Expert Analysis

• 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.

• Series

  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.

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.