Biosimilar Patent Disputes: What Sandoz Appeal May Clarify

Law360, New York (September 5, 2014, 11:21 AM EDT) -- Despite the more than four years since enactment of the Biologics Price Competition and Innovation Act, very little has been decided as to how the act will be applied and implemented. The U.S. Food and Drug Administration continues to seek to develop its own examination guidelines and only recently did the FDA accept the first biosimilar applications.

Key uncharted territory of the Biologics Act is the framework it provides for adjudicating patent disputes between an innovator and an entity seeking approval of an alleged biosimilar. The act provides a specific and unique set of procedures for the exchange of patent information...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!