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Life Sciences
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November 27, 2024
Amid Claims Of Bias, DEA To Kick Off Historic Pot Hearing
The Drug Enforcement Administration's administrative law tribunal will hold a preliminary hearing Monday on the U.S. Department of Justice's proposal to relax restrictions on marijuana, kicking off a historic process that has already been marked by allegations of agency bias.
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November 27, 2024
Up Next At The High Court: Transgender Care, Holocaust Art
The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.
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November 27, 2024
Hospital Sued For Firing Tech Who Reported Lax Drugmaking
A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.
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November 27, 2024
Congressional Dems Urge Biden For More Cannabis Reform
Congressional Democrats are urging President Joe Biden to use his executive authority to take further action on marijuana reforms during the waning weeks of his administration.
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November 26, 2024
Trump Taps Bhattacharya For National Institutes Of Health
President-elect Donald Trump announced Tuesday that he has selected Dr. Jay Bhattacharya, a physician who opposed the use of lockdowns and mask mandates to contain the spread of COVID-19, to lead the National Institutes of Health.
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November 26, 2024
NIH Beats 4th Circ. Bid To Unmask COVID Researcher
National Institutes of Health on Tuesday defeated a circuit court appeal by a whistleblower organization which had sought to uncover the identity of a Wuhan University researcher who submitted sequencing data to an open-access NIH archive.
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November 26, 2024
Beasley Allen Escapes Sanctions For J&J Deposition No Show
A Texas bankruptcy judge on Tuesday laid ground rules for documents and communications to be shared in a messy discovery phase of the Chapter 11 of Red River Talc, Johnson & Johnson's latest liability spinoff, while also saying he wouldn't sanction a Beasley Allen attorney who didn't appear at a deposition last week.
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November 26, 2024
Gilead Gets $31.8M In Calif. Case Over Counterfeit HIV Drugs
Gilead Sciences Inc. has won nearly $32 million in a case involving a scheme to wrongfully repackage HIV treatments and sell them off as counterfeit Gilead products, a California federal judge has ruled.
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November 26, 2024
FDA Seeks Fines Against 18 Retailers Over E-Cig Sales
The U.S. Food and Drug Administration said on Tuesday that it is looking to issue fines against two "brick and mortar" stores and 16 online retailers who had been previously warned over sales of unlawful electronic cigarettes.
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November 26, 2024
Court Asked To Halt DEA's Pot Rescheduling Hearing
The Drug Enforcement Administration's plan to hold administrative hearings on a proposal to reclassify marijuana must be stopped, a psychedelics researcher argued, telling a Washington federal judge that the DEA is not giving a voice to small entity researchers and tribal stakeholders.
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November 26, 2024
Paul Hastings Seeks GenapSys CEO Depo In Malpractice Suit
Paul Hastings LLP has called on a California court to compel the founder and former CEO of GenapSys to sit for a deposition in a legal malpractice suit alleging that the firm improperly drafted board documents that invited an expensive lawsuit and led to the genetic sequencing company's "demise and liquidation."
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November 26, 2024
Navajo Nation's Diné College Awarded 2nd Medical Patent
The School of STEM at Diné College has secured a second patent for a device designed to measure and record various electric signals from the body's organs for diagnostic purposes, making it the only tribal college or university in the nation to receive such patents.
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November 26, 2024
Mexico Floats Retaliation Against New Trump Tariffs
Hours after President-elect Donald Trump threatened new tariffs on China, Canada and Mexico, Mexican President Claudia Sheinbaum signaled that her government would respond with levies of its own Tuesday, imploring Trump to take a more diplomatic approach.
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November 26, 2024
Ex-Regeneron Director Says FMLA Suit Should Stay In Court
A former Regeneron Pharmaceuticals director asked a New York federal court not to toss her suit, saying she put forward sufficient details to back up her accusations that she was fired for lodging a complaint about her supervisor's abuse and requesting a flexible schedule to care for her daughter.
