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Expert Analysis

• Vanda Ruling Opens Door For Contesting FDA Drug Denials

  

  The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration creates new opportunities and considerations for drug companies navigating the FDA approval process, establishing that litigation is an option when the FDA refuses to hold a hearing, say attorneys at Polsinelli.

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  Law School's Missed Lessons: Mastering Time Management

  

  Law students typically have weeks or months to prepare for any given deadline, but the unpredictability of practicing in the real world means that lawyers must become time-management pros, ready to adapt to scheduling conflicts and unexpected assignments at any given moment, says David Thomas at Honigman.

• Rare Del. Oversight Ruling Sends Governance Wake-Up Call

  

  An unusual ruling from the Delaware Court of Chancery recently allowed Caremark oversight claims to proceed against former executives of a company previously known as Teligent, sending a clear reminder that boards and officers must actively monitor and document oversight efforts when addressing mission-critical risks, say attorneys at WilmerHale.

• How Hyperlinks Are Changing E-Discovery Responsibilities

  

  A recent e-discovery dispute over hyperlinked data in Hubbard v. Crow shows how courts have increasingly broadened the definition of control to account for cloud-based evidence, and why organizations must rethink preservation practices to avoid spoliation risks, says Bree Murphy at Exterro.

• Pharma Copay Programs Raise Complex Economic Questions

  

  The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.

• State False Claims Acts Can Help Curb Opioid Fund Fraud

  

  State versions of the federal False Claims Act can play an important role in policing the misuse of opioid settlement funds, taking a cue from the U.S. Department of Justice’s handling of federal fraud cases involving pandemic relief funds, says Kenneth Levine at Stone & Magnanini.

• Beaming Up Lessons From William Shatner's Failed Patent Bid

  

  In a tale that boldly goes where few celebrity inventors have gone before, William Shatner's unsuccessful attempt to patent a smartphone file organization system offers insights about potential pitfalls to avoid in patent applications, say attorneys at King & Spalding.

• The Pros And Cons Of Levying Value-Based Fees On Patents

  

  The potential for a recurring, value-based maintenance fee on patents, while offering some benefits, raises several complications, including that it would likely exceed the U.S. Patent and Trademark Office's statutory authority and reduce research and development activities in the U.S., says Sandip Patel at Marshall Gerstein.

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  Writing Musicals Makes Me A Better Lawyer

  

  My experiences with writing musicals and practicing law have shown that the building blocks for both endeavors are one and the same, because drama is necessary for the law to exist, says Addison O’Donnell at LOIS Law.

• Between The Lines Of EPO's Adoption Of Color Drawings

  

  The European Patent Office's decision to accept patent drawings in color starting in October may enhance clarity in technical disclosures and streamline the examination process, and could also enable new patent filing strategies for international applicants, say attorneys at Miller Canfield.

• What Prop 65 Ruling Means For Cosmetics, Personal Care Biz

  

  A California federal court's recent decision on Proposition 65 warnings is good news for companies in the cosmetics and personal care space, as it will relieve businesses of the need to apply such warnings to products containing titanium dioxide and likely stop a wave of pending failure-to-warn litigation, say attorneys at Morgan Lewis.

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  Adapting To Private Practice: From Va. AUSA To Mid-Law

  

  Returning to the firm where I began my career after seven years as an assistant U.S. attorney in Virginia has been complex, nuanced and rewarding, and I’ve learned that the pursuit of justice remains the constant, even as the mindset and client change, says Kristin Johnson at Woods Rogers.

• 2 Fed. Circ. Rulings Underscore Patent Prosecution Pitfalls

  

  Two recent patent decisions from the Federal Circuit, overturning significant judgments, serve as reminders that claim modifications and cancellations may have substantive effects on the scope of other claims, and that arguments distinguishing prior art and characterizing claims may also limit claim scope, say attorneys at Morgan Lewis.

• Rebutting Price Impact In Securities Class Actions

  

  Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.

• 7 Document Review Concepts New Attorneys Need To Know

  

  For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.