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Life Sciences
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July 12, 2024
Del. Court Finds 1 Of 6 Bylaws Invalid But All Unenforceable
Only one of six contested advance-notice bylaws that Florida pharma company AIM Immuno Tech Inc. adopted in response to an activist shareholder's proxy contest is actually invalid but none remain enforceable because the board adopted them primarily to thwart the shareholder's challenge, Delaware's Supreme Court has ruled.
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July 12, 2024
AI Drugmaker BioXcel Beats Investor Fraud Suit, For Now
A Connecticut federal judge has tossed a proposed securities fraud class action against BioXcel Therapeutics Inc., saying that while shareholders sufficiently alleged the AI-driven drugmaker made misleading statements concerning a dementia drug study's compliance issues, they failed to adequately plead the company intended to deceive or defraud investors.
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July 12, 2024
Whistleblower's Attys Get $5.9M After Losing $11.5M Fee Ask
A Massachusetts federal judge on Thursday awarded a whistleblower's counsel $5.9 million in fees plus $651,845 in costs and expenses after slashing their prior "exorbitant" $11.5 million fee request in May in a decade-old False Claims Act lawsuit alleging Fresenius Medical Care billed Medicare for unnecessary hepatitis tests.
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July 12, 2024
Opioid MDL Plaintiffs Atty Fee Awards Upheld
The Ohio federal judge overseeing the multidistrict litigation over the opioid epidemic denied several law firms' requests to amend the share of legal fees they received in the case, except an appeal from Spangenberg Shibley & Liber, reasoning that one of its attorneys' work has been "invaluable."
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July 12, 2024
Plaintiffs Want Opioid MDL Bellwethers Cut For Lost Emails
Plaintiffs in the multidistrict litigation arising from the opioid epidemic again asked an Ohio federal court on Friday to sever two of four bellwethers, accusing pharmacy benefit managers of preferring to "foster a sideshow" to further draw out litigation after learning of deficiencies in evidence preservation by some of the cities and counties that initiated cases.
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July 12, 2024
Fed. Circ. Upholds Natera's Injunction In Cancer Test IP Fight
The Federal Circuit on Friday upheld a preliminary injunction barring NeoGenomics Laboratories Inc. from selling certain cancer tests while a North Carolina federal court decided whether they infringed Natera Inc. patents.
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July 12, 2024
Fed. Circ. Probes Case With Apple Watch Import Ban At Stake
In a case that could lead to a U.S. International Trade Commission import ban on the Apple Watch amid a patent dispute with AliveCor, Federal Circuit judges asked both companies Friday why a patent office tribunal that invalidated the patents didn't see evidence from the ITC case.
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July 12, 2024
Judge Denies Go-Ahead For Suit Over Invitae Refi Deal
A Delaware bankruptcy judge on Friday told the unsecured creditors of Invitae that they had not shown it was worthwhile to allow them to challenge the bankrupt genetic testing company's 2023 debt refinancing.
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July 12, 2024
No Injury In Suit Targeting J&J Asset Shuffles, Talc Unit Says
Johnson & Johnson wants a New Jersey federal judge to toss a proposed class action alleging that the company has tried to intentionally prevent talc claimants from getting their day in court through a scheme of fraudulent corporate transactions, arguing that the cancer patients failed to show how any of the challenged transactions left it unable to pay its talc claims.
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July 12, 2024
Zimmer Biomet Owes Despite Expired Patents, 7th Circ. Says
Zimmer Biomet Holdings shouldn't have stopped paying royalties on knee replacement devices it developed using an orthopedic surgeon's various patents after those patents expired, the Seventh Circuit said Friday, backing a lower court's decision affirming an arbitration ruling in favor of the surgeon's estate.
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July 12, 2024
Chancery Tosses Centene Shareholders' Medicaid Fraud Suit
The Delaware Chancery Court on Friday dismissed a Centene stockholder derivative lawsuit seeking damages from company directors and officers over allegations of a multistate Medicaid pharmacy benefit billing fraud scheme that the investors said could result in a $1.25 billion liability for the healthcare giant.
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July 12, 2024
Widower Drops Suit Over Surgical Robot-Related Death
A widower agreed Thursday to drop his suit against Intuitive Surgical Inc. over an alleged defect in its da Vinci surgical robots that allowed electricity to arc during his wife's surgery, burning her small intestine and leading to her death.
