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Life Sciences
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May 08, 2025
Ruling Over Expired Bard Patent Causes Split, Justices Told
Atrium Medical has asked the U.S. Supreme Court to review a Ninth Circuit ruling that revived a $53 million breach of contract lawsuit against it by C.R. Bard, saying the appeals court "takes a dramatically different approach" from other circuits on royalty payments.
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May 08, 2025
Colo. Court Sets Next Toxic Tort Bellwether For January
Two more plaintiffs suing a Colorado medical sterilization company will try their claims that emissions from the company's facility caused their cancer, during a second bellwether trial to begin in January 2026, according to a Colorado state judge's order Thursday.
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May 08, 2025
Counterfeit Goods Hit $467B Globally In 2021, Report Says
Counterfeit and pirated goods accounted for $467 billion in global trade in 2021, reflecting a slight increase from pre-pandemic levels, according to a report from the Organization for Economic Cooperation and Development and the European Union Intellectual Property Office.
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May 08, 2025
Court Upholds CMA's £99M Thyroid Drug Price Fines
A U.K. appellate court has not only upheld a finding that drug company Advanz excessively inflated the price of its thyroid tablets for the National Health Service but also reimposed fines against the company's former owner that a lower tribunal had cut by almost a third.
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May 08, 2025
Bayer Says Wash. Law, FDA Preempt IUD Defect Allegations
Bayer Corp. is asking a Washington federal court to throw out a woman's suit seeking to hold the company liable after one of its Mirena-brand IUDs failed and migrated to her abdominal cavity, asserting that Washington law preempts her claims and that the company had already provided warnings about the risks of using it.
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May 08, 2025
Albertsons Says Counties Have 'Paradoxical Status' In MDL
A group of pharmacies led by Albertsons Cos. Inc. have told the Texas Supreme Court that two counties can't assert claims against them in the state's opioid multidistrict litigation while simultaneously denying they qualify as claimants.
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May 08, 2025
Fed. Circ. Weighs If Expert's Testimony Justifies Spine IP Loss
A Federal Circuit panel on Thursday considered how much an expert strayed from a lower court's claim construction in an inventor's patent infringement suit against DePuy Synthes, with one judge questioning if it was merely effective cross-examination that tripped the expert up, and not much more.
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May 08, 2025
Hikma Cuts $50M Deal To End Antitrust Claims In Xyrem MDL
A certified class of Xyrem buyers in 36 states have asked a California federal judge to preliminarily approve Hikma Pharmaceuticals PLC's $50 million deal to resolve antitrust claims accusing Hikma of colluding with rival Jazz Pharmaceuticals to block generic rivals from competing with Jazz's narcolepsy drug.
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May 08, 2025
3rd Circ. Rejects Challenge To Medicare Drug Price Program
The Third Circuit on Thursday rejected AstraZeneca's challenge to the Medicare drug price negotiation program, ruling that the pharmaceutical giant was unable to show how it is injured by the program's guidance or how it violates its due process rights.
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May 08, 2025
Judge Asks DOJ To Define DEI In Health Grant Case
A Massachusetts federal judge on Thursday ordered U.S. Department of Justice lawyers to provide the Trump administration's definitions of diversity, equity and inclusion, saying he needs to know so he can consider whether that is a valid basis for pausing federal health research grants.
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May 08, 2025
Biotech Tells Chancery Drug Co. Abused Merger Prospects
Biotech venture Renovaro Inc. sued cancer-focused, artificial intelligence-assisted drug developer Predictive Oncology Inc. in Delaware's Court of Chancery on Thursday, accusing Predictive of walking away from a merger agreement after its standalone prospects improved upon announcement of the deal.
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May 08, 2025
Elizabeth Holmes Loses Bid For Full 9th Circ. Rehearing
The Ninth Circuit said Thursday it will not reconsider a panel decision refusing to throw out the conviction and 11-year prison sentence of Theranos Inc. founder Elizabeth Holmes.
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May 08, 2025
Ala. Legislature OKs TCJA Research Expense Decoupling
Alabama would decouple from the Tax Cuts and Jobs Act by allowing research expenses to be deducted from a taxpayer's income under a bill sent to the governor.
