Expert Analysis

• Considerations And Calculations For DOJ Clawback Program

  

  The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.

• SEC's Life Sciences Actions Utilize Novel Tools And Theories

  

  Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

• What Case Trends Reveal About Life Sciences Results At ITC

  

  A look at recent U.S. International Trade Commission case data shows that pharmaceuticals, medical devices and other life sciences products constitute a growing share of the technologies involved in Section 337 investigations, with overwhelmingly positive results for companies seeking to protect their IP rights from foreign competitors, say Brian Busey and Daniel Muino at MoFo.

• Series

  ESG Around The World: Japan

  

  Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

• How And Why Your Firm Should Implement Fixed-Fee Billing

  

  Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• Potential Broader Effects Of FDA's Lab-Developed Test Rule

  

  Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

• Opinion

  Judicial Independence Needs Defense Amid Political Threats

  

  Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

• 2 New Ways FDA Is Changing Lab-Developed Test Regulation

  

  The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

• FDI Considerations For UK Venture Capital Transactions

  

  With the U.K. National Security and Investment Act highlighting foreign direct investment matters for venture capital transactions, investors dealing with companies connected to the U.K. should be alive to how the act's requirements can affect deal timelines, structures and terms, say lawyers at Covington.

• How Life Sciences Cos. Can Prevent Securities Class Actions

  

  Though the overall volume of securities fraud class actions has dipped in the last couple of years, life sciences companies remain a particularly popular target for these filings and should employ best practices to minimize risk, say Joni Jacobsen and Angela Liu at Dechert.

• How Law Firms Can Use Account-Based Marketing Strategies

  

  Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

• 11 Ways Senate Bill Would Alter PTAB Practice

  

  Recently proposed legislation, the PREVAIL Act, would change post-grant practice before the U.S. Patent Trial and Appeal Board in several key ways including inter partes review, post-grant review and ex parte reexamination practice, say Jeffrey Shneidman and Jacqueline Tio at Fish & Richardson.

• Navigating Over-The-Counter Product Ads After FTC Warning

  

  Attorneys at Hunton examine advertising substantiation requirements under both the Federal Trade Commission Act and Lanham Act, following recent FTC letters informing hundreds of companies that over-the-counter product marketing claims must be corroborated by scientific evidence.

• A Reminder For Drug Cos. To Confirm Orange Book Listings

  

  A recent policy statement from the Federal Trade Commission highlights the legal danger that pharmaceutical companies can face for improperly listing patents in the U.S. Food and Drug Administration's Orange Book, which is also an issue in the context of Hatch-Waxman litigation, say attorneys at Kirkland.

• Strategic Succession Planning At Law Firms Is Crucial

  

  Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.