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Life Sciences
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March 31, 2025
Despite 'Admirable' Effort, Vertex Kickback Challenge Fails
A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.
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March 31, 2025
Pierson Ferdinand Adds Taylor English Health Pro In Atlanta
Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.
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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.
Expert Analysis
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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.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.