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Life Sciences
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October 07, 2025
Fed. Circ. Focuses On Breadth Of UPenn IP In Eligibility Fight
The University of Pennsylvania and Regenxbio Inc. on Tuesday tried to persuade a Federal Circuit panel that their gene therapy patent should be revived, but at least one judge repeatedly said it's too broad.
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October 07, 2025
Alto Neuroscience Execs Sued Over Rosy Drug Claims
An Alto Neuroscience investor claims CEO Amit Etkin and other directors overstated the efficacy of the psychiatric biotech company's lead drug candidate for treating major depressive disorder, according to a lawsuit filed Tuesday in California federal court that alleges the company's stock price plummeted when the truth came out.
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October 07, 2025
Bausch And Teva Blocked Cheaper IBS Drug, Retailers Say
A slew of retailers on Tuesday accused Bausch Health Cos. Inc. and Teva Pharmaceuticals of working together to keep the generic version of an irritable bowel syndrome drug off the market until 2028, forcing the retailers and other purchasers of the drug to pay monopoly prices.
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October 07, 2025
9th Circ. Revives Ex-Service Members' Antimalarial Drug Suit
A Ninth Circuit panel on Tuesday breathed new life into a lawsuit by four former U.S. military service members who claim drugmakers Hoffman-La Roche Inc. and Genentech Inc. failed to warn them about permanent psychiatric side effects allegedly caused by the antimalarial drug mefloquine.
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October 07, 2025
Emisphere Shareholder Wants Out Of $32M Class Settlement
A major shareholder of Emisphere Technologies has objected to a proposed $32 million settlement in a suit challenging the $1.8 billion sale of the biotechnology company to Novo Nordisk A/S, arguing that the terms of the deal are too low and unfairly benefit Emisphere's controlling shareholder.
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October 07, 2025
Biogen Says Investors Can't Expand Alzheimer's Drug Suit
Biogen Inc. said a class of investors suing over alleged misleading statements in connection with the rollout of the company's Alzheimer's drug should not be allowed to needlessly delay resolution by filing an amended complaint expanding the class period and adding new legal theories and claims.
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October 07, 2025
Drug Tax Outdoes Biblical Punishment, 5th Circ. Judge Says
A Fifth Circuit panel pressed the U.S. Department of Health and Human Services to justify the basis for the Medicare drug pricing program's steep excise tax, asking Tuesday whether the government had ever levied a higher tax in the nation's history.
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October 07, 2025
DC Circ. Denies Biotech Co.'s Nasdaq Delisting Appeal
Chinese biotech Shineco Inc. has lost its bid to block its delisting from the Nasdaq in the D.C. Circuit, which didn't buy its argument the federal government's shutdown prevented the company from petitioning the U.S. Securities and Exchange Commission directly for relief.
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October 07, 2025
Biote Sues In Del. To Block Founder Indemnification Suit
Hormone replacement therapy venture biote Corp. and two affiliates on Tuesday asked the Delaware Court of Chancery for an injunction barring founder Dr. Gary S. Donovitz from pursuing a Texas suit cross-claim seeking indemnification for any liability predating an April 2024 settlement agreement, alleging that earlier deal terms prohibited such claims.
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October 07, 2025
AGs Rip DOJ Bid To Pause Planned Parenthood Funding Suit
The U.S. Department of Justice wants to use the ongoing government shutdown as a "shield" to stop a group of states from seeking an injunction against a halt to Medicaid funding for Planned Parenthood, the states told a Massachusetts federal judge in opposing a possible pause on their lawsuit.
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October 07, 2025
3rd Circ. Won't Rehear J&J Investor Cert. Appeal
The U.S. Court of Appeals for the Third Circuit declined Tuesday to reconsider backing a New Jersey federal judge's class certification order in a Johnson & Johnson investor action alleging the company artificially inflated its stock price by failing to disclose cancer risks.
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October 07, 2025
J&J Hit With $966M Verdict In Calif. Talc Lung Cancer Case
A California state jury has hit Johnson & Johnson with a $966 million verdict in favor of the estate of an 88-year-old woman who died of mesothelioma — the most recent judgment in a string of cases alleging that the company's talc products cause cancer.
