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Life Sciences
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August 07, 2024
Abbott Brass Trim But Can't Nix Investors' Formula Recall Suit
A Chicago federal judge on Wednesday substantially trimmed a derivative suit accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula but rejected the defendants' argument that tossing the suit in its entirety was in shareholders' "best interest."
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August 07, 2024
Judge's Pharma Comments Could Decide Ineligibility Appeal
A Federal Circuit panel on Wednesday was willing to explore Astellas Pharma's argument that a Nebraska federal judge should be taken off its infringement case over the bladder medication Myrbetriq, given statements that showed a potential bias against the pharmaceutical industry, but also made clear that such reassignments are rare and difficult.
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August 07, 2024
Advocates Tell 9th Circ. To Revive Invisalign Monopoly Suit
Competition advocates are backing the revival of a class action accusing the makers of Invisalign of monopolizing the market for clear dental aligners, telling the Ninth Circuit in a new amicus brief that a district court summary judgment ruling for Align Technology creates a dangerous precedent for refusal-to-deal cases.
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August 07, 2024
Teva Finds Some Big-Pharma Friends In Inhaler Patent Fight
Two large pharmaceutical companies have weighed in to ask the Federal Circuit to overturn a ruling that found that Teva's branded drugmaking operation misused a key federal patent database in order to block the release of competing generic asthma inhalers.
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August 07, 2024
NC Biz Court Bulletin: The Battles Making Summer Sizzle
A 1983 championship basketball team's intellectual property rights and a public feud between Cadwalader Wickersham & Taft LLP and its insurer are among the legal battles that have kept North Carolina Business Court judges and Tar Heel state private practice attorneys busy this summer. In case you missed those and others, here are the highlights.
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August 07, 2024
Amgen Waged Lawfare To Overcharge For Drug, Suit Claims
Maryland-based independent licensees of the Blue Cross Blue Shield Association claim pharmaceutical giant Amgen Inc. and its subsidiaries have engaged in unlawful monopolistic practices that have inflated the cost of the blockbuster drug Enbrel.
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August 07, 2024
Ex-Pharma Exec Gets 20 Months In SEC Contempt Case
A former pharmaceutical executive who used an alias to flout a 2016 U.S. Securities and Exchange Commission consent judgment barring him from the securities industry was sentenced Wednesday to 20 months in prison by a judge who called him "incorrigible."
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August 07, 2024
Law Firms Fight J&J Bid To Revive Talc Subpoenas
The Beasley Allen Law Firm, the steering committee of talc plaintiffs suing Johnson & Johnson, and a third-party law firm urged the New Jersey federal court this week to reject a bid from the pharmaceutical company to reinstate subpoenas seeking evidence of alleged third-party litigation funding.
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August 07, 2024
3 Firms Steer $405M G1-Pharmacosmos Pharma Deal
G1 Therapeutics Inc., a North Carolina-based developer of cancer therapies, has agreed to sell the business to the U.S. subsidiary of Denmark's Pharmacosmos A/S, for approximately $405 million, the companies said Wednesday.
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August 07, 2024
2 FDA Pros Join McGuireWoods From Reed Smith, DOJ
McGuireWoods LLP said Wednesday it has added two U.S. Food and Drug Administration regulatory lawyers to its Washington, D.C., office — one who joins from Reed Smith LLP and another who joins from the U.S. Department of Justice.
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August 07, 2024
Jury Deadlocks In Third Illinois Zantac Cancer Trial
An Illinois state judge declared a mistrial Wednesday in a man's lawsuit claiming Boehringer Ingelheim's over-the-counter Zantac caused him to develop prostate cancer, after a jury signaled it could not reach a unanimous verdict.
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August 07, 2024
Rising Star: King & Spalding's Julia Zousmer
Julia Zousmer of King & Spalding LLP helped Boehringer Ingelheim nix roughly 50,000 claims by plaintiffs and an entire cohort of experts in multidistrict litigation over its heartburn medication Zantac, earning her a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Pennsylvania Legislation Passed In 2024: A Midyear Report
Despite a divided legislature in Pennsylvania — the parties have been trading a narrow majority in the House of Representatives and Republicans compose most of the state Senate — lawmakers have managed to send dozens of bills to Democratic Gov. Josh Shapiro's desk in the first half of 2024, including tighter controls on a veterinary drug showing up in heroin, changes to business registrations with the state, and adding arbitration to the tools for family courts.
