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Life Sciences
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February 19, 2025
BP Must Face Contract Claim In Bayer's $12M Benzene Suit
BP can't escape claims that it breached its contract with a chemical supplier currently defending a $12 million lawsuit from Bayer over alleged benzene contamination in two antifungal sprays, an Illinois federal judge ruled on Tuesday.
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February 19, 2025
Wu-Tang Album Owner Wants Shkreli To Pay Fees
The crypto project that holds the only physical copy of a Wu-Tang Clan album that once belonged to Martin Shkreli has asked a Brooklyn federal court to make him pay for months of noncompliance with a preliminary injunction requiring him to account for all copies of the album he may have made.
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February 19, 2025
Simpson Thacher Adds Litigator, Private Funds Pro In Boston
Simpson Thacher & Bartlett LLP has added a litigation attorney from Cooley LLP and a private funds attorney from Ropes & Gray LLP who will both work in Boston, the firm announced Wednesday.
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February 18, 2025
1st Circ. Backs Strict View Of Kickback Law In Blow To FCA
In an eagerly awaited ruling, the First Circuit on Tuesday said a major avenue for False Claims Act enforcement requires proof that kickbacks directly changed treatment decisions, a holding that creates a lopsided circuit split as well as significant challenges for the U.S. Department of Justice and the plaintiffs bar.
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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.
Expert Analysis
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Opinion
Congress Must Consider Accurate Data About Patent Thickets
If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.
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Lights, Camera, Ethics? TV Lawyers Tend To Set Bad Example
Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Law Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.