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Life Sciences
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September 22, 2025
5th Circ.'s 340B Ruling 'Limited,' Pharma Cos. Tell 4th Circ.
The Fifth Circuit's recent refusal to block a Mississippi law regulating the delivery of discounted drugs to rural providers can't be wielded by West Virginia in its battle over the law's constitutionality because of the distinctions between the two state laws, a coalition of pharmaceutical companies told the Fourth Circuit.
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September 22, 2025
In-House Judge Won't Pause FTC's Heart Valve Deal Challenge
An administrative law judge refused to pause the Federal Trade Commission's in-house case challenging Edwards Lifesciences Corp.'s planned $945 million purchase of JenaValve Technology Inc. until after a ruling in the related federal court case.
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September 22, 2025
J&J Ruling Misapplied Goldman Precedent, 3rd Circ. Told
The U.S. Chamber of Commerce and other business organizations are supporting Johnson & Johnson's call for the full Third Circuit to reconsider a ruling that the groups argue could "saddle" companies with investor class-action suits through the misapplication of a recent U.S. Supreme Court ruling.Â
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September 22, 2025
Catching Up With Delaware's Chancery Court
Last week, Match.com secured approval for a $30M settlement over its 2019 reverse spinoff from IAC, and Vice Chancellor Morgan T. Zurn urged decorum among Delaware lawyers, comparing recent legal turmoil to dark times in British monarchy history. Here's the latest from the Chancery Court.
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September 22, 2025
CVS's Omnicare Hits Ch. 11 After $949M FCA Judgment
Omnicare LLC, CVS Health's subsidiary that provides pharmacy services for long-term care facilities, filed for Chapter 11 bankruptcy relief Monday in Texas following a $949 million judgment against Omnicare and CVS issued by a New York federal judge earlier this year.
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September 22, 2025
Wachtell, Paul Weiss Advise On Pfizer's $7.3B Obesity Path
Pfizer Inc. will acquire Metsera Inc. for $4.9 billion in cash, as the U.S. pharmaceutical giant bets on the biotech firm's experimental treatments for obesity and cardiometabolic diseases, the companies said Monday.Â
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September 22, 2025
ProPhase COVID-19 Testing Units Hit Ch. 11 In NJ
Biotechnology company ProPhase Labs Inc. put three of its COVID-19 laboratory testing subsidiaries in Chapter 11 bankruptcy Monday in New Jersey with combined liabilities of more than $13 million, saying it has been underpaid by insurance companies.
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September 21, 2025
Chinese Exec Who Shipped Fentanyl Ingredients Gets 25 Yrs
A Manhattan federal judge on Friday sentenced a Chinese national and chemical company executive to 25 years in prison for shipping large quantities of fentanyl ingredients to the U.S., citing the defendant's "egregious, callous" disregard for the deaths caused by the drugs he helped create.
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September 19, 2025
Stewart Issues Mixed Bag Of Referrals, Denied Petitions
Coke Morgan Stewart issued some of her final decisions as acting director of the U.S. Patent and Trademark Office, discretionarily denying a host of petitions for Patent Trial and Appeal Board review, while also referring a group of Apple Inc.'s petitions to the board for scrutiny.
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September 19, 2025
Call For Gov't Cut Of University Patent Cash Spurs Concern
Commerce Secretary Howard Lutnick's comments that the government should get as much as half of the revenue that universities generate from patents developed with federal funding have caused worry among industry groups and attorneys, who say it would inhibit efforts to commercialize publicly funded inventions.
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September 19, 2025
Goodwin, Latham Steer E-Commerce Co. Pattern's $300M IPO
Top Amazon.com reseller Pattern Group Inc. kicked off its public-market trading debut on the Nasdaq on Friday with a $300 million initial public offering guided by Goodwin Procter LLP, and Latham & Watkins LLP represented the underwriters, which include Goldman Sachs & Co. LLC and J.P. Morgan.
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September 19, 2025
PTAB Invalidates Johns Hopkins Patent In Keytruda Fight
The Patent Trial and Appeal Board has invalidated an anti-cancer therapy patent owned by Johns Hopkins University, handing a win to challenger Merck Sharp & Dohme LLC in a larger fight relating to Merck's Keytruda treatment.
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September 19, 2025
DA In Gilgo Beach Killings Case Talks Advances In DNA Use
Law360 sat down with Suffolk County, New York, District Attorney Ray Tierney, who is prosecuting architect Rex Heuermann on charges that he murdered seven women on Long Island, to discuss the use of a newer form of DNA testing that has passed rigorous admissibility standards for the first time, among other aspects of the case.
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September 19, 2025
Moderna Wants Fed. Circ. Reversal Of Vax Patent Invalidation
Moderna has told the Federal Circuit that the Patent Trial and Appeal Board got it wrong when it found that the success of the inventions behind two of its COVID-19 vaccine patents challenged by Pfizer and BioNTech didn't outweigh the evidence they were invalid as obvious.
