Life Sciences

Opinion

Legal Prediction Is Demanding But Not Impossible

The New Jersey Supreme Court’s recent decision in Balducci v. Cige incorrectly concluded that predicting the length and cost of a case is nearly impossible, and overlooked artificial intelligence's ability to do so, says Joseph Avery with Claudius Legal Intelligence.

Trends In Recent FCPA And Cartel Cases Against Execs

The U.S. Department of Justice has taken more white collar cases against executives to trial this winter, focusing on Foreign Corrupt Practices Act and cartel allegations, and scoring noteworthy victories in a canned tuna price-fixing case and two rate-rigging cases, say attorneys at Miller & Chevalier.

Class Actions Are A Growing Risk For CBD Cos.

Warning letters issued by the U.S. Food and Drug Administration and the Federal Trade Commission have sparked a wave of class actions targeting CBD companies, which could reduce investment in the industry and lower the number of products in the marketplace, says Christopher Binns of Loeb & Loeb.

Coronavirus Drug Shows Global Hurdles To Patent Protection

Recent interplay between patent applications filed by multiple international organizations in connection with a drug treatment for the new coronavirus demonstrates how the requirements of differing jurisdictions can complicate efforts to obtain patent protection, say attorneys at Morris Manning.

States Lead The Way On Drug Pricing Reform

States have demonstrated strong initiative and creativity in targeting high drug costs, though constitutional and federal limits have impeded their reform efforts, say Deborah Gardner and Scott Falin of Ropes & Gray.

Fed. Circ. May Limit USPTO’s Standing To Intervene

The pending Federal Circuit cancer drug patent case Biogen v. Iancu could restrict the U.S. Patent and Trademark Office’s ability to intervene when a successful appellant does not participate, making this a less attractive strategy for petitioners looking to cut costs, says Michelle Divelbiss of Axinn.

How Cos. Can Prepare For Heartburn Drug Cancer Claims

As legal claims mount following the U.S. Food and Drug Administration's recent announcement that traces of a carcinogen were found in a common antacid medication, companies that act soon have the best chance to shape the arc of litigation, say Michael Tanenbaum and Kelly Belnick of Tanenbaum Keale.

The Implications Of USMCA For Biologic Innovation

Last-minute changes to certain exclusivity provisions in the U.S.-Mexico-Canada Agreement are likely to discourage pharmaceutical companies from undertaking the expensive clinical trials needed to discover new uses for biologic medicines, say Irena Royzman and Jennifer Liu at Kramer Levin.

Malpractice Landscape Is Becoming Riskier For BigLaw

A recent survey of lawyers’ professional liability insurers revealed an increase in malpractice claims against law firms, suggesting clients will demand more accountability in the coming decade, say Gerald Klein and Amy Nguyen at Klein & Wilson.

The Long Odds Of Obtaining IPR Reversals On Issues Of Fact

Data from the past year indicates that while obtaining any reversal of an inter partes review decision of the Patent Trial and Appeal Board is statistically unlikely, and even less likely on issues of fact, having the right panel of Federal Circuit judges may improve the odds, says Steven Roth of Lucas & Mercanti.

Series

Judging A Book: Humetewa Reviews 'Guilty People'

In her new book, "Guilty People," Abbe Smith successfully conveys that seeing ourselves in people who commit crime may be the first step to exacting change in our justice system, says U.S. District Judge Diane Humetewa of the District of Arizona.

EPA Hemp Pesticide Approval Is A Big Step For Cannabis

The U.S. Environmental Protection Agency’s recent approval of certain pesticides for the cultivation of hemp is a first for the federal government, and represents a major milestone in the development of a full-fledged, properly regulated and profitable cannabis industry, says Richard Blau of GrayRobinson.

Federal-State Employment Law Divide Reveals Systemic Flaw

The current lack of synchrony between federal and state employment laws suggests a flaw in the system that is testing the limits of our democracy, says Hollie Reiminger at Fisher Phillips.

Takeaways From DOJ Fraud Section's Enforcement Uptick

The Fraud Section of the U.S. Department of Justice's Criminal Division reported a year-over-year increase in prosecutions and settlements, underscoring the agency's willingness to use enforcement to achieve its twin goals of cooperation and enhancing compliance programs, say Kevin Muhlendorf and Madeline Cohen at Wiley Rein.

The US Product Liability Issues Spreading To The EU

U.S. product liability claims are increasingly replicated in the European Union as soon as there is a judgment against a manufacturer, service provider or retailer, and controversial products including glyphosate, talc, cannabis and opioids are particular areas to watch, say Sylvie Gallage-Alwis and Alice Decramer of Signature Litigation.