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August 06, 2024
AstraZeneca Can't Duck $107.5M Patent Loss To Pfizer Unit
An Illinois federal judge on Tuesday refused to upend a jury's determination that AstraZeneca owes $107.5 million in royalty damages for infringing Pfizer-brand cancer treatment patents, rejecting AstraZeneca's arguments that the patents are unenforceable and the asserted claims are invalid.
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August 06, 2024
Baby Sock Co. Can't Beat Investor Suit, But SPAC Brass Can
Digital baby monitoring device manufacturer Owlet Inc. cannot escape a suit accusing it of misleading investors about approvals required from the U.S. Food and Drug Administration to sell its "smart socks," but brass at a blank check company that it merged with will be allowed to exit the suit.
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August 06, 2024
Fed. Circ. Told Edwards Filed Safe Harbor Suit With Bad Intent
The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.
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August 06, 2024
Tech Giants' Fight To Ax Fintiv Rule Returns To Fed. Circ.
Apple and three other major technology companies have again asked the Federal Circuit to abolish a rule allowing the Patent Trial and Appeal Board to refuse to review patents based on related litigation in court, saying it is unlawful because it was implemented without formal rulemaking.
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August 06, 2024
Denver Food Co. Fired VP For Younger Male, Suit Claims
A former vice president of a Denver-area food biotech firm has filed a suit claiming the company violated Colorado's gender and age anti-discrimination laws when it fired and ultimately replaced her after she finished training a younger male successor, who was intended to only take over some of her duties.
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August 06, 2024
Life Sciences Credit Firm Symbiotic Launches With $600M
A new credit firm led by veterans in the healthcare industry announced its launch Tuesday, with more than $600 million in capital earmarked for loans to life sciences companies.
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August 06, 2024
FDA Posts Two Policy Memos On E-Cig Applications
The U.S. Food and Drug Administration on Monday posted two memos outlining the agency's thoughts on two aspects of their reviews of applications to market e-cigarettes, which include chemical components that may pose a risk of cancer.
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August 06, 2024
Pharma Co. Founder Beats Suit Over Short-Swing Trading
The founder of Y-mAbs Therapeutics Inc. beat back a suit alleging he realized more than $2.5 million in so-called short-swing profits after he exchanged his Y-mAbs stock for those of another company, with a New York federal judge saying in a ruling of first impression that the founder does not need to return the gains he received.
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August 06, 2024
Dem Lawmakers Back FTC's Kroger-Albertsons Challenge
A group of Democratic lawmakers is supporting the Federal Trade Commission in its suit to block Kroger's $25 billion acquisition of Albertsons, telling an Oregon federal judge in a friend-of-the-court brief that the agency's fears the deal would harm grocery workers and consumers are well-founded.
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August 06, 2024
Ex-Pfizer Worker Who Traded On Paxlovid Secrets Gets 9 Mos.
A Manhattan federal judge sentenced a former Pfizer Inc. statistician from New Jersey to nine months in prison Tuesday after a jury convicted him of insider trading on secrets about his former company's COVID-19 therapy trials for an illegal $272,000 profit.
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August 06, 2024
Penn Says BioNTech Owes Royalties For COVID-19 Vax
BioNTech was hit with a breach of contract suit Monday in Pennsylvania federal court by the University of Pennsylvania over alleged unpaid royalties on global net sales of its blockbuster COVID-19 vaccine Comirnaty, which was developed using the school's crucial messenger RNA patents and has made more than $75 billion.
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August 06, 2024
Rising Star: White & Case's Adam Acosta
Adam Acosta of White & Case LLP helped secure a Second Circuit win for AbbVie Inc. in a "pay for delay" suit over its hypertension drug Bystolic, earning him a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
Expert Analysis
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.