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First Circuit

Chickening Out: Reason for Trademark Abandonment Irrelevant Without Proof of Intent to Resume

by Karen Gover | Oct 3, 2024 | Trademarks

The US Court of Appeals for the First Circuit affirmed a district court’s summary judgment decision finding that the prior owner of a trademark for fresh chicken had abandoned the mark by failing to use it for three years and failing to show an intent to resume use of the mark. To-Ricos, Ltd. v. Productos Avícolas Del Sur, Inc., Case No. 22-1853 (1st Cir. Sept. 19, 2024) (Montecalvo, Lipez, Thompson, JJ.)

PAS, a Puerto Rico corporation, sold Pollo Picú branded chicken from 2005 to 2011. The Picú trademark consists of a cartoon chicken with the phrase “Pollo Picú” underneath it:

While Pollo Picú was once a well-recognized brand in Puerto Rico, PAS encountered administrative and financial challenges. In 2006 and 2009, it failed to file declarations with the US Patent & Trademark Office (PTO) attesting to the use of the mark as required by Section 8 of the Lanham Act. The PTO therefore canceled the Picú trademark registration. PAS stopped selling chicken bearing the mark after its bank froze PAS’s financing in 2011. The bank filed suit in January 2012 under a preexisting loan agreement in which PAS had granted the bank a lien over PAS’s assets, including the Picú mark. PAS offered to sell the company to To-Ricos, PAS’s main competitor, but no sale occurred.

In October 2014, PAS and the bank signed a settlement agreement requiring PAS to pay a stipulated sum by December 2014 or the bank would foreclose on most of PAS’s assets, but not the Picú mark. The agreement provided that the bank would retain its lien over the mark until the foreclosure proceedings concluded. PAS failed to make the payment, but the bank did not exercise its foreclosure rights. In June 2017, PAS moved for the Commonwealth Court to order the bank to foreclose on PAS’s assets or declare PAS free of its obligations to the bank. The Commonwealth Court granted the motion in November 2019.

In April 2016, To-Ricos applied to register the Picú mark with the PTO. Three months later, PAS applied to re-register the same mark and filed an opposition to To-Ricos’s application. A year later, PAS licensed the right to use the Picú mark in the United States to IMEX. IMEX sold chicken under the mark for a few months but stopped after To-Ricos sent cease and desist letters.

In June 2019, To-Ricos began selling Picú branded chicken. It also filed a lawsuit against PAS, seeking a declaratory judgment establishing To-Ricos as the legal owner of the Picú mark. To-Ricos moved for summary judgment, arguing that PAS had abandoned its mark. PAS opposed. The district court agreed with To-Ricos, noting that PAS admitted to not having used the mark in commerce for at least three consecutive years prior to To-Ricos’s application, and that PAS had not demonstrated its intent to resume use of the mark within that period. PAS appealed.

PAS [...]

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Don’t Share Trade Secrets With Your Fiancé: A Cautionary Tale

by Karen Gover | Aug 15, 2024 | Trade Secrets

The US Court of Appeals for the First Circuit largely affirmed a multimillion-dollar award against a temp agency for misappropriation of trade secrets and unjust enrichment due to its employee’s act of obtaining proprietary information from his fiancée, who worked at a competitor placement firm. BioPoint, Inc. v. Dickhaut, et al., Case No. 23-1575 (1st Cir. July 30, 2024) (Rikelman, Lynch, Howard, JJ.) (Rikelman, dissenting in part).

BioPoint is a Massachusetts-based life sciences consulting firm that places highly skilled candidates in temporary positions at pharmaceutical, biopharmaceutical and medical device companies. Leah Attis was one of the company’s top salespeople. Catapult is a Texas-based placement company. It opened a Boston office in 2017 and hired Attis’s fiancé, Andrew Dickhaut, as managing director. When business did not go well at Catapult’s Boston office, Attis began to help Dickhaut place candidates by giving him proprietary information about candidates and rates from BioPoint’s database, even though Catapult did not initially operate in the life sciences sector. As a result, Catapult eventually entered into a managed services provider agreement with biotechnology company Vedanta, whereby Catapult would manage all of Vedanta’s labor contracts and would have the first opportunity to fill openings there. Attis continued to give Dickhaut information on candidates from BioPoint’s system to help with Vedanta openings.

