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Life Sciences
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June 17, 2024
USC Allegedly Used 'Junk Science' On Black Kidney Patients
The University of Southern California secretly has been using a "junk science" scoring formula that hurts Black patients' eligibility to receive kidney transplants, according to a putative class action in California federal court.
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June 17, 2024
Mifepristone Ruling Means End Of Texas DACA Suit, Feds Say
A Texas-led coalition of states doesn't have standing to challenge the Deferred Action for Childhood Arrivals program after the U.S. Supreme Court's blockbuster decision rejecting a challenge to the abortion drug mifepristone, the Biden administration told the Fifth Circuit on Monday.
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June 17, 2024
DOJ Wants 15 Years For Outcome CEO's $1B Fraud
Federal prosecutors said former Outcome Health CEO Rishi Shah should serve 15 years in prison while Outcome's co-founder and ex-financial chief each serve 10 years following their convictions for running a $1 billion fraud that affected lenders, investors and clients.
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June 17, 2024
Top Patent Eligibility Rulings In The Decade Since Alice
The U.S. Supreme Court's Alice v. CLS Bank decision 10 years ago this week led to scores of inventions being found ineligible for patenting, and rulings since then have fleshed out the law on the contentious topic. Here's a look at the most notable patent eligibility decisions after Alice.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 17, 2024
HUD Freed From Pa. Pot Patients' Suit Over Housing Rebuff
Unless the U.S. Department of Housing and Urban Development fulfills its threat to withhold a Pennsylvania county housing agency's funding for complying with a state court order to admit licensed medical marijuana patients, a lawsuit by the county agency and two potential tenants is premature, a federal judge ruled Monday.
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June 17, 2024
Drugmaker, PE Investor Sued In Del. Over 'Unfair' Deal Terms
Clinical-stage biotechnology firm Omega Therapeutics' board entered into an "unfair" agreement to develop a new drug with the company's controlling private equity stockholder that was heavily tilted in favor of the majority equity holder and Omega insiders, an investor alleged in a lawsuit in Delaware's Chancery Court.
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June 17, 2024
Zantac Suits Must Exit State Court, Conn. Judge Told
A Connecticut state court judge must relinquish jurisdiction over two lawsuits claiming that generic versions of the heartburn drug Zantac caused cancer because state statutes do not subject entities with foreign business registrations to the auspices of Constitution State judges, a pharmaceutical industry attorney argued at a hearing Monday morning.
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June 17, 2024
Fed. Circ. Says Errors Led To Injunction In Trade Secrets Suit
A Federal Circuit panel on Monday overturned a preliminary injunction against a South Korean insulin pump patch manufacturer that allegedly stole trade secrets from a rival, saying a Massachusetts federal court made a series of errors in its determination to grant an injunction.
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June 17, 2024
Catching Up With Delaware's Chancery Court
Proposed amendments to Delaware's General Corporation Law that were prompted by several recent Chancery Court rulings sailed through the state Senate last week despite loud opposition from corporate law professors and other Chancery Court watchers, and Tesla shareholders filed two new suits against CEO Elon Musk.
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June 17, 2024
Talc Claimants Want Documents In Fight Over J&J Unit Venue
Cancer patients with talc damage claims against Johnson & Johnson have urged a New Jersey federal court to give them access to transcripts and exhibits from depositions of top executives at the company's talc unit, saying the information will aid their effort to bar the J&J spinoff from filing a third Chapter 11 outside the Garden State.
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June 14, 2024
Justices Are Asked To Wade Into Blood Pressure Drug IP Fight
United Therapeutics is taking its patent case seeking to stop a rival from selling a drug that competes with its blockbuster treatment for high blood pressure to the U.S. Supreme Court.
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June 14, 2024
Janssen Hit With $150M Verdict In HIV Drug False Claims Suit
A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.
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June 14, 2024
3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks
The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.
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June 14, 2024
Judge Won't Undo Save Of J&J Patent After Fed. Circ. Ruling
A federal court has refused to reconsider a March decision finding Tolmar failed to show a patent on Janssen's blockbuster schizophrenia drug Invega Sustenna was invalid as obvious.
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June 14, 2024
Pfizer Worker's Ex-Wife Can't Raid 401(k) To Collect Damages
The ex-wife of a former Pfizer employee can't use her ex-husband's 401(k) account to collect damages awarded in a defamation suit against him, a Pennsylvania federal judge ruled, saying federal benefits law prevents her from seizing his retirement contributions.
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June 14, 2024
Australian Biotech Firm Telix Pharmaceuticals Pulls US IPO
Australian biotechnology firm Telix Pharmaceuticals Ltd., whose U.S. shares were set to debut trading on Friday, canceled plans for an estimated $202 million U.S. initial public offering, citing unfavorable market conditions.
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June 14, 2024
Biotech Clinches Latest Funding Round With $55M In Tow
Biotechnology company Enveda Biosciences on Friday announced that it has closed its most-recent financing round after raising $55 million from investors, bringing the Boulder, Colorado-based company's total capital fundraising to $230 million.
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June 13, 2024
IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work
A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.
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June 13, 2024
Justices Hand Abortion Advocates An Incomplete Win
The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.
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June 13, 2024
Cooley-Led Diagnostics Firm Tempus AI Raises $411M IPO
Artificial intelligence-powered diagnostics company Tempus AI inc. priced a $410.7 million initial public offering Thursday at the top of its range, represented by Cooley LLP and underwriters counsel Davis Polk & Wardwell LLP.
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June 13, 2024
Thomas Targets Group Standing In Mifepristone Ruling
U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.
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June 13, 2024
Full Fed. Circ. Rejects Rehearing Bids In Xifaxan Case
The Federal Circuit has shot down bids for rehearing filed by both sides in a case involving an April decision that prevents an Alvogen unit from releasing a generic version of Bausch Health's diarrhea and brain disorder drug Xifaxan until 2029.
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June 13, 2024
Feds' Forfeiture Error Won't Tank Outcome Execs' Conviction
Outcome Health executives can't wipe out their $1 billion fraud convictions or receive a new trial despite arguing that improperly frozen assets prevented them from hiring their chosen lawyers, an Illinois federal judge said Wednesday, ruling that they waived their challenge to the forfeiture by waiting too long.
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June 13, 2024
Cannabis Cos. Make Deal Ahead Of Expected DEA Downgrade
An attorney and cannabis entrepreneur is betting that the federal government will reschedule marijuana before winter, announcing his equipment manufacturing firm will ally with a Native American-owned cannabis oil processing company to build out a pharmaceutical cannabis extraction facility.
Expert Analysis
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.