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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.
Navigating Antitrust Issues in the Pharmaceutical and Life Science Industries: Key Trends and Challenges Explored
Price fixing, industry consolidation, and other anti-competitive business practices have long been the subject of intense antitrust scrutiny. To address these perceived flaws and abuses, President Biden issued an executive order on “Promoting Competition in the American Economy,” which calls for measures to ensure the strict enforcement of antitrust laws across several key industries, particularly in healthcare and life sciences.
Advancing Trial Skills: Critical Steps to an Effective Cross-Examination
One integral aspect to increase the chances of winning a trial is the use of cross-examination. While this approach takes extensive planning and preparation, a properly executed and effective cross-examination can be an opportunity to test the reliability and credibility of witness evidence, expose weaknesses, and likely produce a favorable testimony. Thus, practitioners must develop sound strategies and calculated trial preparations to avoid disjointed cross-examination.
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