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Life Sciences
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October 02, 2025
Court Warned Of Harm From Delaying Medical Device Merger
A D.C. federal court refused to pause the Federal Trade Commission's case challenging Edwards Lifesciences Corp.'s planned acquisition of JenaValve Technology Inc. during the government shutdown after the companies argued that "time is of the essence" for a new lifesaving medical device.
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October 01, 2025
Squires Jumps Right Into Patent Eligibility Reform
U.S. Patent and Trademark Office Director John Squires used his first week at the agency to make bold statements about what should be eligible for patenting, with patent owners celebrating his support of diagnostics, crypto and machine learning technologies.
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October 01, 2025
Eli Lilly's Drug Suit Slammed As 'Anti-Competitive' Move
Eli Lilly and Co.'s lawsuit accusing a compounding pharmacy of unlawfully selling untested weight loss drugs should be tossed because the drugmaker didn't show its advertising was deceptive or harmful, the defendant told a Texas federal court this week.
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October 01, 2025
EPA Seeks Dismissal Of Flint Bellwethers, Says It's Not Liable
The U.S. Environmental Protection Agency has defended its timing of using its authority to issue a Safe Drinking Water Act order regarding lead in the city of Flint's water, urging a Michigan federal judge to dismiss claims from bellwether plaintiffs who alleged the agency was negligent in its response to the crisis.
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October 01, 2025
Inventor's $11M Award Slashed To $5M Over Pet Device IP
A New Jersey federal judge has hit two pet supply companies with a $5 million damages bill for misappropriating a woman's idea for a skin medicine applicator for dogs and cats, more than four years after the Federal Circuit faulted the original $11 million award in the long-running case.
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October 01, 2025
Medtronic Knocks Out Investor Suit Over Insulin Pump Issues
Medical device manufacturer Medtronic PLC has escaped proposed investor class action claims it concealed issues affecting a certain insulin pump it makes, hurting investors after its trading prices fell when the company disclosed it had received a related warning letter from the U.S. Food and Drug Administration.
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October 01, 2025
Monthly Merger Review Snapshot
The Federal Trade Commission put the final tweaks on its deal allowing a $13.5 billion merger of marketing companies to move ahead and pushed its bid to block a merger in the medical device coatings industry, while U.K. enforcers launched a number of merger probes.
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October 01, 2025
Texas Judge Sends Mifepristone Challenge To Missouri Court
A closely watched challenge to federal approvals for the abortion medication mifepristone is moving from Texas to Missouri after a federal judge found the plaintiffs remaining in the litigation have no connection to the Lone Star State.
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October 01, 2025
Ga. Atty DQ'd From 'Extremely Weird' Pharma Fraud Case
A Georgia federal judge said Wednesday she intends to disqualify a prominent defense attorney from representing a man charged with lying to investigators amid a criminal fraud probe into his employer, Hi-Tech Pharmaceuticals Inc., but would allow the company to continue footing his legal bills as he seeks new counsel.
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October 01, 2025
Cozen O'Connor Adds Healthcare Litigator To Philly Office
An attorney with more than three decades of experience representing healthcare providers in litigation matters has recently moved his practice to Cozen O'Connor's Philadelphia shop.
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October 01, 2025
Weil, Morgan Lewis Steer Up To $900M Biopharma Purchase
Biopharmaceutical company Halozyme Therapeutics Inc., led by Weil Gotshal & Manges LLP, on Wednesday announced plans to buy fellow biopharma company Elektrofi Inc., advised by Morgan Lewis & Bockius LLP, for up to $900 million.
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September 30, 2025
McKinsey Trims Endo Suit But Can't Nix Indemnification Claim
A New York bankruptcy judge trimmed an adversary suit Monday claiming McKinsey & Co. Inc. should pay at least $1.5 billion to cover costs bankrupt pharmaceutical developer Endo International racked up defending against opioid claims, tossing nearly all allegations with leave to amend, but greenlighting an indemnification claim.
