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Life Sciences
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August 01, 2025
USPTO Tightens Rules On Patent Challengers' Arguments
Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.
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August 01, 2025
AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care
The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.
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August 01, 2025
En Banc 9th Circ. Backs LA Schools In Vax Mandate Fight
A majority en banc Ninth Circuit has affirmed a lower court's decision upholding Los Angeles Unified School District's COVID-19 vaccine mandate for employees, while two partially dissenting judges disagreed with the majority's conclusion that the policy passes constitutional muster.
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August 01, 2025
States Urge High Court To Keep NIH Grant Funds Flowing
A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.
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August 01, 2025
Monthly Merger Review Snapshot
The U.S. Department of Justice abandoned its challenge of a corporate travel management deal, while lawmakers are calling for scrutiny of the agency's recent decision to settle a different case, and the Federal Trade Commission agreed to nix the requirements placed on a pair of oil and gas deals.
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August 01, 2025
OptumRx Moves To DQ Motley Rice In Utah Opioid Case
Pharmacy benefit manager OptumRx has moved to disqualify Motley Rice LLC from representing the state of Utah in an opioid crisis lawsuit, claiming the firm clearly violated ethical rules by investigating OptumRx on behalf of government entities, then suing OptumRx in a private capacity.
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August 01, 2025
J&J Unit's Catheter Rival Scores Injunction After $442M Win
A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.
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July 31, 2025
Hospitals Want To Duck Pharmacy Career Match Program Suit
A professional pharmacy organization and a group of teaching hospitals teed up motions to dismiss Wednesday against proposed class action allegations that they conspired to restrict wages and benefits by funneling new pharmacists through a job-matching program, telling a Maryland federal judge that there's no sign of an agreement.
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July 31, 2025
Biotech Co. Beats Investor Suit Over Antifungal Drug Recall
Biotechnology company Scynexis Inc. has won dismissal, for now, of a proposed investor class action alleging that it triggered a 34% share decline by knowingly misleading investors about manufacturing compliance issues that led to a drug recall, with the court finding the allegations the company should have known and disclosed issues only show "fraud by hindsight."
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July 31, 2025
Robotic Surgery Co.'s Antitrust Appeal Backed At 9th Circ.
Surgical Instrument Service Co. Inc. has received backing at the Ninth Circuit from a trade association and others groups as it looks to revive its case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot.
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July 31, 2025
18 GOP Sens. Urge Trump To Fill IP Negotiator Post
Eighteen Republican U.S. senators urged President Donald Trump to appoint someone to the vacant role of chief innovation and intellectual property negotiator of the U.S. Trade Representative in order to work to remove what they called "market-distorting price controls" in the pharmaceutical industry.
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July 31, 2025
HHS Plans To Test Rebates In 340B Drug Pricing Program
The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.
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July 31, 2025
Honeywell Ex-GC Claims Age Bias Led To Firing At 55
A Honeywell International Inc. former vice president and general counsel accused the Charlotte-based conglomerate of age discrimination, telling a North Carolina federal court that she was fired for turning 55.
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July 31, 2025
ITC Ends Dermatology Needle Import Ban After Settlement
The International Trade Commission has lifted a ban on certain imports of skin treatment devices that infringed patents owned by a South Korean dermatologist's needle business after it settled with a rival.
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July 31, 2025
J&J Fired Sales Worker Who Reported Pay Issue, Suit Says
Johnson & Johnson wrongly credited a former executive sales representative's sales to another worker, leading to lost earned commissions, and then fired him once he complained, the former employee said in a suit in Texas federal court.
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July 30, 2025
3rd Circ. Won't Upend Investors' Class Cert. In J&J Talc Suit
A split Third Circuit on Wednesday upheld a New Jersey federal judge's class certification order in a Johnson & Johnson investor action alleging the company artificially inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, finding the lower court did not err in concluding that common issues predominate in the suit.
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July 30, 2025
Flo Likely To Get Health Privacy Claim Tossed In Meta Case
The California federal judge overseeing a trial on allegations that Flo Health and Meta Platforms Inc. violated the privacy of millions of women who used Flo's period tracker app said Wednesday he'd likely toss the California Confidentiality of Medical Information Act claim, saying the lack of evidence is an "unsurmountable" problem.
