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Life Sciences
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February 04, 2025
Judge Explains Biogen Class Cert. Ruling After 1st Circ. Order
A Massachusetts federal judge on Tuesday said he was reminded of a grade school lesson in long division as he explained his reasoning behind granting class certification and cutting short the class period in a suit against drugmaker Biogen Inc. on the orders of the First Circuit.
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February 04, 2025
Fed. Circ. Grapples With Extensions On Reissued Patents
The Federal Circuit is set to decide when a reissued patent actually expires after fielding arguments Tuesday morning from Merck and the generic-drug makers who are trying to break the pharmaceutical giant's hold on a blockbuster drug that counteracts the effects of anesthesia.
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February 04, 2025
Carcinogenic Risk Unknown When BI Owned Zantac, Jury Hears
Boehringer Ingelheim didn't test whether the active ingredient in its over-the-counter Zantac was degrading into a carcinogenic compound because those risks weren't known when the company owned the drug, Illinois jurors heard Tuesday.
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February 04, 2025
McKesson Paying $850M For Top Stake In Eye Health Co.
Irving, Texas, healthcare services company McKesson Corp. said Tuesday it had agreed to buy a controlling interest in PRISM Vision, an ophthalmology services provider, from private equity firm Quad-C for $850 million.
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February 04, 2025
'Sloppy' Work Hurts Lab's $20.6M Insurance Suit, Judge Says
A Connecticut federal judge said Tuesday that a contract lawsuit against insurer Aetna Inc. and its owner CVS Health Corp., seeking about $20.6 million in payment for laboratory services, seems to "suffer" from the fact that the plaintiff filed dozens of similar cases in short order.
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February 04, 2025
Docs Say DEA Didn't Put All Documents In Pot Hearing Record
A group of doctors who had petitioned to halt the Drug Enforcement Administration's hearings on whether to reschedule cannabis under the Controlled Substances Act are asking the D.C. Circuit to order the agency to add documents to the record that they say have been wrongly excluded.
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February 04, 2025
Doctors Org. Sues Over Health Agency Website Purges
An advocacy organization representing physicians sued the U.S. Office of Personnel Management in D.C. federal court Tuesday after it directed federal agencies to root out references to "gender ideology" on their websites — a move the physicians claim deprives doctors and researchers of needed information.
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February 04, 2025
Life Sciences Group Of The Year: Latham
Latham & Watkins LLP life sciences attorneys got Europe's highest court to scale back the European Commission's ability to oversee mergers, and advised Cerevel Therapeutics on its monumental $8.7 billion acquisition by AbbVie, earning it a spot among the 2024 Law360 Life Sciences Groups of the Year.
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February 04, 2025
Mintz Adds Dentons West Coast Corporate Head In San Diego
Mintz Levin Cohn Ferris Glovsky and Popeo PC continues growing its corporate team, announcing Monday it is bringing in a Dentons emerging companies and venture capital specialist as a member of its San Diego office.
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February 04, 2025
Javice's Texts About Elizabeth Holmes Not Fair Game For Trial
Frank founder Charlie Javice's sympathetic texts about healthcare-sector fraudster Elizabeth Holmes won't be seen by the jury hearing charges that the education startup executive faked data to dupe JPMorgan into a $175 million acquisition, a Manhattan federal judge said Tuesday.
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February 04, 2025
Party-Line Vote Sends Kennedy's HHS Nomination To Senate
Robert F. Kennedy Jr.'s nomination to be the nation's top healthcare official cleared a key confirmation hurdle on Tuesday, setting the stage for the anti-vaccine lawyer and activist to take the helm of the U.S. Department of Health and Human Services.
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February 03, 2025
6th Circ. Axes $650M Judgment Against CVS, Walgreens
The Sixth Circuit has vacated two Ohio counties' $650 million win against CVS Health, Walgreens and Walmart, an expected decision that comes after the Ohio Supreme Court found that the state's product liability law doesn't allow for public nuisance claims to be brought over the opioid crisis.
