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Thee I Dismiss: No Love for Failure to Add Necessary Party

by | Sep 8, 2022 |

After concluding that a trademark owner’s case for failure to add a necessary party was untenable, the US Court of Appeals for the Fifth Circuit affirmed a district court’s dismissal of the case because the necessary party enjoyed sovereign immunity and could not be added. Lee et al. v. Anthony Lawrence Collection, L.L.C. et al., Case No. 20-30769 (5th Cir. Aug. 24, 2022) (Jolly, Elrod, Oldham. JJ.)

Curtis Bordenave and Paige Lee are in the business of owning trademarks. They petitioned the US Patent & Trademark Office (PTO) for a federal registration of the mark THEEILOVE. The phrase “Thee I Love” comes from Jackson State University, which has used the phrase for roughly 80 years. Collegiate Licensing Company is a licensing agent that handles the licensing of Jackson State’s trademarks to manufacturers that make and sell Jackson State merchandise.

Despite Jackson State’s decades-long use of the phrase, it never applied for a federal mark until after Bordenave and Lee had already done so. Jackson State did register a mark under Mississippi law in 2015 for use on vanity plates and in 2019 for use on other merchandise. It also claimed to have common-law rights to the mark under the Lanham Act.

Bordenave and Lee sued Collegiate Licensing Company and a few of the licensees in charge of producing and selling Jackson State’s merchandise for various claims related to their licensing, manufacturing and selling of “Thee I Love” merchandise, including trademark infringement and unfair competition under the Lanham Act. Bordenave and Lee sought damages, a permanent injunction barring the defendants from producing or selling any more “infringing” merchandise, and a declaration that defendants infringed Bordenave and Lee’s registered marks. The defendants moved to dismiss under Fed. R. Civ. Pro.12(b)(1) and (7), arguing that Jackson State was a required party, and because Jackson State enjoys sovereign immunity, Bordenave and Lee’s case should be dismissed. The district court dismissed the case without prejudice under Rule 12(b)(7). Bordenave and Lee appealed.

The Fifth Circuit affirmed the district court’s ruling. First, the Court determined that Jackson State was a required party, stating that Jackson State had an interest in the action that would be impaired or impeded if Jackson State was not joined in the suit. The Court reasoned that even if Jackson State remained free to challenge Bordenave and Lee’s ownership of THEEILOVE elsewhere, it could still face challenges protecting its interest if it was not joined in this action.

Next, because Jackson State has sovereign immunity, the Fifth Circuit considered whether the district court abused its discretion in dismissing the case rather than proceeding without Jackson State. Jackson State enjoys sovereign immunity as an arm of the State of Mississippi. Because Jackson State had a non-frivolous claim here, the Court found that dismissal was required because of the potential injury to Jackson State’s interest as an absent sovereign.

Finally, the Fifth Circuit considered the four factors under Rule 19(b) that determine whether an action should continue without the absent party or be dismissed. [...]

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Secondary Meaning: Consumers Connect Product with Single Anonymous Source

by | Sep 8, 2022 |

Reversing and remanding a district court’s grant of summary judgment in favor of an accused trade dress infringer, the US Court of Appeals for the Ninth Circuit explained that trade dress does not need to be linked to a particular company. If consumers link the trade dress to any single (even anonymous) source or company, that is enough to constitute secondary meaning. P and P Imports LLC v. Johnson Enterprises LLC, DBA Tailgating Pros, Case Nos. 21-55013; -55323 (9th Cir. Aug. 24, 2022) (Tashima, Lee, Cardone, JJ.)

P&P makes and sells a jumbo red-white-and-blue Connect 4 game. Johnson sells a game almost identical in color, style and size. P&P sought to block Johnson from selling its game and sued for trade dress infringement under Lanham Act § 43(a) and unfair competition. During the district court proceeding, P&P’s expert submitted a consumer survey showing that most consumers associated P&P’s trade dress with a single source or company. He also submitted evidence of intentional copying and noted P&P’s advertising efforts as support for secondary meaning. The district court granted summary judgment for Johnson, ruling that P&P failed to present sufficient evidence of secondary meaning. The district court relied on the Ninth Circuit’s 2011 decision in Fleischer Studios v. A.V.E.L.A. to dismiss the survey evidence as irrelevant because the results showed a belief that P&P’s product is from a single source or company but did not show that trade dress was associated with P&P itself. P&P appealed.