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November 25, 2024
Trump Vows Tariffs For Canada, Mexico, China On Day One
President-elect Donald Trump announced on social media Monday that he will implement steep tariffs on America's allies Canada and Mexico, as well as China, immediately after taking the oath of office on Inauguration Day.
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November 25, 2024
Calif. Jury Delivers $35M Verdict In Eyedrop Trademark Row
A Tennessee pharmaceutical company convinced a California federal jury that a rival owes it about $35 million for infringing its trademarks on brands of post-surgical eyedrops.
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November 25, 2024
Calif. Panel Scraps Ex-Medical Supply Exec's $533K Fee Win
A California appeals court has found that an Orange County judge was wrong to order a medical supply company to pay out half a million dollars in legal fees to a former executive who a jury found took confidential files out the door with him.
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November 25, 2024
DEA And Anti-Pot Group Reject Accusations Of Collusion
The Drug Enforcement Administration and a leading anti-cannabis-legalization advocacy group on Monday each pushed back against allegations that they colluded with each other in the run-up to administrative law judge hearings on a proposal to loosen federal restrictions on pot.
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November 25, 2024
Medical Info. Co. Beats Junk Fax Suit Over Free E-Book Offer
A medical information company has once again defeated a long-running Telephone Consumer Protection suit over unsolicited faxes it sent in 2013, with a West Virginia federal judge ruling the plaintiffs produced no evidence that the company got paid when recipients responded to their faxes.
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November 25, 2024
Jury Finds Natera Owes Guardant $292.5M In False Ad Suit
A California federal jury on Monday awarded $292.5 million in actual and punitive damages to medical test maker Guardant Health after finding that its rival Natera falsely advertised its colorectal cancer test Signatera as superior to Guardant's competing product Reveal.
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November 25, 2024
Ex-Epstein Becker Healthcare Ace Joins Polsinelli Team
Polsinelli has added a former Epstein Becker Green partner to its healthcare litigation team as a shareholder, where he'll bring experience in managed care, payor disputes and intellectual property to the firm's Nashville, Tennessee office.
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November 25, 2024
MVP: Cooley's Lila Hope
Lila Hope of Cooley LLP shepherded SystImmune Inc.'s $8.4 billion collaboration with Bristol Myers Squibb Co. and advised Foreseen Biotechnology on its $1 billion licensing agreement with Ipsen, earning her a spot among the 2024 Law360 Life Sciences MVPs.
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November 22, 2024
Trump Makes Picks For FDA, CDC And Surgeon General
President-elect Donald Trump on Friday revealed his nominations for several health agencies, picking Johns Hopkins surgeon and professor Dr. Marty Makary for Food and Drug Administration commissioner, former Rep. Dave Weldon, R-Fla., as the Centers for Disease Control and Prevention director, and Fox News contributor Dr. Janette Nesheiwat for surgeon general.
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November 22, 2024
Natera's Conduct 'Despicable,' Guardant Says As Trial Wraps
Guardant urged a California federal jury at the close of its false advertising trial Friday to make rival Natera pay it hundreds of millions of dollars, saying the competitor's misrepresentation of the companies' competing cancer detection tests was "despicable," while Natera countered it was Guardant that used deceptive marketing.
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November 22, 2024
Pam Bondi's 'Greatest Hits' As Florida Attorney General
In her eight years as attorney general of Florida, Pam Bondi — who has been tapped by President-elect Donald Trump as attorney general — took on pill mills and telemarketing scams targeting the state's large elderly population, while also leading GOP state efforts to battle the Obama administration.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.
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9th Circ.'s High Bar May Limit Keyword Confusion TM Claims
A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.
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Trump Patent Policy May Be Headed In Unexpected Direction
While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.
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What Trump's Next Term May Mean For Biz Immigration
Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.
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Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons
As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.
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Series
Circus Arts Make Me A Better Lawyer
Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.
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How AstraZeneca Ruling Could Change Dosage Patent Claims
If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.
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Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks
A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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How Patent Landscape Analysis Drives Business Growth
Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.