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Can’t Dismiss Lanham Act Claim Based on FDCA Preemption

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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Re-Poster Child for § 230: Immunity under the CDA for Reposting Content of Another

The US Court of Appeals for the First Circuit affirmed a district court’s decision to dismiss claims for defamation under the Communications Decency Act (CDA), 47 USC § 230, and for copyright infringement under the fair use doctrine. Monsarrat v. Newman, Case No. 21-1146 (Kayatta, Lipez, Gelpí, JJ.).

The parties’ dispute arose from a series of posts on a community message board. Residents of the Davis Square neighborhood in Massachusetts maintained a Live Journal forum for several years. In response to a revision of the Live Journal terms of service in 2017, Ron Newman, a member of the community, copied the entirety of the content from the Live Journal forum to another online platform: Dreamwidth. The copied content included a series of allegedly defamatory posts about Jonathan Monsarrat and a post that Monsarrat had copyrighted. Monsarrat sued Newman for both defamation and copyright infringement. Newman moved to dismiss the defamation claim under the CDA, § 230, and the copyright claim under the fair use doctrine. After the district court granted the motions, Monsarrat appealed.

The First Circuit first addressed the defamation claim under § 230. Newman argued that § 230 provided him immunity from defamation. Specifically, § 230 states “[n]o provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” It also provides a shield from state law claims that would be “inconsistent with this section.” Courts apply a three-part analysis to determine whether a defendant is entitled to immunity under § 230:

  1. Is the defendant a “provider or user of an interactive computer service”?
  2. Is the claim based on “information provided by another information content provider”?
  3. Does the claim treat the defendant “as the publisher or speaker” of that information?

Monsarrat did not challenge the fact that Newman was a “user” under the first prong. Regarding the second prong, the analysis hinged on whether Newman was an “information content provider,” which in turn relied on whether Newman was responsible for the allegedly defamatory content in whole or in part. The factual record showed that Newman did nothing but copy the allegedly defamatory posts that had been created by another. Monsarrat unsuccessfully argued that Newman was responsible because Newman copied the posts from Live Journal to a different digital platform with an allegedly different audience. The First Circuit was not persuaded, ruling that providing essentially the same content on a different platform did not make a defendant responsible for that content under § 230. Regarding the third prong, Monsarrat’s complaint clearly alleged that Newman was acting as a publisher. The Court affirmed the dismissal of the defamation claim under § 230.

Monsarrat’s copyright claim related to a Live Journal post by Monsarrat in the Davis Square forum. He had created a post with a link to Live Journal’s harassment policy, a quotation from the policy and a brief message regarding his attempts to report the abuse he felt he had suffered by other [...]

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Can’t Presume Personal Jurisdiction Exists When Challenged

The US Court of Appeals for the First Circuit affirmed a district court order dismissing a trademark infringement case for lack of personal jurisdiction, finding that if challenged, personal jurisdiction cannot be assumed into existence. Motus, LLC v. CarData Consultants, Inc., Case No. 21-1226 (1st Cir. Jan. 18, 2022) (Lynch, Selya, McConnell, JJ.)

Motus is a Delaware corporation headquartered in Boston, Massachusetts. CarData is a Canadian corporation with offices in Colorado, New York and Toronto. Both Motus and CarData offer tools for companies to manage employee expense reimbursement. Motus asserted a trademark over the phrase “corporate reimbursement services,” which was present in the meta title of CarData’s website. In November 2019, Motus asked CarData to remove the phrase from its website, and CarData did so within three days.

Motus nevertheless filed a federal lawsuit in the District of Massachusetts asserting Lanham Act claims for trademark infringement, trademark dilution and other state and federal causes of action. CarData moved to dismiss for lack of personal jurisdiction, among other grounds. The district court granted the motion to dismiss, finding that Motus failed to demonstrate either the existence of personal jurisdiction over CarData or that discovery into CarData’s jurisdictional claims were warranted. Motus appealed.

On appeal, the First Circuit reiterated that Motus bore the burden of demonstrating that the district court’s exercise of personal jurisdiction over CarData was proper, noting that although a plaintiff is not required to plead facts sufficient for personal jurisdiction, “it must—if challenged—ensure that the record contains such facts.” To demonstrate that personal jurisdiction over CarData was proper, Motus had to show that CarData had sufficient “minimum contacts” with the forum that were sufficiently related to the matter at issue and evidenced a “purposeful availment of the privilege of conducting business in the forum,” and also had to show the reasonableness of the exercise of personal jurisdiction in that forum. Motus argued that CarData had sufficient “minimum contacts” with Massachusetts for personal jurisdiction to lie there, primarily because CarData had offices elsewhere in the United States and because CarData maintained a website that was available to serve Massachusetts residents.

Given that Motus’s arguments for personal jurisdiction related primarily to the publicly available nature of CarData’s website to residents of Massachusetts, the First Circuit explained that “[i]n website cases we have recognized that the ‘purposeful availment’ element often proves dispositive.” Here, the Court found nothing in the record suggesting that CarData specifically targeted or did business with Massachusetts residents. The Court rejected Motus’s citation to informational content on the website because it was not specific enough to evidence intentional solicitation of business from any particular state. Nor was there evidence of substantial CarData revenue from Massachusetts. Thus, the Court found that there was no “purposeful availment.”

Finally, the First Circuit affirmed the district court’s denial of jurisdictional discovery into CarData’s “minimum contacts” with Massachusetts. The Court found that although Motus mentioned the availability of jurisdictional discovery in a single sentence in a footnote to its opposition to CarData’s motion to [...]

