Try our Advanced Search for more refined results
Life Sciences
-
June 13, 2024
Teva Wins Pause Of Order Ousting Patents From Orange Book
A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.
-
June 13, 2024
CVS Dodges Discovery Audit In Generic Drug Collusion Suit
A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.
-
June 13, 2024
GOP Lawmakers Want China Patent Data Amid Tech Pact Talks
Republican lawmakers are urging the U.S. Commerce Department to provide a full accounting of whether the U.S. government has funded research that resulted in Chinese patents, arguing they need the data to assess potential national security risks as the Biden administration negotiates a new science and technology agreement with China.
-
June 13, 2024
Vero Biotech Tried To 'String Along' Safety Monitor, Suit Says
Georgia-based medical device maker Vero Biotech LLC reneged on a payment plan with a consulting firm hired to monitor its products, according to a lawsuit filed in Massachusetts state court on Wednesday.
-
June 13, 2024
EU Makes First Ever Formal Pharma Price-Fixing Complaint
European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.
-
June 13, 2024
JP Morgan Closes Debut Life Sciences Fund At Over $500M
J.P. Morgan Private Capital on Thursday announced that it clinched its inaugural life sciences private capital offering with more than $500 million in tow.
-
June 13, 2024
Abortion Medication Case Ends 'With A Whimper' At High Court
A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.
-
June 12, 2024
Tillis Told Drug Patents Are Too Complex For Easy Answers
When and how generic drugs enter the marketplace varies widely among different drugs and isn't necessarily related to how many patents are covering those drugs, the U.S. Patent and Trademark Office said Wednesday in a report requested by a top member of the U.S. Senate's Intellectual Property Subcommittee.
-
June 12, 2024
Lies At Heart Of Fraud Case Over COVID Test Kits, Jurors Told
The retrial of a securities fraud case over a COVID test kit deal that never materialized will center on lies, according to opening statements delivered in New Jersey federal court Wednesday.
-
June 12, 2024
2nd Circ. Backs Brokerage In Suit Over Biotech's Failed IPO
The Second Circuit on Wednesday declined to reinstate a Texas company's suit against an investment brokerage that advised biotech Inpellis on an initial public offering that failed and sent the company to file Chapter 7, ruling a lower court rightly found a global settlement eclipsed the need for a jury trial.
-
June 12, 2024
Lipitor Buyers Get Final OK For $93M Deal In Antitrust Fight
A New Jersey federal judge gave final approval Wednesday to a $93 million settlement between a class of buyers of Lipitor and Pfizer, resolving their claims in sprawling antitrust litigation that Pfizer conspired with a drug manufacturer to delay the release of a cheaper generic version of Lipitor and monopolize the market.
-
June 12, 2024
SPAC Dealmakers Expect Modest Pickup After Market Bottom
Market professionals expect a slow pickup in deals involving special-purpose acquisition companies starting in the second half of 2024, predicting on Wednesday that a leaner market will emerge following the recent crash and imposition of tighter regulations.
-
June 12, 2024
Directors Of Defunct Med Tech SPAC Seek Toss Of Del. Suit
Directors of a special purpose acquisition company that merged with now-defunct medical technology company Better Therapeutics Inc. urged Delaware's Court of Chancery on Wednesday to toss a shareholder's suit about the $15 million de-SPAC merger, saying it wasn't like other problematic SPAC deals.
-
June 12, 2024
Forte Biosciences Reaches $2M Deal To End Chancery Suit
Clinical-stage biopharmaceutical company Forte Biosciences has reached a multipart, $2 million concession-plus-cash settlement in Delaware's Court of Chancery with a private investment fund that ran a board proxy contest after its calls to liquidate the business were met with poison pill pushback.
-
June 12, 2024
'Natural' Toothpaste Brand Loaded With PFAS, Moms Say
Natural toothpaste company RiseWell LLC falsely advertised its kids toothpaste as "natural" and "safe to swallow," two mothers alleged Tuesday in a proposed class action, saying a U.S. Department of Defense-certified laboratory test found 750 times more "forever chemicals" in the toothpaste than researchers found in heavily tainted kale.
-
June 12, 2024
32 AGs Urge Justices Take Up Okla. PBM Law Fight
Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.
-
June 11, 2024
Martin Shkreli Told To Hand Over Wu-Tang Album
A New York federal judge ordered Martin Shkreli on Tuesday to hand over any copies he might have of the Wu-Tang Clan's album he once bought before it was sold off by the federal government to settle a $7.3 million tab from Shkreli's criminal judgment on securities fraud.
-
June 11, 2024
Pharmacy Co. Optio Gets Interim OK For $10M DIP Package
Illinois-based specialty pharmacy chain Optio received interim approval at a first-day hearing Tuesday in Delaware bankruptcy court to access a $10 million in new money debtor-in-possession financing to fund its Chapter 11.
-
June 11, 2024
Fed. Circ. Reinstates Parts Of Blood Analyzer Secrets Verdict
The Federal Circuit decided Tuesday that a Rhode Island jury was right to find that an Italian company's blood analyzer computer code was stolen by a U.S. rival, but another jury will have to determine any damages.
-
June 11, 2024
9th Circ. Judge On Theranos Appeal: 'Good Story' For Holmes
Two Ninth Circuit judges on a three-judge panel expressed concerns Tuesday that the district judge presiding over convicted former Theranos CEO Elizabeth Holmes' criminal trial erred by allowing a layperson witness to offer expert testimony at trial, with one judge saying, "There's a pretty good story here for Ms. Holmes."
-
June 11, 2024
AI No Scarier Than Nail Guns Or Microscopes, Kappos Says
Former U.S. Patent and Trademark Office Director David Kappos cautioned attorneys Tuesday to "keep ourselves grounded" about the use of artificial intelligence in intellectual property, saying it's just a tool like a microscope or nail gun, rather than something justifying "panic."
-
June 11, 2024
NJ Supreme Court Rejects Bid For Roundup Mass Tort
The New Jersey Supreme Court has rejected a request for litigation against Monsanto Co. and Bayer AG to be designated as multicounty litigation because there are too few cases, according to a notice to the bar published Monday.
-
June 11, 2024
Slow IPO Recovery Expected To Accelerate In 2025
More companies are preparing initial public offerings even as the pace of new listings has been slower than anticipated, experts said Tuesday, signaling that an IPO recovery is likely to accelerate next year after investors sort out November election results.
-
June 11, 2024
10 Firms Seek $13M Fee For Effexor Antitrust Deal
Ten law firms asked a New Jersey federal judge on Monday to award $13 million in counsel fees and an additional $2.1 million in costs for representing direct buyers in a $39 million settlement with Pfizer Inc. unit Wyeth over an alleged scheme to delay generic competition for the antidepressant drug Effexor XR.
-
June 11, 2024
WilmerHale Lands Latham Atty To Help Lead Life Sciences
WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.
Expert Analysis
-
Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
-
E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
-
What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
-
5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
-
Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
-
Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
-
Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
-
Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
-
Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
-
Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
-
What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
-
Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
-
Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
-
The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
-
Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.