The marcus evans 5th Product and Pipeline Enhancement for Generics Conference hosted industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally. These leaders shared best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues. Knobbe Martens’ attorneys Steve Maddox and Bill Zimmerman presented on the following topic:
- Analyzing Recent Updates to the Hatch-Waxman Act to Grasp Future Impacts and Challenges
- Studying recent changes that could impact the industry, including 180-day exclusivity and complications regarding patent listings
- Drawing lessons from the close relationship between the patenting of generic products and FDA regulatory approval to pinpoint areas of improvement
- Considering the impact biosimilar products could have on market entry and patent strategies
- Reviewing both real-life rulings and hypotheticals regarding Hatch-Waxman litigation to identify future strategies
