Expert Analysis

• 3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

  

  The U.S. Food and Drug Administration recently published draft guidance documents that sketch the clearest picture yet of the evolving regulatory framework for cell and gene therapies, reflecting an agency that is increasingly comfortable with flexible, science-driven approaches that extend beyond clinical trial models, say attorneys at MoFo.

• How Cos. Should Prepare For Prop 65 Listing Of Bisphenols

  

  California regulators are moving toward classifying all p,p'-bisphenol chemicals as causing reproductive toxicity under Proposition 65, which could require warning notices for a vast range of consumer and industrial products, and open the floodgates to private litigation — so companies should proactively review their suppy chains, says Gregory Berlin at Alston & Bird.

• Rule Amendments Pave Path For A Privilege Claim 'Offensive'

  

  Litigators should consider leveraging forthcoming amendments to the Federal Rules of Civil Procedure, which will require early negotiations of privilege-related discovery claims, by taking an offensive posture toward privilege logs at the outset of discovery, says David Ben-Meir at Ben-Meir Law.

• IP Ownership Risk Grows In Booming Cancer Drug Market

  

  The ownership of intellectual property has become strategically decisive in deals involving valuable cancer therapeutics known as ADCs, as highlighted by the recent Takeda-Innovent deal, with the commercial value of a license resting on the integrity and defensibility of the underlying technology, say attorneys at Loeb & Loeb.

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  My Miniature Livestock Farm Makes Me A Better Lawyer

  

  Raising miniature livestock on my farm, where I am fully present with the animals, is an almost meditative time that allows me to return to work invigorated, ready to juggle numerous responsibilities and motivated to tackle hard issues in new ways, says Ted Kobus at BakerHostetler.

• Surveying The Healthcare Policy Landscape Post-Shutdown

  

  With last week's agreement to reopen the federal government, at least through the end of January, key healthcare legislation that has been in limbo since a December 2024 spending bill fell apart may recapture the attention of Congress, say attorneys at Faegre Drinker.

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• How Litigating Antitrust Fix Helped GTCR Prevail In Court

  

  An Illinois federal judge's recent denial of the Federal Trade Commission's injunction request in the GTCR acquisition of Surmodics joins a developing series of cases in which deal parties have prevailed against government antitrust challenges by proposing a post-complaint fix and litigating the as-amended deal, say attorneys at Paul Weiss.

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  Building With Lego Makes Me A Better Lawyer

  

  Building with Lego has taught me to follow directions and adapt to unexpected challenges, and in pairing discipline with imagination, allows me to stay grounded while finding new ways to make complex deals come together, says Paul Levin at Venable.

• The Rise Of Trade Secret Specificity As A Jury Question

  

  Recent federal appellate court decisions have clarified that determining sufficient particularity under the Defend Trade Secrets Act is a question of fact and will likely become a standard jury question, highlighting the need for appropriate jury instructions that explicitly address the issue, says Amy Candido at Simpson Thacher.

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  Law School's Missed Lessons: Networking 101

  

  Cultivating a network isn't part of the law school curriculum, but learning the soft skills needed to do so may be the key to establishing a solid professional reputation, nurturing client relationships and building business, says Sharon Crane at Practising Law Institute.

• Defeating Estoppel-Based Claims In Legal Malpractice Actions

  

  State supreme court cases from recent years have addressed whether positions taken by attorneys in an underlying lawsuit can be used against them in a subsequent legal malpractice action, providing a foundation to defeat ex-clients’ estoppel claims, says Christopher Blazejewski at Sherin and Lodgen.

• Trade Secret Rulings Reveal The Cost Of Poor Preparation

  

  Two recent federal appellate decisions show that companies must be prepared to prove their trade secrets with specificity, highlighting how an asset management program that identifies key confidential information before litigation arises can provide the clarity and documentation that courts increasingly require, say attorneys at Mintz.