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Life Sciences
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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.
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September 20, 2024
Lawmakers Ask USPTO To Fix Patent Calculation Problem
Federal patent officials need to change standards that could let drug companies hold on to patent rights beyond the time frame they are entitled to, according to federal lawmakers.
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September 20, 2024
Plaintiffs Firms Battle Over Proposed $9B Deal In J&J Talc Suit
Two leading plaintiffs law firms in the multibillion-dollar litigation over Johnson & Johnson's tainted talcum powder are now warring among themselves, with Smith Law Firm PLLC suing Beasley Allen Law Firm for defamation after Beasley Allen accused the former of selling out clients to pay off litigation funders.
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September 20, 2024
Ex-Healthcare Exec Can't Sue GC Over Probe Advice
A former Baxter International treasurer who was fired amid an investigation into improper foreign exchange transactions was correctly blocked from pursuing claims against the healthcare company and its general counsel over advice he received on navigating the probe, an Illinois appellate panel said Friday.
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September 20, 2024
J&J Makes Third Try At Handling Talc Claims In Bankruptcy
A Johnson & Johnson talc unit filed for Chapter 11 protection in Texas bankruptcy court Friday, marking the third time the company has tried to deal with liability from alleged asbestos-contaminated talc with a bankruptcy filing.
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September 20, 2024
Cardinal Health Pays $1.12B For Integrated Oncology Network
Ropes & Gray LLP-advised Cardinal Health on Friday announced that it has agreed to buy the physician-led independent community oncology entity Integrated Oncology Network for $1.115 billion in cash, in a deal that Cardinal says builds on its commitment to helping community healthcare providers hold on to their independence.
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September 20, 2024
Womble Bond Hires New Head Of Int'l Disputes From Dechert
Womble Bond Dickinson has hired a former Dechert LLP partner as the head of its international disputes practice, who will be based in the firm's Washington, D.C., office and will double as a partner in its business litigation practice group, Womble Bond recently announced.
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September 20, 2024
Ga. Airport Pat-Down Caused Catastrophic Injuries, Man Says
A man sued the government and several unnamed parties in Georgia federal court Thursday, alleging that he fractured his thoracic vertebrae, spent 52 days in the hospital and had to undergo surgery after an airport screening incident at Hartsfield-Jackson Atlanta International Airport.
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September 20, 2024
UK Litigation Roundup: Here's What You Missed In London
The past week in London has seen crypto exchange Binance face a new claim from the co-founder of SO Legal, a U.S. immersive art company take on a Bristol venue for copyright violations and Blake Morgan LLP hit with a pension schemes claim by The Trust for Welsh Archeology. Here, Law360 looks at these and other new claims in the U.K.
Expert Analysis
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.