The question before the Ninth Circuit was whether a manufacturer’s red-white-and-blue jumbo rendition of Connect 4 qualified as a protectable trade dress. This required the Court to determine whether P&P’s trade dress had acquired secondary meaning. Secondary meaning exists when “in the minds of the public, the primary significance of [the trade dress] is to identify the source of the product rather than the product itself.”

The Ninth Circuit concluded that the district court applied an incorrect legal standard for determining secondary meaning and that P&P presented sufficient evidence to survive summary judgment. The Court explained that many factors determine whether secondary meaning exists, including “direct consumer testimony; survey evidence; exclusivity, manner, and length of use of a mark; amount and manner of advertising; amount of sales and number of customers; established place in the market; and proof of intentional copying by the defendant.” The Court also noted that in the past it had found the presence of intentional copying and survey evidence sufficient to survive summary judgment.

Turning to the evidence presented by P&P, the Ninth Circuit explained that the district court’s analysis (which required consumers to both recognize P&P’s trade dress and be able to name P&P as the source) conflicted with the Court’s “long-established precedent[] requiring association with only a single—even anonymous—source,” and thus the district court erred by requiring evidence of specific association for secondary meaning. The Court also found strong suggestions that Johnson intentionally copied the P&P game, including the fact that Johnson conducted market research, ordered a copy of the [...]

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Bayou Jambalaya: Sanction Motions, Motions to Vacate and Trade Dress Injunctions

by | Sep 8, 2022 |

The US Court of Appeals for the Fifth Circuit issued a three-part ruling that affirmed the district court’s denial of a motion to vacate as void the judgment based on Rooker-Feldman doctrine because the earlier state and district court decisions were not “inextricably intertwined,” affirmed the district court’s permanent injunction because the district court based it on the Fifth Circuit’s prior decision, and affirmed the denial of a motion for Rule 11 sanctions because the filed motion was different from the Rule-11-mandated notice that was originally served. Uptown Grill, L.L.C. v. Camellia Grill Holdings, Inc., Case No. 21-30639 (5th Cir. Aug. 23, 2022) (Higginbotham, Higginson, Oldham, JJ.)

This dispute arises from three agreements between Uptown Grill and Camellia Grill: the “Cash Sale, the Bill of Sale and the License Agreement. The Cash Sale and Bill of Sale transferred property from Camellia Grill to Uptown Grill. The License Agreement granted a license to Uptown Grill to use certain trademarks and trade dress. In 2011, Camellia Grill sued Uptown Grill for breach of the License Agreement in state court. The state court found that the appellee breached the license and restored to the appellant all rights to the marks. The court did not, however, construe the Bill of Sale.

While the state court litigation was on appeal, Camellia Grill sued Uptown Grill in federal court for trademark infringement. The district court found that the Bill of Sale transferred the trademarks to Uptown Grill before execution of the License Agreement, and therefore found that Camellia Grill’s infringement claim failed. However, the district court also found that the License Agreement limited Uptown Grill’s use of the trade dress to a single restaurant, and the court issued an injunction to that effect. The Fifth Circuit affirmed these findings in a 2019 decision in Uptown Grill, LLC v. Camellia Grill Holdings, Inc., but remanded the issue of whether Uptown Grill’s use of the Camellia grill trade dress at the new restaurant location constituted a breach of the License Agreement.

On remand, Camellia Grill moved for summary judgment that Uptown Grill breached the License Agreement by using the Camellia Grill trade dress after the termination of the License Agreement. Uptown Grill moved for partial summary judgment on the trade dress injunctions, arguing that Camellia Grill lacked standing since Uptown Grill was not using any trade dress at any new locations. Camellia Grill also filed a motion to dismiss for lack of jurisdiction under the Rooker-Feldman doctrine, under which “inferior federal courts do not have the power to modify or reverse state court judgments’ except when authorized by Congress.” Finally, Uptown Grill moved for sanctions against Camellia Grill for “abusive and harassing conduct.” The district court denied both Camellia Grill’s motion to dismiss for lack of jurisdiction and Uptown Grill’s motion for sanctions. The district court determined that Uptown Grill had breached the License Agreement’s post-termination provisions. The court also decided that the trade dress elements should be limited to that which is protectable under [...]

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IPR Estoppel Applies to Claim Not Addressed During Pre-SAS Proceeding

by | Sep 1, 2022 |

In the companion district court case to the Supreme Court’s 2019 Thryv v. Click-to-Call decision regarding the scope of review for inter partes review (IPR) decisions, the US Court of Appeals for the Federal Circuit addressed what it characterized as “a rather unusual set of circumstances” to find that the accused infringer was estopped from challenging in district court the validity of a claim for which the Patent Trial & Appeal Board (Board) had refused to institute IPR. Click-to-Call Techs. LP v. Ingenio, Inc., Case No. 22-1016 (Fed. Cir. Aug. 17, 2022) (Stoll, Schall, Cunningham, JJ.)

