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Life Sciences
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March 03, 2025
Vape Co.'s Challenge Of FDA Penalty Rejected
A Washington, D.C., federal judge has thrown out an online vape retailer's constitutional challenge to a U.S. Food and Drug Administration enforcement proceeding, ruling that claims fell outside the court's jurisdiction.
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March 03, 2025
Jones Day Hires Pair Of Weil IP Litigators In California
Jones Day is expanding its California intellectual property team, announcing Monday that it is bringing in two Weil Gotshal & Manges LLP litigators as partners in the northern part of the state.
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March 03, 2025
3rd Circ. Preview: Litigation Funder, J&J Seek Relief In March
The Third Circuit's case lineup this month will task panels with determining if an American litigation funder can keep its dispute with a German law firm in federal court, and whether Johnson & Johnson can decertify class claims accusing the company of artificially inflating its stock price by failing to disclose the alleged cancer risks of its talc products.
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March 03, 2025
Life Science Consulting Firm Hits Ch. 11 With Sale Plans
Azzur Group, which offers services for pharmaceutical developers, filed for bankruptcy in Delaware with at least $100 million in debt and plans to hold an auction backed by a $56 million stalking horse offer.
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February 28, 2025
Align Tech Deal Directs Buyers To A Monopolist, Judge Says
A California federal judge has soundly rejected Align Technologies Inc.'s proposed $27.5 million antitrust settlement with teeth-aligner buyers, slamming Align as a monopolist and saying that the deal "will direct still more customers to the monopolist."
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February 28, 2025
J&J Talc Spinoff Wraps Two-Week Chapter 11 Trial
A marathon Chapter 11 trial for Johnson & Johnson's talc liability unit wrapped up Friday, with attorneys defending the $10 billion plan against competing efforts to toss the Texas bankruptcy.
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February 28, 2025
Fenwick Adds Longtime Startup Attorney To Insurtech Group
A new attorney has joined tech and life sciences firm Fenwick & West LLP in its regulatory practice and insurtech group, the firm announced, saying her extensive experience working in insurance with established companies as well as emerging startups will help it provide "comprehensive regulatory services."
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February 28, 2025
Sterilization Plant Head 'Shocked' By EPA Cancer Risk Report
The former manager of a Colorado medical sterilization plant testified Friday that he was "shocked" by a 2018 Environmental Protection Agency report that identified the area around the facility as having an increased cancer risk, telling a jury that no regulatory agency until that point had informed him a sterilization chemical might be a risk to the community.
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February 28, 2025
Trump Can't 'Erase' Trans People Via Order, Wash. Judge Says
A Washington federal judge late Friday blocked parts of two of President Donald Trump's executive orders that cut off funding for gender-affirming care for young people, ruling that they violate the Constitution's separation of powers and equal protection guarantees.
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February 28, 2025
Group Blasts Judge's Call For Women In Contraception MDL
A judicial organization dedicated to fighting "leftist lawfare" filed a complaint Thursday against the Florida federal judge overseeing multidistrict litigation over the hormonal contraceptive drug Depo-Provera, claiming that her comments about women needing to be represented in the MDL leadership show an impermissible bias.
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February 28, 2025
Robotic Surgery Co. Appealing Tossed Intuitive Antitrust Case
Surgical Instrument Service Co. Inc. is appealing to the Ninth Circuit after a California federal court tossed its $140 million antitrust case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot at the end of trial.
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February 28, 2025
Dartmouth Wants Fed. Circ. To Ax Fees After Vitamin IP Loss
Dartmouth College is appealing a Delaware federal court's $9.1 million fee award after losing a fight over milk vitamins patented by a biochemist at the school, telling the Federal Circuit that there is no reason it should have presumed that the patents it asserted were "worthless."
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February 28, 2025
Aimmune Shareholders' $27.5M Deal Over Sale To Nestle OK'd
Aimmune Therapeutics Inc. stockholders won preliminary approval in California federal court on Friday for a $27.5 million settlement of their securities fraud class action alleging that Aimmune was falsely undervalued before its merger with Nestlé Health Science SA.
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February 28, 2025
Bioventus Hit With Del. Derivative Suit After NC Class Deal
A Bioventus Inc. stockholder sued 15 current and former directors and officers of the medical device venture in Delaware's Court of Chancery to recover for the company tens of millions in losses tied to alleged mismanagement and corporate duty failures over a two year period.
