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Life Sciences
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January 17, 2025
MSN Wants Generic Entresto Launch After Patent Expired
MSN Pharmaceuticals asked the Federal Circuit Friday to let it launch its generic version of Novartis' blockbuster heart drug Entresto while the drugmakers continue their litigation over a newly expired patent, by lifting a temporary injunction barring that launch.
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January 17, 2025
Bayer, J&J Minimized Drug Reaction Data, 3rd Circ. Told
A doctor urged the Third Circuit on Friday to revive his whistleblower suit against Bayer Corp. and Johnson & Johnson, arguing that the drugmakers' regulatory approval applications played down the side effects of the antibiotics Cipro and Levaquin.
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January 17, 2025
Up Next At High Court: Forum Shopping & TCPA Definitions
The U.S. Supreme Court will return to the bench Tuesday for a short argument session, during which the justices will consider the U.S. Food and Drug Administration's bid to limit forum shopping by manufacturers challenging agency decisions and how much deference district courts must give to Federal Communications Commission orders.
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January 17, 2025
NC Biotech Co. Can't Restrain Co-Founder's Rival Biz Yet
A biotechnology company can't stop its co-founder from conducting research and soliciting customers at his new company using what it believes is stolen confidential information, a North Carolina state court judge said Friday, pointing to a lack of urgency and glaring holes in the record.
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January 17, 2025
3rd Circ. Vexed By Remedies For Defunct Vax Mandate
The Third Circuit wrestled Friday with how it could remedy injuries claimed to be suffered by nurses who lost their jobs for not complying with New Jersey Gov. Phil Murphy's vaccine mandate for healthcare workers, asking what order it could give about something that is no longer in effect and about jobs they no longer have.
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January 17, 2025
Duke U. Strikes Deal In Female Scientist's Pay Bias Suit
Duke University and a female scientist have brokered an agreement to end her suit claiming she was paid less than her male counterparts and was threatened with demotions after complaining about it, according to a Friday filing in North Carolina federal court.
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January 17, 2025
Crown Labs Tops Rival Bid In Quest To Buy Biotech Revance
Skincare product company Crown Laboratories Inc. has offered to raise its all-cash bid to buy healthcare biotech company Revance Therapeutics Inc. from $3.10 per share to $3.65 per share as it seeks to beat out a surprise bid from a Revance shareholder, according to a securities filing on Friday.
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January 17, 2025
1st Circ. Revives Biotech Worker's COVID-19 Vax Challenge
The First Circuit on Thursday resuscitated religious discrimination claims brought by a former pharmaceutical company employee who alleged her employer's COVID-19 vaccination mandate during the pandemic was in conflict with her sincerely held religious beliefs.
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January 17, 2025
Taxation With Representation: Simpson Thacher, Covington
In this week's Taxation With Representation, Eli Lilly and Co. buys a precision breast cancer program, Applied Digital Corp. enters a financing agreement for its high-performance computing business, Clearwater Analytics buys Enfusion, and Lantheus Holdings Inc. buys Life Molecular Imaging Ltd.
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January 16, 2025
Texas Judge Says 3 States Can Pursue Mifepristone Suit
A Texas federal judge said Thursday that Idaho, Missouri and Kansas can continue to challenge federal approvals for the abortion medication mifepristone in Texas federal court after private plaintiffs dropped their claims.
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January 16, 2025
ITC Commissioner Heading To WilmerHale In DC
One of the commissioners of the U.S. International Trade Commission, who had served as the agency's leader for a year and a half, has decided to leave and make the move to WilmerHale, according to the ITC.
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January 16, 2025
EpiPen Direct Buyers, Mylan Ink $75M Antitrust Deal
Mylan Pharmaceuticals has agreed to pay $73.5 million to resolve claims it worked with Pfizer to inflate the price of the latter's popular auto-injecting emergency allergy medication EpiPen, a proposed class of direct purchasers told a Kansas federal judge Wednesday, bringing the total settlement to $123.5 million.
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January 16, 2025
USPTO Seeks Views On 'Traditional Knowledge' IP Treaty
The U.S. Patent and Trademark Office requested comments Thursday on whether the U.S. should sign an international treaty that could require patent applicants to disclose if an invention draws on the traditional knowledge of indigenous people, which has concerned business groups.
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January 16, 2025
Expert Witnesses Limited In J&J Talc Ch. 11 Dismissal Try
A Texas bankruptcy judge limited Thursday the number of expert witnesses that can provide testimony in an upcoming hearing on talc claimants' attempt to dismiss the Chapter 11 case of Johnson & Johnson's talc unit.
