Expert Analysis

• 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.

• What An NCAA Drug Test Change Could Mean For Cannabis

  

  If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.

• FDA's Lab-Developed Test Rule Faces High Hurdles

  

  The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.

• Justices Could Use Purdue To Resolve Related Circuit Split

  

  The U.S. Supreme Court will soon hear Harrington v. Purdue Pharma to determine the validity of nonconsensual third-party releases in bankruptcy, but justices should also take the opportunity to resolve a related circuit split over the constitutional authority of bankruptcy judges to issue final rulings on such releases, says Benjamin Feder at Kelley Drye.

• FTC's Health Co. Suit Indicates Agency's Private Equity Focus

  

  The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.

• Opinion

  'Lead Compound' Rule For Drug Patents Leads Courts Astray

  

  For several years, patent challengers in the chemical and pharmaceutical arts have faced an added impediment to invalidating a patent for obviousness — a "lead compound" rule for prior art that is legally wrong, contravenes several U.S. Supreme Court decisions and is antithetical to public policy, says Roy Wepner at Rutgers.