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Life Sciences
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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.
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August 05, 2024
Inari Agriculture Can't Sink Patent Case Over Corn Seed
A legal fight between a DowDuPont spinoff and a Massachusetts plant breeding startup over the exporting of patent-protected corn seed will continue to grow in Delaware federal court, unimpeded by DuPont researchers' decision to publicly deposit their seeds.
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August 05, 2024
Indivior Accused Of Overstating Prospects Of 3 Opioid Drugs
Drugmaker Indivior PLC has been hit with a proposed investor class action in Virginia federal court over claims it overstated the financial prospects of its drugs used to treat opioid use disorders and the company's ability to forecast such financial projections.
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August 05, 2024
Chinese Drug Co. Says Sanctions In Valsartan MDL Too Harsh
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. told a New Jersey federal court Friday that sanctions authorizing two adverse jury instructions in multidistrict litigation over generic drugs contaminated with carcinogens should be overturned, arguing the plaintiffs did not allege the bad faith required for such a harsh penalty.
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August 05, 2024
J&J, Generics Spar In Remand On Schizophrenia Drug Patent
Following a Federal Circuit ruling that gave generics makers Teva and Viatris a new shot at trying to invalidate the last remaining patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna, the parties are sparring over the impact of the appeals court's decision.
Expert Analysis
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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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.