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CLE

Critical Issues in Hatch-Waxman Litigation

2023-12-18T22:17:23-05:00

The 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.

Restructuring Hospitals Post-Pandemic: What You Should Know About the Value of Bankruptcy

2023-09-28T23:20:03-04:00

The 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.

AI Inventions and Patents: Drafting Patents for Successful Licensing and Enforcement of AI Technology

2024-05-03T04:40:47-04:00

In 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

2024-09-16T18:05:54-04:00

Disputes 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.

A Look at the Crypto Ecosystem: The Rising Risks and Emerging Markets

2023-08-09T22:56:08-04:00

Cryptocurrency 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

2023-08-01T22:38:13-04:00

The 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

2023-06-20T23:26:03-04:00

Trade 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.

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