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Life Sciences
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September 15, 2025
Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK
Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.
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September 15, 2025
AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037
AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.
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September 15, 2025
Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants
More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.
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September 15, 2025
Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit
Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."
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September 15, 2025
Ex-PTAB Leader Reflects On USPTO After Leaving Agency
One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.
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September 15, 2025
Investor Says $16M Ouraring Fight Shouldn't Go To Finland
An early investor in the Oura health and fitness tracker is fighting Ouraring Inc.'s attempt to send his $16 million dispute to arbitration in Finland, saying there is no underlying agreement to arbitrate and his lawsuit should stay in California federal court.
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September 15, 2025
Stewart Says New Policies Seek Fairness For Patent Owners
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."
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September 15, 2025
Eli Lilly Fights $278MÂ Drug Royalties Ruling At 9th Circ.
Eli Lilly urged the Ninth Circuit at a hearing on Monday to reverse a finding that it owes an Arizona company $278 million from insulin-brands sales under their royalty agreement, arguing it is off the hook because Eli Lilly only used that company's technology in manufacturing, not in the final product.
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September 15, 2025
Corcept Can't Escape Teva's Mifepristone Antitrust Suit
Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.
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September 15, 2025
Exactech Gets OK For Ch. 11 Plan Ditching Sponsor Deal
A Delaware bankruptcy judge on Monday approved Exactech's Chapter 11 sale and liquidation plan that drops a previous deal with the joint implant maker's equity sponsor in favor of funding the pursuit of potential legal claims against the sponsor on behalf of creditors.
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September 15, 2025
Novartis, Monte Rosa Ink Up To $5.7B 'Molecular Glue' Deal
Novartis is placing a potential $5.7 billion bet on Monte Rosa Therapeutics, a clinical-stage biotech company, to develop new treatments for immune-related diseases, Monte Rosa said on Monday.Â
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September 12, 2025
Ex-Investor Relations Exec Gets 15 Months For Inside Trades
A former managing director for LifeSci Advisors LLC was sentenced to 15 months in prison on Friday for passing confidential information about several of the investor relations firm's clients to two friends who used it to make over $500,000 in illicit profits.
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September 12, 2025
AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says
AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.
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September 12, 2025
Stewart Issues New Slate Of Discretionary Denials
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart rejected 18 petitions for Patent Trial and Appeal Board review based on discretionary factors on Friday, but didn't introduce new elements to her analysis.
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September 12, 2025
23AndMe Inks $3.25M Data Breach Deal With Canadian Users
23andMe has asked a Missouri bankruptcy judge to approve a $3.25 million settlement reached with a class of 300,000 Canadian citizens whose information was compromised following a cybersecurity breach, touting the deal as an "excellent result" considering limited funds available and other issues implicated by the company's bankruptcy proceedings.
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September 12, 2025
Jury Awards Mallinckrodt $9.5M In Nitric Oxide Patent Suit
A Delaware federal jury awarded Mallinckrodt Pharmaceuticals almost $9.5 million on Friday, finding that French industrial gas company Airgas Healthcare infringed patents covering its inhaled nitric oxide treatment.
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September 12, 2025
Novartis Takes Entresto Bench Trial Loss To Fed. Circ.
Novartis urged the Federal Circuit on Friday to save it from a Delaware federal judge's holding that generic-drug maker MSN Pharmaceuticals did not infringe a patent covering the blockbuster cardiovascular drug Entresto.
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September 12, 2025
US Sprinter Gets 4-Year Doping Ban Despite Oxtail Defense
The international Court of Arbitration for Sport on Friday imposed a four-year suspension on American track and field star Erriyon Knighton, who earned medals in two World Championships and competed in the 2021 and 2024 Summer Olympics in the 200 meters, rejecting his explanation blaming the test result on tainted oxtails.
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September 12, 2025
Saudi Blockade Leads To $100M Award To Qatar Pharma Co.
A Qatari pharmaceutical distributor and its chairman were awarded nearly $100 million in arbitration against Saudi Arabia after its business in the country was left "in shambles" due to a 2017 anti-terrorism blockade, though annulment proceedings in England remain ongoing, according to a newly removed lawsuit.
