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Life Sciences
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October 17, 2024
E-Cig Regs Are Congress' Job, Not FDA's, GOP Pols Tell Justices
Republican lawmakers told the U.S. Supreme Court that Congress, not the U.S. Food and Drug Administration, should regulate flavored e-cigarettes, and that the regulator overstepped its authority by banning the sale of the vape products.
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October 17, 2024
'More Honesty' Needed In Philips IP Row, Judge Says
A Texas federal judge told the owner of a company accused of pilfering around $12 million worth of Philips North America LLC's trade secrets that things might have gone better if he had "been more honest," pointing out that he had given contradictory testimony during a hearing Thursday.
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October 17, 2024
Justices Urged To Fix 'Novel Misreading' Of IP Safe Harbor
Edwards Lifesciences is asking the U.S. Supreme Court to rein in what's covered under a drug-development safe harbor to avoid patent infringement, saying the Federal Circuit wrongfully expanded it in a "novel misreading" of the law.
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October 17, 2024
Northwestern Hits Moderna With Patent Suit Over COVID Vax
Northwestern University has launched a patent infringement lawsuit in Delaware federal court accusing Moderna of wrongly taking research that the school did when the company was making its COVID-19 vaccine.
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October 17, 2024
Amgen Faces Derivative Suit In Del. Over Tax Disclosures
An Amgen Inc. stockholder has sued the company in Delaware's Court of Chancery seeking derivative recoveries for the multinational biopharmaceutical company from its directors and officers based on allegedly false and misleading statements regarding $10.7 billion in federal tax bills and penalties.
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October 17, 2024
Oregon Appeals Court Says E-Cig Rules Violate Free Speech
Oregon's intermediate appellate court ruled Wednesday that a state law governing how e-cigarettes and cannabis vapes can be packaged violated guarantees of free speech enshrined in the state's constitution.
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October 17, 2024
$20B Verizon-Frontier Deal Faces Scrutiny, And Other Rumors
A growing list of Frontier Communications' largest shareholders are concerned about its planned $20 billion takeover by Verizon Communications, and a group of former professional athletes are in talks to buy a stake in the NFL's Buffalo Bills. Here, Law360 breaks down these and other notable rumors from the past week.
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October 17, 2024
Ex-Genzyme Exec Says Anxiety Disclosure Led To Firing
A former marketing director for Sanofi subsidiary Genzyme says he was fired on a pretext after disclosing that he suffers from anxiety, according to a lawsuit filed Wednesday in Massachusetts state court.
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October 17, 2024
Moderna Wants Fees For 'Frivolous' COVID-19 Vax Suit
Moderna is asking a Delaware federal judge to award it about $2.8 million in legal costs for its defense of claims in a patent suit brought by Alnylam Pharmaceuticals over its coronavirus vaccine, arguing the Boston-based company pursued "frivolous" claims that wasted court resources.
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October 16, 2024
Philips Says $12M Sanction Needed For Evidence Destruction
A spoliation sanctions hearing for around $12 million in royalty damages turned terse when the owner of a medical device equipment sale and servicing company seemingly hedged his statements, with a Texas federal judge saying, "Oh my gosh, just answer the question," during the Wednesday hearing.
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October 16, 2024
Apple Heart Rate Monitor Patent Survives PTAB
An administrative patent board has decided not to invalidate an Apple patent that the tech giant once asserted in its ongoing fight with a company in the smartwatch space.
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October 16, 2024
Direct Buyers Get Final OK For $44M Drug Price-Fixing Deal
A Pennsylvania federal court has granted final approval to $44.4 million in settlements between drugmakers Apotex, Breckenridge and Heritage and direct purchasers in a multidistrict litigation over alleged price-fixing in the generic-drug industry.
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October 16, 2024
Pharma Co. Contractor Settles SEC Insider Trading Claim
An information technology consultant for a Massachusetts biopharmaceutical company will pay the U.S. Securities and Exchange Commission over $28,000 to resolve claims he immediately dumped shares of his client when he got wind of its yet-to-be announced plans for major layoffs.
