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Life Sciences
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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.
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August 13, 2024
Ex-McCarter & English Client Wants To Undo Malpractice Loss
A New Jersey pharmaceutical business is urging a New Jersey state court to reconsider its decision to throw out the company's malpractice case against McCarter & English LLP, saying the firm "brazenly" misstated part of the timeline of the case's lengthy history.
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August 13, 2024
Conn. Trial Attys Back McCarter's Bid For Punitive Award
The Connecticut Trial Lawyers Association has asked the state Supreme Court for permission to file a friend-of-court brief supporting McCarter & English LLP's bid for a punitive payout after winning multimillion-dollar judgments in a contract dispute with a former client.
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August 13, 2024
3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal
Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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August 12, 2024
States Want Teva Generic Price Fixing Case Tried 1st
A coalition of state attorneys general suing a slew of generic drugmakers are asking for a Connecticut federal court to proceed with one of the two cases before the other, saying the outcome in that case will have a "significant impact" on settlement talks with other pharmaceutical company plaintiffs.
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August 12, 2024
Glass Tempering Co. Loses Early Exit Bid In NC Patent Fight
A glass processing equipment distributor can't ditch a Finnish competitor's patent infringement suit, a North Carolina federal judge has ruled, finding its rival has sufficiently alleged "exclusionary rights" to the patents for glass tempering.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
States Oppose Shkreli High Court Bid For $64M Disgorgement
State enforcers are opposing a petition from ex-pharmaceutical executive Martin Shkreli asking the U.S. Supreme Court to review a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%
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August 12, 2024
Pacira Patent On Surgery Pain Drug Voided In Win For Generic
Pacira Pharmaceuticals Inc.'s patent on a nonopioid painkiller is invalid, a New Jersey federal judge has ruled, opening the way for generic versions of Exparel, a long-acting injectable for managing postsurgical pain.
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August 12, 2024
King & Spalding Adds Freshfields M&A Ace In Silicon Valley
King & Spalding LLP is expanding its corporate team, announcing Monday it is bringing in a Freshfields Bruckhaus Deringer LLP mergers and acquisitions expert as a partner in its Silicon Valley office.
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August 12, 2024
Del. Judge Says Vaccine IP Claim Actually Mandates Vaccine
Delaware's chief judge was baffled by Alnylam Pharmaceuticals' argument that the word "vaccine" in a patent it claims Pfizer and BioNTech have infringed doesn't actually require a vaccine, leading him to reject the trip down the rabbit hole presented by the company in exchange for "common sense."
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August 12, 2024
The Biggest Georgia Rulings Of 2024 So Far
From upholding a win for a transgender sheriff's deputy who challenged a county health plan's refusal to pay for gender-affirmation surgery, to ruling that a judicial emergency order issued during the pandemic can be used to toll the state's medical malpractice statute of repose, Georgia courts have been busy in the first half of 2024.
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August 12, 2024
Catching Up With Delaware's Chancery Court
Multimillion-dollar share conversions, power struggles in a classic rock band, a good deal for fandom collectibles, and a pindown by two heavyweights were all part of the spectacle in Delaware's Court of Chancery last week. New cases involved pharmaceutical companies, cannabis, drones and liquid-gas exports. In case you missed it, here's the latest from the Chancery Court.
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August 12, 2024
3 Firms Rep As Crown Buys Revance In $924M Deal
Skincare company Crown Laboratories Inc. on Monday announced that it has agreed to merge with aesthetic healthcare biotechnology company Revance Therapeutics Inc. in a $924 million deal built by three law firms.
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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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.