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Life Sciences
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March 11, 2025
Ex-J&J Atty Says She Was Fired For Making Ethics Complaint
A former in-house data privacy attorney for Johnson & Johnson has sued the company for discrimination in New Jersey federal court, alleging that she was passed over for a promotion based on her Latina ethnicity and fired for reporting unethical behavior by the attorney who got the job.
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March 11, 2025
White House Names Ex-Goldman Sachs Atty To Lead USPTO
U.S. President Donald Trump has nominated John Squires, Goldman Sachs' former longtime chief intellectual property counsel, to serve as the next U.S. Patent and Trademark Office director.
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March 10, 2025
Illinois Judge Floats Sanctions In Akorn Mootness Fee Fight
An Illinois federal judge signaled Tuesday that he was open to sanctions including a mandatory violation disclosure against plaintiffs' counsel as he continues navigating a challenge to so-called mootness fees paid to settle and dismiss allegedly baseless Akorn Inc. merger disclosure suits.
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March 10, 2025
Amgen, Fresenius Settle Osteoporosis Drug Patent Dispute
Amgen Inc. and Fresenius Kabi USA have reached an agreement resolving Amgen's allegations that Fresenius infringed a long list of patents covering drugs for treating osteoporosis and preventing bone problems, according to an order issued Friday in New Jersey federal court.
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March 10, 2025
Masimo Founder Urges Toss Of 'Empty Voting' Suit
The founder of Masimo Corp. has urged a New York federal court to permanently toss the medical technology company's suit alleging he manipulated a shareholder vote, arguing that the suit fails to state a plausible claim under the Exchange Act.
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March 10, 2025
Calif. Pharma Exec Pleads Guilty To Insider Trading
A California medical doctor has pled guilty to insider trading in the securities of biopharmaceutical company Acadia Pharmaceuticals Inc. while serving on Acadia's drug safety team, admitting to trading on confidential information that helped him avoid $1.3 million in losses.
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March 10, 2025
DOJ Wants In On Invisalign Monopoly Arguments At 9th Circ.
The U.S. Department of Justice wants to be there when orthodontists and consumers who purchased clear teeth aligners face off with the company behind Invisalign at the Ninth Circuit next month, so it can tell the appellate judges where the lower court went wrong in killing their monopoly suits.
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March 10, 2025
GAO Says NIH Treated Bidders Disparately On $20M IT Deal
The U.S. Government Accountability Office has sustained a protest over a $19.9 million National Institutes of Health software development task order, finding the NIH unreasonably treated similar aspects of the protester's and awardee's bids differently.
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March 10, 2025
CBD Co. Launches More Patent Suits Over Topical Cream
CBD company Metronome LLC has filed another pair of suits in Delaware federal court alleging competitors are infringing its patent with a topical pain relief cream that uses cannabis-derived ingredients.
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March 10, 2025
Fed. Circ. Won't Pause Teva Patent Delisting For Appeal
The Federal Circuit denied on Friday Israeli drugmaker Teva Pharmaceuticals' bid to keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold pending its appeal of the matter to the U.S. Supreme Court.
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March 10, 2025
Ex-Magellan CEO Pleads Guilty Over Faulty Lead Tests
The former CEO of Magellan Diagnostics Inc. admitted Monday to selling faulty devices that tested blood lead levels, the final of three defendants to plead guilty ahead of a jury trial scheduled for April.
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March 07, 2025
FDA Can Take Eli Lilly Weight Loss Drug Off Shortage List
A Texas federal judge has refused to issue an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, ruling that the U.S. Food and Drug Administration was within its authority when it removed the medication from the drug shortage list.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
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March 07, 2025
Hints Of A New High Court Majority Emerge In Trump Cases
The U.S. Supreme Court's recent rejection of President Donald Trump's bid to keep frozen nearly $2 billion in foreign aid funding gave court watchers a glimpse of a coalition majority that could end up thwarting some of the president's more aggressive and novel attempts to expand executive power.
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March 07, 2025
Ohio, PBMs Say High Court Ruling Didn't End Pricing Appeal
Ohio state enforcers have told the Sixth Circuit an appeal in their case accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices was not resolved by a U.S. Supreme Court decision dealing with federal versus state jurisdiction.
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March 07, 2025
New Bellwethers Score Cert. In Generic Drug Price-Fixing MDL
The Pennsylvania federal court overseeing sprawling multidistrict litigation springing from claims that pharmaceutical giants worked together to hike the cost of off-brand drugs has certified several sets of classes for the cases for the MDL's latest bellwethers.
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March 07, 2025
Apple Prevails In Watch Tech Patent Fight At Fed. Circ.
The Federal Circuit handed Apple a significant victory Friday in a dispute that might have led to a ban on imports of its smartwatches, affirming that a competing company's heart monitor patents are invalid and vacating a conflicting U.S. International Trade Commission decision that found the watches infringed those patents.
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March 07, 2025
Ex-Novo Nordisk Worker Can't Reopen Harassment Suit
A former employee of Novo Nordisk can't revive her lawsuit claiming she was let go because she is a Jewish woman and had a back and hip injury, a California state appeals court ruled, finding no issue with a trial court tossing the case after she failed to oppose the move.
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March 07, 2025
Tariffs, Diversity And DOGE Dominate Trump 2.0 'Risk Factors'
Public companies are busily reworking risk disclosures since the arrival of President Donald Trump's second administration, seeking to walk a fine line of being upfront with investors about potential threats to business despite vast legal and policy uncertainties.
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March 07, 2025
Husband Of Ex-Takeda VP Gets 2½ Years For Invoice Scam
The husband of a former Takeda Pharmaceuticals vice president was sentenced in Massachusetts federal court Friday to two and a half years in prison for his role in a scheme to dupe the drug giant out of $2.3 million through bogus invoices.
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March 07, 2025
Taxation With Representation: Kirkland, Wachtell, Skadden
In this week's Taxation With Representation, Walgreens Boots Alliance goes private via a deal with Sycamore Partners, Honeywell buys Sundyne from Warburg Pincus, and Jazz Pharmaceuticals acquires Chimerix.
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March 06, 2025
Don't Give Teva 'Eighth Bite' At $235M Patent Trial, GSK Says
GlaxoSmithKline has told a Delaware federal judge that Teva's request for a new trial in the drugmakers' decade-long, $235 million "skinny label" patent fight over heart failure medication is an "eighth bite at the same apple."
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March 06, 2025
Pfizer Failed To Warn Of Depo-Provera's Tumor Risk, Suit Says
A woman who claims she developed a brain tumor after years of taking the contraceptive Depo-Provera is suing Pfizer and other pharmaceutical companies who manufacture the drug, claiming in Washington federal court they failed to tell patients of the danger even though it is standard on warning labels in Europe and Canada.
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March 06, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Believe it or not, there's still important litigation happening that doesn't involve President Donald Trump, and the proof exists in this month's circuit court calendars. During the remaining weeks of March, arguments will explore numerous high-profile topics, including a law firm's severe punishment for alleged misconduct in 9/11 litigation and a judicial rebuke of Trader Joe's for "an attempt to weaponize the legal system."
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March 06, 2025
FTC Challenges PE Firm's Medical Device Coatings Deal
The Federal Trade Commission moved Thursday to block private equity firm GTCR BC Holdings LLC's planned $627 million acquisition of Surmodics Inc. over concerns about competition for medical device coatings.
Expert Analysis
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.