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Life Sciences
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March 18, 2025
ITC To Review Whether Tourniquet Importers Are Ignoring Ban
The U.S. International Trade Commission said that it is going to look into claims from a tourniquet maker that importers are ignoring a ruling last year that banned foreign counterfeit products.
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March 18, 2025
Full 9th Circ. Mulls Reviving Workers' LA Schools Vax Fight
Unvaccinated workers urged an en banc Ninth Circuit panel Tuesday to affirm a split decision reviving their proposed class action challenging a since-rescinded Los Angeles Unified School District's employee COVID-19 vaccine policy, while the district's counsel defended the policy as necessary and prudent, but also argued the case is moot.
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March 18, 2025
Drugmaker's $10.5M Deal In Investor FDA Approval Suit OK'd
A California federal judge has preliminarily approved a $10.5 million settlement between oncology drug company ImmunityBio and investors who claim they were misled over the likelihood the U.S. Food and Drug Administration would approve the company's bladder cancer drug.
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March 18, 2025
HHS Seeks Early Win Over Lilly, Novartis, BMS In Rebate Row
The U.S. Department of Health and Human Services urged a D.C. federal judge Monday to grant it an early win against behemoth drugmakers' claims that it unlawfully blocked their plans to offer after-the-fact rebates, rather than up-front discounts, to safety-net hospitals via a decades-old federal drug pricing program.
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March 18, 2025
Lab Co-Founder Takes Stand For Gov't In $40M Testing Case
A co-founder of a laboratory accused of submitting $40 million in unnecessary COVID-19 and genetic testing claims to healthcare benefit programs took the stand for the government on Tuesday, first testifying that the lab used an unauthorized test to cut corners and save money before admitting on cross-examination that the test was chosen because it performed better.
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March 18, 2025
J&J Denies 'Evil Motive' In Face Of $30M Talc Damages
Johnson & Johnson did not act with the kind of "evil motive" that would justify a $30 million punitive damages award to a Connecticut man who won a lawsuit alleging its talc products caused his lung cancer, the company argued Tuesday in state court.
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March 18, 2025
Ga. Hospital Failed To Protect Data Of 120K, Patient Says
A former patient of a southwest Georgia hospital hit the provider with a proposed class action Monday over a data breach last year, alleging that it failed to secure 120,000 customers' personal information before it was filched in a cyberattack.
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March 18, 2025
Bausch Eye Vitamin Case Should Go To Jury, Judge Says
The maker of eye care product MacularProtect shouldn't get a ruling clearing it from allegations it infringed Bausch & Lomb patents related to its PreserVision vitamin based on a doctrine allowing patent holders to claim infringement if an accused product is similar enough to the patented invention, a federal magistrate judge in Delaware has said.
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March 18, 2025
MilliporeSigma Says Rival Raided Workers Under Non-Solicits
Life sciences company MilliporeSigma is accusing direct competitor Solvias USA of raiding its roster to hire away several top sales executives, all of whom were still subject to non-solicitation agreements, according to a lawsuit filed Tuesday in Massachusetts state court.
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March 18, 2025
AI Healthcare Co. Accuses Test-Maker Of Infringing Patents
Artificial intelligence-powered diagnostics company Tempus AI has accused medical test-maker Guardant Health of infringing numerous patents related to healthcare records platforms and ways of pinpointing patient biomarkers.
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March 18, 2025
States Oppose Term In Sandoz Price-Fixing Deal With Fla.
State enforcers still locked in price-fixing litigation against generic-drug maker Sandoz are raising objections to a cap on what they could win through settlements in Florida's recent agreement with the company, telling the Connecticut federal judge weighing approval that it would block or delay potential settlements of their own.
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March 18, 2025
Indirect Effexor Buyers Seek Approval Of $2.3M Antitrust Deal
A proposed class of indirect drug purchasers have asked a New Jersey federal judge for his initial sign-off on a $2.25 million deal with Teva Pharmaceuticals to resolve antitrust claims against the company over antidepressant and anxiety disorder treatment Effexor XR.
