Try our Advanced Search for more refined results
Life Sciences
-
May 06, 2025
Trade Secrets Emerge As Path For Cos. To Protect AI Works
Classifying creations of artificial intelligence tools as trade secrets has become a viable alternative to copyrights and patents — a shift that is presenting businesses using AI with a range of strategies and risks they must consider to protect their innovations.
-
May 06, 2025
Trump Orders FDA To Speed Up Drug Plant Approvals
President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.
-
May 06, 2025
Gene-Editing Co. Synthego Hits Ch. 11 With Sights On A Sale
California-based biotechnology company Synthego Corp. filed for Chapter 11 in Delaware bankruptcy court, listing up to $500 million in debt and outlining a plan to sell its assets to its prepetition lender during the proceedings.
-
May 05, 2025
DC Circ. Has Doubts About Narcolepsy Drug Appeal
The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.
-
May 05, 2025
Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight
A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.
-
May 05, 2025
8th Circ. Backs Boehringer's Copyright Win Over Software Co.
The Eighth Circuit upheld a district court's conclusion that Boehringer Ingelheim's veterinary arm and other companies did not infringe the copyrights of software company InfoDeli, saying in an opinion Monday that some elements of the online platforms that InfoDeli built were not entitled to protection.
-
May 05, 2025
Regeneron, Amgen Open Drug 'Bundling' Trial In Del.
The founder and CEO of Regeneron Inc. told a federal jury in Delaware on Monday that a major pharmacy benefit insurer told him in mid-2020 his company was wasting its time in trying to keep a cholesterol-drug supply contract, with Amgen Inc. offering a better-priced but allegedly anticompetitive multidrug portfolio.
-
May 05, 2025
PTAB Says It's Bedtime For Sleep Apnea Patent Claims
Patent board judges have decided to wipe out all the claims in a patent covering a method to treat sleep apnea, which were challenged by a San Diego sleep apnea outfit that says those claims reflect "97 percent" of a patent case over sleep apnea machines in Delaware federal court.
-
May 05, 2025
Trump Admin Urges Dismissal Of States' Abortion Pill Suit
The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.
-
May 05, 2025
Pharma Co. Escapes Investor Liver Drug Trial Suit, For Now
Biopharmaceutical company Akero Therapeutics Inc. and its executives have escaped, for now, a proposed class action alleging they misled investors about the patient population in a clinical trial for Akero's liver disease treatment, with a California federal judge on Monday rejecting the suit's theory of motive for the defendants.
-
May 05, 2025
Rite Aid Hits Bankruptcy Less Than A Year After Previous Ch. 11
Drugstore chain Rite Aid Corp. reentered bankruptcy Monday less than a year after its earlier reorganization plan was approved, filing for Chapter 11 protection in New Jersey bankruptcy court with more than $1 billion in debt and plans for an asset sale.
-
May 05, 2025
Purdue Tells Justices 'Rigid' Fed. Circ. Rule Threatens Patents
Bankrupt OxyContin-maker Purdue Pharma LP wants the U.S. Supreme Court to revive its legal effort to use patent laws to block the release of a competing "crush-resistant" generic painkiller, challenging a Federal Circuit decision that Purdue calls too "rigid."
-
May 05, 2025
Exactech Committee Calls Foul On Ch. 11 Voting Packages
The official committee of unsecured creditors in Exactech Inc.'s Chapter 11 case told a Delaware bankruptcy judge that the company's solicitation packages sent to tort claimants violate court-approved procedures by requiring them to submit five separate ballots for their votes to be counted.
-
May 05, 2025
Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial
A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.
-
May 05, 2025
High Court Won't Hear Challenge To Miss. Ban On Pot Ads
The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.
-
May 02, 2025
Insulin Giants' Antitrust Victory On Shaky Ground At 2nd Circ.
A major legal triumph for manufacturers of wildly popular medications treating diabetes and obesity suddenly looked precarious Friday at the Second Circuit, where judges sounded open to reviving a proposed class action alleging a multibillion-dollar conspiracy in a controversial drug-discount program.
-
May 02, 2025
Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant
Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.
-
May 02, 2025
Plaintiffs Seek Redo Over Sterilization Co.'s Trial Tactics
Four women who claimed a Colorado sterilization company caused their cancers asked a state court to order a new trial, arguing the business won a favorable verdict with prejudicial evidence about law firm ads and by suggesting the women are not "real victims but pawns in a scheme orchestrated by their lawyers."
