Expert Analysis

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• How Litigating Antitrust Fix Helped GTCR Prevail In Court

  

  An Illinois federal judge's recent denial of the Federal Trade Commission's injunction request in the GTCR acquisition of Surmodics joins a developing series of cases in which deal parties have prevailed against government antitrust challenges by proposing a post-complaint fix and litigating the as-amended deal, say attorneys at Paul Weiss.

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  Building With Lego Makes Me A Better Lawyer

  

  Building with Lego has taught me to follow directions and adapt to unexpected challenges, and in pairing discipline with imagination, allows me to stay grounded while finding new ways to make complex deals come together, says Paul Levin at Venable.

• The Rise Of Trade Secret Specificity As A Jury Question

  

  Recent federal appellate court decisions have clarified that determining sufficient particularity under the Defend Trade Secrets Act is a question of fact and will likely become a standard jury question, highlighting the need for appropriate jury instructions that explicitly address the issue, says Amy Candido at Simpson Thacher.

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  Law School's Missed Lessons: Networking 101

  

  Cultivating a network isn't part of the law school curriculum, but learning the soft skills needed to do so may be the key to establishing a solid professional reputation, nurturing client relationships and building business, says Sharon Crane at Practising Law Institute.

• Defeating Estoppel-Based Claims In Legal Malpractice Actions

  

  State supreme court cases from recent years have addressed whether positions taken by attorneys in an underlying lawsuit can be used against them in a subsequent legal malpractice action, providing a foundation to defeat ex-clients’ estoppel claims, says Christopher Blazejewski at Sherin and Lodgen.

• Trade Secret Rulings Reveal The Cost Of Poor Preparation

  

  Two recent federal appellate decisions show that companies must be prepared to prove their trade secrets with specificity, highlighting how an asset management program that identifies key confidential information before litigation arises can provide the clarity and documentation that courts increasingly require, say attorneys at Mintz.

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  The Biz Court Digest: How It Works In Massachusetts

  

  Since its founding in 2000, the Massachusetts Business Litigation Session's expertise, procedural flexibility and litigant-friendly case management practices have contributed to the development of a robust body of commercial jurisprudence, say James Donnelly at Mirick O’Connell, Felicia Ellsworth at WilmerHale and Lisa Wood at Foley Hoag.

• Why Appellees Should Write Their Answering Brief First

  

  Though counterintuitive, appellees should consider writing their answering briefs before they’ve ever seen their opponent’s opening brief, as this practice confers numerous benefits related to argument structure, time pressures and workflow, says Joshua Sohn at the U.S. Department of Justice.

• Navigating DEA Quotas: Key To Psychedelics Industry Growth

  

  As new compounds like DOI enter the Schedule I landscape, manufacturers who anticipate U.S. Drug Enforcement Administration quota regulations, and build quota management into their broader strategy, will be best equipped to meet the growing demand, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega.

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  Mindfulness Meditation Makes Me A Better Lawyer

  

  Mindful meditation enables me to drop the ego, and in helping me to keep sight of what’s important, permits me to learn from the other side and become a reliable counselor, says Roy Wyman at Bass Berry.

• Growth, Harmonization In Focus As Hague System Turns 100

  

  One hundred years after its establishment, the Hague System has grown into an important pillar of international design protection, offering a promising path toward even greater harmonization in design law as its geographic reach continues to expand, say attorneys at Sterne Kessler.

• Lessons From 7th Circ. Decision Affirming $183M FCA Verdict

  

  The Seventh Circuit's decision to uphold a $183 million False Claims Act award against Eli Lilly engages substantively with recurring materiality and scienter questions and provides insights into appellate review of complex trial court judgments, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Kimberly Friday at Osborn Maledon.