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Life Sciences
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May 24, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen an IT engineer seek permission to search a landfill hiding a hard drive supposedly storing millions of pounds in bitcoin, Glencore take on legal action by American Century Investments, gold payment app Glint bring a breach of duty claim against FRP Advisory, and an ongoing dispute between a solicitor and the Solicitors Regulation Authority. Here, Law360 looks at these and other new claims in the U.K.
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May 23, 2024
NJ Justices Toss Direct Appeals Over Hospital Contract Bid
The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.
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May 23, 2024
Fed. Circ. Upends Inventors' Interference Win Over Time-Bar
The Patent Trial and Appeal Board wrongly chose inventors tied to Cook Medical, rather than ones tied to Medtronic, when determining who should prevail in an interference proceeding over catheters, the Federal Circuit held Thursday.
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May 23, 2024
Ex-Judge Pushed False Narrative On Atty Romance, Firm Says
U.S. Bankruptcy Judge David R. Jones of Texas, who resigned last year after his secret relationship with a Jackson Walker LLP partner was revealed, attempted to head off rumors about the relationship by asking the firm to file a false, partial disclosure in 2022, the firm alleged.
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May 23, 2024
Merck To Pay $600M For KKR-Backed Life Sciences Biz
Menlo Park, California-based Gamma Biosciences said Thursday it has agreed to sell its operating company Mirus Bio for $600 million in cash to Merck KGaA, inking the deal under the guidance of Sidley Austin LLP.
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May 23, 2024
Just 57% Of Complex Global Deals Closed Since 2020
About 43% of complex cross-border global deals have failed to close since the start of 2020, while the remaining 57% did close but were highly likely to involve remedies, according to a new report from Weil Gotshal & Manges LLP.
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May 23, 2024
J&J Loses Expedited Bid For Beasley Allen Docs In Talc MDL
Johnson & Johnson has lost its bid in New Jersey federal court to have the Beasley Allen Law Firm quickly produce documents related to what J&J said seems to be an "intentional effort" by the firm to "bias the vote" against a proposed $6.5 billion reorganization plan for its talc subsidiary.
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May 23, 2024
GSK, Boehringer Prevail In 1st Zantac Cancer Trial
A Chicago jury found Thursday that Zantac heartburn medication and its generic counterparts sold by GlaxoSmithKline and Boehringer Ingelheim are not responsible for an Illinois woman's colon cancer and her subsequent, debilitating symptoms, handing the drug companies a decisive victory in the first of hundreds of such cases to go to trial.
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May 22, 2024
Inventor To Take $102M IP Malpractice Row To Ga. High Court
A neurosurgeon pursuing a nearly $102 million legal malpractice case against FisherBroyles LLP and a legal services contractor over a missed patent filing deadline said Wednesday that he is planning to take the dispute to the highest court in the Peach State.
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May 22, 2024
Cancer Patients Target J&J Talc Unit's Asset Shuffles
Cancer patients who have sued Johnson & Johnson alleging that its talcum powder caused their illness alleged Wednesday that the company has tried to intentionally prevent tort victims from getting their day in court through a scheme of fraudulent corporate transactions.
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May 22, 2024
Justices' CFPB Alliance May Save SEC Courts, Not Chevron
A four-justice concurrence to the U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's unique funding scheme last week carries implications for other cases pending before the court that challenge the so-called administrative state, or the permanent cadre of regulatory agencies and career government enforcers who hold sway over vast swaths of American economic life.
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May 22, 2024
FDA Must Act On Sexual Side Effects Of SSRIs, Suit Says
The Food and Drug Administration should be forced to warn the public about the serious sexual side effects of a certain class of depression medications after sitting on a petition asking it to do just that for more than six years, a new lawsuit says.
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May 22, 2024
Evidence Shaky In First Zantac Cancer Trial, Drugmakers Say
Attorneys for GlaxoSmithKline and Boehringer Ingelheim told a Chicago jury Wednesday that no one besides a plaintiff's paid witnesses have said publicly that Zantac heartburn medication causes colon cancer, calling on the jurors to reject claims that the companies owe $640 million for a woman's cancer diagnosis.
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May 22, 2024
Doc Gets 3 Mos. For Alexion Trades Despite 'Meaningful Job'
A doctor was sentenced to three months in prison Wednesday for insider trading on an Alexion Pharmaceuticals acquisition, with a Manhattan federal judge saying the defendant's treatment of critically ill, underserved kidney disease patients does not amount to a "get out of jail free card."
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May 22, 2024
DuPont 'Document Dump' Rattles NC In PFAS Suit
North Carolina and DuPont on Wednesday battled over what the state called a roughly 5 million-page "document dump" ahead of a looming June 3 discovery deadline in its contamination lawsuit, irking a business court judge in the process.
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May 22, 2024
Stryker Agrees To Settle Calif. Misclassification Suit
Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.
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May 22, 2024
MilliporeSigma Avoids Charges As DOJ Extols Self-Disclosure
Life sciences firm MilliporeSigma won’t face charges over the illegal exportation of products to China, in what the Justice Department said Wednesday was the first time its National Security Division had declined prosecution under a policy intended to encourage companies to voluntarily disclose wrongdoing,
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May 22, 2024
Teva, Bristol-Myers Cite Bystolic Against Cancer Drug Case
Celgene and parent Bristol-Myers Squibb pointed a New Jersey federal judge to the dismissal, recently upheld by the Second Circuit, of an antitrust suit over delayed generic competition to AbbVie's hypertension treatment Bystolic to argue the same logic applies to their bid to duck antitrust claims over cancer therapies.
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May 22, 2024
Dickinson Adds Ex-Sheppard Mullin IP Pro In Silicon Valley
Dickinson Wright PLLC said Wednesday that it has added a former Sheppard Mullin Richter & Hampton LLP partner as the newest member of its Silicon Valley office.
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May 22, 2024
Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects
Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.
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May 22, 2024
Covington Reps As Biogen Makes $1.8B Bet On HI-Bio
Biogen Inc. said Wednesday it has agreed to purchase Human Immunology Biosciences, or HI-Bio, a San Francisco-based biotechnology company working on targeted therapies for severe autoimmune diseases, in a deal that could see Biogen pay up to $1.8 billion.
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May 21, 2024
Hawaii Wins $916M From Bristol-Myers, Sanofi Over Plavix
Bristol-Myers Squibb Co. and Sanofi owe more than $916 million to the state of Hawaii for not warning patients of East Asian or Pacific Island ancestry of potential health risks associated with their blood thinner Plavix, a state judge ruled Tuesday, following a trip to the state's highest court.
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May 21, 2024
Ex-AUSA Blames Inexperience For Outcome Forfeiture Error
Former prosecutors who pursued the $1 billion fraud trial against Outcome Health executives said Tuesday they never suspected their asset restraint efforts were an overreach, noting they lacked the expertise to notice potential mistakes themselves.
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May 21, 2024
Sens. Challenge Pharma Lobbyist Over Patent Abuse
U.S. senators from both sides of the aisle took turns at a Tuesday hearing questioning the pharmaceutical industry's top lobbyist over whether patent abuse plays a role in maintaining the high price of prescription drugs.
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May 21, 2024
DC Circ. Says Drugmakers Can Limit Pharmacy Discounts
The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.
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.