Life Sciences

Pharma Ruling Broadens Gov't Drug Procurement Options

In Acetris Health v. U.S., the Federal Circuit's decision that a company sourcing active pharmaceutical ingredients from India could sell them to the U.S. government greatly expanded foreign-produced pharmaceutical products available for U.S. procurement, say attorneys at K&L Gates.

Rebuttal

AI Can't Accurately Predict Case Length And Cost — Yet

A recent Law360 guest article argued that artificial intelligence can precisely estimate the length and cost of a new case, but several limitations will likely delay truly accurate predictions for years to come, says Andrew Russell at Shaw Keller.

FDA-FTC Biosimilar Push Clarifies Antitrust Stance

Recent collaboration between the U.S. Food and Drug Administration and Federal Trade Commission signals the FDA's commitment to addressing anti-competitive behavior in the biosimilar market, while recent draft guidance from the agency highlights considerations for companies developing promotional materials that involve reference products, say Kellie Combs and Deborah Cho of Ropes & Gray.

Prop 65 Chemical Labeling Litigation: Trends And Predictions

Product safety litigation brought under Proposition 65, California's chemical disclosure law, shows no signs of slowing down in the coming year — with short-form labels and manufacturers' responsibility for product warnings likely to be key areas of contention, says Anne Marie Ellis of Buchalter.

What Health Care FCA Trends Tell Us About The Year Ahead

The U.S. Department of Justice showed more initiative in directly bringing health care-related False Claims Act cases despite a decrease in qui tam filings last year, and as scrutiny of the industry continues to rise, several sectors deserve to be watched carefully this year, say attorneys at Epstein Becker.

Lawyers Can Build Trust Through The Spoken Word

As attorneys, we may prefer the precision of written communication, but a phone call or an in-person conversation builds trust by letting others see and hear our authentic selves, rather than something constructed or scripted, says mediator Sidney Kanazawa of ARC.

Fed. Circ. Instructive On Transitional Phrases In Patent Claims

Two recent Federal Circuit decisions construing Actavis' and Amgen's drug patent claims provide key guidance for practitioners on using transitional phrases to avoid rendering a claim indefinite or opening a it up to a prior art attack, say attorneys at Morgan Lewis.

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.