Expert Analysis

• Managing ANDA Venue Issues As Del. And NJ Filings Rise

  

  Delaware and New Jersey have prevailed as the primary forum for pharmaceutical litigation as more generic companies file abbreviated new drug applications, but this venue scheme presents traps for the unwary, and legislation may still be necessary to ensure fairness and predictability, say Timothy Cook and Kevin Yurkerwich at WilmerHale.

• Series

  Writing Thriller Novels Makes Me A Better Lawyer

  

  Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

• What Lawyers Must Know About Calif. State Bar's AI Guidance

  

  Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.

• Industry Must Elevate Native American Women Attys' Stories

  

  The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.

• The Fed. Circ. In Nov.: Factual Support And Appellate Standing

  The Federal Circuit's recent Allgenesis Biotherapeutics v. Cloud Break Therapeutics decision shows that appellate standing requires specific factual support, underscoring the necessary requirements for a patent challenger in an appeal from an inter partes review at the U.S. Patent and Trademark Office, say Jeremiah Helm and Sean Murray at Knobbe Martens.

• White House Activity Is A Band-Aid For Regulating AI In Health

  

  In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

• Understanding Discovery Obligations In Era Of Generative AI

  Excerpt from Practical Guidance

  

  Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.

• Kochava Ruling May Hint At Next Privacy Class Action Wave

  

  The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.

• Forecasting The Impact Of High Court Debit Card Rule Case

  

  John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.

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  ESG Around The World: Mexico

  

  ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

• Opinion

  FDA And Companies Must Move Quickly On Drug Recalls

  

  When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.

• The Case For Post-Bar Clerk Training Programs At Law Firms

  

  In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

• Opinion

  A Telecom Attorney's Defense Of The Chevron Doctrine

  

  The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.

• What's At Stake In Bystolic 'Side Deals' Litigation

  

  In re: Bystolic Antitrust Litigation, which has oral argument set for next month, will likely shed light on how the U.S. Court of Appeals for the Second Circuit views side deals, and could create a circuit split in pleading standards for reverse payment cases, say attorneys at Axinn.

• 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

  

  Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.