-
May 02, 2025
Tax Case Can Proceed Despite Late Name Change, Court Says
The owner of a mail-order medical equipment company can move forward with his lawsuit against the federal government seeking to deduct a $5 million settlement payment, even though he didn't technically add his name to the case until after the deadline, the Court of Federal Claims said.
-
May 02, 2025
Fed. Circ. Gives MSN Short Pause For Entresto Appeal
The Federal Circuit told a Delaware federal judge on Friday to hold off entering final judgment in litigation that would delay MSN Pharmaceuticals Inc. from launching a generic version of Novartis' blockbuster heart medication Entresto.
-
May 02, 2025
Ex-SCWorx CEO Seeks Sentencing Delay Over Restitution Row
The former chief executive of SCWorx Corp. who was convicted of securities fraud after publicizing a $670 million COVID-19 test kit contract that never materialized told a New Jersey federal court Friday that he's seeking a one-month delay in his sentencing, citing the government's statement that it would pursue more than $140 million in restitution.
-
May 02, 2025
CR Bard Owes $20M In Ga. Ethylene Oxide Cancer Trial
A Georgia jury awarded $20 million in compensatory damages on Friday to a man who said his cancer was caused by exposure to ethylene oxide from C.R. Bard's medical sterilization plant, sending the case to a second phase for punitive damages.
-
May 02, 2025
Faegre Drinker Lands Patent Team From Wilson Sonsini
Faegre Drinker Biddle & Reath LLP added a partner, an associate and two patent agents from Wilson Sonsini Goodrich & Rosati PC to bolster its intellectual property practice, the firm has announced.
-
May 02, 2025
Goodwin Adds Scientist IP Partner From Cooley On West Coast
A seasoned life sciences and intellectual property attorney with a doctorate in biochemistry, biophysics and molecular biology has joined Goodwin Procter LLP on the West Coast, the firm announced.
-
May 02, 2025
23andMe Says 1.3M Customers Have Asked To Delete Data
23andMe executives told a meeting of creditors Friday that more than 1.3 million customers have asked the DNA testing company to cancel their accounts and delete their genetic information since it entered Chapter 11.
Editor's Picks
-
Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
-
A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
-
Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
-
7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
-
Top 3 Litigation Finance Deal-Killers, And How To Avoid Them
Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.
-
5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape
In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.
-
How Attys Can Use A Therapy Model To Help Triggered Clients
Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.
-
3 Steps For In-House Counsel To Assess Litigation Claims
Before a potential economic downturn, in-house attorneys should investigate whether their company is sitting on hidden litigation claims that could unlock large recoveries to help the business withstand tough times, says Will Burgess at Hilgers Graben.
-
J&J's Failed 3rd Try Casts Doubt On Use Of 'Texas Two-Step'
A Texas bankruptcy court recently rejected Johnson & Johnson's third attempt to use Chapter 11 to resolve liabilities from allegations of injuries from using talcum powder, suggesting that the U.S. Supreme Court's limitations on nondebtor releases, from 2024's Purdue Pharma ruling, may prove difficult to evade, say attorneys at Cadwalader.
-
Series
Teaching College Students Makes Me A Better Lawyer
Serving as an adjunct college professor has taught me the importance of building rapport, communicating effectively, and persuading individuals to critically analyze the difference between what they think and what they know — principles that have helped to improve my practice of law, says Sheria Clarke at Nelson Mullins.
-
Why Attys Should Get Familiar With Quantum Computing
Quantum computing is projected to pose significant updates to current practices in cryptography, making the issue relevant to policymakers and the legal profession generally, particularly when it comes to data storage, privacy regulations and pharmaceutical industry market changes, say professors at the University of San Francisco.
-
Series
Adapting To Private Practice: From DOJ Enviro To Mid-Law
Practitioners leaving a longtime government role for private practice — as when I departed the U.S. Department of Justice’s environmental enforcement division — should prioritize finding a firm that shares their principles, values their experience and will invest in their transition, says John Cruden at Beveridge & Diamond.
-
Legal Ethics Considerations For Law Firm Pro Bono Deals
If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.
-
Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
-
Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
-
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.
-
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.
-
Perspectives
The Benefits Of Aligning States On Legal Paraprofessionals
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.