Statistics at a Glance

Statistics
at a Glance

 

 

Eighty-Five Percent of Drug Patent FWDs Concerned Patents That Have Also Been Litigated

 

As of July 20, 2017, 85% of 116 drug patent final written decisions (“FWDs”) concerned drug patents that have also been challenged in Federal district court litigation. What is interesting, although perhaps not surprising, is that the overwhelming number of the FWDs on litigated drug patents concerned Orange Book listed patents. Of the 103 FWDs on Orange Book patents, 94% concerned patents that have been challenged in litigation. The numbers for CDER-listed biologic drug patents (“Biologic Drug Patents”) are much lower: there were only 13 FWDs on Biologic Drug Patents, only 15% of which concerned patents that have also been challenged in litigation. These lower numbers for Biologic Drug Patents may not be surprising for a number of reasons: (1) far fewer Biologic Drug Patents have been challenged to date, both in litigation and in IPR; (2) there are far fewer FDA-approved biosimilar drugs than there are generic versions of Orange Book listed reference drugs; and (3) the Biologics Price Competition and Innovation Act of 2009 (BPCIA) “patent dance” (42 U.S.C. § 262(l)) provides a convenient procedure, in advance of market launch, to litigate a narrow subset of biologic drug patents, perhaps reducing the value of pre-emptive IPR challenges.

 

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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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