Expert Analysis

• 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.

• Reading Between The Lines Of HHS' National Lab Opinion

  

  The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.

• ITC Ban On Apple Watch Could Still Be Reversed

  

  The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.

• A Closer Look At Proposed HHS Research Misconduct Rule

  

  The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

• Incontinence Drug Ruling Offers Key Patent Drafting Lessons

  

  In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.

• Why Hemp-Synthesized Intoxicants Need Uniform Regs

  

  State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.

• Opinion

  Life Sciences Regulators Must Write Cloud-Specific Guidance

  

  As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.