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Life Sciences
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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.
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July 29, 2024
NIST Lays Out 200+ Ways To Tackle Generative AI Risks
The National Institute of Standards and Technology has recommended hundreds of actions that can be taken to address issues of data privacy, intellectual property, environmental impact and more raised by generative artificial intelligence.
Expert Analysis
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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.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.