Upon discovering that it lost a candidate placement to Catapult because of Attis’s interventions, BioPoint fired her in December 2019. BioPoint then sued Catapult and Dickhaut for federal and state law claims, alleging misappropriation of trade secrets, tortious interference, and unfair and deceptive trade practices. The case proceeded to trial, and the district court divided the claims between a jury trial for the legal claims and a bench trial for equitable relief. The jury found that Catapult had misappropriated trade secrets and tortiously interfered with BioPoint’s relationship with the candidate that Attis helped Dickhaut place. The jury awarded BioPoint more than $300,000 in damages. At the bench trial on the equitable claims, the district court found that all profits that Catapult derived from its relationship with Vedanta arose on account of misappropriation of trade secrets and were recoverable as unjust enrichment. The district court awarded treble damages jointly against Dickhaut and Catapult, totaling more than $5 million. Catapult appealed.

While the First Circuit largely affirmed the district court and the jury’s findings, the First Circuit found two errors. First, the Court found that the district court erred in awarding BioPoint both the lost profits from the placement of the candidate and the unjust enrichment that accrued to Catapult as the result of the placement. The Court explained that the law does not permit the lost profits to be counted twice and reduced the award by more than $150,000, which was the amount that the district court had awarded for the loss of the candidate.

Second, the First Circuit found that the district court erred in finding Dickhaut jointly and severally liable for the entirety of his employer’s unjust enrichment, calling it “a bridge too far.” Since the [...]

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Fourth Estate Redux: Dismissal for Lack of Registration Not on the Merits

by Karen Gover | Jun 20, 2024 | Copyrights

In the latest development of a complicated eight-year court battle regarding a copyright infringement claim, the US Court of Appeals for the First Circuit vacated and remanded the district court’s dismissal on claim preclusion grounds. The Court concluded that dismissal for failure to register the copyright was not “on the merits,” and therefore preclusion did not apply. Foss v. Marvic Inc. et al., Case No. 23-1214 (1st Cir June 10, 2024) (Barron, C.J.; Lipez, Kayatta, JJ.)

In 2006, Cynthia Foss designed a brochure for Marvic, a purveyor of sunrooms, for $3,000. Foss’s grievance with Marvic began in 2016 when she discovered that Marvic had been using a modified version of that brochure without permission. Foss filed a copyright infringement claim in January 2018 demanding $264,000. She inaccurately alleged that she had applied to register the copyright for the brochure. Eight months later, Foss amended her complaint, falsely alleging that she had registered the brochure with the US Copyright Office in February 2018 when in fact she had only applied for registration.

The district court stayed the action pending the Supreme Court’s decision in Fourth Estate v. Wall-Street, which construed 17 U.S.C. § 411(a) to require registration before a copyright claimant may sue for infringement. After Fourth Estate was issued, the district court dismissed Foss’s copyright infringement claim because the Copyright Office had not acted on her application for copyright. Later, the Copyright Office granted Foss a copyright registration in the brochure. Rather than move for reconsideration of the dismissal of her claim in the first action, Foss filed an appeal, which she lost.

After losing the appeal, Foss filed a second copyright infringement complaint against Marvic based on the same facts as the first. Foss also filed an amended complaint naming Charter Communication. She sought a declaratory judgment that Charter was not entitled to assert a safe harbor defense under the Digital Millenium Copyright Act (DMCA). Marvic and Charter filed motions to dismiss. In February 2023, the district court granted the motions, finding that “[b]ecause Foss’s prior copyright infringement claim against Marvic was dismissed with prejudice, [we] agree[d], for substantially the reasons stated in their supporting memorand[a], that her copyright claims . . . are barred by res judicata.” Foss appealed.

On the issue of claim preclusion, the First Circuit concluded that the first dismissal had not been a “final judgment on the merits” because it was based exclusively on the failure to satisfy the precondition of registration. The Court noted that it had ruled on this issue in Foss v. Eastern States Exposition, another copyright infringement action brought by Foss. The Court explained that, as it concluded in the Eastern States Exposition case, dismissal due to lack of prior registration is “too disconnected from the merits of the underlying claim” to be claim preclusive.