Click-to-Call filed suit against Ingenio alleging patent infringement of 16 claims. Ingenio filed a petition for IPR challenging the 16 claims and one additional dependent claim. The Board only partially instituted the IPR, and in its final written decision addressed and found persuasive un-patentability grounds based on a Dezonno reference but refused to consider grounds based on a Freeman reference (leaving one of the asserted claims unaddressed). Ingenio had successfully requested a stay of the district court suit pending resolution of the IPR. During the appeal of the Board’s decision regarding the IPR, the Supreme Court in SAS Institute, Inc. v. Iancu, overruled the practice of partial institutions. However, Ingenio never sought remand under SAS for the Board to consider its challenge to the unaddressed asserted claim.

After the IPR appeal had run its course, the district court lifted the stay and Ingenio moved for summary judgment of invalidity. Ingenio argued that the unaddressed asserted claim (which was the only asserted claim not found unpatentable in the IPR) was invalid based on the same Dezonno reference that Ingenio had used against the other asserted claims. Click-to-Call argued that 35 U.S.C. § 315(e)(2) estopped Ingenio from raising this invalidity ground. Click-to-Call also moved to amend its selection of asserted claims to add two additional claims that were not at issue in the IPR. The district court found that Dezonno anticipated the unaddressed asserted claim and denied Click-to-Call leave to amend its asserted claims. Click-to-Call appealed.

Click-to-Call argued that Ingenio was estopped from asserting invalidity of the unaddressed asserted claim. The Federal Circuit agreed and found that IPR estoppel applied. Specifically, the Court found that district court erred by only analyzing common law issue preclusion, focusing on whether the argument had been “actually litigated” instead of following the language of IPR estoppel under § 315(e)(2), which estops grounds that “reasonably could have [been] raised.” The Court found that the statutory language precluded Ingenio from arguing that Dezonno anticipated the unaddressed asserted claim. The Court explained that Ingenio’s IPR petition included not only a challenge to the unaddressed asserted claim based upon Freeman, but also unpatentability challenges to other claims based on Dezonno. The Court viewed this as evidence of Ingenio’s awareness of Dezonno as an anticipatory ground that it “reasonably could have raised” in the IPR. The Court was unpersuaded by Ingenio’s arguments that there was no estoppel with regard [...]

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PTO Can and Should Use Alice/Mayo Framework to Assess Eligibility

by | Sep 1, 2022 |

Addressing a challenge of the Alice/Mayo framework in the context of the Administrative Procedure Act (APA) and the Fifth Amendment’s due process clause, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision finding that patent claims directed to analyzing social security benefit applications were patent ineligible under 35 U.S.C. § 101. In re Killian, Case No. 21-2113 (Fed. Cir. Aug. 23, 2022) (Taranto, Clevenger, Chen, JJ.)

Jeffrey Killian filed a patent application related to a system and method for determining eligibility for social security disability insurance (SSDI) benefits through a computer network. The examiner rejected the claims under § 101, finding that they were directed to the abstract idea of “determining eligibility for social security disability insurance . . . benefits” and lacked additional elements amounting to significantly more than the abstract idea because the additional elements were simply generic recitations of generic computer functionalities. Killian appealed to the Board, which affirmed the examiner’s rejection. The Board explained that the claims were directed to the patent ineligible abstract idea of “a search algorithm for identifying people who may be eligible for SSDI benefits they are not receiving,” and that the “determining” and “selecting” limitations of the claims could be performed by the human mind and thus were an “abstract mental process.” Killian appealed.

Killian raised several arguments that generally fell into three categories:

  1. The Alice/Mayo standard is indefinite under the APA.
  2. The § 101 analysis for software violated Killian’s Fifth Amendment due process rights.
  3. Step 2 of the Alice/Mayo analysis has no basis in patent law.

Addressing the first argument, the Federal Circuit noted that the APA cannot apply to the decisions of courts because courts are not agencies. Next, the Court dismissed Killian’s argument that all § 101 decisions are void because the Alice/Mayo standard is indefinite. The Court explained that it has routinely found that mental processes are abstract ideas, including claims that were directed to data gathering, analysis and notification on generic computers. The Court found that nothing in Killian’s claims provided an inventive manner to accomplish the claimed method, and thus the § 101 rejection was entirely proper. As a final point, the Court stated that it was bound to Supreme Court precedent and only new overruling precedent would change the analysis it applied.