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October 16, 2024
Ex-Pharma Co. Employee Traded On GSK Deal Info, SEC Says
The former director of analytical development at Canada-based drug company Bellus Health Inc. has agreed to pay the U.S. Securities and Exchange Commission over $120,000 to settle claims that he sold shares on nonpublic information about pharma giant GSK's impending takeover of his company, according to court filings.
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October 16, 2024
SEC To Settle Claims CBD Exec Took $13M From Hospital
The U.S. Securities and Exchange Commission is ready to make a deal with a former cannabidiol products executive accused of taking $13 million from a hospital after falsely promising to deliver urgently needed masks during the height of the pandemic.
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October 16, 2024
Caremark, Optum Say FTC Insulin Case Gets PBMs All Wrong
Caremark Rx, Express Scripts and OptumRx continue to attack the Federal Trade Commission's in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes, arguing the agency's case lacks authority, facts and the right targets.
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October 16, 2024
Houston Pharma Exec Found Guilty In $160M Health Fraud
A Houston man was convicted on 15 criminal charges in connection with orchestrating a massive healthcare scheme that defrauded the government out of $160 million, following a 10-day trial in which prosecutors said doctors were "bamboozled" by the conspiracy.
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October 16, 2024
AAM, Alvogen Back Sun Pharma In Double Patenting Row
A trade group representing generic-drug makers, a generic-drug company and a plant-breeding technology business have all thrown their support behind Sun Pharmaceutical Industries' bid for the full Federal Circuit to take a closer look at the issue of double patenting.
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October 16, 2024
M&A Pros Cautious About Expected Private Equity Surge
It's an oft-repeated line that private equity activity is set to surge amid pressure to exit older investments and deploy record stores of dry powder, but mergers and acquisitions professionals recently surveyed by Dykema were cautious when asked if they expect private equity to boost deal flow in the next 12 months, with a majority saying they only "somewhat agree."
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October 15, 2024
Horizon Lodges 4-Fold Attack On Tepezza MDL Bellwethers
Horizon Therapeutics argued Tuesday that an Illinois federal judge should toss out nine of the dozen cases selected as bellwethers in multidistrict litigation targeting hearing loss issues with its biologic Tepezza, saying they're preempted because the label was approved with those problems in mind.
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October 15, 2024
Judge Backs Exelixis Cancer Drug Patent Claims
A Delaware federal judge on Tuesday rejected invalidity arguments against three Exelixis patents that MSN Laboratories Private Ltd. said it would be infringing with a proposed generic of blockbuster drug Cabometyx, while also finding that a fourth patent wasn't invalid nor was it infringed.
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October 15, 2024
Motley Rice May Avoid DQ In Boston Opioid Case, Judge Hints
A Massachusetts federal judge on Tuesday appeared skeptical of a bid by pharmacy benefit manager OptumRX to disqualify Motley Rice LLC from representing the city of Boston in a lawsuit over the company's alleged role in the opioid crisis.
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October 15, 2024
GSK Says Moderna's COVID, RSV Vax Infringe MRNA Patents
Moderna's breakthrough COVID-19 vaccine and a related respiratory syncytial virus, or RSV, vaccine were built on mRNA technology discovered by researchers whose patents are owned by GlaxoSmithKline, the latter company alleged in a pair of Delaware lawsuits.
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October 15, 2024
Justices Mull RICO's Scope In Trucker's CBD Case
U.S. Supreme Court justices on Tuesday appeared conflicted whether to sanction a commercial trucker's attempt to bring a racketeering claim against CBD companies, whose allegedly mislabeled products the trucker claims led to his firing.
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October 15, 2024
Walmart, Execs Settle Chancery Opioid Suit For $123M
Walmart and its directors and officers have agreed to a $123 million deal to end a stockholder class derivative lawsuit in Delaware's Court of Chancery that accused the nationwide retailer of multiyear opioid prescription oversight failures, potentially resolving class claims dating to early 2020.
Expert Analysis
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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.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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1 Year At The UPC: Implications For Transatlantic Disputes
In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.