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Life Sciences
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March 31, 2025
Cleary Gains 5-Atty Latham Team Known For Big IP Wins
Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.
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March 28, 2025
Colo. Beats Amgen's Drug Price Cap Challenge, For Now
A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.
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March 28, 2025
Janssen Owes Additional $1.5B In HIV Prescription Trial
A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."
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March 28, 2025
PE Firm Hits Back Against Medical Device Coating Challenge
Private equity firm GTCR BC Holdings LLC told a Federal Trade Commission in-house judge Friday the commission has a warped view of the medical device coatings market, as the firm fights a bid to block its $627 million acquisition of Surmodics Inc.
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March 28, 2025
Purdue Lawsuit Injunction Extended Ahead Of Plan Hearings
Bankrupt drugmaker Purdue Pharma LP received a further extension of a bar on litigation against the company and its owners in the Sackler family as the debtor pursues a late May approval of a disclosure statement describing a Chapter 11 plan premised on a $7.4 billion settlement of opioid claims.
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March 28, 2025
Pot Co.'s Challenge To DEA Admin Procedures Dismissed
A Rhode Island federal judge on Friday dismissed a cannabis company's challenge to the lawfulness of U.S. Drug Enforcement Administration internal administrative law proceedings, finding that the company had failed to show how those procedures would harm it.
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March 28, 2025
13 Drugmakers Seek Dismissal Of Aetna's Price-Fixing Claims
Thirteen pharmaceutical companies asked a Connecticut state judge to throw out health insurer Aetna Inc.'s suit alleging that they conspired to fix the prices of more than 100 generic medications, with most saying the Constitution State is not the proper forum for the claims.
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March 28, 2025
Labcorp Denied Early Win In 401(k) Fee Suit
A North Carolina federal judge denied Labcorp's motion for an early win Friday in a class of employee 401(k) participants' suit alleging their retirement savings were mismanaged, citing the parties' factual disputes over whether recordkeeping fees and investment offerings violated federal benefits law.
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March 28, 2025
Azzur Judge OKs At Least $1.3M In Potential Exec Bonuses
A Delaware bankruptcy judge on Friday approved Azzur Group Holdings LLC's plan to award company executives at least $1.3 million if a Chapter 11 sale yields at least $56 million in proceeds, over the objection of the U.S. Trustee's Office, which flagged a potential conflict of interest for an independent manager.
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March 28, 2025
3rd Circ. Preview: April Arguments Feature Class Action Rows
The Third Circuit's April argument lineup springs into action with securities litigation brought by Walmart investors claiming they were misled about the government's opioid investigation into the company, and a bid to upend an attorney fee award stemming from the settlement of data breach litigation against convenience store chain Wawa.
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March 28, 2025
Fed. Circ. Upholds Janssen's Patent Case Win Over Mylan
The Federal Circuit declined on Friday to undo a lower court ruling that kept Mylan Laboratories Ltd. from releasing a generic version of Janssen Pharmaceuticals Inc.'s schizophrenia drug Invega Trinza, rejecting Mylan's challenge to a finding that the generic drug would cause physicians to infringe a patent covering its dosing regimen.
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March 28, 2025
CureVac RNA Vax Patent Survives BioNTech's EU Challenge
CureVac SE has fended off a challenge from BioNTech SE of its mRNA therapy patent at a European patent authority, paving the way for CureVac to forge ahead with litigation in the companies' home country of Germany accusing BioNTech of infringing its invention.
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March 28, 2025
Taxation With Representation: Norton Rose, Latham, Ashurst
In this week's Taxation With Representation, Dollar Tree sells its Family Dollar business to private equity firms, eye care company Alcon buys medical technology company Lensar and Ithaca Energy PLC buys the U.K. subsidiary of Japan Petroleum Exploration Co. Ltd.
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March 28, 2025
Jury Clears Lab Owners In $40M COVID Test Fraud Case
A Florida jury found two testing lab co-owners not guilty of conspiracy, health care fraud and wire fraud after a nearly four-week-long trial on the government's claims the duo conspired with others to overbill healthcare benefit programs for COVID-19 tests to the tune of $40 million.
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March 27, 2025
Diopsys Inks $14M Deal Resolving Vision Testing FCA Claims
Medical device maker Diopsys Inc. has agreed to pay up to $14.25 million to put to rest allegations it violated the False Claims Act by submitting false Medicare and Medicaid claims for certain vision testing services, according to a U.S. Department of Justice announcement Thursday.
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March 27, 2025
New Procedures Expected To Result In More PTAB Denials
Under new procedures where the director of the U.S. Patent and Trademark Office will decide whether petitions challenging patents should be denied for discretionary reasons, such denials will likely increase, although the policy leaves many unanswered questions, attorneys say.
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March 27, 2025
Vaping Interests Take Challenge To FDA Rule To 5th Circ.
A coalition of vaping interests challenging the U.S. Food and Drug Administration's marketing and recordkeeping regulations has taken the dispute to the Fifth Circuit after a lower district judge tossed the lawsuit, which claimed many in the industry were prohibited from seeking FDA approval for multiple products at once because of the high cost of applying.
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March 27, 2025
Fertility Co. Wants To Pull Device Maker Into Negligence Suit
A fertility products company wants two other companies to share potential liability from a Connecticut state lawsuit alleging that a recalled culture medium was responsible for the loss of embryos a couple were planning to use for in vitro fertilization.
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March 27, 2025
Texas Judge 'Disturbed' By Filings In Weight Loss Drug Case
A Texas federal judge had stern words for a group of compounding pharmacies while refusing to allow them to manufacture Eli Lilly's lucrative weight loss drug, saying he was "increasingly exasperated" with the pharmacies' attempts to dictate how he manages the case.
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March 27, 2025
Fed. Circ. Revives Recor's PTAB Challenge To Medtronic IP
The Federal Circuit on Thursday revived medical technology company Recor Medical's challenge to a Medtronic Ireland Manufacturing patent on a way to treat heart and renal failure, telling the Patent Trial and Appeal Board to once again review the fight.
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March 27, 2025
Fitch Even Sues Ex-IP Client In Effort To End Malpractice Case
Fitch Even Tabin & Flannery LLP has launched a lawsuit asking an Illinois federal court to declare that the co-founder of a former client isn't the inventor behind a prenatal test patent, which the firm said would put a stop to a malpractice case against it in state court.
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March 27, 2025
Oura Gets Samsung's Preemptive IP Strike Tossed, For Now
Samsung Electronics cannot yet seek a declaration that its Galaxy Ring brand of wearable, health-tracking devices does not infringe Oura Health's smart ring patents, a California federal judge ruled Thursday, saying Samsung hasn't shown the Finnish company is threatening to sue for infringement.
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March 27, 2025
Ga. Therapy Clinic Accused Of Refusing OT Payments
A Georgia mental health clinic was sued Wednesday by a former aide who alleged that she was forced to resign her position with the company last year when it refused to give her thousands of dollars of overtime pay she claims she was owed.
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March 27, 2025
Eli Lilly Says Michigan AG's Insulin Pricing Probe Is Baseless
Michigan Attorney General Dana Nessel's case for investigating Eli Lilly's insulin prices is based on fundamentally flawed premises, such as comparing what consumers pay in Michigan to Canada, the drugmaker has told the Michigan Supreme Court in a new brief.
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March 27, 2025
Walgreens To Pay $2.8M For Alleged Medicaid Overcharges
Walgreens will pay $2.8 million under an agreement with federal prosecutors to settle allegations that it submitted inflated prices for some generic medications to Medicaid programs in Massachusetts and Georgia.
Expert Analysis
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.