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February 03, 2025
Apple Seeks Bench Trial Win In Masimo's Trade Secret Suit
Apple Inc. urged a California federal judge Monday to issue a bench trial ruling that it didn't steal Masimo Corp.'s pulse oximetry technology for its smartwatches, arguing no actual trade secrets were at issue and that it used its own independently developed innovations to create the blockbuster product.
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February 03, 2025
DOJ Poised To Prosecute Threat-Makers Against DOGE
A federal prosecutor appointed by President Donald Trump offered Elon Musk his office's support to "protect" the work of the newly created Department of Government Efficiency headed by the billionaire businessman, including "legal action against anyone who impedes your work or threatens your people."
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February 03, 2025
Zantac's Discoloration Merely 'Cosmetic,' Boehringer Rep Says
A Boehringer Ingelheim corporate representative testified Monday that the company considered changes to the color of its over-the-counter Zantac heartburn drug as no more than a harmless "cosmetic" abnormality, as the pills were consistently tested as safe to take.
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February 03, 2025
Allergan Tells 4th Circ. Medicaid Pricing Suit Rightly Tossed
Allergan told the Fourth Circuit that a district court judge was right to dismiss a whistleblower's claims that its predecessor overcharged Medicaid by not aggregating discounts, saying the Medicaid Rebate Statute doesn't require it to do so.
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February 03, 2025
Baby Sock Co. Inks $3.5M Deal In Investor's FDA Approval Suit
Investors suing digital baby monitoring device manufacturer Owlet Inc. have asked a California federal court to preliminarily approve a $3.5 million deal to settle claims the company misled investors about approvals required from the U.S. Food and Drug Administration to sell its "smart socks."
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February 03, 2025
Pro-Palestine Protesters Say UMich Bans Trample Rights
The University of Michigan violated pro-Palestine protesters' rights when it banned them from setting foot on the university's campus, according to a new complaint filed Monday in Michigan federal court.
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February 03, 2025
PharmacyChecker's Legality Weighed In 9th Circ. Appeal
Judges on the Ninth Circuit went back and forth with lawyers on both sides of online drug comparison site PharmacyChecker's antitrust suit against LegitScript on Monday, questioning the latter's claims that PharmacyChecker's entire business is illegal because it facilitates the unsanctioned importation of foreign pharmaceuticals.
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February 03, 2025
J&J Investigations And Gov't Litigation Head Joins O'Melveny
The global practice leader for investigations and government litigation at Johnson & Johnson has joined O'Melveny & Myers LLP after two decades in-house, the firm said Monday.
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February 03, 2025
Asbury Park, Zoning Board, Again Escape Pot Co.'s Suit
A New Jersey federal judge has once again dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its Zoning Board conspired to deny its application in favor of a rival seller, saying the latest amended complaint doesn't shore up the shortcomings in the prior one.
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February 03, 2025
Cystic Fibrosis Drug Developer Sionna Targets $150M IPO
Cystic fibrosis-focused drug developer Sionna Therapeutics Inc. on Monday launched plans for an estimated $150 million initial public offering, joining a growing number of biotechnology companies entering the IPO pipeline, represented by Goodwin Procter LLP and underwriters counsel Ropes & Gray LLP.
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February 03, 2025
DC Judge Joins RI In Blocking Trump Funding Freeze
A D.C. federal judge on Monday temporarily blocked the Trump administration from implementing a freeze on federal spending while a group of nonprofits sue over the move, ruling the pause appears to "suffer from infirmities of a constitutional magnitude."
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February 03, 2025
Goodwin Hires Kirkland Antitrust Partner In DC
Goodwin Procter LLP has hired a career Kirkland & Ellis LLP antitrust litigation attorney, who told Law360 Pulse in a recent interview that she wanted to bring her practice focused on healthcare and life sciences clients to a platform rife with industry expertise.
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January 31, 2025
Justices Implored To Consider Tipster Medical Device Row
A nonprofit formed by Gretchen Carlson, a former Fox News anchor who has advocated against forced arbitration after suing the network's chairman for harassment, has urged the U.S. Supreme Court to consider a whistleblower's challenge to an arbitration award given to a medical device company in a trade secrets dispute.
Expert Analysis
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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.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Firms Must Offer A Trifecta Of Services In Post-Chevron World
After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.