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Life Sciences
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March 26, 2024
Jackson Paints Abortion Clash As Microcosm Of Bigger Brawl
A war of words Tuesday at the U.S. Supreme Court over access to abortion medication marked a climactic moment after a lengthy legal slugfest. But probing questions from Justice Ketanji Brown Jackson illustrated that the main event for reproductive rights was also simply a single round in a much larger fight over the government's regulatory powers.
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March 26, 2024
Banker Describes Confidential Work In 'Shadow Trading' Trial
An Evercore investment banker who worked on Medivation's 2016 sale to Pfizer testified Tuesday in the U.S. Securities and Exchange Commission's novel "shadow trading" trial, saying the defendant was involved in a confidential process that identified biopharma company Incyte as comparable to Medivation — information the defendant is accused of trading on.
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March 26, 2024
Pharmacy Owner Gets 42 Months For $25M Kickback Scam
A medical equipment pharmacy owner was sentenced to 42 months in prison Tuesday for carrying out a $25 million kickback scheme with a patient-leads broker as part of a scheme to falsely bill the federal government for care.
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March 26, 2024
FTC Urges Court To Pause Novant's NC Hospital Deal
The Federal Trade Commission is urging a North Carolina federal court to pause Novant Health's $320 million deal for a pair of hospitals, contending the move would give Novant an "eye-popping" share of the hospital market in a Charlotte suburb.
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March 26, 2024
Opioid Public Nuisance Claims 'Unique,' Ohio High Court Told
Counsel for two Ohio counties that won a $650 million verdict against Walmart, CVS and Walgreens told the Ohio Supreme Court on Tuesday that opioids are a "unique" problem during oral arguments about whether the counties' public nuisance claims are blocked by the state's product liability law.
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March 26, 2024
In Abortion Case, Gorsuch Frets 'Rash' Of National Injunctions
U.S. Supreme Court Justice Neil Gorsuch renewed his criticisms of nationwide injunctions Tuesday, saying a Texas judge's universal order limiting access to popular abortion medication mifepristone turned a potentially small legal challenge into a national debate.
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March 26, 2024
6 Firms Build $340M SPAC Merger For AI-Driven Medicine Biz
Precision medicine company OmnigenicsAI Corp. on Tuesday announced it and artificial intelligence-enabled preventative medicine company MultiplAI Health Ltd., which it recently agreed to acquire, will go public through a merger with blank-check company APx Acquisition Corp. I in a deal built by six firms, valuing the two businesses at a combined $340 million.
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March 26, 2024
Pet Drug Maker Faces EU Probe For Axing Pipeline Dog Med
The European Union's antitrust authority said Tuesday it has launched a probe into whether Zoetis Inc. had illegally blocked competition by acquiring a pipeline product designed to treat pain in dogs and axing a potential rival's deal to sell it.
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March 26, 2024
High Court Wary Of Bid To Limit Abortion Pill Access
The U.S. Supreme Court seemed skeptical Tuesday of efforts by anti-abortion groups to severely limit access to the abortion medication mifepristone, with several justices appearing unconvinced that the groups had the right to sue over the Food and Drug Administration's regulation of the pill.
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March 25, 2024
SEC Kicks Off 'Shadow Trading' Case Against Drug Exec
The U.S. Securities and Exchange Commission said at the start of a California federal "shadow trading" trial that a former Medivation executive made $120,000 by buying stock in a rival after learning his company would be acquired by Pfizer, while the defense said he didn't believe the trades violated securities law.
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March 25, 2024
COVID 'Cure' Claims Can't Sustain Fraud Suit, 9th Circ. Rules
A biopharmaceutical company's "enthusiastic" statements to Fox News and others about a potential COVID-19 cure do not amount to fraud and cannot sustain a shareholder lawsuit accusing the company and its top executives of deceiving the market by pretending that a breakthrough was much more consequential than it actually was, the Ninth Circuit ruled on Monday.
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March 25, 2024
J&J Exec 'Shocked' Over Atty's Ties With Talc Plaintiffs
Johnson & Johnson's vice president of litigation said on Monday he was "utterly shocked and appalled" upon learning an attorney who served as the company's outside counsel was working with its adversary Beasley Allen Law Firm and one of its attorneys in litigation over the alleged link between the company's talcum powder products and ovarian cancer.
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March 25, 2024
Amgen Sues Colorado After Drug's 'Unaffordable' Rating
Amgen has sued the Colorado Prescription Drug Affordability Review Board in federal court after receiving a determination that one of its arthritis drugs is "unaffordable," saying the board is using unconstitutionally "unguided discretion" to impose arbitrary price controls on patent-protected drugs.
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March 25, 2024
PacBio CEO's Words Haunt Patent Invalidity Arguments
A California federal judge concluded Monday that statements made by the chief executive officer of biotech company Pacific Biosciences to investors at an earnings call undermined the company's invalidity arguments in a patent suit it's facing.
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March 25, 2024
PTAB Splits On Medtronic Bladder And Bowel Control Patents
The Patent Trial and Appeal Board has issued split decisions that upheld one Medtronic patent covering an electrical stimulation system used to treat loss of bladder and bowel control and trimmed another patent in challenges brought by a smaller rival in the medical device field.
