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Life Sciences
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
Foley Adds Tech, Life Sciences Partner From IP Boutique
Foley & Lardner LLP has hired a longtime partner from intellectual property boutique Lerner David LLP to strengthen both the transactional and litigation arms of its technology and life science practices in New York.
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December 19, 2024
Judge Wrongly Axed $107M IP Verdict, Pfizer Tells Fed. Circ.
A Pfizer unit has told the Federal Circuit that a federal judge got it wrong when he overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents.
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December 19, 2024
Biotech Co. Hid Eye Drug's Safety Risks, Investor Says
A biotech company concealed the potential risks that emerged during clinical trials of a drug meant to treat age-related vision degradation, according to an investor complaint filed in Massachusetts federal court Thursday.
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December 19, 2024
Medical Supplies Giant, Drone Operator File Confidential IPOs
Private equity-backed medical supplies giant Medline Inc. and drone operator Airo Group Holdings Inc. said Thursday that they confidentially filed plans for initial public offerings with regulators, joining a growing pipeline of IPO prospects for 2025.
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December 19, 2024
McKesson Urges Justices To Keep Hobbs Act's 'Exclusivity'
McKesson Corp. is urging the U.S. Supreme Court to preserve circuit courts' "exclusive" jurisdiction for Federal Communications Commission orders, warning that regulatory consistency nationwide could be undermined if lower courts are allowed to step in.
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December 19, 2024
Medical Device Investors Get Final OK On $15M Deal
A North Carolina federal judge has given final approval to a $15.25 million settlement that will resolve a suit claiming Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices, along with $5 million in attorney fees.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
Labcorp Settles Competition Suit Against Ex-Sales Exec
Less than two weeks after Laboratory Corp. of America Holdings sued its former sales marketing executive and his new employer in North Carolina federal court for allegedly violating noncompete and nonsolicitation agreements, a deal has been reached to end the lawsuit.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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December 19, 2024
Fresenius Loses Invalidity Argument In Nausea Drug IP Fight
Fresenius Kabi USA LLC has lost its arguments in Delaware federal court that claims in a pair of Heron Therapeutics patents for a nausea drug were invalid, keeping Fresenius' generic from entering the market for around a decade.
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December 19, 2024
Philips CPAP Suits Against SoClean Tossed From MDLs
A Pennsylvania federal judge has tossed two complaints from Philips RS North America against SoClean Inc. from multidistrict litigation stemming from a CPAP machine recall, saying one would disrupt the wrap-up of the MDL surrounding Philips' products, while the other should not have been filed directly into the SoClean MDL.
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December 18, 2024
Pharma Trial Consultant To Pay SEC $3M Over Insider Trading
An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.
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December 18, 2024
Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try
A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
J&J Unit Beats Schizophrenia Drug IP Challenge On Remand
Teva Pharmaceuticals USA Inc. has failed to invalidate claims in a patent for a Johnson & Johnson unit's blockbuster schizophrenia medicine, according to a New Jersey federal judge who rejected the generic-drug maker's assertions that the formula was obvious.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
RJ Reynolds Asks Justices To Toss Forum Shopping Argument
R.J. Reynolds Vapor Co. is urging the U.S. Supreme Court to reject the U.S. Food and Drug Administration's argument that the vape company engaged in forum shopping when it challenged denial of one of its applications in the Fifth Circuit, saying its Texas- and Mississippi-based co-petitioners make the Fifth Circuit the proper venue.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
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December 17, 2024
11th Circ. Urged To Block Abortion Clinic Buffer Zone Law
A Florida anti-abortion group urged the Eleventh Circuit on Tuesday to give it another shot at an injunction preventing the city of Clearwater from enforcing a buffer zone ordinance that blocks the group from getting within five feet of the driveway to the city's only abortion clinic.
Expert Analysis
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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.
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Newly Acquired Information Can Be Key In Drug Label Cases
The question of whether federal law preempts state law claims is often central in pharmaceutical labeling cases, like the Fosamax litigation now before the Third Circuit — but parties must also consider whether there is newly acquired information to justify submitting a proposed labeling change in the first place, say attorneys at Arnold & Porter.
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Nvidia Case's Potential Impact On Securities Class Actions
In Nvidia v. Ohman Fonder, the U.S. Supreme Court could strip lower courts of their long-standing ability and obligation to holistically weigh all relevant facts supporting plaintiffs' allegations of securities fraud, which would have a wide-ranging impact on securities fraud class actions in the U.S., say attorneys at Labaton Keller.
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How Attorneys Can Break Free From Career Enmeshment
Ambitious attorneys can sometimes experience career enmeshment — when your sense of self-worth becomes unhealthily tangled up in your legal vocation — but taking the time to discover and realign with your core personal values can help you recover your identity, says Janna Koretz at Azimuth Psychological.
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Key Healthcare Issues That Hinge On The Election Outcome
The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.
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Patent Lessons From 4 Federal Circuit Reversals In September
Cases that were reversed or vacated by the Federal Circuit last month provide helpful clarity on collateral estoppel, patent eligibility, construction of claim terms that have different boundaries across different claims, and the role of courts as neutral arbiter, say attorneys at Bunsow De Mory.
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Lawyers With Disabilities Are Seeking Equity, Not Pity
Attorneys living with disabilities face extra challenges — including the need for special accommodations, the fear of stigmatization and the risk of being tokenized — but if given equitable opportunities, they can still rise to the top of their field, says Kate Reder Sheikh, a former attorney and legal recruiter at Major Lindsey & Africa.
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Opinion
Judicial Committee Best Venue For Litigation Funding Rules
The Advisory Committee on Civil Rules' recent decision to consider developing a rule for litigation funding disclosure is a welcome development, ensuring that the result will be the product of a thorough, inclusive and deliberative process that appropriately balances all interests, says Stewart Ackerly at Statera Capital.
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The Strategic Advantages Of Appointing A Law Firm CEO
The impact on law firms of the recent CrowdStrike outage underscores that the business of law is no longer merely about providing supplemental support for legal practice — and helps explain why some law firms are appointing dedicated, full-time CEOs to navigate the challenges of the modern legal landscape, says Jennifer Johnson at Calibrate Strategies.
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How 2 Proposed Bills Could Transform Patent Law
The Patent Eligibility Restoration Act and the Prevail Act may come up for vote by the Senate Judiciary Committee after the election, and both offer benefits and challenges for inventors and companies seeking to obtain patents, says Philip Nelson at Knobbe Martens.
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Series
Beekeeping Makes Me A Better Lawyer
The practice of patent law and beekeeping are not typically associated, but taking care of honeybees has enriched my legal practice by highlighting the importance of hands-on experience, continuous learning, mentorship and more, says David Longo at Oblon McClelland.
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Budding Lessons From Landmark Plant Seed Patent Battle
The Corteva v. Inari case involving intellectual property rights in genetically modified plants is now proceeding through discovery and potentially to trial, and will raise critical questions that could have a major impact on the agriculture technology industry, say Tate Tischner and Andrew Zappia at Troutman Pepper.
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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Opinion
Legal Institutions Must Warn Against Phony Election Suits
With two weeks until the election, bar associations and courts have an urgent responsibility to warn lawyers about the consequences of filing unsubstantiated lawsuits claiming election fraud, says Elise Bean at the Carl Levin Center for Oversight and Democracy.
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Opinion
Bring Back Patent Models To Shut Down The Patent Trolls
By reintroducing the requirement that inventors submit a miniature working model of their inventions along with their patent, legislators could help to deter patent trolls, reduce frivolous litigation and support legitimate inventors in protecting their innovations, says Darin Gibby at Kilpatrick.