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Life Sciences
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September 20, 2024
Womble Bond Hires New Head Of Int'l Disputes From Dechert
Womble Bond Dickinson has hired a former Dechert LLP partner as the head of its international disputes practice, who will be based in the firm's Washington, D.C., office and will double as a partner in its business litigation practice group, Womble Bond recently announced.
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September 20, 2024
Ga. Airport Pat-Down Caused Catastrophic Injuries, Man Says
A man sued the government and several unnamed parties in Georgia federal court Thursday, alleging that he fractured his thoracic vertebrae, spent 52 days in the hospital and had to undergo surgery after an airport screening incident at Hartsfield-Jackson Atlanta International Airport.
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September 20, 2024
UK Litigation Roundup: Here's What You Missed In London
The past week in London has seen crypto exchange Binance face a new claim from the co-founder of SO Legal, a U.S. immersive art company take on a Bristol venue for copyright violations and Blake Morgan LLP hit with a pension schemes claim by The Trust for Welsh Archeology. Here, Law360 looks at these and other new claims in the U.K.
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September 20, 2024
FTC Accuses Drug Middlemen Of Raising Insulin Prices
The Federal Trade Commission on Friday accused the three largest pharmacy benefits managers, Caremark Rx, Express Scripts and OptumRx, of artificially inflating insulin prices by relying on unfair rebate schemes that hurt competition.
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September 19, 2024
Bills On Patent Eligibility, PTAB Limits Near Senate Markup
Legislation aiming to reduce decisions finding inventions ineligible for patenting and restrict invalidity challenges at the Patent Trial and Appeal Board will likely be considered by the Senate Judiciary Committee next week, a sponsor of the measures said Thursday.
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September 19, 2024
AndroGel Antitrust Case On Hold Amid Settlement Talk
A Pennsylvania federal judge has agreed to pause a class action against Abbott and other drugmakers over allegedly sham patent cases, saying a settlement between the two sides may be in the works.
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September 19, 2024
Ga. Appeals Court Says Hospital Must Get Certificate Of Need
The Georgia Court of Appeals for the second time has said that a Georgia hospital must obtain a new certificate of need from the state to convert its long-term care beds to short-stay acute care beds, following guidance issued by the state's justices earlier this year.
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September 19, 2024
Another Ill. Jury Deadlocks Over Zantac Cancer Claims
There was another mistrial declared on Wednesday in a lawsuit over claims that pharmaceutical company Boehringer Ingelheim's over-the-counter-drug for heartburn, Zantac, caused a man's cancer in a case brought by the Illinois man.
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September 19, 2024
Convicted Drexel Professor Won't Get New Tax Evasion Trial
A Drexel University accounting professor was denied a new trial after being convicted on tax evasion charges for failing to report $3.3 million in income from a Trenton pharmacy, a New Jersey federal judge has ruled, reasoning that the professor's case was not prejudiced by keeping accounting records related to his tax returns from the jury.
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September 19, 2024
Norwich Asks Justices To Allow Sale Of Generic Diarrhea Drug
A New York drugmaker has told the U.S. Supreme Court that the courts have gone too far in preventing the release of a generic version of a blockbuster diarrhea drug, after a lower court found there was a way of using the drug that would infringe certain patents.
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September 19, 2024
Conn. Justices Wonder How 'Malicious' Firm's Ex-Client Was
The Connecticut Supreme Court on Thursday questioned whether an ex-McCarter & English LLP client was "wanton" and "malicious" enough to justify the firm's novel $3.6 million punitive damages bid in a protracted billing dispute that has already fetched the firm judgments totaling more than $2 million on contract claims.
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September 19, 2024
Airline Sinks Bias Suit From Worker Fired Over Drug Test
A Pennsylvania federal judge tossed a race and disability bias suit from an American Airlines worker who said she was fired over a positive drug test triggered by her ADHD medication, ruling she hadn't presented evidence that bias drove the decision to let her go.
