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Life Sciences
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March 11, 2024
Acadia Investors Get Class Cert. In Suit Over Parkinson's Drug
A California federal judge on Monday certified a class of Acadia Pharmaceuticals investors in a lawsuit accusing the company of making false and misleading statements regarding the likelihood that its Parkinson's psychosis drug would also be approved for the broader use of dementia-related psychosis.
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March 11, 2024
Illumina Brass Faces Shareholder Suit Over Grail Deal Debacle
Current and former directors and executives of Illumina, including former U.S. Food and Drug Administration Commissioner Scott Gottlieb, have been hit with a shareholder derivative suit in California federal court over their role in the biotech company's failed $8 billion deal to reacquire its cancer-detection company Grail Inc.
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March 11, 2024
3rd Circ. Finds No Reason To Disturb AbbVie Privilege Ruling
The Third Circuit has found that AbbVie was unable to show that a Pennsylvania federal court went against precedent or made an error when ordering the drugmaker to turn over attorney communications from a "sham" patent case allegedly meant to delay AndroGel competitors.
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March 11, 2024
Judge OKs Eye Care Tech Co.'s $8M DIP Request
A Texas bankruptcy judge on Monday approved optometry software company Eye Care Leaders Portfolio Holdings LLC's request to draw on the remainder of its $8 million in debtor-in-possession funds for its Chapter 11 case, saying the company had given good reason to believe it was poised for a rewarding auction.
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March 11, 2024
Fed. Circ. OKs Boston Drug Developer's Patent Win
A Boston-area biotech developer that has yet to bring a product to market persuaded the Federal Circuit on Monday to affirm a finding by an administrative patent board last year that stripped a smaller Chinese rival of a patent covering a way of using a type of sulfonic acid to potentially treat Alzheimer's disease.
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March 11, 2024
Pfizer Slams Ex-Compliance Officer's Whistleblower Claims
Pfizer has asked a California federal court to again dismiss the bulk of a discrimination and retaliation lawsuit filed by a former compliance officer for the pharmaceutical giant, arguing his latest suit is "largely a regurgitation of his original complaint."
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March 11, 2024
Walmart Fails To Sink Feds' Opioid Crisis Lawsuit
A Delaware federal judge on Monday kept alive a government lawsuit accusing Walmart of fueling the nation's opioid crisis, ruling that the company could be held liable for filling illegitimate prescriptions its compliance officers allegedly failed to flag for unwitting pharmacists.
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March 11, 2024
SEC Can't Rely On 'Flawed' Ruling To Avoid Retrial, Atty Says
A Connecticut lawyer facing retrial in a securities fraud case told the First Circuit that the U.S. Securities and Exchange Commission can't lean on a summary judgment finding that was also flawed.
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March 11, 2024
Pfizer Defeats French Group's Bid For Vax Docs At 2nd Circ.
The Second Circuit said Monday that Pfizer doesn't need to give a French nonprofit the communications between its CEO and the European Commission's president related to a COVID-19 vaccine development agreement, ruling the materials are irrelevant to a jurisdictional issue in the group's legal challenge to the pact in France.
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March 11, 2024
Catching Up With Delaware's Chancery Court
Delaware's Court of Chancery became a hot topic in New Orleans last week as litigators and judges at an annual convention acknowledged the First State's corporate law preeminence is under scrutiny. Back home, the court moved ahead on disputes involving Meta Platforms, Abercrombie & Fitch and Donald Trump.
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March 08, 2024
Trump 'An Existential Threat' To Rule Of Law, Attys Warn
Former President Donald Trump represents an "existential threat" to democracy and the rule of law, legal experts said Friday at a conference on white collar crime in San Francisco.
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March 08, 2024
Inside The Climactic Clash Over Skyrocketing MDL Caseloads
A seven-year showdown over the nation's swelling docket of ultra-high-stakes consumer suits is hurtling toward its moment of truth, as a judicial oversight panel weighs impassioned input from big-name attorneys and judges endorsing everything from sweeping overhauls to the tiniest of tweaks.
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March 08, 2024
Cahill Has 'Great Ambitions' To Take IP Litigation By Storm
Cahill Gordon & Reindel LLP has spent the last year building up a new intellectual property practice, with a veteran of top law firms leading the way and attorneys from White & Case LLP joining the firm earlier this year.
