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Life Sciences
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February 18, 2025
Hikma Appeals To Justices In 'Skinny Label' Patent Case
Hikma Pharmaceuticals USA Inc. has urged the U.S. Supreme Court to review a decision that revived a patent suit over its generic version of Amarin Pharma Inc.'s cardiovascular drug Vascepa, saying the holding "effectively nullifies" a law allowing "skinny labels."
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February 18, 2025
Studies Don't Show Zantac Cancer Risks, Jury Hears
Taking Zantac does not cause prostate cancer, a Children's Hospital Colorado toxicologist testified Tuesday in two men's Illinois retrial of claims that taking the heartburn medication contributed to their diagnoses.
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February 18, 2025
J&J Talc Unit Launches 2-Week $10B Ch. 11 Settlement Trial
A Johnson & Johnson spinoff began its case Tuesday for a $10 billion Chapter 11 settlement of the company's talc liability before a Texas bankruptcy judge while opponents of the deal questioned the legitimacy of the bankruptcy case and the plan vote.
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February 18, 2025
Novo Nordisk Queues Up $830M Suit Over Disappointing Drug
Novo Nordisk is set to initiate an $830 million arbitration claim in New York accusing Singaporean biopharmaceutical company KBP Biosciences of misleading the Danish drugmaker about the potential of a new hypertension drug it subsequently purchased, according to an order from a Singapore court made public on Tuesday.
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February 18, 2025
Convicted Pharma Exec Seeks Trial Redo, Citing Feds' Error
A former pharmacy executive convicted on criminal charges over a healthcare scheme that defrauded the government of $160 million has urged a Texas federal court to grant him a new trial, arguing an admission of error by the federal government necessitates a redo.
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February 18, 2025
Human Rights Atty Sees 'Serious Risks' Of Neural Data Abuse
International human rights attorney Jared Genser spoke with Law360 Healthcare Authority about the "serious risks of misuse and abuse of neurotechnologies" that have led California and Colorado to expand their state consumer privacy laws in the last year to include neural data, with similar bills pending in Montana, Massachusetts and Illinois.
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February 18, 2025
Trump Issues Order Calling For Expanded IVF Access
President Donald Trump signed an executive order Tuesday giving his administration 90 days to develop policy recommendations designed to protect access to in vitro fertilization and sharply reduce out-of-pocket costs for IVF treatment.
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February 18, 2025
Trump Trans Order Is Unconstitutional 'End-Run,' Judge Says
A Washington federal judge has further explained her temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for young people, saying the edict threatens a broad swath of congressionally approved research spending and "amounts to an end-run around the separation of powers."
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February 18, 2025
Vaccine Developer Files Ch. 11 Sale Plan With $11.5M Bid
Omega Therapeutics, which develops mRNA vaccines, filed proposed bidding procedures in Delaware bankruptcy court, saying it hopes to get a sale approved by mid-April and has a stalking-horse bid in hand worth about $11.5 million.
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February 18, 2025
Ex-Goldman Atty Squires Expected To Be Named USPTO Head
John A. Squires — Goldman Sachs' longtime chief intellectual property counsel, co-founder of Fortress' IP Investment fund and current Dilworth Paxson LLP partner — is expected to be chosen as the Trump administration's nominee for U.S. Patent and Trademark Office director, about a half-dozen sources with knowledge of the agency said Tuesday.
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February 14, 2025
FTC's Ferguson, PBMs Agree: Nix Leader Removal Safeguards
Federal Trade Commission Chairman Andrew N. Ferguson offered his own support for enabling the president to readily fire independent agency commissioners at the FTC and beyond, a day after pharmacy benefit managers cited the new U.S. Department of Justice policy in their own battle with the FTC.
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February 14, 2025
Digital Health Co. Beats Some Claims In SPAC Investor Suit
A New Jersey federal judge has dismissed, with leave to amend, claims in an investor suit against a blank check company that took digital health equipment venture Butterfly Network Inc. public, finding that some of the shares the plaintiffs purchased are not traceable to the registration statement at issue in the suit.
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February 14, 2025
Fed. Circ. Risks Relying On 'Science Fiction,' Justices Told
The Federal Circuit's presumption that prior art is always enabled can lead it to "sacrifice true innovations based on earlier science fiction," the owner of invalidated food wrapping patents told the U.S. Supreme Court on Thursday.
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February 14, 2025
Trump Admin To Cut Thousands Of Federal Health Employees
The Trump administration has started to cut thousands of federal healthcare employees, following through on its promises to shrink government and enact mass changes to agencies that oversee the health of millions of Americans.
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February 14, 2025
New Delisting Rules Shorten Leash For Distressed Companies
Distressed companies should take heed of new stock exchange rules that are likely to accelerate delistings for stocks that trade below minimum requirements, particularly targeting businesses that rely on reverse stock splits to inflate their share prices, attorneys say.
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February 14, 2025
CVS Wins Arbitration In Medicare Fee Antitrust Suit
An Arizona federal judge ordered four independent pharmacies to arbitrate their claims accusing CVS of exploiting a Medicare loophole to charge them exorbitant fees, saying several unconscionable provisions in an underlying arbitration clause could be severed.
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February 14, 2025
Fed. Circ. Rejects COVID Test Suit In Gilstrap-Authored Ruling
A California federal judge properly found that Spectrum Solutions LLC didn't infringe a COVID-19 test maker's patent directed to preserving biological samples, the Federal Circuit said Friday in an opinion written by a top patent judge visiting the court.
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February 14, 2025
Some Discovery On Hold In Abbott Infant Formula Case
An Illinois federal judge granted in part a request by Abbott Laboratories to pause a shareholder derivative suit over how it managed the 2022 infant formula crisis, allowing written discovery to go on while staying depositions until May.
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February 14, 2025
Fed. Circ. Ruling Shows Even Small Cos. Can Win At ITC
A small biotech company's recent patent win, where the Federal Circuit held that even its limited domestic investments qualified it to sue at the U.S. International Trade Commission, makes clear that the ITC's powerful import bans aren't just available to major businesses, attorneys say.
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February 14, 2025
8 Things Attys Should Know About Conn.'s $55B Budget
Connecticut Gov. Ned Lamont's two-year budget for the years 2026 and 2027 includes drug price limits, an expansion of the state's unfair trade practices act, key changes to hospital ownership laws and slots for 13 new judges.
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February 14, 2025
Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.
A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.
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February 14, 2025
Camston Wrather Files For Ch. 7 With Over $100M In Debt
California-based sustainable resource recovery company Camston Wrather LLC has filed for Chapter 7 bankruptcy listing liabilities between $100 million and $500 million along with up to $50 million in assets, citing insufficient funding to continue operations.
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February 14, 2025
Tariffs On Drugs And Chips May Not Bring Makers Stateside
The White House's planned tariffs on semiconductors, computer chips and pharmaceuticals are likely to raise prices for consumers and businesses, but won't necessarily lead to the president's stated goal of growing domestic manufacturing, attorneys and others told Law360.
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February 14, 2025
2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty
A Washington federal judge put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.
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February 13, 2025
Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug
A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying Mallinckrodt didn't show enough evidence that Airgas infringed its patents or that it would suffer irreparable harm.
Expert Analysis
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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.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.