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September 12, 2025
Boehringer Misused Forfeited Retirement Funds, Suit Says
Pharmaceutical giant Boehringer Ingelheim cost workers millions of dollars by using forfeited retirement plan funds to cover company contributions rather than administrative fees charged to participants, according to a proposed class action filed in Connecticut federal court.
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September 12, 2025
Ex-Conn. Assistant AG Faces DQ Bid In Price-Fixing Case
Drug companies accused of fixing prices for generics are seeking to disqualify former Connecticut Assistant Attorney General Joseph Nielsen and his law firm from representing insurers in a multidistrict litigation, arguing Nielsen had access to confidential information as a government attorney that he could unfairly use against them now.
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September 12, 2025
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen former Master Chef presenter Gregg Wallace sue the BBC, Elon Musk's xAI take legal action against a staff engineer, and fashion mogul Kevin-Gerald Stanford file a fresh claim against Lion Capital-owned Klotho and EY amid a long-running All Saints share acquisition dispute.
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September 11, 2025
States Push Conn. Court To Ban Generic Drug Price-Fixing
A court order is necessary to prevent pharmaceutical companies and their executives from illegally fixing the prices of generic drugs, a coalition of state enforcers have told a Connecticut federal judge, arguing there is a "reasonable expectation" that the allegedly anticompetitive behavior at the center of multidistrict litigation will happen again.
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September 11, 2025
9th Circ. Says News Article Doesn't Doom Biotronik FCA Suit
The Ninth Circuit revived a False Claims Act suit alleging that Biotronik orchestrated an illicit compensation scheme to boost the implantation of its cardiac devices in patients at Cedars-Sinai Medical Center in Los Angeles, saying the whistleblower's complaint presents new information that is not barred by fraud allegations disclosed in an earlier news article.
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September 11, 2025
Medicare Drug Pricing Plan Survives Novartis' 3rd Circ. Appeal
The Third Circuit ruled Thursday that the Centers for Medicare & Medicaid Services' ability to negotiate "maximum fair prices" with drugmakers doesn't violate their constitutional rights, rejecting an argument by Novartis Pharmaceuticals Corp. that the practice amounted to a raw deal for the pharmaceutical industry.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Fed. Circ. Rulings Refine Patent Claim Construction Standards
Four Federal Circuit patent decisions this year clarify several crucial principles governing patent claim construction, including the importance of prosecution history, and the need for error-free, precise language from claims drafters, say attorneys at Taft.
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How Value-Based Patent Fees May Shape IP Strategies
If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.
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Agentic AI Puts A New Twist On Attorney Ethics Obligations
As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.
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Using Reissue Applications To Strategically Improve Patents
Though reissue applications are an often-overlooked consideration in today's patent environment, they can offer powerful tools for correcting errors, strengthening patent protection, or adapting to evolving business and legal landscapes, says Curtis Powell at Wolf Greenfield.
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FDA Transparency Plans Raise Investor Disclosure Red Flags
The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.
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Series
Being A Professional Wrestler Makes Me A Better Lawyer
Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.
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Patent Claim Lessons From Fed. Circ.'s Teva Decision
The Federal Circuit's recent decision in Janssen v. Teva is an important precedent for parties drafting patent claims or litigating obviousness where the prior art has potentially overlapping ranges for a claimed element, and may be particularly instructive to patent applicants in the pharmaceutical field, say attorneys at Cooley.
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Series
Law School's Missed Lessons: Adapting To The Age Of AI
Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.
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Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning
A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.
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DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech
The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.
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Future-Proof Patent Law By Starting Talent Pipelines Early
Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.
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Demystifying The Civil Procedure Rules Amendment Process
Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.
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How USPTO Examiner Memo Informs Software Patent Drafting
A memorandum recently released by the U.S. Patent and Trademark Office provides useful clues as to how the USPTO and examining corps will evaluate claims in software-implemented inventions for subject matter eligibility going forward, says Michael Lew at Squire Patton.
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How 2nd Circ. Cannabis Ruling Upends NY Licensing
A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.
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Parenting Skills That Can Help Lawyers Thrive Professionally
As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.