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Life Sciences
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May 14, 2025
J&J Unit's Catheter Policy Stopped Free-Riding, Jury Told
A Johnson & Johnson unit sales director took the stand Wednesday in Innovative Health's antitrust case against its medical technology unit Biosense Webster, defending Biosense's policy cutting off clinical cardiac mapping support to hospitals using third-party reprocessed catheters and explaining that the policy prevented competitors from free-riding on its investments in clinical support training.
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May 14, 2025
RJ Reynolds Can Keep Trial Win In Engle Case, Court Says
A Florida appeals court on Wednesday affirmed a verdict in favor of R.J. Reynolds in an Engle progeny suit over a longtime smoker's death, saying counsel's failure to use all their juror challenges invalidates an argument that a juror was unfairly selected.
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May 14, 2025
Integra Brass Face Investor Suit Over FDA Compliance Lapses
Executives and directors of medical device company Integra Lifesciences Inc. were hit with a derivative suit alleging they misled investors about the company's compliance with regulatory standards for over five years, causing share declines when information regarding Integra's violations emerged.
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May 14, 2025
Regeneron-Amgen Trial Goes To Jury With An Extra Day
Federal jurors started deliberating on a Regeneron Pharmaceuticals Inc. antitrust suit late Wednesday accusing Amgen Inc. of tripping up Regeneron's anti-cholesterol drug insurance eligibility by illegally bundling Amgen's competing version with rebates for two unrelated drugs, with potential triple damages in the balance.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.
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May 14, 2025
2nd Circ. Has Tough Questions On Nixing Medical Imaging Award
The Second Circuit appeared divided on Wednesday on whether parties to a medical imaging joint venture could agree to designate New York courts to decide whether to vacate an arbitral award issued in Switzerland under their contract without violating an underlying treaty.
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May 14, 2025
10th Circ. Chilly To Biotech's SEC Asset Freeze Challenge
A panel of Tenth Circuit judges seemed skeptical Wednesday that a lower court had abused its discretion in granting a freeze of a biotech firm's assets in a suit brought by the U.S. Securities and Exchange Commission accusing the company and its founders of misappropriating roughly $9 million.
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May 14, 2025
Harvard Researcher Charged With Smuggling Amid ICE Case
Federal prosecutors on Wednesday unsealed criminal smuggling charges against a Russian national and Harvard Medical School researcher who has been challenging her monthslong detention by U.S. Immigration and Customs Enforcement after she returned to the U.S. from Europe carrying frog embryos.
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May 14, 2025
Alnylam Halts Patent Row Over Pfizer, BioNTech COVID-19 Vax
Alnylam Pharmaceuticals has decided to end a district court patent case over the COVID-19 vaccine made by Pfizer and BioNTech, asking a Delaware federal judge Tuesday to rule that the companies do not infringe its mRNA patents, while potentially setting the stage for an appeal.
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May 14, 2025
Novo Nordisk, Septerna Ink Up To $2.2B Obesity Drug Deal
Denmark's Novo Nordisk said Wednesday it has signed a drug development deal worth up to $2.2 billion with U.S.-based Septerna, part of its continued push to expand treatments for obesity, Type 2 diabetes and related diseases.
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May 14, 2025
D'Oh! Kimberly-Clark Can't Keep Wage Suit In Federal Court
A Pennsylvania federal judge invoked "The Simpsons" as he granted a Kimberly-Clark employee's request to ship his unpaid overtime proposed class action back to state court, saying the paper goods company is trying to "embiggen" the amount in controversy beyond what's feasible.Â
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May 14, 2025
Eckert Seamans Enters NYC With 11 Hawkins Parnell Attys
Eckert Seamans Cherin & Mellott LLC said Wednesday that it has launched an office in New York City with the addition of an 11-attorney team from Hawkins Parnell & Young LLP, while scaling back its New Jersey presence.
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May 14, 2025
Biotech Firm Verax Tells Court Eviction Could End Company
Biotech company Verax Biomedical Inc. has said it faces the prospect of going out of business unless a Massachusetts judge agrees to block its landlord from proceeding with an eviction, at least through the end of its current lease.
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May 14, 2025
RFK Jr. Defends HHS Cuts, Pledges To 'Spend Smarter'
In his first appearance on Capitol Hill since his confirmation, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday characterized a massive reorganization and reductions in workforce as practical moves to optimize the sprawling agency.
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May 14, 2025
Biogen Sues Ex-Collaborator Over Rights To Drug Tech
Biogen said its partner on a since-shelved Alzheimer's drug is trying to claim rights to an unrelated novel therapeutic that the Massachusetts company recently shared with the Swiss partner under a confidentiality agreement, according to a lawsuit filed Tuesday.
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May 13, 2025
Asterisk Doesn't Save CVS In Sanitizer Row, 9th Circ. Told
An attorney for a man suing CVS Pharmacy urged the Ninth Circuit on Tuesday to revive his claims alleging the company misled consumers with a promise its hand sanitizer kills 99.99% of germs, arguing the asterisk on the front label does not clear the company of wrongdoing despite a recent ruling from the circuit that gives significance to that type of asterisk.Â
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May 13, 2025
PTAB Ramps Up Fintiv Denials After Withdrawal Of Memo
Weeks after the U.S. Patent and Trademark Office withdrew a memo that limited when patent challenges could be rejected based on parallel litigation, the Patent Trial and Appeal Board has denied dozens of petitions by citing upcoming trials, mostly in the Eastern District of Texas.
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May 13, 2025
Magistrate Judge Cuts Defendants In J&J Talc Unit Fraud Suit
A New Jersey magistrate judge on Tuesday dropped a collection of defendants from a class action brought by cancer patients alleging that Johnson & Johnson's maneuvers to settle thousands of tort claims through Chapter 11 involved fraud.
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May 13, 2025
Becton Dickinson Sues Baxter Over Infusion Pump Patents
Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.
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May 13, 2025
Regeneron-Amgen Drug Bundling Trial Heads Toward Jury
An economics expert called by Amgen Inc. told a Delaware federal jury Tuesday that none of the company's deals to bundle other discounted major medications with its cholesterol-reducing drug Repatha foreclosed market competition, a day before jurors begin deliberating on an antitrust suit targeting the practice.
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May 13, 2025
10x Genomics, Bruker Strike Deal After $31M Patent Verdict
Gene sequencing technology firm 10x Genomics and scientific instrument maker Bruker Corp. have reached a settlement in a patent infringement lawsuit that previously led biotechnology company NanoString to file for Chapter 11 bankruptcy relief.
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May 13, 2025
NIH Letters Ending Grants Lack Factual Support, Judge Says
A Massachusetts federal judge said Tuesday that a "blast" of hundreds of virtually identical letters in March canceling National Institutes of Health-funded research projects appeared to offer no factual basis, only unsupported assertions that the projects were unscientific or discriminatory.
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May 13, 2025
PBMs Get Bipartisan Bashing At Hearing On Drug Costs
Senators across party lines slammed pharmacy benefit managers on Tuesday, sometimes in coarse language, as they wrestled with how to reduce drug prices for patients while also preventing the closure of rural pharmacies.
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May 13, 2025
Cancer Centers Want Fed. Circ. To Rehear Antibody IP Fight
The Dana-Farber Cancer Institute and Memorial Sloan-Kettering Cancer Center say the full Federal Circuit should review a decision rejecting Xencor's application for an antibody patent, arguing that the decision wrongly created a new precedent that could be harmful to other patents.
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May 13, 2025
Former J&J, Moderna Exec Joins Goodwin Procter In Boston
Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.
Expert Analysis
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.