Follow-On Biologics Patent Litigation: Using Additional Patents and REMS to Protect Market Share
Product Details
Whether Congress passes the Waxman-sponsored follow-on biologics (FOBs) bill or the biotech-friendly Eshoo version doesn't really matter ... brand companies need to prepare for competition now!
The bills are already written and waiting. The only thing left is some back-room wrangling on the exclusivity period. The president is on record saying he wants FOBs. It’s going to happen.
Regardless of the final language, as a brand manufacturer of biologics you need to be preparing for patent challenges to your products today. It is expected approximately 50% of all drugs approved in 2010 will be biopharmaceuticals.
Learn from the industry’s top life sciences intellectual property specialists how patent challenges to biologics will be very different from drugs and get practical strategies for building the strongest possible patent portfolios.
For example:
- While a drug is usually covered by an average of four patents, biologics can have many, many more — covering everything from the R&D to the manufacturing and method of use — complicating the legal strategy for generic competitors.
- How you structure your risk evaluation and mitigation strategy (REMS) could be used to keep a generic competitor off the market.
In this 90-minute audio CD/Transcript, legal experts Chad Landmon and Matt Becker will tell attendees how to use legal and regulatory tools to their advantage and why they need to start now. They’ll also provide a comparison of the competing legislative measures and demonstrate the major differences between them.
Order now for your entire team to listen in and discover:
- The 5 major differences between patent challenges to drugs and those for biologics
- 7 methods companies can build into their patent portfolios to maximize protection (Hint: the more patents, the better)
- Risk assessment techniques that prepare you for possible litigation challenges
- How to use REMS and citizen petitions to fight follow-on biologics
- A comparison of the leading legislative proposals and what provisions they have for notification, patent identification, filing of infringement action and stay-of-approvals
Don’t wait for Congress to act before protecting your product.