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Life Sciences
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April 17, 2024
3 Takeaways From Revived Obviousness Case On J&J Patent
A Federal Circuit ruling from earlier this month that told a judge to reconsider upholding a Johnson & Johnson schizophrenia drug patent emphasizes that analyzing whether a patent is invalid as obvious requires focusing on what it actually claims and an inventor's creativity, attorneys said.
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April 17, 2024
FDA's Foot-Dragging On Menthol Ban Sparks Frustration
The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.
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April 17, 2024
FDA Denies Marketing For 65 MNGO Disposable E-Cigarettes
The latest action by the U.S. Food and Drug Administration on e-cigarettes was to tell a Chinese company to take its range of 65 e-cigarette products in a variety of flavors from menthol to pink lemonade and watermelon off the market.
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April 17, 2024
FDA Tells Justices It Has A Better Vape Case In Mind
The U.S. Food and Drug Administration has told the U.S. Supreme Court that if it wants to address the agency's decision not to approve applications for flavored e-cigarettes, there is a better case in the pipeline than the appeal lodged by Lotus Vaping Technologies that the justices should choose instead.
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April 17, 2024
SEC Has Careful Eye On Disclosures Amid Israel-Hamas War
Against the backdrop of protracted war, the U.S. securities watchdog is urging U.S.-listed Israeli companies to disclose more details describing how the Israel-Hamas conflict is affecting their operations in order to keep investors apprised of risks, lawyers say.
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April 17, 2024
'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years
A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.
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April 17, 2024
Manatt Adds NY Bankruptcy, Financial Regulatory Partners
Manatt Phelps & Phillips LLP announced that it hired a pair of experienced New York-based attorneys who focus their practices on regulatory matters as partners in its bankruptcy and financial regulatory practices.
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April 17, 2024
WashU Medical School Settles Claims Of Asylee Bias, Firing
The Washington University School of Medicine in St. Louis has settled claims that it fired a worker who complained that he was being forced to prove he held asylum, according to the U.S. Department of Justice.
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April 17, 2024
Ex-Pharma Exec's Contempt Plea Rejected By Judge
A Massachusetts federal judge on Wednesday rejected a former pharmaceutical executive's agreement to plead guilty to contempt for using an alias to get around a consent judgment in a U.S. Securities and Exchange Commission fraud case, saying both the former executive and the government knew he'd view the sentence as too low.
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April 17, 2024
Elliott Waives BioMarin Board Deal, Moots Del. Suit
Elliott Investment Management LP has waived an agreement with BioMarin Pharmaceutical Inc. that gave the activist investor three new seats on the biopharmaceutical company's board, mooting a Delaware Chancery Court lawsuit that a BioMarin shareholder filed earlier this month.
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April 16, 2024
House Panel Takes Aim At Change Healthcare, FTC Over Hack
A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share.
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April 16, 2024
Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial
Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.
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April 16, 2024
NC Treasurer Backs FTC On Hospital Merger Challenge
North Carolina's treasurer agreed Monday that Novant Health's $320 million plan to pick up a pair of hospitals is a bad idea, throwing its weight behind the Federal Trade Commission's challenge to the deal in federal court.
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April 16, 2024
IBM Gained Most AI Patents By Far In 2023
IBM obtained more U.S. artificial intelligence patents in 2023 than any other company, with its closest competitors falling behind by more than 300 patents, according to a Harrity Patent Analytics report announced Tuesday.
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April 16, 2024
Life Sciences Group Of The Year: Fenwick
Defending Novo Nordisk's patents for diabetes drug Ozempic and guiding Dice Therapeutics through its $2.4 billion acquisition by Eli Lilly & Co. are among the achievements that put Fenwick & West LLP among Law360's 2023 Life Sciences Groups of the Year.
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April 15, 2024
Taro Inks $36M Investor Deal Over Generics Price-Fixing
Taro Pharmaceutical Industries shareholders asked a New York federal judge Monday to greenlight a $36 million settlement resolving proposed class claims that the company misled investors about alleged generic drug price-fixing that led to a drop in stock price upon news of a U.S. Department of Justice antitrust investigation.
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April 15, 2024
Chancery Denies Forte Biosciences' Bid To Toss Investor Suit
Board members of a struggling clinical-stage biopharmaceutical company who allegedly took defensive measures to stay in power after activist investors pushed the company to liquidate must face a stockholder's Delaware Chancery Court derivative suit that they breached their fiduciary duties to shareholders, a vice chancellor said Monday.
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April 15, 2024
Years After Args, 7th Circ. Continues Mootness Fee Attack
A Seventh Circuit panel said Monday that a Chicago federal judge improperly barred a class action objector from intervening in a suit involving controversial "mootness fees" the appellate court has long criticized, saying he failed to articulate a valid legal reason for doing so.
