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Life Sciences
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June 13, 2025
AbbVie Sues Colo. Over State Discount Drug Law
AbbVie Inc. on Thursday filed suit in Colorado federal court seeking to block an incoming state law it alleges conflicts with the federal 340B drug discount program by forcing pharmaceutical manufacturers to sell drugs at steep discounts to commercial pharmacy chains like Walgreens and CVS.
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June 13, 2025
Stewart Releases Flood Of Discretionary Denial Decisions
The acting U.S. Patent and Trademark Office director issued more than a dozen discretionary denial decisions on Thursday and Friday, where she ruled largely in favor of the challenger, made clear that challenges to young patents have a huge advantage and brought in a denial based on assignor estoppel.
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June 13, 2025
Wash. Judge Tosses IUD Suit Against Bayer For Good
Bayer has beat a negligence lawsuit filed by a woman who claims its Mirena IUD perforated her uterus and migrated after the patient failed to oppose the company's motion to dismiss, a Washington federal judge ruled.
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June 13, 2025
More IPO Prospects Ready To Test Market After Chime's Debut
A venture-backed cancer diagnostics firm and a home insurer are preparing two initial public offerings that could raise $720 million combined next week, joining an energized IPO market following fintech startup Chime Financial Inc.'s debut.
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June 13, 2025
23andMe Founder's $305M Bid Buys Back Co. In Ch. 11 Sale
With a winning bid of $305 million, a nonprofit controlled by 23andMe founder Anne Wojcicki beat out Regeneron Pharmaceuticals to purchase the bankrupt company's assets, 23andMe announced Friday.
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June 13, 2025
Injunction Sought After J&J Unit's Catheter Antitrust Loss
Innovative Health is seeking a permanent injunction that would ban Johnson & Johnson health tech unit Biosense Webster from conditioning the provision of cardiac mapping services on purchases of cardiac catheters, after Innovative Health netted a $442 million trial win on its antitrust claims.
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June 13, 2025
Investor Seeks NY Court's Help In Sinovac Control Battle
An investor is asking a New York federal court for emergency injunctions preserving the status quo as it pursues arbitration in Hong Kong and Beijing stemming from a bitter, yearslong battle for control of Chinese vaccine maker Sinovac.
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June 13, 2025
DC Circ. Urged To Reject Approval For Braille-Free Drug Label
Vanda Pharmaceuticals Inc. is urging the D.C. Circuit to reverse a lower court decision upholding the U.S. Food and Drug Administration's approval of a generic sleep-disorder drug without Braille labeling, a move the company argues jeopardizes patient safety.
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June 13, 2025
Ga. Medical Co. Accused Of Infringing Swedish Co.'s Patents
A Swedish medical device company has sued Georgia-based MedWay Group Inc. in federal court for allegedly infringing its patents for foam dressings used in wound care and management.
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June 13, 2025
2024 Patent Litigation: A Year In Review
The Eastern District of Texas held onto its newly regained title as the busiest patent venue in the U.S., with nearly three times as many cases in 2024 as the once-dominant Western District of Texas. In addition, Patent Trial and Appeal Board filings bounced back after falling to a record low in 2023.
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June 13, 2025
AstraZeneca Inks Up To $5.3B AI Drug Deal With Chinese Firm
AstraZeneca said Friday it has entered into a strategic artificial intelligence-driven research partnership with China's CSPC Pharmaceutical Group in a deal worth as much as $5.3 billion, expanding the British drugmaker's commitments in the country following a shakeup of the company's local leadership.
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June 12, 2025
Roundup Plaintiffs' Rip Of Expert Was Off Base, Jury Hears
A Missouri jury weighing a Roundup cancer case heard expert testimony Thursday that plaintiffs offered a "remarkable mischaracterization" of a defense expert witness on cancer causation when they said in openings that he was "discredited."
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June 12, 2025
Holmes Seeks 2 Year Cut, Commits To Criminal Justice Work
Elizabeth Holmes has asked a California federal judge to knock two years off her 11-year prison sentence, arguing she's eligible for the adjustment under sentencing guidelines and has spent her time behind bars tutoring and advocating for her fellow prisoners.
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June 12, 2025
Florida, Sandoz Say They've Fixed Generic Drug Price-Fix Deal
The Florida Attorney General's Office and Sandoz Inc. have told a Connecticut federal court they've fixed the problems the court identified with a generic drug price-fixing settlement after other states with claims in the case objected to a clause in the deal.
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June 12, 2025
23andMe Ombudsman Not Confident Sale Is Lawful
The privacy expert probing 23andMe's proposed sale of customers' genetic data in bankruptcy told a Missouri federal judge Wednesday that he couldn't determine the deal wouldn't violate state privacy laws and recommended the company be required to obtain consent from its customers before handing over the data.
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June 12, 2025
8th Circ. Upholds Block On Minn. Generic-Drug Price Law
The Eighth Circuit on Thursday backed a lower court's preliminary injunction blocking a Minnesota law that prohibits pharmaceutical manufacturers from imposing an "excessive" price increase on generic or biosimilar drugs, agreeing that the law is likely unconstitutional in regulating prices charged nationwide.
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June 12, 2025
'Forum Shopping' Center Stage At 6th Circ. Drug Pricing Args
As part of an expansive effort to tee up U.S. Supreme Court review, pharmaceutical industry-backed opponents of Medicare's drug price negotiations entered less-than-hospitable territory at the Sixth Circuit, where judges pointedly questioned a local business group's basis for challenging a national healthcare program.
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June 12, 2025
USPTO Tells Fed. Circ. Not To Review Ruling In Xencor Case
The U.S. Patent and Trademark Office has found that the full Federal Circuit doesn't need to review a decision rejecting Xencor Inc.'s application for an antibody patent, saying that a panel of the appellate court applied the right standard.
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June 12, 2025
GlaxoSmithKline Settles Conn. Generic Zantac Suits
GlaxoSmithKline on Thursday agreed to settle two Connecticut lawsuits, one by seven plaintiffs and the other by 11, that claimed generic forms of the brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.
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June 12, 2025
These Firms Are Landing The Most PTAB Work
Intellectual property powerhouse Fish & Richardson again secured the top spot on a list of firms appearing in the most trials over the past three years in front of the Patent Trial and Appeal Board.
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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 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.
Expert Analysis
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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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’s 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’s 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’s 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.