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Life Sciences
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July 29, 2024
Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech
Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.
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July 29, 2024
Gilstrap Finds Nothing Between The Lines Of Barcode Patents
A handful of barcode scanning patents issued to prolific litigant Leigh Rothschild met their fate in Texas, with U.S. District Judge Rodney Gilstrap deciding they "recite no more than generic computer operations."
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July 29, 2024
Vaccine Co. Was Sanctioned For Deliberately Hiding Testing
U.S. Patent and Trademark Office Director Kathi Vidal backed sanctions for Longhorn Vaccines & Diagnostics' "egregious abuse" of the Patent Trial and Appeal Board system because of the patent owner's "deliberate scheme to hide" harmful evidence from the board, she said in an opinion made public Friday.
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July 29, 2024
Boehringer Appeals HHS Win In Medicare Drug Price Suit
Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.
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July 29, 2024
Kirkland-Led Amulet Closes $1.2B Health-Focused Fund
Kirkland & Ellis LLP-advised private equity shop Amulet Capital Partners LP on Monday announced that it successfully closed its third healthcare-focused private equity fund with roughly $1.2 billion in tow.
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July 29, 2024
Legalization Org Taps Cannabis Atty As New Treasurer
The pro-legalization advocacy organization Marijuana Policy Project announced Monday that a preeminent member of the cannabis bar had been tapped as the group's newest treasurer.
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July 29, 2024
GSK Settles Ill. Zantac Cancer Suit
GlaxoSmithKline said Monday it has settled a lawsuit brought by an Illinois man who took the heartburn medication Zantac or its generic counterpart for more than 20 years and claimed the drug caused his prostate cancer.
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July 29, 2024
Firm, Ex-Client Brief Conn. High Court In Punitive Award Case
McCarter & English LLP and ex-client Jarrow Formulas Inc. are weighing in as the Connecticut Supreme Court decides whether a federal court can award law firms punitive damages in suits for breach of contract, as the firm seeks a punitive payout after winning multimillion-dollar judgments in a contract dispute.
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July 29, 2024
Catching Up With Delaware's Chancery Court
Litigation linked to billionaire Elon Musk sparked several filings in Delaware's Court of Chancery last week, including a call for sanctions and hand-wringing about a proposed multibillion-dollar attorney fee. Other court activity centered on Paramount's proposed $4.5 billion stock-and-cash merger with Skydance Media, a couple of deals with Silver Lake Capital, and new cases involving digital publisher The Arena Group, airplane manufacturer Boeing Co., and 3D-imaging and digitization venture Matterport Inc.
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July 29, 2024
Ex-Pharma Exec Seeks Leniency After SEC Contempt Plea
A former pharmaceutical executive is hoping to avoid jail after his use of an alias to circumvent a U.S. Securities and Exchange Commission ban on finance work landed him a criminal contempt conviction, while Boston federal prosecutors are seeking up to 10 months in prison.
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July 26, 2024
'Low-Grade Lawyering': Quinn Emanuel Attys Draw Judge's Ire
A California federal judge considering Guardant Health's sanctions bid in a false advertising case against rival Natera said Friday that representations to the court by Natera's attorneys from Quinn Emanuel Urquhart & Sullivan LLP regarding a proposed expert witness were "less than forthright" and "pretty low-grade lawyering."
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July 26, 2024
Apple Commits To White House Guidelines For Responsible AI
Apple Inc. has signed onto the Biden administration's voluntary guidelines for "responsible" artificial intelligence innovation, joining the likes of Amazon.com Inc., Google LLC, Microsoft Corp. and a dozen other leading tech companies, the White House announced Friday.
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July 26, 2024
Product Liability Cases To Watch 2024: A Midyear Report
Litigation over claims that social media addict children and harm mental health continues to hold attorneys' attention, along with claims that "forever chemicals" are a source of cancer.
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July 26, 2024
Del. Court Won't Let Generic Co. Walk Back Invalidity Promise
Generic-drug maker Mankind Pharma is bound to its promise not to challenge the validity of a patent covering Allergan's glaucoma drug Lumigan after a federal judge in Delaware shot down its argument that recent rulings on obviousness-type double patenting altered the litigation landscape.
