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Life Sciences
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January 17, 2025
Walgreens Knowingly Filled Invalid Prescriptions, Feds Say
The U.S. Department of Justice has accused Walgreens of knowingly filling millions of prescriptions for opioids and other controlled substances that did not have a legitimate medical purpose or were not valid, intervening in cases brought by four whistleblowers in Illinois federal court.
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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.
Expert Analysis
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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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.