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Life Sciences
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September 05, 2024
Pharma Co. Verrica Fails To Shed Investor Suit Over FDA OK
A Pennsylvania federal judge has partially denied Verrica Phamaceuticals Inc.'s second request to throw out a proposed class action filed by investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product.
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September 04, 2024
Albertsons Denied Texas Court Remand In Opioid MDL
An Ohio federal judge overseeing multidistrict litigation over accusations that drug distributors contributed to the opioid epidemic denied a motion to transfer to Texas a portion of the dispute involving pharmacy company Albertsons.
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September 04, 2024
Leech Tishman Combines With Calif. Firm Nelson Hardiman
Leech Tishman is set to add California-based healthcare and life science law firm Nelson Hardiman's 17 attorneys to its Los Angeles office this fall and will do business in the Golden State under the combined name Leech Tishman Nelson Hardiman, the firm announced Tuesday.
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September 04, 2024
Medical Cos. Must Provide Doctor Names In Fla. Qui Tam Suit
A Florida federal judge has ordered several medical companies accused of fraudulently obtaining more Medicare funding than they were owed to produce the names of doctors associated with the companies, saying the difference between employed and affiliate providers isn't relevant.
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September 04, 2024
Bid To Nix Expert Fails As Fed. Circ. OKs $2.3M Patent Verdict
The Federal Circuit on Wednesday upheld a $2.3 million patent verdict against dental imaging device maker Planmeca USA Inc., rejecting the company's argument that plaintiff Osseo Imaging LLC's technical expert was not qualified because his experience came after the invention.
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September 04, 2024
Ga. Justices Won't Disturb Distributors' Opioid Trial Win
The Georgia Supreme Court affirmed a ruling that family members of drug abusers are not entitled to a new trial after a Glynn County jury cleared opioid distributors of wrongdoing, in response to claims regarding an allegedly dishonest juror and flawed jury instructions.
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September 04, 2024
Groups Urge DC Circ. To Reject Pharma Terrorism Liability Claims
Business and nongovernmental organization advocacy groups have urged the D.C. Circuit to rule that terrorism victims can't hold pharmaceutical companies liable for their injuries, citing a U.S. Supreme Court decision rejecting similar liability claims against technology companies.
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September 04, 2024
Zoetis Sanctions Bid Denied In Racehorse Death Suit
A Pennsylvania federal judge denied Wednesday a motion by drugmaker Zoetis Inc. for sanctions against the owners of a 3-year-old racehorse who say it died after being treated with one of the company's antibiotics, saying there's no indication that delays in responding to discovery were in bad faith, and by now the company has received all the relevant documents in the plaintiffs' possession.
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September 04, 2024
Whittaker Seeks $535M Deal In Talc Cases Tied To Berkshire
Bankrupt talc supplier Whittaker Clark & Daniels Inc. asked a New Jersey bankruptcy court to approve a $535 million settlement that will resolve claims against companies including Berkshire Hathaway Inc., chemical distributor Brenntag and DB US Holding Corp.
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September 04, 2024
NC Biz Court Bulletin: Blackbeard IP Fight, Firm Data Breach
As summer winds down, the North Carolina Business Court tackled usage rights pertaining to footage and artifacts from Blackbeard's shipwreck while grappling with uncovering the details of a cyberattack that exposed the data of Cadwalader Wickersham & Taft LLP. In case you missed those and others, here are the highlights.
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September 04, 2024
Chamber Backs Gilead's Immunity In COVID Appeal
The U.S. Chamber of Commerce and a trade association representing drug companies have urged a Michigan state appeals court to rule that Gilead Sciences is immune from a claim that a recalled batch of COVID-19 medication caused a man to suffer two strokes.
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September 04, 2024
Glenmark Will Pay $25M To End Feds' Price-Fixing Suit
Glenmark Pharmaceuticals USA will pay $25 million to resolve allegations that it violated the False Claims Act by conspiring to fix the price of a generic high cholesterol drug, federal prosecutors announced Wednesday.
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September 04, 2024
McCarter & English Rips Challenge To Malpractice Win In NJ
McCarter & English LLP panned a pharmaceutical company's attempt to undo the firm's victory in a malpractice case last month, telling a New Jersey state court that issues the company raised in its motion to reconsider had "no impact" on the decision granting the firm a win.
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September 04, 2024
Trade Group Urges Court To Toss FDA Lab-Test Rule
A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power.
