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Life Sciences
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October 07, 2024
Merck Immune For 'Inflated' Vax Claims To FDA, 3rd Circ. Says
A divided Third Circuit panel inoculated Merck from claims that it tried to prevent competition by making inflated declarations to federal regulators about its mumps vaccine, with the majority ruling Monday that because Merck convinced federal regulators it had extended the vaccine's long-term potency, those assertions can't have been an anticompetitive "sham."
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October 07, 2024
Biotech, Medical Device Firms Prep Three IPOs Totaling $376M
Two venture-backed biotechnology startups and a medical device maker launched plans on Monday for three initial public offerings projected to raise about $376 million combined, adding to a busy schedule of IPOs this week.
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October 07, 2024
Mich. Supreme Court Snapshot: Insulin Prices, Disney Audit
The Michigan Supreme Court's first oral argument session of the 2024-25 term promises to be a busy one, involving an investigation into Eli Lilly's insulin prices with big implications for the scope of Michigan's consumer protection law and Disney's appeal of an order to turn over decades-old uncashed checks to the state treasurer.
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October 07, 2024
Mylan, Novo Nordisk Settle Ozempic Patent Dispute
Mylan Pharmaceuticals and Novo Nordisk have asked the Patent Trial and Appeal Board to terminate Mylan's request to review whether a patent covering Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic holds up, telling the board the two sides have resolved their dispute.
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October 07, 2024
5 Decisions To Know By Outgoing Mass. Chief Judge
Chief Massachusetts U.S. District Judge F. Dennis Saylor IV, who announced Monday that he will step back from full-time judicial service next summer, has presided over numerous significant cases in recent years, including a dispute over the U.S. Securities and Exchange Commission's disgorgement powers and a birth defects suit against GlaxoSmithKline.
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October 07, 2024
Trio Of 1st Circ. Criminal Cases Turned Away By Top Court
The U.S. Supreme Court on Monday declined to review three white collar cases on appeal from the First Circuit, including challenges to a cryptocurrency founder's conviction for investor theft and an Illinois attorney's fraud and money laundering conspiracy verdict.
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October 07, 2024
Justices Won't Hear Kickback Statute 'Willfulness' Case
The U.S. Supreme Court on Monday declined to consider whether a "willful" act under federal anti-kickback law requires a defendant to know their actions violate the law.
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October 07, 2024
High Court Rejects Pleas To Hear 7 Patent Cases
The U.S. Supreme Court on Monday turned down seven petitions seeking review of decisions in patent cases, including appeals dealing with double patenting, patent eligibility and Patent Trial and Appeal Board procedures.
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October 07, 2024
High Court Won't Look At Alabama Frozen Embryo Decision
The U.S. Supreme Court on Monday said it won't consider a challenge to a first-of-its-kind Alabama state court ruling that frozen embryos are legally children.
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October 07, 2024
Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement
The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%.
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October 04, 2024
Top 5 Supreme Court Cases To Watch This Fall
The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.
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October 04, 2024
NJ, Ethics Board Must Hand Over Docs In Retaliation Fight
A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.
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October 04, 2024
DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales
Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.
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October 04, 2024
Regeneron Can't Ax Willful Infringement In COVID Patent Case
Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.
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October 04, 2024
Healthcare Co. Inks Deal In DOL Equal Pay Investigation
A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.
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October 04, 2024
There May Not Be Life On Mars, But There Could Be IP
The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.
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October 04, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.
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October 04, 2024
High Court Takes Up E-Cig 'Forum Shopping' Appeal
The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.
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October 04, 2024
High Court Will Hear TCPA Case Over Online Junk Faxes
The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.
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October 03, 2024
Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion
Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.
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October 03, 2024
Boston Pharma Co. Drops Another Moderna Patent Suit
A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.
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October 03, 2024
Del. Vice Chancellor Slams Fee Terms In Advancement Case
A Delaware vice chancellor balked Thursday at "success fee" terms in a fee advancement case that she suggested made the clients a "human shield" in litigation over attorney expenses in connection with a New Jersey legal malpractice case.
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October 03, 2024
Trulieve Sues Fla. Republican Party Over Anti-Weed Ads
Trulieve, which is Florida's largest medical marijuana company and the principal backer of a ballot initiative to legalize cannabis in the Sunshine State, has sued the state's Republican Party and a pair of television stations for defamation, alleging that they ran misleading anti-weed ads.
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October 03, 2024
FibroGen Suit Alleging Disclosure Failures Tossed In Del.
Biopharmaceutical company FibroGen has beaten a stockholder derivative lawsuit in Delaware's Chancery Court that accused the business and its top officers of fiduciary breaches and insider trading related to its flagship anemia drug, which was once projected to bring in $3.5 billion for the drugmaker before regulators refused to approve its use in the U.S.
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October 03, 2024
12 Lawyers Who Are The Future Of The Supreme Court Bar
One attorney hasn't lost a single U.S. Supreme Court case she's argued, or even a single justice's vote. One attorney is perhaps "the preeminent SCOTUS advocate." And one may soon become U.S. solicitor general, despite acknowledging there are "judges out there who don't like me." All three are among a dozen lawyers in the vanguard of the Supreme Court bar's next generation, poised to follow in the footsteps of the bar's current icons.
Expert Analysis
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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Patent Lessons From 4 Federal Circuit Reversals In April
Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.