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Life Sciences
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May 21, 2025
Squires Talks Fortress, PTAB Invalidations In Senate Hearing
The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.
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May 21, 2025
9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals
Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.
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May 21, 2025
Judge Mulls National Scope Of Bid To Restore COVID Grants
A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.
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May 21, 2025
AbbVie Gets Victory In Allergan Shareholder Suit Upheld
An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.
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May 21, 2025
GOP FTC Renews Calls For Orange Book Patent Delistings
The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.
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May 21, 2025
Kronos Bio Shareholder Says Sale Unfairly Benefits Execs
Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.
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May 21, 2025
Device Maker Who Evaded Tax Gets 2 Years In Prison
A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.
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May 21, 2025
Walgreens Ducks False Ad Suit Over Mucus Relief Meds
An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Barclays Officials Beat Shareholder's Suit At NY High Court
New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.
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May 20, 2025
Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive
Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.
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May 20, 2025
Cancer Drug Co. Beats Investor Suit Over FDA Rejection
Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Medical Supply Co. Faces Ga. Suit Over Unwanted Texts
A Florida-based medical supply company has been hit with a proposed Telephone Consumer Protection Act class action in Georgia federal court by a man who says he received several promotional text messages from the company after he added himself to the National Do Not Call Registry.
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May 20, 2025
Moderna Says Order To Narrow Vax IP Case Should Stay
Moderna has said that a federal judge should ignore a rival mRNA developer's request to rethink his decision limiting issues in a patent suit over the company's COVID-19 vaccines, saying the rival is trying to make new arguments too late.
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May 20, 2025
Creditors Win Fight Against Insider Releases In Azzur Ch. 11
A Delaware bankruptcy judge on Tuesday sustained an objection to insider releases in the Chapter 11 liquidation plan of Azzur Group, finding the pharmaceutical services company had not justified the releases for prepetition conduct of current and former officers, directors, and equity holders.
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May 20, 2025
Biotech Stockholders Challenge Director Pay Levels In Del.
Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.
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May 20, 2025
Sales Exec Admits Role In $70M Brain Scan Kickback Scheme
A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.
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May 19, 2025
Former Kite Pharma Exec Alleges Gender Bias, Retaliation
Gilead Sciences and its subsidiary Kite Pharma have been hit with a suit in California state court by a former company executive alleging she was underpaid compared to her male counterparts and fired while out on medical leave after she raised concerns about equal pay.
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May 19, 2025
SEC's 'Shadow Trading' Win Should Be Tossed, 9th Circ. Told
An ex-Medivation Inc. executive found liable in the U.S. Securities and Exchange Commission's first-ever "shadow trading" case has asked the Ninth Circuit to overturn the verdict, arguing that his company's policies should have kept the matter from going to a jury in the first place.
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May 19, 2025
Ex-CTA Worker Can Take Vaccine Bias Claim To Trial
An ex-Chicago Transit Authority employee fired after refusing COVID-19 vaccination can take his religious discrimination claim to a jury this summer after an Illinois federal judge grilled the agency Monday on its assertion that the plaintiff didn't seek an exemption for sincerely held religious beliefs and rejected its argument that he was "cherry-picking" Catholic doctrine.
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May 19, 2025
Feds Get Early Win In Drugmakers' Suit Over 340B Rebates
A D.C. federal judge awarded an early win to the U.S. Department of Health and Human Services on Friday on claims it illegally blocked drugmakers' efforts to implement rebates instead of discounts in a decades-old drug pricing program, finding the agency has the authority to pre-approve the price reduction models.
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May 19, 2025
Bluebird Beats Patent Case Over Blood Disease Therapies
A Delaware federal judge has tossed a lawsuit against Bluebird Bio alleging two of its multimillion-dollar gene therapy treatments for blood disorders infringed patents held by San Rocco Therapeutics LLC, after the dispute had been narrowed by a previous claim construction ruling.
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May 19, 2025
Biotech Services Company Files Ch. 11 With $60M In Debt
Contracted biotechnology research company AmplifyBio filed for Chapter 11 protection late Friday in Ohio bankruptcy court listing about $60 million in debt, saying it intends to sell its assets after failing to realize sufficient revenue to support its capital-intensive operations.
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May 19, 2025
Wachtell-Led Regeneron To Buy 23andMe, Gaining User Data
Regeneron Pharmaceuticals said Monday it emerged as the winning bidder for 23andMe, agreeing to pay $256 million to scoop the once high-flying consumer genomics firm out of bankruptcy while pledging to uphold strict privacy standards.
Expert Analysis
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.