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Life Sciences
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October 07, 2024
Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement
The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%.
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October 04, 2024
Top 5 Supreme Court Cases To Watch This Fall
The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.
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October 04, 2024
NJ, Ethics Board Must Hand Over Docs In Retaliation Fight
A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.
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October 04, 2024
DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales
Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.
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October 04, 2024
Regeneron Can't Ax Willful Infringement In COVID Patent Case
Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.
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October 04, 2024
Healthcare Co. Inks Deal In DOL Equal Pay Investigation
A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.
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October 04, 2024
There May Not Be Life On Mars, But There Could Be IP
The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.
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October 04, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.
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October 04, 2024
High Court Takes Up E-Cig 'Forum Shopping' Appeal
The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.
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October 04, 2024
High Court Will Hear TCPA Case Over Online Junk Faxes
The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.
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October 03, 2024
Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion
Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.
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October 03, 2024
Boston Pharma Co. Drops Another Moderna Patent Suit
A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.
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October 03, 2024
Del. Vice Chancellor Slams Fee Terms In Advancement Case
A Delaware vice chancellor balked Thursday at "success fee" terms in a fee advancement case that she suggested made the clients a "human shield" in litigation over attorney expenses in connection with a New Jersey legal malpractice case.
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October 03, 2024
Trulieve Sues Fla. Republican Party Over Anti-Weed Ads
Trulieve, which is Florida's largest medical marijuana company and the principal backer of a ballot initiative to legalize cannabis in the Sunshine State, has sued the state's Republican Party and a pair of television stations for defamation, alleging that they ran misleading anti-weed ads.
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October 03, 2024
FibroGen Suit Alleging Disclosure Failures Tossed In Del.
Biopharmaceutical company FibroGen has beaten a stockholder derivative lawsuit in Delaware's Chancery Court that accused the business and its top officers of fiduciary breaches and insider trading related to its flagship anemia drug, which was once projected to bring in $3.5 billion for the drugmaker before regulators refused to approve its use in the U.S.
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October 03, 2024
12 Lawyers Who Are The Future Of The Supreme Court Bar
One attorney hasn't lost a single U.S. Supreme Court case she's argued, or even a single justice's vote. One attorney is perhaps "the preeminent SCOTUS advocate." And one may soon become U.S. solicitor general, despite acknowledging there are "judges out there who don't like me." All three are among a dozen lawyers in the vanguard of the Supreme Court bar's next generation, poised to follow in the footsteps of the bar's current icons.
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October 03, 2024
Stanford Profs Deny Roche's Trade Secret Theft Accusations
Three Stanford University oncology professors sued by subsidiaries of F. Hoffmann-La Roche AG for allegedly stealing confidential information about cancer-detecting technology have denied the accusations, saying in California federal court that Roche's purported trade secrets were not secret, and even if they were, Roche does not own them.
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October 03, 2024
Texas Takes Aim At Insulin Manufacturers For Price-Gouging
Texas sued several major insulin manufacturers and pharmacy benefit managers in Texas state court on Thursday, accusing the companies of running quid pro quo deals to bump insulin prices by as much as 1,000% and violating Texas laws around deceptive trade practices.
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October 03, 2024
Flint Water Judge Wishes Public Knew Case Complexity
A Michigan federal judge on Thursday gave the final approval to a $25 million settlement to end claims from a class of Flint adults and businesses accusing a firm of failing to properly alert officials about the dangers of the city's water, noting that the case took years to resolve because it involved complicated legal issues.
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October 03, 2024
NJ Contractors Accused Of $10M Fraud In Lead Removal Work
A New Jersey construction company billed the city of Newark $10.2 million for replacing 1,500 lead water service lines but never did the work, instead concocting false evidence to show new copper pipes had been installed, federal authorities said Thursday in announcing the arrests of the chief executive and a foreperson.
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October 03, 2024
Cos. Want Federal Rule On Litigation Funding Disclosure
The federal courts should adopt a uniform process for the disclosure of third-party litigation funding in federal cases, a host of companies, including Johnson & Johnson and Google, told the judiciary's Rules Committee.
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October 03, 2024
Ex-US House Energy Committee Atty Joins Foley In DC
Foley & Lardner LLP has announced that a former senior counsel to the U.S. House Committee on Energy and Commerce joined the firm's Washington, D.C., office as counsel in its public policy and government relations practice group.
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October 03, 2024
CVS Pushed To Unwind Aetna Megadeal, And Other Rumors
CVS is exploring strategic options that could break up the business, Kleenex's owner explores a sale at a potential $4 billion value, and Ares is in talks to buy 10% of the Miami Dolphins’ parent. Here, Law360 breaks down these and other notable deal rumors from the past week.
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October 02, 2024
Bard Agrees To Individualized Deals In Hernia Mesh Litigation
Tens of thousands of plaintiffs alleging they were injured by hernia mesh implant devices could resolve their claims against C.R. Bard Inc. under a settlement process unveiled Wednesday, a "decisive step" toward addressing the claims in both state and federal courts, counsel for the plaintiffs said in their announcement.
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October 02, 2024
Chancery To Mull Receiver In Drug Co. Consulting Bill Row
Delaware's Supreme Court has appointed a Superior Court judge to sit as a vice chancellor in a suit seeking a receiver for a Dubai-headquartered bio-pharmaceutical company that has run up nearly $600,000 in $3,000-per-day sanctions and counting for failing to comply with an initial $180,000 judgment.
Expert Analysis
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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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.