Mixed Results as IPR Petitions for Biosimilars Soar
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017. But the results are mixed, with the Patent Trial and Appeal Board denying a high percentage of the petitions. Many of these patents are ultimately litigated in district court under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The challenged patents are referred to as BPCIA patents in this article as they are patents that would be litigated under the BPCIA.
IPR Petitions on the Rise
The Supreme Court's June 12, 2017 decision in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017), the first to interpret the BPCIA, has had no impact on the rise of IPR petitions for biosimilars. The Court held that the BPCIA's pre-suit patent dispute resolution procedures were not enforceable under federal law. Although some viewed obtaining patent certainty in IPR proceedings prior to the events triggering the BPCIA's procedures as a mechanism of potentially avoiding them, the ruling has not reduced the filing of petitions for IPR. Indeed, more than a third of the 85 petitions (29) for biosimilars were filed in the five months after the Supreme Court's decision.
Patents, Products and Players
The biosimilar makers bringing these challenges are also repeat players. Pfizer and its subsidiary Hospira filed a total of 24 petitions. Celltrion is second in line with a total of 17 petitions. Coherus and Sandoz are a close third and fourth with 12 and 10 petitions, respectively, followed by Boehringer Ingelheim (7) and Samsung (5).
Tackling the Same Patents
Timing of Challenges
Lessons So Far
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