Apotex Declines to Participate in IPR Appeal Filed by Amgen; USPTO May Intervene

As we previously reported, in IPR2016-01542, Apotex successfully challenged all 24 claims of Amgen’s U.S. Patent No. 8,952,138, directed to a protein refolding process. Apotex had filed its IPR petition in August 2016, while it was in the midst of BPCIA litigations in which Amgen was asserting the ’138 patent against Apotex in connection with Apotex’s proposed filgrastim and pegfilgrastim biosimilar candidates. In September 2016, however, the district court ruled that Apotex did not infringe the ’138 patent, a decision the Federal Circuit affirmed in November 2017. In February 2018, the PTAB issued a final written decision in the IPR, finding that all claims except claim 18 were unpatentable on obviousness grounds. In March 2018, Apotex requested rehearing with regard to claim 18. More than a year later, in May 2019, the PTAB issued a decision denying rehearing, but sua sponte finding claim 18 to be unpatentable for reasons it had previously overlooked.

Last month, Amgen appealed the PTAB’s IPR ruling to the Federal Circuit. On August 5, counsel for Apotex wrote to the Federal Circuit to inform the Court that Apotex did not intend to participate in the appeal. Today, in light of Apotex’s non-participation, the Federal Circuit amended the case caption to remove Apotex (now, In re: Amgen Inc., et al.) and ordered the Director of the USPTO to inform the Court within 30 days whether the USPTO intends to intervene in the appeal.

Meanwhile, Amgen’s follow-on BPCIA litigation against Apotex remains pending before the district court. The case is currently in discovery, and claim construction proceedings are ongoing. On August 8, Apotex requested an extension of time to submit opening claim construction briefing. This was the third such extension requested by Apotex. In this third request, Apotex provided the following basis for the further extension:

The Parties are currently working on a Stipulation and Unopposed Motion for Substitution of Parties to substitute a new party/entity in place of Apotex in this action. The Parties and their counsel have been diligently working on the transition of this action and related filings, and as a result of same, Apotex requests a brief further extension.

The court papers, however, do not indicate what new party/entity will be replacing Apotex in the litigation.