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January 16, 2025
Merck Defends 3rd Circ. Win In Mumps Vaccine Antitrust Case
Merck urged the Third Circuit not to reconsider a ruling that immunized the company from antitrust claims over submissions it made to federal regulators for its mumps vaccine, arguing the appeals court was right to find the submissions were protected.
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January 16, 2025
Fed. Circ. Urged To Keep Block Of Sun Pharma Alopecia Drug
Incyte Corp. has urged the Federal Circuit to leave in place an injunction a New Jersey judge imposed in November blocking Sun Pharmaceutical from launching the alopecia drug Leqselvi, saying the lower court was correct that the launch would give Sun an improper "head start."
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January 16, 2025
NC Biz Court Bulletin: Judge Bids Adieu, TikTok Wants Out
The North Carolina Business Court's former chief judge hung up his robes for the last time as the court entered the new year with a ruling that shapes the fate of beset real estate company MV Realty's consumer fraud trial and arguments by TikTok Inc. that its platform being "too engaging" isn't enough for the state to begin an enforcement action.
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January 16, 2025
Chamber Slams Opioid Judge's PBM Audit Privilege Ruling
The Sixth Circuit must step in to prevent a pharmacy benefit manager from being forced to turn over internal compliance audit documents, the U.S. Chamber of Commerce has said, arguing a lower court's decision threatens to undermine the existence of in-house counsel's attorney-client privilege.
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January 15, 2025
Novartis Wins Temporary Stay Of MSN's Generic Heart Drug
The D.C. Circuit late Wednesday temporarily halted the U.S. Food and Drug Administration's approval of MSN Pharmaceuticals' generic version of Novartis' blockbuster heart failure drug Entresto, just after federal judges in D.C. and Delaware declined to block the launch of MSN's product.
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January 15, 2025
Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal
Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.
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January 15, 2025
Robo Surgery Co. Caused $140M In Lost Profits, Jury Told
Surgical Instrument Service suffered lost profits of up to $140 million because Intuitive Surgical Inc. blocked it from providing a service that extends the life of an Intuitive da Vinci surgery robot component, an economist told jurors Wednesday in a trial over claims Intuitive abuses its market power.
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January 15, 2025
Quest Diagnostics Gets Meta Data-Share Suit Tossed For Now
Quest Diagnostics got allegations that it unlawfully shared patient data with Meta Platforms through ad tracking software dismissed Tuesday, after persuading a New Jersey federal judge to reconsider his earlier ruling that allowed an eavesdropping claim under California's Invasion of Privacy Act to go forward.
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January 15, 2025
SEC Dings Pharma Co., Ex-CFO Over Prescription Scheme
The U.S. Securities and Exchange Commission announced it has settled claims against bankrupt DMK Pharmaceuticals Corp. and its ex-chief financial officer over their alleged role in a fraudulent scheme to generate revenues using illegal prescriptions for horse medications.
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January 15, 2025
Abbott's Toddler Nutrition Drinks Aren't Healthy, Parents Claim
A trio of parents filed a proposed false advertising class action in Illinois federal court Tuesday alleging Abbott Laboratories touts its toddler drinks sold under the Similac brand as nutritionally proper for children ages 12 months to 36 months, even though the products contain added sugar which is harmful to health.
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January 15, 2025
Justices Asked If Zoning Immunity Can Pass To Private Entity
The Georgia Supreme Court on Wednesday considered whether a hospital authority could transfer its exemption from municipal zoning ordinances to a private buyer in a dispute over whether a hospital site can become an addiction rehabilitation center.
Expert Analysis
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Opinion
Litigation Funding Disclosure Key To Open, Impartial Process
Blanket investor and funding agreement disclosures should be required in all civil cases where the investor has a financial interest in the outcome in order to address issues ranging from potential conflicts of interest to national security concerns, says Bob Goodlatte, former U.S. House Representative for Virginia.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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What NFL Draft Picks Have In Common With Lateral Law Hires
Nearly half of law firm lateral hires leave within a few years — a failure rate that is strikingly similar to the performance of NFL quarterbacks drafted in the first round — in part because evaluators focus too heavily on quantifiable metrics and not enough on a prospect's character traits, says Howard Rosenberg at Baretz+Brunelle.
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Replacing The Stigma Of Menopause With Law Firm Support
A large proportion of the workforce is forced to pull the brakes on their career aspirations because of the taboo surrounding menopause and a lack of consistent support, but law firms can initiate the cultural shift needed by formulating thoughtful workplace policies, says Barbara Hamilton-Bruce at Simmons & Simmons.
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Class Actions At The Circuit Courts: August Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.
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Leveraging Policy Changes To Achieve AI Patent Eligibility
With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.
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Planning Law Firm Content Calendars: What, When, Where
During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.
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Series
Playing Golf Makes Me A Better Lawyer
Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.