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Life Sciences
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July 17, 2025
11th Circ. Says Ex-Quest Diagnostics Worker's FCA Suit Fails
The Eleventh Circuit declined to revive a former Quest Diagnostics Inc. compliance officer's False Claims Act suit against the lab testing company, ruling she had failed to allege a specific claim of medical billing fraud after some 15 years of litigation.
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July 17, 2025
Stanford Trims Roche IP Suit, But Others Face Most Claims
Stanford University was let out of all but one claim brought by subsidiaries of F. Hoffmann-La Roche AG over alleged trade secret theft, but a California federal judge allowed most claims to move forward against several Stanford professors and a startup they founded.
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July 17, 2025
Senators Float 'Patent Thicket' Bill To Limit Generic Litigation
A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.
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July 17, 2025
6 Cases For Patent Attys To Watch In The Second Half Of 2025
The Federal Circuit is considering major questions about when delays in prosecuting patents become bad faith and whether the acting U.S. Patent and Trademark Office director is legally allowed to apply new rules retroactively. Here's what you need to know about these cases and others that attorneys are keeping an eye on for the rest of the year.
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July 17, 2025
Ex-CEO Agrees To $27.5M Judgment In Medicare Fraud Case
A day before his trial was set to begin, the former CEO and owner of the now-defunct laboratory Premier Medical Inc. agreed to a $27.5 million consent judgment, acknowledging he was likely to be found liable in the suit brought against him by the federal government and three states.
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July 17, 2025
Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal
Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements. Â
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July 17, 2025
PE Firm Is Denied FDA Docs For Defense In Deal Challenge
An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.
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July 17, 2025
J&J Loses Bid To DQ Beasley Allen From Talc MDL Committee
A New Jersey federal judge on Thursday denied Johnson & Johnson's bid to remove the Beasley Allen Law Firm from the plaintiffs steering committee in the multidistrict talc litigation but said that changes would be made to the committee's structure.
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July 17, 2025
Iowa Church Says DEA Can't 'Pocket Veto' Drug Exemption
An Iowa church is asking the D.C. Circuit to force the Drug Enforcement Administration to rule on an application it filed more than six years ago for a religious exemption to use a psychedelic in its services, saying the DEA shouldn't be allowed to "pocket veto" the application and leave the church hanging.
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July 16, 2025
Pharmacy Benefit Managers Say Ohio Can't Recast Suit
The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.
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July 16, 2025
Gilgo Beach Killer Case Puts New DNA Science To The Test
The only physical evidence linking the Gilgo Beach serial killings to the defendant, Rex Heuermann, are five hairs that could only be analyzed via a newer technique known as whole genome sequencing, but as the court decides whether the science is jury ready, experts are divided.
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July 16, 2025
Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales
Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.
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July 16, 2025
Glucose Monitoring Co. LifeScan Hits Ch. 11 With $1.7B Debt
LifeScan Global Corp., a company that makes blood glucose monitoring devices, has filed for Chapter 11 protection in Texas bankruptcy court with $1.7 billion of debt and a plan supported by its private equity backer to trim more than 75% of debt by handing the business to existing lenders.
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July 16, 2025
Novartis Denied Bid To Block Generic Entresto In TM Feud
A New Jersey federal judge has rethought her initial decision blocking a Novartis competitor from potentially selling a generic version of a heart failure treatment drug, saying she got it wrong when she earlier analyzed a trade dress claim.
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July 16, 2025
CooperSurgical Wants Conn. Embryo Loss Claims Tossed
CooperSurgical Inc. should not have to face a Connecticut federal lawsuit over embryos lost to its recalled culture medium for in vitro fertilization, the company said in motions to dismiss or pause the litigation based in part on "significant briefing and discovery" in a first-filed case in California.
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July 15, 2025
GTCR Seeks Rival's Sales Data To Counter FTC Challenge
The private equity firm looking to buy medical device coating company Surmodics is seeking Salesforce data from another competitor in the space, saying the information is crucial to showing that the industry will still be competitive if its acquisition is cleared.
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July 15, 2025
Biohaven's Drug Prospects Were Overhyped, Suit Says
Biopharmaceutical company Biohaven Ltd. was hit with an investor suit claiming it overstated the odds that two of its product candidates would receive regulatory approval, hurting investors as it announced disappointing results.
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July 15, 2025
Trump Admin Seeks Win In Harvard $2B Funding Freeze Case
The Trump administration urged a Massachusetts federal judge Monday to grant it summary judgment in Harvard University's lawsuit challenging the government's effort to freeze $2.2 billion in funding, arguing the dispute is a contract fight that belongs in the Federal Claims Court and the allegations fail on the merits.
