Rethinking Retroactivity in Light of the Supreme Court’s Jury Unanimity Requirement

MICHAEL C. DORF

In light of the U.S. Supreme Court’s decision Monday in Ramos v. Louisiana, in which it held that the federal Constitution forbids states from convicting defendants except by a unanimous jury, Cornell law professor Michael C. Dorf discusses the Court’s jurisprudence on retroactivity. Dorf highlights some costs and benefits of retroactivity and argues that the Court’s refusal to issue advisory opinions limits its ability to resolve retroactivity questions in a way that responds to all the relevant considerations.

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In re: Lamictal Direct Purchaser Antitrust Litigation

Court: US Court of Appeals for the Third Circuit

Docket: 19-1655

Opinion Date: April 22, 2020

Judge: Thomas L. Ambro

Areas of Law: Antitrust & Trade Regulation, Class Action, Drugs & Biotech

GSK’s patent to an anti-epilepsy drug, Lamictal, was to expire in 2009. Teva sought to market a generic version of Lamictal, lamotrigine, before GSK’s patent expired. Teva submitted an Abbreviated New Drug Application. GSK sued for infringement. After Teva received a favorable ruling with respect to one claim in 2005, the parties settled. Teva would begin selling lamotrigine six months before it could have had GSK won but later than if it had succeeded in litigation. GSK promised not to launch an authorized generic (AG) version of Lamictal. Had the parties not settled and had Teva succeeded in litigation, it would have been entitled to a 180-day exclusivity period as the generic first filer but GSK could have launched an AG. Companies that directly purchased Lamictal or lamotrigine (Direct Purchasers) sued, claiming the settlement violated the antitrust laws because GSK “paid” Teva to stay out of the market by promising not to launch an AG, resulting in Direct Purchasers paying more than they would have otherwise. The district court certified a class of all companies that purchased Lamictal from GSK or lamotrigine from Teva. The Third Circuit vacated. The district court certified the class without undertaking the required “rigorous” analysis, failing to resolve key factual disputes, assess competing evidence, and weigh conflicting expert testimony, all of which bear heavily on the predominance requirement, and confused injury with damages.

Biogen International GmbH v. Banner Life Sciences, LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1373

Opinion Date: April 21, 2020

Judge: Alan David Lourie

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

Biogen holds the New Drug Application for the active ingredient dimethyl fumarate (DMF), which was FDA-approved in 2013 as Tecfidera®, a twice-daily pill for the treatment of relapsing forms of multiple sclerosis at a daily dose of 480 mg. The 001 patent, “Utilization of Dialkylfumarates,” discloses that dialkyl fumarates may have therapeutic uses “in transplantation medicine and for the therapy of autoimmune diseases,” including multiple sclerosis. After the five-year data exclusivity for Tecfidera® expired, Banner submitted an application under 21 U.S.C. 355(b)(2) to market a twice-daily monomethyl fumarate (MMF) pill at a daily dose of 380 mg. Biogen alleged infringement of the 001 patent. Banner argued that section 156(b)(2) limits the scope of the patent’s extension to methods of using the approved product as defined in 156(f)—DMF, its salts, or its esters—and that MMF is none of those things. Biogen responded that section 156(b)(2) limits extension only to uses of any product within the original scope of the claims. The patent will expire in June 2020. The Federal Circuit affirmed the district court’s finding of non-infringement. The monomethyl ester, covered by claim 1, is not covered by the extension. The scope of a patent term extension under 35 U.S.C. 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient; the product at issue does not fall within those categories.

CardioNet, LLC v. InfoBionic, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 19-1149

Opinion Date: April 17, 2020

Judge: Stoll

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

CardioNet’s 207 patent, titled “Cardiac Monitoring,” claims priority to an application filed in 2004 and describes cardiac monitoring systems and techniques for detecting and distinguishing atrial fibrillation and atrial flutter from other various forms of cardiac arrythmia. The district court dismissed CardioNet’s patent infringement complaint against InfoBionic, finding that the asserted claims of the patent are ineligible under 35 U.S.C. 101. The Federal Circuit reversed, applying the Supreme Court’s two-step “Alice” framework and finding that the asserted claims of the 207 patent are directed to a patent-eligible improvement to cardiac monitoring technology and are not directed to an abstract idea. Nothing in the record suggests that the claims merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter.