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Life Sciences
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June 10, 2025
Drug Cos. Face Persistent Scrutiny Over Physician Kickbacks
Drugmakers continue to become ensnared in — and settle — investigations into illegal payments to healthcare providers for participating in sham speaker programs. These payments raise ethical questions about patient harm and whether settlements, such as Pfizer's and Gilead's earlier this year, are seen as a cost of doing business.
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June 10, 2025
Catching Up With Delaware's Chancery Court
Delaware's Court of Chancery showed new resistance to suits alleging corporate weaponizing of advance notice bylaws, and a new report highlighted the high fees that attorneys are cashing in on in Delaware courts compared to the federal court system. Several new suits were also filed concerning allegedly under- or overvalued sales and acquisitions being pushed through.
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June 10, 2025
Neurocrine Loses Suit Challenging Hormone Treatment Patent
Neurocrine Biosciences has lost its attempt in Delaware federal court to invalidate a patent owned by biotechnology company Spruce Biosciences Inc. relating to the treatment of a hormonal disorder, after a federal judge tossed the lawsuit.
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June 10, 2025
Biopharma Co. Unit Hopes To Shed Empty Facilities In Ch. 11
A subsidiary of biopharmaceutical manufacturer National Resilience Holdco Inc. filed for Chapter 11 protection Tuesday in Delaware bankruptcy court with a reorganization plan involving shutting down offices, manufacturing sites and labs it described as "underutilized."
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June 10, 2025
Reed Smith Int'l Arbitration Pro Jumps To Bracewell In NYC
Bracewell LLP has added an international arbitration practitioner with more than two decades of BigLaw experience across a range of industries and locations, including most recently as a partner at Reed Smith LLP, to its New York roster, as the firm looks to grow the practice area.
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June 09, 2025
Judge To Limit Experts in Biogen, Genentech Drug Royalty Trial
A California federal judge Monday laid out the ground rules for an upcoming high-stakes jury trial between Biogen and Roche Holding AG subsidiary Genentech over patent royalties on multiple sclerosis drug sales, giving each side nine hours to argue their case and saying she plans to limit expert testimony.
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June 09, 2025
Acadia Win On Parkinson's Drug Patent Upheld By Fed. Circ.
The Federal Circuit on Monday upheld the validity of an Acadia Pharmaceuticals Parkinson's disease drug patent, saying the result was compelled by double-patenting precedent the court set last year, but generics maker MSN Laboratories has suggested it may seek en banc review.
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June 09, 2025
RFK Jr. Fires CDC's Entire 17-Member Vaccine Advisory Panel
The U.S. Department of Health and Human Services announced Monday that Secretary Robert F. Kennedy Jr. removed every member of the committee that provides advice and guidance on the use of vaccines to the Centers for Disease Control and Prevention, pledging to replace them with his preferred picks.
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June 09, 2025
Chinese Student Accused Of Smuggling Roundworms To US
A Chinese student pursuing a doctoral degree in Wuhan has been charged with smuggling roundworms to recipients associated with a University of Michigan laboratory and lying to federal agents about it, according to an announcement Monday by the U.S. Attorney's Office for the Eastern District of Michigan.
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June 09, 2025
Gov't Seeks $706M Penalty In FCA Case Against Omnicare, CVS
The government asked a New York federal judge to impose a collective $706 million in civil penalties on Omnicare Inc. and its parent, CVS Health Corp., after a jury found that they submitted millions of false billing claims for healthcare programs.
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June 09, 2025
Edwards Can't Get Fed. Circ. To Overrule PTAB Amendments
The Patent Trial and Appeal Board rightly held that amended claims of a Cardiovalve Ltd. heart valve implant aren't invalid, the Federal Circuit affirmed Monday.
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June 09, 2025
Investment Firm Lead Admits To Insider Trading Biotech Stock
The former head of equity trading at Denver-based capital markets firm Irving Investors LLC admitted to receiving insider information on multiple companies and using that nonpublic knowledge to guide trading decisions to make an unlawful $220,912 profit, Connecticut U.S. Attorney David X. Sullivan announced.
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June 09, 2025
5th Amendment Can't Shield Ex-Exec, Drugmakers Argue
Generic-drug makers urged Connecticut and Pennsylvania courts to compel a former executive to sit for a deposition in ongoing price-fixing litigation despite his invocation of the Fifth Amendment, arguing his testimony is crucial to their defense.
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June 09, 2025
Fitch Even's Ex-IP Client Wants Firm's Patent Suit Tossed
Prenatal-Hope Inc. and its chief executive officer are asking an Illinois federal judge to dismiss a suit in which law firm Fitch Even Tabin & Flannery LLP seeks a declaration that the CEO isn't the inventor behind a prenatal test patent.
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June 09, 2025
Sheppard Mullin Adds Perkins Coie IP Trio In DC, Chicago
Three Perkins Coie LLP intellectual property partners with deep experience representing clients in the pharmaceutical, biotechnology and related industries have jumped to Sheppard Mullin Richter & Hampton LLP.
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June 09, 2025
AI-Powered Cancer Diagnostics Firm Targets $400M IPO
Caris Life Sciences Inc., a developer of artificial-intelligence enhanced cancer diagnostic tests, on Monday launched plans for an estimated $400 million initial public offering, represented by Latham & Watkins LLP and underwriters counsel Cooley LLP.
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June 09, 2025
Hawaii Gov. Vetoes Medical Marijuana Bill Over Privacy Concerns
Hawaii Gov. Josh Green has vetoed a bill modifying the state's medical marijuana program, saying that it would have impinged the privacy rights of the Aloha State's medical cannabis patients.
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June 09, 2025
Rite Aid Gets Stay Of Appeals From Its Earlier Bankruptcy
The New Jersey bankruptcy judge overseeing Rite Aid's current insolvency case pressed pause Monday on appeals of orders he entered last year in the drugstore chain's previous Chapter 11.
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June 09, 2025
Legal, Compliance Heads Named In Mallinckrodt-Endo Merger
Ahead of finalizing their $6.7 billion merger, Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. announced that Mallinckrodt's current chief legal officer and Endo's chief compliance officer will be a part of the executive team that will drive the formation of what the companies said will be a global pharmaceutical industry leader.
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June 09, 2025
Husch Blackwell Hires 5 Quarles & Brady Life Sciences Pros
Amid its efforts to grow in the life sciences space, Husch Blackwell LLP announced Monday that it has brought on three lawyers and two non-attorney professionals from Quarles & Brady LLP.
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June 06, 2025
Masimo Fights Ex-CEO's Bid To Ax Suit Over $450M Demand
Masimo Corp. fought back against founder Joe Kiani's motion to dismiss the company's Delaware Chancery Court suit seeking a declaration that he's not due a $450 million payout after his ouster as CEO, arguing that bid is an "improper attempt to evade" the Delaware court's jurisdiction.
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June 06, 2025
Patent Office Leader Rejects IPRs Based On 12-Year Wait
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart on Friday turned away a series of challenges to Welch Allyn Inc.'s heart monitor patents, determining petitioner iRhythm Technologies Inc. should have disputed them much earlier.
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June 06, 2025
Circle's Smash IPO Could Pave Way For More Crypto Listings
Stablecoin issuer Circle's explosive debut will likely stimulate more crypto listings and possibly jolt the broader pipeline of initial public offerings, capital markets attorneys say.
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June 06, 2025
Justices Reject Eligibility Appeal On Telemedicine Patents
The U.S. Supreme Court declined Friday to review a decision that telemedicine patents asserted against the U.S. government are invalid for claiming only abstract ideas, in the court's latest refusal to reconsider the standard for determining if inventions are eligible for patents.
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June 06, 2025
J&J Unit's $147M Catheter Antitrust Loss Tripled To $442M
Johnson & Johnson health tech unit Biosense Webster's bill in an antitrust trial was upped from $147 million to $442 million after a California federal jury found it stifled competition by conditioning the provision of cardiac mapping services on purchases of cardiac catheters.
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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In 2nd Place, Va. 'Rocket Docket' Remains Old Reliable
The U.S. District Court for the Eastern District of Virginia was again one of the fastest civil trial courts in the nation last year, and an interview with the court’s newest judge provides insights into why it continues to soar, says Robert Tata at Hunton.
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Parsing A Lack Of Antitrust Info-Sharing Enforcement Clarity
Information sharing among competing firms has recently faced dramatic changes in antitrust agency guidance, while courts grapple with the permissible scope of pricing algorithms, leaving companies in limbo, but potential Trump administration changes could offer some reprieve, say attorneys at Axinn.
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What FCA Liability Looks Like In The Cybersecurity Realm
Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say attorneys Rachel Rose and Julie Bracker.
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Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling
After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.
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How Attorneys Can Become Change Agents For Racial Equity
As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.
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CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits
Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.
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Strategies For Litigating In The Unified Patent Court
Since opening its gates two years ago, the European Unified Patent Court has transformed the patent litigation landscape and global litigation strategies, but parties seeking to take advantage of the court's robust processes must be prepared for the front-loaded character of UPC proceedings, say attorneys at McDermott.
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Series
Running Marathons Makes Me A Better Lawyer
After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.
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Series
Law School's Missed Lessons: Supporting A Trial Team
While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.
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Compliance Essentials To Mitigate AI Crime Enforcement Risk
As artificial intelligence systems move closer to accurately mimicking human decision-making, companies must understand how the U.S. Department of Justice might prosecute them for crimes committed by AI tools — and how to mitigate enforcement risks, say attorneys at Paul Hastings.
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Series
Adapting To Private Practice: From US Attorney To BigLaw
When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.
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Most-Favored Nation Drug Pricing Could Shake Up US Pharma
Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.
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The Ins And Outs Of Consensual Judicial References
As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.
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Opinion
Congress Must Restore IP Protection To Drive US Innovation
Congress should pass the RESTORE Patent Rights Act to enforce patent holders' exclusive rights and encourage American innovation, and undo the decades of patent rights erosion caused by the U.S. Supreme Court's 2006 decision in eBay v. MercExchange, says former Chief U.S. Circuit Judge Paul Michel.
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How Focus On Menopause Care Is Fueling Innovation, Access
Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.