Marvic argued that the prior dismissal “with prejudice” constituted a final judgment on the merits and that the dismissal was “a sanction” based on Foss’s “repeatedly ignoring court directives [...]

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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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In Good Hands: Compilation of Publicly Available Information Can Still Be a Trade Secret

by Sarah J. Fischer | Sep 21, 2023 | Trade Secrets

The US Court of Appeals for the First Circuit affirmed a district court decision, finding that a compilation of customer-related information, even if publicly available, is a protectable trade secret. Allstate Insurance Co. v. Fougere, Case No. 22-1258 (1st Cir. Aug. 29, 2023) (Gelpi, Lynch, Thompson, JJ.)

Allstate hired two agents—James Fougere and Sarah Brody-Isbill—to sell the company’s auto and casualty insurance products in Massachusetts. In connection with their employment, both agents signed exclusive employment agreements that imposed numerous responsibilities, including an obligation to maintain information identified by Allstate as confidential, an undertaking not to misuse or improperly disclose the information and a promise to return the information to Allstate when their agency relationships terminated. Allstate eventually terminated its agreement with the agents because of noncompliance with Allstate regulations and Massachusetts state law.

After the agreements were terminated, Allstate believed the agents had retained confidential information belonging to Allstate and had been using it to solicit Allstate customers. Allstate ultimately learned that the agents had kept confidential Allstate spreadsheets that contained the names of thousands of Allstate customers, along with their renewal dates, premiums, types of insurance, Allstate policy numbers, driver’s license numbers, home addresses, phone numbers and email addresses.

Allstate filed suit against the former agents, bringing claims under both Massachusetts law and the federal Defend Trade Secrets Act (DTSA). The agents brought counterclaims under Massachusetts law, alleging that Allstate failed to provide adequate notice before their terminations, misappropriated information that belonged to the agents and wrongfully interfered with the agents’ contractual relations by engaging in bad-faith business practices. On summary judgment, the district court found that the agents misappropriated Allstate’s trade secrets and dismissed the agents’ counterclaims. The agents appealed.

The agents argued that the customer information was available from various publicly available sources and therefore did not constitute a trade secret. The First Circuit disagreed, explaining that the compilation of publicly available information could constitute trade secrets, particularly where attempts to duplicate that information would be “immensely difficult.” The Court also found that the factual record suggested that not all of the customer information was publicly available—and certainly not in the same compilation as it would be from Allstate.

The agents also argued that the customer information had no economic value. In analyzing this argument, the First Circuit looked to the employment agreements between the former agents and Allstate, which specifically stated that the misuse of Allstate’s confidential information would cause “irreparable damages” to Allstate. The employment agreements also provided a mechanism for terminated agents to sell their “economic interest” back to Allstate. The Court also relied on its finding that this sort of information would be valuable to Allstate’s competitors in attempting to market policies to Allstate customers so that the competitor could offer lower pricing. Taken together, the Court found that the customer data had economic value.

The agents next argued that Allstate had not sufficiently protected the customer information. The First Circuit, affirming the district court, found that Allstate had multiple protections in place. [...]

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The Game of Life: Winner Gets Everything Except Attorneys’ Fees

by Connor S. Romm | Jul 13, 2023 | Copyrights

The US Court of Appeals for the First Circuit agreed with the trial court regarding the reasonableness of the plaintiff’s legal positions and found that the trial court did not abuse its discretion in denying the defendants, as the prevailing party, attorneys’ fees. The First Circuit determined that the positions advanced by the unsuccessful plaintiffs were not objectively unreasonable. Markham Concepts, Inc. v. Hasbro, Inc., Case Nos. 19-1927; 21-1957; -1958 (1st Cir. June 22, 2023) (Kayatta, Lipez, Thompson, JJ.)

The underlying case involved a copyright action concerning ownership rights to The Game of Life, a board game that has been widely popular since its launch in 1960. The Game of Life became the center of a long-standing dispute between its creators, Reuben Klamer and Bill Markham. Klamer, a toy developer, conceived the initial idea for the game and enlisted Markham to design and create the game prototype. Markham believed he deserved greater recognition for his contribution and felt the royalty he received was unfairly low.