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September 18, 2024
Axonics Didn't Infringe Medtronic Patents, Calif. Jury Says
Axonics did not infringe three of Medtronic's patents related to its bladder and bowel control device, a California federal jury determined Wednesday.
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September 18, 2024
CVS Unit Pays $60M Over Alleged Insurance Kickback Scheme
CVS Health subsidiary Oak Street will pay $60 million to settle allegations it violated the False Claims Act by paying illegal kickbacks to third-party insurers in return for scouting and inducing Medicare and Medicaid beneficiaries to enroll in its primary care clinics, the U.S. Department of Justice announced Wednesday.
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September 18, 2024
7th Circ. Questions Nixing $183M Eli Lilly Drug Rebate Verdict
A Seventh Circuit judge seemed unsure Wednesday whether to disturb a $183 million verdict against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, questioning whether the company skipped checking legal guidance before calling its price reporting requirements unclear.
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September 18, 2024
Fed. Circ. Revives Astellas Patent Axed As Natural Law
The Federal Circuit on Wednesday vacated a lower court's invalidation of an Astellas Pharma overactive bladder medication patent for claiming only a natural law, saying the holding was improper because the generics makers accused of infringement never made that argument.
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September 18, 2024
Rescheduling Pot Would Not Hasten Research, Report Says
A recently enacted law will continue to make it difficult for medical researchers to conduct studies on marijuana, even if federal restrictions are loosened on the drug, according to a new report published Monday by the Congressional Research Service.
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September 18, 2024
Georgia High Court Won't Hear Missed Patent Deadline Case
The highest court in Georgia has decided not to take up an appeal from a neurosurgeon in his nearly $102 million lawsuit, letting stand a lower court's finding that a patent docketing contractor used by remote law firm FisherBroyles can't be held liable for a missed patent application deadline.
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September 18, 2024
SEC Settles Latest Covington Info Theft Case For $33K
A New Jersey man will pay a $33,000 civil penalty to the U.S. Securities and Exchange Commission for insider trading on confidential merger tips that his cousin stole from a Covington & Burling LLP lawyer, according to a settlement filed in New York federal court on Wednesday.
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September 18, 2024
Ex-Amgen Rep Wasn't Original Whistleblower, Judge Says
A Brooklyn federal judge tossed a former Amgen sales representative's whistleblower suit on Wednesday, saying many elements of his allegations of a kickback scheme had been disclosed in news reports and civil lawsuits prior to his filing.
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September 18, 2024
ITC Looking At Advanced Bionics Implant Patent Claims
The U.S. International Trade Commission said it will look into allegations from Switzerland's Advanced Bionics that Austria's Med-El has been infringing cochlear implant hearing aid technology.
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September 18, 2024
Thermo Fisher Late To Pay Departing Workers, Engineer Says
Thermo Fisher Scientific Inc. and a subsidiary failed to promptly pay all final wages and unused vacation time to departing employees and must now cough up three times the amount of that compensation because of its violation of Massachusetts law, according to a proposed class action filed in state court.
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September 18, 2024
GSK Inks 2 Calif. Zantac Deals
GlaxoSmithKline LLC on Wednesday said that it had reached two settlements in California state court over allegations that its heartburn drug Zantac had caused cancer, although the company did not disclose the deal amounts.
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September 18, 2024
Biotech Co. Escapes Stock-Drop Suit Over COVID-19 Drug
A Massachusetts biotech company won dismissal Wednesday from a proposed class action by investors who say their shares tanked in value after it allegedly came to light that executives had falsely touted an unproven prospective COVID-19 medicine.
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September 18, 2024
Organon To Buy Psoriasis Treatment Biz For Up To $1.2B
Women's healthcare-focused company Organon, advised by Covington & Burling LLP, on Wednesday announced it will purchase Freshfields Bruckhaus Deringer LLP-led Dermavant, a subsidiary of Roivant that develops and commercializes therapies in immuno-dermatology.
Expert Analysis
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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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.