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Life Sciences
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence
A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Generic Drug Org Backs MSN In High Court Entresto Appeal
The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.
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September 04, 2025
GSK Adds Moderna's New COVID Vaccine To Del. IP Suit
GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.
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September 04, 2025
Why The Harvard Funding Case Is 'Clear As Mud' On Appeal
A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.
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September 04, 2025
Sterne Kessler Adds Ex-Deputy Chief PTAB Judge
The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.
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September 04, 2025
DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive
The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.
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September 04, 2025
Monthly Merger Review Snapshot
The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.
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September 04, 2025
Robitussin Maker Must Face Woman's Lung Infection Suit
A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.
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September 04, 2025
PBMs Look To Toss FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."
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September 04, 2025
RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.
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September 04, 2025
3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases
The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.
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September 04, 2025
Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks
After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.
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September 04, 2025
Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans
Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.
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September 04, 2025
Ohio Cannabis Card Network Sued Over Faulty Cybersecurity
An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.
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September 03, 2025
7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit
The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government.
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September 03, 2025
9th Circ. Won't Revive Genentech Ex-Worker's 401(k) Suit
The Ninth Circuit will not reconsider whether fiduciaries for the retirement plan of biotechnology company Genentech violated their duty to be prudent by keeping certain target date retirement funds in the company's retirement portfolio.
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September 03, 2025
Fla. Surgeon General Pushes To End State's Vaccine Mandates
Florida's surgeon general on Wednesday said he intends to work toward undoing all of the state's vaccine mandates, including for schoolchildren.
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September 03, 2025
Judge Backs Harvard In Suit Over Trump's $2B Fund Freeze
The Trump administration illegally froze more than $2 billion in grants earmarked for Harvard University when it failed to offer an explanation as to how cutting the funds addressed the government's stated goal of ending antisemitism on campus, a Massachusetts federal judge ruled Wednesday.
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September 03, 2025
Novartis Inks Up To $5.2B Deal With Chinese Cardio Biotech
China's Argo Biopharmaceutical Co., a biotechnology company developing RNA-based medicines, said Wednesday it has struck an up to $5.2 billion deal with Novartis to advance several treatments for heart and blood vessel conditions.
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September 03, 2025
NC Panel Revives Biotech Co.'s Legal Malpractice Case
A divided North Carolina appellate panel on Wednesday partially revived a biotech company's case accusing its former counsel of botching its defense in a $26 million defamation suit, finding the refiled complaint is not barred by the state's four-year statute of repose on legal malpractice claims.
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September 03, 2025
Insurer Escapes Duty To Cover Lab's Suit Over COVID Tests
Continental Casualty Co. is not obligated to cover a Pennsylvania laboratory in an underlying lawsuit brought by a COVID-19 test manufacturer that accuses the lab of neglecting its responsibilities and falsely disparaging its tests, a Pennsylvania federal judge ruled Friday, finding the claims are barred due to two exclusions within the insurer's policy.
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September 03, 2025
Judge Accepts DNA Evidence In Gilgo Beach Case
A New York state court judge ruled Wednesday that DNA evidence allegedly linking accused Gilgo Beach serial killer Rex Heuermann to the bodies of women found dead on Long Island can be considered by a jury, marking the first time the scientific technique known as whole genome sequencing has passed such rigorous admissibility standards.
Expert Analysis
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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.
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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.