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Life Sciences
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July 10, 2024
RJ Reynolds Urges Toss Of Menthol Suit Against FDA
Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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July 10, 2024
Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman
A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.
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July 10, 2024
Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team
A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.
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July 10, 2024
Ex-CEO Convicted In COVID Test Kit Fraud Case
A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.
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July 09, 2024
Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested
A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.
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July 09, 2024
Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.
Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.
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July 09, 2024
South Africa Drops J&J Probe After TB Drug Price Cuts
South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.
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July 09, 2024
Fla. Judge Won't Nix Antitrust Claims Against Alcon
The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.
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July 09, 2024
HEC Can't Get Damages Over Injunction In Novartis Feud
A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.
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July 09, 2024
BCBS Unit Fails To Stop Religious Vaccine Objector Suits
A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.
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July 09, 2024
3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC
The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.
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July 09, 2024
NJ Panel Revokes Coverage For Pharma Co. In Fraud Row
A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.
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July 09, 2024
Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan
Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.
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July 09, 2024
NJ Jury Begins Deliberating COVID Test Kit Fraud Case
Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.
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July 09, 2024
Terrorism Victims Push To Keep Pharma Suit In DC Circ.
Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told
Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.
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July 08, 2024
Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight
Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.
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July 08, 2024
Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal
Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.
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July 08, 2024
Jurors Told To Decide Who Is Lying In COVID Test Fraud Case
The task for jurors in the retrial of a securities fraud case over a COVID test kit deal that never materialized will be to determine not whether lies were told but who told them, according to closing arguments delivered Monday in New Jersey federal court.
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July 08, 2024
Blank Check Co. Sagaliam Gets Shareholder Suit Trimmed
A Delaware federal judge on Monday trimmed a shareholder suit brought against blank check company Sagaliam Acquisition Corp. over its planned tie-up with biotech company Enzolytics Inc., saying the plaintiffs failed to adequately plead a breach of fiduciary duty claim.
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July 08, 2024
Purdue Creditors Look To Sue Sacklers After Justices' Ruling
The official committee of unsecured creditors in the Chapter 11 case of drugmaker Purdue Pharma asked a New York bankruptcy judge on Monday for standing to bring actions against members of the Sackler family that own the company after the U.S. Supreme Court torpedoed a precarious settlement among the parties.
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July 08, 2024
Biotech Co. Alleges Arbitrator Conflict In Patent Award Fight
Pennsylvania-based biotechnology company Renmatix Inc. is urging the Delaware Court of Chancery to nix an arbitral award favoring Finnish company UPM-Kymmene Corp. in a long-running patent dispute, pointing to an allegedly undisclosed conflict of interest involving the Finnish company's counsel at DLA Piper.
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July 08, 2024
Kirkland, Fenwick Steer Lilly's $3.2B Morphic Acquisition
Eli Lilly and Co. unveiled Monday a $3.2 billion all-cash deal to acquire biopharmaceutical company Morphic Holding Inc., which is developing oral therapies to treat Crohn's disease and other bowel chronic diseases, in a 10-figure transaction guided by Kirkland & Ellis LLP and Fenwick & West LLP.
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July 08, 2024
Ex-Ga. Insurance Chief Wants Lighter Term In Kickback Case
Former Georgia Insurance Commissioner John Oxendine has objected to the government's recommendation that he serve 44 months in prison and pay a $700,000 fine for his role in a multimillion-dollar medical testing kickback scheme, arguing that he is deserving of a lesser sentence.
Expert Analysis
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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.
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.