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Life Sciences
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August 01, 2024
AliveCor Asks 9th Circ. To Revive Apple Watch Antitrust Case
Medical monitoring startup AliveCor Inc. told the Ninth Circuit that Apple Inc. should not be immunized from antitrust claims over the removal of access to heart rate data on the Apple Watch because the change was intended to block competition and not improve the device.
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August 01, 2024
Chancery Denies Ex-InterMune CEO $6M Legal Fee Right
Delaware's Chancery Court rejected on Thursday a bid by former InterMune CEO W. Scott Harkonen to escape demands to repay nearly $6 million in legal fees covered by biotech venture InterMune Inc. and insurers during his unsuccessful defense against a 2009 wire fraud conviction, denying all claims for legal fee indemnification.
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August 01, 2024
JPML Won't Form MDL Of 35 Acne Product Benzene Suits
The Judicial Panel on Multidistrict Litigation on Thursday declined to consolidate 35 suits alleging Johnson & Johnson Consumer Inc., CVS Pharmacy Inc., Target Corp. and others sold acne products that could break down into the carcinogen benzene, saying they don't have enough in common to warrant an MDL.
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August 01, 2024
Former Stimlabs Exec Doesn't Have To Hand Over Devices
A Georgia federal judge on Thursday blocked a biomedical technology company's bid to seize the digital devices of a former executive accused of downloading thousands of internal files containing sensitive product information in the days and weeks leading up to her ouster from the company this year.
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August 01, 2024
Novo Nordisk Loses Challenge To Medicare Drug Price Talks
Another challenge to a Medicare drug price negotiation program has failed after a New Jersey federal judge ruled once again that the program is voluntary and rejected claims that it violates the constitutional rights of pharmaceutical giant Novo Nordisk.
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August 01, 2024
AbbVie Wants Mass. Biotech Firm To Pay Up For Drug Work
AbbVie Inc. says it's still owed nearly $1 million by a Massachusetts biopharmaceutical company for materials and work it provided as the smaller firm prepared to seek U.S. Food and Drug Administration approval of a potential cancer treatment, according to a lawsuit filed in state court.
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August 01, 2024
MoFo Adds 3-Atty IP Litigation Team In NY From Desmarais
A trio of life sciences intellectual property litigation attorneys from Desmarais LLP have joined Morrison Foerster LLP in New York.
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August 01, 2024
Medtronic Still Faces Chancery Claim In Fortis' InPen Suit
Delaware's Court of Chancery has trimmed a suit that stockholders' representative Fortis Advisors LLC filed against Medtronic Minimed Inc. after its 2020 acquisition of insulin pen manufacturer Companion Medical Inc., tossing claims related to a missed milestone but keeping one about a withheld escrow payment.
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August 01, 2024
R1 RCM Going Private In $8.9B Deal Steered By 4 Firms
TowerBrook Capital Partners and Clayton Dubilier & Rice have agreed to take R1 RCM Inc. private in a deal that values the healthcare-focused tech provider at about $8.9 billion, the company said in a Thursday announcement.
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August 01, 2024
DLA Piper Hires Longtime Williams & Jensen Partner In DC
DLA Piper has hired a former Williams & Jensen PLLC attorney who spent 24 years there working on healthcare public policy issues and representing biopharmaceutical companies and various insurance providers, the firm has announced.
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August 01, 2024
Biotech Co. Biedermann Motech Hits Ch. 11 With $34M Debt
Biedermann Motech, a maker of implants for spinal and extremity surgery, filed for Chapter 11 protection in Delaware bankruptcy court with $34 million in debt.
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August 01, 2024
Hogan Lovells Recruits Two From Foley Hoag To Health Team
Hogan Lovells said Thursday it has hired two Foley Hoag partners experienced in complex regulatory, legislative and legal policy affecting medical technology and biopharmaceutical companies to join the firm's health practice.