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March 25, 2024
What To Watch As Opioid Litigation Goes To Ohio High Court
The Ohio Supreme Court on Tuesday will become only the second state high court to hear oral arguments on whether the opioid epidemic is a public nuisance, the controversial legal theory underpinning numerous suits across the country including a $650 million award that two Ohio counties won against Walmart, CVS and Walgreens.
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March 25, 2024
Fed. Circ. Dissent Raises Alarm Over IP Safe Harbor Use
A California federal judge rightly dismissed Edwards Lifesciences Corp.'s infringement suit against Meril Life Sciences Pvt. Ltd., the Federal Circuit held Monday, with a dissent arguing such a holding would "create future mischief."
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March 25, 2024
FTC Intervenes In Teva-Amneal Row To Push Patent Delisting
The Federal Trade Commission waded into another patent fight Friday with a New Jersey federal court amicus brief targeting the same Teva Pharmaceuticals asthma inhaler patents it has already included in a roster of over 100 it believes were improperly listed in a key federal database.
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March 25, 2024
Fla. Pharmacy Says It Was Cut From Federal PrEP Program
A Florida pharmacy says it was abruptly shut out of a federal program that provides free access to preexposure prophylaxis HIV-prevention medication, asking a D.C. federal judge on Monday to force the U.S. Department of Health and Human Services and two contractors to reinstate the pharmacy to the program.
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March 25, 2024
Pilot For UK Billionaire Says Stock Tips Case Is Too Vague
A pilot charged with trading on insider stock tips from U.K. billionaire Joe Lewis told a New York federal judge Friday that prosecutors had failed to identify a piece of information that he knew was non-public, urging the court to toss the case.
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March 25, 2024
Paul Weiss-Led AbbVie Inks Up To $212M Deal For Landos Bio
AbbVie Inc., represented by Paul Weiss Rifkind Wharton & Garrison LLP, said Monday it will pay up to $212.5 million for Cooley LLP-led Landos Biopharma Inc., a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases.
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March 25, 2024
3rd Circ. Won't Rethink AbbVie Privilege Ruling
The Third Circuit refused Monday to reconsider a ruling that found AbbVie was unable to show a lower court went against precedent or made errors when ordering the drugmaker to turn over attorney communications from a patent case allegedly meant to delay an AndroGel rival.
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March 25, 2024
Catching Up With Delaware's Chancery Court
Last week in Delaware's Court of Chancery, litigants battled as Truth Social went public, Carl Icahn and Tripadvisor hit a roadblock, and more shareholders wailed about "invasive" bylaws. Oil drilling and pharmaceutical mergers sparked new lawsuits, and a sewing machine trademark owner sued to end a contract.
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March 25, 2024
Novo Nordisk Inks $1.1B Deal For German Pharma Biz
Danish pharmaceutical giant Novo Nordisk A/S said Monday it has signed a deal to acquire Cardior Pharmaceuticals of Germany for just over €1 billion ($1.1 billion) to widen its focus on cardiovascular diseases.
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March 25, 2024
Kirkland Guides Ingersoll Rand On $2.3B ILC Dover Buy
Kirkland & Ellis LLP is representing Ingersoll Rand on a new agreement to buy ILC Dover from private equity firm New Mountain Capital for more than $2.3 billion, part of Ingersoll's plan to bolster its life sciences business, the industrial products company said Monday.
Expert Analysis
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.
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Class Action Defense: Don't Give Up On Bristol-Myers Squibb
Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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State Regs Sow Discord Between Cannabis, Hemp Industries
Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.
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Series
Playing In A Rock Cover Band Makes Me A Better Lawyer
Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.
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AI May Help Patent Applicants With Functional Claiming
The U.S. Supreme Court recently set what many patent practitioners consider too high a bar for functional claims, but artificial intelligence could alter functionality analysis — conferring predictability that alleviates courts' concerns that practicing the claims requires undue experimentation, say Brian Nolan and Ying-Zi Yang at Mayer Brown.
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How Int'l Regulatory Collabs Can Expedite Pharma Approvals
Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.
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How Executives' Deposition Standards Can Differ
The recent Trustees of Purdue University v. Wolfspeed Inc. decision granting a motion on a protective order for a high-level witness shows how courts can vary in the application of the apex doctrine and analysis under Rule 26 of the Federal Rule of Civil Procedure, say Genevieve Halpenny and John Cook at Barclay Damon.
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Series
The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'
The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.
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Calif. GHG Disclosure Law Will Affect Companies Worldwide
California's Climate Corporate Data Accountability Act, which will require comprehensive greenhouse gas emissions disclosures from large companies operating in the state, will mean compliance challenges for a wide range of industries, nationally and globally, as the law's requirements will ultimately trickle out and down, say attorneys at Brownstein Hyatt.
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Questions Linger After FDA's Lab-Developed Tests Proposal
The U.S. Food and Drug Administration's recently proposed rule regarding its plan to regulate lab-developed tests is light on details, leaving many fundamental questions about the agency's authority and ability to execute its plans, say attorneys at Covington.