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Life Sciences
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December 04, 2023
Catching Up With Delaware's Chancery Court
Blockchain gaming, lithium-battery production, nutrition supplements and Activision's $68.7 billion sale to Microsoft — nothing is too big or complicated for Delaware's Chancery Court to put on its agenda. The year is winding down, but things haven't slowed in the nation's top court of equity. Check here for all the latest news from the Chancery Court.
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December 04, 2023
Ex-FBI Trainee Cops To Trading On Covington Insider Info
A former FBI trainee pled guilty in Manhattan federal court Monday to insider trading on a Merck & Co. acquisition after reading about the deal in the files of his then-girlfriend, an associate at Covington & Burling LLP.
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December 04, 2023
Sidley-Led Roche To Buy US Drugmaker For Up To $3.1B
Swiss pharmaceutical giant Roche said on Monday that it plans to buy Carmot Therapeutics, a developer of obesity and diabetes drugs, for up to $3.1 billion as it seeks to add weight-loss products to its portfolio.
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December 01, 2023
Justices Call O'Connor 'American Hero,' 'Perfect Trailblazer'
Following news of retired U.S. Supreme Court Justice Sandra Day O'Connor's death at the age of 93, current and former high court justices paid public homage to her trailblazing career, devotion to the rule of law and illuminating charisma.
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December 01, 2023
Natera Wins Cancer Test Injunction After $19M IP Verdict
A Delaware federal judge has barred Invitae Corp. from using its Personalized Cancer Monitoring test in certain ways that infringe patents owned by Natera Inc., according to a rare injunction made public Friday.
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December 01, 2023
Former Clerks Say Justice O'Connor Still Worth Emulating
BigLaw attorneys mentored by former U.S. Supreme Court Justice Sandra Day O'Connor, who died Friday after a lengthy battle with dementia, say she'll be remembered as an incisive jurist who always put facts and practical considerations above abstract ideological commitments, as well as a deeply gracious and down-to-earth woman who never let her dedication to the law overshadow her zest for life.
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December 01, 2023
Voters Worried About Health Care Affordability, Poll Shows
Voters are keenly focused on issues like health care affordability and abortion rights, though most of the public is in the dark about the unwinding of the Medicaid continuous enrollment provision and the drug price provisions in the 2022 Inflation Reduction Act, according to a poll released Friday.
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December 01, 2023
Up Next At High Court: Purdue Pharma, Taxes & Job Transfers
The U.S. Supreme Court returns Monday for the last argument session of the calendar year to consider whether bankruptcy courts have the authority to sign off on third-party liability releases in Chapter 11 plans, whether Congress can tax unrealized foreign gains, and which standard should be used to determine the viability of employment discrimination claims.
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December 01, 2023
La. Lab Owner Indicted For $148M Urine Test Billing Scheme
A Baton Rouge, Louisiana, federal grand jury has indicted a man for his alleged role in a scheme to defraud Medicare and Medicaid of over $148 million in unnecessary urine drug testing services, the U.S. Department of Justice has announced.
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December 01, 2023
Congress Has Chance To Adjust Hemp Policy, Report Says
Congress could consider modifying federal hemp policy by relaxing U.S. Department of Agriculture restrictions that some stakeholders say are "overly restrictive and impractical," according to a recently updated Congressional Research Service report.
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December 01, 2023
Med Tech Co. Sues AI Maker Over Use Of 'Judi' Mark
Boston-based AGMednet told a Massachusetts court Friday that the company behind a JUDY-branded AI cloud assistant service, Judefly, wrongfully accused it of trademark infringement, claiming it had used the "Judi" mark for years before Judefly developed its AI tool.
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December 01, 2023
Mass. Lab Execs Guilty Of Bloodwork Kickback Conspiracy
Five health care executives have been convicted by a Texas jury of conspiring to pay Lone Star State doctors bribes for referring patients' bloodwork to a Massachusetts lab in a complicated multistate scheme to get inflated payouts from federal insurance programs.
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December 01, 2023
Clinic Owner, Pharma Tech Sentenced For Fake Clinical Trial
The owner of a Miami medical clinic and a pharmacy technician at the clinic were sentenced in Florida federal court to 71 and 46 months in prison, respectively, for running a fake clinical drug trial.
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December 01, 2023
Leases Don't Disqualify Small Biz Bankruptcies, Court Rules
Companies with long-term leases and similar contracts that exceed $7.5 million shouldn't be barred from seeking protection under a bankruptcy subchapter designed for small businesses, because leases often amount to net assets rather than liabilities and shouldn't count toward the subchapter's debt limit, a New York bankruptcy judge said.
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December 01, 2023
Xencor Scoffs At USPTO Bid To Send Case To Review Panel
Xencor is urging the Federal Circuit to reject what it calls the U.S. Patent and Trademark Office's "eleventh hour" effort to terminate an appeal of a Patent Trial and Appeal Board decision, which backed an examiner's denial of a patent application on antibodies that can be used in autoimmune disease treatments.
