The Federal Circuit for the first time addressed the legal standard for demonstrating standing in an appeal from a final agency decision, such as an inter partes review (IPR) decision. Phigenix, Inc. v. ImmunoGen, Inc., 2017 WL 74762 (Fed. Cir. Jan. 9, 2017). The court dismissed an appeal from an adverse IPR decision on the grounds that appellant Phigenix lacked standing because it failed to meet its burden to show injury in fact. The holding makes clear that non-practicing entities (NPEs)—and even companies like Phigenix falling somewhere in-between a fully operating company and an NPE—will be challenged to establish standing for appellate review.
The hottest recent decisions from the Federal Circuit have centered on post-grant proceedings at the Patent Trial and Appeal Board (PTAB). One such issue involves when the PTAB is immune from appellate review of decisions it makes when it institutes a post-grant proceeding, like an inter partes review petition (IPR). On January 4, the Federal Circuit voted to take the point en banc in Wi-Fi One, LLC v. Broadcom Corp., Docket Nos. 2015-1944, -1945, -1946, where the issue is whether the Federal Circuit can review the PTAB’s determination that the underlying IPRs were filed within the 1-year window of 35 US.C. 315(b).
On October 27, 2016, the Patent Trial and Appeal Board (PTAB) issued four final written decisions invalidating claims of U.S. Patent No. 6,045,501 (“the ’501 Patent”) and U.S. Patent No. 6,315,720 (“the ’720 Patent”) covering Celgene’s cancer drugs Pomalyst® and Revlimid®. Those patents covered methods for ensuring that teratogenic drug prescriptions are not filled for persons that are pregnant or at a high risk of becoming pregnant, and were challenged by Kyle Bass and Coalition for Affordable Drugs VI LLC (“CFAD”). The PTAB found that all claims in both patents were unpatentable on obviousness grounds. On November 25, 2016, Celgene filed petitions for rehearing of all four IPRs with the PTAB, focusing on two claims—claim 10 of the ’501 Patent and claim 10 of the ’720 Patent.
The Federal Circuit ruled in Unwired Planet, LLC v. Google Inc., Docket No. 2015-1812 (Fed. Cir. Nov. 21, 2016) finding that the PTAB used a broad interpretation of the types of patents that can be challenged in a covered business method (CBM) review.
On October 27, 2016, the PTAB issued four final written decisions invalidating claims of U.S. Patent No. 6,045,501 (“the ’501 Patent”) and U.S. Patent No. 6,315,720 (“the ’720 Patent”), covering Celgene’s Pomalyst® and Revlimid®. Those drugs are prescribed to treat multiple myeloma, which is a form of cancer that effects plasma cells typically found in bone marrow. In 2015, Celgene had sales of $5.8 billion for Revlimid®, and $983 million for Pomalyst. Both drugs are known to cause serious birth defects if taken while pregnant.