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Life Sciences
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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.
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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.
Expert Analysis
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Associates Can Earn Credibility By Investing In Relationships
As the class of 2025 prepares to join law firms this fall, new associates must adapt to office dynamics and establish credible reputations — which require quiet, consistent relationship-building skills as much as legal acumen, says Kyle Forges at Bast Amron.
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Puzzling Out When Similar Insurance Claims Are Related
A recent decision in Virginia federal court shows that more than identical allegations of negligent business practices across two lawsuits may be necessary to satisfy the strict definition of relatedness under claims-made liability insurance policies, say attorneys at Hunton.
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A Shifting Trend In FDA Form 483 Disclosure Obligations
A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.
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Trending At The PTAB: IPR Memo And Its Fed. Circ. Backdrop
There are new rules for when and how evidence other than patents or printed publications can be considered in inter partes reviews, and while this change is intended to reflect current Federal Circuit precedent, the U.S. Patent and Trademark Office's memo seems to acknowledge tension with last month's Shockwave decision, say attorneys at Finnegan.
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Lessons From 7th Circ.'s Deleted Chat Sanctions Ruling
The Seventh Circuit’s recent decision in Pable v. Chicago Transit Authority, affirming the dismissal of an ex-employee’s retaliation claims, highlights the importance of properly handling the preservation of ephemeral messages and clarifies key sanctions issues, says Philip Favro at Favro Law.
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Breaking Down The Proposed Hemp Bill
A proposed bill in the U.S. House of Representatives, recently approved by the House Appropriations Committee, contains a rider that would significantly change the definition of hemp and dramatically reshape the current hemp-derived product market, say attorneys at King & Spalding.
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Assessing Federal Securities Class Action Stats In '25 So Far
The settlement amount as a percentage of damages in securities class actions has continued to decline in the first half of 2025, a trend that may be important for assessing exposure and risk in future securities litigation, say analysts at Analysis Group.
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Series
Quilting Makes Me A Better Lawyer
Turning intricate patterns of fabric and thread into quilts has taught me that craftsmanship, creative problem-solving and dedication to incremental progress are essential to creating something lasting that will help another person — just like in law, says Veronica McMillan at Kramon & Graham.
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How Agentic AI Is Testing The Limits Of Patent Law
While a recent Swiss court ruling suggests that human-centric rules regarding inventorship will likely remain in place for the near future, it captures a core tension confronting patent systems worldwide as the technology producing patent-worthy ideas is becoming increasingly autonomous, says Matthew Carey at Marshall Gerstein.
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How To Prep For Potential Passage Of SAFER Banking Act
The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.
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A Former PTAB Judge Weighs The End Of Remote Hearings
Former Patent Trial and Appeal Board Judge Amanda Wieker, now at McGuireWoods, examines the costs and benefits of the PTAB's impending in-person hearing requirement, and offers suggestions for making the most out of this new regime.
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The Future Of Lab-Test Regs After FDA Rescinds Rule
The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.
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SDNY Ruling Reinforces Joint Steering Committee Obligations
The recent Southern District of New York decision in ChemImage v. Johnson & Johnson makes joint steering committees a valuable tool in strategic relationships, as provisions for such committees can now be wielded to demand attention to core issues, say Lisa Bernstein at the University of Chicago Law School, and Reginald Goeke and Brad Peterson at Mayer Brown.
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What 2 Profs Noticed As Transactional Law Students Used AI
After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.
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What Patent Claim 'Invalidity' Means In Different Forums
A recent Federal Circuit order allowing a patent suit to proceed despite similar claims being invalidated in an inter partes review underscores how fractured the patent litigation landscape has become, leading to critical nuances in how district courts, the U.S. International Trade Commission and Patent Trial and Appeal Board treat invalidity, says Jason Hoffman at BakerHostetler.