Tuesday, August 07, 2018

Lanham Act covers ads that drug is FDA-approved/has ANDA

Arbor Pharmaceuticals, LLC v. ANI Pharmaceuticals, Inc., 2018 WL 3677923, No. 17-4910 (D. Minn. Aug. 2, 2018)

Arbor sells prescription erythromycin ethylsuccinate for oral suspension, allegedly the only FDA-approved products of their kind on the market. ANI announced the launch of its own erythromycin ethylsuccinate for oral suspension, allegedly claiming to be a generic version of Arbor’s products and falsely claiming FDA approval/AB-rating pursuant to an approved Abbreviated New Drug Application (ANDA). A product similar to an NDA-approved drug may be approved and marketed based on an ANDA, which requires a showing of therapeutic equivalence; the resulting AB-rating communicates that the product is a true generic.

Arbor alleged that ANI acquired an ANDA from another pharmaceutical company for a discontinued product that had been manufactured using a process that differs from that used by ANI, and that the FDA has notified ANI that its application wasn’t approvable. ANI stated that the relevant ANDA was originally approved in 1978 for Barr Pharmaceuticals, that Barr stopped marketing the approved product in 2003, and that the ANDA was discontinued. ANI said that it filed a supplement to the ANDA with the FDA, detailing changes it made to the manufacturing process, and indicated its intent to market the product if the FDA did not advise otherwise within 30 days. The FDA allegedly didn’t object, so it must know and be ok with it.  [Nice work if you can get it.]

ANI argued that Arbor’s claims were precluded under the FDCA. Despite Pom, courts have continued to find preclusion where a plaintiff’s claims would require a court to interpret and apply the FDCA.  This wasn’t such a case.  Arbor asserted competitive injury and sought to enforce the Lanham Act’s prohibition on false advertising, here false representations of FDA approval.  ANI stated that it owned an ANDA that couldn’t be circumvented by Arbor’s pleadings, and that the FDA tacitly approved of ANI’s actions, but those were just statements in a brief, whereas Arbor alleged that the FDA considered the ANDA discontinued and had so notified ANI.  Also, the FDA has a list of approved generics, and ANI’s product isn’t on the latest printing.  Because the allegations were that ANI falsely promoted its product as a generic equivalent, no interpretation of the FDCA was required.

For the same reason, the primary jurisdiction doctrine didn’t justify declining to decide the case.  Likewise, state and common-law claims weren’t preempted, though the unfair competition claim under Minnesota law was dismissed as merely duplicative of the false advertising claim.

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