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Life Sciences
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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March 31, 2025
Former Stimlabs Exec Must Face Trade Secrets Claims
A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.
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March 31, 2025
Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix
Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.
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March 31, 2025
Nasdaq's Tighter IPO Rules Raise Bar For Small Companies
Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.
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March 31, 2025
Buyer Class Of Surgical Robots Is Certified In Antitrust Fight
A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.
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March 31, 2025
J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal
A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.
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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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State Extended Producer Responsibility Laws: Tips For Cos.
As states increasingly shift the onus of end-of-life product management from consumers and local governments to the businesses that produce, distribute or sell certain items, companies must track the changing landscape and evaluate the applicability of these new laws and regulations to their operations, say attorneys at Alston & Bird.
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Law Firm Executive Orders Create A Legal Ethics Minefield
Recent executive orders targeting BigLaw firms create ethical dilemmas — and raise the specter of civil or criminal liability — for the government attorneys tasked with implementing them and for the law firms that choose to make agreements with the administration, say attorneys at Buchalter.
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Firms Must Embrace Alternative Billing Models Or Fall Behind
As artificial intelligence tools eliminate inefficiencies and the Big Four accounting firms enter the legal market, law firms that pivot from the entrenched billable hour model to outcomes-based pricing will see a distinct competitive advantage, says attorney William Brewer.
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Key Issues To Watch As USPTO Changes Abound
As 2025 continues to unfold, changes at the U.S. Patent and Trademark Office — including new leadership, operational reforms, legislative initiatives and AI-related policies — have potential to influence proceedings, including efforts to prosecute patents and adversarial proceedings before the Patent Trial and Appeal Board, say attorneys at Morgan Lewis.
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Trending At The PTAB: A Pivot On Discretionary Denials
Following the U.S. Patent and Trademark Office's rescission of the 2022 Vidal memorandum and a reversion to the standards under Apple v. Fintiv, petitioners hoping to avoid discretionary denials should undertake holistic review of all Fintiv factors, rather than relying on certain fail-safe provisions, say attorneys at Finnegan.
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How Attorneys Can Master The Art Of On-Camera Presence
As attorneys are increasingly presented with on-camera opportunities, they can adapt their traditional legal skills for video contexts — such as virtual client meetings, marketing content or media interviews — by understanding the medium and making intentional adjustments, says Kerry Barrett.
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Patent Drafting Pointers From Fed. Circ. COVID Test Ruling
The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.
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Opinion
Congress Must Reform The PTAB To Protect Small Innovators
Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.
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Series
Baseball Fantasy Camp Makes Me A Better Lawyer
With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.
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Series
Adapting To Private Practice: From Fed. Prosecutor To BigLaw
Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.
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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.
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Series
Performing Stand-Up Comedy Makes Me A Better Lawyer
Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.