Expert Analysis

• Opinion

  USPTO's Proposed Disclaimer Rule Would Harm Inventors

  

  The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.

• Series

  Being An EMT Makes Me A Better Lawyer

  

  While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.

• Mitigating Incarceration's Impacts On Foreign Nationals

  

  Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.

• Contract Disputes Recap: Saying What Needs To Be Said

  

  Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.

• Lessons On Challenging Class Plaintiffs' Expert Testimony

  

  In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.

• Exploring An Alternative Model Of Litigation Finance

  

  A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.

• Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift

  

  A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.

• Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors

  

  Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.

• Series

  Teaching Yoga Makes Me A Better Lawyer

  

  Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.

• How Clinical Trials Affect Patentability In US And Europe

  

  A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.

• A Vision For Economic Clerkships In The Legal System

  

  As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.

• Opinion

  State-Regulated Cannabis Can Thrive Without Section 280E

  

  Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.

• Key Takeaways From FDA Final Rule On Lab-Developed Tests

  

  Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

• Assessing HHS' Stance On Rare Disease Patient Assistance

  

  The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

• Opinion

  Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

  

  The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.