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Life Sciences
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July 11, 2024
Senate Clears Patent Bill Aiming To Lower Drug Prices
The U.S. Senate on Thursday passed a bill that would pump the brakes on the ability of pharmaceutical companies to steer patients away from generic versions of a drug, a measure that lawmakers said would lower drug costs.
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July 11, 2024
Pfizer's $50M EpiPen Deal Gets Final OK In Antitrust Suit
Pfizer is officially out of a lawsuit accusing it of working with Mylan Pharmaceuticals to inflate the price of the popular auto-injecting emergency allergy medication EpiPen after a Kansas federal judge gave the $50 million settlement his final seal of approval.
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July 11, 2024
IP Forecast: Napa Winery's Ex-Atty Wants Another Trial
A Texas lawyer plans to tell an appeals court why he should receive another trial in a trademark case from a Napa Valley winery, a former client that he claims sold off a "wildly successful California cult wine" out from under him.
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July 11, 2024
Judge Won't Dismiss Cannabis Extraction IP Dispute
Subsidiaries of Canadian cannabis company Halo Collective Inc. can't escape patent infringement claims by a Colorado-based firm specializing in developing techniques for extracting hemp oil, a California federal judge has ruled, rejecting a slew of motions seeking summary judgment.
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July 11, 2024
DC Judge Questions Pharma Co.'s Generic Harm In FDA Spat
A D.C. federal judge on Thursday seemed skeptical about Vanda Pharmaceuticals' claims that waiting for the U.S. Food and Drug Administration to review its challenge to the agency's approval of a generic challenger to its sleep medication would seriously jeopardize the company's future.
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July 11, 2024
Fed. Circ. Pauses Ouster Of Teva Patents From Orange Book
Teva can keep challenged asthma inhaler device patents listed on, and protected by, an important government database after the Federal Circuit agreed Wednesday to pump the brakes on the patents' delisting while the Israeli drugmaker appeals an order won by Amneal in an infringement lawsuit.
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July 11, 2024
Opiate MDL Judge Flags Evidence Preservation Shortfall
An Ohio federal judge has said "at least some" of the plaintiff local government entities in four chosen bellwether cases against pharmacy benefit managers for the multidistrict litigation over the opioid epidemic failed to preserve documents and evidence for trial, warning the parties he may replace those cases.
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July 11, 2024
GSK Asks Judge To Rule In Teva IP Case, Citing Opioid Deals
A GlaxoSmithKline lawyer has urged a Delaware federal judge to make up his mind about a nearly $400 million patent case against Teva Pharmaceuticals in light of unrelated "opioid-related cases" that the Israeli generic-drug maker has been settling in the billions of dollars.
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July 11, 2024
Talc Law Firms Beat J&J Subpoenas Seeking Funding Info
The Beasley Allen Law Firm, another plaintiffs law firm and a litigation funder defeated subpoenas from Johnson & Johnson in talc litigation, with a special master reasoning that the broad swath of discovery permitted in federal courts still has limits.
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July 11, 2024
Deals Rumor Mill: Saudi Aramco, Paramount Global, Carlyle
The Carlyle Group is considering acquiring Baxter International's kidney-care spinoff Vantive for about $4 billion, Aramco attracted more than $31 billion in orders for its $6 billion bond sale, and Paramount Global plans to cut more jobs before its merger with Skydance Media closes. Here, Law360 breaks down these and other notable deal rumors from the past week.
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July 11, 2024
Orrick Adds Wilson Sonsini, Hooper Lundy Healthcare Attys
Orrick Herrington & Sutcliffe LLP has hired seven new attorneys, including three partners who joined its life sciences and health tech platform in the firm's Washington, D.C., and Boston offices, the firm announced Thursday.
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July 11, 2024
Patent Cases To Watch In The Second Half Of 2024
A U.S. Supreme Court case over the reach of the judicially created double patenting doctrine and a dispute over which patents branded drugmakers can list in a federal database are among the cases attorneys will have their eyes on for the rest of the year.
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July 10, 2024
Roundup Cancer Case Revived By Oregon Appellate Panel
An Oregon appellate panel on Wednesday revived a lawsuit claiming Bayer AG subsidiary Monsanto's weedkiller Roundup caused an Oregon man's cancer, saying the judge who oversaw the trial that cleared the company wrongly excluded testimony from an expert for the plaintiff.
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July 10, 2024
Drug Pricing, Overreach Dominate IP Disclaimer Feedback
The U.S. Patent and Trademark Office has received heated feedback regarding its proposal to make follow-on patents easier to invalidate, with drug pricing advocates applauding it, top technology and pharma companies decrying it, and high-profile officials calling the proposal an overstep of the agency's authority.
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July 10, 2024
Medical Imaging Co. Looking To Vacate 'Tainted' Award
A New York federal court has unsealed medical imaging company Molecular Dynamics Ltd.'s still-pending 2022 petition seeking to vacate an allegedly fraudulent arbitral award favoring its former partner in a project to develop cameras in the field of nuclear medicine, revealing more information about the dispute.
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July 10, 2024
GOP Bombards Agencies With Demands After Chevron's End
Republican leaders of major congressional committees Wednesday demanded details from dozens of agencies on policies suddenly shrouded in uncertainty after U.S. Supreme Court conservatives overturned the so-called Chevron doctrine, which for 40 years gave regulators flexibility in rulemaking and advantages in related litigation.
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July 10, 2024
Meijer Says Takeda Can't Force Antitrust Suit Into Arbitration
Meijer argued before a Massachusetts federal court that Takeda waited far too long to try to force the supermarket chain to arbitrate its proposed class action accusing the Japanese pharmaceutical company of conspiring to delay a generic version of its anti-constipation drug Amitiza.
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July 10, 2024
Skin Care Tech Co. Says Suit Shows 'Rough' Year, Not Fraud
Skin care and beauty technology company Cutera Inc. asked a federal judge to toss a shareholder lawsuit that alleged the company exaggerated its financial sustainability and hid compliance issues, saying the company's "rough" year does not establish securities fraud.
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July 10, 2024
Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals
Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.
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July 10, 2024
RJ Reynolds Urges Toss Of Menthol Suit Against FDA
Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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July 10, 2024
Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman
A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.
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July 10, 2024
Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team
A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.
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July 10, 2024
Ex-CEO Convicted In COVID Test Kit Fraud Case
A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.
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July 09, 2024
Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested
A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.
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July 09, 2024
Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.
Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.
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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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.