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Life Sciences
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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.
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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.Â
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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 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 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.
Expert Analysis
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
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Keys To Handling Digital Investigations In Pharma IP Litigation
In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
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Series
Power To The Paralegals: The Value Of Unified State Licensing
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.
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Defense Strategies After Justices' Personal Injury RICO Ruling
In Medical Marijuana v. Horn, the U.S. Supreme Court recently held that the Racketeer Influenced and Corrupt Organizations Act can be invoked by some plaintiffs with claims arising from personal injuries — but defense counsel can use the limitations on civil RICO claims to seek early dismissal in such cases, say attorneys at Debevoise.
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Series
Law School's Missed Lessons: Preparing For Corporate Work
Law school often doesn't cover the business strategy, financial fluency and negotiation skills needed for a successful corporate or transactional law practice, but there are practical ways to gain relevant experience and achieve the mindset shifts critical to a thriving career in this space, says Dakota Forsyth at Olshan Frome.