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October 07, 2025
La. Challenges Mail-Order Access To Abortion Medication
The state of Louisiana on Monday sued federal regulators for expanding access to the abortion medication mifepristone under the Biden administration, alleging the removal of an in-person dispensing requirement allows the drug to be mailed illegally into anti-abortion states.
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October 07, 2025
Holland & Knight Adds Ex-EPA GC As Team Co-Chair In DC
Tampa, Florida-headquartered Holland & Knight LLP has hired as its new co-chair of the national environmental practice a former Hunton Andrews Kurth LLP partner who served as the U.S. Environmental Protection Agency's general counsel during Donald Trump's first term and as the top attorney in Florida's Department of Environmental Protection.
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October 07, 2025
Ex-Sprinter Gets 18 Mos. For Doping Scheme, COVID-19 Fraud
A Manhattan federal judge sentenced a former Olympic-level sprinter to 18 months in prison Tuesday, after he admitted to scheming to provide track stars with doping substances, and also to applying for fraudulent COVID-19 era business loans.
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October 06, 2025
Justices Pressed To Overturn TM Denial Of Dark Green Gloves
Surgical glove manufacturer PT Medisafe Technologies has asked the U.S. Supreme Court to wipe out a precedential Federal Circuit decision rejecting the company's attempt to claim a trademark for dark green surgical gloves, arguing that "thousands of such marks" have been registered.
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October 06, 2025
Fed. Circ. Examines $41.8M Seagen Cancer Drug Patent Case
With a $41.8 million infringement verdict against Daiichi Sankyo at stake, a Federal Circuit panel Monday grappled with whether a Seagen breast cancer treatment patent adequately described the claimed invention and would enable a skilled person to use it.
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October 06, 2025
Supplement Co. Sold Soviet-Era Drug As Sleep Aid, Suit Says
An addict in recovery hit Hi-Tech Pharmaceuticals Inc. with a proposed class action on Friday in Georgia federal court alleging that he bought a sleep aid sold as a dietary supplement that actually contains a dangerous, addictive sedative first developed by the Soviet Union in the 1960s.
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October 06, 2025
Fed. Circ. Vacates J&J's $20M Loss Over Patent Ownership
The Federal Circuit freed Johnson & Johnson subsidiary DePuy Synthes from a $20 million infringement verdict on Monday, saying the orthopedic surgeon suing it didn't own the asserted knee replacement patents.
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October 06, 2025
Gilead Gets HIV Generic Drugs Barred From Market Until 2036
Gilead Sciences Inc. said Monday it is keeping generic forms of its HIV treatment Biktarvy off of the market until 2036 following a series of settlements with competitors.
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October 06, 2025
2 Firms To Lead Humana Investor Suit Over Post-COVID Costs
Glancy Prongay & Murray LLP and The Rosen Law Firm will co-lead consolidated shareholder derivative claims against healthcare giant Humana Inc. alleging its brass made the company downplay the "pent-up demand" that pushed up patient utilization rates on the heels of the COVID-19 pandemic.
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October 06, 2025
Neuriva 'Brain Health' Products Don't Work, Class Suit Claims
A proposed class of buyers sued Reckitt Benckiser LLC in Illinois federal court on Monday, alleging its Neuriva line of products make promises about supporting brain health that they come nowhere near delivering.
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October 06, 2025
Law Profs Say CareDx False Ad Verdict Should Stand
Two law professors have urged the Third Circuit to grant medical testing company CareDx's request for another chance to argue why its $45 million false advertising verdict against a rival should be reinstated, saying a ruling nixing the verdict will disallow juries from using circumstantial evidence and encourage false advertisers to "try their luck."
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October 06, 2025
3rd Circ. Rejects Novo Nordisk's Medicare Pricing Challenge
The Third Circuit on Monday shot down another challenge to the Medicare drug price negotiation program, denying claims by pharmaceutical giant Novo Nordisk that Congress illegally delegated too much authority to the executive branch.
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October 06, 2025
Hagens Berman Fights Sanctions Over Thalidomide Suits
Plaintiffs firm Hagens Berman Sobol Shapiro LLP strenuously denied claims that it should be sanctioned for filing since-dropped product liability cases, responding to a judge's show cause order by saying it spent hundreds of hours researching the legal theories it pursued before filing the cases and devoted substantial time and resources to them.
Expert Analysis
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.