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July 30, 2025
Illumina To Pay $9.8M To Resolve Cybersecurity Qui Tam Case
Biotechnology company Illumina Inc. has agreed to pay $9.8 million in a settlement with the U.S. Department of Justice to put to rest a first-of-its-kind False Claims Act suit alleging the company violated cybersecurity regulations for medical devices, according to an announcement Wednesday.
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July 30, 2025
No Philly Clause Is Valid In Med Mal Case, Pa. Panel Says
A Pennsylvania appellate panel said Wednesday that a contract a patient signed before surgery mandating that any legal actions must be heard in Bucks County is valid and enforceable, affirming a trial court's transfer of the medical malpractice suit from plaintiff-friendly Philadelphia County.
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July 30, 2025
CVS Can't Arbitrate RICO Suit Over Alleged 'No Generic' Policy
CVS effectively forfeited its arbitration rights in proposed class action litigation accusing it of conspiring to block Medicare beneficiaries from accessing generic versions of prescription drugs, a Pennsylvania federal judge ruled in denying the company's bid to enforce an arbitration agreement.
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July 30, 2025
FDA's Vaccine Chief Is Out After Loyalty To Trump Questioned
Dr. Vinay Prasad's tenure as the top vaccine regulator at the U.S. Food and Drug Administration ended abruptly this week following intense criticism from conservative activists who questioned his loyalty to President Donald Trump.
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July 30, 2025
Mich. PBM Opioid Suit Belongs In State Court, Judge Told
Counsel for the State of Michigan argued Wednesday that a lawsuit accusing pharmacy benefit managers Express Scripts and OptumRx of fueling the opioid crisis is not subject to federal officer removal and should be sent back to state court.
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July 30, 2025
ImmunityBio Investors Nab Initial OK On Derivative Suit Deal
A California federal judge has granted initial approval to a deal ending derivative claims that ImmunityBio executives failed to disclose manufacturing deficiencies that doomed the company's lead cancer drug application.
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July 30, 2025
GTCR Denied Rival's Old Sales Prospects Data In FTC Case
An Illinois federal judge refused Tuesday to force a rival medical device coatings company to cough up old sales projections data so private equity firm GTCR BC Holdings can defend against a Federal Trade Commission challenge to its $627 million purchase of Surmodics.
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July 30, 2025
DHS Sinks Docs' Free Speech Suit Over COVID Policies
A Texas federal judge on Wednesday dismissed free speech claims brought against the U.S. Department of Homeland Security and three specialty medical boards by a doctor group claiming the government and boards punished them for disapproving of COVID-19 vaccines and mandates.Â
Expert Analysis
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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.
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Opinion
The BigLaw Settlements Are About Risk, Not Profit
The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.
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Neb.'s Cannabis Regulatory Void Poses Operational Risks
With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.
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Opinion
Courts Must Revitalize Robust Claim Construction
Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.
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What Gene Findings Mean For Asbestos Mesothelioma Claims
Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.
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Series
Brazilian Jiujitsu Makes Me A Better Lawyer
Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.
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Fed. Circ. In April: Introducing New Evidence During IPR
The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.
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FDA Commissioner Speech Suggests New Vision For Agency
In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.
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DOJ Export Declination Highlights Self-Reporting Benefits
The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.
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AG Watch: Texas Expands Use Of Consumer Protection Laws
In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.
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Series
Power To The Paralegals: An Untapped Source For Biz Roles
Law firms looking to recruit legal business talent should consider turning to paralegals, who practice several key skills every day that prepare them to thrive in marketing and client development roles, says Vanessa Torres at Lowenstein Sandler.
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A Path Forward For Colo. Pot Products After Failed Safety Test
As cannabis products in Colorado face increasingly rigorous contamination testing, decontamination and remediation can be an alternative to destruction after a failed safety check, in certain circumstances, so understanding the nuances of these procedures is vital, say attorneys at Troutman Pepper.
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Series
Playing Poker Makes Me A Better Lawyer
Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.
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What EU 'Killer Acquisition' Study Means For Pharma Deals
The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.