Statistics at a Glance

Statistics
at a Glance

 

At the May 2018 Managing IP PTAB Forum in New York, Corinne Atton presented statistics relating to the claim types that have been challenged in IPRs on patents that have been identified as reading on CDER-listed biologic drugs, and IPRs concerning Orange Book listed patents.

Of note, as of March 31, 2018:

  • Compound claims have been challenged in only 8% of Orange Book IPRs;
  • The most commonly challenged claim types in Orange Book IPRs are formulation claims (challenged in 42% of petitions), and method of treatment claims (challenged in 41% of petitions);
  • By contrast, formulation claims have only been challenged in 17% of Biologic drug IPRs;
  • And method of treatment claims have been challenged in 57% of Biologic drug IPRs.

 

Biologic Drug IPR Petitions include IPR petitions relating to CDER-listed biologic products and drugs for which follow-on products are approved under the 505(b)(2) pathway, such as insulin.  IPR petitions relating to manufacturing patents that may be relevant to multiple products (for example, U.S. Patent No. 6,331,415 (a “Cabilly” patent)) are not included.

Orange Book Drug IPR Petitions include IPR petitions relating to patents that have been listed in the FDA’s Orange Book. 

 

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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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