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Justia Weekly Opinion Summaries

Drugs & Biotech
July 17, 2020

Table of Contents

Nguyen v. NewLink

Drugs & Biotech, Securities Law

US Court of Appeals for the Second Circuit

Kuykendall v. Accord Healthcare, Inc.

Civil Procedure, Drugs & Biotech, Products Liability

US Court of Appeals for the Fifth Circuit

Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd.

Drugs & Biotech, Intellectual Property, Patents

US Court of Appeals for the Federal Circuit

COVID-19 Updates: Law & Legal Resources Related to Coronavirus

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Legal Analysis and Commentary

The Future of Faithless Electors and the National Popular Vote Compact: Part Two in a Two-Part Series

VIKRAM DAVID AMAR

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In this second of a two-part series of columns about the U.S. Supreme Court’s recent decision in the “faithless elector cases, Illinois Law dean and professor Vikram David Amar describes some good news that we may glean from those cases. Specifically, Amar points out that states have many ways of reducing elector faithlessness, and he lists three ways in which the Court’s decision paves the way for advances in the National Popular Vote (NPV) Interstate Compact movement.

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Impoverishing Women: Supreme Court Upholds Trump Administration’s Religious and Moral Exemptions to Contraceptive Mandate

JOANNA L. GROSSMAN

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SMU Dedman School of Law professor Joanna L. Grossman comments on the U.S. Supreme Court’s recent decision upholding the Trump administration’s religious and moral exemptions to the contraceptive mandate of the Affordable Care Act (ACA). Grossman provides a brief history of the conflict over the growing politicization of contraception in the United States and argues that the exemptions at issue in this case should never have been promulgated in the first place because they have no support in science or public policy.

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Drugs & Biotech Opinions

Nguyen v. NewLink

Court: US Court of Appeals for the Second Circuit

Docket: 19-642

Opinion Date: July 13, 2020

Judge: John M. Walker

Areas of Law: Drugs & Biotech, Securities Law

Plaintiffs filed a class action under S.E.C. Rule 10b-5, 17 C.F.R. 240.10b-5, following the failure of NewLink's Phase 3 clinical trial for a novel pancreatic cancer drug and the resulting decline in the market value of NewLink shares. The Second Circuit held that defendants' statements about the efficacy of their pancreatic cancer drug were puffery, not material misrepresentations. However, the court held that plaintiffs plausibly pled material misrepresentation and loss causation for defendants' statements about the scientific literature and the design of their clinical trial. Therefore, the court affirmed the district court's dismissal in part regarding the 2013-2016 Assessments; vacated the dismissal in part regarding the September, March, and Enrollment statements; and remanded for further proceedings.

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Kuykendall v. Accord Healthcare, Inc.

Court: US Court of Appeals for the Fifth Circuit

Docket: 19-30640

Opinion Date: July 16, 2020

Judge: Stephen Andrew Higginson

Areas of Law: Civil Procedure, Drugs & Biotech, Products Liability

The Fifth Circuit affirmed the district court's dismissal of plaintiff's complaint alleging that she used defendants' prescription chemotherapy drug and now suffers from permanent hair loss. As a plaintiff in this multidistrict litigation (MDL), plaintiff was required to serve defendants with a completed fact sheet disclosing details of her personal and medical history soon after filing her short form complaint. She failed to do so in this case. The court applied the Deepwater Horizon two-factor test to the district court's dismissal of plaintiff's case and held that the district court was not required to make specific factual findings on each of the Deepwater Horizon prongs before dismissing plaintiff's case. The court explained that plaintiff exhibited a clear record of delay sufficient to meet the first prong in the Deepwater Horizon test, and lesser sanctions would not have served the best interests of justice. The court also held that the district court did not abuse its discretion in denying plaintiff's motion for reconsideration.

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Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd.

Court: US Court of Appeals for the Federal Circuit

Docket: 19-2050

Opinion Date: July 14, 2020

Judge: Alan David Lourie

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

Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells, which are responsible for processing information to develop an immune response in the body using receptors on their surfaces. The named inventor Dr. Honjo, a professor at Kyoto University, had shared information with Drs. Wood and Freeman until about 2001. In 2002, Honjo filed his patent application in Japan. Each patent at issue case claims priority from that patent application; none include Freeman and Wood as inventors. The Federal Circuit affirmed that Drs. Freeman and Wood should be deemed inventors of the subject matter of the patents alongside Dr. Honjo, 35 U.S.C. 116(a). The inventorship of a complex invention may depend on partial contributions to conception over time, and there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public. Earlier publication of an invention is obviously a potential hazard to patentability, but the publication of a portion of a complex invention does not necessarily defeat joint inventorship of that invention.

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