U.S. Patent No. 8,329,172 (“the ’172 patent”), a Biogen-owned patent covering a treatment regime for low-grade B-cell non-Hodgkin’s lymphoma, has been a relatively frequent subject of our posts. We first wrote about it in March of 2017, reporting on the filing of Celltrion’s IPR petition against the patent, then again that May, reporting on Pfizer’s first attempt to have the PTAB invalidate the patent. Most recently, in November, we reported that the PTAB denied institution of Pfizer’s petition, joining denials of the Celltrion petition as well as an earlier effort by Boehringer Ingelheim. On July 9, 2018, the PTAB ordered institution of a second IPR petition filed by Pfizer, the first IPR to be instituted on the ’172 patent after multiple attempts.

In the article reporting on the denied Pfizer petition, we discussed how a challenge to the asserted prior art as actually being available as a printed publication led to the denial of institution of Pfizer’s petition. There, the Board found that a version of the label for Rituxan® relied upon in the ground of the petition was not adequately supported in the petition as having been made available to interested artisans. The issue came down to Pfizer not demonstrating that the actual document had ever been distributed, rather than whether the contents of the document had been made available.

In December 2017, Pfizer filed another IPR challenging the validity of the ’172 patent, IPR2018-00285. The petition in this IPR directly discussed the procedural failure of the previous petition, and Pfizer clearly attempted to avoid the same issue as thoroughly as possible. First, Pfizer substituted the challenged Rituxan® label for a journal article containing the same information and which was clearly published and accessible well before the critical date of the patent.  Next, Pfizer presented a second ground challenging the ’172 patent, where three different versions of the Rituxan® label were used with each argued to be an adequate printed publication. Finally, Pfizer essentially copied the substance of its prior IPR to avoid fairness issues with responding to the arguments made in the Patent Owner’s Preliminary Response in the previous IPR, and it argued that the new petition should not be rejected as a “follow-on” petition because the earlier IPR had never been addressed on the merits.

Biogen’s Preliminary Response addressed the merits of the petition, but also argued that institution should be denied under 35 U.S.C. § 325(d) because substantially the same prior art and arguments had been presented to the PTAB in the three prior petitions. Biogen also presented an argument that the petition should not be instituted under the seven factors presented in the precedential General Plastic PTAB decision.

On July 9, 2018, the PTAB entered its decision granting institution, finding that the petition had shown a reasonable likelihood of success for either of the grounds set forth in the petition. The same panel of administrative patent judges decided both this and the previous Pfizer petition, with the author of the previous dissent now writing the opinion and the previous majority opinion author now writing her own dissent.

The PTAB’s decision regarding § 325(d) noted that although the statute grants discretion to decline institution based on the presentation of the same or substantially the same art, the statute does not require the result and the Board’s discretion may take into account the facts of each case. The Board here found that the petition presented new arguments relative to the earlier Boeheringer and Celltrion petitions, and the previous Pfizer petition involved a split in the panel as to the public accessibility of the Rituxan® label that was not at issue in this IPR.

The panel also was not persuaded that the seven General Plastic factors required them to exercise their discretion to deny the petition, as the panel had not reached the issue of actually applying the asserted art to the claim and the use of the prior decision regarding the question of printed publication status was limited and not in a manner that would have the panel deny the petition.

The dissenting opinion focused primarily on the General Plastic factors and that Pfizer’s reliance on the previous opinion as a roadmap in drafting its petition should have warranted denial of institution under 35 U.S.C. § 314(a). Specifically, the dissent was critical of Pfizer’s characterization of its changes to its petition as being only a “procedural” issue, as the dissent states the question of whether asserted art is a printed publication requires substantive consideration and goes to the heart of the PTAB’s patentability analysis. The dissent spelled out its specific concerns as being that Pfizer 1) previously filed a petition directed to the same claim, 2) knew of the newly asserted references at the time of the original petition, 3) had access to the prior Preliminary Response and institution decision, and 4) did not provide adequate explanation for its previous failure to demonstrate that the Rituxan® label qualified as a printed publication, and for these reasons, denial of institution was warranted.

Although Pfizer obtained a positive result here with the first IPR instituted against the ’172 patent, the dissent continues to demonstrate the importance for petitioners of clearly demonstrating such threshold statutory requirements as showing all your art to be a patent or printed publication. The PTAB may not always be so kind as to grant “a second bite at the apple,” as this petition was characterized by the dissent.