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July 26, 2024
Indivior To Pay $86M To Settle Opioid Claims By 5 States
Indivior will pay $86 million to settle claims by a group of state attorneys general over the drugmaker's alleged contributions to the American opioid crisis.
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July 26, 2024
Hearing Set Over Bid To Recuse Judge In Philly Zantac Cases
A Philadelphia judge will hear arguments next month over a recusal motion filed by plaintiffs' counsel in the city's Zantac mass tort program that argues the judge should remove himself from the proceedings after he disclosed his wife is a partner at Reed Smith, which represents GlaxoSmithKline, a manufacturer of the drug.
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July 26, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen U.K. band The 1975 face action by Future Sound Asia after its performance in Malaysia resulted in a festival's cancelation, Spectrum Insurance hit by The Motoring Organization following their dispute over information misuse, and a former police constable pursue defamation against a colleague for allegedly instigating a campaign of harassment against her. Here, Law360 looks at these and other new claims in the U.K.
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July 25, 2024
3rd Circ. Again Tosses J&J Talc Unit's 'Texas Two-Step' Ch. 11
The Third Circuit on Thursday affirmed the dismissal of the reworked Chapter 11 case of Johnson & Johnson's talc unit that used a controversial "Texas two-step" maneuver, saying the company still hasn't displayed the financial distress required to justify bankruptcy protection.
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July 25, 2024
Seattle, Monsanto Ink $160M Deal Over PCBs In Duwamish
Bayer AG's Monsanto Co. has agreed to pay $160 million to resolve allegations that it contaminated Seattle's stormwater and drainage systems as well as the Lower Duwamish Waterway with polychlorinated biphenyls, the city attorney's office announced Thursday.
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July 25, 2024
Pfizer Calls GSK Patents In COVID Vax Case Unenforceable
Pfizer and BioNTech have fired back at GlaxoSmithKline's patent suit against them over the COVID-19 vaccine, saying GSK's patents are unenforceable because the company delayed in filing its applications and then crafted them to cover the blockbuster vaccine after it became available.
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July 25, 2024
DC Panel Upholds FDA's Win Against Ipsen's Generics Suit
A D.C. panel declined to revive Ipsen's challenge to regulators' refusal to classify its acromegaly drug as a biologic, which would have blocked generic versions of it, finding Thursday the drug's active ingredient doesn't meet the Food, Drug and Cosmetic Act's definition of a protein to be considered a biologic.
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July 25, 2024
Shkreli Says He Has Right To Use Wu-Tang Clan Album Copies
Martin Shkreli pushed back on a crypto project's bid to force him to hand over copies of the one-of-a-kind Wu-Tang Clan album he once owned, saying his original purchase agreement of the album entitled him to make the copies and the album's current crypto owner hasn't shown how Shkreli's duplicates irreparably harm the value of the original.
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July 25, 2024
Ex-Pharma Exec's Counsel Accused Of Reading Stolen Emails
A New Jersey pharmaceutical startup wants to disqualify the "tainted" attorneys of a former executive who was allegedly caught spying on the CEO, claiming the attorneys should have immediately shielded their eyes when they realized their client was using stolen, privileged emails to carry out an "attempted shakedown."
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July 25, 2024
Loeb & Loeb Says Ex-GC's Sanctions Motion Is Bogus
Loeb & Loeb LLP urged a Colorado federal judge Wednesday to reject a former general counsel's allegations that it deliberately sent a thumb drive of documents that aren't text searchable, saying they are actually searchable and would have otherwise sent over 64,000 physical pages that weren't.
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July 25, 2024
Deals Rumor Mill: Wiz-Google, Daily Telegraph, Medline IPO
Cybersecurity startup Wiz has rebuffed a buyout offer from Google, former British finance minister Nadhim Zahawi is preparing a $773 million bid for the Daily Telegraph, and medical supplies giant Medline is preparing an initial public offering for 2025. Here, Law360 breaks down these and other notable deal rumors from the past week.
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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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.