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Expert Analysis

• State, Federal Disconnect Sows Confusion For CBD Industry

  

  The U.S. Food and Drug Administration’s renewed focus on CBD-infused foods, and its recent announcement that it would not develop rules for hemp-derived CBD, exposes a divide between state and federal regulation, resulting in market confusion that will need to be resolved by Congress, say attorneys at the Law Offices of Omar Figueroa.

• Fielding Remote Work Accommodation Requests Post-COVID

  

  The Eighth Circuit's recent decision in Mobley v. St. Luke's may indicate how a court will analyze whether remote work is a reasonable accommodation under the Americans with Disabilities Act in an instance where an employee successfully performed work remotely during the pandemic, providing a road map for employers, says Kenneth Winkler at Berman Fink.

• Texas' Medical Cannabis Program May Soon Be Sittin' Pretty

  

  A number of recently filed bills in Texas signal serious momentum for the state’s anemic medical cannabis program, and though its precise future is still hazy, a robust industry in the Lone Star State would have a profound impact on the national market, say Slates Veazey and Whitt Steineker at Bradley Arant.

• The Terms Every Monitorship Agreement Should Include

  

  Little of the recent discussion around corporate compliance monitorships has focused on how they should be structured, but drafting a clear and comprehensive agreement at the outset is crucial to maximizing a monitorship’s success, says Scott Garland at Affiliated Monitors.

• Courts Must Apply Correct Causal Standard In Kickback Cases

  

  Despite clear statutory language and supporting legislative history, the government and some courts have been incorrectly interpreting the Anti-Kickback Statute's "resulting from" language, which could lead to detrimental effects for innocent patients and physicians if not corrected, say attorneys at Covington.

• Higher Ed Can't Recycle Cannabis Policies For Psychedelics

  

  As efforts to legalize and decriminalize psychedelic substances proliferate, higher education must recognize the nuanced legal issues that distinguish these drugs from cannabis, and consider a unique approach to the possession, use and research of psychedelics on campus, say attorneys at Saul Ewing.

• Issues To Watch In Fla.'s Telehealth Genetic Counseling Bills

  

  Two recently introduced Florida bills would expand the state’s telehealth statute to include genetic counseling services, and though they currently don’t have opposition, they may have to overcome data privacy and out-of-state licensing concerns, say Erika Alba and Jacqueline Acosta at Foley & Lardner.

• 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.