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Critical Issues in Hatch-Waxman Litigation
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.
Hart-Scott-Rodino (HSR) Filing Developments: Analyzing Recent FTC Trends
The Federal Trade Commission (FTC) recently released the annual adjustments to the transaction thresholds under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), which increased the minimum dollar threshold for premerger reporting.
Anti-dumping (AD) and Countervailing Duties (CVD): A 2020 Update
There has been an upsurge in antidumping (AD) and countervailing duties (CVD) petitions in recent years. Commerce Department and International Trade Commission practice has evolved with this increase in the caseload. Not only can these duties be very significant, but some of these new developments make it harder for foreign manufacturers and U.S. importers to assess potential AD and CVD risk.
COVID-19 and Antitrust Risks: How Businesses Should Respond
The Coronavirus Disease 2019 (COVID-19) pandemic has significantly distressed the global market today. Companies suffer from interrupted supply chains and income losses as a result of paralyzed business operations. Practitioners think that this consequential business disruption may lead companies to collaborate with competitors in the hopes of keeping them afloat amidst the troubled economy. However, this move can also potentially violate the competition law.
Trends and Developments on FCPA Enforcement: Hot Buttons to Consider
To deter the increasing number of bribery and corruption offenses among US entities, intensified Foreign Corrupt Practices Act (FCPA) enforcement actions continue to be a focus area this year. Specifically, the FCPA is requiring companies to retain their company’s record “in reasonable detail, [and to] accurately and fairly reflect the transactions and dispositions of [assets]” to conform with the FCPA’s books and records requirements. Failure to comply could lead to legal lawsuits and hefty fines.
Data Breach Litigation in the 2020 Landscape: Practical Tips and Strategies to Avoid the Pitfalls
With the fast-growing problem and increasingly sophisticated threats of cyber security and data breaches, litigation and other related cases continue to hound the landscape. These lawsuits have brought large numbers of damages to individuals and industries, such as consumers and financial institutions over the years.
Responding to and Dealing with SEC Investigations: A Comprehensive Guide
When a certain company is served with a subpoena from the Securities and Exchange Commission (SEC), it indicates that the Commission has obtained sufficient information to get a formal investigation order. It can be harrowing for any business entity to be served with such order as it may have a significant impact on the company’s resources and overall reputation.
Class Certifications: Trends, Developments and Effective Strategies
Class certification under the Federal Rule of Civil Procedure 23 has been a complex and challenging battle for plaintiffs and defendants alike. With the shifting legal interpretation and stringent analysis, the certification process has become increasingly difficult and costly.
Here Comes California Consumer Privacy Act (CCPA): How to Stay Compliant
Intended to enhance consumer privacy rights and data use transparency, the California Consumer Privacy Act (CCPA) of 2018 is regarded as the most comprehensive privacy law in the U.S. The Act, which went into effect on January 1, 2020, imposes stringent privacy requirements with significant impacts on many entities that do business with California residents.
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