dr. Schaefer in Massachusetts. Unfortunately, Ward’s condition did not improve under the experimental protocol but instead worsened because he was compelled to delay dialysis treatments while using ACP-501. Ward stopped the experimental protocol; began regular dialysis; and sued Dr. Schaefer, the NIH doctors and the drug manufacturer. The district court dismissed the claims against most of the plaintiffs, but the claims of fraud and failure to obtain informed consent against Dr. Schaefer went to trial. Ward’s signed consent form was admitted into evidence at trial, but he claimed he had no memory of discussing it with his doctors or signing it. The jury found in favor of Dr. Schaefer on all claims. Ward appealed.

Ward argued that the court erred in refusing to allow the introduction of the patent for ACP-501 because the patent specified that it was a method for reducing arterial cholesterol in patients not suffering from LCAT deficiency. Ward argued that this language in the patent made clear that the drug was not appropriate for patients like him. The district court ruled that the patent was inadmissible because it had been offered without foundation, and that it had nothing to do with the issues of fraud and informed consent. On appeal, the First Circuit offered a different analysis but arrived at the same outcome, holding that the Fed. R. Evid. 403 balancing test “disposes of the matter.”

The First Circuit noted that the patent’s description of ACT-501 “is of absolutely no relevance to Dr. Schaefer’s alleged failure to apprise Ward of the potential risks and rewards of taking the drug through expanded access.” The Court went on to point out that even if the single sentence in the patent pointing to its exclusion for patients with LCAT [...]

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