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Life Sciences
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December 18, 2024
Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try
A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
J&J Unit Beats Schizophrenia Drug IP Challenge On Remand
Teva Pharmaceuticals USA Inc. has failed to invalidate claims in a patent for a Johnson & Johnson unit's blockbuster schizophrenia medicine, according to a New Jersey federal judge who rejected the generic-drug maker's assertions that the formula was obvious.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
RJ Reynolds Asks Justices To Toss Forum Shopping Argument
R.J. Reynolds Vapor Co. is urging the U.S. Supreme Court to reject the U.S. Food and Drug Administration's argument that the vape company engaged in forum shopping when it challenged denial of one of its applications in the Fifth Circuit, saying its Texas- and Mississippi-based co-petitioners make the Fifth Circuit the proper venue.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
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December 17, 2024
11th Circ. Urged To Block Abortion Clinic Buffer Zone Law
A Florida anti-abortion group urged the Eleventh Circuit on Tuesday to give it another shot at an injunction preventing the city of Clearwater from enforcing a buffer zone ordinance that blocks the group from getting within five feet of the driveway to the city's only abortion clinic.
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December 17, 2024
Laser Maker Loses Bid To Trim Patent Suit In Mass.
A Massachusetts federal judge has shot down laser maker NKT Photonics' bid to dodge allegations it infringed one of the patents asserted in a lawsuit from a company owned by a University of Michigan professor.
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December 17, 2024
Express Scripts, OptumRx Can't Ditch LA County Opioid Suit
A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.
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December 17, 2024
Sandoz Cuts $275M Deal For More Price-Fixing Claims
Swiss drugmaker Sandoz said Tuesday it has reached a $275 million settlement to end claims from consumers, insurers and others in the sprawling multidistrict litigation over alleged price-fixing in the generic-drug industry.
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December 17, 2024
Stanford Profs Say Roche's Trade Secret Claims Time-Barred
Stanford University's trustees and three of its professors have asked a California federal court to dismiss trade secret theft claims bought by subsidiaries of F. Hoffmann-La Roche AG, arguing that the allegations are time-barred because the companies were on notice of the purported misappropriation for over three years before filing suit.
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December 17, 2024
House GOP Asks CVS How Its PBM Treats Smaller Pharmacies
Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.
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December 17, 2024
The Biggest Georgia Legal Developments Of 2024
From navigating bombshell prosecutor romance allegations in the Georgia election interference case against President-elect Donald Trump and his co-defendants to vacating a $1.7 billion verdict against Ford Motor Co. in a fatal "Super Duty" rollover case, to seeing the state's longest-running criminal trial to a close, 2024 was a busy year for courts in the Peach State.
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December 17, 2024
Feds Intervene In $200M FCA Case Against CVS
The federal government has intervened in a whistleblower case accusing CVS and its subsidiaries of pocketing more than $200 million in overpayments, in order to defend the constitutionality of the False Claims Act's whistleblower provisions.
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December 17, 2024
Drug Co. Investor Sues In Del. Over $140M Insider Windfall
A pension fund investor in Cerevel Therapeutics Holdings Inc. has sued Bain Capital Investors LLC and other alleged insiders of the company in Delaware's Court of Chancery, accusing them of lining up a secondary offering in the biopharmaceutical venture before disclosure of its planned sale to AbbVie.
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December 16, 2024
Ginkgo Bioworks Investors Get Final OK Of $17.8M Settlement
Investors in biotech company Ginkgo Bioworks Holdings Inc. have gotten final approval for their $17.75 million deal to end proposed class action claims that the company and its leaders distorted Ginkgo's finances, mischaracterizing certain related party deals, to garner shareholder support for its merger with a special purpose acquisition company.
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December 16, 2024
Becton Dickinson To Pay SEC $175M Over Pump Claims
Becton Dickinson & Co. has agreed to pay $175 million to settle the U.S. Securities and Exchange Commission's allegations that the medical device manufacturer misled investors about the risks of selling its Alaris infusion pump and overstated its income, the agency announced Monday.
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December 16, 2024
11th Circ. Appears Wary Of Doc's New Trial Bid In $27.5M Case
The Eleventh Circuit on Monday questioned whether a Georgia doctor and his medical practice should get a new trial in a $27.5 million False Claims Act case on the basis that he and an expert who wasn't allowed to testify at trial believed the thousands of treatments he billed for were medically necessary and could be covered by Medicare, saying that contention seems to contradict the doctor's prior statements.
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December 16, 2024
The Biggest Patent Decisions Of 2024
This year's notable patent decisions from the Federal Circuit provided clearer guidelines on double patenting and opened the door for new ways to invalidate design patents. Here's a look at the cases from 2024 that will shape patent litigation going forward.
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December 16, 2024
Allele, Regeneron Settle COVID Treatment Patent Suit
Allele Biotechnology and Regeneron Pharmaceuticals have settled litigation accusing the latter of infringing a patent used in developing treatments and vaccines for COVID-19, a New York federal judge said Monday.
Expert Analysis
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A Look At The PTAB's Assessment Of Prior Art Exceptions
The Patent Trial and Appeal Board's approach over the last 10 years to assessing Section 102(b) prior art exceptions reveals a few trends, including that evidence of common ownership may have a higher likelihood of successfully disqualifying prior art under Section 102(b)(2)(C) at the institution stage, say Louis Panzica and David Holman at Sterne Kessler.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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How Patent Litigation Is Changing Amid Decline In Filings
Marked by a notable decline in case filings and preferred venue shifts, patent litigation has undergone significant changes over the last decade and litigation hot spots have shifted, encouraging a more strategic approach to patent disputes, says Saishruti Mutneja at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.
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Series
Collecting Art Makes Me A Better Lawyer
The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.
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Del. Dispatch: Cautionary Tales Of 2 Earnout Effort Breaches
The Delaware Court of Chancery's tendency to interpret earnout provisions precisely as written, highlighted in two September rulings that found buyers breached their shareholder obligations when they failed to make reasonable efforts to hit certain product development milestones, demonstrates the paramount importance of precisely wording these agreements, say attorneys at Fried Frank.
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Takeaways From Novo Nordisk's Fight For Market Exclusivity
Generic competitors’ challenge to Novo Nordisk’s patents in hopes of capturing a portion of the rapidly expanding Type 2 diabetes and obesity treatment market highlights the role of abbreviated new drug application litigation, inter partes review and multidistrict litigation in patent defense, says Pedram Sameni at Patexia.
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Using Primacy And Recency Effects In Opening Statements
By understanding and strategically employing the primacy and recency effects in opening statements, attorneys can significantly enhance their persuasive impact, ensuring that their narrative is both compelling and memorable from the outset, says Bill Kanasky at Courtroom Sciences.
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Secret Service Failures Offer Lessons For Private Sector GCs
The Secret Service’s problematic response to two assassination attempts against former President Donald Trump this summer provides a crash course for general counsel on how not to handle crisis communications, says Keith Nahigian at Nahigian Strategies.
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Opinion
Bill Is Key To Protecting US Economy From Patent Piracy
It is critical that Congress pass a recently introduced bill that would protect U.S. investors from intellectual property theft by restoring court-ordered injunctions as the default remedy in patent infringement cases to ensure inventors get the justice they deserve, says Andrei Iancu at Sullivan & Cromwell.
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.