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Life Sciences
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July 30, 2024
Judge Wants Device Warning Answers From Mich. Justices
A Michigan federal judge ruled Tuesday that medical device manufacturer NuVasive Inc. must face a patient suit alleging its limb-lengthening device caused metal poisoning, while also asking the Michigan Supreme Court to break its silence on medical manufacturers' duty to warn patients directly.
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July 30, 2024
Chancery Rejects Forte-Camac Deal As 'Not Fair' To Class
A Delaware Chancery Court judge on Tuesday rejected a settlement between Forte Biosciences Inc. and Camac Partners LLC that would have ended the activist investor's class action over Forte's alleged board entrenchment, finding that the proposed deal gave Camac "unique and personal benefits" that weren't shared with the rest of the class.
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July 30, 2024
Psychedelics And The Law: A Midyear Review
A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.
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July 30, 2024
DOD Contractors Must Face Suit Over 'Made In U.S.A.' Label
A pair of whistleblowers who claim that tourniquets and other medical equipment sold to the U.S. Department of Defense was mislabeled as "made in U.S.A." can continue with most of their False Claims Act suit against two contractors, a Pennsylvania federal judge said.
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July 30, 2024
Litigator Rejoins Faegre Drinker From Medical Device Co.
Faegre Drinker Biddle & Reath LLP's newest lateral hire is stepping back into private practice after two years as associate general counsel for orthopedic implant company Exactech, and should be a familiar face around the firm's Indianapolis office.
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July 30, 2024
What Mass. Attys Will Be Watching In The 2nd Half Of 2024
Two potentially sweeping Massachusetts high court rulings and a long-awaited employment bill lingering in the State House are among the issues Bay State attorneys say they are monitoring closely heading into the latter half of 2024.
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July 29, 2024
Genzyme Says Sarepta's Dystrophy Gene Therapy Infringes IP
Sanofi's biotechnology company Genzyme Corp. hauled Sarepta Therapeutics into Delaware federal court on Friday, alleging Sarepta's gene therapy treatment for Duchenne muscular dystrophy infringed two of its patents for manufacturing certain therapeutics.
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July 29, 2024
Medical Co. Can't Get Alleged Fraudulent Arbitral Award Nixed
A New York federal judge has declined to vacate an arbitral award issued by a Swiss tribunal to a Singapore company in a dispute over a medical imaging joint venture, rejecting arguments that an agreement struck by the parties meant that a New York court could decide the issue.
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July 29, 2024
NIST Lays Out 200+ Ways To Tackle Generative AI Risks
The National Institute of Standards and Technology has recommended hundreds of actions that can be taken to address issues of data privacy, intellectual property, environmental impact and more raised by generative artificial intelligence.
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July 29, 2024
Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech
Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.
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July 29, 2024
Gilstrap Finds Nothing Between The Lines Of Barcode Patents
A handful of barcode scanning patents issued to prolific litigant Leigh Rothschild met their fate in Texas, with U.S. District Judge Rodney Gilstrap deciding they "recite no more than generic computer operations."
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July 29, 2024
Vaccine Co. Was Sanctioned For Deliberately Hiding Testing
U.S. Patent and Trademark Office Director Kathi Vidal backed sanctions for Longhorn Vaccines & Diagnostics' "egregious abuse" of the Patent Trial and Appeal Board system because of the patent owner's "deliberate scheme to hide" harmful evidence from the board, she said in an opinion made public Friday.
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July 29, 2024
Boehringer Appeals HHS Win In Medicare Drug Price Suit
Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.
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July 29, 2024
Kirkland-Led Amulet Closes $1.2B Health-Focused Fund
Kirkland & Ellis LLP-advised private equity shop Amulet Capital Partners LP on Monday announced that it successfully closed its third healthcare-focused private equity fund with roughly $1.2 billion in tow.
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July 29, 2024
Legalization Org Taps Cannabis Atty As New Treasurer
The pro-legalization advocacy organization Marijuana Policy Project announced Monday that a preeminent member of the cannabis bar had been tapped as the group's newest treasurer.
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July 29, 2024
GSK Settles Ill. Zantac Cancer Suit
GlaxoSmithKline said Monday it has settled a lawsuit brought by an Illinois man who took the heartburn medication Zantac or its generic counterpart for more than 20 years and claimed the drug caused his prostate cancer.
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July 29, 2024
Firm, Ex-Client Brief Conn. High Court In Punitive Award Case
McCarter & English LLP and ex-client Jarrow Formulas Inc. are weighing in as the Connecticut Supreme Court decides whether a federal court can award law firms punitive damages in suits for breach of contract, as the firm seeks a punitive payout after winning multimillion-dollar judgments in a contract dispute.
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July 29, 2024
Catching Up With Delaware's Chancery Court
Litigation linked to Elon Musk sparked several filings in Delaware's Court of Chancery last week, including a call for sanctions and hand-wringing about a proposed multibillion-dollar attorney fee. Here, Law360 looks at this and other highlights from last week in Delaware's Chancery Court.
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July 29, 2024
Ex-Pharma Exec Seeks Leniency After SEC Contempt Plea
A former pharmaceutical executive is hoping to avoid jail after his use of an alias to circumvent a U.S. Securities and Exchange Commission ban on finance work landed him a criminal contempt conviction, while Boston federal prosecutors are seeking up to 10 months in prison.
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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.
Expert Analysis
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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3 Infringement Defenses To Consider 10 Years Post-Nautilus
In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.
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9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense
The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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Investors Can Aid In The Acceptance Of Psychedelic Medicine
Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.
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Class Actions At The Circuit Courts: May Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.
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Perspectives
Trauma-Informed Legal Approaches For Pro Bono Attorneys
As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.
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Series
Playing Music Makes Me A Better Lawyer
My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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How Attys Can Avoid Pitfalls When Withdrawing From A Case
The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.
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Using A Children's Book Approach In Firm Marketing Content
From “The Giving Tree” to “Where the Wild Things Are,” most children’s books are easy to remember because they use simple words and numbers to tell stories with a human impact — a formula law firms should emulate in their marketing content to stay front of mind for potential clients, says Seema Desai Maglio at The Found Word.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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Patent Lessons From 4 Federal Circuit Reversals In April
Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.