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Life Sciences
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June 13, 2024
Abortion Medication Case Ends 'With A Whimper' At High Court
A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.
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June 12, 2024
Tillis Told Drug Patents Are Too Complex For Easy Answers
When and how generic drugs enter the marketplace varies widely among different drugs and isn't necessarily related to how many patents are covering those drugs, the U.S. Patent and Trademark Office said Wednesday in a report requested by a top member of the U.S. Senate's Intellectual Property Subcommittee.
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June 12, 2024
Lies At Heart Of Fraud Case Over COVID Test Kits, Jurors Told
The retrial of a securities fraud case over a COVID test kit deal that never materialized will center on lies, according to opening statements delivered in New Jersey federal court Wednesday.
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June 12, 2024
2nd Circ. Backs Brokerage In Suit Over Biotech's Failed IPO
The Second Circuit on Wednesday declined to reinstate a Texas company's suit against an investment brokerage that advised biotech Inpellis on an initial public offering that failed and sent the company to file Chapter 7, ruling a lower court rightly found a global settlement eclipsed the need for a jury trial.
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June 12, 2024
Lipitor Buyers Get Final OK For $93M Deal In Antitrust Fight
A New Jersey federal judge gave final approval Wednesday to a $93 million settlement between a class of buyers of Lipitor and Pfizer, resolving their claims in sprawling antitrust litigation that Pfizer conspired with a drug manufacturer to delay the release of a cheaper generic version of Lipitor and monopolize the market.
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June 12, 2024
SPAC Dealmakers Expect Modest Pickup After Market Bottom
Market professionals expect a slow pickup in deals involving special-purpose acquisition companies starting in the second half of 2024, predicting on Wednesday that a leaner market will emerge following the recent crash and imposition of tighter regulations.
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June 12, 2024
Directors Of Defunct Med Tech SPAC Seek Toss Of Del. Suit
Directors of a special purpose acquisition company that merged with now-defunct medical technology company Better Therapeutics Inc. urged Delaware's Court of Chancery on Wednesday to toss a shareholder's suit about the $15 million de-SPAC merger, saying it wasn't like other problematic SPAC deals.
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June 12, 2024
Forte Biosciences Reaches $2M Deal To End Chancery Suit
Clinical-stage biopharmaceutical company Forte Biosciences has reached a multipart, $2 million concession-plus-cash settlement in Delaware's Court of Chancery with a private investment fund that ran a board proxy contest after its calls to liquidate the business were met with poison pill pushback.
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June 12, 2024
'Natural' Toothpaste Brand Loaded With PFAS, Moms Say
Natural toothpaste company RiseWell LLC falsely advertised its kids toothpaste as "natural" and "safe to swallow," two mothers alleged Tuesday in a proposed class action, saying a U.S. Department of Defense-certified laboratory test found 750 times more "forever chemicals" in the toothpaste than researchers found in heavily tainted kale.
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June 12, 2024
32 AGs Urge Justices Take Up Okla. PBM Law Fight
Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.
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June 11, 2024
Martin Shkreli Told To Hand Over Wu-Tang Album
A New York federal judge ordered Martin Shkreli on Tuesday to hand over any copies he might have of the Wu-Tang Clan's album he once bought before it was sold off by the federal government to settle a $7.3 million tab from Shkreli's criminal judgment on securities fraud.
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June 11, 2024
Pharmacy Co. Optio Gets Interim OK For $10M DIP Package
Illinois-based specialty pharmacy chain Optio received interim approval at a first-day hearing Tuesday in Delaware bankruptcy court to access a $10 million in new money debtor-in-possession financing to fund its Chapter 11.
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June 11, 2024
Fed. Circ. Reinstates Parts Of Blood Analyzer Secrets Verdict
The Federal Circuit decided Tuesday that a Rhode Island jury was right to find that an Italian company's blood analyzer computer code was stolen by a U.S. rival, but another jury will have to determine any damages.
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June 11, 2024
9th Circ. Judge On Theranos Appeal: 'Good Story' For Holmes
Two Ninth Circuit judges on a three-judge panel expressed concerns Tuesday that the district judge presiding over convicted former Theranos CEO Elizabeth Holmes' criminal trial erred by allowing a layperson witness to offer expert testimony at trial, with one judge saying, "There's a pretty good story here for Ms. Holmes."