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July 31, 2024
Del. Justices Reject New Earnout Claim In $300M Deal Appeal
Delaware's Supreme Court on Wednesday upheld dismissal of a post-sale stockholder representative suit challenging denial of accelerated, post-closing "earnout" payments after the merger of Edwards Lifesciences and Valtech Cardio Ltd., rejecting a stockholder bid to introduce post-appeal developments.
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July 31, 2024
2nd Circ. Paves Way For Conn. Zantac Bellwether, Attys Say
A recent decision by the Second Circuit that upheld the remand to state court of product liability lawsuits alleging that generic versions of Zantac may have caused cancer has paved the way for more than 850 additional plaintiffs to move forward in state court, according to a recent filing.
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July 31, 2024
AI Prior Art Is Either Nothing New Or A Red Flag, USPTO Told
Technology companies, drugmakers and various industry organizations have represented to the U.S. Patent and Trademark Office that they're torn on how artificial intelligence should be used when determining whether something is patentable over prior art.
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July 31, 2024
Del. Judge Clears Lupin's Generic Kidney Disease Drug
A ruling out of a Delaware federal court on Wednesday prevented a major Japanese pharmaceutical company from using patent law to block an Indian rival's efforts to market a generic version of a blockbuster kidney disease treatment.
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July 31, 2024
Novartis Says FDA Wrongly OK'd Generic Heart Drug
Pharmaceutical company Novartis alleges the U.S. Food and Drug Administration unlawfully approved a generic version of the drugmaker's heart failure medication Entresto in a new lawsuit in D.C. federal court.
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July 31, 2024
Inhaler Patents 'Must Be' In Orange Book, Teva Tells Fed. Circ.
Teva Pharmaceuticals USA Inc. urged the Federal Circuit to upend a lower court decision ejecting inhaler device patents from an important government database, arguing that the delisting, won by Amneal Pharmaceuticals Inc. in an infringement lawsuit, ignores broad protection envisioned under intellectual property law.
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July 31, 2024
1st Circ. Mostly Backs $5M Award In Biotech Recruiting Spat
The First Circuit left intact the vast majority of a $5 million post-trial award against a life sciences recruiting firm found to have misappropriated trade secrets from a rival involving placements at Takeda and Vedanta Biosciences.
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July 31, 2024
5 Trials To Watch In The 2nd Half Of 2024
Upcoming high-profile trials over star lawyer Tom Girardi's alleged fraud, Hunter Biden's taxes and Washington state's "patent troll" law are among the cases to watch in the latter half of the year.
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July 31, 2024
AIG Units Off Hook In Defending McKesson Opioid Suits
Two AIG insurers have no duty to defend McKesson Corp. over claims it intentionally over-distributed opioids, a California federal court ruled, saying the three underlying suits do not allege a potentially covered occurrence under policies issued between 1999 and 2004.
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July 30, 2024
Life Sciences Cases To Watch 2024: A Midyear Report
From the U.S. Supreme Court down to the federal district courts, judges and lawmakers are grappling with questions crucial to the life sciences industry. Here are some of the biggest life sciences cases to watch in the second half of 2024.
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July 30, 2024
2024 Product Liability Areas To Watch
The growing movement in state laws about whether consumers can repair their own products is catching attorneys' eyes, as well as recent changes in rules that govern multidistrict litigation, which often involve pharmaceuticals and medical devices.
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July 30, 2024
Cook Medical Vein Filter Claims Came Too Late, 7th Circ. Says
The Seventh Circuit on Tuesday upheld Cook Medical LLC's win in a woman's lawsuit claiming the company's inferior vena cava filter caused her to develop abdominal pain and that the device fractured when it was removed, saying the suit was filed after the statute of limitations had expired.
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July 30, 2024
DC Circ. Finds NIH's Comment Restrictions Unconstitutional
The National Institutes of Health violated the First Amendment when the agency used keyword filters to hide comments from animal rights activists on its official Facebook and Instagram pages, a D.C. Circuit panel ruled Tuesday.
Expert Analysis
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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Patent Lessons From 4 Federal Circuit Reversals In April
Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.