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Life Sciences
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December 02, 2025
Monthly Merger Review Snapshot
The FTC urged a D.C. court to block a deal involving a new heart valve treatment, and courts rejected the commission's monopolization case over Meta's past acquisitions and the agency's challenge of a medical device coatings deal. Here, Law360 looks at the major merger review developments from November.
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December 02, 2025
Defamation Litigation Roundup: FDA, Lively, Alexander Bros.
In this month's review of defamation fights, Law360 highlights a pharmaceutical company's suit against a former U.S. Food and Drug Administration official, as well as the latest decision siding against President Donald Trump in his fights with media companies.
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December 02, 2025
UK Importer Must Pay Tax On PPE, Court Affirms
A logistics company must pay £1.4 million ($1.8 million) in customs duties and value-added tax for personal protective equipment imported from China to the U.K. during the COVID-19 pandemic in 2020, a London court ruled, finding the business failed to comply with regulations to make those goods duty- and tax-free.
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December 02, 2025
Under New Chair, Fed. Vax Panel To Redo Hep B Vote
The new chair of an influential federal vaccine advisory panel is set to lead a vote this week on whether to roll back federal recommendations that newborns get vaccinated against hepatitis B.
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December 02, 2025
Fed. Circ. Erases $41.8M Verdict Over Seagen Cancer Drug IP
The Federal Circuit in a precedential opinion Tuesday reversed a $41.8 million verdict against Daiichi Sankyo for infringing a Seagen breast cancer treatment patent, saying a lower court should have found that the patent didn't adequately describe the claimed invention or enable a skilled person to use it.
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December 02, 2025
Hagens Berman Referred To DOJ For Alleged Misconduct
A Pennsylvania federal judge on Tuesday recommended to the U.S. Department of Justice that it investigate powerhouse plaintiffs firm Hagens Berman Sobol Shapiro LLP's conduct in connection with several since-dropped product liability cases that a special master found to be filed in bad faith.
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December 02, 2025
MVP: Williams & Connolly's David M. Krinsky
David M. Krinsky of Williams & Connolly LLP's life sciences practice represented Pfizer in patent infringement litigation filed by companies like Moderna and Enanta Pharmaceuticals Inc., and won a victory for Merck before the Federal Circuit, earning him a spot as one of the 2025 Law360 Life Sciences MVPs.
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December 02, 2025
CVS Will Pay $37.8M To Settle Insulin Pen Overbilling Claims
CVS has agreed to pay $37.76 million to settle allegations that the major pharmacy retailer violated federal law by overdispensing and overbilling for insulin pens to government healthcare programs, federal prosecutors said Tuesday.
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December 01, 2025
Bristol-Myers Must Face Trimmed $6.7B Celgene Investor Suit
A Manhattan federal judge Monday trimmed UMB Bank's lawsuit accusing Bristol-Myers Squibb of slow-walking the U.S. Food and Drug Administration approval process for three drugs to avoid paying shareholders $6.7 billion owed from its 2019 acquisition of Celgene Corp.
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December 01, 2025
Hospitals Slam HHS' Move From Drug Discounts To Rebates
The American Hospital Association is leading litigation challenging the Trump administration's abrupt changes to a decades-old program governing the distribution of discounted prescriptions to low-income patients, telling a Maine federal court Monday that the government is unlawfully ignoring the costly impacts a rebate system will have on hospitals.
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December 01, 2025
1st Circ. Tosses Omni's Medicare Fraud Suit Over UTI Tests
A First Circuit panel declined to revive Omni Healthcare's False Claims Act suit accusing MD Labs of billing Medicare for unnecessary urinary tract infection tests, explaining in a published opinion Monday that Omni Healthcare's own staff ordered each test — sometimes even replacing doctors' orders for cheaper tests with the pricier ones.
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December 01, 2025
Merck Wants Fed. Circ. Redo On Decision Backing Axed IP
German drugmaker Merck has asked the Federal Circuit to rethink its decision upholding the invalidation of claims in two patents on the blockbuster multiple sclerosis drug Mavenclad, saying the ruling creates a rule where inventors' work can later be used against them.
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December 01, 2025
2nd Circ. Backs Anti-Abortion Groups' Free Speech Rights
New York Attorney General Letitia James can't sue faith-based groups promoting a so-called treatment to reverse medication-induced abortions, finding the groups are likely to succeed on the merits of their First Amendment challenge, the Second Circuit said Monday.
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December 01, 2025
UK To Raise Pharma Spending For US Tariff Protection
The United States and United Kingdom announced a deal Monday that includes a commitment to exclude U.K. pharmaceutical imports from any future U.S. tariff actions while the U.K. will pay higher costs for certain drugs.
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December 01, 2025
FDA Withdraws Proposed Talc Cosmetics Testing Rule
The U.S. Food and Drug Administration on Friday pulled back a proposed rule that would have required cosmetics manufacturers to test for asbestos in their talc products, saying it may have unintended consequences beyond those goods.
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December 01, 2025
Mich. Law Firm's Misrepresentation Voids Policy, Insurer Says
An insurer asked a Michigan federal court to rescind and void a law firm's professional liability policy, saying the firm failed to disclose a potential malpractice claim arising out of its representation of the owner of medical services companies in a racketeering lawsuit and related whistleblower action.
