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Life Sciences
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November 25, 2024
BREAKING: 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 Guardant Health after finding that rival medical test maker Natera falsely advertised its colorectal cancer assay 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.
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November 22, 2024
CooperSurgical Product Caused Embryo Loss, Couple Say
Connecticut-based medical device company CooperSurgical Inc. produced a defective culture media that led to the destruction of six embryos conceived through assisted reproductive technology, a California couple have claimed in a lawsuit that seeks an array of damages for negligence and an alleged delay in recalling the product.
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November 22, 2024
Mich. Justices Want To Know If 3M Water Challenge Is Moot
The Michigan Supreme Court ordered additional briefing Friday in 3M Co.'s challenge to regulations on PFAS in drinking water to address whether subsequent regulatory changes made 3M's lawsuit moot, echoing a focal point of last week's oral arguments in the case.
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November 22, 2024
Bondi Vowed Trump Payback. Ex-Colleagues Aren't Worried.
U.S. attorney general nominee Pam Bondi is an outspoken ally of President-elect Donald Trump and vowed during the campaign that his "prosecutors will be prosecuted," but people who've worked with her say she's well qualified to serve as the nation's top cop and downplayed concerns that she would politicize the U.S. Department of Justice.
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November 22, 2024
Vitamin Co. Must Freeze Owner Payouts Amid $1.4M Tax Fight
A Connecticut federal judge has granted the federal government a temporary restraining order in a $1.4 million tax fight with a vitamin company, barring distributions to the owners unless the company allocates 20% to the court's registry to help cover the potential liability.
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November 22, 2024
Walmart Class Attys In $123M Opioid Deal Seek $24.6M Fee
Three plaintiffs firms known for shareholder litigation are seeking $25 million in fees for their work on a $123 million settlement with Walmart in Delaware's Chancery Court, ending a suit that claimed oversight failures at the retail giant led to reckless opioid prescriptions and massive liabilities.
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November 22, 2024
Avante Health Parent Cleared To Sell For $72.5M In Ch. 11
A Delaware bankruptcy judge on Friday approved the $72.5 million sale of Jordan Health, the corporate parent of medical equipment company Avante Health, to an affiliate of Staple Street Capital after the debtor reached a settlement with unsecured creditors.
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November 22, 2024
Halozyme Pulls €2B Bid After Evotec Fails To Engage In Talks
California-based biopharmaceutical company Halozyme Therapeutics Inc. on Friday said it has withdrawn its €2 billion ($2.1 billion) proposal to acquire European biotechnology company Evotec SE, saying that Evotec's board made it clear it was not interested in a potential combination.
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November 22, 2024
MVP: Skadden's Graham Robinson
Graham Robinson of Skadden Arps Slate Meagher & Flom LLP represented Iveric Bio in its $5.9 billion sale to global pharmaceutical company Astellas Pharma Inc., earning him a spot among the 2024 Law360 Life Sciences MVPs.
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November 22, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen cash-strapped Thurrock Borough Council bring a £40 million ($50 million) negligence claim against 23 other local authorities over its solar investments from a not-for-profit local government body, AstraZeneca sue a fire safety company following a blaze at its Cambridge headquarters last year, and a director who was convicted in 2016 for corporate manslaughter face action by Manolete Partners. Here, Law360 looks at these and other new claims in the U.K.
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November 21, 2024
SEC Denied Civil Penalties Over Pot Pill Exec's 'Inexperience'
The SEC will score $86,000 in disgorgement and interest from a former executive of C3 International Inc. for falsely claiming the company's cannabis pill was projected to generate millions of dollars in revenue, but the court found the defendant's conduct did not warrant the civil penalty the agency requested.
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November 21, 2024
Boehringer Trial Over Zantac's Cancer Link Ends In Mistrial
A California state judge declared a mistrial Thursday, ending a monthslong trial over product liability claims by a bladder cancer survivor who alleges Boehringer Ingelheim Pharmaceuticals Inc. failed to disclose cancer risks associated with the company's Zantac heartburn medication, according to the plaintiff's counsel.
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November 21, 2024
SEC Seeks More Data On Nasdaq Plan To Speed Up Delistings
The U.S. Securities and Exchange Commission has postponed deciding on a Nasdaq proposal that would accelerate delistings of companies with low-priced stocks that take extended time to regain compliance or rely on reverse-stock splits to elevate their share prices, saying more data is needed before it takes action.
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November 21, 2024
Trump Selects Ex-Fla. AG Pam Bondi As New AG Pick
President-elect Donald Trump announced Thursday that he has selected Pam Bondi, a former attorney general of Florida, as his new pick for U.S. attorney general, just hours after former U.S. Rep. Matt Gaetz withdrew his name from consideration amid allegations of sexual misconduct and drug use.
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November 21, 2024
IP Atty Fights To Revive Allergan FCA Suit At 9th Circ.
A patent attorney urged the Ninth Circuit on Thursday to revive False Claims Act allegations against Allergan over dementia drug patents, arguing his client used his expertise to discover the patents were fraudulently issued to block generics and that these are the kinds of FCA cases the government welcomes from experts.
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November 21, 2024
In Tight Vote, Senate Panel OKs Bill To Set New PTAB Limits
The Senate Judiciary Committee on Thursday narrowly voted to advance a bill that would impose new restrictions on Patent Trial and Appeal Board challenges, with several members expressing concern that it could drive up the cost of prescription drugs.
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November 21, 2024
MVP: Fenwick's Douglas Cogen
Douglas Cogen of Fenwick & West LLP's life sciences practice guided cardiovascular device company Shockwave Medical through a record-breaking acquisition by Johnson & Johnson, while he simultaneously shepherded multiple biopharma companies through multibillion-dollar deals, earning him recognition as a 2024 Law360 Life Sciences MVPs.
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November 20, 2024
Musk, Ramaswamy Say High Court Rulings OK Federal Cuts
Billionaire Elon Musk and former presidential candidate Vivek Ramaswamy, President-elect Donald Trump's picks to lead a newly created "Department of Government Efficiency," on Wednesday said two recent U.S. Supreme Court rulings will give them the authority to cut off power to regulatory agencies and conduct massive federal layoffs.
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November 20, 2024
Ex-Pharma CEO Demands Legal Fees For SEC Probe
Cancer treatment development company Eagle Pharmaceuticals Inc.'s founder and ex-CEO told Delaware's Chancery Court Wednesday that he is entitled to legal fees he says the company owes him in connection with a U.S. Securities and Exchange Commission probe into the company's accounting practices, saying he continues to incur fees in addition to the $875,000 he has already requested.
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November 20, 2024
USPTO Unveils Patent Fee Hikes Set To Take Effect In January
The U.S. Patent and Trademark Office on Wednesday released a final rule that will increase many patent-related fees on Jan. 19, recalibrating some proposed hikes that had drawn criticism from attorneys and industry groups while leaving others intact.
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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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.
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In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling
When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.
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Marching In On Orange Book Drugs May Have Limited Effect
Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.