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Life Sciences
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September 26, 2025
Stewart Keeps Discretion Duty As Squires Takes On RPIs, AI
In John Squires' first week as U.S. Patent and Trademark Office director, he walked back precedent from the first Trump administration, claimed machine learning should be patent-eligible, and designated Deputy Director Coke Morgan Stewart to continue handling discretionary denial reviews.
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September 26, 2025
Semler Scientific, Bard To Pay $37M To End FCA Claims
The Department of Justice announced on Friday that two companies have agreed to pay nearly $37 million to resolve claims that they knowingly recommended healthcare providers submit erroneous Medicare claims for tests for diagnosing artery disease.
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September 26, 2025
Judge Criticizes Push For Harsher Sentence In CytoDyn Case
A Maryland judge on Friday blasted federal prosecutors for seeking an enhanced sentence for a former biotech executive convicted of fraud for his role in the CytoDyn stock inflation scheme, saying the government wanted a harsher sentence for allegations he was already acquitted of at trial.
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September 26, 2025
CareDx Asks 3rd Circ. To Rethink $45M False Ad Case
Medical testing company CareDx has asked the Third Circuit for a panel rehearing or a rehearing before the entire circuit to consider reinstating a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.
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September 26, 2025
Inotiv Inks $8.75M Investor Deal Over Animal Welfare Claims
Medical research services provider Inotiv Inc. and its shareholders asked an Indiana federal court to approve an $8.75 million settlement to resolve investors' claims the company concealed that its subsidiaries were under investigation by the U.S. Department of Justice for animal welfare and smuggling violations.
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September 26, 2025
Bayer Investors Seek Final OK Of $38M Settlement, Atty Fees
Bayer AG shareholders have asked a California federal judge to give final approval of its $38 million settlement with the German multinational to end claims it downplayed litigation risks related to the weedkiller Roundup, saying the deal, which seeks over $10 million in attorney fees, is fair.
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September 26, 2025
Illumina And Grail Nix Investor Suit Over Failed Deal, For Now
Illumina and Grail on Friday defeated a proposed class action alleging they lied to investors who bought artificially inflated Illumina stock whose prices plunged following several purported disclosures, after a California federal judge said the investors hadn't adequately pled which disclosures corrected any alleged misstatements that caused their losses.
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September 26, 2025
Cellectis, AstraZeneca Face IP Suit From Cell Engineering Co.
A cell engineering company sued pharmaceutical giant Cellectis Inc. on Friday, claiming it had used patented gene-editing protein research technology and purported to license it for use to AstraZeneca.
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September 26, 2025
DC Circ. Won't Stop FDA From Approving Entresto Generic
The D.C. Circuit on Friday shot down Novartis' attempt to block the U.S. Food and Drug Administration's approval of a generic version of its most lucrative drug, the heart disease medication Entresto.
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September 26, 2025
Chemical Plant Spat Must Unfold In NY, NC Court Is Told
A Swiss chemical technology company urged a North Carolina state judge Friday to toss a suit alleging that it bungled work on a $200 million plant, arguing during a hearing that it is not a construction company as defined in a state law undergirding where the claims can be litigated.
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September 26, 2025
High Court Pauses Distribution Of $4B Foreign Aid
The U.S. Supreme Court ruled Friday that the Trump administration can hold onto $4 billion in frozen foreign aid funding while Congress considers a proposal to cut it, pausing a lower court order that required the federal government to spend the money before the end of the month.
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September 26, 2025
Trump Announces 100% Tariff On Drug Imports Starting Oct. 1
President Donald Trump announced a slew of new Section 232 tariffs to be imposed beginning Oct. 1, including a 100% tariff on drug imports and new rates for semi trucks, kitchen cabinets, bathroom vanities and upholstered furniture.
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September 26, 2025
Taxation With Representation: De Brauw, Hengeler Mueller
In this week's Taxation With Representation, power grid operator TenneT Holding sells a stake in its German transmission business to institutional investors, Pfizer Inc. acquires biotechnology company Metsera Inc., and Dutch brewer Heineken NV buys most of Costa Rica's FIFCO beverage and retail operations.