In its previous ruling on the merits, the First Circuit affirmed the district court’s decision in favor of the Hasbro defendants (including Klamer). The Hasbro defendants then sought attorneys’ fees, which the district court denied. Hasbro appealed and moved for appellate attorneys’ fees.

Although both the district court and the First Circuit examined various factors, such as Markham’s motivations and the need for compensation or deterrence, the key factor for both courts in determining whether to award legal fees hinged on the reasonableness of Markham’s litigation arguments.

The merits of the underlying case revolved around the termination right provided by the Copyright Act of 1976 (1976 Act), which allows authors to terminate copyright grants after a certain period and thereby disentangle themselves from agreements made before the true value of their work became apparent. This right does not apply to works made for hire. In this instance, the issue of whether The Game of Life qualified as a work made for hire was determined under the Copyright Act of 1909 (1909 Act), as the game was created long before the 1976 Act took effect. Under the 1909 Act, Markham had to meet the “instance and expense” test, which treats contractors as employees of the party commissioning the work, thereby presuming copyright ownership in the latter. The district court held that The Game of Life was a work for hire because it was created at Klamer’s instance and expense.

Markham’s primary argument relied on the 1989 Supreme Court decision in Reid, which interpreted “employee” for purposes of the work-for-hire test as being defined according to “the general common law of agency.” Although Markham acknowledged that Reid was directed to the 1976 Act, he contended that the logic of Reid should extend to the 1909 Act, thereby nullifying the “instance and expense” test in favor of the general common law of agency.

Four years after the Supreme Court’s decision in Reid, however, the First Circuit applied the “instance and expense” test in Forward to a work covered [...]

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First Circuit: Claim Preclusion Shouldn’t Apply to Bar Claims Under VARA

by Hannah Cohen | May 25, 2023 | Copyrights

Addressing for the first time whether federal res judicata law recognizes the alternative determinations doctrine, the US Court of Appeals for the First Circuit determined that a plaintiff’s claims under the Visual Artists Rights Act (VARA) were not precluded by a previous action in which she brought a federal copyright claim against the defendant. Foss v. Eastern States Exposition, Case No. 22-1313 (1st Cir. May 10, 2023) (Barron, Howard, Montecalvo, JJ.)

Cynthia Foss previously brought a federal copyright action against Eastern States Exposition that was dismissed. The previous action did not involve any claim under VARA. Eastern argued that claim preclusion should apply to bar the claim, and the district court agreed. Foss appealed.

To establish federal claim preclusion, a party must establish that there is a final judgment on the merits in an earlier suit, sufficient similarity between the causes of action asserted in the earlier and later suits, and sufficient identicality between the parties in the two suits. Foss did not dispute that the first and third requirements were satisfied, and thus the First Circuit’s decision turned on whether the second requirement was met.

Foss argued that the “alternative determinations” doctrine should apply. This doctrine strips a dismissal of claim preclusive effect if the dismissal rests on multiple grounds, not all of which would on their own render the dismissal claim preclusive. Whether the doctrine should apply was a matter of first impression in the First Circuit. Foss argued that the previous dismissal was in part based on “her failure to allege that she had satisfied the registration-related precondition to copyright infringement suits under § 411(a),” which was not a merits-based dismissal and therefore had no preclusive effect. Eastern argued that even if the First Circuit adopted the alternative determinations doctrine, the Court should limit the doctrine because the district court “rigorously considered” the merits-based rationale for dismissal in the previous action.

The First Circuit adopted the alternative determinations doctrine and rejected Eastern’s contention that the doctrine should not apply in the instant case because Eastern did not provide support for the contention that the district court in the previous action “rigorously considered” the merits-based grounds for dismissal of Foss’s federal copyright claims. The Court then remanded the case for further consideration, noting that Eastern might argue that the alternative disputes doctrine should be limited in this instance because of Foss’s failure to allege satisfaction of the precondition to suit, which might be prejudicial to Eastern.

