Expert Analysis

• FTC Orange Book Move Signals New Pharma Patent Scrutiny

  

  The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.

• AI Can Help Lawyers Overcome The Programming Barrier

  

  Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

• How Legal Teams Can Prep For Life Sciences' Tech Revolution

  

  The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

• Preparing Law Students For A New, AI-Assisted Legal World

  

  As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

• Series

  ESG Around The World: South Korea

  

  Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

• General Counsel Need Data Literacy To Keep Up With AI

  

  With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

• Trending At The PTAB: Administrative Procedure

  

  A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.

• Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits

  

  Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.

• Navigating Discovery Of Generative AI Information

  

  As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.

• FDA's Lab-Developed Test Rule May Bring Historic Challenges

  

  If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.

• Finding Focus: Strategies For Attorneys With ADHD

  

  Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.

• A Look At DOJ's New Nationwide Investment Fraud Approach

  

  Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.

• Earnout Contract Considerations After NC Good Faith Ruling

  

  The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.

• FDA's Off-Label Comms Guidance Is A Reluctant Step Forward

  

  The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.

• How Biden's AI Order Stacks Up Against Calif. And G7 Activity

  

  Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.