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Life Sciences
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March 10, 2025
Amgen, Fresenius Settle Osteoporosis Drug Patent Dispute
Amgen Inc. and Fresenius Kabi USA have reached an agreement resolving Amgen's allegations that Fresenius infringed a long list of patents covering drugs for treating osteoporosis and preventing bone problems, according to an order issued Friday in New Jersey federal court.
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March 10, 2025
Masimo Founder Urges Toss Of 'Empty Voting' Suit
The founder of Masimo Corp. has urged a New York federal court to permanently toss the medical technology company's suit alleging he manipulated a shareholder vote, arguing that the suit fails to state a plausible claim under the Exchange Act.
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March 10, 2025
Calif. Pharma Exec Pleads Guilty To Insider Trading
A California medical doctor has pled guilty to insider trading in the securities of biopharmaceutical company Acadia Pharmaceuticals Inc. while serving on Acadia's drug safety team, admitting to trading on confidential information that helped him avoid $1.3 million in losses.
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March 10, 2025
DOJ Wants In On Invisalign Monopoly Arguments At 9th Circ.
The U.S. Department of Justice wants to be there when orthodontists and consumers who purchased clear teeth aligners face off with the company behind Invisalign at the Ninth Circuit next month, so it can tell the appellate judges where the lower court went wrong in killing their monopoly suits.
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March 10, 2025
GAO Says NIH Treated Bidders Disparately On $20M IT Deal
The U.S. Government Accountability Office has sustained a protest over a $19.9 million National Institutes of Health software development task order, finding the NIH unreasonably treated similar aspects of the protester's and awardee's bids differently.
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March 10, 2025
CBD Co. Launches More Patent Suits Over Topical Cream
CBD company Metronome LLC has filed another pair of suits in Delaware federal court alleging competitors are infringing its patent with a topical pain relief cream that uses cannabis-derived ingredients.
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March 10, 2025
Fed. Circ. Won't Pause Teva Patent Delisting For Appeal
The Federal Circuit denied on Friday Israeli drugmaker Teva Pharmaceuticals' bid to keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold pending its appeal of the matter to the U.S. Supreme Court.
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March 10, 2025
Ex-Magellan CEO Pleads Guilty Over Faulty Lead Tests
The former CEO of Magellan Diagnostics Inc. admitted Monday to selling faulty devices that tested blood lead levels, the final of three defendants to plead guilty ahead of a jury trial scheduled for April.
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March 07, 2025
FDA Can Take Eli Lilly Weight Loss Drug Off Shortage List
A Texas federal judge has refused to issue an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, ruling that the U.S. Food and Drug Administration was within its authority when it removed the medication from the drug shortage list.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
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March 07, 2025
Hints Of A New High Court Majority Emerge In Trump Cases
The U.S. Supreme Court's recent rejection of President Donald Trump's bid to keep frozen nearly $2 billion in foreign aid funding gave court watchers a glimpse of a coalition majority that could end up thwarting some of the president's more aggressive and novel attempts to expand executive power.
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March 07, 2025
Ohio, PBMs Say High Court Ruling Didn't End Pricing Appeal
Ohio state enforcers have told the Sixth Circuit an appeal in their case accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices was not resolved by a U.S. Supreme Court decision dealing with federal versus state jurisdiction.
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March 07, 2025
New Bellwethers Score Cert. In Generic Drug Price-Fixing MDL
The Pennsylvania federal court overseeing sprawling multidistrict litigation springing from claims that pharmaceutical giants worked together to hike the cost of off-brand drugs has certified several sets of classes for the cases for the MDL's latest bellwethers.
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March 07, 2025
Apple Prevails In Watch Tech Patent Fight At Fed. Circ.
The Federal Circuit handed Apple a significant victory Friday in a dispute that might have led to a ban on imports of its smartwatches, affirming that a competing company's heart monitor patents are invalid and vacating a conflicting U.S. International Trade Commission decision that found the watches infringed those patents.
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March 07, 2025
Ex-Novo Nordisk Worker Can't Reopen Harassment Suit
A former employee of Novo Nordisk can't revive her lawsuit claiming she was let go because she is a Jewish woman and had a back and hip injury, a California state appeals court ruled, finding no issue with a trial court tossing the case after she failed to oppose the move.
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March 07, 2025
Tariffs, Diversity And DOGE Dominate Trump 2.0 'Risk Factors'
Public companies are busily reworking risk disclosures since the arrival of President Donald Trump's second administration, seeking to walk a fine line of being upfront with investors about potential threats to business despite vast legal and policy uncertainties.
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March 07, 2025
Husband Of Ex-Takeda VP Gets 2½ Years For Invoice Scam
The husband of a former Takeda Pharmaceuticals vice president was sentenced in Massachusetts federal court Friday to two and a half years in prison for his role in a scheme to dupe the drug giant out of $2.3 million through bogus invoices.
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March 07, 2025
Taxation With Representation: Kirkland, Wachtell, Skadden
In this week's Taxation With Representation, Walgreens Boots Alliance goes private via a deal with Sycamore Partners, Honeywell buys Sundyne from Warburg Pincus, and Jazz Pharmaceuticals acquires Chimerix.
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March 06, 2025
Don't Give Teva 'Eighth Bite' At $235M Patent Trial, GSK Says
GlaxoSmithKline has told a Delaware federal judge that Teva's request for a new trial in the drugmakers' decade-long, $235 million "skinny label" patent fight over heart failure medication is an "eighth bite at the same apple."
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March 06, 2025
Pfizer Failed To Warn Of Depo-Provera's Tumor Risk, Suit Says
A woman who claims she developed a brain tumor after years of taking the contraceptive Depo-Provera is suing Pfizer and other pharmaceutical companies who manufacture the drug, claiming in Washington federal court they failed to tell patients of the danger even though it is standard on warning labels in Europe and Canada.
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March 06, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Believe it or not, there's still important litigation happening that doesn't involve President Donald Trump, and the proof exists in this month's circuit court calendars. During the remaining weeks of March, arguments will explore numerous high-profile topics, including a law firm's severe punishment for alleged misconduct in 9/11 litigation and a judicial rebuke of Trader Joe's for "an attempt to weaponize the legal system."
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March 06, 2025
FTC Challenges PE Firm's Medical Device Coatings Deal
The Federal Trade Commission moved Thursday to block private equity firm GTCR BC Holdings LLC's planned $627 million acquisition of Surmodics Inc. over concerns about competition for medical device coatings.
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March 06, 2025
Walgreens Boots Inks $24B Go-Private Deal With Sycamore
Walgreens Boots Alliance said Thursday it has agreed to be purchased by private equity firm Sycamore Partners in a transaction with a total value of up to $23.7 billion, as the storied retailer looks to reverse years of financial declines by going private.
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March 06, 2025
No Cancer Therapy Patent For AbbVie, Says Federal Circuit
The Federal Circuit declined on Thursday to second-guess a Virginia federal judge who sided with the U.S. Patent and Trademark Office in refusing to issue a patent requested to cover a purportedly new way of administering a clinical stage cancer treatment to an AbbVie unit.
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March 06, 2025
Attys Seek $30M Fees In Walgreens Rx Overcharge Deal
Attorneys for unions and consumers who struck a $100 million settlement of Walgreens prescription overcharge fee claims asked an Illinois federal judge for a $30 million cut of that pot, arguing the amount would pay for seven years of meaningful work they put into the case.
Expert Analysis
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.