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Life Sciences
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June 13, 2024
Supreme Court Rejects Abortion Pill Limits On Standing
The U.S. Supreme Court on Thursday rejected a Fifth Circuit decision that had imposed restrictions on the abortion medication mifepristone, finding a coalition of anti-abortion groups lacked standing to challenge the U.S. Food and Drug Administration's regulation of the drug.
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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.
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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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.