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Life Sciences
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July 26, 2024
'Low-Grade Lawyering': Quinn Emanuel Attys Draw Judge's Ire
A California federal judge considering Guardant Health's sanctions bid in a false advertising case against rival Natera said Friday that representations to the court by Natera's attorneys from Quinn Emanuel Urquhart & Sullivan LLP regarding a proposed expert witness were "less than forthright" and "pretty low-grade lawyering."
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July 26, 2024
Apple Commits To White House Guidelines For Responsible AI
Apple Inc. has signed onto the Biden administration's voluntary guidelines for "responsible" artificial intelligence innovation, joining the likes of Amazon.com Inc., Google LLC, Microsoft Corp. and a dozen other leading tech companies, the White House announced Friday.
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July 26, 2024
Product Liability Cases To Watch 2024: A Midyear Report
Litigation over claims that social media addict children and harm mental health continues to hold attorneys' attention, along with claims that "forever chemicals" are a source of cancer.
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July 26, 2024
Del. Court Won't Let Generic Co. Walk Back Invalidity Promise
Generic-drug maker Mankind Pharma is bound to its promise not to challenge the validity of a patent covering Allergan's glaucoma drug Lumigan after a federal judge in Delaware shot down its argument that recent rulings on obviousness-type double patenting altered the litigation landscape.
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July 26, 2024
Indivior To Pay $86M To Settle Opioid Claims By 5 States
Indivior will pay $86 million to settle claims by a group of state attorneys general over the drugmaker's alleged contributions to the American opioid crisis.
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July 26, 2024
Hearing Set Over Bid To Recuse Judge In Philly Zantac Cases
A Philadelphia judge will hear arguments next month over a recusal motion filed by plaintiffs' counsel in the city's Zantac mass tort program that argues the judge should remove himself from the proceedings after he disclosed his wife is a partner at Reed Smith, which represents GlaxoSmithKline, a manufacturer of the drug.
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July 26, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen U.K. band The 1975 face action by Future Sound Asia after its performance in Malaysia resulted in a festival's cancelation, Spectrum Insurance hit by The Motoring Organization following their dispute over information misuse, and a former police constable pursue defamation against a colleague for allegedly instigating a campaign of harassment against her. Here, Law360 looks at these and other new claims in the U.K.
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July 25, 2024
3rd Circ. Again Tosses J&J Talc Unit's 'Texas Two-Step' Ch. 11
The Third Circuit on Thursday affirmed the dismissal of the reworked Chapter 11 case of Johnson & Johnson's talc unit that used a controversial "Texas two-step" maneuver, saying the company still hasn't displayed the financial distress required to justify bankruptcy protection.
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July 25, 2024
Seattle, Monsanto Ink $160M Deal Over PCBs In Duwamish
Bayer AG's Monsanto Co. has agreed to pay $160 million to resolve allegations that it contaminated Seattle's stormwater and drainage systems as well as the Lower Duwamish Waterway with polychlorinated biphenyls, the city attorney's office announced Thursday.
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July 25, 2024
Pfizer Calls GSK Patents In COVID Vax Case Unenforceable
Pfizer and BioNTech have fired back at GlaxoSmithKline's patent suit against them over the COVID-19 vaccine, saying GSK's patents are unenforceable because the company delayed in filing its applications and then crafted them to cover the blockbuster vaccine after it became available.
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July 25, 2024
DC Panel Upholds FDA's Win Against Ipsen's Generics Suit
A D.C. panel declined to revive Ipsen's challenge to regulators' refusal to classify its acromegaly drug as a biologic, which would have blocked generic versions of it, finding Thursday the drug's active ingredient doesn't meet the Food, Drug and Cosmetic Act's definition of a protein to be considered a biologic.
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July 25, 2024
Shkreli Says He Has Right To Use Wu-Tang Clan Album Copies
Martin Shkreli pushed back on a crypto project's bid to force him to hand over copies of the one-of-a-kind Wu-Tang Clan album he once owned, saying his original purchase agreement of the album entitled him to make the copies and the album's current crypto owner hasn't shown how Shkreli's duplicates irreparably harm the value of the original.
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July 25, 2024
Ex-Pharma Exec's Counsel Accused Of Reading Stolen Emails
A New Jersey pharmaceutical startup wants to disqualify the "tainted" attorneys of a former executive who was allegedly caught spying on the CEO, claiming the attorneys should have immediately shielded their eyes when they realized their client was using stolen, privileged emails to carry out an "attempted shakedown."
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July 25, 2024
Loeb & Loeb Says Ex-GC's Sanctions Motion Is Bogus
Loeb & Loeb LLP urged a Colorado federal judge Wednesday to reject a former general counsel's allegations that it deliberately sent a thumb drive of documents that aren't text searchable, saying they are actually searchable and would have otherwise sent over 64,000 physical pages that weren't.
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July 25, 2024
Deals Rumor Mill: Wiz-Google, Daily Telegraph, Medline IPO
Cybersecurity startup Wiz has rebuffed a buyout offer from Google, former British finance minister Nadhim Zahawi is preparing a $773 million bid for the Daily Telegraph, and medical supplies giant Medline is preparing an initial public offering for 2025. Here, Law360 breaks down these and other notable deal rumors from the past week.
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July 24, 2024
Clinic Drops Case Against Maker Of Body-Sculpting Devices
BTL Industries Inc., a Massachusetts company that sells body-sculpting equipment, and a Connecticut aesthetic clinic have mutually agreed to dismiss a lawsuit accusing the Bay State company of using misleading profit projections and illegal trade restraints that unfairly penalized equipment buyers and caused hefty investments to wither.
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July 24, 2024
Rite Aid's Elixir Buyer Must Pay Additional $50M In Ch. 11 Sale
Prescription benefits group MedImpact owes an extra $50 million on top of $576 million it paid Rite Aid for its former benefits division Elixir, a New Jersey bankruptcy judge ruled Wednesday, saying his earlier ruling on $200 million in disputed liabilities from the sale didn't fundamentally disrupt a post-closing price adjustment.
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July 24, 2024
Patent Cap In Drug Pricing Bill Seen As Having Muted Effect
The U.S. Senate recently passed a bill aiming to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars, but attorneys say the measure's numerous exceptions make it unlikely to have a major effect on litigation or consumer costs.
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July 24, 2024
McCarter & English Beats Biotech Malpractice Suit In NJ
McCarter & English LLP defeated a New Jersey biotechnology company's legal malpractice suit this week, following a New Jersey state judge's finding that the malpractice claims should have been brought in an earlier round of litigation over unpaid legal fees.
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July 24, 2024
Ex-Pharma Exec Gets Jail For Insider Trading On Kodak Loan
A Manhattan federal judge sentenced a former pharmaceutical executive from South Carolina to three months in prison Wednesday for taking over $500,000 of illegal trading profit based on his advance knowledge that Kodak would get a massive pandemic-era government loan.
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July 24, 2024
Priest Loses Fee Bid After 'Split Baby' SEC Verdict
A Greek Orthodox priest and hedge fund founder who largely beat a U.S. Securities and Exchange Commission suit is not entitled to recoup $1.7 million in legal fees because the commission was justified in bringing the case, a Boston federal judge ruled Tuesday.
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July 23, 2024
Meet The Lead Ozempic Lawyers
The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.
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July 23, 2024
Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient
Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
Invitae's Ch. 11 Plan Needs Tweaking, Judge Says
A New Jersey bankruptcy judge said he would confirm the Chapter 11 liquidation plan for genetic testing company Invitae, if it made changes to how it handled distributions to certain creditors.
Expert Analysis
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.