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Life Sciences
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October 16, 2024
Apple Heart Rate Monitor Patent Survives PTAB
An administrative patent board has decided not to invalidate an Apple patent that the tech giant once asserted in its ongoing fight with a company in the smartwatch space.
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October 16, 2024
Direct Buyers Get Final OK For $44M Drug Price-Fixing Deal
A Pennsylvania federal court has granted final approval to $44.4 million in settlements between drugmakers Apotex, Breckenridge and Heritage and direct purchasers in a multidistrict litigation over alleged price-fixing in the generic-drug industry.
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October 16, 2024
Pharma Co. Contractor Settles SEC Insider Trading Claim
An information technology consultant for a Massachusetts biopharmaceutical company will pay the U.S. Securities and Exchange Commission over $28,000 to resolve claims he immediately dumped shares of his client when he got wind of its yet-to-be announced plans for major layoffs.
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October 16, 2024
Ex-Pharma Co. Employee Traded On GSK Deal Info, SEC Says
The former director of analytical development at Canada-based drug company Bellus Health Inc. has agreed to pay the U.S. Securities and Exchange Commission over $120,000 to settle claims that he sold shares on nonpublic information about pharma giant GSK's impending takeover of his company, according to court filings.
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October 16, 2024
SEC To Settle Claims CBD Exec Took $13M From Hospital
The U.S. Securities and Exchange Commission is ready to make a deal with a former cannabidiol products executive accused of taking $13 million from a hospital after falsely promising to deliver urgently needed masks during the height of the pandemic.
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October 16, 2024
Caremark, Optum Say FTC Insulin Case Gets PBMs All Wrong
Caremark Rx, Express Scripts and OptumRx continue to attack the Federal Trade Commission's in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes, arguing the agency's case lacks authority, facts and the right targets.
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October 16, 2024
Houston Pharma Exec Found Guilty In $160M Health Fraud
A Houston man was convicted on 15 criminal charges in connection with orchestrating a massive healthcare scheme that defrauded the government out of $160 million, following a 10-day trial in which prosecutors said doctors were "bamboozled" by the conspiracy.
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October 16, 2024
AAM, Alvogen Back Sun Pharma In Double Patenting Row
A trade group representing generic-drug makers, a generic-drug company and a plant-breeding technology business have all thrown their support behind Sun Pharmaceutical Industries' bid for the full Federal Circuit to take a closer look at the issue of double patenting.
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October 16, 2024
M&A Pros Cautious About Expected Private Equity Surge
It's an oft-repeated line that private equity activity is set to surge amid pressure to exit older investments and deploy record stores of dry powder, but mergers and acquisitions professionals recently surveyed by Dykema were cautious when asked if they expect private equity to boost deal flow in the next 12 months, with a majority saying they only "somewhat agree."
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October 15, 2024
Horizon Lodges 4-Fold Attack On Tepezza MDL Bellwethers
Horizon Therapeutics argued Tuesday that an Illinois federal judge should toss out nine of the dozen cases selected as bellwethers in multidistrict litigation targeting hearing loss issues with its biologic Tepezza, saying they're preempted because the label was approved with those problems in mind.
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October 15, 2024
Judge Backs Exelixis Cancer Drug Patent Claims
A Delaware federal judge on Tuesday rejected invalidity arguments against three Exelixis patents that MSN Laboratories Private Ltd. said it would be infringing with a proposed generic of blockbuster drug Cabometyx, while also finding that a fourth patent wasn't invalid nor was it infringed.
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October 15, 2024
Motley Rice May Avoid DQ In Boston Opioid Case, Judge Hints
A Massachusetts federal judge on Tuesday appeared skeptical of a bid by pharmacy benefit manager OptumRX to disqualify Motley Rice LLC from representing the city of Boston in a lawsuit over the company's alleged role in the opioid crisis.
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October 15, 2024
GSK Says Moderna's COVID, RSV Vax Infringe MRNA Patents
Moderna's breakthrough COVID-19 vaccine and a related respiratory syncytial virus, or RSV, vaccine were built on mRNA technology discovered by researchers whose patents are owned by GlaxoSmithKline, the latter company alleged in a pair of Delaware lawsuits.
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October 15, 2024
Justices Mull RICO's Scope In Trucker's CBD Case
U.S. Supreme Court justices on Tuesday appeared conflicted whether to sanction a commercial trucker's attempt to bring a racketeering claim against CBD companies, whose allegedly mislabeled products the trucker claims led to his firing.
