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Life Sciences
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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.
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July 30, 2024
Litigator Rejoins Faegre Drinker From Medical Device Co.
Faegre Drinker Biddle & Reath LLP's newest lateral hire is stepping back into private practice after two years as associate general counsel for orthopedic implant company Exactech, and should be a familiar face around the firm's Indianapolis office.
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July 30, 2024
What Mass. Attys Will Be Watching In The 2nd Half Of 2024
Two potentially sweeping Massachusetts high court rulings and a long-awaited employment bill lingering in the State House are among the issues Bay State attorneys say they are monitoring closely heading into the latter half of 2024.
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July 29, 2024
Genzyme Says Sarepta's Dystrophy Gene Therapy Infringes IP
Sanofi's biotechnology company Genzyme Corp. hauled Sarepta Therapeutics into Delaware federal court on Friday, alleging Sarepta's gene therapy treatment for Duchenne muscular dystrophy infringed two of its patents for manufacturing certain therapeutics.
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July 29, 2024
Medical Co. Can't Get Alleged Fraudulent Arbitral Award Nixed
A New York federal judge has declined to vacate an arbitral award issued by a Swiss tribunal to a Singapore company in a dispute over a medical imaging joint venture, rejecting arguments that an agreement struck by the parties meant that a New York court could decide the issue.
Expert Analysis
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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3 Infringement Defenses To Consider 10 Years Post-Nautilus
In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.
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9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense
The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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Investors Can Aid In The Acceptance Of Psychedelic Medicine
Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.
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Class Actions At The Circuit Courts: May Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.
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Perspectives
Trauma-Informed Legal Approaches For Pro Bono Attorneys
As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.
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Series
Playing Music Makes Me A Better Lawyer
My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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How Attys Can Avoid Pitfalls When Withdrawing From A Case
The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.