Life Sciences

Expert Analysis

• Q&A

  A Chat With Bryan Cave Innovation Chief Katie DeBord

  

  In this monthly series, Amanda Brady of Major Lindsey & Africa interviews management from top law firms about the increasingly competitive business environment. Here we feature Katie DeBord, chief innovation officer at Bryan Cave Leighton Paisner LLP.

• FDA Streamlines 510(k) Process, As Courts Reconsider It

  

  The U.S. Food and Drug Administration is expediting the Section 510(k) approval process for Class II medical devices, while courts are accepting the argument that 510(k) approval signifies safety and effectiveness — with implications for punitive damages awards, say Caitlin McHugh and Matthew Smith of Drinker Biddle & Reath LLP.

• When A Patent Disclosure Is Not A Disclosure

  

  ​The Federal Circuit has explained that patent descriptions do not require any particular form of disclosure.​ ​However, the court's recent decision in ​FWP IP v. Biogen point​s​ to a heightened scrutiny of descriptions when an applicant amends or adds new claims to cover a competitor’s activities, say Martin Pavane and Darren Mogil of Cozen O’Connor.

• Simple Secrets For Improving Your CLE

  

  With few cases going to trial, many attorneys keep their oral-presentation skills sharp by teaching continuing legal education programs. To avoid giving a CLE that falls flat and damages your reputation, you must fashion a thoughtful message, control its presentation, and nail the beginning and ending, says Daniel Karon of Karon LLC.

• It’s Time For Law Firms To Start Talking About Gen Z

  

  Since the oldest members of Generation Z aren’t even finished with law school yet, law firm management is in a unique position to prepare for their entrance into the legal workforce, says Eliza Stoker of Major Lindsey & Africa.

• Should Juries Try To Predict FDA Drug Labeling Decisions?

  

  The U.S. Supreme Court's review of Merck v. Albrecht promises to shape the way decisions of regulatory agencies — such as the U.S. Food and Drug Administration’s rejection of a drug manufacturer’s proposed label warning — can be interpreted by juries, say Alan Klein and Matthew Decker at Duane Morris LLP.

• A Post-Election Survey Of The Health Care Ecosystem

  

  Health care featured prominently in the 2018 midterm election campaign. Here, attorneys with Debevoise & Plimpton LLP offer thoughts on what the election results and a divided Congress mean for different sectors of the health care industry.

• Pharmaceutical Warnings: A Changing Landscape

  

  Pharmaceutical warnings and the way they are regulated and litigated are evolving. Brand-name manufacturers face failure-to-warn suits for generic versions of their products, while generic companies may soon have to update warnings on drugs for which there are no longer brand-name versions, say Chris Essig and Schuyler Ferguson of Winston & Strawn LLP.

• What To Expect From New Democratic Investigation Efforts

  

  The new Democratic House majority is expected to direct much of its attention to executive branch oversight and accountability. Companies and their legal counsel should be prepared for a dramatically changed collateral environment as investigations cover a wide range of topics, say attorneys at WilmerHale.

• Q&A

  Back To School: Yale's Linda Greenhouse Talks Journalism

  

  In this series featuring law school luminaries, Yale Law School lecturer and Pulitzer Prize-winning reporter Linda Greenhouse discusses her coverage of the U.S. Supreme Court, the conservatives' long game and trends in journalism.