By Kunyong Yang and Cary Miller, Ph.D.

On January 19, 2017, the PTAB instituted inter partes review of U.S. Patent No. 8,822,438 (“the ’438 patent”) filed by Wockhardt Bio AG (“Wockhardt”) (IPR2016-01582).  The ’438 patent is owned by Janssen Oncology, Inc. (“Janssen”) and is the subject of several ongoing inter partes reviews, one of which was filed by Amerigen Pharm., Inc. (“Amerigen”) which was instituted on May 31, 2016 (IPR2016-00286).  The ’438 patent is also being asserted in several district court proceedings against Amerigen, Wockhardt and other defendants.

The ’438 patent describes methods for treating hormone sensitive cancers with CYP17 inhibitors such as abiraterone acetate in combination with steroids such as prednisone or dexamethasone.  Claim 1 recites:

1. A method for the treatment of a prostate cancer in a human comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone.

Wockhardt challenged claims 1–20 of the ’438 patent as obvious over several references.  Janssen did not specifically address the obviousness arguments in its responses.  As such, the PTAB was persuaded by Wockhardt’s obviousness arguments and instituted the IPR.

Rather than addressing Wockhardt’s obviousness arguments, Janssen mainly argued that: (A) the IPR petition should be denied because Wockhardt failed to identify Amerigen as a real party-in-interest; and (B) the IPR should be denied under 35 U.S.C. § 325(d) since it presented the same prior art and substantially the same arguments as the previously instituted Amerigen IPR.  The PTAB rejected Janssen’s arguments on both grounds.

Regarding the real party-in-interest issue, Janssen argued that Wockhardt and Amerigen are more than just codefendants in a patent lawsuit related to the ’438 patent.  Although the content and discussion of the evidence provided by Janssen are redacted from the decision, the PTAB, in rejecting Janssen’s argument at this time, emphasized that “[a]lthough we may consider the relationship between the parties, the focus of our real party-in-interest inquiry is the relationship between a party and a proceeding.”

Regarding the § 325(d) issue, while acknowledging that the instant IPR and the Amerigen IPR assert similar challenges to patentability based on some of the same prior art, the PTAB pointed out that Wockhardt’s IPR petition includes new references, it uses different expert declarants, and noted the parties may make different arguments about secondary considerations of non-obviousness.  In the end, the PTAB refused to exercise its discretion under 35 U.S.C. § 325(d) to decline the instant IPR stating that Wockhardt is not attempting to get “a second bite at the apple by an identical petitioner” and it is not seeking to cure any problems in the Amerigen IPR since the Amgerigen IPR was granted.  While it instituted the IPR, the PTAB has implemented a condensed schedule in order to decide the instant IPR around the same time as the Amerigen IPR.

The decision emphasizes the importance the PTAB places on establishing a relationship between a party and an IPR proceeding when determining whether the party is a real party-in-interest.  The decision also illustrates that the PTAB has broad discretion as to whether to decline an IPR petition under 35 U.S.C. § 325(d) as duplicative.

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Dr. Cary Miller’s practice focuses on assisting life sciences clients with their patent issues. She works with clients in patent prosecution, prelitigation analysis, PTAB proceedings, and patent litigation. Prior to joining Jones Day, Cary participated in numerous biotechnology and pharmaceutical patent lawsuits including representing companies in Hatch-Waxman litigation, biosimilars litigation, and in litigation relating to DNA sequencing.