What’s at Stake in Espinoza v. Montana Department of Revenue? What the Equal Protection Clause Means in the Context of Classifications Based on Religiosity

VIKRAM DAVID AMAR, ALAN E. BROWNSTEIN

Illinois Law dean Vikram David Amar and UC Davis emeritus professor Alan E. Brownstein comment on a case before the U.S. Supreme Court that raises the question whether a religiously neutral student-aid program in Montana that affords students the choice of attending religious schools violates the religion clauses or the Equal Protection Clause of the U.S. Constitution. Amar and Brownstein express no opinion as to whether the courts’ often-expressed concerns about striking down invidiously motivated laws can be effectively overcome, but they contend that jurists who reject invalidating invidiously motivated laws must explain why reasons sufficient in other contexts are not persuasive in this case.

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Critcher v. L'Oreal USA, Inc.

Court: US Court of Appeals for the Second Circuit

Docket: 19-2474

Opinion Date: May 11, 2020

Judge: Jose A. Cabranes

Areas of Law: Drugs & Biotech, Government & Administrative Law

The Food Drug and Cosmetic Act's (FDCA) broad preemption clause, 21 U.S.C. 379s, bars plaintiffs from seeking to impose additional or different labeling requirements through their state-law claims, especially when Congress and the FDA already have provided for specific labeling requirements. Plaintiffs filed suit against L’Oréal, alleging common law claims for unjust enrichment and breach of the implied warranty of merchantability, as well as claims under eight state consumer protection statutes. Plaintiffs believed they were being deceived into buying more product, because a portion of each of the liquid cosmetics they purchased could not be extracted. The Second Circuit affirmed the district court's dismissal of the complaint, holding that plaintiffs' state law claims at issue are preempted by the FDCA. In this case, plaintiffs alleged that their injuries resulted from the fact that the labels of the various L’Oréal products omitted certain critical information—specifically, that the creams could not be fully dispensed from their respective containers. Plaintiffs also admit that the packages comply with federal labeling requirements. The court explained that, if plaintiffs were permitted to move forward with their claims, they would be using state law to impose labeling requirements on top of those already mandated in the FDCA and the regulations promulgated thereunder.

Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1924

Opinion Date: May 8, 2020

Judge: Jimmie V. Reyna

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Eage filed suit, alleging infringement of four patents under the doctrine of equivalents, stemming from Slayback’s new drug application for a generic version of Eagle’s branded bendamustine product, BELRAPZO®. Bendamustine is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. The district court entered a judgment of non-infringement on the pleadings. The Federal Circuit affirmed, rejecting Eagle’s arguments that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and therefore dedicated ethanol to the public and that the district court improperly applied the dedication disclosure doctrine at the pleadings stage, in the presence of factual disputes and without drawing all inferences in Eagle’s favor. The disclosure-dedication doctrine bars application of the doctrine of equivalents: “when a patent drafter discloses but declines to claim subject matter, . . . this action dedicates the unclaimed subject matter to the public.” The application of the doctrine is a question of law. The asserted patents disclose ethanol as an alternative to propylene glycol in the “pharmaceutically acceptable fluid” claim limitation. The only reasonable inference that can be made from the disclosures is that a skilled artisan would understand the patents to disclose ethanol as an alternative to the claimed propylene glycol.