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Life Sciences
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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.Â
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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.Â
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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.
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September 02, 2025
Auto Injection, Ypsomed Settle Insulin Pen Patent Dispute
Auto Injection Technologies LLC said Tuesday that it has settled its lawsuit in Texas federal court claiming Swiss drugmaker Ypsomed infringed a pair of drug delivery patents acquired from Sanofi-Aventis.
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September 02, 2025
Speculation Can't Halt Medical Coatings Merger, GTCR Says
GTCR BC Holdings LLC should be allowed to merge the nation's leading medical coatings supplier with the second leading provider because federal regulators spent two weeks simply relying on speculation and theory to prove its losing antitrust case, the private equity subsidiary argued.
Expert Analysis
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Does Research Tool Safe Harbor Cover AI Drug Development?
As artificial intelligence increasingly takes root in drug development, many questions may emerge regarding current gaps in courts' application of the research tool exception to the safe harbor defense against patent infringement, and whether that defense applies to AI-based tools, say attorneys at Arnold & Porter.
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Series
Law School's Missed Lessons: Navigating Client Trauma
Law schools don't train students to handle repeated exposure to clients' traumatic experiences, but for litigators practicing in areas like civil rights and personal injury, success depends on the ability to view cases clinically and to recognize when you may need to seek help, says Katie Bennett at Robins Kaplan.
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Opinion
4 Former Justices Would Likely Frown On Litigation Funding
As courts increasingly confront cases involving hidden litigation finance contracts, the jurisprudence of four former U.S. Supreme Court justices establishes a constitutional framework that risks erosion by undisclosed financial interests, says Roland Eisenhuth at the American Property Casualty Insurance Association.
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How Attys Can Use AI To Surface Narratives In E-Discovery
E-discovery has reached a turning point where document review is no longer just about procedural tasks like identifying relevance and redacting privilege — rather, generative artificial intelligence tools now allow attorneys to draw connections, extract meaning and tell a coherent story, says Rose Jones at Hilgers Graben.
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Leveraging Diligence Findings For Better Life Sciences Deals
Life sciences parties should utilize due diligence strategically to review and draft deal documents, address issues identified during the diligence, and craft solutions to achieve the party's transactional goals, says Anna Zhao at Gunner Cooke.
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IP Due Diligence Tips For AI Assets In M&A Transactions
Artificial intelligence systems' integration into business operations creates new considerations for intellectual property due diligence in mergers and acquisitions and financing transactions, and implementing a practical approach to identifying AI assets can help avoid litigation and losses, say Armin Ghiam and Senna Hahn at Hunton.
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How McKesson Ruling Will Inform Interpretations Of The TCPA
Amid the U.S. Supreme Court's ruling in McLaughlin Chiropractic Associates v. McKesson, we can expect to see both plaintiffs and defendants utilizing the decision to revisit the Federal Communications Commission's past Telephone Consumer Protection Act interpretations and decisions they did not like, says Jason McElroy at Saul Ewing.
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AbbVie Frees Taxpayers From M&A Capital Loss Limitations
The U.S. Tax Court’s June 17 opinion in AbbVie v. Commissioner, finding that a $1.6 billion break fee was an ordinary and necessary business expense, marks a pivotal rejection of the Internal Revenue Service’s position on the tax treatment of termination fees related to failed mergers or acquisitions, say attorneys at Holland & Knight.
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Opinion
New USPTO Leadership Must Address Low-Quality Patents
With John Squires in line to become the new director of the U.S. Patent and Trademark Office, the agency has an opportunity to refocus its mission on prioritizing quality in patent examination and taking a harsher stance against low-quality patents and patent trolls, says Jill Crosby at Engine Advocacy & Foundation.
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Opinion
High Court Must Overrule Outdated Patent Eligibility Doctrine
A certiorari petition should directly ask the U.S. Supreme Court to correct its 1972 patent decision in Gottschalk v. Benson, the critical point where patent eligibility law veered from the statutory text toward judicial policymaking, says Robert Greenspoon at Dunlap Bennett.
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Series
Playing The Violin Makes Me A Better Lawyer
Playing violin in a string quartet reminds me that flexibility, ambition, strong listening skills, thoughtful leadership and intentional collaboration are all keys to a successful legal practice, says Julie Park at MoFo.
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The State Of AI Adoption In The Patent Field
The use of generative artificial intelligence in patent-related practices has lagged behind early predictions, which may be explained by a number of core concerns that organizations must address before seriously considering adoption, say attorney Michael Drapkin and leadership coach Michael Colacchio.
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Purdue Case Could Transform Patent Obviousness Analyses
If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.
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Federal Regs Order May Spell Harsher FDCA Enforcement
A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.
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Series
Law School's Missed Lessons: Practicing Self-Care
Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.