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September 25, 2025
COVID-19 Orders Could Save Embryo Loss Case, Court Hears
Responding to last-minute arguments during a summary judgment hearing, a Connecticut Superior Court judge Thursday ordered attorneys to brief whether COVID-19 executive orders might save a Massachusetts woman's claims that her fertility doctors misplaced or destroyed her frozen embryos.
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September 25, 2025
Judge Plans To Let ITC Take Lead In Apple Watch Patent Fight
A D.C. federal judge said Thursday that she is not inclined to block a U.S. Customs and Border Protection decision permitting Apple Watch imports amid a patent dispute with Masimo Corp., because the U.S. International Trade Commission will soon address the same issue.
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September 25, 2025
Perrigo Mostly Beats US In $163M Tax Refund Dispute
A Michigan federal court largely sided Thursday with pharmaceutical company Perrigo in a $163 million tax refund case, rejecting the government's claim that the company's transactions with a foreign entity lacked economic substance and were meant only to avoid taxes.
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September 25, 2025
MiMedx, FDA Ordered To Rework Args In Wound Care Case
Biomedical company MiMedx Group Inc. and the U.S. Food and Drug Administration have been ordered to reframe their briefs in a suit in which the company seeks to overturn the agency's classification of a wound care treatment as a biological product.
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September 25, 2025
Pa. High Court Backs Two-Lab Rule For Medical Pot Products
The Pennsylvania Supreme Court on Thursday upheld a state rule requiring medical marijuana businesses to test their products at two separate laboratories, finding that the state law's emphasis on public safety empowered regulators to impose the requirement.
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September 25, 2025
Dr. Reddy's To Keep Generic Cancer Drug Off Market Until 2030
Indian pharmaceutical group Dr. Reddy's Laboratories Inc. has agreed to keep its generic version of a cancer drug made by Eisai Ltd. off the market until 2030 as part of a deal to settle the Japanese drugmaker's lawsuit in New Jersey federal court alleging patent infringement.
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September 25, 2025
AstraZeneca Asks High Court To 'Unscramble' Drug Price Law
As legal losses pile up for drug manufacturers in their fight to overturn the Medicare Drug Price Negotiation program, pharma giant AstraZeneca is asking the U.S. Supreme Court to decide if the program infringes on its constitutional rights.
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September 25, 2025
Labcorp Workers Balk At Paying For Expert's Biz Class Airfare
Labcorp shouldn't be reimbursed for its expert witness's round-trip business class flight and other ancillary costs it wants a group of employees to pay after fending off claims that it mismanaged their retirement savings, the workers have told a North Carolina federal judge.
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September 25, 2025
SmartLabs Accused Of Dodging Rent On Cambridge Lab
Boston-headquartered SmartLabs is facing a lawsuit over millions in unpaid rent owed to the landlord of one of its Cambridge facilities, according to a complaint filed in Massachusetts state court.
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September 25, 2025
Depo-Provera MDL Plaintiff Numbers Balloon To 1,300
The plaintiffs in a multidistrict litigation claiming Pfizer failed to warn consumers of a link between brain tumors and the hormonal contraceptive Depo-Provera now number more than 1,300, with more expected to file suits ahead of a hearing Monday on whether their claims are preempted by federal law.
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September 25, 2025
In-House Life Sciences Lawyer Joins WilmerHale In Boston
An attorney specializing in the life sciences will be returning to private practice next month after more than nine years as an in-house counsel for several pharmaceutical and biotechnology companies, joining WilmerHale's Boston office.
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September 25, 2025
Families Cite Trump In Bid To Revive Tylenol Autism Claims
Families suing the maker of Tylenol quickly cited President Donald Trump's words this week as they pushed the Second Circuit to overturn a lower-court ruling that barred their expert witnesses from testifying that prenatal exposure to the medicine can cause autism.
Expert Analysis
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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.
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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.