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October 15, 2024
Walmart, Execs Settle Chancery Opioid Suit For $123M
Walmart and its directors and officers have agreed to a $123 million deal to end a stockholder class derivative lawsuit in Delaware's Court of Chancery that accused the nationwide retailer of multiyear opioid prescription oversight failures, potentially resolving class claims dating to early 2020.
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October 15, 2024
Novartis To Appeal Ruling In Entresto Generic Drug Fight
Swiss drugmaker Novartis said Tuesday that it plans to appeal a ruling from over the weekend that scuttled its suit over the U.S. Food and Drug Administration's approval of a generic version of Entresto, the drugmaker's blockbuster heart failure medication.
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October 15, 2024
Feds Cut Whistleblowers Out Of Kickback Deal, Court Told
Whistleblowers who accused a medical device company of a kickback scheme said Tuesday that the government left them out to dry when it settled False Claims Act claims with surgeons for $3.3 million and refused to share any of it with them.
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October 15, 2024
Skadden Picks Up Arbitration Co-Head From Sidley In Asia
The co-leader of Sidley Austin LLP's global arbitration, trade and advocacy group has been tapped to lead Skadden Arps Slate Meagher & Flom LLP's international litigation and arbitration group in Asia, the firm announced on Monday.
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October 15, 2024
Law Firms Diverge As Anti-ESG Pushback Continues
A continuing onslaught of legislation and litigation opposing corporate environmental, social and governance actions has created a fork in the road for law firms, with some choosing to scale back efforts and others pushing ahead with their internal ESG and diversity, equity and inclusion goals.
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October 15, 2024
The 2024 Law360 Pulse Social Impact Leaders
Check out our Social Impact Leaders ranking, analysis and interactive graphics to see which firms stand out for their engagement with social responsibility and commitment to pro bono service.
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October 15, 2024
Ill. Home Health Kickbacks Ruling Intact After Justices Pass
The nation's top court said Tuesday it won't review a Seventh Circuit decision largely affirming that a home health care company broke federal kickback laws, leaving intact its holding that the company must pay millions in damages.
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October 14, 2024
Baker McKenzie Leads Lundbeck's $2.6B Deal For US Pharma
Lundbeck said Monday that it has agreed to buy Longboard, a U.S. biopharmaceutical business, for $2.6 billion in cash as the Danish drug giant aims to capture a drug with "blockbuster potential" to treat a rare form of epilepsy.
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October 11, 2024
Pharmacist Gets Up To 15 Years In Mich. For Fatal Outbreak
A pharmacist charged for the deaths in a 2012 fatal fungal meningitis outbreak was sentenced Friday afternoon in Michigan state court to 7½ to 15 years in prison, concluding the state's case that had been pending for six years, the pharmacist's attorney has announced.
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October 11, 2024
High Court's TCPA Grant Set To Broaden Loper Bright's Blow
On the heels of the U.S. Supreme Court dealing a major blow to the power of federal agencies to interpret laws, the justices are poised to again boost judicial authority and potentially release a torrent of litigation challenging the established tome of regulations crafted under the Telephone Consumer Protection Act.
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October 11, 2024
Apotex Accused Of Infringing Novo Nordisk Diabetes Drug
The largest producer of generic drugs in Canada is infringing U.S. patents for Rybelsus, a medication for people with Type 2 diabetes that also is used for weight loss, drugmaker Novo Nordisk Inc. claimed in a federal lawsuit.
Expert Analysis
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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
Since the U.S. Supreme Court overturned the Chevron deference standard in June, this Expert Analysis series has featured attorneys discussing the potential impact across 36 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.
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6 PTAB Events To Know From The Last 6 Months
The first half of 2024 brought a flurry of Patent Trial and Appeal Board developments that should be considered in post-grant strategies, including proposed rules on discretionary denial and director review, and the first decisions of the Delegated Rehearing Panel, say attorneys at Fish & Richardson.
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Opinion
Atty Well-Being Efforts Ignore Root Causes Of The Problem
The legal industry is engaged in a critical conversation about lawyers' mental health, but current attorney well-being programs primarily focus on helping lawyers cope with the stress of excessive workloads, instead of examining whether this work culture is even fundamentally compatible with lawyer well-being, says Jonathan Baum at Avenir Guild.