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Life Sciences
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August 05, 2025
Ex-USPTO Heads, Judges Oppose Anti-Patent Thicket Bill
A pro-innovation group composed of former U.S. Patent and Trademark Office officials and former Federal Circuit judges on Tuesday asked Congress to oppose a bill introduced last month that would limit so-called patent thickets used by pharmaceutical companies to restrict the production of generic counterparts to their drugs.
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August 05, 2025
Stewart Won't Reconsider Her 1st Settled Expectations Denial
The acting U.S. Patent and Trademark Office director on Tuesday stood by her first-ever decision that an older patent shouldn't have to face Patent Trial and Appeal Board scrutiny.
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August 05, 2025
Lead Kicked From Pharma Investor Case Over Rogue Emails
The lead plaintiff in a securities class action against Spectrum Pharmaceuticals in Manhattan federal court was removed from the case Tuesday when a federal judge found he broke confidentiality rules by going behind his lawyers' backs in an attempt to push his own settlement plan and fixating on unrelated conspiracy theories.
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August 05, 2025
A Free Exercise 'Blueprint' In Colo. Abortion Reversal Order
A Colorado federal judge's decision to allow medication abortion "reversals" on free exercise grounds could serve as a model for other lawsuits meant to legitimize a practice that is outside the standard practice of medicine.
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August 05, 2025
Rising Star: Baker McKenzie's Piotr Korzynski
Piotr "Pete" Korzynski, a partner at Baker & McKenzie LLP and a go-to attorney for complex, international life sciences mergers and acquisitions, is recognized for his technical skill and client dedication, notably leading Olink's $3.1 billion acquisition by Thermo Fisher Scientific and Lundbeck's $2.6 billion acquisition of Longboard Pharmaceuticals and doing significant pro bono work, earning him a spot among the mergers and acquisitions attorneys honored by Law360 as Rising Stars.
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August 05, 2025
Teva Settles Claims Over Delayed Generic Asthma Inhalers
Teva Pharmaceuticals has settled a 2023 lawsuit by a coalition of union healthcare funds accusing the company of thwarting the introduction of a generic version of its QVAR inhalers to the market, according to a filing in Massachusetts federal court.
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August 05, 2025
Fla. Biz Won't Sell Knockoff Weight Loss Drugs After AG Deal
A string of Florida companies and their owner have agreed to stop selling what Connecticut authorities called "bootleg" GLP-1 weight loss drugs nationwide and enter into a $300,000 settlement, records in a consumer protection enforcement action show.
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August 05, 2025
Pharma Startup Claims Lupin Stole Inhaler Trade Secrets
Pharmaceutical startup Transpire Bio has accused Lupin Pharmaceuticals and its affiliates of stealing trade secrets related to the development of generic inhalers, alleging in a Florida federal complaint that a Lupin scientist briefly took a job with Transpire and returned to Lupin with confidential information.
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August 05, 2025
Gibson Dunn, Wachtell Advise On $1.5B Vision Implant Deal
Global eye care company Alcon announced Tuesday that it has agreed to acquire STAAR Surgical Co. for approximately $1.5 billion in cash, aiming to broaden its portfolio in the growing surgical vision correction market.
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August 04, 2025
Trump's Sons Back 'New America' SPAC's $300M IPO Filing
Donald Trump Jr. and Eric Trump are backing a new special-purpose acquisition company that, with guidance from Paul Hastings LLP and Holland & Knight LLP, plans to raise $300 million and will target the technology, healthcare and logistics sectors, according to a Securities and Exchange Commission filing on Monday.
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August 04, 2025
MOVEit Data Breach MDL Advances With Slimmed Frame
A Massachusetts federal judge has pared down but declined to toss sprawling multidistrict litigation over a data breach tied to Progress Software's MOVEIt file transfer tool, with negligence and several other claims allowed to proceed against the software vendor and four bellwether groups of companies that used the tool.
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August 04, 2025
GTCR Says Buyer In Place For Potential FTC Divestiture Deal
Private equity firm GTCR BC Holdings told an Illinois federal court it has a signed agreement with a buyer for a deal that should fix the concerns raised by the Federal Trade Commission over its planned $627 million purchase of a medical device coatings company.
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August 04, 2025
Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling
The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.
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August 04, 2025
Chemical Group Says Fluoride Judge Got It Wrong
The American Chemistry Council told the Ninth Circuit that a California federal judge who ruled that current limits on fluoride in drinking water aren't protective enough misinterpreted the Toxic Substances Control Act and urged reversal of his decision.
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August 04, 2025
Investors Say Novo Nordisk Misled Them Over Drug Demand
Novo Nordisk was hit with a proposed securities class action in New Jersey federal court alleging the company misled investors over its revenue outlook for 2025 by allegedly overstating the likelihood patients would switch to its branded diabetes and weight loss drugs.
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August 04, 2025
Moderna Seeks To Be Cleared In $5B COVID Vax Patent Case
Moderna has urged a Delaware federal judge to clear it in a rival mRNA developer's $5 billion patent suit over the company's COVID-19 vaccines, saying it is shielded because it made them for the federal government.
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August 04, 2025
Rising Star: Keker's Bailey Heaps
Bailey Heaps of Keker Van Nest & Peters LLP helped two chemistry professors defeat a lawsuit centering on the commercialization of a scientific breakthrough and won an $80 million verdict in a dispute over a milestone payment, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 04, 2025
Barnes & Thornburg Adds Leader Of FDA Practices At 2 Firms
Barnes & Thornburg LLP has hired the former leader of both Husch Blackwell LLP and Michael Best & Friedrich LLP's U.S. Food and Drug Administration-focused practices who brings a perspective to its Washington, D.C., office that includes working at the agency for more than a decade.
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August 04, 2025
Healthcare Investor Clinches $1.86B For 5th Credit Fund
Healthcare investment firm OrbiMed, advised by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP, on Monday announced that it wrapped its latest fund after securing $1.86 billion of investment commitments, which will be used to partner with healthcare companies across various sectors.
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August 04, 2025
Ex-FDA Chief Of Staff Joins Hogan Lovells' Pharma Team
The former chief of staff at the U.S. Food and Drug Administration, who most recently was a senior policy adviser there in the commissioner's office, has joined Hogan Lovells' Washington, D.C., team as a partner, the firm announced Monday.
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August 01, 2025
Meta Illegally Recorded Flo Users' Data, Calif. Jury Finds
A California federal jury Friday found Meta Platforms Inc. liable for violating the state's wiretap law by using a data analytics tool to retrieve sensitive health data from users of the popular menstrual tracking app Flo, in what plaintiffs' counsel called "one of the first times" a major tech company has been held accountable for such practices.
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August 01, 2025
Wheeling & Appealing: Midyear Highlights For Every Circuit
In this special edition of Wheeling & Appealing, we're spotlighting key decisions and developments in every circuit court during the first half of 2025, while also previewing August's most intriguing oral arguments, including a remarkably "fierce" showdown between Edible Arrangements and 1-800-Flowers with millions of dollars in attorney fees on the line.
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August 01, 2025
IP Owners Largely Win In Stewart's Newest Discretion Orders
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart dismissed most of the 50 petitions for inter partes review addressed in her latest decisions over discretionary denials at the Patent Trial and Appeal Board.
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August 01, 2025
USPTO Tightens Rules On Patent Challengers' Arguments
Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.
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August 01, 2025
AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care
The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.
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.