Biologic Patent Landscapes

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Biologic Patent Landscapes
About Biologic Patent Landscapes™

About Biologic Patent Landscapes™

Patent data is not readily available for biologics—the FDA Orange Book only lists the patents and regulatory exclusivities protecting small-molecule and peptide drugs.

Biologic Patent Landscapes was founded to address this critical knowledge gap.

Who we are

Biologic Patent Landscapes is an experienced team of biopharmaceutical patent attorneys in the Boston area who have developed algorithms to identify the U.S. patents that actually protect biologic drugs. They continuously verify and update this information and can provide it to you.

Our clients

  • biopharmaceutical companies
  • patent litigators
  • payers, wholesalers, distributors

No Orange Book for Biologics

Owners of FDA-approved pharmaceuticals must disclose all patents covering their drugs to the FDA, which then lists them in the “Orange Book.”  A generic drug launch may be timed to the expiration of all Orange Book-listed patents—or sooner, if the validity of pending patents is successfully challenged.

There is no Orange Book for biologics.  Rather, the Biologic Price Competition and Innovation Act of 2009 (BPCIA) provides for an optional exchange of patent information between the owner of the branded biologic and a biosimilar developer.

Why aren’t the owners of branded biologics required to disclose their patents to the FDA?  Unlike generic drugs, multiple patents typically cover biologics, including the biologic itself, formulations, encoding DNA, manufacture methods, therapeutic uses, and devices for administration.

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