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July 12, 2024
Ex-Quantix Worker Sues Abbott Labs Over Drug Test Firing
A former employee of Quantix SCS LLC is suing the company, Abbott Laboratories Inc. and two other drug testing companies, saying he was wrongly fired after testing positive for THC and the companies did not consider that it could have resulted from his use of legal CBD products.
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July 12, 2024
AbbVie Brings Atty-Client Privilege Fight To Supreme Court
Drugmaker AbbVie has set its sights on the U.S. Supreme Court, asking justices to weigh in on a discovery battle over what it believes are privileged attorney-client communications relating to a "sham" Pennsylvania patent case.
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July 12, 2024
Ex-Magellan Execs Waive Conflicts Over Past Shared Counsel
Two former Magellan Diagnostics executives charged with conspiring to hide defects in the company's lead testing devices agreed on Friday to waive any potential conflict created by their prior joint representation by a Donnelly Conroy & Gelhaar LLP attorney.
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July 11, 2024
Senate Clears Patent Bill Aiming To Lower Drug Prices
The U.S. Senate on Thursday passed a bill that would pump the brakes on the ability of pharmaceutical companies to steer patients away from generic versions of a drug, a measure that lawmakers said would lower drug costs.
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July 11, 2024
Pfizer's $50M EpiPen Deal Gets Final OK In Antitrust Suit
Pfizer is officially out of a lawsuit accusing it of working with Mylan Pharmaceuticals to inflate the price of the popular auto-injecting emergency allergy medication EpiPen after a Kansas federal judge gave the $50 million settlement his final seal of approval.
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July 11, 2024
IP Forecast: Napa Winery's Ex-Atty Wants Another Trial
A Texas lawyer plans to tell an appeals court why he should receive another trial in a trademark case from a Napa Valley winery, a former client that he claims sold off a "wildly successful California cult wine" out from under him.
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July 11, 2024
Judge Won't Dismiss Cannabis Extraction IP Dispute
Subsidiaries of Canadian cannabis company Halo Collective Inc. can't escape patent infringement claims by a Colorado-based firm specializing in developing techniques for extracting hemp oil, a California federal judge has ruled, rejecting a slew of motions seeking summary judgment.
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July 11, 2024
DC Judge Questions Pharma Co.'s Generic Harm In FDA Spat
A D.C. federal judge on Thursday seemed skeptical about Vanda Pharmaceuticals' claims that waiting for the U.S. Food and Drug Administration to review its challenge to the agency's approval of a generic challenger to its sleep medication would seriously jeopardize the company's future.
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July 11, 2024
Fed. Circ. Pauses Ouster Of Teva Patents From Orange Book
Teva can keep challenged asthma inhaler device patents listed on, and protected by, an important government database after the Federal Circuit agreed Wednesday to pump the brakes on the patents' delisting while the Israeli drugmaker appeals an order won by Amneal in an infringement lawsuit.
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July 11, 2024
Opiate MDL Judge Flags Evidence Preservation Shortfall
An Ohio federal judge has said "at least some" of the plaintiff local government entities in four chosen bellwether cases against pharmacy benefit managers for the multidistrict litigation over the opioid epidemic failed to preserve documents and evidence for trial, warning the parties he may replace those cases.
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July 11, 2024
GSK Asks Judge To Rule In Teva IP Case, Citing Opioid Deals
A GlaxoSmithKline lawyer has urged a Delaware federal judge to make up his mind about a nearly $400 million patent case against Teva Pharmaceuticals in light of unrelated "opioid-related cases" that the Israeli generic-drug maker has been settling in the billions of dollars.
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July 11, 2024
Talc Law Firms Beat J&J Subpoenas Seeking Funding Info
The Beasley Allen Law Firm, another plaintiffs law firm and a litigation funder defeated subpoenas from Johnson & Johnson in talc litigation, with a special master reasoning that the broad swath of discovery permitted in federal courts still has limits.
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July 11, 2024
Deals Rumor Mill: Saudi Aramco, Paramount Global, Carlyle
The Carlyle Group is considering acquiring Baxter International's kidney-care spinoff Vantive for about $4 billion, Aramco attracted more than $31 billion in orders for its $6 billion bond sale, and Paramount Global plans to cut more jobs before its merger with Skydance Media closes. Here, Law360 breaks down these and other notable deal rumors from the past week.
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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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.