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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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.

Warsaw Orthopedic, Inc. v. Sasso

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1583

Opinion Date: October 14, 2020

Judge: Pauline Newman

Areas of Law: Civil Procedure, Intellectual Property, Patents

Under the 1999 Agreement, Medtronic purchased Dr. Sasso's inventions, agreeing to royalty payments based on Medtronic’s sales of the defined Medical Device until “the last to expire of the patents included in Intellectual Property Rights, or if no patent application(s) issue into a patent having valid claim coverage of the Medical Device, then seven (7) years from the Date of First Sale of the Medical Device.” The initial patent application was filed in November 1999; two patents issued, both entitled “Screw Delivery System and Method.” Medtronic made royalty payments in 2002-2018. Sasso claimed that Medtronic was not paying royalties on sales of all relevant devices, and filed suit in Indiana state court. A judgment in Sasso's favor is on appeal. Medtronic sought a federal declaratory judgment. While Sasso describes the state court action as a contract case for payment for patent rights, Medtronic describes the federal action as a patent case in which payment requires valid patents. The Federal Circuit affirmed the dismissal of the suit without prejudice, based on abstention in view of the concurrent action in Indiana state court between the same parties concerning the same dispute. District courts possess significant discretion to dismiss or stay claims seeking declaratory relief, even when they have subject matter jurisdiction.