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Life Sciences
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September 29, 2025
House GOP Lawmakers Back ITC Import Ban Won By Oura
A group of House Republicans want the U.S. Trade Representative to uphold the U.S. International Trade Commission's decision to block Ultrahuman and RingConn from importing products it held infringed an Ouraring Inc. wearable computing device patent.
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September 29, 2025
No New Trial In Eyedrop TM Case, But Damages Cut To $11M
A California federal judge has rejected a motion for a new trial in a trademark case between eyedrop makers after a jury awarded one side $35 million, saying there was plenty of evidence to support a finding of infringement while reducing the damages award to about $11.2 million.
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September 29, 2025
6th Circ. Won't Revive Software Development IP Case
The Sixth Circuit has declined to revive copyright infringement and trade secrets claims brought by a business communications company over a software development tool, saying the company waited too long to look into its concerns that a rival was distributing a modified version of the software.
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September 29, 2025
Terumo Secures $5M Cost Award After Beating Cancer Claims
A Colorado state judge has granted a healthcare company over $5 million in costs following the company's win in its first bellwether trial against Lakewood residents who claim its medical sterilization facility caused their cancer.
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September 29, 2025
Catching Up With Delaware's Chancery Court
A Delaware vice chancellor expressed disappointment and concern over what she says is a "breakdown" in "civility and respect" that has emerged in recent Delaware corporate litigation. A $30 million settlement was approved in the five-year running Match.com reverse spinoff suit, and the top brass of Estée Lauder were hit with a derivative suit for allegedly covering up the company's reliance on prohibited, duty-free "gray market" sales of its products in China.
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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.
Expert Analysis
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.