FDA Moves Leave Peptides In A Legal Gray Zone

While the U.S. Food and Drug Administration has taken a concrete step forward on reclassifying certain peptides, the practical consequence of their interim status cannot be overstated — these substances are no longer designated as posing a significant safety risk, but they have not been affirmatively authorized for compounding, say attorneys at Sheppard.

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Bass Fishing Makes Me A Better Lawyer

Landing a trophy striped bass and closing a big deal both require cultivating the patience to finesse — not force — your way to desired outcomes, changing course when your old approach isn’t working and learning from the ones that got away, says Jon Ruiss at Alston & Bird.

How Reincorporating In Texas May Alter Earnout Disputes

While the DExit debate has focused on shareholder suits, far less attention has been paid to what reincorporating in Texas means for M&A disputes, making it particularly important to understand the nuances between Delaware and Texas earnout jurisprudence, say attorneys at Selendy Gay.

Coordinating Life Sciences IP Strategies In The US And EU

As postgrant practice for life sciences patents is restructured in the U.S. and European Union simultaneously, patent owners will need to implement transatlantic coordination that treats international proceedings as components of a single intellectual property risk architecture, says Paul Calvo at Sterne Kessler.

What Durnell Ruling Means For Mo. Roundup Settlement

While the U.S. Supreme Court’s recent ruling in Monsanto v. Durnell forecloses the failure-to-warn theory that carried most of the claims against Monsanto in a pending class action in Missouri state court, it leaves untouched the question of whether the class was assembled merely to contain the defendant's liability, says attorney Gregg Goldfarb.

Why Biotech Cos. Need Litigation Plans Before Bad News

Biotech companies should take proactive steps to respond to the growing trend of securities litigation filed against them, due to the inherently uncertain nature of their business models and heightened scrutiny of clinical trial disclosures, regulatory communications and investor-facing statements, says Wesley Horton at FBFK.

10 Years, 150 Cases: The Rise And Fall Of Post-Halo Damages

When the U.S. Supreme Court decided Halo v. Pulse in 2016, patent practitioners predicted that enhanced damages would become easier to win, but analysis of every contested district court ruling on a motion for enhanced damages in the last 10 years shows that courts have shown increasing restraint, say attorneys at Reichman Jorgensen.

Legal Risks Of Using AI To Screen Psychedelic Trial Patients

Though using artificial intelligence to preemptively identify drug trial participants likely to experience placebo effects could produce clearer research results, sponsors will need to be ready for the new legal questions these methods raise about informed consent, accountability for algorithmically derived criteria, and potential bias in data training sets, says Kimberly Chew at Husch Blackwell.

After Durnell, Connecting Science And Causation Will Be Key

The U.S. Supreme Court's June 25 decision in Monsanto v. Durnell narrowed label-based failure-to-warn claims — meaning that going forward, viable theories will depend even more on whether experts can reliably connect scientific evidence to the causal proposition the law requires, says Alex Smolak at Weill Cornell Medicine-Qatar.

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Choral Singing Makes Me A Better Lawyer

Singing in the New York City Bar Chorus — a hobby partly inspired by the late U.S. District Judge Richard Owen, who infused my clerkship year with opera music — has improved my legal career by refining my abilities to listen, exude confidence and develop emotional intelligence, says Bonnie Baker at Friedman Kaplan.

Attorney Mental Health Is An Ethical Obligation In The AI Era

As attorneys cope with the increasing unpredictability that artificial intelligence and constant policy changes have created, particularly in practice areas where they carry the emotional weight of clients’ most consequential life events, otherwise soft discussions about self-care are a matter of professional competence, says attorney Jack Jrada.

The Case For Using Final-Offer Damages Forms In IP Suits

Recent Federal Circuit decisions, such as Ollnova v. Ecobee, that scrutinize verdict forms in patent infringement disputes potentially render the final-offer damages selection procedure more attractive, though it should not be seen as a replacement for patent damages doctrine, says Brandon Theiss at Addy Hart.

Key Tips For Patenting Antibody-Drug Conjugate Inventions

Recent decisions highlight the significant challenges that can arise when patenting antibody-drug conjugates, which require strategic considerations for satisfying heightened written description and enablement requirements, says Xiaoban Xin at FisherBroyles.

$885M IBS Drug Verdict Tests Pay-For-Delay Limits

The outcome in the Amitiza Antitrust Litigation is significant because it is the first jury trial win for private antitrust plaintiffs in a suit challenging a patent settlement reverse payment since the U.S. Supreme Court adopted the rule-of-reason legal framework in 2013, offering a blueprint for pay-for-delay claims, say attorneys at Katten.

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Power To The Paralegals: Burnout As A Structural Problem

Law firm leadership can best retain their paralegals not by encouraging self-care, but by seeking top-down structural solutions for the quiet proliferation of responsibilities and the vicarious exposure to client trauma that particularly drive burnout in this vital role, says Erika Sneeringer at Brockstedt Mandalas.