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 fate of method of treatment claim challenges in IPRs filed against patents that have been identified as reading on CDER-listed biologic drugs, versus IPRs filed against Orange Book listed patents.

Of note, as of March 31, 2018:

  • The institution rate of method of treatment claim challenges in the Orange Book context is slightly higher than in the Biologic drug context: 74% (Orange Book) to 62% (Biologic drug);
  • In final written decisions, method of treatment claims have been found unpatentable in 46% of IPRs concerning Orange Book listed patents;
  • The data set for Biologic drug challenges at the final written decision stage is currently limited (13 IPRs), but so far, method of treatment claims have been found unpatentable in 85% of these 13 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.

 

BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only.  Neither the information nor any opinion expressed on BiologicsHQ constitute legal advice, create an attorney-client relationship, or constitute a solicitation for business.

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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