The Federal Circuit also rejected Killian’s due process argument. Killian argued that his due process rights were violated because he did not have an opportunity to appear in the other cases regarding patent eligibility. As an initial matter, the Court noted that no “void-for-vagueness” doctrine argument was put forward, and the doctrine requires a case-by-case analysis. The Court found that this was not a close case, as data gathering and analysis methods run afoul of established § 101 precedent. Next, the Court addressed the common law approach of not requiring “a single governing definitional context” and a comparison to previously decided cases finding it appropriate. Killian’s due process rights were found to [...]

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Yes, and It Counts! Single Purchase in Forum Establishes Personal Jurisdiction over Infringer

by | Sep 1, 2022 |

The US Court of Appeals for the Seventh Circuit affirmed exercise of personal jurisdiction over a foreign online retailer for a trademark infringement claim where the trademark owner purchased the only allegedly infringing article sold in the forum. NBA Properties, Inc. v. HANWJH, Case No. 21-2909 (7th Cir. Aug. 16, 2022) (Ripple, Scudder, JJ.)

NBA Properties owns the trademarks for the National Basketball Association (NBA) and NBA teams. HANWJH is a China-based online retailer that sells allegedly infringing NBA branded products on a well-known e-commerce site. HANWJH offered 205 allegedly infringing products that were available for purchase in Illinois, the forum state. HANWJH’s only online order in Illinois was made by an investigator for NBA Properties who purchased a pair of basketball shorts for delivery to an Illinois address. The shorts were delivered to the Illinois address before NBA Properties filed suit against HANWJH.

NBA Properties sued HANWJH for trademark infringement and counterfeiting under 15 U.S.C. § 1114 and false designation of origin under 15 U.S.C. § 1125(a) in the Northern District of Illinois. NBA Properties sought and received a temporary restraining order and preliminary injunction, including a temporary asset restraint on HANWJH’s bank account. After HANWJH failed to timely answer the complaint, NBA Properties moved for default judgment. HANWJH moved to dismiss the case for lack of personal jurisdiction, arguing the following:

  • Operating a website is not sufficient on its own to establish personal jurisdiction.
  • A single transaction by the plaintiff cannot support the exercise of personal jurisdiction.
  • Even if the exercise of personal jurisdiction were otherwise appropriate, such exercise would offend the traditional notions of fair play and substantial justice.

The district court denied HANWJH’s motion to dismiss and entered a default. HANWJH failed to object to the motion for default judgment, and the district court entered a final judgment. HANWJH appealed.

The Seventh Circuit reviewed the “minimum contacts” International Shoe criterion before turning to a more recent line of cases applying this standard to online retailers. Citing its 2020 decision in Curry v. Revolution Laboratories, the Court noted that the minimum contacts requirement is satisfied if “the defendant reasonably could foresee that its product would be sold in the forum.” The Court reasoned that allowing customers to order products from a website to the forum and then fulfilling an order to the forum can form the basis of personal jurisdiction—even when the only orders to the forum were made by the plaintiff, as long as the orders were made before filing suit. Applying these principles, the Court found that HANWJH had purposefully directed conduct at Illinois by establishing an online store, demonstrating a willingness and capacity to ship goods to Illinois and intentionally shipping an infringing product to an Illinois address. The Court explained that it was irrelevant that only a single allegedly infringing article was sold in Illinois and that it was purchased by the plaintiff, because the proper focus of the analysis was on HANWJH’s purposeful conduct. The Court also concluded that HANWJH’s [...]

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DMCA Scienter Requirement Not Satisfied without Evidence of Knowledge of Inducement or Concealment

by | Sep 1, 2022 |

Interpreting a provision of the Digital Millennium Copyright Act (DMCA), 17 U.S.C. § 1202(b), for the first time, the US Court of Appeals for the Eleventh Circuit affirmed a summary judgment ruling that the plaintiff failed to satisfy the second scienter requirement of § 1202(b) by not showing that the defendant knew, or had reasonable grounds to know, that its actions would induce, enable, facilitate or conceal a copyright claim. Victor Elias Photography, LLC v. Ice Portal, Inc., Case No. 21-11892 (11th Cir. Aug. 12, 2022) (Newsom, Marcus, JJ; Covington, Distr. J.)

