Critical Issues in Hatch-Waxman Litigation
Marvin Monzon2023-12-18T22:17:23-05:00The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.
Antitrust Class Certification: Staying Ahead of the Curve Amid Evolving Standards
Joenel2023-08-08T22:50:51-04:00Restructuring Hospitals Post-Pandemic: What You Should Know About the Value of Bankruptcy
lazupardo2023-09-28T23:20:03-04:00The primary cause of the escalation of financial hardship among healthcare institutions can be attributed to the "COVID hangover" which resulted in a surge of labor and supply expenses due to nursing shortage and persisting supply chain complications. Consequently, numerous hospitals are contemplating bankruptcy as a plausible alternative for restructuring their operations.
The Growing Data Privacy Concerns Raised by the IoT: Smart Approaches to Manage Risks
Ahmed Zidan2023-09-25T22:10:55-04:00AI Inventions and Patents: Drafting Patents for Successful Licensing and Enforcement of AI Technology
Joenel2024-05-03T04:40:47-04:00In the ever-changing field of artificial intelligence (AI), innovation serves as the foundation for progress. The act of patenting AI inventions goes beyond a mere legal procedure; it is a strategic step that safeguards your intellectual property, opens doors to commercial success, and advances technology. However, the journey to patent AI technology is far from straightforward, with a landscape filled with nuances, complexities, and unique challenges.
Troubleshooting Guide to Construction Claims: How to Manage Changes and Delays
Ahmed Zidan2024-09-16T18:05:54-04:00Disputes and claims have continuously increased along with the evolving landscape of construction industry. As the sector navigates the complex post-pandemic era, a new set of conflicts is anticipated to take shape. Companies that are best prepared for potential changes and delays are likely to be in a favorable position to mitigate the risk of costly litigation.
ABCs of Hedge Fund and Private Equity Fund Formation
Joenel2023-05-10T04:13:26-04:00Establishing a private fund can be an overwhelming task. Aside from various legal considerations, several areas continue to present a mix of opportunities and challenges for successful fund formation, including digitization and inflation.
Recent Trends and Key Issues in FINRA Arbitration and Enforcement
Marvin Monzon2023-11-13T16:52:10-05:00A Look at the Crypto Ecosystem: The Rising Risks and Emerging Markets
Joenel2023-08-09T22:56:08-04:00Cryptocurrency markets experienced a series of disastrous setbacks in 2022 which resulted in significant losses This great turmoil underscores the volatility risks in the crypto landscape. Regulators are also ramping up its enforcement efforts to protect consumers and address increasing illicit activities. As an aggressive government crackdown is anticipated in the coming months, industry participants must keep an eye on emerging developments to avoid legal pitfalls.
2023 Securities Litigation and Enforcement Mid-Year Update
lazupardo2023-08-01T22:38:13-04:00The Securities and Exchange Commission (SEC) has actively pursued significant enforcement actions for FY 2023 H1 period, zeroing in on various violations within the securities industry. Notably, the SEC has taken measures against unregistered cryptocurrency exchanges and securities offerings while continuing to ramp up its enforcement efforts in the ESG space.
Trade Challenges and Opportunities Amid the Wide-Ranging Economic Sanctions
lazupardo2023-06-20T23:26:03-04:00Trade compliance is becoming more complex as the economic sanctions regime continuously evolves. Emerging changes are drastically affecting various aspects of international trade such as imports, exports, foreign investments, and oil prices. Recently, Canada has introduced new legislation to include definitions of ownership and control and introduced new rules for seizing and forfeiting assets of Russian nationals, thereby pushing the boundaries of international sanctions law.