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September 19, 2025
Rite Aid Gets OK To Seek Votes On Dual-Track Ch. 11 Plan
A New Jersey bankruptcy judge on Friday approved drugstore chain Rite Aid's bid to take votes on a Chapter 11 plan as the debtor weighs whether to complete a deal with McKesson Corp. or formally seek to dismiss its bankruptcy case.
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September 19, 2025
CDC Panel Urges Caution On COVID Vax, Punts On Hep B
A panel of advisers at the Centers for Disease Control and Prevention on Friday voted unanimously to recommend that people receiving the COVID-19 vaccine this season do so only after discussing it with their health providers.
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September 18, 2025
Federal Vaccine Panel Votes To Tweak MMRV Recommendation
A panel of federal vaccine advisers on Thursday changed its recommendation for a long-used vaccine for children but allowed a key government program to continue paying for the shots.
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September 18, 2025
Cytokinetics Investor Sues Over Heart Drug Approval Claims
Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.
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September 18, 2025
Brothers Blame Associate For $90M HIV Drug Fraud Scheme
Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.
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September 18, 2025
HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices
Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr.Â
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September 18, 2025
Senate Confirms Squires To Lead USPTO
The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.
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September 18, 2025
Senate Confirms Trump's Pick To Lead DOL Benefits Arm
The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.
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September 18, 2025
Steptoe Adds Jones Day Biotech Patent Pro To NY Office
Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.
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September 18, 2025
Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case
Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.
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September 18, 2025
NJ City Makes 3rd Escape From Pot Co.'s Zoning Suit
For the third time, a New Jersey federal judge has dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its zoning board conspired to deny its application for a medical marijuana store.
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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Pharma Copay Programs Raise Complex Economic Questions
The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.
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State False Claims Acts Can Help Curb Opioid Fund Fraud
State versions of the federal False Claims Act can play an important role in policing the misuse of opioid settlement funds, taking a cue from the U.S. Department of Justice’s handling of federal fraud cases involving pandemic relief funds, says Kenneth Levine at Stone & Magnanini.
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Beaming Up Lessons From William Shatner's Failed Patent Bid
In a tale that boldly goes where few celebrity inventors have gone before, William Shatner's unsuccessful attempt to patent a smartphone file organization system offers insights about potential pitfalls to avoid in patent applications, say attorneys at King & Spalding.
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The Pros And Cons Of Levying Value-Based Fees On Patents
The potential for a recurring, value-based maintenance fee on patents, while offering some benefits, raises several complications, including that it would likely exceed the U.S. Patent and Trademark Office's statutory authority and reduce research and development activities in the U.S., says Sandip Patel at Marshall Gerstein.
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Series
Writing Musicals Makes Me A Better Lawyer
My experiences with writing musicals and practicing law have shown that the building blocks for both endeavors are one and the same, because drama is necessary for the law to exist, says Addison O’Donnell at LOIS Law.
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Between The Lines Of EPO's Adoption Of Color Drawings
The European Patent Office's decision to accept patent drawings in color starting in October may enhance clarity in technical disclosures and streamline the examination process, and could also enable new patent filing strategies for international applicants, say attorneys at Miller Canfield.
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What Prop 65 Ruling Means For Cosmetics, Personal Care Biz
A California federal court's recent decision on Proposition 65 warnings is good news for companies in the cosmetics and personal care space, as it will relieve businesses of the need to apply such warnings to products containing titanium dioxide and likely stop a wave of pending failure-to-warn litigation, say attorneys at Morgan Lewis.
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Series
Adapting To Private Practice: From Va. AUSA To Mid-Law
Returning to the firm where I began my career after seven years as an assistant U.S. attorney in Virginia has been complex, nuanced and rewarding, and I’ve learned that the pursuit of justice remains the constant, even as the mindset and client change, says Kristin Johnson at Woods Rogers.
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2 Fed. Circ. Rulings Underscore Patent Prosecution Pitfalls
Two recent patent decisions from the Federal Circuit, overturning significant judgments, serve as reminders that claim modifications and cancellations may have substantive effects on the scope of other claims, and that arguments distinguishing prior art and characterizing claims may also limit claim scope, say attorneys at Morgan Lewis.
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Rebutting Price Impact In Securities Class Actions
Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.
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7 Document Review Concepts New Attorneys Need To Know
For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.
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Ruling On Labor Peace Law Marks Shift For Cannabis Cos.
Currently on appeal to the Ninth Circuit, an Oregon federal court’s novel decision in Casala v. Kotek, invalidating a state law that requires labor peace agreements as a condition of cannabis business licensure, marks the potential for compliance uncertainty for all cannabis employers in states with labor peace mandates, say attorneys at Sheppard Mullin.
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Fed. Circ. Rulings Refine Patent Claim Construction Standards
Four Federal Circuit patent decisions this year clarify several crucial principles governing patent claim construction, including the importance of prosecution history, and the need for error-free, precise language from claims drafters, say attorneys at Taft.
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How Value-Based Patent Fees May Shape IP Strategies
If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.
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Agentic AI Puts A New Twist On Attorney Ethics Obligations
As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.