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April 15, 2024
TTAB Sides With Pharma Co.'s Opposition To 'SageForth' TM
The Trademark Trial and Appeal Board has ruled in favor of biopharmaceutical company Sage Therapeutics Inc.' opposition to a psychological service provider's attempt to register "SageForth" as a trademark, saying the name is likely to cause confusion with Sage Therapeutics' treatments for postpartum depression.
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April 15, 2024
Hold This COVID Vax Patent Case, Judge Recommends
One of the suits over Pfizer's blockbuster COVID-19 vaccine hit a snag in Virginia federal court Friday when a judge recommended pausing the case to wait for a ruling in a related dispute over patent ownership involving one of BioNTech's other partners.
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April 15, 2024
Catching Up With Delaware's Chancery Court
Last week, Delaware justices mulled whether one Chancery Court vice chancellor properly voided four company bylaws — just as another vice chancellor voided one more. Fights among Truth Social investors continued, and shareholders launched new cases involving Macy's, United Airlines, and Clayton Dubilier & Rice LLC and Stone Point Capital LLC.
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April 15, 2024
Orrick Adds Kramer Levin Life Sciences Head In NY
The former head of Kramer Levin Naftalis & Frankel LLP's life sciences practice has jumped to the intellectual property litigation team at Orrick Herrington & Sutcliffe LLP in New York, Orrick said Monday.
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April 15, 2024
Pharmacy, Courier Co. Settle Driver's Classification Suit
A delivery driver and a CVS-owned pharmacy and a logistics and courier firm told an Illinois federal court that they have reached a settlement resolving claims that the company misclassified workers as independent contractors and paid them neither minimum nor overtime premium wages.
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April 15, 2024
Justices Won't Nix FDA Labeling Preemption For State Claims
The Supreme Court on Monday let stand lower court findings that the unique authority of the federal Food and Drug Administration preempted and, therefore, justified dismissing a proposed class action that alleged a Johnson & Johnson subsidiary broke Massachusetts law by misbranding Lactaid drug products as dietary supplements.
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April 15, 2024
Life Sciences Group Of The Year: Cooley
Cooley LLP advised Horizon Therapeutics during its massive sale to Amgen Inc. — defeating an antitrust challenge along the way — and helped Moderna Inc. win a patent case centering on its COVID-19 vaccine, earning the firm a place among Law360's 2023 Life Sciences Groups of the Year.
Expert Analysis
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Series
Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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How The PTAB Landscape Shifted In 2023
Attorneys at Finnegan consider the impact of noteworthy Patent Trial and Appeal Board developments in 2023, including rulemaking, litigation, precedential decisions and director reviews that affected PTAB practice, and offer a reference for examining future proceedings and strategies.
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New Pharma Guidelines Bring Pitfalls For Compounders
New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.
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Opinion
What Happens If High Court Rejects Releases In Purdue Ch. 11
Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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Coming To Terms With Means-Plus-Function Patent Claims
Made-up patent claim terms can open arguments that means-plus-function claim interpretation applies under the Patent Act, but a series of practice tips, including the use of structural language immediately after introducing a claim element, can help avoid such perceptions, says Brad Luchsinger at Harness IP.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.
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Opinion
Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.
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How Clients May Use AI To Monitor Attorneys
Excerpt from Practical Guidance
Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.
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7 Enforcement Predictions For US Export Controls, Sanctions
Federal agencies' assertions of coming increases in export-control and sanctions-violations enforcement are not new, but recent improvements in resources and inter-agency cooperation allow for certain predictions about how the administration’s latest approach to enforcement may be applied going forward, say attorneys at Akin.
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How AI Executive Order Aims To Compete For Foreign Talent
Immigration provisions within the Biden administration's executive order on artificial intelligence take a strategic approach to promoting the U.S. as a destination for AI and STEM talent by streamlining visa processing, enhancing educational and exchange programs, and improving current visa programs and pathways to permanent residency, says Eric Bord at Morgan Lewis.
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Series
ESG Around The World: Singapore
Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.
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Series
The Pop Culture Docket: Judge D'Emic On Moby Grape
The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.
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Navigating Asset Tracing Challenges In Bankruptcy
A Virginia court’s recent ruling in Health Diagnostic Laboratory Inc.'s bankruptcy highlights the heightened demand for asset tracing and the strategic use of the lowest intermediate balance rule in recovering funds from commingled accounts, says Daniel Lowenthal at Patterson Belknap.
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Reading The Fine Print On FDA's Prescription Drug Ad Rule
The U.S. Food and Drug Administration's new final rule regarding the disclosure of risks and side effects in ads for prescription drugs includes some broad and potentially subjective language, and some missed opportunities to address how traditional media formats have changed in recent years, say attorneys at Ropes & Gray.