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Life Sciences
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August 15, 2024
Pharma Co. TM Dispute Doesn't Belong In Florida, Judge Says
A trademark lawsuit between two drug companies with similar names does not belong in a Florida federal court, a judge in West Palm Beach has ruled.
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August 15, 2024
Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent
Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.
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August 15, 2024
Paul Hastings Adds M&A, Shareholder Activism Lawyer
Paul Hastings LLP announced Thursday that it has boosted the firm's mergers and acquisitions and shareholder activism platform with a longtime Goodwin Procter LLP partner.
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August 14, 2024
Costco Wants PFAS Kirkland Brand Baby Wipes Suit Tossed
Costco hit back at a proposed class action over its fragrance-free "natural" baby wipes filed earlier this summer in California federal court, saying that the suit is trying to scare parents by alleging the wipes are tainted with so-called forever chemicals.
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August 14, 2024
J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival
Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.
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August 14, 2024
NC Judge OKs $15.2M Deal For Medical Device Investors
A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
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August 14, 2024
AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case
A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs
The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.
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August 14, 2024
Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit
A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.
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August 14, 2024
Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda
A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.
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August 14, 2024
Zantac Judge Won't Step Aside Over Wife's Reed Smith Role
A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.
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August 13, 2024
SEC Drops Insider Trading Suit Against Ex-Mylan Exec
The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case.
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August 13, 2024
Entresto Release Delayed As Novartis Goes To Fed. Circ.
A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.
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August 13, 2024
Mother Can't Revive Suit Against GE For Child's Brain Damage
A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.
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August 13, 2024
Spinal Implant Patents Verdict Must Stand, Pa. Judge Says
A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
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August 13, 2024
Janssen Wants New FCA Trial As Relators Seek $1.85B Win
Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.
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August 13, 2024
Fed. Circ. Restores J&J, Allergan's Viberzi IP After Del. Loss
The Federal Circuit fully revived claims of patents covering Allergan's bowel treatment drug Viberzi on Tuesday, overruling a Delaware federal judge who said the claims don't meet obviousness-type double patenting or written description requirements.
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August 13, 2024
Former Sprinter Eyes Plea Deal In 2020 Olympics Doping Case
A onetime world-class sprinter from the Atlanta area is in talks to resolve charges that he illegally provided banned performance-enhancement drugs while training other athletes ahead of the 2020 Tokyo Olympic Games, a Manhattan federal judge heard Tuesday.
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August 13, 2024
DC Circ. Backs EPA's Ethylene Oxide Cancer Risk Value
The D.C. Circuit on Tuesday upheld federal environmental regulators' assessment of the cancer risk from exposure to certain chemical manufacturers' ethylene oxide emissions, rejecting a challenge from a chemical company and two chemical associations that argued the risk assessment was arbitrary and capricious.
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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
'Clever' Scheme Is Concealing Talc Litigation Funding, J&J Says
The Beasley Allen Law Firm needs to disclose alleged litigation funding fueling its litigation over Johnson & Johnson's talcum powder even if that funding was not given directly to the firm since the disclosure rules apply to "parties" and not "law firms," J&J has told a New Jersey federal court.
Expert Analysis
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Series
Playing Hockey Makes Me A Better Lawyer
Nearly a lifetime of playing hockey taught me the importance of avoiding burnout in all aspects of life, and the game ultimately ended up providing me with the balance I needed to maintain success in my legal career, says John Riccione at Taft.
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For Lawyers, Pessimism Should Be A Job Skill, Not A Life Skill
A pessimistic mindset allows attorneys to be effective advocates for their clients, but it can come with serious costs for their personal well-being, so it’s crucial to exercise strategies that produce flexible optimism and connect lawyers with their core values, says Krista Larson at Stinson.
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HHS Opioid Rule Generally Benefits Providers And Patients
The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.
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Trump's NY Civil Fraud Trial Spotlights Long-Criticized Law
A New York court’s recent decision holding former President Donald Trump liable for fraud brought old criticisms of the state law used against him back into the limelight — including its strikingly broad scope and its major departures from the traditional elements of common law fraud, say Mark Kelley and Lois Ahn at MoloLamken.
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Opinion
Requiring Leave To File Amicus Briefs Is A Bad Idea
A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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4 Ways To Motivate Junior Attorneys To Bring Their Best
As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.
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Negotiating Milestones In Pharma Licenses Requires Care
For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.