Words Matter: Court Sides with Translation Company in Insurance Coverage Dispute

by Hannah Cohen | Dec 8, 2022 | Trade Secrets

The US Court of Appeals for the First Circuit concluded that a company’s general liability insurer was obligated to provide coverage for legal fees incurred in fending off a trade secret and defamation lawsuit brought by a competitor. Lionbridge Tech., LLC v. Valley Forge Ins. Co., Case No. 21-1698 (1st Cir. Nov. 21, 2022) (Kayatta, Selya, Thompson, JJ.)

Lionbridge and TransPerfect are competitors in the language-translation industry. TransPerfect sued Lionbridge for misappropriation of trade secrets and defamation. TransPerfect alleged that Lionbridge concocted a scheme through its corporate owner to feign interest in acquiring TransPerfect and, through this scheme, improperly gained access to TransPerfect’s trade secrets, which could be used to poach TransPerfect’s customers and otherwise undermine TransPerfect’s business.

Shortly after the lawsuit was filed, Lionbridge informed its liability insurance carrier, Valley Forge, about the litigation. Valley Forge initially indicated that it would provide Lionbridge with coverage for legal costs associated with the litigation. Valley Forge subsequently disputed the requested coverage based on both the reasonableness of the fees incurred and the nature of the suit. Lionbridge filed suit against Valley Forge seeking full coverage from Valley Forge for its defense costs. The dispute centered on whether the fees incurred could be considered injury arising out of “[o]ral or written publication, in any manner, of material that slanders or libels a person or organization or disparages a person’s or organizations goods, products, or services,” as provided by Lionbridge’s insurance policy. The district court granted summary judgment in favor of Valley Forge, finding that Valley Forge did not owe Lionbridge a duty to defend under the relevant policy provisions and exclusions. Lionbridge appealed.

The First Circuit reversed, explaining that an insurer’s duty to defend depends on whether the allegations in the underlying litigation are reasonably susceptible to an interpretation that the policy provisions apply. The focus of the inquiry is the source of the injury, not any specific theories of liability set forth in the underlying complaint. The Court explained that this inquiry required a comparison of the allegation made in the underlying litigation against the insurance policy provisions.

After analyzing the underlying complaint against the insurance policy, the First Circuit determined that the policy provisions applied because the allegations “roughly sketch[ed]” an injury arising from a defamation claim. TransPerfect’s claims were rooted in alleged reputational harm to its business, which fit within the relevant provision. The Court noted that complete overlap between the policy provisions and the claims was not required.

The First Circuit next considered whether any policy coverage exclusions applied to preclude coverage. The relevant exclusions fell into two buckets:

Injuries caused by an insured with direct knowledge that its actions would inflict injury, or injuries arising out of an oral or written publication that the insured knows is false
Trade secret misappropriation.

Valley Forge carried the burden of proving that either or both categories of exclusions applied. The Court concluded that the first category did not apply because Valley Forge failed to show that all allegations [...]

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And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

by Paul Devinsky | Oct 6, 2022 | Trade Secrets

In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit (characterizing the matter as the “entrepreneurial equivalent of musical chairs”) affirmed a dismissal of a trade secret claim against a foreign defendant but not against the related US entity, and found that the case qualified under Rule 54(b) for the “narrow exception” to the finality rule. Amyndas Pharmaceutical, SA v. Zealand Pharma A/S, Case No. 21-1781 (1st Cir. Sept. 2, 2022) (Barron, Selya, Kayatta, JJ.)

Amyndas is a Greek company with a US affiliate. It is a biotechnology firm that researches and develops therapeutics targeting a part of the immune system known as the complement system. One area of Amyndas’s research deals with “complement inhibitors.”

Amyndas’s research yielded compstatin, a peptide that selectively inhibits the C3 protein (which plays a role in activating the complement system). Amyndas also developed a related peptide (AMY-101) that targets that protein. Amyndas owns trade secrets and confidential information related to this work.

Zealand Pharma, a Danish biotechnology firm, contacted Amyndas about a potential partnership for the development of complement-related therapeutics. The firms entered into a confidential disclosure agreement (CDA) regarding information-sharing “for the purposes of evaluating a possible business/services relationship between the parties and their respective Affiliates.” Amyndas started giving Zealand Pharma access to confidential information (including confidential information about AMY-101). The firms also entered into a second CDA—with added protections—for “the evaluation or formation of a possible business and/or services and/or collaborative relationship.”