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December 01, 2025
What MDL Judges Can Get Done With A New Civil Rule
As the first federal procedure rule geared toward multidistrict litigation goes into effect, judges will have a new buffet of best practices to guide them, but little in the way of hand-tying mandates.
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December 01, 2025
Squire Patton Brings On DLA Piper Patent Litigator In SF
Squire Patton Boggs LLP is growing its intellectual property team, announcing Monday it is bringing on a DLA Piper patent litigation attorney as a partner in its San Francisco office.
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December 01, 2025
MVP: Sidley's Sally Wagner Partin
Sally Wagner Partin of Sidley Austin LLP represented Stryker Corp. in its $4.9 billion acquisition of the maker of medical technology used to remove blood clots without the need for clot-dissolving drugs, earning her a spot as one the 2025 Law360 Life Sciences MVPs.
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December 01, 2025
Meet The Attys Arguing Gov't Subpoena Power At High Court
Law360 introduces the lawyers appearing at the U.S. Supreme Court on Tuesday in a case focused on an anti-abortion crisis center and a state attorney general's attempt to subpoena details on its donors.
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December 01, 2025
Catching Up With Delaware's Chancery Court
The Delaware Chancery Court saw a slate of corporate law clashes this past week, from fast-moving injunction fights in consumer product and real estate markets to multibillion-dollar oversight claims against crypto executives and fresh battles over control for two sports teams.
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November 26, 2025
Health Plans Defend Renewed Biogen MS Drug Scheme Suit
Health plans claiming Biogen Inc. illegally stifled competition for its multiple sclerosis drug Tecfidera have said an Illinois federal judge should let their latest complaint proceed to discovery because it fixes earlier pleading deficiencies and better outlines the drugmaker's allegedly anticompetitive scheme.
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November 26, 2025
Calif. Cannabis Workers Settle Suit Over Quotas, Lack Of Pay
Hourly agricultural laborers who accused California cannabis company Glass House Brands Inc. and some of its subsidiaries of bilking them out of sick pay, minimum wage and lunch breaks while enforcing quotas have agreed to settle what is left of their state court labor violation lawsuit for $305,000.
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November 26, 2025
Paratek Beats Suit Alleging $462M Sale Built On D&O Interests
A Delaware vice chancellor tossed investor challenges to Paratek Pharmaceuticals' $462 million sale to Gurnet Point Capital and Novo Holdings, saying it was not reasonably conceivable that directors and officers undermined better deal prospects in order to protect personal interests.
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November 26, 2025
GTCR Drops FTC Constitutional Challenge Over Merger Case
GTCR BC Holdings LLC has agreed to dismiss its constitutional claims against the Federal Trade Commission after enforcers dropped their case challenging the private equity firm's $627 million purchase of medical device coatings company Surmodics Inc.
Expert Analysis
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2 Fed. Circ. Rulings Underscore Patent Prosecution Pitfalls
Two recent patent decisions from the Federal Circuit, overturning significant judgments, serve as reminders that claim modifications and cancellations may have substantive effects on the scope of other claims, and that arguments distinguishing prior art and characterizing claims may also limit claim scope, say attorneys at Morgan Lewis.
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Rebutting Price Impact In Securities Class Actions
Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.
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7 Document Review Concepts New Attorneys Need To Know
For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.
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Ruling On Labor Peace Law Marks Shift For Cannabis Cos.
Currently on appeal to the Ninth Circuit, an Oregon federal court’s novel decision in Casala v. Kotek, invalidating a state law that requires labor peace agreements as a condition of cannabis business licensure, marks the potential for compliance uncertainty for all cannabis employers in states with labor peace mandates, say attorneys at Sheppard Mullin.
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Fed. Circ. Rulings Refine Patent Claim Construction Standards
Four Federal Circuit patent decisions this year clarify several crucial principles governing patent claim construction, including the importance of prosecution history, and the need for error-free, precise language from claims drafters, say attorneys at Taft.
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How Value-Based Patent Fees May Shape IP Strategies
If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.
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Agentic AI Puts A New Twist On Attorney Ethics Obligations
As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.
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Using Reissue Applications To Strategically Improve Patents
Though reissue applications are an often-overlooked consideration in today's patent environment, they can offer powerful tools for correcting errors, strengthening patent protection, or adapting to evolving business and legal landscapes, says Curtis Powell at Wolf Greenfield.
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FDA Transparency Plans Raise Investor Disclosure Red Flags
The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.
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Series
Being A Professional Wrestler Makes Me A Better Lawyer
Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.
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Patent Claim Lessons From Fed. Circ.'s Teva Decision
The Federal Circuit's recent decision in Janssen v. Teva is an important precedent for parties drafting patent claims or litigating obviousness where the prior art has potentially overlapping ranges for a claimed element, and may be particularly instructive to patent applicants in the pharmaceutical field, say attorneys at Cooley.
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Series
Law School's Missed Lessons: Adapting To The Age Of AI
Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.
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Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning
A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.
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DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech
The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.
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Future-Proof Patent Law By Starting Talent Pipelines Early
Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.