The Patent Trial and Appeal Board (PTAB) denied Pfizer, Inc.'s ("Petitioner") petition to institute an inter partes review (IPR) of the sole claim of Biogen Inc.'s ("Patent Owner") U.S. Patent 8,329,172 (the "'172 Patent"). That claim covers a method of treating B-cell lymphoma by using a certain chemotherapy followed by maintenance therapy with the drug Rituxan. The petition relied on three potential prior art references, including a document identified as IDEC Pharmaceuticals and Genentech, Inc.'s 1997 product label for Rituxan. Patent Owner argued that the record contained no evidence that the document identified as the product label was publicly available before the patent's priority date.
Petitioner relied on several supporting documents in an attempt to show that the Rituxan label was publicly accessible before the '172 Patent's August 11, 1998, priority date. Petitioner had recently obtained from the Food and Drug Administration's (FDA's) website a document purporting to be the original 1997 label, but the fact that the label is available today does not indicate whether it was available before August 11, 1998. Petitioner next relied on a printout of a January 23, 1998, version of a Genentech webpage related to Rituxan. However, that webpage did not show that the specific document relied on in the IPR petition was available in January 1998, or that the webpage itself was publicly accessible as of January 1998. Petitioner also relied on a November 1998 article that referred to an unspecified Rituxan package insert. However, that article was published after the priority date and did not identify a version of the package insert or in any way indicate that the exhibit relied on in the petition was, in fact, publicly accessible. The majority came to a similar conclusion with respect to the 1999 Physician's Desk Reference. The panel majority concluded that Petitioner had failed to show that the specific document on which it relied as a prior art reference was publicly accessible prior to the '172 Patent's priority date. Without that reference, Petitioner's obviousness arguments failed, and the PTAB declined to institute review.
Judge Snedden dissented. Although he agreed that the record, as it stood at the time of the decision on institution, did not convincingly establish that the Rituxan label was publicly available before the '172 Patent's priority date, the record also contained no evidence that the Rituxan label was not publicly accessible. Indeed, the record was devoid of any statement from Patent Owner indicating that the label was not publicly accessible as of August 11, 1998. Judge Snedden explained that the statute governing institution of an IPR requires the Petitioner to show only a "reasonable likelihood" that one or more claims are unpatentable. In his view, the record as a whole showed that, had trial been instituted and Petitioner entitled to discovery, there was a reasonable likelihood that Petitioner would have been able to meet its burden at trial.
Pfizer, Inc. v. Biogen, Inc., IPR2017-01166, Paper No. 9 (PTAB Nov. 13, 2017)
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