Victor Elias is a professional photographer who takes photographs for hotels and resorts throughout the United States, Mexico and the Caribbean. Between 2013 and 2017, Elias took pictures for Starwood Hotels & Resorts and Wyndham Hotel & Resorts. As part of his process, Elias embedded copyright management information (CMI) into the image files.

During this period and into 2018, Starwood and Wyndham contracted with Ice Portal (a division of Shiji at the time of the appeal) to process thousands of images, including 220 images taken by Elias, and make them available to online travel agents. This processing included converting the images to JPEG format, making copies in various industry-standards sizes and optimizing the files for faster display. The processing sometimes resulted in the loss of an image file’s metadata. In 2016, Elias discovered infringing online uses of his images that lacked the embedded CMI. He filed suit against Ice Portal, contending that the stripping of metadata resulted in loss of his embedded CMI, which violated two sections of the DMCA: 17 U.S.C. §§ 1202(a) and 1202(b).

Following discovery, the district found that Elias could not “satisfy the ‘second scienter requirement’ of the statute” and granted Shiji’s motion for summary judgment. Relying on the 2018 Ninth Circuit case Stevens v. Corelogic, the district court found that Elias had not established that Shiji “knew or had reason to know that its action would induce, enable, facilitate, or conceal infringement.” The court determined that Elias failed to demonstrate that the removal of CMI “is the reason, or even the likely reason, for the infringing use of the images,” or that “Shiji was even aware that searching for terms embedded in the extended attributes was a method used by copyright holders to find infringement on the internet.” Elias appealed.

Because this was a novel issue for the Eleventh Circuit, the Court interpreted § 1202(b) as an issue of first impression. After considering the plain terms of the statute and the opinions of sister circuits, the Court agreed with its sister circuits that to satisfy the scienter requirement of §1202(b), a plaintiff “must make an affirmative showing . . . [that] the defendant was aware [of] or had reasonable grounds to be aware of the probable future impact of its actions.”

Elias urged the Eleventh Circuit to adopt a standard that would only require a plaintiff to demonstrate that CMI was knowingly removed without consent and that the defendant either “knows, or has [...]

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File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

by | Sep 1, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s abbreviated new drug application (ANDA) specification controlled the § 271(e)(2) infringement inquiry, and that there were no clear errors by the district court that would warrant reconsideration of the § 271(a)-(b) ruling. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc., Case No. 21-2342 (Fed. Cir. Aug. 18, 2022) (Moore, Prost, Hughes, JJ.)

Par is the maker of Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Par sued Eagle, an ANDA filer seeking to market a generic version of Vasostrict®, asserting infringement of two Orange Book-listed patents. The claims of both asserted patents required a vasopressin composition with a rounded pH between 3.7 and 3.9 (i.e., a pH between 3.65 and 3.94 before rounding). Par argued that Eagle infringed because Eagle’s ANDA sought approval for a product with a pH of 3.64, just 0.01 beneath the claimed range, and because “real-world” evidence purportedly showed that the pH of Eagle’s product drifts up over time. Accordingly, Par asserted infringement under § 271(e)(2), based on the filing of Eagle’s ANDA, and also sought a declaratory judgment that Eagle’s planned generic product would infringe under § 271(a)-(b). The district court disagreed. Par appealed.

Turning first to the issue of infringement under § 271(e)(2), the Federal Circuit explained that because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with their ANDAs, if an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. The Court stated, however, that if an ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the US Food & Drug Administration (FDA), to assess whether a proposed product will infringe.

The Federal Circuit found that in Eagle’s case, “the inquiry begins and ends with Eagle’s ANDA specification.” Eagle’s ANDA contained both a release specification, requiring the generic product to have a pH range of 3.4–3.6 (i.e., up to 3.64 before rounding) at the time of distribution, and a stability specification, requiring that same pH range throughout the entirety of the product’s shelf life. Par argued that the stability specification was irrelevant to the infringement inquiry because the FDA cannot ensure that every product Eagle sells complies with the stability specification. The Court disagreed, finding that the district court did not clearly err in ruling that Eagle’s ANDA defined a product outside the scope of Par’s claims.

As to Par’s declaratory judgment claim under § 271(a)-(b), the Federal Circuit found that the district court did not commit clear error in its consideration of Par’s infringement arguments. The district court considered but did not find compelling Par’s evidence of an upward pH drift in Eagle’s post-release pH data [...]

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Can’t Dismiss Lanham Act Claim Based on FDCA Preemption

by | Aug 25, 2022 |

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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