Both CDAs included an identical “Governing Law” provision stipulating that the CDAs would “be interpreted and governed by the laws of the country (applicable state) in which the defendant resides” and a forum-selection clause stipulating that “any dispute arising out of th[e CDA] shall be settled in the first instance by the venue of the defendant.”

Zealand Pharma also began its own research program focused on complement therapeutics. It did not inform Amyndas of this initiative. Although negotiations continued, the firms ultimately decided not to collaborate. Amyndas later terminated its information-sharing relationship with Zealand Pharma.

Zealand Pharma later formed Zealand US, a Delaware corporation. Without Amyndas’s knowledge or consent, Zealand Pharma also filed two European patent applications for compstatin analogues and later an international patent application designating the United States and claiming priority to the earlier EU applications.

After the international applications were published, Amyndas learned that they described “compstatin analogues that are capable of binding to C3 protein and inhibiting complement activation,” which had been the focus of Amyndas’s research and a subject of Amyndas’s confidential information-sharing with Zealand Pharma.

The other defendant, Alexion, is an established player in the complement therapeutics field and a proprietor of Soliris, a complement inhibitor that targets a protein in the complement system. Soliris is approved by the US Food and Drug Administration (FDA) and previously was the only FDA-approved and clinically available [...]

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Can’t Dismiss Lanham Act Claim Based on FDCA Preemption

by Tim Dunker | Aug 25, 2022 | Trademarks

The US Court of Appeals for the First Circuit affirmed-in-part and vacated-in-part a district court ruling dismissing claims under the Lanham Act and Massachusetts consumer protection law based on statements on a website regarding compliance with the Food, Drug, and Cosmetic Act (FDCA). Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC, Case No. 21-1492 (1st Cir. Aug. 12, 2022) (Barron, Howard, Thompson, JJ.)

Azurity is a specialty pharmaceutical company that markets a hydrochloride vancomycin drug that received pre-market approval from the US Food & Drug Administration (FDA). Edge Pharma is a drug compounding company that also markets a hydrochloride vancomycin drug that competes with Azurity’s drug but has not yet received FDA approval. In 2020, Azurity filed suit against Edge in the US District Court for the District of Massachusetts under both the Lanham Act and a Massachusetts consumer protection law based on statements that Edge allegedly made on its website. Azurity argued that these statements represented or conveyed the impression that Edge was not in violation of Section 503B of the FDCA, which authorizes drug compounders that meet certain conditions to market their drugs without first obtaining FDA approval. Azurity alleged that these statements were literally false and/or misleading and that other statements holding out Edge’s drug as superior to Azurity’s were similarly false and/or misleading. Edge moved to dismiss Azurity’s claims for failure to state a claim on which relief could be granted.

The district court granted Edge’s motion as to Azurity’s Lanham Act claim on the ground that the FDCA precluded Azurity’s claim. The district court stated that the claim would require it to interpret the meaning of Section 503B in a way that would interfere with the FDA’s authority to administer and enforce the FDCA. The district court also ruled that Azurity’s consumer protection claim failed because it was premised on the same allegations as Azurity’s Lanham Act claim. Azurity appealed.

The FDCA requires FDA pre-approval to market any drug. However, there are exemptions for “compounded” drugs and “outsourcing facilities” that manufacture compounded drugs. The FDCA provides registration and compliance requirements to be considered an “outsourcing facility.”

Edge made several statements on its website regarding alleged FDCA compliance, FDCA registration and other commercially available options for its compounded drug. The First Circuit referred to these as compliance statements, registration statements and superiority statements, respectively. With respect to Edge’s compliance and registration statements, the Court did not find that the FDCA precluded Azurity’s claims and instead adopted the framework used by the Ninth and District of Columbia Circuits. The First Circuit noted that those circuits established that, “[a]bsent a clear and unambiguous ruling from a court or agency of competent jurisdiction, statements by laypersons that purport to interpret the meaning of a statute or regulation are opinion statements, and not statements of fact,” and thus, as such, are “not generally actionable under the Lanham Act.” The Court found that Azurity’s reliance on a non-binding FDA guidance document regarding “essentially a copy” provision of Section 503B was not a [...]

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