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June 11, 2024
AI No Scarier Than Nail Guns Or Microscopes, Kappos Says
Former U.S. Patent and Trademark Office Director David Kappos cautioned attorneys Tuesday to "keep ourselves grounded" about the use of artificial intelligence in intellectual property, saying it's just a tool like a microscope or nail gun, rather than something justifying "panic."
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June 11, 2024
NJ Supreme Court Rejects Bid For Roundup Mass Tort
The New Jersey Supreme Court has rejected a request for litigation against Monsanto Co. and Bayer AG to be designated as multicounty litigation because there are too few cases, according to a notice to the bar published Monday.
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June 11, 2024
Slow IPO Recovery Expected To Accelerate In 2025
More companies are preparing initial public offerings even as the pace of new listings has been slower than anticipated, experts said Tuesday, signaling that an IPO recovery is likely to accelerate next year after investors sort out November election results.
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June 11, 2024
10 Firms Seek $13M Fee For Effexor Antitrust Deal
Ten law firms asked a New Jersey federal judge on Monday to award $13 million in counsel fees and an additional $2.1 million in costs for representing direct buyers in a $39 million settlement with Pfizer Inc. unit Wyeth over an alleged scheme to delay generic competition for the antidepressant drug Effexor XR.
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June 11, 2024
WilmerHale Lands Latham Atty To Help Lead Life Sciences
WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.
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June 11, 2024
FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine
The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.
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June 10, 2024
5 Teva Inhaler Patents Kicked Out Of Orange Book
A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.
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June 10, 2024
Bankrupt UpHealth Warned Of Criminal Charges In India
A court in India said it has received a criminal charge sheet issued by an investigative governmental agency in Calcutta against bankrupt American healthcare company UpHealth, targeting it and executives over accusations that they conspired to defraud a local healthcare system.
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June 10, 2024
DOJ, FDA Form Task Force To Crack Down On Illegal E-Cigs
The U.S. Department of Justice and the U.S. Food and Drug Administration on Monday said that a federal multi-agency task force has been founded to stop illegal sales of e-cigarettes.
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June 10, 2024
Baltimore Lands $45M Deal With Allergan In Opioid Litigation
Baltimore has put to rest its claims that Allergan played a part in the opioid crisis, reaching a $45 million settlement with the pharmaceutical company, an amount the city called "unprecedented" in an announcement on Monday.
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June 10, 2024
9th Circ. Says Choctaw's Dispute With CVS Must Be Arbitrated
A Ninth Circuit panel forced the Choctaw Nation to arbitrate a dispute over prescription drug reimbursement with CVS Health Corp. subsidiaries, affirming an Arizona federal judge's order in a published opinion Monday.
Expert Analysis
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Opinion
Proposed MDL Management Rule Needs Refining
Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.
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Why Oncology Deal Making Continues To Fuel Biotech M&A
The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.
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Opinion
Judicial Independence Is Imperative This Election Year
As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.
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Opinion
NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Document Retention Best Practices To Lower Litigation Risks
As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.
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Series
Riding My Peloton Bike Makes Me A Better Lawyer
Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.
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Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs
The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.
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Spartan Arbitration Tactics Against Well-Funded Opponents
Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.
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Uncertainty Surrounds Patent Eligibility Restoration Bill
A recent U.S. Senate hearing regarding the Patent Eligibility Restoration Act, a bill that aims to overhaul patent eligibility law and establish clearer statutory exclusions, marks a pivotal moment in the ongoing patent eligibility debate, but the law’s fate remains uncertain as discussions continue, say attorneys at Marshall Gerstein.
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CSA Case Could Shift Intrastate Commercial Cannabis
In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.
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How AI May Be Used In Fintech Fraud — And Fraud Detection
Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.
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What Recent Study Shows About AI's Promise For Legal Tasks
Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.
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Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness
The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.
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11th Circ. FMLA Ruling Deepens Divide Over Causation
The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.
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Decline In Same-Industry M&A Tells A Nuanced Policy Story
In light of newly available Hart-Scott-Rodino Act data suggesting that intraindustry mergers are down overall and pharmaceutical and hospital intraindustry transactions tend to face greater antitrust scrutiny than in the past, attorneys at Morgan Lewis explore whether Biden administration enforcement policies may be curbing pro-competitive strategic M&A.