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Expert Analysis

• Questions Surround FDA's Orphan Drug Exclusivity Approach

  

  In light of a new U.S. Food and Drug Administration notice, which contrasts with an Eleventh Circuit ruling on orphan drug exclusivity, the exact scope of orphan drug exclusivity periods appears uncertain and companies may want to reconsider their strategies for requesting designations, say Jacqueline Berman and Nikita Bhojani at Morgan Lewis.

• Preparing For An Era Of Regulated Artificial Intelligence

  

  In light of developing regulatory activity aimed at governing the use of artificial intelligence, companies should implement best practices that focus on the fundamental principles that are driving regulators' actions, say attorneys at Troutman Pepper.

• Lessons On Prior Art From PTAB's Genetic Testing Decisions

  

  The Patent Trial and Appeal Board's recent finding that none of the challenged claims in LabCorp v. Ravgen were unpatentable shows that practitioners should avoid cherry-picking prior art references, and know what the art does and doesn't teach, say Jameson Gardner and Thomas Irving at Finnegan.

• Incorrect Inventorship On Patents Is A Tough Claim To Prove

  

  The Federal Circuit's recent decision to reverse and remand a district court's ruling that patents were invalid in Plastipak Packaging v. Premium Waters highlights the difficulties of sustaining claims of misjoinder or nonjoinder of inventors as a strategy to invalidate patents, says Andrew Berks at Gallet Dreyer.

• The Issues Shaping Labor Market Antitrust Litigation In 2023

  

  Questions about whether traditional antitrust analysis should apply to labor market abuses will continue to define litigation over agreements restricting employment this year, as courts grapple with the sufficiency of pleadings, parties' evidentiary burdens, affirmative defenses and jury instructions, say Manly Parks and Randy Kim at Duane Morris.

• How Ohio Software Ruling Implicates Crypto Insurance Claims

  

  The Ohio Supreme Court's recent decision in EMOI Services v. Owners Insurance, holding that software can never be physically damaged, has limited precedential value for property claims, but serious implications for cases involving loss or damage to intangible assets like cryptocurrency and non-fungible tokens, say Jane Warring and Shannon O’Malley at Zelle.

• NY Adult Survivors Act Look-Back: What Orgs Must Know

  

  With the look-back window for New York's Adult Survivors Act now open, survivors of past sexual abuse have a new opportunity to file civil claims — so organizations that could face litigation should take specific steps to ensure best practices both before and after lawsuits arise, say Michael Appelbaum and Christina Holdsworth at Goldberg Segalla.

• 7th Circ. Ruling Highlights Risks Of Foreign Debt Collateral

  

  The Seventh Circuit’s recent ruling in a retired surgeon’s bankruptcy case is a reminder for borrowers to be cognizant of where their creditors are located, and for creditors to be aware of the risks that accompany accepting additional collateral located in a foreign jurisdiction, says Mark Gensburg at Nelson Mullins.

• In Holmes' Sentencing, Judge Has Warning For All Companies

  

  In sentencing ex-Theranos CEO Elizabeth Holmes to 11 years in prison, a federal judge issued a scathing statement about the company’s culture of fraud — revealing an important lesson about how an organization’s core values can help mitigate compliance risk, say Scott Maberry and Joseph Jay at Sheppard Mullin.

• Potential Upheaval For FDA Regulation Of Stem Cell Clinics

  

  If upheld by the Ninth Circuit, a recent California federal court ruling that a stem cell clinic's products are not subject to the Federal Food, Drug and Cosmetic Act could fundamentally alter the U.S. Food and Drug Administration's ability to regulate stem cell therapies, say attorneys at Ropes & Gray.

• Top 10 Whistleblowing And Retaliation Events of 2022

  

  From huge whistleblower bounty awards to the U.S. Securities and Exchange Commission's renewed focus on employer restrictions and adoption of new whistleblower-friendly rules, 2022 saw highly impactful whistleblower and retaliation events that will have far-reaching impact, say attorneys at Proskauer.

• Florida's Medical Marijuana Industry: 2022 In Review

  

  2022 saw the medical marijuana market in Florida continue with several measured steps forward, bringing with it a host of new business opportunities and litigation challenges — and leaving open questions about adult-use legalization, says Richard Blau at GrayRobinson.

• Medical Malpractice Settlements Shouldn't Require NDAs

  

  Hospitals and insurance companies can go to great lengths to avoid accountability — as depicted in the recent Netflix film "The Good Nurse" — and nondisclosure agreements used to settle medical malpractice cases out of court leave patients without crucial information when seeking treatment, says Andrew Barovick at Sandra Radna.