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Life Sciences
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September 24, 2024
Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs
Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.
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September 24, 2024
Trio Used Penny Stock Co. For Wide-Ranging Fraud, SEC Says
A trio of defendants faces U.S. Securities and Exchange Commission allegations they orchestrated a wide-ranging investment scheme to illegally profit off of a purported solar company and bogus claims about a rapid COVID-19 test, targeting investors and even the company's own transfer agent to enrich themselves.
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September 24, 2024
Moderna Execs Hyped Ineffective RSV Vax, Suit Says
Officers and directors of Moderna misled investors about the efficacy of its RSV vaccine, causing share prices to dive when it was revealed in June to have only about a 50% efficacy rate after 18 months, a new shareholder suit alleges.
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September 24, 2024
Firms Allowed To Exit IP Case After Gaining Philips' Consent
A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.
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September 24, 2024
8th Circ. Won't Revive Pot Shop's Discrimination Suit
The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.
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September 24, 2024
NJ Judge Leaves J&J Ch. 11 Venue Change To Texas Judge
A New Jersey bankruptcy judge on Tuesday declined the U.S. trustee's request to move Johnson & Johnson's latest talc-unit Chapter 11 from Texas to the Garden State, saying the issue could be as ably decided by a Texas court while avoiding a thorny issue of authority.
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September 23, 2024
J&J Talc Claims Paused In Latest Spinoff Ch. 11
A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.
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September 23, 2024
Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11
A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.
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September 23, 2024
Bio Lab Settles Conn. False-Claims Allegations For $1.73M
Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.
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September 23, 2024
Fired Sotera Exec's Vesting Suit Goes Forward In Del.
Delaware's Court of Chancery dismissed on Monday some claims in a former Sotera Health Co. executive's suit accusing the lab-testing and sterilization firm of wrongly refusing to grant him severance benefits and equity awards worth millions, while holding other claims for trial.
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September 23, 2024
GSK Claims Pfizer Hasn't Proven Misconduct In Vax IP Fight
GlaxoSmithKline is urging a Delaware federal judge to block Pfizer and BioNTech's claims that it has misused its patents tied to COVID-19 vaccination technology, or that it and a predecessor acted inappropriately when applying for those patents.
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September 23, 2024
Fed. Circ. OKs Novartis Loss In Eye Syringe Patent Feud
The Federal Circuit has backed a Patent Trial and Appeal Board finding that more than two dozen claims in a Novartis pre-filled eye injection syringe patent weren't patentable.
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September 23, 2024
Amneal Latest Generic EpiPen Maker To Fight Colo. Law
Amneal Pharmaceuticals has sued Colorado in federal court alleging that a state drug affordability program resulted in unconstitutional takings of its generic epinephrine auto-injectors.
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September 23, 2024
Cancer Test Cos. Strike Deal For Partial End To Patent Row
Natera Inc. and Neogenomics Laboratories Inc. said they reached a confidential yet partial settlement Friday in their dispute covering intellectual property for a Natera DNA test meant to detect cancer.
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September 23, 2024
Insurer Freed From Damaged Blood Plasma Suit
A supplier of blood plasma can't secure coverage for a nearly $820,000 blood plasma shipment declared a total loss because of excessive temperature variation and shipping delays, a Georgia federal court ruled, finding the supplier failed to abide by separate temperature and delay warranties in its policy.
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September 23, 2024
J&J Accuses Beasley Allen Of Casting Bogus Talc Ballots
Johnson & Johnson has accused the Beasley Allen Law Firm of casting about two dozen false ballots against the company's latest talc bankruptcy plan without voters' consent and urged a New Jersey federal court to remove the firm from the plaintiff's steering committee as a consequence.
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September 23, 2024
RSV Vaccine Biz Secures $100M For Series B Funding Round
Biopharmaceutical company Vicebio Ltd. on Monday announced that it secured its Series B funding round after securing $100 million led by science-focused investment firm TCGX.
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September 23, 2024
Kratom Co. Gets Claims Trimmed In Addiction False Ad Row
A California federal judge has tossed four out of six claims from a proposed class action alleging Ashlynn Marketing Group Inc. hid from buyers the addictive qualities of its kratom products, leaving only fraud and Consumer Legal Remedies Act claims.
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September 20, 2024
House To Weigh Patent Bill Aimed At Cutting Drug Prices
The U.S. House of Representatives is expected to consider a bill soon that has already cleared the Senate and could streamline patent litigation by curbing the number of patents that makers of biologic drugs can assert over biosimilar drugs.
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September 20, 2024
ITC Has Been Launching Fewer Section 337 Investigations
Intellectual property activity at the U.S. International Trade Commission has "decreased somewhat," the agency said in a report Friday.
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September 20, 2024
Alnylam Seeks To End Inventorship Suit Tied To COVID Vax
Alnylam Pharmaceuticals, which alleges that COVID-19 vaccines made by Pfizer and Moderna infringe its patents, has moved in Delaware federal court to dismiss a suit by former collaborator Acuitas Therapeutics Inc. seeking to have its scientists added as inventors on the patents.
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September 20, 2024
3rd Circ. Rejects 'Close' Case For Preemption In Fosamax MDL
A U.S. Food and Drug Administration letter denying changes to the label of Merck's osteoporosis drug Fosamax does not count as a final agency action triggering federal preemption of state law "failure to warn" claims, the Third Circuit ruled Friday in a precedential decision.
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September 20, 2024
Del. Justices Uphold Toss Of AmerisourceBergen Syringe Suit
Delaware's Supreme Court upheld with little comment Friday a lower court dismissal of a nearly 5-year-old shareholder derivative suit accusing AmerisourceBergen Corp. directors of failing to investigate and stop illegal repackaging of cancer drugs.
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September 20, 2024
IPO Trio Looks To Raise $536M Combined As Autumn Begins
Three companies spanning the energy, healthcare and life sciences industries are preparing initial public offerings that could raise $536 million combined in the coming week, guided by six law firms, signaling an upturn in IPOs as autumn begins.
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September 20, 2024
DuPont Cos. Can't Escape Cape Fear River PFAS Suit
A North Carolina federal judge said DuPont and several corporate spin-offs can't escape a lawsuit brought by four Tar Heel State residents who claim the companies knowingly poisoned the Cape Fear River with toxic forever chemicals pollution.
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.