Is the So-Called Mandate Without Any Tax Consequences Unconstitutional? And If So, How Should a Court Remedy That? Part Three in a Series Examining Underexplored Issues in the California v. Texas Affordable Care Act Case

VIKRAM DAVID AMAR, EVAN CAMINKER, JASON MAZZONE

In this third of a series of columns examining underexplored issues in the California v. Texas case challenging the Affordable Care Act (ACA), Illinois law dean Vikram David Amar, Michigan Law dean emeritus Evan Caminker, and Illinois law professor Jason Mazzone consider whether the so-called individual mandate of the ACA, now without any tax consequences, is unconstitutional, as the challengers argue. The authors explain why, in their view, the challengers are incorrect, regardless of whether the word “shall” in the ACA is interpreted as obligatory or not.

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Kroessler v. CVS Health Corp.

Court: US Court of Appeals for the Ninth Circuit

Docket: 19-55671

Opinion Date: October 9, 2020

Judge: Eric F. Melgren

Areas of Law: Constitutional Law, Drugs & Biotech

The Ninth Circuit reversed the district court's dismissal of a putative class action against CVS based on Federal Food, Drug, and Cosmetic Act (FDCA) preemption of California state law claims. Plaintiff alleged that the supplement he purchased, and five additional CVS glucosamine-based supplements, did not provide the advertised benefits. The FDCA distinguishes between "disease claims" and "structure/function claims" that manufacturers make about their products, applying different regulatory standards to each. The panel held that the district court erred in concluding that the FDCA preempts plaintiff's state law causes of action simply because CVS's glucosamine-based supplements present only structure/function claims. The panel explained that Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019), was distinguishable from this case and the district court erred by applying it. Furthermore, the district court erred by greatly expanding the present state of federal preemption jurisprudence under the FDCA, contrary to public policy. The panel also held that the district court erred in dismissing the complaint without granting plaintiff leave to amend to add allegations regarding an implied disease claim. In this case, plaintiff may have been able to "bolster" his complaint with allegations of extra-label evidence showing that CVS's glucosamine-based supplements present implied disease claims. Accordingly, the panel remanded for further proceedings.

Immunex Corp v. Sanofi-Aventis U.S. LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1749

Opinion Date: October 13, 2020

Judge: Sharon Prost

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

Immunex’s 487 patent is directed to antibodies that bind to the human interleukin-4 receptor, the resulting inhibition of which is significant for treating various inflammatory disorders, such as arthritis, dermatitis, and asthma. Amid infringement litigation, Sanofi filed three inter partes review (IPR) petitions challenging claims 1–17 of the patent. Two were instituted. In one final written decision, the Board concluded that claims 1–17 were unpatentable as obvious over two prior references. Immunex appealed, contesting the construction of the claim term “human antibodies.” In the other IPR, involving a subset of the same claims, the Board did not invalidate the patents for reasons of inventorship. Sanofi contested the Board’s inventorship determination. In consolidated appeals, the Federal Circuit upheld the Board’s claim construction, affirming the invalidity decision, leaving valid no claims at issue in the inventorship appeal.

St. Jude Medical, LLC v. Snyders Heart Valve LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 19-2108

Opinion Date: October 15, 2020

Judge: Richard Gary Taranto

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

The Snyders patent describes and claims an artificial heart valve and a system for inserting the valve. In 2017, St. Jude filed two petitions under 35 U.S.C. 311–19, seeking inter partes reviews (IPR) of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30. The Patent Trial and Appeal Board instituted two reviews, each addressing all the challenged claims. In IPR-105, the Board ruled that St. Jude failed to establish unpatentability of any of the challenged claims, rejecting the contention that all the challenged claims were anticipated by the Leonhardt patent and would have been obvious over Leonhardt plus either the Anderson patent or the Johnson and Imachi patents. In IPR-106, the Board found claims 1, 2, 6, and 8 anticipated by the Bessler patent, but it rejected St. Jude’s contentions as to all other claims, finding that St. Jude had not proved, as to all but claims 1, 2, 6, and 8, anticipation by Bessler or obviousness over Bessler combined with either Anderson or Johnson and Imachi. The Federal Circuit affirmed the decision in IPR-105; reversed the finding in IPR-106 that Bessler anticipated claims 1, 2, 6, and 8; did not reach the anticipation argument as to claim 28; and affirmed the obviousness rejection in IPR-106.