Biotechnology companies now have a number of routes to challenge patents under the America Invents Act (AIA). The AIA was fully implemented in March 2013; however, new procedures for challenging and protecting patents and changes to existing procedures came into play beginning in September 2012. The first Inter Partes Review (IPR) hearing was held in August 2013 and has been widely discussed and evaluated. Timing has also become an important consideration in view of the Federal Circuit’s Fresenius v. Baxter International decision, for which en banc reconsideration has been requested. Decisions on which process to use and how to defend challenges can affect not only whether suitable patent protection can be maintained, but also limits or expands viable defenses in later challenges either in court or through the U.S. Patent & Trademark Office (USPTO). The potential impact of these changes will be discussed from various perspectives.



This activity has been approved for Minimum Continuing Legal Education credit by the State Bar of California in the amount of 1.0 hours, of which 1.0 hours applies to the general credit requirement, and by the State Bar of New York in the amount of 1.5 credit hours, of which 1.5 credit hours can be applied toward the areas of professional practice requirement.  Venable certifies this activity conforms to the standards for approved education activities prescribed by the rules and regulations of the State Bar of California and State Bar of New York, which govern minimum continuing legal education. Venable is a State Bar of California and State Bar of New York approved MCLE provider. This program is appropriate for both experienced and newly admitted attorneys.

Key Takeaways:

  • Investigate the mechanisms available for challenging patents before the USPTO, the Courts and the International Trade Commission
  • Analyze strategies and issues to consider when challenging or defending patent validity
  • Assess the risks and benefits associated with the various types of actions that can be used to challenge patent validity

Ability Level: All

Session ID: 2443

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