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Life Sciences
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June 12, 2025
Fla.-Based Med Spa Chain Files For Ch. 11 After Expansion
Contour Spa LLC, a Florida-based chain of fat-burning med spas, filed for Chapter 11 protection after a rapid expansion and a sprawling and decentralized operational system led to financial challenges that ate into revenues.
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June 12, 2025
8th Circ. Stubs Out Challenge To FDA Menthol Vape Denial
The Eighth Circuit on Thursday threw out a challenge from SWT Global Supply Inc. to the U.S. Food and Drug Administration's denial of its application to market menthol-flavored e-cigarettes, saying the agency didn't arbitrarily or capriciously find that the company's sales plan failed to meet its standards for promoting public health.
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June 12, 2025
Rising PTAB Filings Follow Surge In Patent Cases
The number of petitions filed with the Patent Trial and Appeal Board ticked up last year, following a similar increase in federal court litigation and suggesting that activity at the board has somewhat stabilized, according to a new report.
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June 12, 2025
Harvard Researcher Held By ICE Over Specimens Released
A Harvard Medical School researcher and Russian national who has been detained by U.S. immigration authorities since聽February, when frog embryo specimens were found in her luggage at Logan Airport, was released from custody Thursday while she awaits trial on a smuggling charge.
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June 12, 2025
Judiciary Committee Clears Squires For Full Senate Vote
The U.S. Senate Judiciary Committee approved former Goldman Sachs intellectual property attorney John Squires to serve as U.S. Patent and Trademark Office director on Thursday, putting his nomination in the hands of the full Senate.
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June 12, 2025
Greenberg Traurig Adds IP Atty From Kilpatrick In NY
Greenberg Traurig LLP has boosted its intellectual property offerings in New York with the addition of an experienced litigator from Kilpatrick Townsend & Stockton LLP.
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June 12, 2025
5 Firms Guide $1.25B BioNTech, CureVac Oncology Deal
German biotech firm BioNTech SE said Thursday that it will acquire CureVac NV, a clinical-stage mRNA specialist, in an all-stock oncology-focused deal valuing it at about $1.25 billion and involving five legal advisers.聽
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June 12, 2025
Chancery Tags AstraZeneca Unit For $180M 'Expectation' Loss
Rejecting calls for a $755 million award, a Delaware vice chancellor ruled late Wednesday that a biopharmaceutical company's shareholders are due $180.9 million in post-merger "expectation damages" plus interest after an AstraZeneca PLC unit's failure to reasonably pursue an acquired drug prospect.
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June 11, 2025
9th Circ. Doubts Kleenex Ad Fight Belongs In District Court
Two judges on a Ninth Circuit panel doubted Wednesday that they have jurisdictional authority to revive a putative class action alleging Kimberly-Clark Corp.'s Kleenex Wet Wipes Germ Removal products mislead consumers about its ability to kill germs, saying repeatedly that the consumers' complaint has not met their burden to establish jurisdiction.
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June 11, 2025
PTAB Issues Mixed Group Of Discretionary Denial Decisions
The Patent Trial and Appeal Board has invoked its discretion to free Nike Inc. and Cleveland Medical Devices from having their patents scrutinized, but refused to do so for Vermeer Manufacturing Co.
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June 11, 2025
RFK Jr. Picks Vaccine Critics As Part Of CDC Panel Overhaul
Robert F. Kennedy Jr., secretary of the聽U.S. Department of Health and Human Services, announced Wednesday he appointed eight new members to a vaccine advisory panel, just two days after he removed 17 existing members of the panel, which provides advice and guidance on the use of vaccines to the Centers for Disease Control and Prevention.
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June 11, 2025
IP, Health Law Scholars Object To 23andMe Ch. 11 Data Sale
A number of university scholars urged a Missouri bankruptcy judge to require that DNA testing company 23andMe聽Holding Co.'s asset sale be contingent on the final buyer maintaining policies that benefit biomedical researchers.
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June 11, 2025
Fed. Circ. Backs PTAB Invalidation Of Agilent CRISPR Patents
The Federal Circuit on Wednesday affirmed Patent Trial and Appeal Board decisions finding every claim invalid in two Agilent Technologies patents on the gene-editing tool CRISPR, sealing a win for Synthego Corp., which has been accused of infringing them.
