High Court Won't Hear FDA Stem Cell Regulation Fight

By Gianna Ferrarin

The U.S. Supreme Court on Tuesday declined to review a circuit court holding that a stem cell treatment derived from a patient's own tissue is subject to Food, Drug and Cosmetic Act regulations.

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Ōura Valuation Soars To $11B After $900M Financing Round

By Jade Martinez-Pogue

Fitness-tracking ring maker Ōura on Tuesday revealed it had reached a roughly $11 billion valuation after securing over $900 million in a funding round, which it says will help it develop new technologies, speed up artificial intelligence and product innovation, and expand global distribution.

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Profile

Meet HHS General Counsel Michael Stuart

By Gianna Ferrarin

Michael Stuart, a former chief federal prosecutor for West Virginia, has been confirmed by the U.S. Senate to serve as general counsel for the Department of Health and Human Services, where he has promised to make healthcare fraud enforcement a priority. 

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Analysis

Relief Concerns Grow As Sectoral Tariff Actions Build

By Dylan Moroses

Importers' hopes for relief from industrywide tariffs are lagging alongside the trade deals President Donald Trump is trying to broker for some goods, while the administration's accelerated rollout of sectoral levies is also stoking concerns the government may be hamstringing its onshoring goals.

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NJ, Del. Judges Stress Value Of Local Counsel For IP Attys

By Dani Kass

Six judges with significant experience overseeing pharmaceutical patent litigation in the districts of New Jersey and Delaware urged litigators on Tuesday to rely on the expertise of local counsel if they're hoping to impress the court.

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Skinny Labels, Orange Book Take Center Stage In IP Talks

By Dani Kass

Patent litigators focused on pharmaceuticals and biotechnology met Tuesday to work through the biggest issues in their industries, including possible reform to skinny label law, frustration with position-switching in litigation, concerns about when to list patents in the U.S. Food and Drug Administration's Orange Book and data on the relatively low impact of new policies at the U.S. Patent and Trademark Office.

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6th Circ. Won't Revive Allergy Tester's Antitrust Case

By Matthew Perlman

The Sixth Circuit refused to revive an allergy testing and treatment company's antitrust case accusing an insurer and a medical group of conspiring to squeeze it out of the market, after finding that doctors are the ones being directly harmed by the alleged activity.

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Embryo Loss Class Claims Hinge On Calif. Suit, Judge Says

By Brian Steele

A Connecticut federal judge may pause a proposed class action blaming CooperSurgical Inc. for embryo losses during in vitro fertilization until a class certification motion is decided in a first-filed case in California, but the plaintiff will have until the end of the month to decide if she wants to proceed with only her direct claims instead.

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Blood Test Co. Can't Escape Willful Infringement Claims

By Elliot Weld

A company that makes diagnostic medical tests has been denied a bid to escape from a medical research firm's claims that it willfully infringed patents when a judge held that reading the allegations in combination creates a plausible basis that the company had knowledge of the patents.

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Attempts To Revive Stroke Treatment Patents Fail At Fed. Circ.

By Theresa Schliep

The Federal Circuit on Tuesday tossed without analysis a challenge to Patent Trial and Appeal Board rulings that invalidated patents covering a stroke treatment system, letting stand one of the decisions deemed precedential by a former U.S. Patent and Trademark Office director.

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Catching Up With Delaware's Chancery Court

By Jarek Rutz and Jeff Montgomery

Last week at the Delaware Chancery Court, Vice Chancellor Lori W. Will ruled that Carlos Vasallo remains the CEO of Caribevision TV Network LLC, finding that majority investors' attempt to remove him under a defective 2019 agreement was invalid for lack of proper notice.

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Full 3rd Circ. Won't Rethink $45M CareDx False Ad Case

By Emily Field

The Third Circuit on Tuesday turned down medical testing company CareDx's request to have a full panel mull whether to reinstate a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.

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Freshfields Guides J&J's Planned Orthopedics Unit Spinoff

By Al Barbarino

Johnson & Johnson said Tuesday it intends to separate its orthopedics business into a stand-alone company within the next 18 to 24 months, with Freshfields LLP advising on the planned spinoff of the unit. 

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Covington, Sidley Guide $700M BioCryst Allergic Disease Deal

By Al Barbarino

BioCryst Pharmaceuticals Inc. will purchase Astria Therapeutics Inc., a biopharmaceutical company focused on therapies for allergic and immunologic diseases, in a cash and stock deal worth about $700 million, the companies announced Tuesday.

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Ex-WH Ethics Attys Slam 'Vindictive' Comey, James Charges

By Jack Karp

Three former White House ethics attorneys have filed complaints with the U.S. Department of Justice over what they call the "vindictive and meritless" criminal prosecutions of former FBI Director James Comey and New York Attorney General Letitia James.

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Jack Smith And Other Ex-DOJ Staffers Slam Trump Purge

By Lauren Berg

Former U.S. Department of Justice employees, including former special counsel Jack Smith, spoke out Wednesday in support of colleagues fired or forced to resign by the Trump administration, issuing a warning about the "existential crisis" born from efforts to use the agency to punish the president's political opponents.

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High Court Leans Toward Limiting Voting Rights Act Suits

By Katie Buehler

The U.S. Supreme Court's conservative supermajority seemed ready Wednesday to further limit the use of the Voting Rights Act in challenging alleged racial discrimination in legislative redistricting, but appeared divided over how to accomplish that.

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Vought Aims To Close CFPB Within '2 Or 3 Months'

By Jon Hill

White House budget chief Russell Vought said Wednesday that he wants to shutter the Consumer Financial Protection Bureau and expects to succeed in the next few months, despite the Trump administration's claims in court that the agency is just being downsized.

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DHS Says Seizure Of Atty's Phone Tied To Employment Probe

By Julie Manganis

The government is pushing back on a Massachusetts immigration attorney's allegations that his work phone was seized in retaliation for his criticism of the Trump administration and advocacy for noncitizens, saying it's looking into whether he violated federal employment verification laws.

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Goldstein Can't Dismiss 2016 Tax Charges As Time-Barred

By Jared Foretek

A Maryland federal judge denied SCOTUSblog co-founder Tom Goldstein's motion to dismiss four of the 22 federal tax charges brought against him in January, ruling that his defense that the counts stemming from the 2016 tax year should be time-barred will have to be raised at trial.

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Chief Judge Bars Civil Arrests In Cook County Courts

By Celeste Bott

Cook County's top judge issued an order Wednesday prohibiting the warrantless civil arrest of individuals attending court proceedings in Chicago-area state courthouses, as the federal government has ramped up immigration enforcement and arrests in the area.

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NY Court Tosses Most Of Ex-Lil Wayne Atty's Contract Claims

By Emily Sawicki

A New York state judge has dismissed most counterclaims a former attorney for Lil Wayne pursued in a fee dispute with his ex-client, but the lawyer may still attempt to collect some funds he claims to be owed by the rap star.

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Some Federal Workers Win Quick Block On Shutdown Layoffs

By Bonnie Eslinger

A California federal judge on Wednesday granted a request from two unions representing thousands of federal workers to immediately block the Trump administration from laying them off during the government shutdown, saying she believes the plaintiffs will show that "what's being done here is both illegal and is in excess of authority."

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