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Life Sciences
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May 22, 2024
Dickinson Adds Ex-Sheppard Mullin IP Pro In Silicon Valley
Dickinson Wright PLLC said Wednesday that it has added a former Sheppard Mullin Richter & Hampton LLP partner as the newest member of its Silicon Valley office.
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May 22, 2024
Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects
Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.
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May 22, 2024
Covington Reps As Biogen Makes $1.8B Bet On HI-Bio
Biogen Inc. said Wednesday it has agreed to purchase Human Immunology Biosciences, or HI-Bio, a San Francisco-based biotechnology company working on targeted therapies for severe autoimmune diseases, in a deal that could see Biogen pay up to $1.8 billion.
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May 21, 2024
Hawaii Wins $916M From Bristol-Myers, Sanofi Over Plavix
Bristol-Myers Squibb Co. and Sanofi owe more than $916 million to the state of Hawaii for not warning patients of East Asian or Pacific Island ancestry of potential health risks associated with their blood thinner Plavix, a state judge ruled Tuesday, following a trip to the state's highest court.
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May 21, 2024
Ex-AUSA Blames Inexperience For Outcome Forfeiture Error
Former prosecutors who pursued the $1 billion fraud trial against Outcome Health executives said Tuesday they never suspected their asset restraint efforts were an overreach, noting they lacked the expertise to notice potential mistakes themselves.
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May 21, 2024
Sens. Challenge Pharma Lobbyist Over Patent Abuse
U.S. senators from both sides of the aisle took turns at a Tuesday hearing questioning the pharmaceutical industry's top lobbyist over whether patent abuse plays a role in maintaining the high price of prescription drugs.
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May 21, 2024
DC Circ. Says Drugmakers Can Limit Pharmacy Discounts
The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.
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May 21, 2024
MetLife Workers Tell 3rd Circ. Higher Premiums Give Standing
A group of MetLife Group Inc. retirees insisted to the Third Circuit on Tuesday that they would have had lower health insurance premiums had MetLife not kept millions in pharmacy rebates, and that MetLife's actions gave them standing to sue — or at least to seek more information on how the company should spend the money.
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May 21, 2024
CohnReznick Adds PwC Partner To International Tax Practice
CohnReznick has a new principal in its international tax practice who previously served as a partner at PwC, the firm announced.
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May 21, 2024
SPAC Investor's Suit Changes Came Too Late, Chancery Rules
A shareholder of a special-purpose acquisition company that merged with a now-defunct medical technology company in 2021 waited too long to amend his year-old proposed class action and must defend the case against a motion to dismiss in June, Delaware's Court of Chancery said Tuesday.
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May 21, 2024
PE Firms Close Separate Funds With Nearly $1.3B Total In Tow
Winston & Strawn LLP-advised private equity shop Paceline Equity Partners LLC and Kirkland & Ellis LLP-advised private equity firm Eir Partners on Tuesday separately announced that they have clinched funds totaling nearly $1.3 billion combined, with the former's fund focusing on corporate debt and real assets and the latter's targeting healthcare technology investments.
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May 21, 2024
Cooley Atty Returns From Deputy GC In-House Role In Boston
Cooley LLP's latest emerging companies and venture capital practice partner, James Schneider, started his career as a sports journalist covering local high school football games and didn't consider shifting careers until after the final whistle of a Thanksgiving Day game while rushing to meet a deadline, he told Law360 Pulse on Tuesday.
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May 21, 2024
Strategic Hiring Was The New Normal For BigLaw In 2023
The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.
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May 21, 2024
The Law360 400: Tracking The Largest US Law Firms
The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.
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May 21, 2024
Paul Hastings' FDA Chair Departs For Arnold & Porter
The chair of the U.S. Food and Drug Administration practice at Paul Hastings LLP has left for Arnold & Porter Kaye Scholer LLP just a few months after joining Paul Hastings, the firm said Tuesday.
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May 20, 2024
Ex-IRS Agent, Five Others Sentenced In COVID Fraud Scheme
A former Internal Revenue Service agent, his brother and four other defendants have pled guilty to participating in a scheme that netted more than $3 million in fraudulent COVID-19 pandemic relief loans.
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May 20, 2024
Lab Says GSK Hid Zantac Cancer Risk From Feds For Decades
A Connecticut laboratory claims that GlaxoSmithKline defrauded federal health insurance programs for billions by hiding for 40 years that Zantac decomposes into a carcinogen even when just sitting on the shelf, in a lawsuit filed Monday in Pennsylvania federal court.
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May 20, 2024
Teladoc Faces Suit Over Mental Health Platform's Losses
Telemedicine giant Teladoc Health Inc. and two of its executives face a proposed investor class action alleging trading prices for Teladoc shares fell after the company disclosed that its flagship mental health counseling platform saw membership and revenue declines despite increased advertising costs.
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May 20, 2024
Ultragenyx Must Face Suit Over Use Of Henrietta Lacks' Cells
The family of the late Henrietta Lacks, a Black woman whose cells were harvested without her knowledge to create the first immortalized human cell line, can pursue their suit alleging Ultragenyx Pharmaceutical "made a fortune" using her stolen cells to develop gene therapy treatments, a Maryland federal judge ruled Monday.
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May 20, 2024
USPTO Clarifies Means-Plus-Function Claims For Antibodies
The U.S. Patent and Trademark Office's new Appeals Review Panel clarified the use of means-plus-function claiming when patenting antibodies, while continuing to reject claims of a Xencor Inc. patent application related to treating autoimmune diseases.
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May 20, 2024
McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL
A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.
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May 20, 2024
Judge Tosses Acuitas' COVID Biotech IP Suit
A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.
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May 20, 2024
Local Governments Seek Sanctions For PBMs In Opioid MDL
Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.
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May 20, 2024
iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry
Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.
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May 20, 2024
J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan
Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.
Expert Analysis
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Key Legal Trends For Healthcare And Life Sciences In 2024
Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.
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Series
ESG Around The World: South Africa
While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.