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Life Sciences
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June 02, 2025
Judge Allows Obviousness Defense At Bladder Drug Retrial
A Delaware federal judge has released two makers of generic bladder drugs from a stipulation that barred them from arguing patents held by rival Astellas Pharma Inc. are invalid for obviousness, since two other generic-drug makers targeted in the consolidated litigation could make the same argument at a bench trial later this year.
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June 02, 2025
Monthly Merger Review Snapshot
The Federal Trade Commission finally dropped its long-pending challenge of Microsoft's purchase of video game developer Activision Blizzard, as enforcers pushed monopolization cases seeking to break up Google, Meta and Live Nation, while also pursuing several traditional merger cases. Here, Law360 looks at the major merger review developments from May.
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June 02, 2025
4 Mass. Rulings You May Have Missed In May
Massachusetts judges grappled with accusations of fraud in the sale of a struggling life sciences company and gave the benefit of the doubt to a vendor who allegedly sold the state gallons of ineffective hand sanitizer, among other notable rulings last month.
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June 02, 2025
Judge Denies UTC Bid To Block Liquidia's Lung Drug
A North Carolina federal judge has refused to temporarily block Liquidia Technologies Inc. from selling its own version of United Therapeutics Corp.'s blockbuster lung disease treatment Tyvaso.
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June 02, 2025
Allergan Entities Get Booted From Botox Patent Suit In Del.
A Delaware federal judge has dismissed a pair of Allergan units from a suit alleging two biotechnology companies infringed patents related to Botox products, finding one unit had not shown it was actually the exclusive licensee to the disputed patents, while another agreed to be dismissed.
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June 02, 2025
Foley & Lardner Opens In Nashville With 3 Holland & Knight Attys
Foley & Lardner LLP has chosen Nashville as the location for its 27th office worldwide, bringing on three attorneys who had been at Holland & Knight LLP to work on regulatory, tax and transactional matters, the firm announced Monday.
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June 02, 2025
J&J Again Seeks To Block Beasley Allen In NJ Talc Litigation
Johnson & Johnson has opposed a New Jersey talc claimant's motion for the pro hac vice admission of two attorneys from The Beasley Allen Law Firm, claiming the partners' conduct in its talc unit's bankruptcy proceedings warrants denial of the application.
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June 02, 2025
Defamation Litigation Roundup: Cheetos, NASCAR, OpenAI
In this month's review of ongoing defamation fights, Law360 looks back on developments in a man's case against Frito-Lay Inc. over what he called the company's defamatory statements disputing his role in the invention of a flavor of Cheetos.
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June 02, 2025
High Court Rejects Bard Patent Misuse Dispute
The U.S. Supreme Court on Monday said it won't consider the Ninth Circuit's decision to revive a $53 million breach of contract suit C.R. Bard Inc. filed against Atrium Medical Corp. over patent royalties and patent misuse.
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May 30, 2025
Pharma Co. Hid Cancer Study Method Problems, Investor Claims
Biotechnology company UroGen Pharma Ltd. and three current and former executives are facing a proposed investor class action in New Jersey federal court alleging the company failed to disclose methodology flaws affecting a study of its lead drug candidate that ultimately doomed its bid for U.S. Food and Drug Administration approval.
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May 30, 2025
$5.2M Generic Drug Price-Fixing MDL Deal Gets Final OK
Apotex Corp. will be paying $5.2 million to settle claims from a class of indirect purchasers alleging the drugmaker was working with other pharmaceutical companies to hike up the price of certain generic medications.
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May 30, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Saying that June's circuit court calendars include important arguments in all practice areas would be hyperbolic — but just slightly. That's because significant showdowns are imminent involving appellate procedure principles, "click-to-cancel" rules, government procurement protests, judiciary employment protections and litigation risk insurance — as well as President Donald Trump's felony convictions and extraordinary deportation measures.
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May 30, 2025
Crowdfunding, Reg A Deals Grow Slowly As SEC Weighs Ideas
Equity crowdfunding and expanded Regulation A offerings have grown slowly since going live over the past decade, according to new data, leaving open questions on whether regulators will ease rules to bolster these alternatives to traditional capital raising.
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May 30, 2025
TopCo Settles Suit Over Cough Syrup Billed As 'Non-Drowsy'
The parties in a lawsuit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup makes users sleepy told an Illinois federal judge that they've reached a binding settlement that would end the case.
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May 30, 2025
ITC Issues Import Block On Ascletis Liver Disease Drugs
The U.S. International Trade Commission has issued an order blocking a Hong Kong-listed drug developer from importing treatments for a type of liver disease for the next seven years.
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May 30, 2025
Generic-Drug Makers Near Exit From Depo-Provera MDL
Attorneys for the plaintiffs in a multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive Depo-Provera told a Florida federal judge that they are close to dismissing claims against three manufacturers of generic versions of the drug.
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May 30, 2025
DLA Piper Adds Healthcare Regulatory Atty In DC Office
DLA Piper strengthened its healthcare regulatory resources in Washington, D.C., with the recent addition of an attorney who previously served as acting general counsel for the U.S. Department of Health and Human Services.