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July 15, 2025
Patent Fight Over Xtandi Erupts Anew Before RFK Jr.
A new dispute is playing out over the price of a prostate cancer drug that was developed at University of California, Los Angeles, and is being sold by Pfizer, with the federal government being pushed on the issue of using its authority to allow early entry of generics.
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July 15, 2025
Court Blocks Generic Selenium Products Amid Patent Suit
A New Jersey federal judge has temporarily blocked a group of generic-drug companies from selling versions of a selenium injection treatment covered by patents owned by American Regent Inc., which accused the group of patent infringement.
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July 15, 2025
The Biggest IP Agency Developments Of 2025: Midyear Report
The U.S. Patent and Trademark Office and the U.S. Copyright Office have not been spared from the Trump administration's shake-ups and changes across the federal government in the first half of the year.
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July 15, 2025
Split 4th Circ. Rejects GenBioPro Abortion Ban Challenge
A split Fourth Circuit panel on Tuesday rejected GenBioPro's challenge to a West Virginia law banning medication abortion with narrow exceptions, with the majority finding the ban does not conflict with federal regulators' statutory authority to impose safety requirements on drug manufacturers.
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July 15, 2025
9th Circ. Backs Nature's Way Loss In Supplements TM Suit
The Ninth Circuit on Tuesday upheld a lower court's finding that a Doctor's Best Inc. brand of supplements didn't infringe a trademark of competitor Nature's Way Products LLC because the Doctor's Best products were all sold outside the U.S.
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July 15, 2025
Abbott Brass Ignoring Call For Formula Plant Probe, Suit Says
An Abbot shareholder has launched a derivative lawsuit in Illiniois state court accusing the company's leaders of improperly sitting on her demand to investigate a baby formula shortage caused by safety and regulatory violations that she said executives and officers hid from the public.
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July 15, 2025
Fed. Circ. Temporarily Blocks MSN's Entresto Generic
The Federal Circuit gave Novartis Pharmaceuticals Corp. a temporary reprieve Tuesday from having to face generic competition for its top-selling drug, Entresto, after losing a bench trial in Delaware.
Expert Analysis
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Fed. Circ. Ruling Reaffirms Listing Elements Separately Is Key
The Federal Circuit's decision last month in Regeneron v. Mylan reaffirms a critical principle in patent law: When a claim lists elements separately, the clear implication is that they are distinct elements, say attorneys at Taft.
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State Extended Producer Responsibility Laws: Tips For Cos.
As states increasingly shift the onus of end-of-life product management from consumers and local governments to the businesses that produce, distribute or sell certain items, companies must track the changing landscape and evaluate the applicability of these new laws and regulations to their operations, say attorneys at Alston & Bird.
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Law Firm Executive Orders Create A Legal Ethics Minefield
Recent executive orders targeting BigLaw firms create ethical dilemmas — and raise the specter of civil or criminal liability — for the government attorneys tasked with implementing them and for the law firms that choose to make agreements with the administration, say attorneys at Buchalter.
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Firms Must Embrace Alternative Billing Models Or Fall Behind
As artificial intelligence tools eliminate inefficiencies and the Big Four accounting firms enter the legal market, law firms that pivot from the entrenched billable hour model to outcomes-based pricing will see a distinct competitive advantage, says attorney William Brewer.
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Key Issues To Watch As USPTO Changes Abound
As 2025 continues to unfold, changes at the U.S. Patent and Trademark Office — including new leadership, operational reforms, legislative initiatives and AI-related policies — have potential to influence proceedings, including efforts to prosecute patents and adversarial proceedings before the Patent Trial and Appeal Board, say attorneys at Morgan Lewis.
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Trending At The PTAB: A Pivot On Discretionary Denials
Following the U.S. Patent and Trademark Office's rescission of the 2022 Vidal memorandum and a reversion to the standards under Apple v. Fintiv, petitioners hoping to avoid discretionary denials should undertake holistic review of all Fintiv factors, rather than relying on certain fail-safe provisions, say attorneys at Finnegan.
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How Attorneys Can Master The Art Of On-Camera Presence
As attorneys are increasingly presented with on-camera opportunities, they can adapt their traditional legal skills for video contexts — such as virtual client meetings, marketing content or media interviews — by understanding the medium and making intentional adjustments, says Kerry Barrett.
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Patent Drafting Pointers From Fed. Circ. COVID Test Ruling
The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.
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Opinion
Congress Must Reform The PTAB To Protect Small Innovators
Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.
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Series
Baseball Fantasy Camp Makes Me A Better Lawyer
With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.
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Series
Adapting To Private Practice: From Fed. Prosecutor To BigLaw
Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.
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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.