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Life Sciences
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March 04, 2025
PBMs Ask 8th Circ. To Pause FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked the Eighth Circuit to pause the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices as they push their constitutional claims against the agency.
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March 04, 2025
After 'Historic Low' In 2023, Number Of ITC Cases Soar In 2024
The U.S. International Trade Commission saw a significant uptick in disputes last year, according to a Tuesday report by a firm that represents expert witnesses used in litigation.
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March 04, 2025
In Rare Move, Texas Judge Shuns Out-Of-State BigLaw Attys
Two out-of-state BakerHostetler attorneys' "frequent" work in the Lone Star State has sunk their bids to be admitted pro hac vice in a lawsuit accusing the U.S. Food and Drug Administration of catering to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic.
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March 04, 2025
Freezer Co. Drops Supplier Suit Over $15M Embryo Loss
Freezer maker Chart Inc. has dropped its lawsuit alleging one of its suppliers should pay part of a $15 million verdict stemming from an implosion of Chart's cryopreservation tanks in 2018, which destroyed human eggs and embryos, according to an order Monday.
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March 04, 2025
Colo. Biotech, Founders Owe SEC $14.3M Over Fraud Claims
A Colorado federal judge has ordered a biotech startup and two of its founders to pay the U.S. Securities and Exchange Commission roughly $14.3 million and barred them from serving as officers and directors of public companies after finding that they fraudulently raised over $10 million by overstating their own investments in the company.
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March 04, 2025
IRS Asks To Toss Abbott Labs' FOIA Action For Tax Records
Discovery limitations in a U.S. Tax Court case apply to documents related to an Internal Revenue Service investigation of Abbott Laboratories' transfer policies and thus mean that Abbott can't access them with a Freedom of Information Act request, the IRS told a D.C. federal court.
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March 04, 2025
Lead Testing Operations Chief To Admit Misbranding Charge
The former chief operating officer of Magellan Diagnostics will admit to defrauding the public by hiding flaws in the company's lead testing devices for years, according to a filing in Massachusetts federal court.
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March 04, 2025
Feds Seek 40 Mos. For Husband Of Ex-Takeda Exec
The husband of a former Takeda Pharmaceuticals vice president should spend more than three years in custody for his role in a fraudulent invoice scheme that netted the couple $2.3 million, prosecutors have told a federal judge in Massachusetts.
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March 03, 2025
Ultragenyx Loses Bid To Toss Suit Over Henrietta Lacks' Cells
A Maryland federal judge on Monday refused to toss a lawsuit lodged by the family of the late Henrietta Lacks against biotechnology company Ultragenyx for allegedly profiting off her stolen "immortal" cells, saying proof Ultragenyx engaged in intrastate business in Maryland would thwart its contention the lawsuit was filed too late.
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March 03, 2025
Full Fed. Circ. Won't Take On Teva's Orange Book Appeal
The Federal Circuit on Monday rejected a request for an en banc rehearing from Teva Pharmaceuticals challenging a panel decision finding that the company improperly listed its asthma inhaler patents on a key U.S. Food and Drug Administration database that lists patents for drugs.
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March 03, 2025
Sandoz Settles Florida's Generic Drug Price-Fixing Claims
Sandoz AG reached a settlement with Florida that ends federal antitrust claims the Sunshine State lodged against the drugmaker within wider litigation claiming numerous pharmaceutical companies and individuals participated in a conspiracy to fix generic drug prices, according to a Friday court filing.
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March 03, 2025
Teva Should Face Key Copaxone Antitrust Claims, Court Told
Mylan and pharmaceutical wholesalers should be allowed to proceed with some, but not all, parallel claims accusing Teva of using regulatory deception, false advertising, improper rebates and more to delay generic competition to its Copaxone multiple sclerosis treatment, a special master has recommended in New Jersey federal court.