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February 28, 2025
NFL Alums Say Vaccine Fund Misuse Claims Should Fail
The National Football League's largest alumni organization has hit back at a lawsuit that accused it of forcing a biotechnology company out of a COVID-19 vaccine outreach program, arguing Thursday that no underlying contract exists on which to stake the suit.
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February 28, 2025
China Signals Retaliation Following Extra 10% US Tariff
The Chinese government said Friday it will pursue additional "countermeasures" if President Donald Trump's administration follows through on plans to impose an extra 10% tariff on Chinese goods.
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February 28, 2025
Taxation With Representation: Gibson Dunn, Skadden
In this week's Taxation With Representation, Blackstone acquires Safe Harbor Marinas, National Grid sells its green subsidiary in the U.S. to Brookfield, Apollo Global Management buys Bridge Investment Group Holdings Inc., and Teleflex splits into two publicly traded companies.
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February 28, 2025
Goodwin, White & Case Build BridgeBio's $949M SPAC Deal
Clinical-stage biopharmaceutical company BridgeBio Oncology Therapeutics, advised by Goodwin Procter LLP, on Friday announced plans to go public via a merger with special purpose acquisition company Helix Acquisition Corp. II, advised by White & Case LLP, in a deal that gives the combined business an implied pro forma enterprise value of $949 million.
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February 27, 2025
Don't Fault Sterilization Co. For What It Didn't Know, Jury Told
A sterilization company's expert told a Colorado state jury Thursday that the company can't be held responsible for not using pollution controls that didn't yet exist, arguing the company has always reasonably controlled emissions of a toxic sterilization chemical based on what was known at the time.
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February 27, 2025
Liquidia Challenge To UTC's Tyvaso Exclusivity Fails
United Therapeutics Corp. is entitled to exclusivity over its blockbuster lung disease treatment Tyvaso through May, and the U.S. Food and Drug Administration was right to hold off approving a competitor until then, a D.C. federal judge said Thursday.
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February 27, 2025
CooperSurgical Says Unique IVF Claims Require Separate Trials
Fertility company CooperSurgical Inc. is pushing back against the suggestion that four lawsuits accusing the company of negligently destroying embryos with its recalled culture media could be consolidated into one trial, saying the couples' varied location and unique IVF situations preclude joining them.
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February 27, 2025
CVS Freed From Hospital's Suit Over Drug Pricing Program
A Pennsylvania hospital's antitrust lawsuit claiming CVS forced healthcare providers participating in a federal discount drug program to go through the pharmacy chain's administrator has been tossed, with a federal judge ruling the hospital fell short in its allegations of anticompetitive behavior.
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February 27, 2025
$40M Deal OK'd For Suit Over Emergent Vax Flub
A Maryland federal judge approved a $40 million settlement between Emergent BioSolutions Inc. and a class of investors claiming that it misled them about its ability to meet the demands of two high-profile contracts to produce components of COVID-19 vaccines, leading the stock price to tumble after production deficiencies were discovered.
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February 27, 2025
OpenEvidence Says Rival's Attack Targeted Its AI 'Blueprint'
Medical artificial intelligence company OpenEvidence accused a Canadian competitor of launching cyberattacks on its system, executing dozens of attempts to trick the platform into handing over some of the technology's most valuable code, according to a Massachusetts federal lawsuit.
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February 27, 2025
Lead Testing Co. Director To Admit False Statements
A former quality assurance director for Magellan Diagnostics will plead guilty to making misleading statements to the government about a malfunction in a device that measures lead levels in blood, according to filings in Massachusetts federal court Thursday.
Expert Analysis
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Think Like A Lawyer: Note 3 Simple Types Of Legal Complexity
Cases can appear complex for several reasons — due to the number of issues, the volume of factual and evidentiary sources, and the sophistication of those sources — but the same basic technique can help lawyers tame their arguments into a simple and persuasive message, says Luke Andrews at Poole Huffman.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.
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9th Circ.'s High Bar May Limit Keyword Confusion TM Claims
A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.
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Trump Patent Policy May Be Headed In Unexpected Direction
While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.