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March 18, 2025
Greenberg Traurig Boosts Litigation Team With 4 Denver Attys
A team of four litigators have joined Greenberg Traurig LLP's growing Denver office, including a shareholder who was tapped to lead the office's litigation practice.
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March 17, 2025
Novartis Nabs Partial Ban Against MSN's Heart Drug Generic
Novartis AG succeeded Monday in blocking a competitor from potentially selling a similar-looking generic drug for treating heart failure, with a New Jersey federal judge remarking that MSN Laboratories Pvt. Ltd. "could have distinguished its pills," though she was less convinced that the name "Novadoz" was confusingly similar to "Novartis."
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March 17, 2025
Ex-Opioid Co. CEO Wants Out Of Law Firm's Billing Suit
A convicted former CEO of an opioid distributor is urging a New York federal judge to dismiss his criminal defense firm's suit against him over an alleged unpaid $150,000 expert witness tab, saying the suit fails because of "the clear and unambiguous language of the retainer agreements."
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March 17, 2025
New Bills Target 'Patent Thickets' And 'Product Hopping'
A bipartisan group of senators is backing two bills it says will use the patent system to lower the price of prescription drugs, in part by targeting "patent thickets" and making "product hopping" a violation of antitrust laws.
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March 17, 2025
Doctor Pays $700K To Settle Feds' Medicare Fraud Suit
A doctor and his Ringgold, Georgia, practice have agreed to pay $700,000 to settle allegations that they knowingly submitted false claims to Medicare for medically unnecessary chelation therapy.
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March 17, 2025
Jazz Inks Insurer Class Deal As Xyrem Antitrust Trial Nears
Jazz Pharmaceuticals and a certified insurer class told a California federal judge Monday that they have reached a settlement-in-principle in antitrust litigation accusing Jazz of working with pharma rival Hikma to block generic competitors to Jazz's narcolepsy drug, while two opt-out insurer plaintiffs and defendant Hikma have not reached any deals ahead of a May trial.
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March 17, 2025
Court Won't Toss Biotech Co.'s Antitrust Counterclaim
A California federal court refused to toss claims from biotech company Zymo Research Corp. accusing rival Qiagen GmbH of filing a "sham" patent infringement suit against it to discredit a potential competitor in the DNA extraction market.
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March 17, 2025
Full 7th Circ. Won't Revive Suit Over Late Medicaid Payments
The full Seventh Circuit has answered the "enormous question" of whether a Chicago hospital can sue the state of Illinois to force the managed-care organizations it contracts with to make timely Medicaid payments, concluding the hospital doesn't have a federal right to prompt payments for fear of turning federal trial courts into "de facto Medicaid claims processors."
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March 17, 2025
NC AG Fights TikTok's Early Exit From Addiction Suit
North Carolina is pushing back on TikTok's bid to sidestep a lawsuit accusing it of knowingly addicting young users to its platform, arguing that the state court has jurisdiction because the company has engaged directly with "over a million children and teens" within its borders.
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March 17, 2025
Yale Says Researcher's Omissions Doom $28M Incubator Suit
Yale University told a Connecticut state court that it sufficiently pled its counterclaims against a researcher who accused it of destroying his "life's work" by unplugging an incubator filled with $28 million in grants and private money's worth of genetic materials, arguing the researcher lied to get his job.
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March 17, 2025
Austrian Biotech BIA Hits Ch. 15, Says Exec Stole $22M
Austrian biotechnology firm BIA has filed for Chapter 15 protection in Delaware to recover assets in the U.S., alleging an executive fraudulently transferred roughly $22 million in company funds and left it insolvent.
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March 17, 2025
Seeger Weiss Atty Tapped To Lead Depo-Provera Plaintiffs
A Florida federal judge on Sunday selected Christopher Seeger of Seeger Weiss LLP to lead the team representing plaintiffs in the multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive drug Depo-Provera.
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March 17, 2025
4 Firms Guide Up To $1.14B Sale Of PE-Backed Biotech
Taiho Pharmaceuticals on Monday announced plans to acquire private equity-backed Swiss biotechnology company Araris Biotech for up to $1.14 billion in a deal built by four law firms.
Expert Analysis
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.