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Life Sciences
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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.
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January 15, 2025
Del. Justices Mull 'Reasonable' Effort Duty In Drug Biz Deal
An attorney for former stockholders of Ception Therapeutics Inc. told Delaware's top court on Wednesday that a now-retired vice chancellor "asked the wrong question" in dismissing a suit alleging breaches of an agreement to use commercially reasonable efforts before abandoning a new drug prospect.
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January 15, 2025
DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years
Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.
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January 15, 2025
3rd Circ. Preview: NFL Concussion Benefits Fight Tops January
The case of late NFL players' family members who say they shouldn't have to exhume their loved ones' remains to receive benefits from the national concussion settlement takes center stage in the Third Circuit's January argument session.
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January 15, 2025
Chinese Execs Sent Fentanyl Precursor To NY, Jury Told
A novel fentanyl-trafficking case went to trial in New York federal court on Wednesday, with prosecutors arguing that two Chinese chemical executives inked a multimillion-dollar deal to export the raw materials for the drug to a Manhattan lab in 2023.
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January 15, 2025
Former FDA Official Joins King & Spalding Life Sciences Team
King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.
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January 15, 2025
FDA Bans Red Dye No. 3, Citing Cancer Link In Animal Studies
The U.S. Food and Drug Administration on Wednesday said that it is banning the use of a red dye, Red No. 3, which gives food and drinks a bright red color but has also been linked to cancer in animals.
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January 15, 2025
Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team
Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.
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January 15, 2025
Justices Say Nixing Federal Claims Ends Federal Jurisdiction
The U.S. Supreme Court on Wednesday said a proposed class action over alleged mislabeling of prescription dog food was appropriately sent back to state court, holding that once the plaintiff dropped her federal claims, the federal courts no longer had jurisdiction.
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January 14, 2025
Abbott, Novartis Settle HIV Test Patent Beef Ahead Of Trial
Abbott Laboratories, Novartis and Grifols have reached a settlement in a yearslong battle over a patent covering a method for replicating DNA, putting to rest the litigation less than a month before it was set to go to trial, according to an entry in Illinois federal court posted Monday.
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January 14, 2025
Conn. City Hits PBMs And Pharma Cos. With Insulin Pricing Suit
A city partway between New Haven and Hartford took pharmacy benefit managers and drug makers including CVS Health Corp., Eli Lilly and Co. and Novo Nordisk Inc. to Connecticut federal court on Monday, alleging that they conspired to keep diabetes medications and insulin at needlessly high prices.
Expert Analysis
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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.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.