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June 11, 2025
PepGen Faces Investor Suit Over Muscular Dystrophy Drug
Clinical-stage biotech company PepGen Inc. has been hit with a proposed shareholder class action alleging it misled investors about the efficacy and commercial prospects of its muscular dystrophy drug, causing share price declines as investors learned of the drug's clinical trials' shortcomings.
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June 11, 2025
These Firms Are Landing The Most Patent Litigation Work
Rabicoff Law LLC reclaimed its status as the most active firm for patent plaintiffs, having filed more than twice as many cases in 2024 as it did in 2023, according to a new report from Lex Machina.
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June 11, 2025
New Patent Cases Rebound As EDTX Seals Top Venue Spot
The number of new patent suits filed in 2024 increased 22.2% over 2023, bouncing back from a historically slow year, and the Eastern District of Texas further cemented its status as the most popular patent venue after a rule change made another Texas district less attractive to plaintiffs.
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June 11, 2025
Vedder Price Boosts IP, Exec Compensation Teams In NY
Vedder Price PC has bulked up its New York office with the addition of an intellectual property attorney from Vinson & Elkins LLP and an executive compensation and employee benefits pro from Schulte Roth & Zabel LLP.
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June 11, 2025
J&J's Beasley Allen DQ Bid Based On 'Innuendo,' Court Told
A California couple ripped Johnson & Johnson's renewed bid to block two Beasley Allen Law Firm attorneys from representing them in their suit accusing the company of selling carcinogenic talc-based baby powder, arguing the company's opposition is based largely on "innuendo" rather than proof of misconduct by the lawyers.
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June 10, 2025
Stewart's Newest Discretionary Denial Has Attys On Edge
The acting U.S. Patent and Trademark Office director's decision on Friday to reject patent challenges due to the petitioner's long-standing knowledge of a patent has many attorneys bracing for either a massive rise or dip in Patent Trial and Appeal Board filings.
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June 10, 2025
States Sue To Block 23andMe From Selling DNA Data In Ch. 11
A bipartisan coalition of 28 attorneys general has sued 23andMe Inc. in Missouri bankruptcy court seeking to block the genetic-testing company from auctioning off its 15 million customers' personal genetic information without their explicit consent in its ongoing Chapter 11 proceeding.
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June 10, 2025
IT Co. Urges 1st Circ. To Affirm It's Blameless For Data Breach
An information security technology company urged the First Circuit on Tuesday to affirm that it isn't liable for a 2018 data breach that exposed confidential information of more than 277,000 of the medical device maker's patients, arguing that the insurer assignee of the device maker had no valid points.
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June 10, 2025
Ill. Judge Questions Standing In Biogen Antitrust Suit
An Illinois federal judge seemed skeptical Tuesday that health benefit plans accusing Biogen of impairing competition for聽its multiple sclerosis drug, Tecfidera, have standing to bring their lawsuit under decades-old precedent allowing only direct purchasers to recoup damages.
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June 10, 2025
Ala. Judge Orders Trans Health Org. To Publish Training Vids
In a case challenging Alabama's ban on gender-affirming care for youths, a federal judge this week ordered a trans health organization to publish video recordings of the group's conferences and a medical training course, after the group had sought to protect the content's confidentiality.聽
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June 10, 2025
House 23andMe Hearing Raises National Security Concerns
Lawmakers pressed current and former 23andMe executives during a House Oversight Committee hearing Tuesday over national security and consumer privacy in connection with a planned Chapter 11 sale of 15 million customers' DNA profiles.
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June 10, 2025
Dog Owner Defends Tick Meds Suit Against Elanco, Retailers
A consumer plaintiff has urged an Indiana federal judge not to dismiss her proposed class action accusing Elanco Animal Health Inc. of paying off alleged co-conspirators Chewy, Petco, PetMed Express, PetSmart and PetSense to聽not carry cheaper generative alternatives to the Advantix topical flea and tick pet prevention drugs.
Expert Analysis
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration鈥檚 shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump鈥檚 nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office鈥檚 enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there鈥檚 no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.