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September 30, 2025
3rd Circ. Parses 'Could' And 'Would' In Lipitor Lawsuit
A Third Circuit panel questioned Tuesday whether drug wholesalers and health plans had offered enough evidence that Pfizer Inc. and Ranbaxy Laboratories Ltd. conspired to delay generic competition for the cholesterol drug Lipitor, focusing on whether the U.S. Food and Drug Administration would have approved the competitor earlier than November 2011.
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September 30, 2025
Biogen Told To Pay Genentech $88M After IP Royalties Mistrial
Biogen MA Inc. owes Genentech Inc. more than $88 million in royalties related to expired patents, a California federal judge ruled Tuesday in a rare post-mistrial verdict arrangement.
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September 30, 2025
4 Federal Circuit Clashes To Watch In October
The Federal Circuit will hear arguments next week in cases where a nearly $42 million patent win for Seagen hangs in the balance due to a later post-grant review invalidity decision and where Regenxbio is seeking to undo the invalidation of its gene therapy patent for covering a natural product.
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September 30, 2025
Blue Cross Insurers Sanctioned For 2-Year Discovery Drawout
An Illinois federal judge has ordered a host of Blue Cross and Blue Shield insurers to pay the fees and costs Walgreens incurred in an overbilling suit while helping to work through discovery production, which took two years to remediate with a special master.
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September 30, 2025
HHS Moves To Suspend Harvard From Funding
The civil rights office at the U.S. Department of Health and Human Services is moving to cut off Harvard University from future funding, a maneuver legal experts say could stymie healthcare and biomedical research.
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September 30, 2025
Judge Freezes Chinese Cos.' Assets In X-Ray IP Suit
Two Chinese companies were barred from doing business in the United States and had their U.S.-based assets frozen by a Chicago federal judge until they comply with an earlier injunction order, with the judge stopping short of referring the pair and two of their executives for criminal contempt charges.
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September 30, 2025
Hospital Urges Justices To Review 7th Circ. Medicaid Ruling
A Chicago hospital urged the U.S. Supreme Court to take up its petition for review of a Seventh Circuit ruling that had shut down its suit against the state of Illinois seeking enforcement of timely Medicaid payments, saying it's an "excellent opportunity" to address "resulting uncertainties" after a recent ruling against Planned Parenthood.
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September 30, 2025
Pharma Co. Asks Judge To Toss 'Vague' Investor Class Action
Counsel for Marinus Pharmaceuticals Inc. told a Pennsylvania federal judge Tuesday that a shareholder class action alleging the company misled investors about the potential success of an epilepsy drug was based solely on "vague and uncorroborated" statements from confidential witnesses.
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September 29, 2025
Supreme Court Considers 7 Patent Petitions
The U.S. Supreme Court held its first conference Monday, presenting the justices with several petitions of interest to patent practitioners before the court's new term kicks off next week.
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September 29, 2025
Pfizer Says Drugmaker Moving Too Early On Arthritis Generic
Pfizer has asked a Delaware federal court to block generic-drug maker Prinston Pharmaceutical from moving forward with plans to sell a generic version of the arthritis drug Xeljanz that would allegedly infringe Pfizer's patent.
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September 29, 2025
Tribe Drops Price-Fixing Suit Against Drugmakers, PBMs
The Miccosukee Tribe in Florida has dropped its lawsuit alleging drugmakers and pharmacy benefit managers Eli Lilly, Express Scripts, CVS Health and other companies illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a notice of voluntary dismissal.
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September 29, 2025
Honeywell Says Ex-GC's Age Bias Suit Belongs Only In China
A former vice president and general counsel for a Honeywell International Inc. subsidiary is seeking a redo for her age discrimination claims despite the fact that her employment contracts say those claims must be litigated in China, Honeywell told a North Carolina federal court Friday.
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September 29, 2025
CTA Could Face Second Ill. Jury Over Vaccine Bias Allegations
An Illinois federal judge has found there are too many open questions to give a win to the Chicago Transit Authority in a former employee's suit over its decision to terminate him after he sought a religious exemption to the agency's mandatory COVID-19 vaccination policy.
Expert Analysis
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.