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School’s Out: Trademark Settlement Agreement Enforceable

Addressing issues relating to jurisdiction, contract enforceability and trademarks, the US Court of Appeals for the First Circuit concluded that two schools that used similar names had a valid and enforceable settlement agreement obligating one school to pay for the other to change its name. The Commonwealth School, Inc. v. Commonwealth Academy Holdings LLC, Case No. 20-1112 (1st Cir. Apr. 14, 2021) (Selya, J.)

It came to the attention of a Boston private school, The Commonwealth School (the School), that a more recently founded private school in Springfield, Massachusetts, was operating under a similar name, Commonwealth Academy (the Academy). In 2016, the School brought suit against the Academy under the federal Lanham Act, claiming that the School had a trademark on its “Commonwealth School” name, and that “Commonwealth Academy” infringed on that trademark. The parties entered into settlement mediation, and agreed that the School would pay the Academy $25,000 and in return the Academy would change its name to “Springfield Commonwealth Academy.”

The district court issued an order that a settlement was reached. Three years passed, and the Academy took steps to change its name in promotional materials and on its website. But the School would not pay the Academy because it claimed the Academy still had the “Commonwealth Academy” name appearing prominently on its students’ basketball jerseys. At a hearing to resolve the dispute, the district court reversed its earlier order: the parties had not actually reached a settlement agreement because there had been no “meeting of the minds” for contract formation, despite the other steps the Academy took to fulfill the agreement. The district court dismissed the case because neither party showed cause to reopen the case. The Academy appealed, arguing that the district court erred in refusing to enforce the settlement agreement.

The First Circuit addressed three main issues on appeal: (1) whether there was appellate jurisdiction to hear the appeal, (2) whether the district court had subject matter jurisdiction to hear the initial settlement agreement dispute, and (3) on the merits, whether the settlement agreement was a validly formed contract.

The First Circuit concluded it had jurisdiction to review the district court’s dismissal order. Generally, under the final judgment rule, only final decisions are appealable. But here, the order at issue was merely interlocutory, meaning it was issued during the course of litigation. The Academy claimed the order was in fact reviewable because the order resulted in the case’s dismissal, and thus it should fall under the merger doctrine exception, where interlocutory orders merge into final judgments. The Court considered this in the context of the School’s failure to prosecute, and whether the order actually fell under an exception to the exception – i.e., where a dismissal is based on a failure to prosecute, it does not fall under the merger doctrine. In its analysis, the Court considered the policy considerations underlying the merger doctrine: to preserve integrity of the final judgment rule by preventing any reward for bad faith tactics. Here, the School, as the [...]

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Fourth Estate Registration Requirement Defeats Pro Se Copyright Infringement Plaintiff

The US Court of Appeals for the First Circuit affirmed dismissal of a copyright infringement claim for failure to register the copyright, and affirmed summary judgment against plaintiff on related state law claims where the plaintiff was deemed to have admitted statements that undermined its claims. Foss v. Marvic Inc., Case No. 20-1008 (1st Cir. Apr. 12, 2021) (Lynch, J.)

In 2006, sunroom purveyor Marvic contracted with graphic designer Foss to create a marketing brochure. Foss presented a $3,000 estimate, which Marvic paid, and Marvic began using the brochure soon after. In 2018, Foss (pro se) filed suit, demanding $264,000 for alleged copyright infringement on the basis that in 2016, she discovered that Marvic had been using a modified version of the brochure in print and online without asking for or receiving her permission. Foss alleged inaccurately that she had “applied for official U.S. Copyright Registrations” for the brochure.

Marvic moved to dismiss, and Foss filed an amended complaint stating six causes of action, including copyright infringement and five state-law claims. Foss alleged that she had registered the brochure with the US Copyright Office, but in fact she had only applied (after filing the original complaint) for registration. Marvic moved to dismiss the copyright and breach of contract claims. Foss did not oppose, and the district court dismissed the case. Foss then moved to reopen the case, a motion that the district court granted. Foss filed an opposition to Marvic’s earlier motion to dismiss and retained counsel, who first appeared on the day the district court heard Marvic’s motions.

In support of dismissal, Marvic argued that Foss had not established registration of her copyright, noting the then-existing circuit split as to whether mere application or successful registration was required to support a claim of infringement in federal court. The First Circuit stayed the case pending the Supreme Court’s decision in Fourth Estate. After the Supreme Court held that successful registration is required, the district court lifted the stay and dismissed the copyright claim but not the breach of contract claim.

Later, Marvic served a request for admissions, to which Foss’s counsel failed to respond. Marvic moved that the statements in its request be deemed admitted. The district court granted the motion. Two weeks later, Foss’s counsel moved to withdraw, having been suspended from the practice of law.

Foss, pro se again, moved for reconsideration and for more time to respond to the request for admissions, but the district court denied the motions. Marvic moved for summary judgment on the state law claims, which the district court granted, largely relying on Foss’s deemed admissions. Foss appealed.

The First Circuit held that it was not error to dismiss Foss’s copyright claim under Fourth Estate. The Court rejected as waived Foss’s argument that the district court should have stayed the case pending registration since Foss had not sought such relief below. The Court also rejected Foss’s argument that dismissal became improper when the failure to register was cured since the [...]

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Antitrust Liability Risk When Listing Patents in Orange Book

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J).

In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product.

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