Follow-On Biologics Patent Litigation: Using Additional Patents and REMS to Protect Market Share

Held May 27, 2009

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.

This audio CD/Transcript is a must for anyone who wants to know what the biotech industry in the U.S. will look like once the FDA begins approving follow-on products, including:
  • Compliance officers
  • Medical affairs
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Business development officers
  • Executive management
  • Science officers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Chad Landmon is a partner with the law firm Axinn, Veltrop & Harkrider LLP. He practices primarily in the areas of patent and other intellectual property litigation, as well as counseling, antitrust and food and drug law. A significant portion of Chad’s practice is spent in the firm’s FDA and biomedical practice groups, in which he provides counseling and litigation services relating to patent, FDA and antitrust issues involving the development and marketing of new and generic drug products. The FDA matters involve numerous issues relating to the Hatch-Waxman Amendments, including marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling and other issues relating to the FDA approval process. 

Chad has petitioned the FDA and litigated disputes involving a variety of issues, including the generic exclusivity period and pediatric exclusivity. He frequently speaks and writes about issues relating to the Hatch-Waxman Amendments and pharmaceutical patent litigation. He also serves on the editorial advisory board of Generic Line, a publication of FDAnews.

Matt Becker is a partner with the law firm Axinn, Veltrop & Harkrider LLP. His practice focuses on intellectual property litigation, analysis and counseling. Matt’s intellectual property litigation practice predominantly includes patent infringement and trade secret litigation. His counseling practice focuses on advising clients about avoiding third-party intellectual property rights in conjunction with product development, conducting patent infringement and validity analyses, and providing strategic advice regarding patent portfolio development. Matt is a member of the firm’s intellectual property, biomedical and complex litigation practice groups.

Matt has served as lead counsel in significant patent infringement lawsuits, disputes concerning patent inventorship and patent ownership, claims of breach of license agreements, trade secret misappropriation, breach of contract and business torts. Many of these actions have involved the chemical or electrical arts. He has handled a significant number of Hatch-Waxman pharmaceutical patent infringement litigations and has litigated patent infringement cases involving electronic components of nuclear detection equipment, embedded computers, brushless DC fans and hard drive motors, specialty optical fibers, product packaging, tools and hardware, and various business methods. His role in these matters has included the development of trial strategy, Markman hearings, jury trials and all aspects of discovery.

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