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March 03, 2025
Sanofi Grilled By Judge Over $1.2M In Amgen Patent Saga
A federal judge in Delaware has told lawyers for Sanofi to rethink some of a $1.2 million costs bid, pointing to issues he had with the "bells and whistles" in litigation costs the French pharmaceutical giant had proposed after its successful defense of a decade-long patent fight by Amgen over cholesterol medication.
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March 03, 2025
Calif. Farm Sues Tenn. Sheriff Over $3.9M In Destroyed Hemp
A California hemp farm is suing a Tennessee sheriff's department, alleging that a deputy wrongly arrested a driver who was carrying $3.9 million in legal hemp and had it destroyed.
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March 03, 2025
Boston Scientific Buying $600M Ultrasound System Developer
Boston Scientific Corp. announced Monday it will pay up to $540 million to acquire the 90% it doesn't already own of private medical device company SoniVie Ltd., which developed an ultrasound system, in an agreement that carries a total value of about $600 million.
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March 03, 2025
5 Mass. Rulings You May Have Missed In February
Justices in Suffolk County Superior Court's business litigation session tackled a range of issues in February, including greenwashing, consumer protection and development disputes.
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March 03, 2025
Convicted Drexel Professor Gets 2 Years For Tax Evasion
A Drexel University accounting professor convicted on tax evasion charges for failing to report $3.3 million in income from a Trenton, New Jersey, pharmacy was sentenced to two years in federal prison on Monday, according to acting U.S. Attorney Vikas Khanna.
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March 03, 2025
Vape Co.'s Challenge Of FDA Penalty Rejected
A Washington, D.C., federal judge has thrown out an online vape retailer's constitutional challenge to a U.S. Food and Drug Administration enforcement proceeding, ruling that claims fell outside the court's jurisdiction.
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March 03, 2025
Jones Day Hires Pair Of Weil IP Litigators In California
Jones Day is expanding its California intellectual property team, announcing Monday that it is bringing in two Weil Gotshal & Manges LLP litigators as partners in the northern part of the state.
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March 03, 2025
3rd Circ. Preview: Litigation Funder, J&J Seek Relief In March
The Third Circuit's case lineup this month will task panels with determining if an American litigation funder can keep its dispute with a German law firm in federal court, and whether Johnson & Johnson can decertify class claims accusing the company of artificially inflating its stock price by failing to disclose the alleged cancer risks of its talc products.
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March 03, 2025
Life Science Consulting Firm Hits Ch. 11 With Sale Plans
Azzur Group, which offers services for pharmaceutical developers, filed for bankruptcy in Delaware with at least $100 million in debt and plans to hold an auction backed by a $56 million stalking horse offer.
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February 28, 2025
Align Tech Deal Directs Buyers To A Monopolist, Judge Says
A California federal judge has soundly rejected Align Technologies Inc.'s proposed $27.5 million antitrust settlement with teeth-aligner buyers, slamming Align as a monopolist and saying that the deal "will direct still more customers to the monopolist."
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February 28, 2025
J&J Talc Spinoff Wraps Two-Week Chapter 11 Trial
A marathon Chapter 11 trial for Johnson & Johnson's talc liability unit wrapped up Friday, with attorneys defending the $10 billion plan against competing efforts to toss the Texas bankruptcy.
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February 28, 2025
Fenwick Adds Longtime Startup Attorney To Insurtech Group
A new attorney has joined tech and life sciences firm Fenwick & West LLP in its regulatory practice and insurtech group, the firm announced, saying her extensive experience working in insurance with established companies as well as emerging startups will help it provide "comprehensive regulatory services."
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February 28, 2025
Sterilization Plant Head 'Shocked' By EPA Cancer Risk Report
The former manager of a Colorado medical sterilization plant testified Friday that he was "shocked" by a 2018 Environmental Protection Agency report that identified the area around the facility as having an increased cancer risk, telling a jury that no regulatory agency until that point had informed him a sterilization chemical might be a risk to the community.
Expert Analysis
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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.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.