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.

• 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.

• 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.

• Opinion

  USPTO Has A Chance To Correct Double-Patenting Doctrine

  

  Now that the issue of obviousness-type double patenting is front and center before the U.S. Patent and Trademark Office's Appeals Review Panel, the agency should put an end to the practice of rejecting earlier-expiring patents in favor of later-expiring ones, say attorneys at Orrick.

• Navigating Life Sciences Deals Amid Heightened Scrutiny

  

  With pricing reform initiatives, national security legislation and evolving trade policy currently contributing to meaningful uncertainty for life sciences companies, it is important to proactively structure deals to avoid downstream complications, say attorneys at Cooley.

• 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.

• When Trade Secret Litigation And Criminal Law Collide

  

  An increasing convergence of trade secret litigation and white collar defense, especially with several recent criminal prosecutions from the Justice Department, should prompt businesses and counsel to adapt within the overlapping landscapes, says Kenneth Notter at MoloLamken.

• Opinion

  PTAB Needs Reform To Protect Inventors From Larger Cos.

  

  The Promoting and Respecting Economically Vital American Innovation Leadership Act is necessary because it will impose additional requirements on patent validity challenges and prevent large corporations from taking advantage of the Patent Trial and Appeal Board to overwhelm small inventors with repeated litigation, says Eb Bright at ExploraMed Development.

• 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.

• Moderna Case Highlights Overlooked Hurdle In Biopharma IP

  

  The recent settlement of the patent litigation involving Moderna's COVID-19 vaccine in Delaware federal court shows that patent portfolios covering enabling platform technologies can create significant freedom-to-operate risk even when their owners are not direct competitors developing the therapeutic product, says Olga Berson at Thompson Coburn.