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Life Sciences
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February 19, 2025
3rd Circ. Doubts Alleged Cancer Risk Devalued Drug
A Third Circuit panel on Wednesday seemed skeptical that a woman who bought and used a weight loss drug suffered financial harm after she found out it could cause cancer, with the judges aggressively pushing back on her argument that she did not get what she paid for.
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February 19, 2025
LA Gardasil Trial Against Merck Bagged After 3 Weeks
A Los Angeles state court trial over the alleged dangers of Merck & Co. Inc.'s human papillomavirus vaccine Gardasil was abruptly called off after three weeks of testimony, with a new panel of jurors slated to hear the case next fall instead.
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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.
Expert Analysis
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.