PTAB Denies Petition to Institute IPR Because Petitioner Failed to Make Threshold Showing That a Reference Was Publicly Accessible Prior to Patent’s Priority Daterence Was Publicly Accessible Prior to Patent’s Priority Date

Nov 15, 2017

Reading Time : 2 min

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)

Share This Insight

Previous Entries

IP Newsflash

December 18, 2025

The Federal Circuit recently vacated a $20 million jury verdict in favor of a patentee and remanded with instructions to dismiss the case for lack of subject matter jurisdiction, finding that the patentee did not own the asserted patents at the time it filed suit and therefore lacked standing.

...

Read More

IP Newsflash

December 17, 2025

The Federal Circuit recently affirmed a Patent Trial and Appeal Board decision finding claims that had been subject to an ex parte reexamination unpatentable. As a threshold issue, the court held that IPR estoppel under 35 USC § 315(e)(1) does not apply to ongoing ex parte reexaminations. Accordingly, the Patent Office did not err in continuing the reexamination after issuing final written decisions in co-pending IPRs.

...

Read More

IP Newsflash

December 15, 2025

The District of Delaware recently denied a defendant’s motion to dismiss plaintiff’s demand for enhanced damages based on willful infringement pursuant to 35 U.S.C. § 284, explaining that neither a demand for damages under § 284 nor an accusation of willful infringement amount to a claim for relief that can be subject to dismissal under Rule 12(b)(6).

...

Read More

IP Newsflash

December 9, 2025

The Federal Circuit recently denied a petition for a writ of mandamus that challenged the PTO Director’s reliance on “settled expectations” to discretionarily deny two inter partes review (IPR) petitions. In so doing, the court explained that, while it was not deciding whether the Director’s use of “settled expectations” was correct, the petitioner’s arguments about what factors the Director may consider when deciding whether to institute an IPR or post-grant review (PGR) are not generally reviewable and did not provide sufficient basis for mandamus review here.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.