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Life Sciences
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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.
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July 30, 2024
AIDS Org Sues Express Scripts For PBM Monopoly
The world's largest HIV/AIDS healthcare organization is joining the slew of litigants suing pharmacy benefit manager Express Scripts, claiming in a new complaint that the pharmacy giant has leveraged monopoly power in Louisiana to suppress competition among independent specialty pharmacies that focus on rare and complex medical conditions.
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July 30, 2024
Judge Wants Device Warning Answers From Mich. Justices
A Michigan federal judge ruled Tuesday that medical device manufacturer NuVasive Inc. must face a patient suit alleging its limb-lengthening device caused metal poisoning, while also asking the Michigan Supreme Court to break its silence on medical manufacturers' duty to warn patients directly.
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July 30, 2024
Chancery Rejects Forte-Camac Deal As 'Not Fair' To Class
A Delaware Chancery Court judge on Tuesday rejected a settlement between Forte Biosciences Inc. and Camac Partners LLC that would have ended the activist investor's class action over Forte's alleged board entrenchment, finding that the proposed deal gave Camac "unique and personal benefits" that weren't shared with the rest of the class.
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July 30, 2024
Psychedelics And The Law: A Midyear Review
A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.
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July 30, 2024
DOD Contractors Must Face Suit Over 'Made In U.S.A.' Label
A pair of whistleblowers who claim that tourniquets and other medical equipment sold to the U.S. Department of Defense was mislabeled as "made in U.S.A." can continue with most of their False Claims Act suit against two contractors, a Pennsylvania federal judge said.
Expert Analysis
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.