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March 08, 2024
FDA Pumps Brakes On Eli Lilly Alzheimer's Drug Approval
The U.S. Food and Drug Administration is delaying an approval decision on Eli Lilly and Co.'s Alzheimer's drug donanemab, the company said Friday, throwing a wrench in what was expected to be a smooth approval process for the experimental neurodegenerative treatment.
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March 08, 2024
UK Enforcers To Appeal Nixed £100M Hydrocortisone Fine
Britain's competition enforcer is planning to appeal a tribunal's ruling that upended more than £100 million ($128.6 million) in fines against several drug companies for allegedly reaching agreements that increased the price of hydrocortisone tablets.
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March 08, 2024
Colo. DNA Scientist Fudged Data For 650 Cases, Police Say
A former DNA scientist for the Colorado Bureau of Investigation manipulated data for years, the bureau announced Friday, stating that an investigation has identified more than 650 cases affected since 2008.
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March 08, 2024
7th Circ. Wants 'Roadmap' For Ill. Workplace Disease Law
The Seventh Circuit has asked the Illinois Supreme Court to weigh in on the state's Workers' Occupational Diseases Act, saying it needs a "roadmap" to handle claims for asbestos and other diseases that manifest belatedly as it considers a widow's suit alleging her husband's exposure to a toxic chemical while working for Goodrich Corp. led to his death.
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March 08, 2024
Sorrento Gets OK For $2M Ch. 11 Funding Infusion, Asset Sale
A Texas bankruptcy judge on Friday approved drug developer Sorrento Therapeutics Inc.'s bid for an asset sale and $2 million in funds to fuel its Chapter 11 case, saying they represented the only option outside of a transition to Chapter 7.
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March 07, 2024
Abortion, Drug Costs Top Health Issues in State Of The Union
President Joe Biden laid out a forceful healthcare agenda in his State of the Union address on Thursday, promising to ramp up efforts to control drug prices and pledging to reinstate the federal right to an abortion if voters elect a pro-abortion Congress.
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March 07, 2024
Petition Watch: Student Athletes, Oil Spills & Preemption
The U.S. Supreme Court receives thousands of petitions for review each term, but only a few make the news. Here, Law360 looks at four petitions filed in the past three weeks that you might've missed: questions over whether student athletes have a business interest in being eligible to play college sports, how much oil is needed to qualify as an oil spill, whether an exemption to the Fourth Amendment applies to artificial intelligence and whether consumers can sue drug companies under state law for violating federal regulations.
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March 07, 2024
Judges Say Facing Threats And Vitriol Now Part Of The Job
Federal judges spoke Thursday about the challenges of the profession in the 21st century, describing how they've either received threats or know of warnings against colleagues, with one jurist saying she received 11 death threats during her first three months on the bench.
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March 07, 2024
Judge Doubts Medicare Drug Pricing Amounts To 'Taking'
A New Jersey federal judge on Thursday bristled at the position by pharmaceutical companies that Medicare's drug price negotiation program is an unconstitutional "taking" that undercuts their bottom line, suggesting that the drug powerhouses needed more numbers to back their argument.
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March 07, 2024
IP Forecast: 2nd Circ. To Consider Whether Seltzer Is Beer
The Modelo brand will head to the Second Circuit next week to argue that a Manhattan jury erred when it found that Corona's flavored seltzer is just about the same as beer in light of a contract that the companies entered. 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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March 07, 2024
Harpoon Shareholder Sues For Records On $680M Merck Buy
A shareholder of Harpoon Therapeutics Inc. sued in Delaware's Court of Chancery Thursday for corporate documents related to the company's proposed $680 million cash buyout by Merck, saying the proposed deal appears to unfairly "lock in a windfall for select Harpoon investors."
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March 07, 2024
Sens. Tell Stores To Get Illegal E-Cigs Off Their Shelves
Five U.S. senators on Thursday told the heads of major convenience store and gas station chains to stop sales of unauthorized flavored e-cigarette products, saying that their illegal sales pose a major threat to public health, especially children's.
Expert Analysis
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Fed. Circ. Elekta Holding May Make Patent Prosecution Harder
The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.
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Class Action Defense: Don't Give Up On Bristol-Myers Squibb
Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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State Regs Sow Discord Between Cannabis, Hemp Industries
Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.
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Series
Playing In A Rock Cover Band Makes Me A Better Lawyer
Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.