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May 30, 2025
Former Pfizer Atty, Motley Rice Adviser Joins DiCello Levitt
A former Pfizer vice president and assistant general counsel, who last June entered into a consulting agreement with Motley Rice LLC, is joining DiCello Levitt as a partner as part of the firm's Washington, D.C., public client practice group, the firm recently announced.
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May 29, 2025
AstraZeneca Inks $51.4M Settlement In Pay-For-Delay Case
AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC have agreed to shell out a combined $51.4 million to put to rest allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic drug Seroquel XR, according to a filing Thursday in Delaware federal court.
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May 29, 2025
CMS Seeks Hospital Responses On Gender Dysphoria Care
The Centers for Medicare & Medicaid Services is asking hospitals to produce information on gender dysphoria care provided to children and adolescents, noting in an oversight letter that the U.S. government has "serious concerns" surrounding hormone therapy and other gender-affirming medical interventions.
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May 29, 2025
Monsanto-Funded Researcher Influenced Panel, Jury Hears
A Missouri jury hearing the latest trial over cancer claims related to Monsanto's glyphosate pesticides heard Thursday that a Monsanto-funded researcher was able to change the course of a prestigious international panel weighing the chemical's carcinogenicity.
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May 29, 2025
Express Scripts Says Arkansas Can't Ban PBM Pharmacies
Pharmacy benefits manager Express Scripts sued the state of Arkansas in federal court Thursday, alleging that the state's recently enacted law banning PBMs from owning pharmacies in the state violated the U.S. Constitution and ran afoul of federal law governing military employee benefits.
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May 29, 2025
Delaware Justices Asked To Review Corporate Law Rework
A biopharmaceutical company stockholder has sought direct certification of a derivative suit to Delaware's Supreme Court, asking for state constitutional review of legislation approved in March that limits avenues for challenges to some corporate acts.
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May 29, 2025
Judge Favors Vanda But Seeks Deal Over Drug Approval
A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.
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May 29, 2025
Ex-USPTO Solicitor Says He's Against Squires Nomination
A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.
Expert Analysis
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A Breakdown Of Trump's Order On Drug Pricing
The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.
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Cosmetic Co. Considerations As More States Target PFAS
In the first quarter of the year, seven states introduced or passed legislation focused on banning the sale of cosmetics that contain PFAS, making it necessary for businesses to adjust their product testing and supply chain practices, product formulations, marketing strategies, and more, say attorneys at Alston & Bird.
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Del. Bill Reflects Nat'l Tug-Of-War Between Cannabis, Alcohol
As Delaware's bill targeting hemp-derived THC beverages and ingestible products moves through the general assembly, it reads like a local regulatory fix — but in reality, it's a microcosm of a national power struggle playing out state-by-state across the cannabis frontier, says attorney Peter Murphy.
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$38M Law Firm Settlement Highlights 'Unworthy Client' Perils
A recent settlement of claims against law firm Eckert Seamans for allegedly abetting a Ponzi scheme underscores the continuing threat of clients who seek to exploit their lawyers in perpetrating fraud, and the critical importance of preemptive measures to avoid these clients, say attorneys at Lockton Companies.
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Maintaining Legal Compliance For GenAI In Life Sciences
As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.
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Trending At The PTAB: The Influence Of Litigation Arguments
Recent decisions from the Patent Trial and Appeal Board shed light on the varying extent to which the board considers patent owners' district court arguments, particularly with respect to the meaning of claim terms, say attorneys at Finnegan.
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Series
Teaching Business Law Makes Me A Better Lawyer
Teaching business law to college students has rekindled my sense of purpose as a lawyer — I am more mindful of the importance of the rule of law and the benefits of our common law system, which helps me maintain a clearer perspective on work, says David Feldman at Feldman Legal Advisors.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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Series
Law School's Missed Lessons: Mastering Discovery
The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.
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Maneuvering The Weeds Of Cannabis Vertical Integration
The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.
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Opinion
The IRS Shouldn't Go To War Over Harvard's Tax Exemption
If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.
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Series
Playing Guitar Makes Me A Better Lawyer
Being a lawyer not only requires logic and hard work, but also belief, emotion, situational awareness and lots of natural energy — playing guitar enhances all of these qualities, increasing my capacity to do my best work, says Kosta Stojilkovic at Wilkinson Stekloff.
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Crisis Management Lessons From The Parenting Playbook
The parenting skills we use to help our kids through challenges — like rehearsing for stressful situations, modeling confidence and taking time to reset our emotions — can also teach us the fundamentals of leading clients through a corporate crisis, say Deborah Solmor at the Wisconsin Alumni Research Foundation and Cara Peterman at Alston & Bird.
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Justices' Labcorp Questions Explore Class Cert. Tensions
At the recent oral argument before the U.S. Supreme Court in Laboratory Corporation of America Holdings v. Davis, the justices' questioning highlighted a fundamental tension between constitutional standing requirements, the procedural framework of Rule 23, and the practical challenges of managing large, diverse classes in complex litigation, say attorneys at Winston & Strawn.
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4 Legislative Proposals Reflect Growing Scrutiny Of Pharma IP
Bipartisan legislative momentum in Congress, including a recent package of bills targeting exclusivity strategies that delay generic and biosimilar competition, signals growing scrutiny of life sciences intellectual property strategies, so biologics companies and investors must pay attention to new strategic, compliance and litigation risks, says Olga Berson at Thompson Coburn.