Newly released statistics (2015-06-30 PTAB Statistics) from the USPTO reveal that the number of bio/pharma IPR challenges almost doubled in 2015, even though fiscal year 2015 still has three months to go. Last year, there were only 66 bio/pharma IPR petitions filed. This fiscal year, so far 113 bio/pharma IPR petitions have been filed as of June 30th.
Petitioners are often challenging bio/pharma patents that have been involved in prior litigation, such as the recently filed Cabilly ‘415 patent IPR petition. Also, ANDA filers are increasingly turning to IPR to challenge bio/pharma patents, such as in Amneal v. Supernus. Parallel proceedings may increase the complexity of IPR due to the need for protective orders and motions to seal if confidential information from litigation proceedings is introduced into the IPR.
Although there has been a rapid increase in bio/pharma IPR petitions, there are still relatively few that have reached final decisions. Also, a number of them have settled before any final decision or even before institution. This makes it difficult to assess whether challengers are faring better in the PTAB than in the courts. Challengers may also be more willing to use IPR against bio/pharma patents when they have other defenses still available to use in litigation (such as non-infringement or section 112 invalidity) that will not be estopped by an unsuccessful IPR.
Let’s Talk Compliance | Provider Relief Fund: Reporting Requirements and Compliance Concerns