Expert Analysis

• The Road Ahead For Drug Development In The US

  

  Against the backdrop of drug manufacturers potentially looking to move development efforts overseas, the U.S. Food and Drug Administration's latest guidance on new approach methodologies signals the FDA is likely to be receptive to industry innovation that makes U.S.-based drug development faster or less expensive, creating opportunities and compliance risks for tech companies, say attorneys at Morgan Lewis.

• FDA's Crackdown On Drug Ads Conflicts With Precedent

  

  Recent U.S. Food and Drug Administration warning letters to drug manufacturers targeting direct-to-consumer advertising raise significant constitutional concerns, and directly clash with prior FDA stances, say attorneys at Sidley.

• Series

  Ultramarathons Make Me A Better Lawyer

  

  Completing a 100-mile ultramarathon was tougher, more humbling and more rewarding than I ever imagined, and the experience highlighted how long-distance running has sharpened my ability to adapt to the evolving nature of antitrust law and strengthened my resolve to handle demanding, unforeseen challenges, says Dan Oakes at Axinn.

• Determining When Engineered Biologics May Be Patentable

  

  The Federal Circuit's recent decision in Regenxbio v. Sarepta, concluding that engineered cells with DNA from different organisms are not patent-ineligible natural phenomena, raises questions surrounding what framework courts will use to evaluate the patent eligibility of engineered biologics moving forward, says Robert Frederickson at Goodwin.

• Informal Announcements Are Reshaping FDA Regulations

  

  The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal channels to announce major policy changes reflects a valid desire to modernize and accelerate regulatory efforts, but it could lead to diminished transparency, increased industry burden and reduced policy durability, says Rachel Turow at Skadden.

• Berk May Spur More Pushback Against Med Mal Gatekeeping

  

  The U.S. Supreme Court’s recent decision in Berk v. Choy may appear to be a run-of-the-mill reminder that a federal procedural rule trumps its state counterpart, but it could inspire more challenges to state-created prerequisites to filing medical malpractice lawsuits, say attorneys at Decof Mega.

• Verdicts Signal Product Liability's Expansion To Digital Realm

  

  Last week's landmark verdict in K.G.M. v. Meta Platforms Inc., along with other recent verdicts that apply product liability theories to online services that rely on algorithmic design and user engagement features, make it clear that companies must evaluate digital product design through a litigation lens, say attorneys at Arnold & Porter.

• Getting The Most Out Of Learning And Development Programs

  Excerpt from Practical Guidance

  

  Junior associates can better develop the legal, business and interpersonal skills they need for long-term success by approaching their firms’ learning and development programs armed with five tips for getting the most out of these resources, says Lauren Hakala at Reed Smith.

• OhioHealth Suit Signals Higher Antitrust Heat On Hospitals

  

  The recent antitrust lawsuit against OhioHealth by the U.S. Justice Department and Ohio attorney general shows that federal and state enforcers are closely examining the competition issues in the healthcare sector, including restrictive contracts and antisteering practices, say attorneys at Freshfields.

• A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

  

  The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for potentially exposing and entrenching the Federal Circuit's movement away from its previous framework for identifying obvious noninfringement cases, says Nicholas Nowak at Nowak IP Group.

• Del. Blackbaud Ruling Signals A New Era For Cyberinsurance

  

  The recent Delaware Supreme Court ruling in Travelers v. Blackbaud shows that cyberinsurance is moving into a second maturity phase, in which insurers will increasingly attempt to recover their payments from vendors and insureds will face new pressure to justify cyber incident reimbursements, say Steven Teppler at Mandelbaum Barrett and Jade Davis at Shumaker.

• Opinion

  AI Presents A Make-Or-Break Moment For Outside Counsel

  

  The rapid adoption of artificial intelligence by corporate legal departments is forcing a long-overdue reset of the relationship between inside and outside counsel, and introducing a significant opportunity to shed frustrating inefficiencies and strengthen collaboration for firms willing to embrace the shift, says Intel Chief Legal Officer April Miller Boise.

• DOJ Actions Suggest Expansion Of Healthcare Enforcement

  

  Recent actions by the U.S. Department of Justice and U.S. Food and Drug Administration suggest that federal healthcare enforcement efforts are moving away from traditional program-based fraud and toward cases centered on product integrity, regulatory transparency and telehealth marketing, effectively widening the government's enforcement playbook, say attorneys at MoFo.

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  Watching Hallmark Movies Makes Me A Better Lawyer

  

  I realize you may be judging me for watching, and actually enjoying, Hallmark Channel movies, but the escapism and storylines actually demonstrate qualities and actions that lead to an efficient, productive and positive legal practice, says Karen Ross at Tucker Ellis.

• New Orphan Drug Law Provides A Key Fix For Pharma Cos.

  

  The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-standing interpretation of "same disease or condition," related to orphan drug exclusivity, resolving years of regulatory uncertainty and litigation that have discouraged rare disease research, say attorneys at Spencer Fane.