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December 01, 2023
J&J MedTech Buys Heart Device Maker Laminar In $400M Deal
Johnson & Johnson MedTech on Thursday announced the $400 million acquisition of Laminar Inc., a medical device maker focused on reducing the risk of stroke.
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December 01, 2023
Purdue's High Court Case Puts Bankruptcy Pragmatism On Trial
Purdue Pharma's oral arguments before the U.S. Supreme Court on Monday are likely to cover several exalted ideas, including the constitutional limits of America's bankruptcy code and the moral implications of letting billionaires off the hook for their company's role in the opioid epidemic. But some experts say the case threatens a humbler factor at the very heart of bankruptcy practice itself: pragmatism.
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December 01, 2023
4 Decisions For Which Justice O'Connor Will Be Remembered
Many of the hotly divided cases at the U.S. Supreme Court came down to Justice Sandra Day O’Connor, a central force on the bench whose savviness at striking compromises and taking a pragmatic approach to resolve disputes is on full display in four opinions.
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December 01, 2023
Justice O'Connor Shattered Barriers, Built Bridges
A Southwestern cowgirl who will always be known as the first woman to sit on the U.S. Supreme Court, Justice Sandra Day O’Connor inspired those around her with an indomitable work ethic, a deep affection for public service and an innate ability to drive consensus among her colleagues.
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December 01, 2023
Sandra Day O'Connor, First Woman On Supreme Court, Dies
Retired U.S. Supreme Court Justice Sandra Day O'Connor, the court's first female member, died Friday at 93, according to the court. Justice O'Connor's position at the ideological center of the court gave her outsized influence in controversial cases during her 25-year tenure.
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November 30, 2023
DeSantis, Newsom Square Off Over Healthcare In Fox Debate
Two heavyweight governors from opposite ends of the country — Republican Ron DeSantis and Democrat Gavin Newsom — clashed over gender-affirming care, abortion rights and pandemic restrictions in a prime-time debate Thursday, underscoring the stakes for healthcare policy in next year's presidential election.
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November 30, 2023
Pfizer Overhyped Its COVID-19 Vax Efficacy, Texas AG Claims
Texas Attorney General Ken Paxton filed a consumer protection lawsuit Thursday in Lubbock County accusing Pfizer Inc. of over-touting the efficacy of its COVID-19 vaccine, seeking more than $10 million for violations of the Lone Star State's Deceptive Trade Practices Act.
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November 30, 2023
IP Forecast: Beauty And The Copyright-Protected Beast
A federal courthouse in Oakland will be center stage next week for a jury trial over allegations that Disney owes profits from the billion-dollar Emma Watson blockbuster "Beauty and the Beast" remake to ex-Microsoft executive Steve Perlman's digital effects company for infringing copyright-protected software to make the movie's live-action beast. Here's a look at that case — plus all the other major intellectual property matters on deck in the coming week.
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November 30, 2023
SEC Waives $40M Fine For Mallinckrodt In Medicaid Scheme
The U.S. Securities and Exchange Commission announced Thursday that it has waived a $40 million civil penalty against pharmaceutical company Mallinckrodt for overcharging Medicaid for one of its flagship drugs, saying the agency considered Mallinckrodt's financial condition and settled its claims on the company's commitment to retain a compliance consultant.
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November 30, 2023
Premera Launches Fresh Takeda Antitrust Suit Over IBS Drug
A Blue Cross affiliate has once again lodged a proposed class action against Takeda Pharmaceuticals over an alleged conspiracy to keep generic versions of the drug Amitiza off the market, filing a tweaked version of its suit just weeks after a Massachusetts federal judge threw out its initial attempt.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Managing ANDA Venue Issues As Del. And NJ Filings Rise
Delaware and New Jersey have prevailed as the primary forum for pharmaceutical litigation as more generic companies file abbreviated new drug applications, but this venue scheme presents traps for the unwary, and legislation may still be necessary to ensure fairness and predictability, say Timothy Cook and Kevin Yurkerwich at WilmerHale.
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Series
Writing Thriller Novels Makes Me A Better Lawyer
Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.
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What Lawyers Must Know About Calif. State Bar's AI Guidance
Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.
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Industry Must Elevate Native American Women Attys' Stories
The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.
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The Fed. Circ. In Nov.: Factual Support And Appellate Standing
The Federal Circuit's recent Allgenesis Biotherapeutics v. Cloud Break Therapeutics decision shows that appellate standing requires specific factual support, underscoring the necessary requirements for a patent challenger in an appeal from an inter partes review at the U.S. Patent and Trademark Office, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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Kochava Ruling May Hint At Next Privacy Class Action Wave
The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.
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Forecasting The Impact Of High Court Debit Card Rule Case
John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.
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Series
ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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Opinion
FDA And Companies Must Move Quickly On Drug Recalls
When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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Opinion
A Telecom Attorney's Defense Of The Chevron Doctrine
The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.
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What's At Stake In Bystolic 'Side Deals' Litigation
In re: Bystolic Antitrust Litigation, which has oral argument set for next month, will likely shed light on how the U.S. Court of Appeals for the Second Circuit views side deals, and could create a circuit split in pleading standards for reverse payment cases, say attorneys at Axinn.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.