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September 04, 2024
Ga. Justices Affirm Rejection Of Class In Patient Privacy Suit
The Georgia Supreme Court said Wednesday that a Fulton County trial court acted within its discretion when it denied class certification for a suit over a release of patient records from a private mental health hospital, overturning a Georgia Court of Appeals ruling.
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September 04, 2024
J&J Hit With $1B Damages In Del. Merger Milestone Fight
Johnson & Johnson owes more than $1 billion to a medical robotics developer and entrepreneur caught up in a multibillion-dollar post-acquisition dispute, a Delaware vice chancellor ruled Wednesday.
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September 04, 2024
Arnold & Porter Adds Mintz Healthcare Enforcement Leader
After setting up shop in Boston a little less than a year ago, Arnold & Porter Kaye Scholer LLP announced Tuesday that it was welcoming the co-chair of Mintz Levin Cohn Ferris Glovsky and Popeo PC's healthcare enforcement defense group.
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September 03, 2024
Louisiana Frees Aurobindo, Sandoz From Price-Fixing Suits
The state of Louisiana has dropped its remaining claims in three Connecticut-based lawsuits by a collection of state attorneys general against more than three dozen pharmaceutical companies alleging a generic drug price-fixing scheme, truncating assertions that accuse myriad drugmakers of Sherman Act violations.
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September 03, 2024
Teva Investors Get Go-Ahead To Resume Kickbacks Class Suit
A shareholder's certified class action against pharmaceutical company Teva can resume after being paused for two years, as the company says it is working towards a settlement with the U.S. Department of Justice over related claims it used kickbacks to raise the price of its multiple sclerosis drug Copaxone, a Philadelphia federal judge has decided.
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September 03, 2024
Fed. Circ. Mulls PTAB Ruling's Effect On Liquidia Drug Launch
A Federal Circuit panel on Tuesday grappled with whether a Delaware judge was correct to hold that Liquidia Technologies could launch a hypertension drug after a United Therapeutics patent the company was found to infringe was held unpatentable by the Patent Trial and Appeal Board.
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September 03, 2024
Monsanto Keeps Trial Win In Missouri Roundup Cancer Suit
A Missouri appeals panel on Tuesday let Monsanto Co. keep a trial court win in a suit by a man alleging he contracted non-Hodgkin's Lymphoma through exposure to glyphosate in the company's Roundup weed killer, finding the trial court rightly excluded one of his experts from testifying.
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September 03, 2024
HQ Specialty Looks To Fix Patent Flaws After Delaware Trial
HQ Specialty Pharma Corp. said Tuesday that it will correct flaws in its patent for an injectable calcium supplement that led a federal jury in Delaware to find it partially invalid last week and then will seek a court order to stop generic-drug maker Fresenius Kabi USA LLC from selling its allegedly infringing product.
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September 03, 2024
Teva Patents Don't Belong In Orange Book, Fed. Circ. Told
Amneal Pharmaceuticals Inc. is urging the Federal Circuit to preserve a lower court decision ejecting inhaler device patents from an important government database, arguing that the delisting, won in an infringement lawsuit from Teva Pharmaceuticals USA Inc., properly separated out device patents from drug patents.
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September 03, 2024
Aesthetic Laser Co. Tells Jury Of Rival's 'Corporate Raid'
Medical aesthetic business Cynosure told a Boston federal jury Tuesday that two former employees and an industry rival launched a "calculated corporate raid" by poaching dozens of sales and marketing personnel, violating a host of noncompete and non-solicitation agreements while the departing workers pocketed trade secrets on their way out the door.
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September 03, 2024
3rd Circ.: Biotech Must Pay Royalties Despite Expired Patents
A cancer drug biotechnology company must pay royalties to a research firm despite the expiration of the applicable patents, a Third Circuit panel ruled in a precedential decision Tuesday, concluding that the biotech's royalty obligation is calculated differently than the one in a U.S. Supreme Court case it cited.
Expert Analysis
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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.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage
The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.
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3 Ways Agencies Will Keep Making Law After Chevron
The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.
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Roundup
After Chevron
In the month since the U.S. Supreme Court overturned the Chevron deference standard, this Expert Analysis series has featured attorneys discussing the potential impact across 26 different rulemaking and litigation areas.
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Series
After Chevron: Expect Few Changes In ITC Rulemaking
The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.