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May 08, 2025
Biotech Co. Accelerate Diagnostics Hits Ch. 11 With Sale Plan
Medical technology company Accelerate Diagnostics Inc. filed for Chapter 11 protection in Delaware bankruptcy court Thursday with $90.2 million of debt and a plan to sell the business to lender Indaba Capital Management for $36.9 million.
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May 07, 2025
J&J Unit's Catheter Tying Policy Hurt Rival, Antitrust Jury Told
Innovative Health's CEO told a California federal jury considering its antitrust claims Wednesday that Johnson & Johnson unit Biosense Webster enforced a policy to cut off support to hospitals that didn't use its catheters after Innovative received FDA approval to reprocess Biosense's electrophysiology catheters, devastating Innovative's business.
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May 07, 2025
FDA Gets Win In Eli Lilly Weight Loss Drug Shortage Fight
A Texas federal judge on Wednesday refused to reverse a U.S. Food and Drug Administration decision to remove Eli Lilly & Co.'s popular weight loss drug from a national shortage list, denying a request from pharmacies that produce copycat doses of the drug and entering judgment in favor of the FDA.
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May 07, 2025
Investors Fight J&J, Kenvue Bid To Nix IPO Fraud Suit
A New Jersey federal judge shouldn't reconsider his decision to sustain IPO fraud claims against pharmaceutical giant Johnson & Johnson and a former subsidiary, investors suing the companies said Wednesday by arguing that the judge was right to find that the companies should have disclosed a "serious challenge" to the effectiveness of a common medication ingredient in public filings.
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May 07, 2025
Fertility Co. Accused Of Selling Bogus Tests Wasting Embryos
Women who sought fertility treatment filed a proposed class action against CCRM Fertility in Colorado federal court Wednesday, alleging the fertility clinic chain "aggressively" marketed its preimplantation genetic testing to thousands of vulnerable patients despite knowing the test is unreliable and wasted preciously limited, viable embryos.
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May 07, 2025
Patent Examiners Tell GAO Quantity Beats Quality
Patent examiners at the U.S. Patent and Trademark Office feel like they're pressured to sacrifice patent quality in the interest of getting more patents out the door, the Government Accountability Office said in a report released Wednesday exploring what it called "persistent examination and quality challenges" at the agency.
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May 07, 2025
Fed. Circ. Clears Way For Sun Pharma Alopecia Drug
Incyte Corp. can't challenge a board ruling preserving claims in a Sun Pharmaceutical Industries patent covering an alopecia areata drug, the Federal Circuit said Wednesday, finding the company's plans to sell its own product weren't firm enough to give it standing.
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May 07, 2025
Rite Aid Cleared For Quick Ch. 11 Sale Plans
A New Jersey bankruptcy judge on Wednesday approved retail pharmacy chain Rite Aid's plans to host a Chapter 11 auction next week for prescription files, drug inventory and other pharmacy assets during its second bankruptcy.
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May 07, 2025
$525M Nuke Services Deal Faces Canada Competition Probe
Canada's competition regulator said Wednesday it has obtained court orders to get information from several companies as part of its investigation of nuclear technology firm BWX Technologies Inc.'s proposed $525 million acquisition of nuclear engineering company Kinetrics Inc.
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May 07, 2025
Insulet Pursues EOFlow's Finances After $60M Ruling
A Massachusetts federal judge has ordered a Korean wearable insulin patch maker to respond to discovery requests as Insulet Corp. looks to collect a nearly $60 million trade secrets judgment, including information concerning an ongoing arbitration with Medtronic PLC stemming from a nixed acquisition deal.
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May 07, 2025
Shionogi To Acquire Torii Pharma Through $1.1B Tender Offer
Japanese pharmaceutical company Shionogi & Co. plans to acquire Torii Pharmaceutical Co. through a tender offer that values the Tokyo-listed drugmaker at approximately 156 billion Japanese yen (nearly $1.1 billion), Shionogi said in a Wednesday announcement.
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May 07, 2025
Walgreens Wants 'Far-Fetched' Shareholder Suit Tossed
Walgreens contends that a proposed class action alleging it inflated share prices by concealing the lack of viability of its pharmacy division and primary clinic investment must be dismissed because it lacks factual allegations to back its claim that Walgreens made any misstatements to shareholders about its financial outlook, let alone with fraudulent intent.
Expert Analysis
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.